ICU MEDICAL INC/DE
For the period ended Jun 30, 2025. Filed Aug 7, 2025.
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Jun 30, 2025 · Filed Aug 7, 2025
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Notes to Condensed Consolidated Financial Statements
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
Note 1: Basis of Presentation
The accompanying unaudited interim condensed consolidated financial statements of ICU Medical, Inc., ("ICU" or the "Company"), a Delaware corporation, have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S.") and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and reflect all adjustments, consisting of only normal recurring adjustments, which are, in the opinion of management, necessary for a fair statement of the consolidated results for the interim periods presented. Results for the interim period are not necessarily indicative of results for the full year. Certain information and footnote disclosures normally included in annual consolidated financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. The condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Annual Report on Form 10-K of ICU for the year ended December 31, 2024.
We develop, manufacture and sell innovative medical products used in infusion therapy, vascular access, and vital care applications. ICU's product portfolio includes ambulatory, syringe, and large volume IV pumps and safety software; dedicated and non-dedicated IV sets, needlefree IV connectors, peripheral IV catheters, closed system transfer devices, pharmacy compounding systems, and sterile IV solutions, as well as a range of respiratory, anesthesia, patient monitoring, and temperature management products. We sell the majority of our products globally through our direct sales force and through independent distributors throughout the U.S. and internationally. We also sell certain products on an original equipment manufacturer basis to other medical device manufacturers. All subsidiaries are wholly owned and are included in the condensed consolidated financial statements. All intercompany balances and transactions have been eliminated.
Certain reclassifications have been made to the prior year financial statements and footnotes to conform to the presentation used in the current year. On the condensed consolidated balance sheet, we combined prepaid income taxes with the "prepaid expenses and other current assets" line item. On the condensed consolidated statement of cash flows, we combined provision for doubtful accounts, provision for warranty, returns and field action, and usage of spare parts with the "other" line item. In Note 12: Prepaid Expenses and Other Current Assets we combined deferred costs, deferred tax charge and foreign exchange contracts with the "other" line item. In Note 16: Accrued Liabilities we combined operating lease liability, restructuring accrual, accrued sales taxes and other taxes, accrued freight, accrued audit and professional services, distribution fees, warranties and returns, legal accrual, defined benefit plan, foreign exchange forward contracts with the "other" line item. These reclassifications had no impact on the reported results of operations.
Note 2: New Accounting Pronouncements
Recently Issued Accounting Standards Not Yet Adopted
In October 2023, the FASB issued ASU 2023-06, Disclosure Improvements - Codification Amendments in Response to the SEC's Disclosure Update and Simplification Initiative. The amendments in this update modify the disclosure or presentation requirements of a variety of Topics in the Accounting Standards Codification ("ASC") in response to the SEC’s Release No. 33-10532, Disclosure Update and Simplification Initiative, and align the ASC’s requirements with the SEC’s regulations. For entities within the scope, the guidance will be applied prospectively with the effective date for each amendment to be the date on which the SEC's removal of that related disclosure from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. If the SEC has not removed the related disclosure from its regulations by June 30, 2027, the amendments will be removed from the Codification and will not become effective. We are currently assessing what impact this guidance will have on the Company's consolidated financial statements and related disclosures.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740) - Improvements to Income Tax Disclosures. The amendments in this update expand disclosures in an entity’s income tax rate reconciliation table and regarding cash taxes paid information. The update will be effective for annual periods beginning after December 15, 2024 and is applicable to our Annual Report on Form 10-K for the fiscal year December 31, 2025, with early application permitted. We are currently assessing the effect of this update on the Company's consolidated financial statements and related disclosures.
In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses. The guidance requires disclosure of disaggregated income statement expense information about specific categories (including purchases of inventory, employee compensation, depreciation, and intangible asset amortization) in the notes to financial statements. In January 2025, FASB released ASU 2025-01 to clarify the guidance will be effective for annual periods beginning after December 15, 2026. This update will be applicable to our Annual Report on Form 10-K for the fiscal year December 31, 2027, with early application permitted. We are currently assessing the effect of this update on our consolidated financial statements and related disclosures.
Note 3: Restructuring, Strategic Transaction and Integration
Restructuring, strategic transaction and integration expenses were $16.2 million and $32.9 million for the three and six months ended June 30, 2025, respectively, as compared to $17.1 million and $33.2 million for the three and six months ended June 30, 2024, respectively.
Restructuring
During the three and six months ended June 30, 2025 restructuring charges were $8.2 million and $15.0 million, respectively, as compared to $7.7 million and $13.0 million for the three and six months ended June 30, 2024, respectively, and were primarily related to facility closure costs and severance costs.
The following table summarizes the activity in our restructuring-related accrual by major type of cost for the three and six months ended June 30, 2025 (in thousands), which is included in accrued liabilities and other long-term liabilities on the condensed consolidated balance sheets:
| Severance Pay and Benefits | Retention and Facility Closure Costs | Total | |
|---|---|---|---|
| Accrued balance, January 1, 2025 | $9,538 | $407 | $9,945 |
| Charges incurred | 2,401 | 4,397 | 6,798 |
| Payments | (3,482) | (2,905) | (6,387) |
| Other(1) | (900) | — | (900) |
| Currency translation | 155 | 14 | 169 |
| Accrued balance, March 31, 2025 | $7,712 | $1,913 | $9,625 |
| Charges incurred | 4,289 | 3,934 | 8,223 |
| Payments | (3,930) | (2,538) | (6,468) |
| Currency translation | 287 | 95 | 382 |
| Accrued balance, June 30, 2025 | $8,358 | $3,404 | $11,762 |
(1) Relates to prior year accrued restructuring charges for estimated severances costs that were reclassed to other accounts during the three months ended March 31, 2025.
Strategic Transaction and Integration Expenses
We incurred and expensed $8.0 million and $17.9 million in strategic transaction and integration expenses during the three and six months ended June 30, 2025, respectively, as compared to $9.4 million and $20.2 million in strategic transaction and integration expenses during the three and six months ended June 30, 2024, respectively, which are included in restructuring, strategic transaction and integration expenses in our condensed consolidated statements of operations. The strategic transaction and integration expenses during the three and six months ended June 30, 2025 and 2024 were primarily related to ongoing consulting expenses and employee costs incurred to integrate our Smiths Medical business acquired in 2022. The three and six months ended June 30, 2025 also included transaction costs related to the sale of a 60% ownership in our IV Solutions business in the second quarter of 2025.
Note 4: Assets Held For Sale and Disposal of Business
Assets Held For Sale
On November 12, 2024, we entered into a purchase agreement (the "Agreement") with Otsuka Pharmaceutical Factory America, Inc., a Delaware corporation ("OPF") to divest a controlling interest in our IV Solutions business. As of December 31, 2024, we concluded the initial criteria for classification as held for sale were met, and accordingly we presented the IV Solution's net assets as held for sale in our condensed consolidated balance sheet.
The following table summarizes the carrying values of the assets and liabilities presented as held for sale in our condensed consolidated balance sheet as of December 31, 2024 (in thousands):
| As of | |
|---|---|
| Assets: | December 31, 2024 |
| Accounts receivable, net of allowance of $465 at December 31, 2024 | $13,331 |
| Inventories | 88,656 |
| Prepaid expenses and other current assets | 4,140 |
| Property, plant and equipment, net | 155,426 |
| Other assets | 22,829 |
| Total assets held for sale | $284,382 |
| Liabilities: | |
| Accounts payable | $13,533 |
| Accrued liabilities | 19,378 |
| Total liabilities held for sale | $32,911 |
| Net assets held for sale | $251,471 |
Disposal of IV Solutions Business
On May 1, 2025, we sold to OPF a 60% ownership interest in Otsuka ICU Medical LLC (the "joint venture"), an entity we formed in 2025 and to which we contributed the net assets of our IV Solutions business. Upon the sale and as a result of a loss of control, we derecognized the net assets that comprised our IV Solutions business and recorded our retained 40% ownership interest at its estimated fair value as an equity method investment in the joint venture (see Note 11: Investment Securities). We have the ability to exercise significant influence over operating and financial policies of the joint venture, primarily through having two of the five seats on its Board of Directors.
Preliminary cash proceeds from the sale, subject to conventional purchase price adjustments, were $209.5 million. We also are entitled to contingent consideration if the joint venture exceeds planned revenues or gross margin for the year ended December 31, 2026. Additionally, we have agreed to provide commercial, logistics, administrative, and other services, including continuing to provide certain manufacturing services for component parts for a period of up to five years from transaction close (see below table). Certain logistic and warehouse costs incurred on behalf of and reimbursed by the joint venture are pass-through expenses and net to zero within cost of goods sold in the condensed consolidated statement of operations. Other services are provided in exchange for fixed fee arrangements or reimbursement of our costs, depending on the respective terms of service negotiated. Fees charged for the services are recorded as reductions to the costs incurred to provide such services in the condensed consolidated statement of operations. Those services provided under fixed price arrangements were determined to be at less than fair value and, as such, we recognized an unfavorable contract liability of $20.2 million to account for the difference between the fair value of services to be provided and the estimated cost of providing such services over the five years from transaction close. The unfavorable contract liability is presented within other liabilities in our condensed consolidated balance sheet, with the current portion included in accrued liabilities. This liability is being released to our condensed consolidated statement of operations as reduction to the costs incurred to provide the respective services within selling, general and administrative expenses.
For the three and six months ended June 30, 2025, we recognized $2.6 million in fixed and variable service fees related to reimbursed expenses under the various transition service agreements and $0.7 million related to the release of the unfavorable contract liability. The fees, reimbursements and release of unfavorable contract liability serve to reduce the same line items as their respective incurred expenses within cost of goods sold or selling, general, and administrative expenses in our condensed consolidated statement of operations.
Fair value for our retained 40% ownership interest was determined using a market approach based on the proceeds received from OPF for its 60% controlling ownership interest. Fair value for services was estimated using a market approach based on observable margins for comparable services and the difference between the fair value of services and the estimated cost to provide the services through the term of the services agreement was discounted using our effective borrowing rate.
The combined effect of the transaction was a gain of $41.8 million, comprising the sum of a $45.6 million gain from the disposal of a 60% ownership interest in the joint venture, a $16.4 million gain from the difference between the fair value of our retained 40% ownership interest in the joint venture and our carrying value of that same proportionate ownership interest, and a $20.2 million unfavorable contract liability recorded upon disposition. The gain is presented as a separate line item in our condensed consolidated statement of operations. No gain related to contingent consideration was recorded. We will record such gain, if any, if and when the measurement period has ended and we have concluded that a payment will be received.
As part of the transaction, we provided OPF a call option to acquire our retained 40% ownership in the joint venture. Additionally, OPF provided us with a put option giving us the right to compel OPF to purchase our retained 40% ownership interest in the joint venture. The call and put options are exercisable at certain specified dates and for specified amounts based on certain historical financial metrics as set forth in the joint venture's Operating Agreement beginning five years after the closing. The call and put options were not recorded in our condensed consolidated financial statements since they do not meet the definition of a derivative specifically due to the absence of a net settlement feature.
Related Party Transactions
We account for our retained 40% interest in the joint venture as an equity method investment (see Note 11: Investment Securities), having the ability to exercise significant influence over operating and financial policies of the joint venture, primarily through having two of the five seats on its Board of Directors. Additionally, in connection with the closing of the transaction on May 1, 2025, we entered into certain agreements with OPF, which cover the governance of the joint venture and require us to provide certain commercial, logistics, manufacturing supply, administrative, and other services for a period of up to five years from transaction close.
The following table presents condensed consolidated financial statement data resulting from transactions with the joint venture (in thousands):
| Three months ended June 30, | Six months ended June 30, | |
|---|---|---|
| 2025 | 2025 | |
| Condensed consolidated statement of operations: | ||
| Manufacturing services agreement revenue | $3,513 | $3,513 |
| Manufacturing services agreement cost of goods sold | $(3,101) | $(3,101) |
| Service fees - Otsuka ICU Medical LLC (cost of goods sold) | $117 | $117 |
| Service fees - Otsuka ICU Medical LLC (selling, general & administrative) | $2,074 | $2,074 |
| Equity in earnings of unconsolidated affiliates | $2,837 | $2,837 |
The joint venture is a pass-through entity for income tax purposes and, as such, does not record income tax at the entity level. We record our equity in earnings of unconsolidated affiliates before any related income tax recognized as a separate line item in our condensed consolidated statements of operations. Income taxes on our share of the joint venture's earnings are included within provision for income taxes in our consolidated statements of operations.
As of June 30, 2025, a $10.4 million related-party payable to the joint venture was included within accrued liabilities in our condensed consolidated balance sheet.
Note 5: Revenue
Revenue Recognition
Our business units are Consumables, Infusion Systems and Vital Care. The vast majority of our sales of these products within these business units are made on a stand-alone basis to hospitals and distributors. Revenue is typically recognized upon transfer of control of the products, which we deem to be at point of shipment. For purposes of revenue recognition for our software licenses and renewals, we consider the control of these products to be transferred to a customer at a certain point in time; therefore, we recognize revenue at the start of the applicable license term.
Payment is typically due in full within 30 days of delivery or the start of the contract term. Revenue is recorded in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. We include variable consideration in net sales only to the extent that a significant reversal in revenue is not probable when the uncertainty is resolved. Our variable consideration includes distributor chargebacks, product returns and end customer rebates with distributor chargebacks representing the majority and subject to the greatest judgment.
Chargebacks are the difference between the prices we charge our distribution customers at the time they purchase our products and the contracted prices we have with the end customer, most often in the U.S. and Canada. When a distributor sells our products to one of our contracted end customers, the distributor typically will claim a refund from us for the chargeback amount which we process as a credit to the distributor.
In estimating the transaction price to present as net revenue for sales to distributors, we must estimate the expected chargeback amount that we will refund to the distributor after they sell our product to a contracted end customer. Determining the appropriate chargeback reserve requires judgment around the following assumptions:
(i) The estimated chargeback amount (the difference between the price we invoice the distributor and the contractually agreed price with specified end customers); and
(ii) The estimated period of time between the sale to the distributor and the receipt of a chargeback claim.
For purposes of estimating the expected chargeback amount, we utilize actual recent historical chargebacks paid to the specific distributor for similar products as determined at either a product or product-family level. While individual chargeback rates can vary significantly depending on the product and contracted prices with distributors and end customers, our chargeback reserve estimate is not overly sensitive to those individual price changes due to the long-term nature of our distributor and end customer contracts as well as consistency in purchasing patterns. Additionally, the use of the actual chargeback history to calculate an average chargeback rate has historically resulted in a reasonable estimation of overall current contract rates.
For purposes of estimating the period of time between the sale to the distributor and the receipt of a chargeback claim, we utilize several sources of information including actual inventory quantities of our products on hand at distributors. This inventory on hand information is received from the distributors or, when specific quantities are not provided, estimated by using the targeted days of inventory on hand for distributors. Historical experience of actual chargebacks paid has indicated that use of this information has reasonable predictive value of outstanding chargebacks and accounts for the variability of purchasing
patterns and expected timing and volume of sales to end customers. The value of the chargeback reserve generally represents approximately two months of obligation due to the timing difference between the initial sale to a distributor and the processing of a chargeback claim after the product is sold to the end customer.
The chargeback reserve estimates change from period-to-period primarily based on changes in revenue from/and the inventory levels of distributors. Our judgments regarding the information used to calculate the chargeback reserve are consistent from period to period; however, on a regular basis, we evaluate the adequacy of the chargeback reserve to reassess and ensure that the variable consideration is appropriately constrained, and the likelihood of future revenue reversal is not probable. We use metrics including chargeback provision as a percentage of gross revenue, movements in inventory on hand at distributors, trends in accrued versus paid chargebacks and impacts from price changes and similar metrics.
The chargeback reserve reflects a reasonable estimate of the amount of consideration using the expected value method and is recorded as a reduction of accounts receivable, net on the consolidated balance sheets.
We also offer certain volume-based rebates to both our distribution and end customers, which is recorded as variable consideration when calculating the transaction price. Rebates are offered on both a fixed and tiered/variable basis. In both cases, we use information available at the time, including current contractual requirements, our historical experience with each customer and forecasted customer purchasing patterns, to estimate the most likely rebate amount.
We also warrant products against defects and have a policy permitting the return of defective products, for which we accrue and expense at the time of sale using information available at that time and our historical experience. We also provide for extended service-type warranties, which we consider to be separate performance obligations. We allocate a portion of the transaction price to the extended service-type warranty based on its estimated relative selling price, and recognize revenue over the period the warranty service is provided.
Arrangements with Multiple Performance Obligations
We also enter into arrangements which include multiple performance obligations. The most significant judgments related to these arrangements include:
Identifying the various performance obligations of these arrangements.
Estimating the relative standalone selling price of each performance obligation, typically using a directly observable method or calculated on a cost plus margin basis method.
Revenue Disaggregated
The following table represents our revenues disaggregated by product line (in thousands):
| Three months ended June 30, | Six months ended June 30, | |||
|---|---|---|---|---|
| Product line | 2025 | 2024 | 2025 | 2024 |
| Consumables | $273,133 | $261,816 | $539,359 | $505,855 |
| Infusion Systems | 167,696 | 163,638 | 333,996 | 320,976 |
| Vital Care | 108,037 | 171,001 | 280,213 | 336,279 |
| Total Revenues | $548,866 | $596,455 | $1,153,568 | $1,163,110 |
The following table represents our revenues disaggregated by geography (in thousands):
| Three months ended June 30, | Six months ended June 30, | |||
|---|---|---|---|---|
| Geography | 2025 | 2024 | 2025 | 2024 |
| United States | $335,432 | $383,140 | $723,676 | $749,295 |
| Europe, the Middle East and Africa | 99,059 | 95,310 | 194,747 | 193,699 |
| APAC | 58,404 | 61,224 | 117,816 | 113,077 |
| Other Foreign | 55,971 | 56,781 | 117,329 | 107,039 |
| Total Revenues | $548,866 | $596,455 | $1,153,568 | $1,163,110 |
Contract Balances
The following table presents the changes in our contract balances for the six months ended June 30, 2025 and 2024 (in thousands), which is included in accrued liabilities and other long-term liabilities on the condensed consolidated balance sheets:
| Contract Liabilities | |
|---|---|
| Beginning balance, January 1, 2025 | $39,403 |
| Equipment revenue recognized | (33,525) |
| Equipment revenue deferred due to implementation | 30,365 |
| Software revenue recognized | (6,348) |
| Software revenue deferred due to implementation | 2,473 |
| Government grant income recognized(1) | (1,024) |
| Other deferred revenue recognized | (1,156) |
| Other deferred revenue | 390 |
| Ending balance, June 30, 2025 | $30,578 |
| Beginning balance, January 1, 2024 | $42,177 |
| Equipment revenue recognized | (16,951) |
| Equipment revenue deferred due to implementation | 20,593 |
| Software revenue recognized | (10,232) |
| Software revenue deferred due to implementation | 10,427 |
| Government grant income recognized(1) | (1,029) |
| Other deferred revenue recognized | (1,602) |
| Other deferred revenue | 423 |
| Ending balance, June 30, 2024 | $43,806 |
(1) The government grant income deferred is amortized over the life of the related depreciable asset as a reduction to depreciation expense.
Our contract liabilities are included in accrued liabilities or other long-term liabilities in our condensed consolidated balance sheet based on the expected timing of revenue recognition.
As of June 30, 2025, revenue from remaining performance obligations is as follows:
| Recognition Timing | ||
|---|---|---|
| (in thousands) | < 12 Months | > 12 Months |
| Equipment deferred revenue | $12,295 | $403 |
| Software deferred revenue | 6,670 | 1,877 |
| Government grant deferred income(1) | 2,064 | 6,318 |
| Other deferred revenue(2) | 890 | 61 |
| Total | $21,919 | $8,659 |
(1) The government grant deferred income is amortized over the life of the related depreciable asset as a reduction to depreciation expense.
(2) Other deferred revenue includes pump development programs, purchased training and extended warranty.
Note 6: Segment Data
The Company has a single operating and reportable segment. The Company derives revenues from the manufacture and sale of our medical products which are used in infusion therapy, vascular access, and vital care applications. Our product portfolio includes ambulatory, syringe, and large volume IV pumps and safety software; dedicated and non-dedicated IV sets, needlefree IV connectors, IV catheters, sharps safety products, and sterile IV solutions; closed system transfer devices and pharmacy compounding systems; as well as a range of respiratory, anesthesia, patient monitoring, and temperature management products. Our product lines, as disclosed in Note 5: Revenue, were determined to be a single operating segment as discrete financial information by product-line is limited to revenue and standard cost. Other cost of sale expenses, which include above-site manufacturing costs, manufacturing variances and supply chain costs including freight and warehousing are not allocated to individual product lines. Similarly, quality, regulatory and other operating expenses are only provided to our chief operating decision maker ("CODM") at the consolidated level.
For information on disaggregation of revenues by product-line and geography, see Note 5: Revenue.
Ourchief executive officer is our CODM. Our CODM uses net profit (loss) to manage our business activities on a consolidated basis and to evaluate and assess the performance of the Company when determining how to allocate capital resources. Our segment performance is monitored and resource allocation is determined during the consolidated annual budget/forecast processes. The measure of segment assets is reported on the consolidated balance sheets as total assets. Expenditures for additions to long-lived assets were $22.0 million and $38.9 million for the three and six months ended June 30, 2025 and $21.9 million and $40.7 million for the three and six months ended June 30, 2024, respectively.
The following table presents information about our segment revenue, segment profit or loss, and significant segment expenses (in thousands):
| Three months ended June 30, | Six months ended June 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| REVENUES | $548,866 | $596,455 | $1,153,568 | $1,163,110 |
| Less: | ||||
| Standard COGS(1) | 249,816 | 298,429 | 543,224 | 581,430 |
| Quality remediation/recall(2) | 5,706 | 3,924 | 15,686 | 11,422 |
| Other COGS(3) | 85,280 | 86,674 | 176,485 | 177,586 |
| Selling, general and administrative | 159,392 | 159,549 | 316,625 | 317,206 |
| Research and development | 21,867 | 23,390 | 45,158 | 45,232 |
| Restructuring and integration | 16,218 | 17,136 | 32,915 | 33,241 |
| Other segment items(4) | (46,157) | 238 | (47,626) | 228 |
| Interest expense | 23,065 | 26,648 | 48,328 | 53,066 |
| Income tax provision | 1,178 | 1,873 | 5,748 | 4,576 |
| Equity in earnings of unconsolidated affiliates | (2,837) | — | (2,837) | — |
| Consolidated net income (loss) | $35,338 | $(21,406) | $19,862 | $(60,877) |
(1) Represents the average annual budgeted cost of producing each good sold in the period.
(2) Represents significant labor and material costs to replace or repair a product outside the scope of standard warranty and compliance costs related to quality systems and manufacturing operations.
(3) Includes costs related to capitalized manufacturing variances to standard COGS, supply chain and logistics costs including freight, inventory management and reserves, hardware service, quality and regulatory, and operations and supply chain management costs.
(4)Includes changes in fair value of contingent earn-out, interest income, gain/loss on disposition of assets, gain/loss on foreign exchange, other miscellaneous income/expense, and gain on sale of business.
For information on depreciation expense, see Note 14: Property, Plant, & Equipment. For information on amortization expense, see Note 15: Goodwill and Intangible Assets, Net.
Significant Customers
We sell products worldwide, on credit terms on an unsecured basis, as an OEM supplier, to independent medical supply distributors and directly to end customers. The manufacturers and distributors, in turn, sell our products to healthcare providers. For the three and six months ended June 30, 2025, our consolidated worldwide net sales to a single distributor were 19%, and 18%, respectively, and for the three and six months ended June 30, 2024, were 17%.
Geographic Information
The table below presents our gross long-lived assets, consisting of property, plant and equipment, by country or region (in thousands):
| As of | ||
|---|---|---|
| June 30, 2025 | December 31, 2024 | |
| Costa Rica | 160,676 | 156,149 |
| Mexico | 117,835 | 111,043 |
| Other LATAM | 64,060 | 55,451 |
| Canada | 1,918 | 5,284 |
| Italy | 34,560 | 29,124 |
| Spain | 19,914 | 17,141 |
| Czech Republic | 13,804 | 11,909 |
| Other Europe | 11,580 | 11,445 |
| APAC | 29,754 | 27,550 |
| Total Foreign | $454,101 | $425,096 |
| United States* | 628,671 | 610,547 |
| Worldwide Total | $1,082,772 | $1,035,643 |
*As of December 31, 2024, we presented within the assets held for sale line item in our consolidated balance sheet, the gross long-lived assets that were part of a disposal group that met the criteria as held for sale during the fourth quarter of 2024 (See Note 4: Assets Held For Sale and Disposal of Business).
Note 7: Leases
We determine if an arrangement is a lease at inception. Our operating lease assets are separately stated in operating lease right-of-use ("ROU") assets and our financing lease assets are included in other assets on our condensed consolidated balance sheets. Our lease liabilities are included in accrued liabilities and other long-term liabilities on our condensed consolidated balance sheets. We have elected not to recognize an ROU asset and lease liability for leases with terms of twelve months or less.
Lease ROU assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. Most of our leases do not provide an implicit rate; therefore, we use our incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term based on the information available at commencement date. Our lease ROU assets exclude lease incentives and initial direct costs incurred. Our lease terms include options to extend when it is reasonably certain that we will exercise that option. All of our leases have stated lease payments, which may include fixed rental increases. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term.
Our leases are for corporate, research and development and sales and support offices, manufacturing and distribution facilities, device service centers and certain equipment. Our leases have original lease terms ofone year tofifteen years, some of which include options to extend the leases for up to an additional five years. For all of our leases, we do not include optional periods of extension in our current lease terms because we determined the exercise of options to extend is not reasonably certain.
The following table presents the components of our lease cost (in thousands):
| Three months ended June 30, | Six months ended June 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Operating lease cost | $5,103 | $5,638 | $10,129 | $11,452 |
| Finance lease cost — interest | 107 | 47 | 161 | 80 |
| Finance lease cost — reduction of ROU asset | 623 | 301 | 812 | 555 |
| Short-term lease cost | 5 | — | 7 | — |
| Total lease cost | $5,838 | $5,986 | $11,109 | $12,087 |
Interest expense on our finance leases is included in interest expense, net in our condensed consolidated statements of operations. The reduction of the operating and finance ROU assets is included as noncash lease expense in costs of goods sold and selling, general and administrative expenses in our condensed consolidated statements of operations.
The following table presents the supplemental cash flow information related to our leases (in thousands):
| Six months ended June 30, | ||
|---|---|---|
| 2025 | 2024 | |
| Cash paid for amounts included in the measurement of lease liabilities: | ||
| Operating cash flows from operating leases | $8,906 | $11,730 |
| Operating cash flows from finance leases | $161 | $80 |
| Right-of-use assets obtained in exchange for lease obligations: | ||
| Operating leases | $11,654 | $8,650 |
| Finance leases | $1,713 | $1,202 |
The following table presents the supplemental balance sheet information related to our operating leases (in thousands, except lease term and discount rate):
| As of | ||
|---|---|---|
| June 30, 2025 | December 31, 2024 | |
| Operating leases | ||
| Operating lease right-of-use assets | $58,888 | $53,295 |
| Accrued liabilities | $13,201 | $15,695 |
| Other long-term liabilities | 49,431 | 40,777 |
| Total operating lease liabilities | $62,632 | $56,472 |
| Weighted-Average Remaining Lease Term | ||
| Operating leases | 6.6 years | 5.8 years |
| Weighted-Average Discount Rate | ||
| Operating leases | 5.31% | 4.90% |
The following table presents the supplemental balance sheet information related to our finance leases (in thousands, except lease term and discount rate):
| As of | ||
|---|---|---|
| June 30, 2025 | December 31, 2024 | |
| Finance leases | ||
| Finance lease right-of-use assets | $4,372 | $3,259 |
| Accrued liabilities | $1,535 | $1,066 |
| Other long-term liabilities | 3,053 | 2,332 |
| Total finance lease liabilities | $4,588 | $3,398 |
| Weighted-Average Remaining Lease Term | ||
| Finance leases | 3.2 years | 3.5 years |
| Weighted-Average Discount Rate | ||
| Finance leases | 5.96% | 5.63% |
As of June 30, 2025, the maturities of our operating and finance lease liabilities for each of the next five years and thereafter are approximately (in thousands):
| Operating Leases · Finance Leases | ||
|---|---|---|
| Remainder of 2025 | $8,207 | $911 |
| 2026 | 14,802 | 1,691 |
| 2027 | 12,305 | 1,311 |
| 2028 | 9,660 | 823 |
| 2029 | 7,830 | 248 |
| 2030 | 4,562 | 47 |
| Thereafter | 16,686 | — |
| Total Lease Payments | 74,052 | 5,031 |
| Less imputed interest | (11,420) | (443) |
| Total | $62,632 | $4,588 |
Note 8: Net Income (Loss) Per Share
Basic net income (loss) per share is computed by dividing net income (loss) by the weighted-average number of common shares outstanding during the period. Diluted income (loss) per share is computed by dividing net income (loss) by the weighted-average number of common shares outstanding during the period plus dilutive securities. Dilutive securities include outstanding common stock options and unvested restricted stock units, less the number of shares that could have been purchased with the proceeds from the exercise of the options, using the treasury stock method. Options and restricted stock units that are anti-dilutive are not included in the treasury stock method calculation. A net loss for the three and six months ended June 30, 2024 causes all of the potentially dilutive common shares to be antidilutive and, accordingly, they were not included in the computation of diluted earnings per share, and basic and diluted net loss per share are equal for each of these periods.
The following table presents the calculation of net earnings per common share (“EPS”) — basic and diluted (in thousands, except per share data):
| Three months ended June 30, | Six months ended June 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Net income (loss) | $35,338 | $(21,406) | $19,862 | $(60,877) |
| Weighted-average number of common shares outstanding (basic) | 24,645 | 24,393 | 24,593 | 24,295 |
| Dilutive securities(1) | 63 | — | 153 | — |
| Weighted-average common and common equivalent shares outstanding (diluted) | 24,708 | 24,393 | 24,746 | 24,295 |
| EPS — basic | $1.43 | $(0.88) | 0.81 | $(2.51) |
| EPS — diluted | $1.43 | $(0.88) | 0.80 | $(2.51) |
| Total anti-dilutive stock options and restricted stock awards | 65 | 216 | 40 | 202 |
(1)Due to the net loss for the three and six months ended June 30, 2024, there are no potentially dilutive common shares included in the computation of diluted earnings per share.
Note 9: Derivatives and Hedging Activities
Hedge Accounting and Hedging Program
The purposes of our cash flow hedging programs are to manage the foreign currency exchange rate risk on forecasted revenues and expenses denominated in currencies other than the functional currency of the operating unit, and to manage floating interest rate risk associated with future interest payments on the variable-rate term loans issued in 2022. We do not issue derivatives for trading or speculative purposes.
To receive hedge accounting treatment, all hedging relationships are formally documented at the inception of the hedge, and the hedges must be highly effective in offsetting changes to future cash flows on hedged transactions. The derivative instruments we utilize, including various foreign exchange contracts and interest rate swaps, are designated and qualify as cash flow hedges. Our derivative instruments are recorded at fair value on the condensed consolidated balance sheets and are classified based on the instrument's maturity date. We record gains or losses from changes in the fair values of the derivative instruments as a component of other comprehensive income (loss) and we reclassify those gains or losses into earnings in the same line item associated with the forecasted transaction and in the same period during which the hedged transaction affects earnings. If the underlying forecasted transaction does not occur, or it becomes probable that it will not occur, we reclassify the gain or loss on the related derivative instrument from accumulated other comprehensive loss into earnings immediately.
Foreign Currency Exchange Rate Risk
Foreign Exchange Forward Contracts
We enter into foreign exchange forward contracts to hedge a portion of our forecasted foreign currency-denominated revenues and expenses to minimize the effect of foreign exchange rate movements on the related cash flows. These contracts are agreements to buy or sell a quantity of a currency at a predetermined future date and at a predetermined exchange rate. Our foreign exchange forward contracts hedge exposures principally denominated in Mexican Pesos ("MXN"), Euros ("EUR"), Czech Koruna ("CZK"), Japanese Yen ("JPY"), Swedish Krona ("SEK"), Danish Krone ("DKK"), Chinese Renminbi ("CNH"), Canadian Dollar ("CAD"), U.S. Dollar ("USD") and Australian Dollar ("AUD") and have varying maturities with an average term of approximately nine months. The total notional amount of these outstanding derivative contracts as of June 30, 2025 was $137.6 million, which included the notional equivalent of $31.3 million in CAD, $41.8 million in EUR, $38.8 million in MXN, $16.9 million in USD and $8.8 million in other foreign currencies, with terms currently through January 2026.
Floating Interest Rate Risk
In 2022, we entered into interest rate swaps to reduce the interest rate volatility on our variable-rate term loan A and variable-rate term loan B (see Note 18: Long-Term Debt). We exchange, at specified intervals, the difference between fixed and floating interest amounts calculated by reference to an agreed-upon notional amount. Effective March 30, 2022, the term loan A swap, as amended, has an initial notional amount of $300.0 million, reducing to $150.0 million evenly on a quarterly basis excluding its final maturity on March 30, 2027. We pay a fixed rate of 1.32% and will receive the greater of 3-months USD Secured Overnight Financing Rate ("SOFR") or (0.15)%. The total notional amount of this outstanding derivative as of June 30, 2025 was approximately $197.4 million. Effective March 30, 2022, the term loan B swap, as amended, has an initial notional amount of $750.0 million, reducing to $46.9 million evenly on a quarterly basis through its final maturity on March 30, 2026. We pay a fixed rate of 1.17% and will receive the greater of 3-months USD SOFR or 0.35%. The total notional amount of this outstanding derivative as of June 30, 2025 was approximately $140.6 million.
In June 2023, we entered into an additional interest rate swap that hedges both term loan A and term loan B interest payments. The total notional amount of the swap is $300.0 million. The hedge matures on June 30, 2028. We pay a fixed rate of 3.88% and will receive 3-months USD SOFR.
These swaps effectively convert the relevant portion of the floating-rate term loans to fixed rates.
The following table presents the fair values of our derivative instruments included within the Condensed Consolidated Balance Sheets (in thousands):
| Derivatives Designated as Cash Flow Hedging Instruments | |||
|---|---|---|---|
| Condensed Consolidated Balance Sheet Location | Foreign Exchange Contracts | Interest Rate Swaps | Gross Derivatives |
| Prepaid expenses and other current assets | $3,434 | $— | $3,434 |
| Total assets | $3,434 | $— | $3,434 |
| Accrued liabilities | $2,971 | $— | $2,971 |
| Other long-term liabilities | — | 2,084 | 2,084 |
| Total liabilities | $2,971 | $2,084 | $5,055 |
| Prepaid expenses and other current assets | $6,716 | $11,038 | $17,754 |
| Other assets | — | 5,724 | 5,724 |
| Total assets | $6,716 | $16,762 | $23,478 |
| Accrued liabilities | $7,391 | $— | $7,391 |
| Total liabilities | $7,391 | $— | $7,391 |
We recognized the following (losses) gains on our derivative instruments designated as cash flow hedges in other comprehensive income before reclassifications to net income (loss) (in thousands):
| (Losses) Gains Recognized in Other Comprehensive Income (Loss) | ||||
|---|---|---|---|---|
| Three months ended June 30, | Six months ended June 30, | |||
| 2025 | 2024 | 2025 | 2024 | |
| Derivatives designated as cash flow hedging instruments: | ||||
| Foreign exchange forward contracts | $1,830 | $(3,965) | $1,656 | $975 |
| Interest rate swaps | (7,974) | 4,512 | (12,065) | 17,905 |
| Total derivatives designated as cash flow hedging instruments | $(6,144) | $547 | $(10,409) | $18,880 |
The following table presents the effects of our derivative instruments designated as cash flow hedges on the Condensed Consolidated Statements of Operations (in thousands):
| Gains (Losses) Reclassified From Accumulated Other Comprehensive Income (Loss) into Income | |||||
|---|---|---|---|---|---|
| Three months ended June 30, · Six months ended June 30, | |||||
| Location of Gains (Losses) Recognized in Net Loss | 2025 | 2024 | 2025 | 2024 | |
| Derivatives designated as cash flow hedging instruments: | |||||
| Foreign exchange forward contracts | Total revenues | $164 | $633 | $874 | $1,333 |
| Foreign exchange forward contracts | Cost of goods sold | (393) | 1,059 | (1,407) | 2,339 |
| Interest rate swaps | Interest expense | 3,316 | 7,291 | 7,072 | 15,255 |
| Total derivatives designated as cash flow hedging instruments | $3,087 | $8,983 | $6,539 | $18,927 | |
As of June 30, 2025, we expect an estimated $0.5 million in deferred gains on the outstanding foreign exchange contracts and an estimated $0.3 million in deferred losses on the interest rate swaps will be reclassified from accumulated other comprehensive loss to net income during the next 12 months concurrent with the underlying hedged transactions also being reported in net income.
Note 10: Fair Value Measurements
Fair value is the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. There are three levels of inputs that may be used to measure fair value:
Level 1: quoted prices in active markets for identical assets or liabilities;
Level 2: inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; or
Level 3: unobservable inputs that are supported by little or no market activity and that are significant to the fair values of the assets or liabilities.
Recurring Fair Value Measurements
We measure certain assets and liabilities on a recurring basis, including contingent earn-out liabilities and derivative financial instruments.
Contingent Earn-out Liabilities
In 2022, we acquired Smiths Medical with a combination of cash consideration and share consideration issued at closing. Total consideration for the acquisition included a potential earn-out payment of $100.0 million in cash contingent on our common stock achieving a certain volume-weighted average price (the "Price Targets") from the closing date to either the third or fourth anniversary of closing and provided Smiths beneficially owns at least 50.0% of the shares of common stock issued at closing at the time the Price Target is achieved. For the three and six months ended June 30, 2024, the change in fair market value of the earn-out was $(0.3) million and $— million, respectively, and is included in income from operations in a separate line. During July 2024, Smiths sold 1.2 million common shares of ICU Medical, Inc. The sale of shares when combined with other sales in prior periods renders Smiths unable to achieve the contingent consideration based on certain price targets during the third and fourth anniversary of closing as Smiths no longer meets the required minimum beneficial ownership percentage. Accordingly, the valuation of the contingent earn-out liability as of December 31, 2024 was zero.
In November 2021, we acquired a small foreign infusion systems supplier. Total consideration for the acquisition included a potential earn-out payment of up to $2.5 million, consisting of (i) a cash payment of $1.0 million contingent on the achievement of certain revenue targets for the annual period ended December 31, 2022 and, separately, (ii) a cash payment of $1.5 million contingent upon obtaining certain product-related regulatory certifications. As of December 31, 2022, the measurement period related to the contingent earn-out based on certain revenue targets ended and based on the actual revenue achieved during the measurement period the fair value of the contingent earn-out was determined to be zero as the minimum threshold for earning the earn-out was not met. As of December 31, 2024, the earn-out measurement period related to certain product-related regulatory certifications had ended and the product-related regulatory certification had not been achieved, accordingly, the estimated fair value for the contingent consideration was reduced to zero.
In August 2021, we entered into an agreement with one of our international distributors whereby that distributor would not compete with us in a specific territory for a three-year period that ended September 2024. The terms of the agreement included a contingent earn-out payment. The contingent earn-out payment could not exceed $6.0 million and was to be earned based on certain revenue targets over a twelve-month measurement period determined by the highest four consecutive quarters commencing over a two-year period starting on the closing date of the agreement and provided that the distributor is in compliance with its obligations under the agreement. As of December 31, 2023, the earn-out measurement period ended. The fair value of the contingent earn-out was determined to be $3.4 million and was paid out in the first quarter of 2024.
Foreign Exchange Contracts and Interest Rate Contracts
The fair value of our Level 2 foreign exchange contracts is estimated using observable market inputs such as known notional value amounts, spot and forward exchange rates. These inputs relate to liquid, heavily traded currencies with active markets which are available for the full term of the derivative.
The fair value of our Level 2 interest rate swaps is estimated using a pricing model that reflects the terms of the contracts, including the period to maturity, and relies on observable market inputs such as known notional value amounts and USD interest rate curves.
Our assets and liabilities measured at fair value on a recurring basis consisted of the following Level 1, 2 and 3 inputs as defined above (in thousands):
| Fair value measurements as of June 30, 2025 | ||||
|---|---|---|---|---|
| Total carryingvalue | Quoted pricesin activemarkets foridenticalassets (level 1) | Significantotherobservableinputs (level 2) | Significantunobservableinputs (level 3) | |
| Assets: | ||||
| Foreign exchange contracts: | ||||
| Prepaid expenses and other current assets | $3,434 | $— | $3,434 | $— |
| Total Assets | $3,434 | $— | $3,434 | $— |
| Liabilities: | ||||
| Foreign exchange contracts: | ||||
| Accrued liabilities | $2,971 | $— | $2,971 | $— |
| Interest rate swaps: | ||||
| Other long-term liabilities | 2,084 | — | 2,084 | — |
| Total Liabilities | $5,055 | $— | $5,055 | $— |
| Fair value measurements as of December 31, 2024 | ||||
|---|---|---|---|---|
| Total carryingvalue | Quoted pricesin activemarkets foridenticalassets (level 1) | Significantotherobservableinputs (level 2) | Significantunobservableinputs (level 3) | |
| Assets: | ||||
| Foreign exchange forwards: | ||||
| Prepaid expenses and other current assets | $6,716 | $— | $6,716 | $— |
| Interest rate contracts: | ||||
| Prepaid expenses and other current assets | 11,038 | — | 11,038 | — |
| Other assets | 5,724 | — | 5,724 | — |
| Total Assets | $23,478 | $— | $23,478 | $— |
| Liabilities: | ||||
| Foreign exchange contracts: | ||||
| Accrued liabilities | $7,391 | $— | $7,391 | $— |
| Total Liabilities | $7,391 | $— | $7,391 | $— |
Nonrecurring Fair Value Measurements
We measure certain items on a nonrecurring basis due to particular circumstances or when specific transactions occur such as a retained investment resulting from a partial sale. On May 1, 2025, we measured our retained equity method investment in Otsuka ICU Medical LLC (see Note 11: Investment Securities) at fair value in connection to the sale of a 60% interest of our IV Solutions business (see Note 4: Assets Held for Sale and Disposal of Business). The fair value was estimated using a market-based approach and is classified as a Level 3 fair value measurement.
Note 11: Investment Securities
Investments in Non-Marketable Equity Securities
Investments in Unconsolidated Affiliates
We hold equity method investments in certain entities. We apply the equity method of accounting for investments in unconsolidated affiliates when we determine we have a significant influence, but not a controlling interest in the investee. We determine whether we have significant influence by considering key factors such as ownership interest, representation on the board of directors, participation in policy making decisions, business relationship and material intra-entity transactions, among other factors. Our equity method investments are reported at cost and adjusted each period for our share of the investee's income or (loss) and dividend paid, if any. We eliminate any intra-entity profits to the extent of our beneficial interest. We assess our equity method investments for impairment on an annual basis or whenever events or circumstances indicate that the carrying value of the investment may not be recoverable.
On April 24, 2025, the Company completed the formation of the Otsuka ICU Medical LLC (“joint venture”) and transferred the assets, liabilities and operations that comprise the IV Solutions business to the joint venture. Pursuant to the agreement, we sold 60% of our IV Solutions business to OPF and the Company retained 40% ownership interest in the business. The initial investment was recorded in the amount of $125.8 million. As provided under the joint venture's Operating Agreement, each of OPF and the ICU Medical Entities have been granted certain exclusive call and put options, respectively, with respect to the ICU Medical Entities' remaining ownership interest in the joint venture. Such options are exercisable at certain specified dates and for such amounts as are set forth in the Operating Agreement beginning five years after the transaction closing. If exercised, they could effectively eliminate the Company’s ownership interest. See Note 4: Assets Held for Sale and Disposal of Business for more information.
We also own approximately 20% non-marketable equity interest in a nonpublic company and entered into a three-year distribution agreement where we have the exclusive rights to market, sell and distribute the company's products in exchange for a cash payment of $3.3 million. In addition, we were granted an exclusive license for all of the seller's intellectual property. At the expiration of the distribution agreement we have the right but not the obligation to acquire the remaining interest in the business.
Our investment in unconsolidated affiliates consist of the following (in thousands):
| As of | ||
|---|---|---|
| June 30, 2025 | December 31, 2024 | |
| Otsuka ICU Medical LLC | $128,662 | $— |
| Other equity method investment | 2,963 | 3,038 |
| $131,625 | $3,038 | |
Our recorded share of our investees' income was $2.8 million for the three and six months ended June 30, 2025. There were no such balances in 2024. We did not receive any dividend distributions from these investments during the three and six months ended June 30, 2025 and 2024.
Note 12: Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consist of the following (in thousands):
| As of | ||
|---|---|---|
| June 30, 2025 | December 31, 2024 | |
| Other prepaid expenses and receivables* | $29,645 | $17,312 |
| Prepaid insurance and property taxes* | 6,358 | 10,284 |
| VAT/GST receivable | 10,031 | 4,445 |
| Interest rate contracts** | — | 11,038 |
| Prepaid income taxes | 14,810 | 11,244 |
| Other* | 23,277 | 27,208 |
| $84,121 | $81,531 | |
*As of December 31, 2024, certain prepaid expense account balances that are part of a disposal group that met the criteria for assets held for sale during the fourth quarter of 2024 were combined with other disposal group assets and presented as a separate line item "Assets Held For Sale" in our consolidated balance sheet (See Note 4:Assets Held For Sale and Disposal of Business).
**See Note 9: Derivatives and Hedging Activities
Note 13: Inventories
Inventories are stated at the lower of cost or net realizable value with cost determined using the first-in, first-out method. Inventory costs include material, labor and overhead related to the manufacturing of our products.
Inventories consist of the following (in thousands):
| As of | ||
|---|---|---|
| June 30, 2025 | December 31, 2024 | |
| Raw materials | $283,874 | $265,275 |
| Work in process | 48,317 | 37,528 |
| Finished goods | 284,283 | 281,873 |
| Total inventories | $616,474 | $584,676 |
As of December 31, 2024, inventory account balances that are part of a disposal group that met the criteria for assets held for sale during the fourth quarter of 2024 were combined with other disposal group assets and presented as a separate line item "Assets Held For Sale" in our consolidated balance sheets (See Note 4:Assets Held For Sale and Disposal of Business).
Note 14: Property, Plant and Equipment
Property, plant and equipment consists of the following (in thousands):
| As of | ||
|---|---|---|
| June 30, 2025 | December 31, 2024 | |
| Machinery and equipment(1) | $421,294 | $400,861 |
| Land, building and building improvements(1) | 178,951 | 177,089 |
| Molds | 101,730 | 96,318 |
| Computer equipment and software(1) | 122,202 | 122,208 |
| Furniture and fixtures(1) | 27,866 | 27,871 |
| Instruments placed with customers(2) | 142,010 | 124,290 |
| Construction in progress(1) | 88,719 | 87,006 |
| Total property, plant and equipment, cost(1) | 1,082,772 | 1,035,643 |
| Accumulated depreciation(1) | (630,330) | (592,897) |
| Property, plant and equipment, net(1) | $452,442 | $442,746 |
(1) As of December 31, 2024, certain property, plant and equipment category account balances that are part of a disposal group that met the criteria for assets held for sale during the fourth quarter of 2024 were combined with other disposal group assets and presented as a separate line item "Assets held For Sale" in our consolidated balance sheets.
(2)Instruments placed with customers consist of drug-delivery and monitoring systems placed with customers under operating leases.
Depreciation expense was $16.9 million and $33.8 million for the three and six months ended June 30, 2025, respectively, as compared to $22.3 million and $44.7 million for the three and six months ended June 30, 2024, respectively. Depreciation expense included in costs of goods sold was $15.4 million and $30.2 million, for the three and six months ended June 30, 2025, respectively, as compared to $19.4 million and $38.8 million for the three and six months ended June 30, 2024, respectively.
Note 15: Goodwill and Intangible Assets, Net
Goodwill
The following table presents the changes in the carrying amount of our goodwill (in thousands):
| Total | |
|---|---|
| Balance as of January 1, 2025 | $1,432,772 |
| Currency translation | 69,148 |
| Balance as of June 30, 2025 | $1,501,920 |
Intangible Assets, Net
Intangible assets, carried at cost less accumulated amortization and amortized on a straight-line basis, were as follows (in thousands):
| Weighted-Average Amortization Life in Years · June 30, 2025 | |||||
|---|---|---|---|---|---|
| Cost · AccumulatedAmortization · Net | |||||
| Patents | 10 | $38,718 | $24,148 | $14,570 | |
| Customer contracts | 12 | 10,202 | 7,300 | 2,902 | |
| Non-contractual customer relationships | 8 | 563,987 | 273,327 | 290,660 | |
| Trademarks | 1 | 5,425 | 5,425 | — | |
| Trade name | 15 | 18,245 | 8,967 | 9,278 | |
| Developed technology(1) | 10 | 627,611 | 262,023 | 365,588 | |
| Non-compete | 3 | 9,100 | 9,100 | — | |
| Total amortized intangible assets | $1,273,288 | $590,290 | $682,998 | ||
| Internally developed software(2) | $15,011 | $15,011 | |||
| Total intangible assets | $1,288,299 | $590,290 | $698,009 | ||
(1)Developed technology primarily consists of acquired patented technologies and internally developed software. Upon completion of development, the assets are amortized over their estimated useful lives.
(2)Internally developed software will be reclassified to developed technology and amortized when the projects are complete and the assets are ready for their intended use.
| Weighted-Average Amortization Life in Years · December 31, 2024 | |||||
|---|---|---|---|---|---|
| Cost · AccumulatedAmortization · Net | |||||
| Patents | 10 | $36,811 | $22,913 | $13,898 | |
| Customer contracts | 12 | 9,818 | 6,994 | 2,824 | |
| Non-contractual customer relationships | 8 | 546,404 | 236,267 | 310,137 | |
| Trademarks | 1 | 5,425 | 5,425 | — | |
| Trade name | 15 | 18,239 | 8,357 | 9,882 | |
| Developed technology(1) | 10 | 619,540 | 227,869 | 391,671 | |
| Non-compete | 3 | 9,100 | 9,100 | — | |
| Total amortized intangible assets | $1,245,337 | $516,925 | $728,412 | ||
| Internally developed software(2) | $12,377 | $12,377 | |||
| Total intangible assets | $1,257,714 | $516,925 | $740,789 | ||
(1)Developed technology primarily consists of acquired patented technologies and internally developed software. Upon completion of development, the assets are amortized over their estimated useful lives.
(2)Internally developed software will be reclassified to developed technology and amortized when the projects are complete and the assets are ready for their intended use. During 2024, we reclassified $33.2 million to developed technology.
Intangible assets with definite lives are amortized on a straight-line basis over their estimated useful lives. Intangible asset amortization expense was $32.7 million and $65.3 million for the three and six months ended June 30, 2025, respectively, as compared to $33.1 million and $66.2 million during the three and six months ended June 30, 2024, respectively. Intangible asset amortization expense included in cost of goods sold was $1.0 million and $2.1 million, for the three and six months ended June 30, 2025, respectively. There were no such balances for the three and six months ended June 30, 2024.
As of June 30, 2025 estimated annual amortization for our intangible assets for each of the next five years and thereafter is approximately (in thousands):
| Remainder of 2025 | $65,763 |
| 2026 | 132,233 |
| 2027 | 121,100 |
| 2028 | 120,502 |
| 2029 | 117,406 |
| 2030 | 53,264 |
| Thereafter | 72,730 |
| Total | $682,998 |
Note 16: Accrued Liabilities
Accrued liabilities consist of the following (in thousands):
| As of | ||
|---|---|---|
| June 30, 2025 | December 31, 2024 | |
| Salaries and benefits | $83,464 | $60,815 |
| Incentive compensation | 42,796 | 59,445 |
| Deferred revenue | 21,919 | 30,358 |
| Italy medical device payback provision(1) | 29,287 | 23,937 |
| Field service corrective action(2) | 25,488 | 32,844 |
| Other | 110,844 | 99,524 |
| $313,798 | $306,923 | |
(1)Related to potential payments associated with the IMDP (as defined below) as a result of 2015 legislation enacted requiring medical device companies to make payments to the Italian government based on regional expenditure ceilings (see Note 20: Commitments and Contingencies for further details).
(2)Primarily includes field corrective actions associated with certain products in connection with a 2021 Warning Letter (as defined below) received by Smiths Medical from the FDA following an inspection of Smiths Medical's Oakdale, Minnesota Facility (see Note 20: Commitments and Contingencies for further details).
As of December 31, 2024, certain accrued liability account balances that were part of a disposal group that met the criteria for assets held for sale during the fourth quarter of 2024 were presented as a separate line item "Liabilities held for sale" in our consolidated balance sheet (See Note 4:Assets Held For Sale and Disposal of Business).
Note 17: Income Taxes
Income taxes were accrued at an estimated effective tax rate of 3% and 25% for the three and six months ended June 30, 2025, respectively, as compared to (10)% and (8)% for the three and six months ended June 30, 2024, respectively.
The effective tax rate for the three and six months ended June 30, 2025 differs from the federal statutory rate of 21% principally because of the effect of the mix of U.S. and foreign incomes, section 162(m) excess compensation, federal and state valuation allowance, and tax credits. The effective tax rate during the three and six months ended June 30, 2025 included a tax expense of $6.1 million related to the sale of a 60% interest of our IV solutions business. Additionally, there were unrecognized tax benefits released as a result of the expiration of statute of limitations during the three and six months ended June 30, 2025 of $5.0 million.
The Company regularly assesses the realizability of deferred tax assets and records a valuation allowance to reduce the deferred tax assets to the amount that is more likely than not to be realized. In assessing the realizability of our deferred tax assets, we weigh all available positive and negative evidence. This evidence includes, but is not limited to, historical earnings, scheduled reversal of taxable temporary differences, tax planning strategies and projected future taxable income. Due to the weight of objectively verifiable negative evidence, the Company recorded a change to the valuation allowance against certain
U.S. federal and state deferred tax assets, resulting in a $2.7 million tax benefit and $3.7 million tax expense during the three and six months ended June 30, 2025, respectively. The significant piece of objectively verifiable negative evidence evaluated was the recent U.S. cumulative losses. The company's ability to use our deferred tax assets depends on the amount of taxable income in future periods. Based on current earnings and anticipated future earnings along with expected changes in our deferred tax asset and liability balances, it is likely that the current valuation allowance position will be adjusted during the year. An additional valuation allowance may be required beyond the current year if future earnings are not sufficient to support the realization of deferred tax assets.
In December 2022, the European Union (EU) agreed to implement Pillar Two, the OECD’s global minimum tax rate of 15% for multinationals that meet a global revenue threshold. All of the EU countries and some of the non-EU countries in which we operate have enacted or have announced plans to enact legislation to adopt Pillar Two. The Pillar Two legislation has been effective for our fiscal year beginning January 1, 2024. For fiscal year 2025, we have considered the impact of Pillar Two on our tax provision and effective tax rate. However, the Pillar Two rules continue to evolve and their application may alter our tax obligations in certain countries in which we operate for fiscal periods beyond 2025 as we continue to assess the impact of tax legislation in these jurisdictions.
On July 4, 2025, the U.S. enacted H.R. 1 "A bill to provide for reconciliation pursuant to Title II of H. Con. Res. 14", commonly referred to as the One Big Beautiful Bill Act (“OBBBA”). The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. We are currently assessing its impact on our consolidated financial statements as additional guidance becomes available and uncertainty remains regarding the timing and interpretation by tax authorities in affected jurisdictions. As the legislation was signed into law after the close of our second quarter, the impacts are not included in our operating results for the three and six months ended June 30, 2025.
The effective tax rate for the three and six months ended June 30, 2024 differs from the federal statutory rate of 21% principally because of the effect of the mix of U.S. and foreign incomes, state income taxes, section 162(m) excess compensation, federal and state valuation allowance, and tax credits. Additionally, there were unrecognized tax benefits released as a result of the expiration of statute of limitations during the three and six months ended June 30, 2024 of $3.9 million and $4.0 million, respectively.
The Company recorded a valuation allowance of $10.4 million and $20.5 million tax expense, against certain U.S. federal and state deferred tax assets during the three and six months ended June 30, 2024, respectively. The significant piece of objectively verifiable negative evidence evaluated was the recent U.S. cumulative losses.
Note 18: Long-Term Debt
2022 Credit Agreement
In 2022, in connection with the acquisition of Smiths Medical, we entered into a Credit Agreement (the "Credit Agreement") with Wells Fargo Bank, National Association, Wells Fargo Securities, LLC, Barclays Bank PLC and certain other financial institutions (the “Lenders”) for $2.2 billion of senior secured credit facilities. The senior secured credit facilities include (i) a five-year Tranche A term loan of $850.0 million (the "Term Loan A"), (ii) a seven-year Tranche B term loan of $850.0 million (the "Term Loan B") and (iii) a five-year revolving credit facility of $500.0 million (the "Revolving Credit Facility"), with separate sub-limits of $50.0 million for letters of credit and swingline loans (collectively, the "Senior Secured Credit Facilities"). We used the proceeds from borrowings under the Term Loan A and the Term Loan B (collectively, the "Term Loans") to fund a portion of the cash consideration for the purchase of Smiths Medical and the related fees and expenses incurred in connection with the acquisition. We did not incur borrowings under the Revolving Credit Facility on the closing date of the acquisition. The proceeds from any future borrowings under the Revolving Credit Facility may be used for working capital and other general corporate purposes.
In connection with entering into the Credit Agreement in 2022, we incurred $37.8 million in debt discount and issuance costs, which were allocated to the Term Loan A, the Term Loan B and the Revolving Credit Facility based on lender commitment amounts relative to each type of fees paid. The lender and third-party discount and issuance costs allocated to the Term Loan A and the Term Loan B were $15.8 million and $13.4 million, respectively, the current unamortized balances are reflected as a direct deduction from the face amount of the corresponding term loans on the condensed consolidated balance sheets. These costs are being amortized to interest expense over the respective terms of the loans using the effective interest method. The issuance costs allocated to the Revolving Credit Facility were $8.6 million, which are capitalized and included in prepaid expenses and other current assets and other assets on our condensed consolidated balance sheets. These costs are being amortized to interest expense over the term of the Revolving Credit Facility using the straight-line method.
The net funds received from the Term Loan A and the Term Loan B, after deducting debt issuance costs, were $834.2 million and $836.6 million, respectively.
Maturity Dates
The maturity date for the Term Loan A and the Revolving Credit Facility is January 6, 2027, and the maturity date for the Term Loan B is January 6, 2029. Pursuant to the terms and conditions of the Credit Agreement, the maturity dates of the Term Loans and the Revolving Credit Facility may be extended upon our request, subject to the consent of the Lenders.
Interest Rate Terms
In general, the Term Loans and borrowings under the Revolving Credit Facility denominated in U.S. dollars bear interest, at our option, on either: (1) the Base Rate, as defined below, plus the applicable margin, as indicated below ("Base Rate Loans") or (2) the Adjusted Term Secured Overnight Financing Rate ("Adjusted Term SOFR"), as defined below, plus the applicable margin, as indicated below ("Term SOFR Loans").
The Base Rate is defined as the highest of (a) the Prime Rate, (b) the Federal Funds Rate plus 0.50% and (c) Adjusted Term SOFR (as defined below) for a one-month period plus, in each case,1.00%.
Adjusted Term SOFR is the rate per annum equal to (a) the Term SOFR plus (b) the Term SOFR Adjustment. Term SOFR is the forward-looking term rate based on SOFR and is calculated separately for Term SOFR Loans and Base Rate Loans, as specified in the Credit Agreement. The Term SOFR Adjustment is a percentage per annum of 0.10% for Base Rate Loans and between 0.10% to 0.25% for Term SOFR Loans based on the applicable interest period.
Revolving Credit Facility Commitment Fee
The Revolving Credit Facility has a per annum commitment fee at an initial rate of 0.25% which is applied to the available amount of the Revolving Credit Facility. Effective on the first Adjustment Date, as defined in the Credit Agreement, occurring subsequent to our quarter ended June 30, 2022, the commitment fee is determined by reference to the leverage ratio in effect from time to time as set forth in the table below.
Applicable Interest Margins
The Term Loan A and borrowings under the Revolving Credit Facility have an initial applicable margin of 0.75% per annum for Base Rate Loans and 1.75% per annum for Term SOFR Loans.
Effective on the first Adjustment Date, as defined in the Credit Agreement, occurring subsequent to our quarter ended June 30, 2022, the applicable margin for the Term Loan A and borrowings under the Revolving Credit Facility is determined by reference to the leverage ratio in effect from time to time as set forth in the following table:
| Leverage Ratio | Applicable Margin for Term SOFR Loans | Applicable Margin for Base Rate Loans | Commitment Fee Rate |
|---|---|---|---|
| Greater than 4.00 to 1.0 | 2.25% | 1.25% | 0.35% |
| Less than or equal to 4.00 to 1.0 but greater than 3.00 to 1.0 | 2.00% | 1.00% | 0.30% |
| Less than or equal to 3.00 to 1.0 but greater than 2.50 to 1.0 | 1.75% | 0.75% | 0.25% |
| Less than or equal to 2.50 to 1.0 but greater than 2.00 to 1.0 | 1.50% | 0.50% | 0.20% |
| Less than or equal to 2.00 to 1.0 | 1.25% | 0.25% | 0.15% |
The Term Loan B has an initial applicable margin of 1.5% per annum for Base Rate Loans and 2.5% per annum for Term SOFR Loans.
Effective on the first Adjustment Date, as defined in the Credit Agreement, occurring subsequent to our quarter ended June 30, 2022, the applicable margin for the Term Loan B is determined by reference to the leverage ratio in effect from time to time as set forth in the following table:
| Leverage Ratio | Applicable Margin for Term SOFR Loans | Applicable Margin for Base Rate Loans |
|---|---|---|
| Greater than 2.75 to 1.0 | 2.50% | 1.50% |
| Less than 2.75 to 1.0 | 2.25% | 1.25% |
Principal Payments
Principal payments on the Term Loans are due on the last day of each calendar quarter commencing on June 30, 2022.
The Term Loan A amortizes in nineteen consecutive quarterly installments in an amount equal to 2.50% of the original principal amount in each of the first two years,5.00% in each of the third and fourth years and 7.50% in the fifth year, with a final payment of the remaining outstanding principal balance due on the maturity date.
The Term Loan B matures in twenty-seven consecutive quarterly installments in an amount equal to 0.25% of the original principal amount, with a final payment of the remaining outstanding principal balance due on the maturity date.
We may borrow, prepay and re-borrow amounts under the Revolving Credit Facility, in accordance with the terms and conditions of the Credit Agreement, with all outstanding amounts due at maturity.
For the six months ended June 30, 2025 and 2024, total principal payments on the Term Loans were $247.8 million and $25.5 million, respectively. During the first quarter of 2025 we made a prepayment of $35.0 million on Term Loan B. During the second quarter of 2025 we made a prepayment of $200 million on Term Loan A, which was paid with the proceeds from the sale of our IV Solutions business, see Note 4: Assets Held For Sale and Disposal of Business.
Interest Payments
Interest payments on Base Rate Loans are payable quarterly in arrears on the last business day of each calendar quarter and the applicable maturity date. Interest periods on Term SOFR Loans are determined, at our option, as either one, three or six months and will be payable on the last day of each interest period and the applicable maturity date. In the case of any interest periods of more than three months' duration, the interest payment are payable on each day prior to the last day of such interest period that occurs at three-month intervals.
The commitment fee on the Revolving Credit Facility is payable quarterly in arrears on the third business day following the last day of each calendar quarter and at the maturity date. The commitment fee is included in interest expense in our condensed consolidated statements of operations.
Guarantors and Collateral
Our obligations under the Credit Agreement are unconditionally guaranteed, on a joint and several basis, by ICU Medical, Inc. and certain of our existing subsidiaries.
Debt Covenants
The Credit Agreement contains affirmative and negative covenants, including certain financial covenants. The negative covenants include restrictions regarding the incurrence of liens and indebtedness, certain merger and acquisition transactions, asset sales and other dispositions, other investments, dividends, share purchases and payments affecting subsidiaries, changes in nature of business, fiscal year or organizational documents, prepayments and redemptions of subordinated and other junior debt, transactions with affiliates, and other matters.
The financial covenants include the Senior Secured Leverage Ratio and the Interest Coverage Ratio, both defined below, and pertain to the Term Loan A and the Revolving Credit Facility.
The Senior Secured Leverage Ratio is defined, at any measurement date, as the ratio of: (a) all Funded Debt, as defined in the Credit Agreement, that is secured by a lien on any asset or property minus the lesser of (i) all unrestricted cash and cash equivalents and (ii) $500.0 million, to (b) Consolidated EBITDA, as defined in the Credit Agreement, for the most recently completed four fiscal quarters, calculated on a pro forma basis. The maximum Senior Secured Leverage Ratio is 4.50 to 1.00 until June 30, 2024. Thereafter, the maximum Senior Secured Leverage Ratio is 4.00 to 1.00, with limited permitted exception.
The Interest Coverage ratio is defined, at any measurement date, as the ratio of Consolidated EBITDA, as defined in the Credit Agreement, to Consolidated Interest Expense, as defined in the Credit Agreement, paid or payable in cash, for the most recently completed four fiscal quarters. The minimum Interest Coverage ratio is 3.00 to 1.00.
We were in compliance with all financial covenants as of June 30, 2025.
The Credit Agreement contains customary events of default, including, among others: non-payments of principal and interest; breach of representations and warranties; covenant defaults; cross-defaults and cross-acceleration to certain other material indebtedness; the existence of bankruptcy or insolvency proceedings; certain events under ERISA; material judgments; and a change of control. If an event of default occurs and is not cured within any applicable grace period or is not waived, the administrative agent and the Lenders are entitled to take various actions, including, without limitation, the acceleration of all amounts due and the termination of commitments under the Senior Secured Credit Facilities.
The carrying values of our long-term debt consist of the following (in thousands):
| Effective Interest Rate | As of June 30, 2025 | Effective Interest Rate | As of December 31, 2024 | |
|---|---|---|---|---|
| Senior Secured Credit Facilities: | ||||
| Term Loan A — principal | 7.16% | $559,688 | 8.03% | $770,313 |
| Term Loan B — principal | 7.50% | 789,500 | 8.38% | 826,625 |
| Revolving Credit Facility — principal | —% | — | —% | — |
| Less unamortized debt issuance costs(1) | (11,457) | (14,080) | ||
| Total carrying value of long-term debt | 1,337,731 | 1,582,858 | ||
| Less current portion of long-term debt | — | 51,000 | ||
| Long-term debt, net | $1,337,731 | $1,531,858 | ||
(1)Comprised of $4.4 million and $7.0 million relating to the Term Loan A and the Term Loan B, respectively, as of June 30, 2025. Comprised of $6.1 million and $8.0 million relating to the Term Loan A and the Term Loan B, respectively, as of December 31, 2024.
As of June 30, 2025, the aggregate amount of principal repayments of our long-term debt (including any current portion) for each of the next five years and thereafter is approximately (in thousands):
| Remainder of 2025 | $— |
| 2026 | — |
| 2027 | 559,688 |
| 2028 | — |
| 2029 | 789,500 |
| 2030 | — |
| Total | $1,349,188 |
The following table presents the total interest expense related to our long-term debt (in thousands):
| Three months ended June 30, | Six months ended June 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Contractual interest | $23,868 | $31,851 | $50,756 | $64,126 |
| Amortization of debt issuance costs | 1,783 | 1,704 | 3,483 | 3,411 |
| Commitment fee — Revolving Credit Facility | 342 | 379 | 717 | 758 |
| Total long-term debt-related interest expense | $25,993 | $33,934 | 54,956 | 68,295 |
We currently hedge against the contractual interest expense on our long-term debt (see Note 9: Derivatives and Hedging Activities).
Note 19: Stockholders' Equity
Treasury Stock
In August 2019, our Board approved a share purchase plan to purchase up to $100.0 million of our common stock. This plan has no expiration date. During the three months ended June 30, 2025 and 2024, we did not purchase any shares of our common stock under our share purchase plan. As of June 30, 2025, all of the $100.0 million available for purchase was remaining under the plan. We are currently limited on share purchases in accordance with the terms and conditions of our Credit Agreement (see Note 18: Long-Term Debt).
For the six months ended June 30, 2025, we withheld 61,066 shares of our common stock from employee vested restricted stock units in consideration for $8.7 million in payments made on the employees' behalf for their minimum statutory income tax withholding obligations. For the six months ended June 30, 2024, we withheld 112,876 shares of our common stock from employee vested restricted stock units in consideration for $11.7 million in payments made on the employees' behalf for their minimum statutory income tax withholding obligations. Treasury stock is used to issue shares for stock option exercises and restricted stock grants.
Accumulated Other Comprehensive (Loss) Income ("AOCI")
The components of AOCI, net of tax, were as follows (in thousands):
| Foreign Currency Translation Adjustments | Unrealized Losses on Cash Flow Hedges | Other Adjustments | Total | |
|---|---|---|---|---|
| Balance as of January 1, 2025 | $(146,942) | $5,722 | $1,819 | $(139,401) |
| Other comprehensive income (loss) beforereclassifications | 39,890 | (3,260) | — | 36,630 |
| Amounts reclassified from AOCI | — | (2,624) | — | (2,624) |
| Other comprehensive income (loss) | 39,890 | (5,884) | — | 34,006 |
| Balance as of March 31, 2025 | $(107,052) | $(162) | $1,819 | $(105,395) |
| Other comprehensive income (loss) before reclassifications | 81,569 | (6,524) | — | 75,045 |
| Amounts reclassified from AOCI | — | (2,292) | — | (2,292) |
| Other comprehensive income (loss) | 81,569 | (8,816) | — | 72,753 |
| Balance as of June 30, 2025 | $(25,483) | $(8,978) | $1,819 | $(32,642) |
| Foreign Currency Translation Adjustments | Unrealized Gains (Losses) on Cash Flow Hedges | Other Adjustments | Total | |
|---|---|---|---|---|
| Balance as of January 1, 2024 | $(76,784) | $21,884 | $1,819 | $(53,081) |
| Other comprehensive (loss) income beforereclassifications | (22,817) | 13,908 | — | (8,909) |
| Amounts reclassified from AOCI | — | (7,548) | — | (7,548) |
| Other comprehensive (loss) income | (22,817) | 6,360 | — | (16,457) |
| Balance as of March 31, 2024 | $(99,601) | $28,244 | $1,819 | $(69,538) |
| Other comprehensive (loss) income before reclassifications | (15,865) | 436 | — | (15,429) |
| Amounts reclassified from AOCI | — | (6,818) | — | (6,818) |
| Other comprehensive loss | (15,865) | (6,382) | — | (22,247) |
| Balance as of June 30, 2024 | $(115,466) | $21,862 | $1,819 | $(91,785) |
Note 20: Commitments and Contingencies
Legal Proceedings
From time to time, we are involved in various legal proceedings, most of which are routine litigation, in the normal course of business. Our management does not believe that the resolution of the unsettled legal proceedings that we are involved with will have a material adverse impact on our financial position or results of operations.
Off-Balance Sheet Arrangements
In the normal course of business, we have agreed to indemnify our officers and directors to the maximum extent permitted under Delaware law and to indemnify customers as to certain intellectual property matters or other matters related to sales of our products. There is no maximum limit on the indemnification that may be required under these agreements.
Although we can provide no assurances, we have never incurred, nor do we expect to incur, any material liability for indemnification.
Contingencies
Prior to being acquired, during 2021, Smiths Medical received a Warning Letter from the U.S. Food and Drug Administration ("FDA") following an inspection of Smiths Medical’s Oakdale, Minnesota Facility (the "2021 Warning Letter"). The 2021 Warning Letter cited, among other things, failures to comply with FDA's medical device reporting requirements and failures to comply with applicable portions of the Quality System Regulation. A provision for the estimated costs related to the field service corrective actions identified as of the closing date of the acquisition was recorded on the opening acquired balance sheet of Smiths Medical in the amount of $55.1 million. The initial estimate recorded was based on a probability-weighted estimate of the costs required to settle the obligation related to known field corrective actions. The actual costs to be incurred are dependent upon the scope of the work necessary to achieve regulatory clearance, including potential additional field corrective actions, and could differ from the original estimate. For the three and six months ended June 30, 2025, we recorded a net reversal to the provision of $2.4 million and $0.7 million, respectively, to adjust the estimated cost to complete the field corrective actions to the amounts expected to be incurred based on historical experience. As of June 30, 2025, approximately $25.8 million of the $32.6 million of accrued field service corrective action recorded was related to the 2021 Warning Letter.
In 2015, legislation was enacted in Italy which requires medical device companies to make payments to the Italian government if Italy's medical device expenditures for certain years exceeded annual regional expenditure ceilings. Since its enactment, the legislation has been subject to appeals in the Italian court system. In the third quarter of 2024, Italy's Constitutional Court issued two judgments, one of which confirmed the legitimacy of the legislation on the Italy Medical Device Payback ("IMDP"); however, litigation proceedings are still pending and the ultimate resolution remains unknown. Recent examination of the legislation by the Italian Government has prompted potential amendments that if converted into law, could result in an opportunity for companies to settle certain historical periods (2015-2018) for less than the original assessed value. Therefore, the timing and amount of payments could ultimately differ from our current expectations (see Note 16: Accrued Liabilities for details on amounts accrued for potential payments related to the IMDP).
In April 2025, the Company received a warning letter from the FDA following an inspection of Smiths Medical's Oakdale, Minnesota Facility that occurred from July 23, 2024 through August 9, 2024 (the "2025 Warning letter"). The 2025 Warning Letter noted changes the Company made to the MedFusion™ Model 4000 Syringe Infusion Pump and CADD™ Solis VIP Ambulatory Infusion Pump that could affect the safety or effectiveness of these devices and therefore require new 510(k) clearance. The Company is seeking clearance for its next generation of MedFusion and CADD infusion pumps and submitted 510(k) applications to the FDA in July 2025. The Company cannot, however, give any assurances that the FDA will be satisfied with its response or its expected timing to address the matters cited in the 2025 Warning Letter. Until the matters cited in the 2025 Warning Letter are resolved to the FDA’s satisfaction, additional legal or regulatory action may be taken without further notice. As a result, the outcome and the financial impact of the 2025 Warning Letter cannot be predicted at this time. Accordingly, no loss contingency has been recorded for the 2025 Warning Letter, and the likelihood of loss is not considered probable and reasonably estimable as of June 30, 2025.
Commitments
We have non-cancelable operating lease agreements where we are contractually obligated to pay certain lease payment amounts (see Note 7: Leases).
Note 21: Collaborative and Other Arrangements
On February 3, 2017, we entered into two Manufacturing and Supply Agreements ("MSAs") whereby (i) Pfizer would manufacture and supply us with certain agreed upon products for an initial five-year term with a one-time two-year option to extend and (ii) we will manufacture and supply Pfizer certain agreed upon products for a term of five or ten years depending on the product, also with a one-time two-year option to extend. We no longer purchase products from Pfizer under the MSA as described in (i) above.
The MSA described in (ii) above provides each party with mutually beneficial interests and is jointly managed by both Pfizer and ICU. On January 1, 2021, we amended our MSA with Pfizer, whereby we manufacture and supply certain agreed upon products to Pfizer. The MSA was amended on December 31, 2024 to extend the term through 2027 for certain Solutions and Abboject products and ICU’s rights and obligations relating to such Solutions products have been assigned as of January 24, 2025 to the joint venture. The terms of the MSA with Pfizer relating to ICU are immaterial. Changes to the terms of the MSA include (i) amendments to our level of supply of products to Pfizer and (ii) updates to our supply price for 2025.
Note 22: Accounts Receivable Purchase Program
On January 19, 2023, we entered into a revolving $150 million uncommitted receivables purchase agreement with Bank of The West, which was subsequently acquired by BMO Bank, N.A. ("BMO") in February 2023. This agreement provided for a less expensive form of capital. The discount rate applied to the sold receivables equals a rate per annum equal to the sum of (i) an applicable margin, plus (ii) Term SOFR for a period equal to the discount period which is calculated with respect to the payment terms of the specific receivable. The accounts receivable sold have payment terms ranging between 30 and 60 days, and are related to customer accounts with good credit history. The transfer of the purchased accounts receivable under the agreement is intended to be an absolute and irrevocable transfer constituting a true sale as the transferred receivables have been isolated beyond the reach of the Company and our creditors, even in bankruptcy or other receivership. We do not retain effective control over the sold receivables and BMO has the right upon purchase to pledge and/or exchange the transferred assets without restrictions. The Company acts as collection agent for BMO and collection services are undertaken by our accounts receivable personnel in their normal course of business and collected funds are remitted to BMO. We do not have any continuing involvement with the sold receivables other than the collection services which does not provide us with more than a trivial benefit. The discount rate has been negotiated net of consideration for the collection services, the cost of collection is immaterial to the Company; therefore, we did not separately record any related servicing assets or liabilities related to the sold receivables.
The following table presents information in connection with the purchase program (in thousands):
| Three months ended June 30, | Six months ended June 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Trade receivables sold(1) | $10,009 | $172,755 | $10,009 | $348,447 |
| Cash received in exchange for trade receivables sold(2) | 9,978 | 171,682 | 9,978 | 346,282 |
| Loss on sale of receivables(3) | 32 | 1,073 | 32 | 2,165 |
(1)Represents carrying value of trade receivables sold to BMO.
(2) Cash proceeds received from BMO.
(3) Reflected in other expense, net in our condensed consolidated statement of operations.
As of June 30, 2025, cash remaining to be collected on behalf of BMO was $10.0 million which has been removed from our condensed consolidated balance sheets as of June 30, 2025 and is reflected as cash provided by operating activities in the condensed consolidated statement of cash flows in each respective period. As of December 31, 2024, we were not actively utilizing the program and there were no outstanding balances to be collected on behalf of BMO.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.