IRADIMED CORPORATION.
TABLE OF CONTENTS TO ANNUAL REPORT ON FORM 10-K
For the Fiscal Year Ended December 31, 2023
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| PART I | | 1 |
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| ITEM 1. | | BUSINESS | | 1 |
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| ITEM 1A. | | RISK FACTORS | | 20 |
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| ITEM 1B. | | UNRESOLVED STAFF COMMENTS | | 42 |
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| ITEM 1C. | | CYBERSECURITY | | 42 |
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| ITEM 2. | | PROPERTIES | | 43 |
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| ITEM 3. | | LEGAL PROCEEDINGS | | 44 |
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| ITEM 4. | | MINE SAFETY DISCLOSURES | | 44 |
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| PART II | | | | 45 |
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| ITEM 5. | | MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES | | 45 |
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| ITEM 6. | | [RESERVED] | | 47 |
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| ITEM 7. | | MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | | 48 |
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| ITEM 7A. | | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | | 54 |
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| ITEM 8. | | FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA | | 54 |
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| ITEM 9. | | CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE | | 54 |
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| ITEM 9A. | | CONTROLS AND PROCEDURES | | 55 |
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| ITEM 9B. | | OTHER INFORMATION | | 55 |
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| ITEM 9C. | | DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS | | 56 |
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| PART III | | | | 56 |
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| ITEM 10. | | DIRECTORS, EXECUTIVE OFFICERS, AND CORPORATE GOVERNANCE | | 56 |
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| ITEM 11. | | EXECUTIVE COMPENSATION | | 56 |
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| ITEM 12. | | SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS | | 56 |
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| ITEM 13. | | CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE | | 56 |
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| ITEM 14. | | PRINCIPAL ACCOUNTANT FEES AND SERVICES | | 56 |
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| PART IV | | | | 57 |
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| ITEM 15. | | EXHIBITS AND FINANCIAL STATEMENT SCHEDULES | | 57 |
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| EXHIBIT INDEX | | 57 | |
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| SIGNATURES | | 59 | |
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| INDEX TO FINANCIAL STATEMENTS | | F-1 | |
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CAUTIONARY STATEMENTS REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K (this “Form 10-K” or “Annual Report”)within the meaning under Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements include, but are not limited to, statements regarding our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, and are not guarantees of future performance. The words “may,” “will,” “anticipate,” “believe,” “expect,” “continue,” “could,” “estimate,” “future,” “expect,” “intends,” “might,” “plan,” “possible,” “potential,” “aim,” “strive,” “predict,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.
The forward-looking statements in this Annual Report include, among other things, statements about:
| ● | our ability to receive 510(k) clearance for our products and product candidates, complete inspections conducted by the U.S. Food & Drug Administration (“FDA”) or other regulatory bodies resulting in favorable outcomes, additional actions by or requests from the FDA, including a request to cease domestic distribution of products, or other regulatory bodies and unanticipated costs or delays associated with the resolution of these matters; |
| ● | the timing and likelihood of regulatory approvals or clearances from the FDA or other regulatory bodies and regulatory actions on our product candidates and product marketing activities; |
| ● | unexpected costs, expenses and diversion of management attention resulting from actions or requests posed to us by the FDA or other regulatory bodies; |
| ● | our primary reliance on a limited number of products; |
| ● | our ability to retain the continued service of our key professionals, including key management, marketing and scientific personnel, and to identify, hire and retain such additional qualified professionals; |
| ● | our expectations regarding the sales and marketing of our products, product candidates and services; |
| ● | our expectations regarding the integrity of our supply chain for our products; |
| ● | the potential for adverse application of environmental, health and safety and other laws and regulations of any jurisdiction on our operations; |
| ● | our expectations for market acceptance of our new products; |
| ● | the potential for our marketed products to be withdrawn due to recalls, patient adverse events or deaths; |
| ● | our ability to successfully prepare, file, prosecute, maintain, defend, including in cases of infringement, and enforce patent claims and other intellectual property rights on our products; |
| ● | our ability to identify and pursue development of additional products; |
| ● | the implementation of our business strategies; |
| ● | the potential for exposure to product liability claims; |
| ● | our financial performance expectations and interpretations thereof by securities analysts and investors; |
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| ● | our ability to compete in the development and marketing of our products and product candidates with existing companies and new market entrants in our industry; |
| ● | difficulties or delays in the development, production, manufacturing and marketing of new or existing products and services, including difficulties or delays associated with obtaining requisite regulatory approvals or clearances associated with those activities; |
| ● | changes in laws and regulations or in the interpretation or application of laws or regulations, as well as possible failures to comply with applicable laws or regulations as a result of possible misinterpretations or misapplications; |
| ● | cost-containment efforts of our customers, purchasing groups, third-party payers and governmental organizations; |
| ● | costs associated with protecting our trade secrets and enforcing our patent, copyright and trademark rights, and successful challenges to the validity of our patents, copyrights or trademarks; |
| ● | actions of regulatory bodies and other government authorities, including the FDA and foreign counterparts, that could delay, limit or suspend product development, manufacturing or sales or result in recalls, seizures, consent decrees, injunctions and monetary sanctions; |
| ● | costs or claims resulting from potential errors or defects in our manufacturing that may injure persons or damage property or operations, including costs from remediation efforts or recalls; |
| ● | the results, consequences, effects or timing of any commercial disputes, patent infringement claims or other legal proceedings or any government investigations; |
| ● | interruption in our ability to manufacture our products or an inability to obtain key components or raw materials or increased costs in such key components or raw materials; |
| ● | uncertainties in our industry due to the effects of government-driven or mandated healthcare reform; |
| ● | competitive pressures in the markets in which we operate; |
| ● | potential negative impacts resulting from climate change or other environmental, social and governance and sustainability related matters; |
| ● | the impact on our operations and financial results of any public health emergency and any related policies and actions by governments or other third parties; |
| ● | breaches or failures of our or our vendors’ or customers’ information technology systems or products, including by cyber-attack, data leakage, unauthorized access or theft; |
| ● | the loss of, or default by, one or more key customers or suppliers; |
| ● | unfavorable changes to the terms of key customer or supplier relationships; |
| ● | weakening of economic conditions, or the anticipation thereof, that could adversely affect the level of demand for our products; |
| ● | geopolitical risks, including from international conflicts and upcoming elections in the United States and other countries, which could, among other things, lead to increased market volatility; and |
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| ● | other risks detailed in our filings with the United States Securities and Exchange Commission (the “SEC”). |
We have included important factors in the cautionary statements included in this Annual Report, particularly in “Item 1A. Risk Factors”, that could cause actual results or events to differ materially from the forward-looking statements that we make. You should read this Form 10-K and the documents that we have filed as exhibits to this Annual Report completely and with the understanding that our actual future results may be materially different from what we expect. These forward-looking statements are based on information available as of the date of this Form 10-K, and current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. Accordingly, forward-looking statements should not be relied upon as representing our views as of any subsequent date, and we do not undertake any obligation to update or revise any forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
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