Protalix BioTherapeutics Inc 2024年度报告

FOR ANNUAL AND TRANSITION REPORTS PURSUANT TO SECTIONS 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934 (Mark One) ☒ANNUAL REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934For the fiscalyear endedDecember31, 2024OR☐TRANSITION REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934For the transition period fromto001-33357(Commission file number) PROTALIX BIOTHERAPEUTICS,INC. (Exact name of registrant as specified in its charter) Indicate by check mark if the registrant is not required to file reports pursuant to Section13 or Section15(d)of the Act. Yes◻No⌧ Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or 15(d)of the Securities Exchange Act of 1934during the preceding 12months (or for such shorter period that the registrant was required to file such reports), and (2)has been subject to such filing requirements forthe past 90days.Yes⌧No◻ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule405 ofRegulation S-T (§232.405 of this chapter) during the preceding 12months (or for such shorter period that the registrant was required to submit such files). Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or anemerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule12b-2of the Exchange Act. Largeacceleratedfiler☐Acceleratedfiler☐Non-accelerated filer☒Smallerreportingcompany☒Emerging growth company☐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 accounting standards provided pursuant to Section13(a)of the Exchange Act.☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal controlover financial reporting under 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 auditreport.☐ 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 thefiling reflect the correction of an error to previously issued financial statements.☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation receivedby any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Act).Yes◻No⌧ On March14, 2025, approximately78,032,585shares of the Registrant’s common stock, par value $0.001 per share, were outstanding. Portions of the registrant’s proxy statement related to its 2025 Annual Stockholders’ Meeting to be filed subsequently are incorporated by reference intoPart III of this Annual Report on Form 10-K. Except as expressly incorporated by reference, the registrant’s proxy statement shall not be deemed to be part of thisreport. PROTALIX BIOTHERAPEUTICS, INC.2024 FORM10-K ANNUAL REPORTTABLE OF CONTENTS PagePARTICautionary Statement Regarding Forward-Looking Statements1Item1.Business3Item1A.Risk Factors35Item1B.Unresolved Staff Comments61Item1C.Cybersecurity61Item2.Properties62Item3.Legal Proceedings62Item4.Mine Safety Disclosures62PARTIIItem5.Market for Registrant’s Common Equity, Related Stockholder Matters and IssuerPurchases of Equity Securities63Item6.[Reserved]63Item7.Management’s Discussion and Analysis of Financial Condition and Results ofOperations64Item7A.Quantitative and Qualitative Disclosures About Market Risk72Item8.Financial Statements and Supplementary Data73Item9.Changes in and Disagreements with Accountants on Accounting and FinancialDisclosure73Item9A.Controls and Procedures73Item9B.Other Information74Item9C.Disclosure Regarding Foreign Jurisdictions that Prevent Inspections74PARTIIIItem10.Directors, Executive Officers and Corporate Governance75Item11.Executive Compensation75Item12.Security Ownership of Certain Beneficial Owners and Management and RelatedStockholder Matters75Item13.Certain Relationships and Related Transactions, and Director Independence75Item14.Principal Accountant Fees and Services75PARTIVItem15.Exhibits and Financial Statement Schedules76Item16.Form10-K Summary79Signatures80 PARTI Except where the context otherwise requires, the terms “we,” “us,” “our” or “the Company,” referto the business of Protalix BioTherapeutics,Inc. and its consolidated subsidiaries, and “Protalix” or“ProtalixLtd.” refers to the business of ProtalixLtd., our wholly-owned subsidiary and soleoperating unit. C