MeiraGTx Holdings plc 2024年度报告

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of thischapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See thedefinitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accountingstandards provided pursuant to Section 13(a) of the Exchange Act.☐ Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an errorto previously issued financial statements.☐ As of June 28, 2024, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the registrant’s ordinary shares held by non-affiliatesof the registrant was approximately $272,320,427 (based upon the closing sale price of the registrant’s ordinary shares on that date on the Nasdaq Global Select Market).As of March 9, 2025, the registrant had 78,854,936 ordinary shares outstanding. DOCUMENTS INCORPORATED BY REFERENCE Portions of the registrant’s definitive Proxy Statement relating to its 2025 annual shareholder meeting to be filed with the SEC within 120 days after the end of the fiscal yearended December 31, 2024 are incorporated herein by reference in Part III of this Annual Report on Form 10-K. CONTENTS PagePART I4Item 1.Business4Item 1A.Risk Factors52Item 1B.Unresolved Staff Comments114Item 1C.Cybersecurity114Item 2.Properties115Item 3.Legal Proceedings115Item 4.Mine Safety Disclosures115PART II116Item 5.Market For Registrant’s Common Equity, Related Stockholder Matters And Issuer PurchasesOf Equity Securities116Item 6.[Reserved]116Item 7.Management’s Discussion And Analysis Of Financial Condition And Results Of Operations116Item 7A.Quantitative And Qualitative Disclosures About Market Risk136Item 8.Financial Statements And Supplementary DataF-1Item 9.Changes In And Disagreements With Accountants On Accounting And Financial Disclosure137Item 9A.Controls And Procedures137Item 9B.Other Information138Item 9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections138PART III139Item 10.Directors, Executive Officers And Corporate Governance139Item 11.Executive Compensation139Item 12.Security Ownership Of Certain Beneficial Owners And Management And RelatedStockholder Matters139Item 13.Certain Relationships And Related Transactions, And Director Independence140Item 14.Principal Accountant Fees And Services140PART IV141Item 15.Exhibits and Financial Statement Schedules141Item 16.Form 10-K Summary146 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (the “Form 10-K”) contains forward-looking statements that can involve substantialrisks and uncertainties. All statements other than statements of historical facts contained in this Form 10-K, including,but not limited to, statements regarding our future results of operations and financial position, business strategy,financing, licensing and manufacturing arrangements, prospective products, development and timing of productcandidates, timing of and expected success and efficacy of our product candidates, plans and objectives for futureoperations, expected future results of anticipated products and prospects, and plans and objectives of management areforward-looking statements. These statements involve known and unknown risks, uncertainties and other importantfactors that may cause our actual results, performance or achievements to be materially different from any futureresults, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,”“plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,”“potential,” “would” or “continue” or the negative of these terms or other similar expressions. The forward-lookingstatements in this Form 10-K are only predictions. We have based these forward-looking statements largely on ourcurrent expectations and projections about future events and financial trends that we believe may affect our business,financial condition and results of operations. These forward-look