{"url_path":"/sec/plx/10-k/2026/cover-page","section_key":"cover-page","section_title":"Cover Page","topic":"sec","document":{"doc_type":"10-K","doc_date":"2026-03-18","source_url":"https://www.sec.gov/Archives/edgar/data/1006281/0001104659-26-029858-index.html","accession_number":"0001104659-26-029858","cik":"0001006281","ticker":"PLX","issuer_name":"Protalix BioTherapeutics, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1006281/0001104659-26-029858-index.html","primary_entity_key":"0001006281","primary_entity_name":"Protalix BioTherapeutics, Inc."},"word_count":2146,"has_tables":true,"body_markdown":"PROTALIX BIOTHERAPEUTICS, INC._December 31, 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of Contents](#TOC)\n\nF\n\n​\n\n**UNITED STATES**\n\n**SECURITIES AND EXCHANGE COMMISSION**\n\n**Washington, D.C. 20549**\n\n​\n\n**FORM ****10-K**\n\n​\n\n​\n\n**FOR ANNUAL AND TRANSITION REPORTS PURSUANT TO SECTIONS 13 OR 15(d)**\n\n**OF THE SECURITIES EXCHANGE ACT OF 1934**\n\n**(Mark One)**\n\n**☒**\n\n**ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**\n\n​\n\n​\n\n​\n\n​\n\n​\n\n**For the fiscal year ended****December 31, 2025**\n\n​\n\n**OR**\n\n**☐**\n\n**TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934**\n\n​\n\n​\n\n​\n\n​\n\n​\n\n**For the transition period from****                       ****  to****                      ******\n\n​\n\n**001-33357**\n\n**(Commission file number)**\n\n​\n\n**PROTALIX BIOTHERAPEUTICS, INC.**\n\n**(Exact name of registrant as specified in its charter)**\n\n​\n\n**Delaware**\n\n**65-0643773**\n\n**State or other jurisdiction**\n\n**of incorporation or organization**\n\n**(I.R.S. Employer**\n\n**Identification No.)**\n\n \n\n \n\n**2 University Plaza**\n\n**Suite 100**\n\n**Hackensack****,****NJ**\n\n**07601**\n\n \n\n** **\n\n**(Address of principal executive offices)**\n\n**(Zip Code)**\n\n​\n\n**(****201****)****696-9345**\n\n**Registrant’s telephone number, including area code**\n\n**Securities registered pursuant to Section 12(b) of the Act:**\n\nTitle of each class\n\n  ​ ​ ​\n\nTrading Symbol(s)\n\n  ​ ​ ​\n\nName of each exchange on which registered\n\nCommon stock, $0.001 par value\n\n​\n\nPLX\n\n​\n\nNYSE American\n\n​\n\n**Securities registered pursuant to Section 12(g) of the Act:**\n\n**None**\n\n​\n\nIndicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes  ◻  No  ⌧\n\nIndicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes  ◻  No  ⌧\n\nIndicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes  ⌧  No  ◻\n\nIndicate 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 this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).  Yes  ⌧  No  ◻\n\nIndicate 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 definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.\n\nLarge accelerated filer\n\n☐\n\nAccelerated filer\n\n☐\n\nNon-accelerated filer\n\n☒\n\nSmaller reporting company\n\n☒\n\n \n\n \n\nEmerging growth company\n\n☐\n\nIf 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 Section 13(a) of the Exchange Act. ☐\n\nIndicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over 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 audit report. ☐\n\nIf 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 error to previously issued financial statements. ☐\n\nIndicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐\n\nIndicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes  ◻   No  ⌧\n\nThe aggregate market value of the voting common stock held by non-affiliates of the Registrant as of June 30, 2025 was approximately $113.1 million, based on the closing price for shares of the Registrant’s common stock reported by the NYSE American for such date.\n\nOn March 1, 2026, approximately 80,571,642 shares of the Registrant’s common stock, par value $0.001 per share, were outstanding.\n\n​\n\n**DOCUMENTS INCORPORATED BY REFERENCE**\n\nPortions of the registrant’s proxy statement related to its 2026 Annual Stockholders’ Meeting to be filed subsequently are incorporated by reference into Part 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 this report.\n\n​\n\n​\n\n​\n\n​\n\n[Table of Contents](#TOC)\n\nPROTALIX BIOTHERAPEUTICS, INC.\n\n2025 FORM 10-K ANNUAL REPORT\n\nTABLE OF CONTENTS\n\n​\n\n \n\n \n\n**Page**\n\n[**PART I**](#PARTI_803173)\n\n[Cautionary Statement Regarding Forward-Looking Statements](#CAUTIONARY_STATEMENT_REGARDING_FORWARD)\n\n1\n\n[Item 1.](#Item1Business_89253)\n\n[Business](#Item1Business_89253)\n\n3\n\n[Item 1A.](#Item1ARiskFactors_654735)\n\n[Risk Factors](#Item1ARiskFactors_654735)\n\n31\n\n[Item 1B.](#Item1BUnresolvedStaffComments_626044)\n\n[Unresolved Staff Comments](#Item1BUnresolvedStaffComments_626044)\n\n57\n\n[Item 1C.](#Item1CCybersecurity)\n\n[Cybersecurity](#Item1CCybersecurity)\n\n57\n\n[Item 2.](#Item2Properties_907582)\n\n[Properties](#Item2Properties_907582)\n\n58\n\n[Item 3.](#Item3LegalProceedings_932888)\n\n[Legal Proceedings](#Item3LegalProceedings_932888)\n\n58\n\n[Item 4.](#Item4MineSafetyDisclosures_147620)\n\n[Mine Safety Disclosures](#Item4MineSafetyDisclosures_147620)\n\n58\n\n[**PART II**](#PARTII_453527)\n\n[Item 5.](#Item5MarketforRegistrantsCommonEquityRel)\n\n[Market for Registrant’s Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities](#Item5MarketforRegistrantsCommonEquityRel)\n\n59\n\n[Item 6.](#Item6Reserved)\n\n[[Reserved]](#Item6Reserved)\n\n59\n\n[Item 7.](#Item7ManagementsDiscussionandAnalysisofF)\n\n[Management’s Discussion and Analysis of Financial Condition and Results of Operations](#Item7ManagementsDiscussionandAnalysisofF)\n\n60\n\n[Item 7A.](#Item7AQuantitativeandQualitativeDisclosu)\n\n[Quantitative and Qualitative Disclosures About Market Risk](#Item7AQuantitativeandQualitativeDisclosu)\n\n70\n\n[Item 8.](#Item8FinancialStatementsandSupplementary)\n\n[Financial Statements and Supplementary Data](#Item8FinancialStatementsandSupplementary)\n\n71\n\n[Item 9.](#Item9ChangesinandDisagreementswithAccoun)\n\n[Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](#Item9ChangesinandDisagreementswithAccoun)\n\n71\n\n[Item 9A.](#Item9AControlsandProcedures_730194)\n\n[Controls and Procedures](#Item9AControlsandProcedures_730194)\n\n71\n\n[Item 9B.](#Item9BOtherInformation_882944)\n\n[Other Information](#Item9BOtherInformation_882944)\n\n72\n\n[Item 9C.](#Item9C)\n\n[Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](#Item9C)\n\n72\n\n[**PART III**](#PARTIII_463758)\n\n[Item 10.](#Item10DirectorsExecutiveOfficersandCorpo)\n\n[Directors, Executive Officers, and Corporate Governance](#Item10DirectorsExecutiveOfficersandCorpo)\n\n73\n\n[Item 11.](#Item11ExecutiveCompensation_376320)\n\n[Executive Compensation](#Item11ExecutiveCompensation_376320)\n\n73\n\n[Item 12.](#Item12SecurityOwnershipofCertainBenefici)\n\n[Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](#Item12SecurityOwnershipofCertainBenefici)\n\n73\n\n[Item 13.](#Item13CertainRelationshipsandRelatedTran)\n\n[Certain Relationships and Related Transactions and Director Independence](#Item13CertainRelationshipsandRelatedTran)\n\n73\n\n[Item 14.](#Item14PrincipalAccountantFeesandServices)\n\n[Principal Accountant Fees and Services](#Item14PrincipalAccountantFeesandServices)\n\n73\n\n[**PART IV**](#PARTIV_377623)\n\n[Item 15.](#Item15ExhibitsandFinancialStatementSched)\n\n[Exhibits and Financial Statement Schedules](#Item15ExhibitsandFinancialStatementSched)\n\n74\n\n[Item 16.](#Item16Form10KSummary_450405)\n\n[Form 10-K Summary](#Item16Form10KSummary_450405)\n\n77\n\n[Signatures](#SIGNATURES_579077)\n\n78\n\n​\n\n​\n\n​\n\n​\n\n[Table of Contents](#TOC)\n\n*Except where the context otherwise requires, the terms “we,” “us,” “our” or “the Company,” refer to the business of Protalix BioTherapeutics, Inc. and its consolidated subsidiary, and “Protalix” or “Protalix Ltd.” refers to the business of Protalix Ltd., our wholly-owned subsidiary and sole operating unit.*\n\nCAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS\n\nThe statements set forth under the sections entitled “[Business](#Item1Business_89253),” “[Management’s Discussion and Analysis of Financial Condition and Results of Operations](#Item7ManagementsDiscussionandAnalysisofF)” and “[Risk Factors](#Item1ARiskFactors_654735),” and other statements included elsewhere in this Annual Report on Form 10-K, particularly with respect to our plans and strategy for our business and related financing, include forward-looking statements within the meanings of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, including statements regarding expectations, beliefs, intentions or strategies for the future. When used in this report, the terms “anticipate,” “believe,” “estimate,” “expect,” “can,” “continue,” “could,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and other words or phrases of similar import, as they relate to our company, our subsidiaries or our management, are intended to identify forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are only predictions and reflect our views as of the date they are made with respect to future events and financial performance, and we undertake no obligation to update or revise, nor do we have a policy of updating or revising, any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events, except as may be required under applicable law. Forward-looking statements are subject to many risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements.\n\nExamples of the risks and uncertainties include, but are not limited to, the following:\n\n●risks related to the commercialization of Elfabrio® (pegunigalsidase alfa-iwxj), our approved product for the treatment of adult patients with Fabry disease;\n\n●risks relating to Elfabrio’s market acceptance, competition, reimbursement, and regulatory actions, including as a result of the boxed warning contained in the approval received from the U.S. Food and Drug Administration, or FDA, for the product;\n\n●risks related to the regulatory approval and commercial success of our other product and product candidates, if approved;\n\n●risks related to our expectations with respect to the projected market of our products and product candidates;\n\n●failure or delay in the commencement or completion of our preclinical studies and clinical trials, which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to satisfactorily demonstrate non-inferiority to approved therapies; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and/or inability to monitor patients adequately during or after treatment;\n\n●the risk that the results of the clinical trials of our product candidates will not support the applicable claims of safety or efficacy and that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics;\n\n●the possible disruption of our operations due to the regional conflict in Iran and the military actions between Israel and Iran, the Hamas terrorist organization located in the Gaza Strip, Hezbollah, the Houthis terrorist group that controls parts of Yemen, and others, including as a result of the disruption of the operations of certain regulatory authorities and of certain of our suppliers, collaborative partners, licensees, clinical trial sites, distributors and customers, and the risk that the current hostilities will result in increased regional conflict;\n\n●delays in the approval or potential rejection of any applications we file with the FDA, European Medicines Agency, or EMA, or other health regulatory authorities for our other product candidates, and other risks relating to the review process;\n\n[Table of Contents](#TOC)\n\n●risks associated with global conditions and developments such as new or increased tariffs, new or changed trade restrictions, supply chain challenges, the inflationary environment and tight labor market, and instability in the banking industry, which may adversely impact our business, operations, and ability to raise additional financing if and as required and on terms acceptable to us;\n\n●risks related to any transactions we may effect in the public or private equity or debt markets to raise capital to finance future research and development activities, general and administrative expenses, and working capital;\n\n●risks relating to our evaluation and pursuit of strategic partnerships;\n\n●risks relating to our ability to manage our relationship with our collaborators, distributors, and partners, including, but not limited to, Pfizer Inc., or Pfizer, and Chiesi Farmaceutici S.p.A., or Chiesi;\n\n●risks related to the amount and sufficiency of our cash, cash equivalents, and short-term bank deposits;\n\n●risks relating to changes to interim, top-line, or preliminary data from clinical trials that we announce or publish;\n\n●risks relating to the compliance by Fundação Oswaldo Cruz, or Fiocruz, an arm of the Brazilian Ministry of Health, or the Brazilian MoH, with its purchase obligations under the Supply and Technology Transfer Agreement that we entered into with Fiocruz in June 2013, or the Brazil Agreement, which may have a material adverse effect on us and may result in our terminating such agreement;\n\n●risk of significant lawsuits, including stockholder litigation, which is common in the life sciences sector;\n\n●our dependence on performance by third-party providers of services and supplies, including without limitation, clinical trial services;\n\n●the inherent risks and uncertainties in developing drug platforms and products of the type we are developing;\n\n●the impact of development of competing therapies and/or technologies by other companies;\n\n●risks related to our supply of drug products to Pfizer;\n\n●potential product liability risks, and risks of securing adequate levels of related insurance coverage;\n\n●the possibility of infringing a third-party’s patents or other intellectual property rights and the uncertainty of obtaining patents covering our products and processes and successfully enforcing our intellectual property rights against third-parties; and\n\n●risks relating to changes in healthcare laws, rules, and regulations in the United States or elsewhere.\n\nGiven these uncertainties, you should not place undue reliance on these forward-looking statements. Companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in advanced or late-stage clinical trials, even after obtaining promising earlier trial results or preliminary findings for such clinical trials. Even if favorable testing data is generated from clinical trials of a drug product, the FDA or foreign regulatory authorities may not accept or approve a marketing application filed by a pharmaceutical or biotechnology company for the drug product.\n\nThese and other risks and uncertainties are detailed under the “[Risk Factors](#Item1ARiskFactors_654735)” section of this Annual Report and are described from time to time in the reports we file with the U.S. Securities and Exchange Commission, or the Commission.\n\n2\n\n[Table of Contents](#TOC)\n\nPART I"}