IRadimed Corporation (NASDAQ:IRMD) Q1 2022 Earnings Conference Call April 29, 2022 11:00 AM ET Company Participants Roger Susi – President and Chief Executive Officer Matt Garner – Controller Conference Call Participants Scott Henry – ROTH Capital Lisa Springer – Singular Research Operator Welcome to the IRadimed Corporation First Quarter 2022 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. A ...

Company Overview - IRadimed is the world's only non-magnetic MRI patient care technology company[4] - The company's products include non-magnetic IV infusion pump systems and patient monitors[7] - IRadimed holds the number 2 market position in its sector[7] Market and Growth - The company targets a $3.1 billion capital and consumables market, including $1.4 billion for IV pumps, $1.1 billion for monitors, and $0.6 billion for ferromagnetic detectors[10] - Channel expansion, particularly in U S ambulatory imaging centers, presents a 3X revenue growth opportunity within 5 years (based on 2019 revenue)[12] - The company aims to fuel market penetration by accelerating hospital MRI pump adoption and gaining share in MRI monitor replacements[11] Financial Performance - The company's revenue for 2021 was $41.8 million[19] - Revenue is projected to be between $51.4 million and $52.2 million in 2022[19, 20] - Adjusted EPS is projected to be between $0.91 and $1.01 in 2022[18, 20] - The company has a strong financial profile with 77% gross margins[19] - As of December 31, 2021, the company had 6,062 IV pumps and 1,138 monitors[16] - As of December 31, 2022, the company had $62.5 million in cash and investments[21] MRI Safety and Risks - MRI adverse events are trending up, with a 600% increase reported to the FDA[4] - Mechanical issues account for 58% of FDA reported MRI adverse event types[5] - Projectile incidents account for 11% of FDA reported MRI adverse event types[5]

```markdown [PART I](index=5&type=section&id=PART%20I) This section provides an overview of the company's business, risks, properties, legal matters, and mine safety disclosures [ITEM 1. BUSINESS](index=5&type=section&id=ITEM%201.%20BUSINESS) IRADIMED CORPORATION specializes in **MRI-compatible** medical devices, including **IV infusion pump** and **patient vital signs monitoring systems** - **IRADIMED CORPORATION** develops, manufactures, markets, and distributes **MRI-compatible** medical devices and related accessories, disposables, and services[15](index=15&type=chunk) - The company is the only known provider of a non-magnetic **IV infusion pump system** specifically designed for safe use during **MRI** procedures, eliminating dangers associated with standard pumps in magnetic fields[16](index=16&type=chunk)[40](index=40&type=chunk) Financial Highlights | Metric | 2021 (Millions) | | :----- | :-------------- | | Revenue | **$41.8** | | Operating Income | **$9.8** | | Operating Profit Margin | **23.5%** | [Overview](index=5&type=section&id=Overview) **IRADIMED CORPORATION** develops, manufactures, markets, and distributes **MRI-compatible** medical devices and related accessories, disposables, and services - **IRADIMED CORPORATION** develops, manufactures, markets, and distributes **MRI-compatible** medical devices and related accessories, disposables, and services[15](index=15&type=chunk) - The company's primary products are the **MRidium 3860+ MRI Compatible IV Infusion Pump System** and the **IRadimed 3880 MRI Compatible Patient Vital Signs Monitoring System**, both designed for safe and accurate operation in **MRI** environments[16](index=16&type=chunk)[18](index=18&type=chunk) - As of December 31, 2021, the company had sold approximately **6,062** **MRI compatible IV infusion pump systems** and **1,138** of its **3880 MRI compatible patient vital signs monitoring systems**[21](index=21&type=chunk) [History and Development](index=7&type=section&id=History%20and%20Development) Founder Roger Susi pioneered **MRI-compatible** patient monitoring and **IV infusion systems**, with the **MRidium 3860+** becoming the sole **MRI-compatible IV infusion pump system** on the market - Founder Roger Susi pioneered **MRI-compatible** patient monitoring systems in **1986** and the first non-magnetic **MRI-compatible IV infusion system** in **2004**[19](index=19&type=chunk)[25](index=25&type=chunk) - The first-generation **MRidium MRI compatible IV infusion pump system** received FDA 510(k) clearance in March **2005**[26](index=26&type=chunk) - The second-generation **MRidium 3860+** was introduced in **2009**, adding SpO2 monitoring and wireless capability, and is currently the only **MRI compatible IV infusion pump system** on the market[28](index=28&type=chunk) - The **3880 MRI compatible patient vital signs monitoring system** began international shipments in December **2016** and received FDA 510(k) clearance in October **2017**[29](index=29&type=chunk) [Industry](index=8&type=section&id=Industry) **MRI** is a widely used, non-invasive medical imaging technique, but its environment poses hazards requiring specialty equipment, as standard infusion pumps are dangerous - **MRI** is a widely used, non-invasive medical imaging technique, considered safer than radiation-based scans, especially for children, leading to expanded use in new procedures like cardiac stress testing and intraoperative **MRI**[32](index=32&type=chunk) - The **MRI** environment poses hazards due to powerful static, pulsed gradient, and pulsed radio frequency fields, necessitating specialty equipment designed for safety and performance[33](index=33&type=chunk) - Standard infusion pumps are dangerous in **MRI** environments due to magnetic and electronic components, leading to workarounds like long **IV** lines or shielded boxes, which introduce risks such as infusion inaccuracies, medication waste, delayed alarms, and projectile accidents[16](index=16&type=chunk)[35](index=35&type=chunk)[37](index=37&type=chunk)[39](index=39&type=chunk) [Market Opportunities](index=9&type=section&id=Market%20Opportunities) The global target market for **MRI compatible IV infusion pump systems** and **patient vital signs monitoring systems** is substantial, with potential for expanded deployment in critical care settings - The global target market for **MRI compatible IV infusion pump systems** is estimated at approximately **37,800** units, including **27,350** based on **MRI** scanners in acute care facilities and an additional **10,450** for critical care departments in U.S. hospitals[41](index=41&type=chunk) - The global target market for **MRI compatible patient vital signs monitoring systems** is estimated at approximately **32,600** units, comprising **27,350** based on **MRI** scanners and an additional **5,250** for critical care departments in U.S. hospitals[42](index=42&type=chunk) - There is potential for expanded deployment of **MRI compatible** devices within Intensive Care Units (**ICU**), Emergency Rooms (**ER**), and other critical care departments to facilitate safer intra-hospital transport and uninterrupted patient monitoring during **MRI** procedures[43](index=43&type=chunk)[44](index=44&type=chunk) [Strategy](index=10&type=section&id=Strategy) The company aims to lead in **MRI** patient care by developing and commercializing a portfolio of **MRI-compatible** products, driving market awareness, innovating, and expanding sales globally - The company's objective is to lead in providing safe and effective care for **MRI** patients by developing and commercializing a portfolio of **MRI-compatible** products, accessories, disposables, and services[47](index=47&type=chunk) - Key growth strategies include driving market awareness of **MRI-compatible IV infusion pumps** and **patient vital signs monitoring systems**, continuing innovation in **MRI-compatible** patient care products, and acquiring synergistic companies or technologies[48](index=48&type=chunk)[51](index=51&type=chunk)[52](index=52&type=chunk)[53](index=53&type=chunk) - The commercial strategy focuses on developing the U.S. direct sales force, expanding international sales through distributors, supporting efforts with evidence-based information on safety and efficiency, and providing best-in-class customer service and user experience[55](index=55&type=chunk)[57](index=57&type=chunk)[58](index=58&type=chunk)[59](index=59&type=chunk) [Our Products](index=14&type=section&id=Our%20Products) **IRADIMED** offers two primary **MRI-compatible** products: the **MRidium 3860+ IV Infusion Pump System** and the **3880 Patient Vital Signs Monitoring System**, both designed for safe operation near **MRI** scanners - **IRADIMED** offers two primary **MRI-compatible** products: the **MRidium 3860+ IV Infusion Pump System** and the **3880 Patient Vital Signs Monitoring System**, both designed for safe operation close to **MRI** scanners[62](index=62&type=chunk)[64](index=64&type=chunk)[77](index=77&type=chunk) - The **MRidium 3860+ pump system** is non-magnetic, operates up to **10,000** gauss, and offers features like a dose rate calculator, bolus dose programming, and a **12-hour** battery life; it uses proprietary single-use **IV** tubing sets[64](index=64&type=chunk)[66](index=66&type=chunk)[67](index=67&type=chunk) - Optional features for the **MRidium 3860+** include the **3861 Side Car** for a second **IV** channel, a **3865 Wireless Remote Display/Control**, a **Dose Error Reduction System** (**DERS**), and an integrated **Masimo SET® SpO2** monitor[70](index=70&type=chunk)[71](index=71&type=chunk)[73](index=73&type=chunk)[74](index=74&type=chunk)[75](index=75&type=chunk) - The **3880 Monitor** is compact, lightweight, operates up to **30,000** gauss, and includes wireless **ECG**, SpO2, and non-invasive blood pressure; optional features include non-magnetic respiratory CO2, invasive blood pressure, patient temperature, and a multi-gas anesthetic agent unit[77](index=77&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk) [Intellectual Property](index=18&type=section&id=Intellectual%20Property) The company protects its proprietary technology through **15** issued U.S. patents and **4** issued foreign patents, trade secrets, and confidentiality agreements, though future success is not solely dependent on patents - The company protects its proprietary technology through patents, trade secrets, and confidentiality agreements[81](index=81&type=chunk) - **IRADIMED** holds **15** issued U.S. patents and **4** issued foreign patents, with remaining lives ranging from **1** to **19** years, covering its **IV infusion pump system** and **patient vital signs monitoring system**[82](index=82&type=chunk) - While patents are important, the company does not believe its future success is materially dependent solely on them, also relying on trade secrets and confidentiality agreements[81](index=81&type=chunk)[83](index=83&type=chunk) [Sales and Marketing](index=18&type=section&id=Sales%20and%20Marketing) **IRADIMED** utilizes a direct sales force in the U.S. and independent distributors internationally, with sales cycles lengthening due to **COVID-19** - **IRADIMED** employs a direct sales force in the U.S. (**21** field sales representatives, **3** regional sales directors, **4** clinical application specialists) and independent distributors in approximately **80** countries internationally[20](index=20&type=chunk)[84](index=84&type=chunk) Revenue by Geographic Region | Geographic Region | 2021 (%) | 2020 (%) | 2019 (%) | | :---------------- | :------- | :------- | :------- | | United States | **80.0** | **77.4** | **80.3** | | International | **20.0** | **22.6** | **19.7** | Revenue by Product Type | Product Type | 2021 (%) | 2020 (%) | 2019 (%) | | :---------------------------- | :------- | :------- | :------- | | Devices | **64.7** | **60.3** | **72.1** | | Disposable, service and other | **30.6** | **33.8** | **23.1** | | Amortization of extended warranty agreements | **4.7** | **5.9** | **4.8** | Backlog (in millions) | Year | Backlog ($) | | :--- | :---------- | | 2021 | **$10.9** | | 2020 | **$4.4** | | 2019 | **$1.6** | - Selling cycles for devices historically range from **three** to **six** months, but have lengthened due to the **COVID-19** pandemic[86](index=86&type=chunk) - The company partners with Group Purchasing Organizations (**GPOs**) in the U.S. to sell products to member hospitals, paying a **3%** administrative fee on sales[88](index=88&type=chunk) [Manufacturing and Suppliers](index=19&type=section&id=Manufacturing%20and%20Suppliers) Products are assembled in Winter Springs, Florida, relying on single-source suppliers for critical components, while maintaining **ISO 13485** certification and **CE Mark** compliance - Products are assembled, tested, and packaged at the company's facility in Winter Springs, Florida, using components and sub-assemblies from outside suppliers[89](index=89&type=chunk) - Some critical raw materials and parts, such as the non-magnetic ultrasonic motor for the **IV infusion pump**, are sourced from single suppliers, posing supply chain risks[90](index=90&type=chunk) - The company maintains a quality management system, is **ISO 13485** certified, and meets European Medical Device Directive requirements for the **CE Mark**, with recertification in October **2021**[91](index=91&type=chunk)[94](index=94&type=chunk) [Competition](index=21&type=section&id=Competition) The medical products industry is highly competitive, with **IRADIMED's MRidium MRI compatible IV infusion pump system** being the only true **MRI compatible IV infusion pump** available, while the **MRI compatible patient vital signs monitor** market is well-developed - The medical products industry is highly competitive, with many large, established companies having greater resources and market advantages[95](index=95&type=chunk) - **IRADIMED's MRidium MRI compatible IV infusion pump system** is believed to be the only true **MRI compatible IV infusion pump** available, following Bayer Radiology's withdrawal of its competing product[97](index=97&type=chunk) - Competition for the **IV infusion pump** also comes from manufacturers of 'shielded box' solutions (e.g., B. Braun, Fresenius Kabi) and conventional **IV infusion pump** manufacturers whose products are used in workaround solutions[99](index=99&type=chunk)[100](index=100&type=chunk) - The market for **MRI compatible patient vital signs monitors** is well-developed and highly competitive, with dominant players like Invivo Research (now Philips NV), General Electric, and Schiller AG[103](index=103&type=chunk)[104](index=104&type=chunk) [Seasonality](index=23&type=section&id=Seasonality) The company's business is seasonal, with third-quarter sales typically lower due to summer vacations, though **COVID-19** may continue to alter buying patterns - The company's business is seasonal, with third-quarter sales typically lower due to the summer vacation season in the U.S., Europe, and Japan[105](index=105&type=chunk) - **COVID-19** may continue to alter customer buying patterns, deviating from historical seasonal trends[105](index=105&type=chunk) [Research and Development](index=23&type=section&id=Research%20and%20Development) Research and development efforts focus on innovative **MRI-compatible** products, leveraging core competencies and feedback from healthcare facilities - Research and development efforts focus on innovative **MRI-compatible** products, leveraging core competencies and feedback from strategic relationships with healthcare facilities[107](index=107&type=chunk) Research and Development Expenses | Year | R&D Expense (Millions) | % of Revenue | | :--- | :--------------------- | :----------- | | 2021 | **$1.9** | **4.6%** | | 2020 | **$1.9** | **6.0%** | | 2019 | **$1.4** | **3.7%** | [Employees](index=24&type=section&id=Employees) As of December 31, 2021, **IRADIMED** had **110** full-time employees across various functions, with no union representation and good employee relations - As of December 31, 2021, **IRADIMED** had **110** full-time employees across manufacturing, service, sales, marketing, customer support, regulatory affairs, quality assurance, finance, administration, and research and development[110](index=110&type=chunk) - No employees are represented by a labor union, and the company considers its employee relations to be good[110](index=110&type=chunk) [Regulatory Matters](index=24&type=section&id=Regulatory%20Matters) Medical device products are subject to extensive regulation by the FDA and international authorities, requiring pre-market clearance, post-market compliance, and adherence to fraud and anti-bribery laws - Medical device products are subject to extensive regulation by the FDA in the U.S. and other domestic and foreign governmental authorities, covering design, testing, manufacturing, labeling, promotion, and post-market surveillance[111](index=111&type=chunk)[112](index=112&type=chunk) - Most medical devices require either 510(k) clearance or Premarket Approval (**PMA**) from the FDA before marketing; all current U.S. products were cleared via the 510(k) process[113](index=113&type=chunk) - The FDA's **2014** guidance on 'Infusion Pumps Total Product Life Cycle' established substantial additional pre-market requirements, making the regulatory clearance process for infusion pumps more time-consuming and costly[114](index=114&type=chunk)[200](index=200&type=chunk) - Post-market requirements include adherence to Quality System Regulation (**QSR**), adverse event reporting, and potential recalls; non-compliance can lead to severe sanctions[115](index=115&type=chunk)[116](index=116&type=chunk) - The company and its customers are subject to healthcare fraud and abuse laws (e.g., Anti-kickback Statute, Federal False Claims Act), with violations punishable by criminal or civil sanctions[118](index=118&type=chunk) - International regulations, such as the EU's Medical Device Regulation (**MDR**) effective May **2021**, impose enhanced requirements for clinical evidence, traceability, and post-market surveillance, requiring re-certification of products[119](index=119&type=chunk)[120](index=120&type=chunk) - Global activities are subject to anti-bribery laws like the U.S. Foreign Corrupt Practices Act and the U.K. Bribery Act, prohibiting improper payments to non-U.S. government officials[124](index=124&type=chunk) [ITEM 1A. RISK FACTORS](index=28&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company faces significant risks across business, financial, industry, intellectual property, and common stock ownership - The **COVID-19** pandemic has adversely affected and may continue to impact the company's business, financial condition, and operations through reduced demand, supply chain disruptions, and financial strains on healthcare systems[137](index=137&type=chunk)[138](index=138&type=chunk)[139](index=139&type=chunk) - The company's financial performance is highly dependent on the sale of its **MRidium 3860+ MRI compatible IV infusion pump system** and **3880 MRI compatible patient vital signs monitoring system**, making it vulnerable to disruptions in their sale or market obsolescence[140](index=140&type=chunk)[142](index=142&type=chunk) - Dependence on a limited number of single-source suppliers for critical components, such as the ultrasonic motor, poses a significant risk of supply interruptions, increased costs, and delays in product manufacturing[146](index=146&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk) - The company manufactures and stores all its products at a single facility in Winter Springs, Florida, making it highly vulnerable to natural disasters or other disruptions that could severely interrupt production and impact financial results[157](index=157&type=chunk) - The medical device industry is highly regulated, and changes in government regulations, failure to obtain or maintain FDA clearances, or non-compliance with quality systems regulations could force modifications to product development, manufacturing, marketing, and pricing, or lead to sanctions[180](index=180&type=chunk)[181](index=181&type=chunk)[183](index=183&type=chunk) - The company's success relies on its ability to protect intellectual property through patents, trade secrets, and confidentiality agreements, but faces risks from infringement, misappropriation, and costly litigation[205](index=205&type=chunk)[206](index=206&type=chunk)[208](index=208&type=chunk) [Risks Relating to Our Business and Financial Condition](index=30&type=section&id=Risks%20Relating%20to%20Our%20Business%20and%20Financial%20Condition) The company faces risks from **COVID-19** impacts, dependence on limited products, supply chain vulnerabilities, single manufacturing facility, and reliance on key personnel - The **COVID-19** pandemic has caused and may continue to cause adverse effects on demand for products, manufacturing capacity, supply chains, and distribution systems, leading to potential delays in customer payments and financial stress[137](index=137&type=chunk)[138](index=138&type=chunk)[139](index=139&type=chunk) - The company's revenue and profitability are significantly dependent on the **MRidium 3860+ MRI compatible IV infusion pump system** and the **3880 MRI compatible patient vital signs monitoring system**, making it vulnerable to product obsolescence or regulatory actions[140](index=140&type=chunk)[141](index=141&type=chunk)[142](index=142&type=chunk) - Reliance on single-source suppliers for critical components, such as the ultrasonic motor, creates a risk of supply interruptions, increased costs, and delays in product manufacturing if these suppliers fail to meet demand or cease operations[146](index=146&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk) - The company's single manufacturing and storage facility in Florida exposes it to significant business interruption risks from natural disasters or other events[157](index=157&type=chunk) - Inability to collect on accounts receivables, failure to maintain relationships with Group Purchasing Organizations (**GPOs**), and cost-containment efforts by customers could adversely affect sales and profitability[158](index=158&type=chunk)[159](index=159&type=chunk)[161](index=161&type=chunk) - The company is highly dependent on its founder, Chairman, President, and CEO, Roger Susi, for new product development, and the loss of key personnel could materially harm the business[166](index=166&type=chunk)[167](index=167&type=chunk) - Engaging in related party transactions, such as the lease agreement with an entity controlled by Roger Susi, presents potential conflicts of interest and may impair investor confidence[171](index=171&type=chunk) [Risks Related to Our Industry](index=41&type=section&id=Risks%20Related%20to%20Our%20Industry) The medical device industry faces extensive government regulation, product liability, international operating risks, and healthcare policy changes, with non-compliance leading to severe sanctions - The medical device industry is subject to extensive government regulation (FDA, foreign agencies), and changes or non-compliance can lead to fines, injunctions, product recalls, or delays in approvals for new products[180](index=180&type=chunk)[181](index=181&type=chunk)[183](index=183&type=chunk) - Operating outside the U.S. exposes the company to risks such as foreign regulatory changes, currency fluctuations, trade restrictions, political instability, and diminished intellectual property protection[184](index=184&type=chunk)[185](index=185&type=chunk) - Product liability risks are inherent in medical device manufacturing, and insurance coverage may be inadequate to cover potential losses from claims or lawsuits[186](index=186&type=chunk) - Defects or failures in products or quality control systems could lead to adverse event reports, recalls, safety alerts, negative publicity, and regulatory actions, harming market acceptance and reputation[187](index=187&type=chunk)[189](index=189&type=chunk)[190](index=190&type=chunk) - U.S. healthcare policy changes, including the Patient Protection and Affordable Care Act (**ACA**), and increased scrutiny over the medical device industry, could adversely affect demand for products and business operations[192](index=192&type=chunk)[194](index=194&type=chunk)[195](index=195&type=chunk) - Compliance with healthcare fraud and abuse laws (e.g., anti-kickback, false claims) and anti-bribery laws (e.g., **FCPA**) is critical, and violations could result in significant liability, fines, and restrictions on operations[196](index=196&type=chunk)[197](index=197&type=chunk)[198](index=198&type=chunk)[199](index=199&type=chunk) [Risks Relating to our Intellectual Property](index=47&type=section&id=Risks%20Relating%20to%20our%20Intellectual%20Property) The company's success depends on protecting its intellectual property through patents, trademarks, and trade secrets, but faces risks from infringement, misappropriation, and costly litigation - The company's success depends on its ability to protect intellectual property through patents, trademarks, trade secrets, and confidentiality agreements, but there's no guarantee these measures will prevent infringement or misappropriation[205](index=205&type=chunk)[206](index=206&type=chunk) - Litigation may be necessary to enforce intellectual property rights, which can be costly, time-consuming, and may not adequately protect proprietary information, especially in countries with weaker **IP** laws[205](index=205&type=chunk)[206](index=206&type=chunk)[207](index=207&type=chunk) - Reliance on unpatented trade secrets, know-how, and confidential information is risky, as these can be difficult to protect and may be unintentionally or willfully disclosed by employees or competitors[208](index=208&type=chunk)[209](index=209&type=chunk)[210](index=210&type=chunk) - Delays in patent review and approval could prevent timely intellectual property protection, impacting the ability to commercialize products and generate sufficient revenues[211](index=211&type=chunk) - The medical device industry is prone to patent litigation, which could result in substantial damages, require licensing agreements, or force product redesigns, adversely affecting business and financial condition[212](index=212&type=chunk)[213](index=213&type=chunk)[214](index=214&type=chunk) [Risks Related to Ownership of Our Common Stock](index=50&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) The common stock price is subject to significant volatility, capital allocation decisions may reduce financial flexibility, and the founder's influence, along with public company compliance costs, pose risks - The common stock price is subject to significant fluctuations and volatility due to factors like product commercial success, regulatory changes, competition, operating results, and economic conditions[221](index=221&type=chunk)[223](index=223&type=chunk) - Any use of capital for stock repurchases or cash dividends could reduce financial flexibility, potentially hindering strategic initiatives or the ability to withstand operating losses, and adversely affecting stock price[224](index=224&type=chunk)[225](index=225&type=chunk)[226](index=226&type=chunk) - Future needs for additional capital may lead to the sale of equity or debt securities, resulting in dilution for stockholders or restrictive covenants[227](index=227&type=chunk)[228](index=228&type=chunk) - Roger Susi, the founder and CEO, holds a significant percentage of stock, allowing him to exert substantial influence over stockholder approval matters, potentially conflicting with other shareholders' interests[229](index=229&type=chunk) - Being a public company imposes reporting requirements (Exchange Act, Sarbanes-Oxley Act), increasing compliance costs, diverting management attention, and making it harder to attract and retain qualified personnel and board members[230](index=230&type=chunk)[231](index=231&type=chunk)[232](index=232&type=chunk) - Failure to establish and maintain adequate internal controls over financial reporting could materially harm the business, financial position, and operating results, and negatively impact stock price[233](index=233&type=chunk)[235](index=235&type=chunk) [ITEM 1B. UNRESOLVED STAFF COMMENTS](index=55&type=section&id=ITEM%201B.%20UNRESOLVED%20STAFF%20COMMENTS) There are no unresolved staff comments from the SEC - The company has no unresolved staff comments[240](index=240&type=chunk) [ITEM 2. PROPERTIES](index=55&type=section&id=ITEM%202.%20PROPERTIES) The company's principal offices and manufacturing facility are located in a leased **23,100** square-foot facility in Winter Springs, Florida, from Susi, LLC, renewed until May **31**, **2024** - The company's principal offices and manufacturing facility are located in a leased **23,100** square-foot facility in Winter Springs, Florida[241](index=241&type=chunk) - The facility is leased from Susi, LLC, an entity controlled by the company's founder, President, Chief Executive Officer, and Chairman of the Board of Directors, Roger Susi[241](index=241&type=chunk) - The lease was renewed for an additional **five** years, with a new expiration date of May **31**, **2024**, and will automatically renew for successive **one-year** terms unless terminated[241](index=241&type=chunk) [ITEM 3. LEGAL PROCEEDINGS](index=55&type=section&id=ITEM%203.%20LEGAL%20PROCEEDINGS) The company is involved in routine legal proceedings and claims but believes adequate reserves have been made, and no pending litigation is expected to materially adversely affect its operations - The company is involved in legal proceedings and claims arising in the ordinary course of business[243](index=243&type=chunk) - Management believes adequate reserves have been made for these liabilities[243](index=243&type=chunk) - No pending litigation is expected to have a material adverse effect on the company's liquidity, access to capital markets, or ability to conduct daily operations[243](index=243&type=chunk) [ITEM 4. MINE SAFETY DISCLOSURES](index=55&type=section&id=ITEM%204.%20MINE%20SAFETY%20DISCLOSURES) This item is not applicable to the company - Mine Safety Disclosures are not applicable to **IRADIMED CORPORATION**[244](index=244&type=chunk) [PART II](index=56&type=section&id=PART%20II) This section covers market information, financial condition, operations, market risk, financial statements, and internal controls [ITEM 5. MARKET FOR REGISTRANT'S COMMON STOCK, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES](index=56&type=section&id=ITEM%205.%20MARKET%20FOR%20REGISTRANT%27S%20COMMON%20STOCK%2C%20RELATED%20STOCKHOLDER%20MATTERS%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES) The company's common stock trades on Nasdaq, experiencing price volatility, with recent special dividends and share repurchases for tax purposes - **IRADIMED's** common stock has been publicly traded on the Nasdaq Capital Market under the symbol 'IRMD' since July **16**, **2014**[247](index=247&type=chunk) - The stock market has experienced significant price fluctuations, and various factors, both internal and external, could cause the company's common stock price to fluctuate substantially[248](index=248&type=chunk) - As of February **28**, **2022**, the company had **3** stockholders of record, excluding beneficial holders[249](index=249&type=chunk) - On February **7**, **2022**, the Board of Directors declared a special cash dividend of **$1.00** per common share, paid on February **24**, **2022**[250](index=250&type=chunk) Issuer Purchases of Equity Securities (2021) | Period | Total Number of Shares Purchased | | :--------------------------- | :------------------------------- | | January 1, 2021—December 31, 2021 | **13,992** | - The shares purchased primarily reflect shares withheld for taxes on the vesting of restricted stock, with no shares repurchased under an open market repurchase authorization in **2021**[253](index=253&type=chunk)[254](index=254&type=chunk) [ITEM 6. [RESERVED]](index=58&type=section&id=ITEM%206.%20%5BRESERVED%5D) This item is reserved and contains no information [ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS](index=58&type=section&id=ITEM%207.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) This section analyzes **IRADIMED's** financial condition and operations, including business overview, highlights, accounting policies, and liquidity - The company develops, manufactures, markets, and distributes **MRI-compatible** medical devices, including **IV infusion pump systems** and **patient vital signs monitoring systems**, along with related accessories, disposables, and services[261](index=261&type=chunk)[262](index=262&type=chunk)[264](index=264&type=chunk) Financial Highlights | Metric | 2021 (Millions) | 2020 (Millions) | 2019 (Millions) | | :---------------------- | :-------------- | :-------------- | :-------------- | | Revenue | **$41.8** | **$31.7** | **$38.5** | | Diluted EPS | **$0.74** | **$0.11** | **$0.78** | | Cash Provided by Operations | **$11.3** | **$5.8** | **$10.2** | Estimated Installed Base of Medical Devices | Device Type | 2021 | 2020 | 2019 | | :-------------------------------- | :---- | :---- | :---- | | **IV Infusion Pump Systems** | **6,062** | **5,794** | **5,515** | | **Patient Vital Signs Monitoring Systems** | **1,138** | **794** | **539** | - The **COVID-19** pandemic continues to disrupt global supply and distribution channels, impacting demand, manufacturing, and payments, with future effects remaining uncertain[268](index=268&type=chunk)[269](index=269&type=chunk)[270](index=270&type=chunk) - Critical accounting policies include revenue recognition, contract liabilities, capitalized contract costs, accounts receivable, inventory valuation, warranty, stock-based compensation, and income taxes, all requiring significant estimates and judgments[272](index=272&type=chunk)[273](index=273&type=chunk) [Our Business](index=59&type=section&id=Our%20Business) **IRADIMED** develops, manufactures, markets, and distributes **MRI-compatible** medical devices, uniquely offering a non-magnetic **IV infusion pump system** for safe **MRI** use - **IRADIMED** develops, manufactures, markets, and distributes **MRI-compatible** medical devices, including the **MRidium® MRI compatible IV infusion pump system** and the **3880 MRI compatible patient vital signs monitoring system**[261](index=261&type=chunk)[262](index=262&type=chunk)[264](index=264&type=chunk) - The company is the only known provider of a non-magnetic **IV infusion pump system** designed for safe use during **MRI** procedures, addressing the dangers of standard pumps in magnetic environments[262](index=262&type=chunk) - Revenue is generated from device sales, accessories, extended warranty agreements, services, and disposable products, primarily to hospitals and acute care facilities in the U.S. and internationally[265](index=265&type=chunk) [Financial Highlights and Outlook](index=59&type=section&id=Financial%20Highlights%20and%20Outlook) **IRADIMED** reported **$41.8 million** in revenue and **$0.74** diluted **EPS** in **2021**, with **COVID-19** continuing to impact operations and a **$0.8 million** **CARES Act** benefit in **2020** Financial Highlights | Metric | 2021 (Millions) | 2020 (Millions) | 2019 (Millions) | | :---------------------- | :-------------- | :-------------- | :-------------- | | Revenue | **$41.8** | **$31.7** | **$38.5** | | Diluted EPS | **$0.74** | **$0.11** | **$0.78** | | Cash Provided by Operations | **$11.3** | **$5.8** | **$10.2** | Estimated Installed Base of Medical Devices | Device Type | 2021 | 2020 | 2019 | | :-------------------------------- | :---- | :---- | :---- | | **IV Infusion Pump Systems** | **6,062** | **5,794** | **5,515** | | **Patient Vital Signs Monitoring Systems** | **1,138** | **794** | **539** | - The **COVID-19** pandemic continues to cause disruptions in global supply and distribution channels, impacting demand for products and potentially leading to adverse effects on future results of operations and cash flows[268](index=268&type=chunk)[269](index=269&type=chunk)[270](index=270&type=chunk) - The **CARES Act** provided a **$0.8 million** benefit in **2020** by allowing the carryback of net operating losses, resulting in a **$1.4 million** income tax receivable[271](index=271&type=chunk) [Critical Accounting Policies and Estimates](index=61&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Financial statement preparation requires significant management estimates for revenue recognition, inventory, intangible assets, stock-based compensation, warranty, and income taxes - The preparation of financial statements requires management to make significant estimates and assumptions, including those related to revenue recognition, allowances for doubtful accounts, inventory valuation, intangible assets, stock-based compensation, warranty obligations, and income taxes[272](index=272&type=chunk)[273](index=273&type=chunk) - Revenue is recognized when control of promised products or services is transferred to the customer, typically at a point in time, except for extended warranty agreements which are recognized ratably over the agreement period[279](index=279&type=chunk)[283](index=283&type=chunk) - Contract liabilities (deferred revenue) include advance payments, in-transit shipments, and extended warranty agreements, recognized as performance obligations are satisfied[282](index=282&type=chunk)[283](index=283&type=chunk) - Inventory is valued at the lower of standard cost or net realizable value, with regular evaluations for obsolescence or excess usage[288](index=288&type=chunk) - Stock-based compensation expense for stock options, restricted stock units, and performance-based restricted stock units is recognized over the requisite service or performance period, with fair values estimated using models like Black-Scholes or Monte Carlo simulation[291](index=291&type=chunk)[292](index=292&type=chunk)[293](index=293&type=chunk)[294](index=294&type=chunk) - Income taxes are accounted for using the asset and liability method, recognizing deferred tax assets and liabilities based on temporary differences and assessing the likelihood of their realization[295](index=295&type=chunk)[296](index=296&type=chunk) [Results of Operations](index=68&type=section&id=Results%20of%20Operations) This section provides a comparative analysis of the company's revenue, cost of revenue, gross profit, operating expenses, and income taxes for **2021**, **2020**, and **2019** Statements of Operations Data as a Percentage of Total Revenue | Metric | 2021 (%) | 2020 (%) | 2019 (%) | | :-------------------------- | :------- | :------- | :------- | | Revenue | **100.0** | **100.0** | **100.0** | | Cost of revenue | **23.4** | **25.7** | **22.9** | | Gross profit | **76.6** | **74.3** | **77.1** | | General and administrative | **23.4** | **38.7** | **27.1** | | Sales and marketing | **25.2** | **32.0** | **23.8** | | Research and development | **4.6** | **6.0** | **3.7** | | Total operating expenses | **53.2** | **76.7** | **54.7** | | Income (loss) from operations | **23.5** | (**2.4**) | **22.5** | | Other income, net | **0.0** | **0.4** | **1.0** | | Income (loss) before provision for income taxes | **23.5** | (**1.9**) | **23.5** | | Provision for income tax expense (benefit) | **1.2** | (**6.3**) | (**1.5**) | | Net income | **22.3** | **4.3** | **25.0** | [Comparison of the Years Ended December 31, 2021 and 2020](index=68&type=section&id=Comparison%20of%20the%20Years%20Ended%20December%2031%2C%202021%20and%202020) In **2021**, total revenue increased by **31.8%** to **$41.8 million**, driven by higher U.S. and international sales and device unit sales, with improved gross profit margin and decreased general and administrative expenses Revenue by Geographic Region (2021 vs 2020) | Geographic Region | 2021 (Millions) | 2020 (Millions) | Change (%) | | :---------------- | :-------------- | :-------------- | :--------- | | United States | **$33.5** | **$24.5** | **36.4** | | International | **$8.3** | **$7.2** | **16.3** | | Total Revenue | **$41.8** | **$31.7** | **31.8** | Revenue by Type (2021 vs 2020) | Revenue Type | 2021 (Millions) | 2020 (Millions) | Change (%) | | :----------------------------------------- | :-------------- | :-------------- | :--------- | | **MRI compatible IV infusion pump system** | **$13.3** | **$9.3** | **42.0** | | **MRI compatible patient vital signs monitoring system** | **$13.8** | **$9.8** | **41.2** | | Total Devices revenue | **$27.1** | **$19.1** | **41.6** | | Disposables, service and other | **$12.8** | **$10.7** | **19.3** | | Amortization of extended warranty agreements | **$1.9** | **$1.9** | **4.1** | | Total Revenue | **$41.8** | **$31.7** | **31.8** | - Unit sales for **MRI compatible IV infusion pumps** increased from **279** in **2020** to **385** in **2021**, while **patient vital signs monitoring systems** increased from **255** to **344** units[304](index=304&type=chunk)[305](index=305&type=chunk) - Gross profit margin increased from **74.3%** in **2020** to **76.6%** in **2021**, driven by favorable overhead variance adjustments and higher average selling prices[308](index=308&type=chunk) - General and administrative expenses decreased by **20.4%** due to lower stock compensation, legal, and professional costs, partially offset by higher regulatory and payroll expenses[310](index=310&type=chunk) - Sales and marketing expenses increased by **3.9%** due to higher sales commissions, activities, and software costs[311](index=311&type=chunk) - Research and development expenses remained consistent at **$1.9 million**[312](index=312&type=chunk) - The effective tax rate decreased significantly from **321.9%** in **2020** to **5.2%** in **2021**, primarily due to higher income before taxes and discrete tax benefits[314](index=314&type=chunk) [Comparison of the Years Ended December 31, 2020 and 2019](index=70&type=section&id=Comparison%20of%20the%20Years%20Ended%20December%2031%2C%202020%20and%202019) In **2020**, total revenue decreased by **17.7%** to **$31.7 million**, primarily due to declines in U.S. sales and **IV infusion pump** sales, leading to a lower gross profit margin and increased operating expenses Revenue by Geographic Region (2020 vs 2019) | Geographic Region | 2020 (Millions) | 2019 (Millions) | Change (%) | | :---------------- | :-------------- | :-------------- | :--------- | | United States | **$24.5** | **$30.9** | (**20.7**) | | International | **$7.2** | **$7.6** | (**5.3**) | | Total Revenue | **$31.7** | **$38.5** | (**17.7**) | Revenue by Type (2020 vs 2019) | Revenue Type | 2020 (Millions) | 2019 (Millions) | Change (%) | | :----------------------------------------- | :-------------- | :-------------- | :--------- | | **MRI compatible IV infusion pump system** | **$9.3** | **$18.1** | (**48.1**) | | **MRI compatible patient vital signs monitoring system** | **$9.8** | **$9.7** | **0.6** | | Total Devices revenue | **$19.1** | **$27.8** | (**31.1**) | | Disposables, service and other | **$10.7** | **$8.9** | **20.3** | | Amortization of extended warranty agreements | **$1.9** | **$1.8** | **1.6** | | Total Revenue | **$31.7** | **$38.5** | (**17.7**) | - Unit sales for **MRI compatible IV infusion pumps** decreased from **519** in **2019** to **279** in **2020**, while **patient vital signs monitoring systems** decreased slightly from **278** to **255** units[319](index=319&type=chunk)[320](index=320&type=chunk) - Gross profit margin decreased from **77.1%** in **2019** to **74.3%** in **2020**, primarily due to unfavorable overhead variance adjustments[323](index=323&type=chunk) - General and administrative expenses increased by **17.4%** due to higher stock compensation and payroll, including **$3.2 million** related to the former CEO's separation[325](index=325&type=chunk) - Sales and marketing expenses increased by **10.8%** due to higher payroll and sales commissions[326](index=326&type=chunk) - Research and development expenses increased by **32.8%** due to higher payroll and employee recruiting fees[327](index=327&type=chunk) - The effective tax rate was **321.9%** in **2020**, compared to (**6.5%)** in **2019**, influenced by a loss before income taxes, tax benefits from stock options, and the **CARES Act NOL** carryback[329](index=329&type=chunk) [Liquidity and Capital Resources](index=73&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is primarily supported by **$62.5 million** in cash and investments, **$72.2 million** in stockholders' equity, and **$69.4 million** in working capital as of December **31**, **2021**, with sufficient sources for the next **12** months - Principal liquidity sources include cash and cash equivalents, investments, and cash flow from operations[330](index=330&type=chunk) Key Financial Position Metrics | Metric | 2021 (Millions) | 2020 (Millions) | | :---------------------- | :-------------- | :-------------- | | Cash and Investments | **$62.5** | **$52.0** | | Stockholders' Equity | **$72.2** | **$61.4** | | Working Capital | **$69.4** | **$58.8** | Cash Flow Summary (in millions) | Activity | 2021 | 2020 | 2019 | | :------------------------ | :---- | :---- | :---- | | Net cash provided by operating activities | **$11.3** | **$5.8** | **$10.2** | | Net cash provided by investing activities | **$0.6** | **$0.2** | **$3.2** | | Net cash provided by financing activities | **$0.0** | **$0.5** | **$2.0** | - Cash provided by operations increased by **$5.5 million** in **2021** to **$11.3 million**, positively impacted by higher net income and non-cash adjustments[333](index=333&type=chunk) - The company believes its current liquidity sources are sufficient to meet projected cash requirements for at least the next **12** months[344](index=344&type=chunk) Contractual Obligations as of December 31, 2021 (in millions) | Obligation Type | Total ($) | Less than 1 Year ($) | 1-3 Years ($) | 3-5 Years ($) | More than 5 Years ($) | | :-------------------------- | :-------- | :------------------- | :------------ | :------------ | :-------------------- | | Unconditional purchase obligations | **$5.6** | **$5.5** | **$0.1** | **$0.0** | **$0.0** | | Operating lease obligations | **$3.1** | **$0.4** | **$0.8** | **$1.8** | **$0.0** | | Total | **$8.7** | **$5.9** | **$0.9** | **$1.8** | **$0.0** | - The company has no off-balance sheet arrangements[347](index=347&type=chunk) [ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=77&type=section&id=ITEM%207A.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) The company is exposed to market risks primarily from foreign currency exchange rates, particularly the Japanese Yen, and interest rate fluctuations, though the impact on net income and corporate bond fair value is expected to be immaterial - The company is exposed to foreign currency exchange risk, primarily related to the Japanese Yen, as some cost of revenue is denominated in Yen[348](index=348&type=chunk)[349](index=349&type=chunk) - A **10%** uniform increase or decrease 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**, **2021**[349](index=349&type=chunk) - Interest rate risk affects interest income from bank money-market funds and short-term investments; a **100** basis point change in market interest rates would result in an approximate **$380,000** change in interest income[350](index=350&type=chunk) - The fair value of corporate bonds held as short-term investments is sensitive to interest rate changes, but the expected change in fair value from a **100** basis point shift is considered immaterial[351](index=351&type=chunk)[353](index=353&type=chunk) [ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA](index=79&type=section&id=ITEM%208.%20FINANCIAL%20STATEMENTS%20AND%20SUPPLEMENTARY%20DATA) This section incorporates by reference the audited financial statements and supplementary data, including selected unaudited quarterly financial data, prepared consistently with audited statements - The Financial Statements and Supplementary Data are incorporated by reference from information beginning on Page F-1 of this Form 10-K[354](index=354&type=chunk) - Selected quarterly financial data for the **eight** quarters ending December **31**, **2021**, is presented on an unaudited basis, prepared consistently with the audited financial statements[355](index=355&type=chunk)[356](index=356&type=chunk) Selected Quarterly Financial Data (Unaudited) - 2021 | Metric (Thousands) | Dec 31, 2021 | Sep 30, 2021 | Jun 30, 2021 | Mar 31, 2021 | | :----------------- | :----------- | :----------- | :----------- | :----------- | | Revenue | **$11,873** | **$10,907** | **$9,810** | **$9,224** | | Gross profit | **$9,250** | **$8,406** | **$7,332** | **$7,062** | | Income from operations | **$3,110** | **$3,087** | **$1,844** | **$1,777** | | Net income | **$3,893** | **$2,576** | **$1,470** | **$1,387** | | Diluted EPS | **$0.31** | **$0.20** | **$0.12** | **$0.11** | Selected Quarterly Financial Data (Unaudited) - 2020 | Metric (Thousands) | Dec 31, 2020 | Sep 30, 2020 | Jun 30, 2020 | Mar 31, 2020 | | :----------------- | :----------- | :----------- | :----------- | :----------- | | Revenue | **$8,546** | **$7,699** | **$6,795** | **$8,678** | | Gross profit | **$6,439** | **$5,741** | **$4,930** | **6,464** | | Income (loss) from operations | **$651** | **$785** | (**$2,929**) | **$737** | | Net income (loss) | **$637** | **$1,075** | (**$2,112**) | **$1,769** | | Diluted EPS | **$0.05** | **$0.09** | (**$0.17**) | **$0.14** | [ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE](index=80&type=section&id=ITEM%209.%20CHANGES%20IN%20AND%20DISAGREEMENTS%20WITH%20ACCOUNTANTS%20ON%20ACCOUNTING%20AND%20FINANCIAL%20DISCLOSURE) There have been no changes in or disagreements with accountants on accounting and financial disclosure - There are no changes in or disagreements with accountants on accounting and financial disclosure[359](index=359&type=chunk) [ITEM 9A. CONTROLS AND PROCEDURES](index=80&type=section&id=ITEM%209A.%20CONTROLS%20AND%20PROCEDURES) Management concluded that the company's disclosure controls and internal control over financial reporting were effective as of December **31**, **2021**, with no material changes during the fourth quarter - As of December **31**, **2021**, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[360](index=360&type=chunk) - Management is responsible for establishing and maintaining a system of internal control over financial reporting to provide reasonable assurance regarding the reliability of financial reporting[361](index=361&type=chunk) - Based on an assessment using the **COSO** framework, management concluded that internal control over financial reporting was effective as of December **31**, **2021**[362](index=362&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended December **31**, **2021**, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[363](index=363&type=chunk) [ITEM 9B. OTHER INFORMATION](index=82&type=section&id=ITEM%209B.%20OTHER%20INFORMATION) This item is not applicable and contains no additional information - This item is not applicable[365](index=365&type=chunk) [PART III](index=83&type=section&id=PART%20III) This section details directors, executive compensation, security ownership, related transactions, and accounting fees [ITEM 10. DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE](index=83&type=section&id=ITEM%2010.%20DIRECTORS%2C%20EXECUTIVE%20OFFICERS%2C%20AND%20CORPORATE%20GOVERNANCE) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the definitive proxy statement for the **2022** Annual Meeting of Stockholders - Information for this item is incorporated by reference from the registrant's definitive proxy statement for the **2022** Annual Meeting of Stockholders[368](index=368&type=chunk) [ITEM 11. EXECUTIVE COMPENSATION](index=83&type=section&id=ITEM%2011.%20EXECUTIVE%20COMPENSATION) Information regarding executive compensation is incorporated by reference from the definitive proxy statement - Information for this item is incorporated by reference from the Proxy Statement[369](index=369&type=chunk) [ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS](index=83&type=section&id=ITEM%2012.%20SECURITY%20OWNERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%20AND%20MANAGEMENT%20AND%20RELATED%20STOCKHOLDER%20MATTERS) Information concerning security ownership of certain beneficial owners and management, including equity compensation plan information, is incorporated by reference from the definitive proxy statement - Information for this item, including Equity Compensation Plan Information, is incorporated by reference from the Proxy Statement[370](index=370&type=chunk) [ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE](index=83&type=section&id=ITEM%2013.%20CERTAIN%20RELATIONSHIPS%20AND%20RELATED%20TRANSACTIONS%2C%20AND%20DIRECTOR%20INDEPENDENCE) Information regarding certain relationships, related transactions, and director independence is incorporated by reference from the definitive proxy statement - Information for this item is incorporated by reference from the Proxy Statement[371](index=371&type=chunk) [ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES](index=83&type=section&id=ITEM%2014.%20PRINCIPAL%20ACCOUNTING%20FEES%20AND%20SERVICES) Information regarding principal accounting fees and services is incorporated by reference from the definitive proxy statement - Information for this item is incorporated by reference from the Proxy Statement[372](index=372&type=chunk) [PART IV](index=84&type=section&id=PART%20IV) This section outlines exhibits, financial statement schedules, and the Form 10-K summary [ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES](index=84&type=section&id=ITEM%2015.%20EXHIBITS%20AND%20FINANCIAL%20STATEMENT%20SCHEDULES) This section lists the financial statements, financial statement schedules, and exhibits filed as part of this Form 10-K, including the Exhibit Index - This section details the financial statements, financial statement schedules, and exhibits filed as part of this Form 10-K[378](index=378&type=chunk) - Financial Statements are incorporated by reference to information beginning on Page F-1[378](index=378&type=chunk) - A comprehensive Exhibit Index is provided, listing various documents including the Amended and Restated Certificate of Incorporation, Bylaws, Equity Incentive Plans, Lease Agreement, Employment Agreements, and Supply Agreements[377](index=377&type=chunk) [ITEM 16. FORM 10-K SUMMARY](index=84&type=section&id=ITEM%2016.%20FORM%2010-K%20SUMMARY) This item indicates that there is no Form 10-K Summary provided - No Form 10-K Summary is provided[375](index=375&type=chunk) [FINANCIAL STATEMENTS](index=87&type=section&id=FINANCIAL%20STATEMENTS) This section presents audited financial statements, including balance sheets, operations, cash flows, and comprehensive notes [Report of Independent Registered Public Accounting Firm](index=88&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) RSM US LLP issued an unqualified opinion on **IRADIMED CORPORATION's** financial statements for **2021** and **2020**, confirming U.S. **GAAP** conformity and no critical audit matters - RSM US LLP issued an unqualified opinion on **IRADIMED CORPORATION's** financial statements for the years ended December **31**, **2021** and **2020**[391](index=391&type=chunk) - The financial statements are presented fairly, in all material respects, in conformity with accounting principles generally accepted in the United States of America (**U.S. GAAP**)[391](index=391&type=chunk) - The audit was conducted in accordance with **PCAOB** standards, and no critical audit matters were identified[393](index=393&type=chunk)[395](index=395&type=chunk) [Balance Sheets](index=89&type=section&id=Balance%20Sheets) The balance sheets show total assets increased to **$82.88 million** in **2021**, driven by cash, with total liabilities and stockholders' equity also rising Balance Sheet Summary (in thousands) | Metric | Dec 31, 2021 | Dec 31, 2020 | | :---------------------- | :----------- | :----------- | | **Assets:** | | | | Cash and cash equivalents | **$61,999** | **$50,069** | | Total current assets | **$76,245** | **$63,736** | | Total assets | **$82,881** | **$71,067** | | **Liabilities:** | | | | Total current liabilities | **$6,823** | **$4,917** | | Total liabilities | **$10,708** | **$9,682** | | **Stockholders' Equity:** | | | | Total stockholders' equity | **$72,174** | **$61,385** | - Cash and cash equivalents increased significantly from **$50.07 million** in **2020** to **$62.00 million** in **2021**[398](index=398&type=chunk) - Total current assets increased by **$12.51 million**, and total assets increased by **$11.81 million** from **2020** to **2021**[398](index=398&type=chunk) - Total stockholders' equity increased by **$10.79 million**, reflecting net income and stock-based compensation[398](index=398&type=chunk) [Statements of Operations](index=90&type=section&id=Statements%20of%20Operations) Net income significantly increased to **$9.33 million** in **2021**, driven by a **31.8%** revenue increase and improved gross profit margin, recovering from a lower **2020** performance Statements of Operations Summary (in thousands) | Metric | 2021 | 2020 | 2019 | | :-------------------------- | :---------- | :---------- | :---------- | | Revenue | **$41,815** | **$31,717** | **$38,517** | | Cost of revenue | **$9,765** | **$8,143** | **$8,816** | | Gross profit | **$32,050** | **$23,574** | **$29,701** | | Total operating expenses | **$22,232** | **$24,331** | **$21,054** | | Income (loss) from operations | **$9,818** | (**$756**) | **$8,647** | | Income (loss) before provision for income taxes | **$9,836** | (**$617**) | **$9,043** | | Provision for income tax expense (benefit) | **$511** | (**$1,986**) | (**$588**) | | Net income | **$9,325** | **$1,369** | **$9,631** | | Basic EPS | **$0.76** | **$0.11** | **$0.85** | | Diluted EPS | **$0.74** | **$0.11** | **$0.78** | - Revenue increased by **$10.1 million** (**31.8%**) in **2021** compared to **2020**, reaching **$41.81 million**[401](index=401&type=chunk) - Net income significantly increased to **$9.33 million** in **2021** from **$1.37 million** in **2020**[401](index=401&type=chunk) - The company reported income from operations of **$9.82 million** in **2021**, a substantial recovery from a loss of (**$0.76 million**) in **2020**[401](index=401&type=chunk) [Statements of Comprehensive Income](index=91&type=section&id=Statements%20of%20Comprehensive%20Income) Comprehensive income for **2021** was **$9.31 million**, slightly lower than net income due to unrealized losses on available-for-sale securities Statements of Comprehensive Income Summary (in thousands) | Metric | 2021 | 2020 | 2019 | | :-------------------------- | :---------- | :---------- | :---------- | | Net income | **$9,325** | **$1,369** | **$9,631** | | Other comprehensive (loss) income | (**$20**) | **$7** | **$73** | | Comprehensive income | **$9,305** | **$1,376** | **$9,704** | - In **2021**, the company reported an other comprehensive loss of (**$20,075**), primarily due to unrealized losses on available-for-sale securities[404](index=404&type=chunk) - Comprehensive income for **2021** was **$9.31 million**, slightly less than net income[404](index=404&type=chunk) [Statements of Stockholders' Equity](index=92&type=section&id=Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity increased to **$72.17 million** in **2021**, primarily driven by net income and stock-based compensation, partially offset by other comprehensive loss Stockholders' Equity Summary (in thousands) | Metric | Dec 31, 2021 | Dec 31, 2020 | Dec 31, 2019 | | :-------------------------- | :----------- | :----------- | :----------- | | Total Stockholders' Equity | **$72,174** | **$61,385** | **$55,524** | | Net income | **$9,325** | **$1,369** | **$9,631** | | Stock-based compensation | **$1,459** | **$3,962** | **$1,855** | | Net share settlement of restricted stock units | (**$599**) | (**$1,208**) | (**$473**) | | Exercise of stock options | **$623** | **$1,730** | **$2,493** | - Total stockholders' equity increased by **$10.79 million** from December **31**, **2020**, to December **31**, **2021**[407](index=407&type=chunk) - The increase in equity was primarily driven by net income of **$9.33 million** and stock-based compensation of **$1.46 million** in **2021**[407](index=407&type=chunk) - Common stock shares outstanding increased from **12,308,432** in **2020** to **12,544,024** in **2021**[407](index=407&type=chunk) [Statements of Cash Flows](index=93&type=section&id=Statements%20of%20Cash%20Flows) Net cash provided by operating activities increased to **$11.26 million** in **2021**, primarily due to higher net income, with positive contributions from investing and financing activities Statements of Cash Flows Summary (in thousands) | Activity | 2021 | 2020 | 2019 | | :-------------------------------------- | :---------- | :---------- | :---------- | | Net cash provided by operating activities | **$11,258** | **$5,817** | **$10,233** | | Net cash provided by investing activities | **$648** | **$247** | **$3,201** | | Net cash provided by financing activities | **$24** | **$522** | **$2,020** | | Net increase in cash and cash equivalents | **$11,931** | **$6,587** | **$15,454** | | Cash and cash equivalents, end of year | **$61,999** | **$50,069** | **$43,482** | - Net cash provided by operating activities increased by **$5.44 million** in **2021**, primarily due to higher net income[333](index=333&type=chunk)[410](index=410&type=chunk) - Net cash provided by investing activities increased to **$0.65 million** in **2021**, mainly from proceeds from maturities of investments[337](index=337&type=chunk)[410](index=410&type=chunk) - Net cash provided by financing activities was **$0.02 million** in **2021**, resulting from stock option exercises offset by taxes paid for restricted stock units[340](index=340&type=chunk)[410](index=410&type=chunk) [Notes to Financial Statements](index=94&type=section&id=Notes%20to%20Financial%20Statements) The notes provide detailed disclosures on organization, significant accounting policies, financial line items, risks, and recent accounting pronouncements - The company develops, manufactures, markets, and distributes **MRI-compatible IV infusion pump systems** and **patient vital signs monitoring systems**[412](index=412&type=chunk) - Significant accounting policies include revenue recognition (transfer of control, standalone selling price), contract liabilities (deferred revenue)

Financial Data and Key Metrics Changes - Q4 2021 revenue was $11.9 million, a 39% increase over Q4 2020, and a 9% increase over Q3 2021 [5][13] - Non-GAAP earnings were $0.33, representing a 373% increase compared to Q4 2020 [5][18] - Gross margin improved to 77.9% in Q4 2021 from 75.3% in Q4 2020 [15] - Operating expenses were $6.1 million, or 51.7% of revenue, down from 67.7% in the previous year [17] Business Line Data and Key Metrics Changes - Device revenue increased by 49.7% to $8 million in Q4 2021, driven by a 50.9% increase in monitor revenue and a 48.5% increase in IV pump revenue [13][14] - Revenue from disposables and service rose by 24.3% to $3.4 million [15] - Revenue from maintenance contracts remained consistent at $0.5 million [15] Market Data and Key Metrics Changes - Domestic sales increased by 33.3% to $9.5 million, while international sales surged by 66.8% to $2.4 million [13] - Domestic revenue accounted for 79.8% of total revenue in Q4 2021, down from 83.1% in Q4 2020 [13] Company Strategy and Development Direction - The company is focusing on regulatory clearance for its next-generation IV pump and expects potential clearance in the second half of 2022 [7][10] - The company anticipates continued market share growth with its monitor and plans to ramp up sales of the ferromagnetic detector (FMD) in 2022 [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong demand for products, with record bookings up 39% year-over-year [6][10] - The company expects revenue for 2022 to be between $51.4 million and $52.2 million, with GAAP earnings of $0.82 to $0.90 [11] - Management noted that supply chain issues are being managed, with expectations for improvement in the second half of 2022 [38] Other Important Information - Cash from operations grew to $11.3 million for the full year 2021, up from $5.8 million in 2020 [19] - The company recognized a tax benefit of approximately $779,000 in Q4 2021 compared to a tax expense of $27,000 in Q4 2020 [18] Q&A Session Summary Question: Is the backlog tilted in one category versus the other? - Management indicated that backlog is healthy across pumps, monitors, and disposables [23] Question: Does production catch up to feel the backlog? - Management believes there is a steady-state backlog and discussions are ongoing about managing lead times [24] Question: Is the guidance reliant on the next-generation pump? - No revenue from the next-gen pump is included in the guidance; significant contributions are expected in 2023 [26][27] Question: How do you see sales unfolding in the U.S. market versus the European market? - The domestic market is recovering faster than Europe, which is still facing COVID-related challenges [37] Question: What assumptions are being made about supply chain issues in 2022? - Management sees a glimmer of hope for easing supply chain issues in the second half of the year [38] Question: What are the priorities for allocating capital given the cash position? - Discussions regarding capital allocation are ongoing at the board level, but no specific comments were provided [41]

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2021 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q 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) Delaware 73-1408526 (State or other j ...

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 June 30, 2021 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) Delaware 73-1408526 (State or other jurisd ...

IRadimed Corporation (NASDAQ:IRMD) Q2 2021 Earnings Conference Call July 30, 2021 11:00 AM ET Company Participants Roger Susi - President & Chief Executive Officer Chris Scott - Chief Financial Officer & Chief Operating Officer Conference Call Participants Scott Henry - ROTH Capital Lisa Springer - Singular Research Operator Welcome to the IRadimed Corporation Second Quarter 2021 Financial Results Conference Call. Currently, all participants are in a listen-only mode. And at the end of the call, we’ll condu ...

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, 2021 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 Corporation (NASDAQ:IRMD) Q1 2021 Earnings Conference Call April 30, 2021 11:00 AM ET Company Participants Roger Susi – President and Chief Executive Officer Chris Scott – Chief Financial Officer Conference Call Participants Scott Henry – ROTH Capital Lisa Springer – Singular Research Operator Welcome to the IRadimed Corporation’s First Quarter 2021 Financial Results Conference Call. [Operator Instructions] As a reminder, this call is being recorded today, April 30, 2021, and contains time-sensitiv ...

Investor Presentation March 2021 Forward-Looking Statements Except for historical facts, the statements in this presentation, as well as oral statements or other written statements made or to be made by IRADIMED CORPORATION (the "Company"), are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and involve risks and uncertainties. These statements relate to future events or our future financial performance or condition and involve unknown risks, uncertainti ...