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IRADIMED CORPORATION Announces FDA 510(k) Clearance for MRidium® 3870 Infusion Pump System
Globenewswire· 2025-05-29 12:30
WINTER SPRINGS, Fla., May 29, 2025 (GLOBE NEWSWIRE) -- Iradimed Corporation (NASDAQ: IRMD), a global leader in innovative medical devices for MRI environments, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its next-generation MRidium® 3870 IV Infusion Pump System. This advanced, MRI-compatible infusion pump extends Iradimed’s unique position as the world’s only supplier of non-magnetic MRI infusion pump devices, established with our first-generation device ...
iRadimed(IRMD) - 2025 Q1 - Quarterly Report
2025-05-05 20:30
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) - 2025 Q1 - Earnings Call Transcript
2025-05-05 14:02
IRadimed (IRMD) Q1 2025 Earnings Call May 05, 2025 09:00 AM ET Company Participants Roger Susi - Founder, Chairman, CEO & PresidentJohn Glenn - Chief Financial Officer Conference Call Participants Frank Takkinen - Senior Research Analyst Operator Welcome to the Amerit Corporation First Quarter of twenty twenty five Financial Results Conference Call. Currently, all participants are in a listen only mode. And at the end of the call, we will conduct a question and answer session. This call is being recorded to ...
IRadimed (IRMD) Lags Q1 Earnings Estimates
ZACKS· 2025-05-05 13:11
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 ...
iRadimed(IRMD) - 2025 Q1 - Earnings Call Transcript
2025-05-05 13:00
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]
iRadimed(IRMD) - 2025 Q1 - Quarterly Results
2025-05-05 11:00
[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)
CORRECTION -- IRADIMED CORPORATION to Hold First Quarter of 2025 Financial Results Conference Call on May 5, 2025
Globenewswire· 2025-04-28 13:53
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].
IRADIMED CORPORATION to Hold First Quarter of 2025 Financial Results Conference Call on May 5, 2025
Globenewswire· 2025-04-28 12:30
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 ...
IRadimed Corporation: Steady, Low-Risk Grower In The Devices Space
Seeking Alpha· 2025-04-08 17:25
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]
IRADIMED CORPORATION To Participate at the 37th Annual Roth Conference
Globenewswire· 2025-03-10 12:30
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]