Financial Data and Key Metrics Changes - For Q1 2025, the company achieved revenue of $19.5 million, an 11% increase from $17.6 million in Q1 2024 [4][13] - Gross profit margin was reported at 76.1%, consistent with Q1 2024 [14] - GAAP diluted earnings per share increased by 16% to $0.37 from $0.32 in Q1 2024 [15] - Non-GAAP adjusted net income was $5.3 million or $0.42 per diluted share, up 17% from $4.6 million or $0.36 per diluted share in Q1 2024 [16] Business Line Data and Key Metrics Changes - Revenue from IV infusion pump systems grew 16% to $6 million, while disposable revenue increased 23% to $4.9 million [13][14] - Patient vital signs monitoring systems revenue remained steady at $6.5 million [14] - Service revenue remained stable at $1 million [14] Market Data and Key Metrics Changes - Domestic sales accounted for 82% of total revenue in Q1 2025, up from 76% in Q1 2024 [13] - Domestic revenue increased 19% to $16 million, while international sales declined 15% to $3.5 million [14] Company Strategy and Development Direction - The company is focused on increasing monitoring sales in 2025, anticipating a decline in pump revenues later in the year [22] - The new 3,870 MRIV pump is expected to contribute to revenue in 2026, with clearance anticipated in mid-2025 [10] - The company is nearing completion of a new facility, with full operations expected by July 2025 [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the impact of tariffs, noting that only 3% of revenue is linked to high-tariff sources [6][8] - The FDA's responsiveness has been positive, with ongoing interactions indicating progress towards device clearance [27] - The company expects Q2 2025 revenue guidance of $19.7 million to $19.9 million, with full-year revenue guidance of $78 million to $82 million [11][12] Other Important Information - Operating expenses increased to $9.4 million, primarily due to higher general and administrative costs [15] - Cash flow from operations was $4.3 million, up 10% from Q1 2024 [16] Q&A Session Summary Question: Inquiry about disposables performance - Management indicated that the strong disposable revenue was partly due to working down backlog and expects growth to align with capital growth [18][19] Question: Composition of bookings and monitoring sales recovery - Management confirmed strong bookings for monitoring systems in Q1 and early Q2, indicating confidence in recovery [21][24] Question: Status of FDA interactions and clearance timeline - Management provided updates on FDA interactions, indicating ongoing communication and a hopeful timeline for clearance within a few weeks [25][27]

Core Viewpoint - iRadimed (IRMD) reported quarterly earnings of $0.42 per share, slightly missing the Zacks Consensus Estimate of $0.43 per share, but showing an increase from $0.36 per share a year ago [1][2] Financial Performance - The company posted revenues of $19.51 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 0.26%, compared to $17.6 million in the same quarter last year [2] - Over the last four quarters, iRadimed has exceeded consensus revenue estimates four times [2] Stock Performance - iRadimed shares have declined approximately 2.8% since the beginning of the year, while the S&P 500 has seen a decline of 3.3% [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating it is expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.45 on revenues of $20.31 million, and for the current fiscal year, it is $1.79 on revenues of $80.81 million [7] - The trend of estimate revisions for iRadimed is mixed, which could change following the recent earnings report [6] Industry Context - The Medical - Instruments industry, to which iRadimed belongs, is currently ranked in the top 28% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

Financial Data and Key Metrics Changes - For Q1 2025, the company achieved revenue of $19.5 million, an 11% increase from $17.6 million in Q1 2024 [4][11] - Gross profit margin was reported at 76.1%, consistent with Q1 2024 [12] - GAAP diluted earnings per share increased by 16% to $0.37 from $0.32 in Q1 2024 [13] - Non-GAAP adjusted net income was $5.3 million or $0.42 per diluted share, up 17% from $4.6 million or $0.36 per diluted share in Q1 2024 [14] Business Line Data and Key Metrics Changes - Revenue from IV infusion pump systems grew 16% to $6 million, while disposable revenue increased 23% to $4.9 million [11][12] - Patient vital signs monitoring systems revenue remained steady at $6.5 million [12] - Domestic sales accounted for 82% of total revenue, up from 76% in Q1 2024, with domestic revenue increasing 19% to $16 million [12] Market Data and Key Metrics Changes - International sales declined 15% to $3.5 million [12] - Device revenue increased 9% to $13 million, driven by pump revenue and FMD systems [12] Company Strategy and Development Direction - The company is focused on increasing monitoring sales in 2025, anticipating a decline in pump revenues later in the year [21] - The new 3,870 MRIV pump is expected to be a revenue driver in 2026, with clearance anticipated in mid-2025 [9][10] - The company is nearing completion of a new facility, with full operations expected by July 2025 [10] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the impact of tariffs, noting that only 3% of revenue is connected to high tariff sources [6][7] - The FDA's responsiveness has been positive, with ongoing interactions indicating progress towards device clearance [25][27] - The company expects Q2 2025 revenue guidance of $19.7 million to $19.9 million, reiterating full-year revenue guidance of $78 million to $82 million [10] Other Important Information - Operating expenses were $9.4 million, or 48% of revenue, down from 49% in Q1 2024 [12] - Cash flow from operations was $4.3 million, up 10% from $3.9 million in Q1 2024 [14] Q&A Session Summary Question: Any anomalies in disposable revenue growth? - Management indicated that some backlog was worked down in Q1, contributing to the growth, but expects future growth to align with capital growth [17][18] Question: Confidence in monitoring sales recovery? - Management emphasized efforts to boost monitoring sales through adjusted compensation structures, with strong bookings already seen in Q2 [20][22] Question: Status of FDA interactions and clearance timeline? - Management noted ongoing interactive questions from the FDA, suggesting a positive sign, with expectations for clarity in the next three to four weeks [24][27]

[Financial Performance and Outlook](index=1&type=section&id=Financial%20Performance%20and%20Outlook) This section details IRADIMED's Q1 2025 financial performance, management commentary, guidance, and comprehensive financial analysis [Q1 2025 Financial Highlights](index=1&type=section&id=Q1%202025%20Financial%20Highlights) IRADIMED reported its fifteenth consecutive quarter of record revenue, reaching $19.5 million in Q1 2025, an 11% year-over-year increase, with GAAP diluted EPS growing 16% to $0.37 and non-GAAP diluted EPS rising 17% to $0.42 Q1 2025 Key Financial Metrics (YoY) | Metric | Q1 2025 (USD) | Q1 2024 (USD) | Change | | :--- | :--- | :--- | :--- | | Revenue | $19.5M | $17.6M | +11% | | Net Income | $4.7M | $4.1M | +15% | | GAAP Diluted EPS | $0.37 | $0.32 | +16% | | Non-GAAP Net Income | $5.3M | $4.6M | +15% | | Non-GAAP Diluted EPS | $0.42 | $0.36 | +17% | - The Board of Directors declared a regular quarterly cash dividend of **$0.17 per share**, payable on May 30, 2025[5](index=5&type=chunk)[7](index=7&type=chunk) [Management Commentary](index=1&type=section&id=Management%20Commentary) The CEO attributed the strong Q1 performance to sustained demand for the company's innovative products and operational excellence, with a new manufacturing facility on track for completion in July 2025 - The company achieved its **fifteenth consecutive quarter of record revenue**, highlighting sustained demand[3](index=3&type=chunk) - The new manufacturing facility is expected to be completed in **July 2025**, positioning the company to support planned growth[3](index=3&type=chunk)[10](index=10&type=chunk) [Financial Guidance](index=1&type=section&id=Financial%20Guidance) IRADIMED reaffirmed its full-year 2025 guidance and issued Q2 2025 guidance, projecting revenue and non-GAAP diluted EPS ranges for both periods Q2 2025 Financial Guidance | Metric | Guidance Range (USD) | | :--- | :--- | | Revenue | $19.7M - $19.9M | | GAAP Diluted EPS | $0.37 - $0.40 | | Non-GAAP Diluted EPS | $0.41 - $0.44 | Full Year 2025 Financial Guidance (Reaffirmed) | Metric | Guidance Range (USD) | | :--- | :--- | | Revenue | $78.0M - $82.0M | | GAAP Diluted EPS | $1.55 - $1.65 | | Non-GAAP Diluted EPS | $1.71 - $1.81 | - The non-GAAP guidance for the full year and second quarter of 2025 excludes estimated stock-based compensation expense, net of tax, of approximately **$2.6 million** and **$0.6 million**, respectively[12](index=12&type=chunk) [Detailed Financial Analysis](index=2&type=section&id=Detailed%20Financial%20Analysis) This section details the company's financial performance, highlighting revenue growth from devices and domestic sales, alongside profitability, cash flow, and balance sheet health [Revenue Analysis](index=2&type=section&id=Revenue%20Analysis) Total revenue for Q1 2025 increased 11% YoY to $19.5 million, driven by a 9% increase in device revenue, particularly MRI Compatible IV Infusion Pump Systems, with domestic sales accounting for 82% Revenue by Segment (Q1 2025 vs Q1 2024, in USD) | Segment | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | MRI Compatible IV Infusion Pump Systems | 5,999,212 | 5,192,680 | | MRI Compatible Patient Vital Signs Monitoring Systems | 6,544,679 | 6,461,658 | | Total Devices revenue | 12,962,095 | 11,904,038 | | Disposables | 4,947,088 | 4,013,875 | | Services and other | 1,041,255 | 1,193,075 | | **Total revenue** | **19,510,637** | **17,598,119** | - Domestic sales represented **82%** of total revenue for Q1 2025, compared to **76%** for the same period in 2024[9](index=9&type=chunk) [Profitability Analysis](index=2&type=section&id=Profitability%20Analysis) The company maintained a strong gross profit margin of 76.1%, with income from operations growing 14.4% to $5.4 million and net income increasing 13.3% to $4.7 million - The gross profit margin was constant at **76.1%** for the three months ended March 31, 2025 and 2024[9](index=9&type=chunk) Condensed Statement of Operations (Q1 2025 vs Q1 2024, in USD) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Gross Profit | 14,842,806 | 13,387,723 | | Income from Operations | 5,431,456 | 4,748,347 | | Net Income | 4,687,429 | 4,136,533 | [Cash Flow and Balance Sheet](index=2&type=section&id=Cash%20Flow%20and%20Balance%20Sheet) Cash flow from operations for Q1 2025 was $4.3 million, a 10% increase YoY, but free cash flow declined significantly to $0.4 million due to increased capital expenditures for a new facility, while the balance sheet remains strong - Cash flow from operations increased by **10%** to **$4.3 million** in Q1 2025[10](index=10&type=chunk) Free Cash Flow (Q1 2025 vs Q1 2024, in USD) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash provided by operating activities | 4,292,092 | 3,883,155 | | Less: Capital Expenditures | (3,917,300) | (478,804) | | **Free cash flow** | **374,792** | **3,404,351** | - The company anticipates spending an additional **$3.0 million** in cash on its new facility until its expected completion in **July 2025**[10](index=10&type=chunk) Key Balance Sheet Items (in USD) | Metric | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Total Assets | 101,729,435 | 98,325,775 | | Total Liabilities | 11,675,005 | 11,507,019 | | Total Stockholders' Equity | 90,054,430 | 86,818,756 | [Non-GAAP Financial Measures](index=2&type=section&id=Use%20of%20Non-GAAP%20Financial%20Measures) The company utilizes non-GAAP financial measures, such as non-GAAP net income and free cash flow, to offer investors additional perspectives on its operating performance, primarily by excluding stock-based compensation expenses - The company uses non-GAAP measures to provide supplemental perspectives on performance, primarily by excluding stock-based compensation expense, net of tax[13](index=13&type=chunk)[15](index=15&type=chunk) Reconciliation of GAAP to Non-GAAP Net Income (Q1 2025, in USD) | Metric | Amount | | :--- | :--- | | Net income (GAAP) | 4,687,429 | | Stock-based compensation expense, net of tax | 654,243 | | **Non-GAAP net income** | **5,341,672** | | Non-GAAP net income per share – diluted | $0.42 | - Free cash flow is calculated as net cash from operating activities less capital expenditures for internal software and property/equipment purchases[16](index=16&type=chunk) [Corporate Information](index=3&type=section&id=Corporate%20Information) This section details IRADIMED CORPORATION's MRI-compatible medical device business and Q1 2025 earnings conference call information [About IRADIMED CORPORATION](index=3&type=section&id=About%20IRADIMED%20CORPORATION) IRADIMED CORPORATION is a medical device company specializing in innovative MRI-compatible products, including the MRidium® IV infusion pump and Iradimed 3880 patient vital signs monitoring system, ensuring patient safety during MRI procedures - The company is the sole known provider of a non-magnetic IV infusion pump system (MRidium®) specifically designed for safe use during MRI procedures[23](index=23&type=chunk) - The Iradimed 3880 MRI-compatible patient vital signs monitoring system is designed to operate dependably in magnetic fields up to **30,000 gauss**, allowing it to be used almost anywhere in an MRI scanner room[24](index=24&type=chunk) - The company's products enable seamless and safe fluid delivery and uninterrupted vital signs monitoring for critically ill patients and sedated children during MRI scans[23](index=23&type=chunk)[25](index=25&type=chunk) [Conference Call Information](index=3&type=section&id=Conference%20Call) The company held a conference call on May 5, 2025, to discuss its Q1 2025 financial results, with a webcast and recording available on its investor relations website - A conference call to discuss the earnings release was scheduled for **9:00 a.m. Eastern Time** on **May 5, 2025**[20](index=20&type=chunk) - The call was made available via webcast on the company's investor relations website, with a recording available after the event[21](index=21&type=chunk)

Company Overview - IRADIMED CORPORATION is a leader in developing innovative MRI-compatible medical devices, specifically known for its non-magnetic intravenous infusion pump system designed for safe use during MRI procedures [3]. - The company has developed the MRidium® MRI compatible IV infusion pump system, which features a non-magnetic ultrasonic motor and non-ferrous parts to ensure safe and predictable delivery of anesthesia and IV fluids during MRI scans [3]. Product Offerings - The 3880 MRI compatible patient vital signs monitoring system is designed with non-magnetic components, allowing it to operate in magnetic fields up to 30,000 gauss, ensuring patient safety during MRI procedures [4]. - The Iradimed 3880 system includes features such as wireless ECG, wireless SpO2, non-magnetic respiratory CO2 monitoring, and advanced multi-gas anesthetic agent unit, facilitating effective communication of vital signs to clinicians [4]. Upcoming Events - The company will release its 2025 first quarter financial results before the market opens on May 5, 2025, followed by a conference call at 9:00 a.m. Eastern Time to discuss the results [1]. - Interested participants can register for the conference call through a provided link, and a recording will be available on the company's website after the call [2].

Core Viewpoint - Iradimed Corporation will release its 2025 first quarter financial results on May 5, 2025, and will host a conference call to discuss these results [1] Company Overview - Iradimed Corporation is a leader in developing MRI-compatible medical devices, specifically known for its non-magnetic intravenous infusion pump system designed for safe use during MRI procedures [3] - The company has developed the MRidium® MRI compatible IV infusion pump system, which eliminates dangers associated with standard infusion pumps that contain magnetic components [3] - The Iradimed 3880 MRI compatible patient vital signs monitoring system is designed with non-magnetic components, allowing it to operate in magnetic fields up to 30,000 gauss, ensuring patient safety during MRI procedures [4] Product Features - The MRidium® system provides accurate and safe delivery of anesthesia and IV fluids during MRI scans, crucial for critically ill patients and children who require sedation [3] - The Iradimed 3880 system features wireless ECG, SpO2 monitoring, non-magnetic respiratory CO2 monitoring, and advanced multi-gas anesthetic agent unit capabilities [4]

Company Overview - IRadimed Corporation (NASDAQ: IRMD) is a small company focused on developing, manufacturing, and selling MRI-compatible products, generating a consistent revenue stream [1] - The company has demonstrated steady revenue growth, achieving 14 consecutive quarters of growth [1] Industry Insights - The company operates within the medical device industry, specifically targeting MRI-compatible technologies, which is a niche market with potential for continued demand [1]

Core Insights - Iradimed Corporation will participate in the 37th Annual Roth Conference, hosting one-on-one meetings between management and investors on March 17 and 18, 2025 [1] Company Overview - Iradimed Corporation is a leader in developing innovative MRI-compatible medical devices, including the design, manufacture, marketing, and distribution of these devices and related services [2] - The company is the only provider of a non-magnetic intravenous infusion pump system designed for safe use during MRI procedures, addressing dangers associated with standard infusion pumps [3] Product Highlights - The MRidium® MRI-compatible IV infusion pump system features a non-magnetic ultrasonic motor and non-ferrous parts, ensuring safe and predictable delivery of anesthesia and IV fluids during MRI procedures [3] - The 3880 MRI-compatible patient vital signs monitoring system operates in magnetic fields up to 30,000 gauss, allowing for continuous monitoring of critically ill patients during MRI scans [4] - Key features of the IRADIMED 3880 include wireless ECG, wireless SpO2, non-magnetic respiratory CO2 monitoring, and advanced anesthetic agent measurement capabilities [4]

Regulatory Risks - The company received notice of examination from the U.S. Internal Revenue Service (IRS) for the tax year ended December 31, 2021, which could adversely affect financial results [204]. - The medical device industry is subject to extensive government regulation, primarily by the FDA, which could result in delays or increased costs for product development and marketing [208]. - The company is subject to healthcare fraud and abuse regulations that could result in significant liability and require changes to business practices [224]. - Regulatory changes could restrict the company's ability to manufacture and sell products, leading to higher costs or lower revenues [211]. - The company may face challenges in maintaining compliance with FDA and other regulatory requirements, which could disrupt business operations [230]. - The development and use of Artificial Intelligence (AI) presents risks that could impact operations, including compliance with evolving laws and regulations [207]. Intellectual Property Risks - The company relies on a combination of patents, trademarks, trade secrets, and contractual provisions to protect its intellectual property, but cannot guarantee the adequacy of these measures [232]. - The transition to a "first inventor to file" system in the U.S. may complicate the patent application process, potentially affecting the company's competitive advantage [234]. - The company faces risks related to the enforcement of its intellectual property rights, which could result in substantial expenses and impact its ability to commercialize products [241]. - Patent litigation and other intellectual property proceedings could lead to significant costs and management distraction, adversely affecting the company's competitive position [245]. - The company may need to engage in costly litigation to defend its intellectual property rights, which could divert resources and impact financial performance [246]. Financial Performance and Dividends - The company has declared a regular quarterly cash dividend of $0.17 per share, but future dividends will depend on various factors including cash generation and capital needs [254]. - The company may need to raise additional funds through equity or debt securities, which could dilute existing shareholders and affect stock price [256]. - Compliance with public company regulations increases legal and financial costs, potentially diverting management's attention from core business activities [257]. Market and Currency Risks - Sales to customers outside of the U.S. accounted for approximately 17% of net revenues in 2024, with expectations for future growth from international markets [213]. - The company operates in approximately 80 countries, with most sales and purchases denominated in U.S. Dollars, exposing financial results to foreign currency exchange rate fluctuations [341]. - The company faces foreign currency risks primarily related to the Japanese Yen, with potential fluctuations in net income due to transaction gains and losses from Yen-denominated accounts payable [342]. - A 10% change in the U.S. Dollar's strength relative to the Yen would have an immaterial impact on net income for the year ended December 31, 2024 [342]. - Interest income is sensitive to changes in U.S. market interest rates, with an expected change of approximately $489,000 in interest income for a 100 basis point change from levels at December 31, 2024 [343]. Ownership and Influence - The founder, Roger Susi, owns approximately 36% of the company's outstanding common stock, allowing him to exert significant influence over shareholder matters [260]. Product Liability - The company carries third-party product liability insurance with maximum coverage of $5 million, but faces a deductible of $50,000 per occurrence and $150,000 in the aggregate [217]. Negative Publicity - Negative publicity related to product safety issues could materially affect the company's financial position and market value [218].

Financial Data and Key Metrics Changes - Revenue for Q4 2024 was reported at $19.4 million, an increase of 11% compared to Q4 2023 [16] - For fiscal year 2024, revenue increased 12% to $73.2 million [16] - Gross profit for Q4 2024 was $76.1 million, with a gross margin of 76.1%, slightly down from 76.9% in Q4 2023 [17][18] - GAAP diluted earnings per share increased 11% from Q4 2023 to $0.40 per share [21] - Non-GAAP adjusted net income for Q4 2024 was $0.44 per diluted share, up from $0.39 in Q4 2023 [21] Business Line Data and Key Metrics Changes - Domestic sales increased 21% to $16.5 million, while international sales decreased 24% to $2.9 million [17] - Device revenue increased 12% to $14.3 million in Q4 2024, driven by a 34% increase in pump revenue [17] - Revenue from disposables and services increased by 9% for both Q4 2024 and fiscal 2024 [17] Market Data and Key Metrics Changes - Domestic revenue accounted for approximately 85% of total revenue in Q4 2024, compared to 78% in Q4 2023 [17] - The company expects to see strong performance in the first half of 2025, supported by a strong backlog [47] Company Strategy and Development Direction - The company plans to focus on monitor sales in 2025, with adjustments made to sales team incentives [26][29] - A new facility is under construction, with completion expected by June 2025 [12][23] - The company anticipates launching the new 3870 MR IV pump in mid-2025, with significant sales expected in 2026 [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving FDA clearance for the new pump by mid-2025, despite potential delays [10] - The company expects revenue guidance for Q1 2025 to be between $19.2 million and $19.4 million [13] - Management noted that tariffs on certain components would have a negligible impact on gross margins [60] Other Important Information - Operating expenses for Q4 2024 were $9 million, or 46% of revenue, compared to $8.3 million, or 47% of revenue, in Q4 2023 [18] - Cash from operations increased to $6 million for Q4 2024, up from $3.9 million in Q4 2023 [22] Q&A Session Summary Question: Will the sales force focus more on the monitor business in 2025? - Management confirmed that the sales team will indeed focus more on the monitor business, expecting significant impacts in 2025 [26][27] Question: Has there been a shift in focus of the sales force? - Management indicated that minor adjustments were made to sales goals, which have already shown positive results in Q4 [29] Question: What are the expectations for R&D spending and gross margins in 2025? - R&D spending is expected to remain consistent, with gross margins projected to be in the 76% to 77% range [31][33] Question: How is the backlog expected to change throughout the year? - Management noted that the backlog is currently strong, particularly for pumps, but expects monitors to gain a larger share as the year progresses [47] Question: How many pumps are expected to be renewed starting in 2026? - Management anticipates replacing about 800 to 1,000 systems, leading to a significant increase in pump sales [53][54]