ICU Medical(ICUI)

Search documents
ICUI Stock Gains Following Latest FDA Approvals for Precision IV Pumps
ZACKS· 2025-04-08 17:05
ICU Medical, Inc. (ICUI) , yesterday, announced the FDA’s 510(k) clearance for the Plum Solo precision IV pump, a single-channel complement to the dual-channel Plum Duo. The company also received the 510(k) clearance for updated versions of the Plum Duo precision IV pump and LifeShield infusion safety software, completing the initial launch of the ICU Medical IV Performance Platform.The Plum Solo expands the capabilities of the IV Performance Platform by offering a single-channel pump designed to work along ...
ICU Medical Introduces Its New Category of Infusion Devices With FDA Clearances of Plum Solo™ and Plum Duo™ Precision IV Pumps
Prnewswire· 2025-04-07 12:00
New devices address infusion delivery variability and expand the ICU Medical IV Performance Platform. SAN CLEMENTE, Calif., April 7, 2025 /PRNewswire/ -- ICU Medical Inc. (NASDAQ:ICUI), a worldwide leader in the development, manufacture and sale of innovative medical devices, has announced 510(k) regulatory clearance from the U.S. Food and Drug Administration (FDA) for the Plum Solo™ precision IV pump, a single-channel complement to the dual-channel Plum Duo™. ICU Medical also received 510(k) clearance for ...
ICU Medical to Present at the 24th Annual Needham Virtual Healthcare Conference
GlobeNewswire· 2025-03-24 12:30
SAN CLEMENTE, Calif., March 24, 2025 (GLOBE NEWSWIRE) -- ICU Medical (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical products, today announced that Company management will present at the 24th Annual Needham Virtual Healthcare Conference being held April 7-10, 2025. ICU Medical’s presentation will be on Monday, April 7, 2025 at 8:00 a.m. PT (11:00 a.m. ET). Company management will also be participating in one-on-one meetings on Monday, April 7, 2025. The presentation wi ...
ICU Medical to Participate at the KeyBanc Healthcare Forum
Newsfilter· 2025-03-07 13:40
Group 1 - ICU Medical will participate in a fireside chat at the KeyBanc Healthcare Forum on March 19, 2025, at 8:15 a.m. PT (11:15 a.m. ET) [1] - The fireside chat will be available for live webcast and replay on the company's website [2] - ICU Medical is a global leader in infusion systems and critical care products, focusing on quality, innovation, and value for clinical customers [3]
ICU Medical(ICUI) - 2024 Q4 - Earnings Call Transcript
2025-02-28 10:18
Financial Data and Key Metrics Changes - Revenue for Q4 was $622 million, representing a total company growth of 9% on a constant currency basis or 8% reported, aided by a temporary shortage in IV Solutions [9][10] - Adjusted EBITDA was $106 million, an increase of 22% compared to $86 million last year [27] - Adjusted diluted earnings per share (EPS) for the quarter was $2.11, compared to $1.57 last year [25] Business Segment Data and Key Metrics Changes - Consumables business grew 6% both in constant currency and reported terms in Q4 [11] - IV Systems business grew 7% reported and 4% constant currency, marking the best absolute quarter in pumps [12] - Vital Care segment grew 16% on a constant currency and reported basis, primarily due to the national shortage in IV Solutions [13] Market Data and Key Metrics Changes - The broader demand and utilization environment in Q4 remained solid across almost every geography [10] - The capital environment is stable, with necessary investments being completed [10] Company Strategy and Development Direction - The company is preparing for a joint venture with Otsuka Pharmaceutical Factory, which is expected to enhance operational capabilities and customer service [14] - Focus on improving profitability through operational efficiencies and innovation in product offerings [44][49] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about achieving healthy revenue growth in all differentiated product lines and addressing under-earning issues [16][49] - The company aims to improve free cash flow and profitability by completing quality remediation and integration activities [40][53] Other Important Information - The company expects the IV Solutions JV transaction to close in the second quarter of 2025, impacting financial reporting [29][30] - Anticipated reduction in adjusted revenue of $350 million and adjusted EBITDA of $25 million post-JV transaction [31] Q&A Session Summary Question: What is driving the growth in Consumables? - Management indicated that growth was driven by a combination of new installs, global growth, and pricing [60] Question: What was the EBITDA margin excluding IV Solutions in 2024? - Management did not disclose specific figures but suggested using reported revenue and EBITDA for estimates [62] Question: What is the demand environment for capital equipment? - Management noted that capital outlays are being made, and transactions are moving forward [80] Question: Can you elaborate on the balance sheet and leverage after the JV? - Management stated a comfortable leverage ratio around 2 times is targeted, with expected deleveraging from the JV transaction [92] Question: What are the drivers for achieving the $500 million EBITDA goal? - Management highlighted sustained revenue growth, gross margin improvements, and currency stabilization as key drivers [128]
ICU Medical(ICUI) - 2024 Q4 - Earnings Call Transcript
2025-02-28 03:57
ICU Medical, Inc. (NASDAQ:ICUI) Q4 2024 Earnings Conference Call February 27, 2025 4:30 PM ET Company Participants John Mills - ICR, IR Vivek Jain - Chairman and CEO Brian Bonnell - Chief Financial Officer Conference Call Participants Jayson Bedford - Raymond James Brett Fishbin - KeyBanc Capital Markets Charlie Strauzer - CJS Securities Michael Toomey - Jefferies Joseph Conway - Needham Operator Good day. And welcome to the ICU Medical, Inc. Fourth Quarter 2024 Earnings Conference Call. All participants wi ...
ICU Medical(ICUI) - 2024 Q4 - Earnings Call Presentation
2025-02-28 03:56
ICU Medical, Inc Q4 2024 Conference Call Presentation February 27, 2025 1 Disclosures 2 Warming Anesthesia & Resp Pain Kits Critical Care IV Solutions Infusion Therapy Oncology Vascular Access Consumables Infusion Systems Vital Care Ambulatory Syringe LVP Infusion Tracheostomy > Any statement concerning Management's expectation with respect to future results is a forward-looking statement based upon the best information currently available to Management and assumptions Management believes are reasonable, bu ...
ICU Medical (ICUI) Q4 Earnings and Revenues Top Estimates
ZACKS· 2025-02-28 00:25
Group 1 - ICU Medical reported quarterly earnings of $2.11 per share, exceeding the Zacks Consensus Estimate of $1.48 per share, and up from $1.57 per share a year ago, representing an earnings surprise of 42.57% [1] - The company achieved revenues of $621.62 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 3.95%, and an increase from $587.86 million year-over-year [2] - Over the last four quarters, ICU Medical has consistently surpassed consensus EPS and revenue estimates [2] Group 2 - The stock has underperformed the market, losing about 0.6% since the beginning of the year compared to the S&P 500's gain of 1.3% [3] - The current consensus EPS estimate for the upcoming quarter is $1.14 on revenues of $569.1 million, and for the current fiscal year, it is $6.94 on revenues of $2.23 billion [7] - The Zacks Industry Rank indicates that the Medical - Products sector is in the bottom 49% of over 250 Zacks industries, which may impact stock performance [8] Group 3 - The estimate revisions trend for ICU Medical is mixed, resulting in a Zacks Rank 3 (Hold), suggesting the stock is expected to perform in line with the market in the near future [6] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]
ICU Medical(ICUI) - 2024 Q4 - Annual Report
2025-02-27 22:24
Acquisition and Organizational Changes - The company completed the acquisition of Smiths Medical in January 2022, which has resulted in organizational changes and an increase in business size[19]. - The Smiths Medical acquisition in January 2022 has increased organizational size and complexity, requiring effective integration to maintain reputation[19]. - The company has incurred substantial debt to finance the Smiths Medical acquisition, which may restrict its ability to engage in additional transactions[19]. - The company has incurred substantial debt to finance the Smiths Medical acquisition, which may restrict future transactions[19]. Economic and Market Risks - The company faces significant risks from global macroeconomic conditions, including prolonged inflation and rising interest rates, which could adversely affect operations[17]. - Heightened inflation and rising interest rates have adversely affected operations, with potential future impacts[17]. - The company is subject to pressures to reduce healthcare costs, which may adversely affect pricing and profitability[17]. - The company must navigate pressures to reduce healthcare costs, which may affect pricing and profitability[17]. - International sales present additional risks related to competition and higher credit risk[19]. Supplier and Operational Risks - The company is dependent on single and limited source third-party suppliers, exposing it to risks of supplier interruptions and performance degradation[19]. - The company is dependent on limited third-party suppliers, exposing it to risks of business interruptions and performance degradation[19]. - The company faces significant risks including competition, demand decline, and inability to recover product development investments[13]. Regulatory and Compliance Risks - The company must comply with FDA regulations, and any failure could interrupt manufacturing operations and negatively impact sales[19]. - Compliance with FDA regulations is critical; failure to resolve existing warnings could lead to significant sanctions[17]. - The company has identified potential disruptions at the FDA and other agencies that could hinder product development and approval processes[19]. - Disruptions at government agencies could hinder product development and approval processes, negatively impacting business[17]. Financial Performance Risks - The company is exposed to risks related to foreign currency exchange rates, which could impact financial performance[19]. - Risks related to foreign currency exchange rates could adversely impact financial performance[19]. - The company anticipates challenges in recovering substantial investments in product development through commercial sales[17]. - The company emphasizes the importance of protecting its information technology systems against security breaches to avoid operational disruptions[19].
ICU Medical(ICUI) - 2024 Q4 - Annual Results
2025-02-27 21:10
Financial Performance - Fourth quarter 2024 revenue was $629.8 million, a 7.9% increase from $587.9 million in the same period last year[3] - GAAP gross profit for Q4 2024 was $227.3 million, compared to $171.6 million in Q4 2023, resulting in a gross margin of 36.1% versus 29.2%[3] - Adjusted EBITDA for Q4 2024 was $105.5 million, up from $86.3 million in Q4 2023[3] - Total revenues for the twelve months ended December 31, 2024, were $2.38 billion, an increase of $122.9 million from $2.26 billion in 2023[15] - Consumables revenue for Q4 2024 was $268.1 million, a $14.1 million increase from $254.0 million in Q4 2023[5] - The company reported a GAAP net loss of $(23.8) million for Q4 2024, compared to a net loss of $(17.1) million in Q4 2023[3] - Net loss for the twelve months ended December 31, 2024, was $117.688 million, compared to a net loss of $29.655 million in 2023[17] - Adjusted EBITDA for the three months ended December 31, 2024, was $105.515 million, up from $86.266 million in 2023, reflecting a year-over-year increase of about 22.3%[36] - The adjusted (non-GAAP) net income was $52.1 million, with diluted earnings per share of $2.11, compared to a net loss of $32.0 million and a diluted loss per share of $0.97 on a GAAP basis[37] - The adjusted income before income taxes was $90.2 million, which is 15% of total revenues, indicating a significant improvement from the previous period[37] Future Projections - For fiscal year 2025, the company estimates a GAAP net loss between $(45) million to $(28) million, translating to a net loss per share of $(1.81) to $(1.11)[7] - Excluding the impact from the IV Solutions joint venture, adjusted EBITDA for FY 2025 is expected to be between $395 million to $425 million, with adjusted EPS ranging from $6.55 to $7.25[8] - The IV Solutions joint venture is anticipated to close in Q2 2025, potentially reducing adjusted EBITDA guidance by $15 million to $20 million[8] - For fiscal year 2025, the company projects a GAAP net loss between $45 million and $28 million, with adjusted EBITDA expected to be between $395 million and $425 million[43] - The company anticipates total non-GAAP adjustments for fiscal year 2025 to be between $440 million and $453 million[43] - The projected GAAP loss per share for fiscal year 2025 is estimated to be between $(1.81) and $(1.11)[43] Cash Flow and Liquidity - Cash and cash equivalents increased to $308.6 million as of December 31, 2024, from $254.2 million a year earlier[13] - Net cash provided by operating activities increased to $204.033 million in 2024 from $166.201 million in 2023, representing an increase of approximately 22.7%[17] - Cash and cash equivalents at the end of the period increased to $308.566 million in 2024 from $254.222 million in 2023, marking a growth of approximately 21.4%[17] - The company reported a net cash used in investing activities of $88.960 million in 2024, slightly higher than $87.947 million in 2023[17] - Free cash flow for the three months ended December 31, 2023, was $16.162 million, with net cash provided by operating activities amounting to $40.192 million[41] Expenses and Costs - The company incurred $8.2 million in restructuring and strategic transaction costs, impacting the overall financial results[37] - Research and development expenses amounted to $22.4 million, accounting for 4% of total revenues[37] - The total operating expenses, including selling, general, and administrative expenses, were $158.8 million, which is approximately 25% of total revenues[37] - The company reported a restructuring, strategic transaction, and integration expense of $10.731 million for the three months ended December 31, 2023[40] - The quality system and product-related remediation costs amounted to $24.003 million for the same period[40] Debt and Financial Adjustments - Principal repayments of long-term debt increased to $51.000 million in 2024 from $29.688 million in 2023, indicating a significant rise of about 72.2%[17] - Total non-GAAP adjustments for the three months ended December 31, 2024, amounted to $129.343 million, compared to $103.413 million in 2023[36] - The provision for doubtful accounts increased to $5.800 million in 2024 from $0.838 million in 2023, showing a substantial rise of over 590%[17] - The company recorded a change in fair value of contingent earn-out of $(3.991) million during the reporting period[40] Exchange Rate Impact - The effect of exchange rate changes on cash resulted in a decrease of $4.929 million in 2024, contrasting with an increase of $3.163 million in 2023[17]