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ICU MEDICAL INC/DE

ICUI
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Business Summary

ICU Medical, Inc. develops, manufactures, and sells innovative medical products used in infusion therapy, vascular access, and vital care applications. The company's primary customers are acute care hospitals, wholesalers, ambulatory clinics and alternate site facilities, such as outpatient clinics, home health care providers, and long-term care facilities. The industry is highly competitive, with competition based on brand recognition, product quality, price, and innovation. The company believes its ability to effectively compete is determined by its ability to provide a wide breadth of cost-effective, high quality products. The smart pump market in recent years has been troubled with security concerns and product recalls.

Primary competitors named in the filing include Becton Dickinson, Baxter International, B. Braun Medical, Angiodynamics, Teleflex, EquaShield, Medtronic, Moog Medical, Fresenius Kabi, Edwards Lifesciences, Belmont, Medical Technologies, and Intersurgical plc. The company believes its ability to compete depends upon numerous factors including continued product innovation, the quality, convenience and reliability of its products, access to distribution channels, patent protection and pricing. The company believes the added breadth of its acquired product portfolios have increased its competitiveness as it can now provide a one-stop shop for customers and offer more flexible competitive pricing. The company also believes its infusion pump product offering will enable it to achieve sales of a larger volume of higher margin infusion consumables, and it believes it has a wider customer reach through its unified distribution channels.

The company generates revenue through the manufacture and sale of medical products used in infusion therapy, vascular access, and vital care applications. Revenue is recognized when control of promised goods is transferred to customers, which for the majority of sales is deemed to be at point of shipment. The company sells globally through its own direct sales force and through independent distributors, serving customers in over 100 countries. The majority of sales are denominated in U.S. dollars, with some sales denominated in Euros, Canadian dollars, Japanese Yen, British Pound and Australian dollars as well as other currencies. In 2025, 2024, and 2023, worldwide net sales to a single distributor accounted for 18%, 18%, and 16% of consolidated net sales, respectively.

The Consumables business unit includes Infusion Therapy, Oncology, Vascular Access and Tracheostomy products. Infusion Therapy products include non-dedicated infusion sets, extension sets, needle-free connectors, and disinfection caps, with primary products including the Clave needlefree products, Neutron catheter patency device, Tego needlefree connector, and ClearGuard, SwabCap and SwabTip disinfection caps. Oncology products include ChemoLock CSTD, ChemoClave CSTD, and Deltec GRIPPER non-coring needles for portal access. Vascular Access products include Jelco safety and conventional peripheral IV catheters, Safe-T Wing venipuncture and blood collection devices, Port-A-Cath implantable ports, Portex arterial blood sampling syringes, PowerWand midline catheters, and Cleo subcutaneous infusion catheters and sets. Tracheostomy products include Portex BLUselect PVC tracheostomy tubes, Portex Bivona silicone tracheostomy tubes, and Portex BLUperc percutaneous insertion kits. Consumables revenue was $1,109.2 million in 2025, $1,038.9 million in 2024, and $969.1 million in 2023.

The Infusion Systems business unit offers a comprehensive portfolio of infusion pumps, dedicated IV sets, software and professional services. Large Volume Pump hardware includes the Plum Duo and Plum Solo precision infusion pumps, which received FDA 510(k) clearance in April 2025, and the Plum 360 infusion pumps. Ambulatory Infusion Hardware includes CADD ambulatory infusion pumps and disposables. Syringe Infusion Hardware includes Medfusion syringe infusion pumps. IV Medication Safety Software includes LifeShield infusion safety software, ICU Medical MedNet software, and PharmGuard medication safety software. Professional services teams work with customers to develop safe and efficient infusion systems. Infusion Systems revenue was $684.2 million in 2025, $652.4 million in 2024, and $629.0 million in 2023. The Vital Care business unit includes IV Solutions, Hemodynamic Monitoring, General Anesthesia and Respiratory, Temperature Management Solutions and Regional Anesthesia/Pain Management products. IV Solutions products include a broad portfolio of injection, irrigation, nutrition and specialty IV solutions. Hemodynamic Monitoring products include the Cogent 2-in-1 system, CardioFlo system, TDQ and OptiQ catheters, TriOx catheters, Transpac transducers, SafeSet system, and MEDEX LogiCal system. General Anesthesia & Respiratory products include Portex acapella bronchial hygiene products. Temperature Management solutions include Level 1 rapid infusion and fluid warming products. Regional Anesthesia/Pain Management Trays include Epidural, Spinal, Combined, Peripheral Nerve Block, and Specialty Trays. Vital Care revenue was $437.9 million in 2025, $690.7 million in 2024, and $661.0 million in 2023.

In November 2024, the company entered into a purchase agreement with Otsuka Pharmaceutical Factory America, Inc. to divest a controlling interest in its IV Solutions business. In April 2025, ICU Medical Pearl LLC (n/k/a Otsuka ICU Medical LLC) was formed, and the assets, liabilities and operations comprising the IV Solutions product line were transferred to the joint venture. In May 2025, upon closing, the company sold a 60% ownership interest in the joint venture to OPF and retained a 40% ownership interest. The total sales price, inclusive of final price adjustments, was $211.2 million , of which $200.0 million of the proceeds were used to pay down a portion of outstanding Term Loan A long-term debt during the second quarter of 2025. On October 31, 2025, the company amended its Existing Credit Agreement to refinance its existing Term Loan A and Revolving Credit Facilities, including a new five-year term loan A facility of $750.0 million and a new five-year revolving credit facility of $500.0 million . The proceeds from the new Term Loan A were primarily used to directly repay in full the $559.7 million of outstanding principal of the existing Term Loan A and directly repay $190.0 million of the outstanding balance of the Term Loan B. During 2025, the company made total prepayments of $290.0 million on its long-term debt. The company's common stock purchase plan, authorizing the repurchase of up to $100.0 million of common stock, had all $100.0 million remaining available for purchase as of December 31, 2025.

Total revenues were $2.2 billion in 2025, $2.4 billion in 2024, and $2.3 billion in 2023. Gross margins were 36.8% , 34.6% , and 32.8% for 2025, 2024, and 2023, respectively. Net income (loss) was $0.7 million in 2025, $(117.7) million in 2024, and $(29.7) million in 2023. Diluted EPS was $0.03 in 2025, $(4.83) in 2024, and $(1.23) in 2023. Cash provided by operations was $179.8 million in 2025, $204.0 million in 2024, and $166.2 million in 2023.

Business Outlook

The company estimates that capital expenditures in 2026 will be in the range of $85 million to $100 million . The company estimates the investment needed in 2026 for restructuring and integration expenses along with spending to support quality systems and quality compliance objectives to be in the range of $60 million to $80 million , which includes acquired accrued field action liabilities.

The company continues to execute several integration initiatives, including remaining enterprise systems conversions, manufacturing plant consolidation efforts and supply chain integration projects related to the Smiths Medical acquisition. The company has filed a 510(k) application for new clearance for a refreshed CADD infusion pump in July 2025 and has filed a 510(k) application for new clearances for the next generation MedFusion infusion pump in July 2025. The company expects to order semi-automated or fully automated assembly machines for certain products in 2026. The company anticipates making additional investments in machinery and equipment in its manufacturing operations in Costa Rica, Europe, Mexico and the U.S. to support new and existing products and in infusion pumps that get placed with customers outside the U.S.

The increase in gross margin in 2025, as compared to 2024, was primarily driven by the impact of the sale of a 60% interest of the IV Solutions business, which is a lower margin business, as well as price increases, the impact of foreign exchange rates, lower supply chain costs and the realization of integration synergies. These improvements were partially offset by an increase in IEEPA tariff costs of $25.7 million in 2025. During 2025, the company incurred $33.6 million in incremental reciprocal tariffs as a result of tariffs imposed by the U.S. Administration in 2025, of which $7.9 million was capitalized and $25.7 million was expensed.

The company's manufacturing facilities are concentrated in the United States, Costa Rica, Mexico, and Czech Republic. The company operates regional device service centers in Salt Lake City, Utah; Grasbrunn, Germany; San Laurent, Quebec, Canada; Taipei, Taiwan; and Rydalmere, Australia. The company purchases many components and raw materials from numerous suppliers in various countries, with certain components and raw materials available only from a single supplier. The company currently attempts to manage the risk associated with such suppliers by means of inventory management, relationship management and evaluation of alternative sources when feasible.

Research and development costs were $87.5 million in 2025, $88.6 million in 2024, and $85.3 million in 2023. The company estimates that capital expenditures in 2026 will be in the range of $85 million to $100 million . The company's common stock purchase plan, which authorized the repurchase of up to $100.0 million of its common stock, was approved by the Board of Directors in August 2019 and has no expiration date. As of December 31, 2025, all of the $100.0 million available for purchase was remaining under the plan. The company has never paid dividends and does not anticipate paying dividends in the foreseeable future as the Board of Directors intends to retain future earnings for use in the business to pay down long-term debt or to purchase shares.

The U.S. administration has continued to engage in trade discussions and impose tariffs on imports from other countries. On July 31, 2025, the U.S. announced that the 10% baseline reciprocal tariff on imports from all countries would be raised to 15% for certain countries, including Costa Rica. The majority of global revenues are from products manufactured in Costa Rica and Mexico manufacturing facilities and imported into the U.S. The tariffs as currently implemented are likely to have a material impact on the company's business, financial condition and results of operations. In September 2025, the U.S. Commerce Department initiated a national security investigation into imports of medical consumables and equipment under Section 232 of the Trade Expansion Act, which could result in potential tariffs imposed in addition to the country-based tariffs and/or could reduce the benefits received from currently available exemptions such as the USMCA. The company faces exposure to adverse movements in foreign currency exchange rates due to its operations in foreign markets, with primary exposures currently with the Euro, Mexican Peso, Canadian Dollar, Czech Koruna, Costa Rican Colon, Japanese Yen, Chinese Renminbi, and the Australian Dollar against the U.S. dollar.

Risk Factors

The company derives a significant portion of its revenues from non-U.S. sales and from products manufactured at its non-U.S. facilities which are then imported to the U.S., making it subject to risks related to tariffs, retaliatory counter measures and further escalation of trade tensions. During 2025, the company incurred $33.6 million in incremental reciprocal tariffs. The company is dependent on single and limited source third-party suppliers, which subjects its business to risks of supplier business interruptions. The company received a warning letter from the FDA on April 4, 2025 regarding certain modifications made to its cleared MedFusion Model 4000 Syringe Infusion Pump and CADD Solis VIP Ambulatory Infusion Pump, and there is no guarantee it will be able to close out this warning letter in a timely manner. The company has a substantial amount of debt, with long-term debt outstanding of $1.3 billion at December 31, 2025, which could adversely affect its business by restricting its ability to engage in additional transactions or incur additional indebtedness. The company's ability to compete depends on continued product innovation, and the medical device industry is characterized by rapid product development and technological advances, placing its products at risk of obsolescence.

Management Priorities

Management's message emphasizes the company's focus on providing quality, innovation and value to clinical customers worldwide. The company's strategic priorities include completing the integration of the Smiths Medical business, resolving the FDA warning letter received on April 4, 2025 regarding modifications to the MedFusion Model 4000 Syringe Infusion Pump and CADD Solis VIP Ambulatory Infusion Pump, and managing the impact of tariffs and trade policy changes. Management believes the company will be able to ultimately close out the warning letter, though there is no guarantee it will be able to do so in a timely manner. The company estimates capital expenditures in 2026 will be in the range of $85 million to $100 million and estimates the investment needed in 2026 for restructuring and integration expenses along with spending to support quality systems and quality compliance objectives to be in the range of $60 million to $80 million .

View Source Annual Report on SEC.gov ↗

References

  1. [1] Item 7, MD&A — Consumables
  2. [2] Item 7, MD&A — Consumables
  3. [3] Item 7, MD&A — Consumables
  4. [4] Item 7, MD&A — Infusion Systems
  5. [5] Item 7, MD&A — Infusion Systems
  6. [6] Item 7, MD&A — Infusion Systems
  7. [7] Item 7, MD&A — Vital Care
  8. [8] Item 7, MD&A — Vital Care
  9. [9] Item 7, MD&A — Vital Care
  10. [10] Item 7, MD&A — Disposition of our IV Solutions Business
  11. [11] Item 7, MD&A — Disposition of our IV Solutions Business
  12. [12] Item 7, MD&A — Credit Facilities and Access to Capital
  13. [13] Item 7, MD&A — Credit Facilities and Access to Capital
  14. [14] Item 7, MD&A — Credit Facilities and Access to Capital
  15. [15] Item 7, MD&A — Credit Facilities and Access to Capital
  16. [16] Item 7, MD&A — Fiscal 2025 Principal Pre-Payments
  17. [17] Item 5, Market for Registrant's Common Equity
  18. [18] Item 5, Market for Registrant's Common Equity
  19. [19] Item 7, MD&A — Consolidated Results of Operations
  20. [20] Item 7, MD&A — Consolidated Results of Operations
  21. [21] Item 7, MD&A — Consolidated Results of Operations
  22. [22] Item 7, MD&A — Gross Margins
  23. [23] Item 7, MD&A — Gross Margins
  24. [24] Item 7, MD&A — Gross Margins
  25. [25] Item 8, Consolidated Statements of Operations
  26. [26] Item 8, Consolidated Statements of Operations
  27. [27] Item 8, Consolidated Statements of Operations
  28. [28] Item 8, Consolidated Statements of Operations
  29. [29] Item 8, Consolidated Statements of Operations
  30. [30] Item 8, Consolidated Statements of Operations
  31. [31] Item 7, MD&A — Historical Cash Flows
  32. [32] Item 7, MD&A — Historical Cash Flows
  33. [33] Item 7, MD&A — Historical Cash Flows
  34. [34] Item 7, MD&A — Capital Expenditures
  35. [35] Item 7, MD&A — Capital Expenditures
  36. [36] Item 7, MD&A — Other Future Capital Investments
  37. [37] Item 7, MD&A — Other Future Capital Investments
  38. [38] Item 7, MD&A — Gross Margins
  39. [39] Item 7, MD&A — 2025 Events
  40. [40] Item 7, MD&A — 2025 Events
  41. [41] Item 7, MD&A — 2025 Events
  42. [42] Item 1, Business — Research and Development
  43. [43] Item 1, Business — Research and Development
  44. [44] Item 1, Business — Research and Development
  45. [45] Item 7, MD&A — Capital Expenditures
  46. [46] Item 7, MD&A — Capital Expenditures
  47. [47] Item 5, Market for Registrant's Common Equity
  48. [48] Item 5, Market for Registrant's Common Equity
  49. [49] Item 7, MD&A — 2025 Events
  50. [50] Item 7, MD&A — Credit Facilities and Access to Capital
  51. [51] Item 7, MD&A — Capital Expenditures
  52. [52] Item 7, MD&A — Capital Expenditures
  53. [53] Item 7, MD&A — Other Future Capital Investments
  54. [54] Item 7, MD&A — Other Future Capital Investments
  55. [55] Item 8, Consolidated Statements of Operations
  56. [56] Item 8, Consolidated Statements of Operations
  57. [57] Item 8, Consolidated Statements of Operations
  58. [58] Item 8, Consolidated Statements of Operations
  59. [59] Item 8, Consolidated Statements of Operations
  60. [60] Item 8, Consolidated Statements of Operations
  61. [61] Item 8, Consolidated Statements of Operations
  62. [62] Item 8, Consolidated Statements of Operations
  63. [63] Item 8, Consolidated Statements of Operations
  64. [64] Item 8, Consolidated Statements of Operations
  65. [65] Item 8, Consolidated Statements of Operations
  66. [66] Item 8, Consolidated Statements of Operations
  67. [67] Item 7, MD&A — Gross Margins
  68. [68] Item 7, MD&A — Gross Margins
  69. [69] Item 7, MD&A — Gross Margins
  70. [70] Item 8, Consolidated Statements of Operations
  71. [71] Item 8, Consolidated Statements of Operations
  72. [72] Item 8, Consolidated Statements of Operations
  73. [73] Item 8, Consolidated Balance Sheets
  74. [74] Item 8, Consolidated Balance Sheets
  75. [75] Item 8, Consolidated Balance Sheets
  76. [76] Item 8, Consolidated Balance Sheets
  77. [77] Item 8, Consolidated Statements of Operations
  78. [78] Note 3, Assets Held For Sale and Disposal of Business
  79. [79] Note 3, Assets Held For Sale and Disposal of Business
  80. [80] Note 3, Assets Held For Sale and Disposal of Business
  81. [81] Item 8, Consolidated Statements of Operations
  82. [82] Item 8, Consolidated Statements of Operations
  83. [83] Item 8, Consolidated Statements of Operations
  84. [84] Item 8, Consolidated Statements of Operations
  85. [85] Item 8, Consolidated Statements of Operations
  86. [86] Item 8, Consolidated Statements of Operations
  87. [87] Note 4, Revenue
  88. [88] Note 4, Revenue
  89. [89] Note 4, Revenue
  90. [90] Note 4, Revenue
  91. [91] Note 4, Revenue
  92. [92] Note 4, Revenue
  93. [93] Note 4, Revenue
  94. [94] Note 4, Revenue
  95. [95] Note 4, Revenue

Analysis on 9/27/2026