Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File No.: 001-36534 IRADIMED CORPORATION (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorpora ...

IRadimed (IRMD) came out with quarterly earnings of $0.42 per share, missing the Zacks Consensus Estimate of $0.43 per share. This compares to earnings of $0.36 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -2.33%. A quarter ago, it was expected that this maker of IV devices that can be used in MRI machines would post earnings of $0.45 per share when it actually produced earnings of $0.44, delivering a surprise of -2.22%.Ove ...

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 - The company reported record revenue of $19.5 million for Q1 2025, an increase of 11% compared to $17.6 million in Q1 2024[3] - GAAP diluted EPS for Q1 2025 was $0.37, reflecting a 16% increase from $0.32 in Q1 2024, while non-GAAP diluted EPS was $0.42, up 17% from $0.36[7] - Revenue for Q1 2025 increased to $19,510,637, up 10.3% from $17,598,119 in Q1 2024[33] - Non-GAAP net income for Q1 2025 was $5.3 million, an increase of 15% from $4.6 million in Q1 2024[8] - Net income for Q1 2025 rose to $4,687,429, a 13.3% increase from $4,136,533 in Q1 2024[33] - Non-GAAP net income for Q1 2025 was $5,341,672, compared to $4,633,159 in Q1 2024, reflecting a 15.3% increase[35] - Basic net income per share increased to $0.37 in Q1 2025 from $0.33 in Q1 2024, while diluted EPS rose to $0.37 from $0.32[33] Future Guidance - The company expects Q2 2025 revenue to be between $19.7 million and $19.9 million, with GAAP diluted EPS guidance of $0.37 to $0.40 and non-GAAP diluted EPS of $0.41 to $0.44[4] - For the full year 2025, the company reaffirms revenue guidance of $78.0 million to $82.0 million, with GAAP diluted EPS of $1.55 to $1.65 and non-GAAP diluted EPS of $1.71 to $1.81[4] Cash Flow and Expenses - Cash flow from operations for Q1 2025 was $4.3 million, a 10% increase from $3.9 million in Q1 2024[10] - Free cash flow for Q1 2025 was $374,792, a significant decrease from $3,404,351 in Q1 2024, primarily due to increased capital expenditures[37] - Operating expenses for Q1 2025 totaled $9,411,350, an increase from $8,639,376 in Q1 2024, driven by higher general and administrative and sales and marketing costs[33] Assets and Equity - Total current assets as of March 31, 2025, were $75,136,765, slightly up from $74,706,209 as of December 31, 2024[31] - Total assets increased to $101,729,435 as of March 31, 2025, compared to $98,325,775 as of December 31, 2024[31] - Total stockholders' equity grew to $90,054,430 as of March 31, 2025, up from $86,818,756 as of December 31, 2024[31] Sales and Dividends - Domestic sales accounted for 82% of total revenue in Q1 2025, up from 76% in the same period of 2024[9] - The company declared a regular quarterly cash dividend of $0.17 per share, payable on May 30, 2025[5] Profit Margins - The gross profit margin remained constant at 76.1% for both Q1 2025 and Q1 2024[9] - Gross profit for Q1 2025 was $14,842,806, representing a gross margin of 76.0%, compared to $13,387,723 and a margin of 76.1% in Q1 2024[33] Capital Expenditures - The company anticipates spending approximately $3.0 million in cash for the construction of its new facility in Orlando, Florida, expected to be completed in July 2025[10]

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].

WINTER SPRINGS, Fla., April 28, 2025 (GLOBE NEWSWIRE) -- IRADIMED CORPORATION (NASDAQ: IRMD) announced today that the Company will release its 2025 first quarter financial results before the market opens on Friday, May 5, 2025. Iradimed management will host a conference call the same day beginning at 9:00 a.m. Eastern Time to discuss those results and to answer questions. IRADIMED CORPORATION is a leader in the development of innovative magnetic resonance imaging ("MRI") compatible medical devices. We are t ...

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]