CAUTIONARY STATEMENTS REGARDING FORWARD-LOOKING STATEMENTS
Certain statements contained in this Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 (this “Quarterly Report”)that are not historical facts may constitute forward-looking statements within the meaning of 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”), and are intended to be covered by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. When used in this Quarterly Report the words “believe,” “anticipate,” “expect,” “may,” “will,” “assume,” “should,” “predict,” “could,” “would,” “intend,” “targets,” “estimates,” “projects,” “plans,” and “potential,” and other similar words and expressions of the future, are intended to identify such forward-looking statements, but other statements not based on historical information may also be considered forward-looking, including statements about the Company’s future financial and operating results and the Company’s plans, objectives, and intentions. All forward-looking statements are subject to risks, uncertainties, and other factors that may cause the actual results, performance, or achievements of the Company to differ materially from any results, performance, or achievements expressed or implied by such forward-looking statements. These forward-looking statements are subject to known and unknown risks, uncertainties and other factors that could cause the actual results to differ materially from the statements, including, but not limited to:
| ● | 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; |
| ● | our ability to compete in the development and marketing of our products and product candidates with other companies 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 |
| ● | other risks detailed in our filings with the United States Securities and Exchange Commission (the “SEC”). |
These forward-looking statements involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements. Forward-looking statements should, therefore, be considered in light of various factors, including those set forth under “Part I, Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report, and under “Part I, Item 1A. Risk Factors” and “Part II, Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 (the “2023 Annual Report”) and those set forth from time to time in our other filings with the SEC. These documents are available through our website or through the SEC's Electronic Data Gathering and Analysis Retrieval system at http://www.sec.gov. In light of such risks and uncertainties, we caution you not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this Quarterly Report, or if earlier, as of the date they were made. We do not intend to, and disclaim any obligation to, update or revise any forward-looking statements unless required by securities law.
Unless expressly indicated or the context requires otherwise, references in this Quarterly Report to “IRADIMED,” the “Company,” “we,” “our,” and “us” refer to IRADIMED CORPORATION.
