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NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES<table style="border-collapse:collapse;border:0;"><tr><td style="width:36pt;padding:0pt;"/><td style="vertical-align:text-top;white-space:nowrap;width:18pt;padding:0pt;">a.</td><td style="padding:0pt;">General</td></tr></table>Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the “Company”) and its wholly-owned subsidiaries, Protalix Ltd. and Protalix B.V. (collectively, the “Subsidiaries”), are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company’s proprietary ProCellEx® protein expression system (“ProCellEx”). To date, the Company has successfully developed taliglucerase alfa (marketed under the name BioManguinhos alfataliglicerase in Brazil and certain other Latin American countries and Elelyso® in the rest of the territories) for the treatment of Gaucher disease that has been approved for marketing in the United States, Brazil, Israel and other markets. The Company has a number of product candidates in varying stages of the clinical development process. The Company’s strategy is to develop proprietary recombinant proteins that are therapeutically superior to existing recombinant proteins currently marketed for the same indications.The most advanced investigational drug in the Company’s product pipeline is pegunigalsidase alfa, or PRX-102, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder, which was the subject of a phase III clinical program. The PRX-102 phase III clinical program included three separate studies, which are referred to as the BALANCE study, the BRIDGE study and the BRIGHT study, each of which has been completed. The studies were designed to evaluate the potential for improved efficacy and better quality of life for adult patients with Fabry disease and to evaluate the safety of the Company’s drug/therapy. The phase III clinical program analyzed two potential dosing regimens: 1 mg/kg every two weeks and 2 mg/kg every four weeks. In addition, the phase III clinical program included two extension studies in which subjects that participated in the Company’s phase I/II clinical trials and phase III clinical trials had the opportunity to enroll and continue to be treated with PRX-102. As of March 1, 2023, sponsorship of the two open-label extension studies was transferred to the Company’s development and commercialization partner for PRX-102, Chiesi Farmaceutici S.p.A. (“Chiesi”).The U.S. Food and Drug Administration (the “FDA”) has indicated that the biologics license application (“BLA”) for PRX-102 for the potential treatment of adult patients with Fabry disease resubmitted on November 9, 2022 by the Company, together with Chiesi, was considered a complete, class 2 response and set a PDUFA action date of May 9, 2023. The initial BLA for PRX-102 was submitted to the FDA on May 27, 2020 under the FDA’s Accelerated Approval pathway, and was subsequently accepted by the FDA and granted Priority Review designation. However, in April 2021, the FDA issued a Complete Response Letter (CRL) in response to the initial BLA. In preparation for the BLA resubmission, the Company and Chiesi participated in a Type A (End of Review) meeting with the FDA on September 9, 2021. As part of the meeting minutes provided by the FDA, which included the preliminary comments and meeting discussion, the FDA, in principle, agreed that the data package proposed to the FDA for a BLA resubmission has the potential to support a traditional approval of PRX-102 for the treatment of Fabry disease. The data package in the BLA resubmission, given the change in the regulatory landscape in the United States, included the final two-year analyses of the Company’s phase III BALANCE clinical trial of PRX-102, which was completed in July 2022, and long-term data from the Company’s open-label extension study of PRX-102 in adult patients treated with a 2 mg/kg every four weeks dosage of PRX-102.On February 7, 2022, the Company, together with Chiesi, submitted a Marketing Authorization Application (“MAA”) for PRX-102 to the European Medicines Agency (“EMA”) which was subsequently validated by the EMA. The submission was made after the October 8, 2021 meeting the Company held, together with Chiesi, with the Rapporteur and Co-Rapporteur of the EMA regarding PRX-102.The MAA submission included a comprehensive set of preclinical, clinical and manufacturing data compiled from the Company’s completed and ongoing clinical studies evaluating PRX-102 as a potential alternative treatment for adult patients with Fabry disease, including data from the Company’s completed 12–month switch–over phase III BRIGHT clinical trial in adult patients with Fabry disease treated with a 2 mg/kg every four weeks dosage to support an additional potential treatment regimen for Fabry patients. As part of the EMA review process, Chiesi and the Company responded to the Day 120 list of questions in September 2022 (following a 3-month clock-stop period) and the list of outstanding issues of Day 180 in December 2022. An essential portion of the Day 120 response included the submission of the final analysis of the two-year BALANCE study (the final Clinical Study Report), and an interim analysis of the Company’s long-term, open-label extension study of PRX-102 in adult patients with Fabry disease treated with the 2 mg/kg every four weeks dosage.On February 24, 2023, the Company, together with Chiesi, announced that the EMA’s Committee for Medicinal Products for Human Use (the “CHMP”) adopted a positive opinion, recommending marketing authorization for PRX-102. The CHMP opinion was referred for final action to the European Commission (the “EC”). A final EC decision on the MAA is expected in the beginning of May 2023.In addition to PRX-102, the Company’s product pipeline currently includes, among other candidates:<table style="border-collapse:collapse;font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:10pt;margin-top:0pt;table-layout:fixed;width:100%;border:0pt;"><tr><td style="width:54pt;"/><td style="font-family:'Times New Roman','Times','serif';font-size:10pt;vertical-align:text-top;white-space:nowrap;width:18pt;padding:0pt;">(1)</td><td style="padding:0pt;">PRX-115, the Company’s plant cell-expressed recombinant PEGylated uricase (urate oxidase) – a chemically modified enzyme to treat severe gout; and</td></tr></table><table style="border-collapse:collapse;font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;table-layout:fixed;width:100%;border:0pt;"><tr><td style="width:54pt;"/><td style="font-family:'Times New Roman','Times','serif';font-size:10pt;vertical-align:text-top;white-space:nowrap;width:18pt;padding:0pt;">(2)</td><td style="padding:0pt;">PRX-119, the Company’s plant cell-expressed PEGylated recombinant human DNase I product candidate being designed to elongate half-life in the circulation for NETs-related diseases.</td></tr></table><div style="margin-top:10pt;"/>Obtaining marketing approval with respect to any product candidate in any country is dependent on the Company’s ability to implement the necessary regulatory steps required to obtain such approvals. The Company cannot reasonably predict the outcome of these activities.On July 2, 2021, the Company entered into an At The Market Offering Agreement (the “2021 Sales Agreement”) with H.C. Wainwright & Co., LLC, as the Company’s sales agent (the “Agent”) which was amended on May 2, 2022. Pursuant to the terms of the 2021 Sales Agreement, the Company was able to sell, from time to time through the Agent, shares of its common stock, par value $0.001 per share (the “Common Stock”), having an aggregate offering price of up to $20.0 million (the “ATM Shares”). Upon execution of the 2021 Sales Agreement, the Company terminated the ATM Equity OfferingSM Sales Agreement it had entered into on October 1, 2020 with BofA Securities, Inc. (“BofA Securities”). During the term of the sales agreement with BofA Securities, the Company sold a total of 3,296,123 shares of Common Stock for total gross proceeds of approximately $13.8 million.As of March 31, 2023, the Company sold a total of 13,980,060 ATM Shares for total gross proceeds of approximately $20.0 million under the 2021 Sales Agreement, thereby completing the ATM program under said agreement.On February 27, 2023, the Company entered into an At The Market Offering Agreement (the “2023 Sales Agreement”) with the Agent. Pursuant to the terms of the 2023 Sales Agreement, the Company may sell, from time to time through the Agent, ATM Shares having an aggregate offering price of up to $20.0 million. As of March 31, 2023, shares of Common Stock for total gross proceeds of approximately $16.5 million remain available to be sold under the 2023 Sales Agreement.On October 19, 2017, Protalix Ltd. and Chiesi entered into an Exclusive License and Supply Agreement (the “Chiesi Ex-US Agreement”) pursuant to which Protalix Ltd. granted to Chiesi an exclusive license for all markets outside of the United States to commercialize pegunigalsidase alfa. On July 23, 2018, Protalix Ltd. entered into an Exclusive License and Supply Agreement with Chiesi (the “Chiesi US Agreement”) with respect to the commercialization of pegunigalsidase alfa in the United States.Under each of the Chiesi Ex-US Agreement and the Chiesi US Agreement (collectively, the “Chiesi Agreements”), Chiesi made an upfront payment to Protalix Ltd. of $25.0 million in connection with the execution of each agreement. In addition, under the Chiesi Ex-US Agreement, Protalix Ltd. is entitled to additional payments of up to $25.0 million in pegunigalsidase alfa development costs and to receive additional payments of up to $320.0 million, in the aggregate, in regulatory and commercial milestone payments. Under the Chiesi US Agreement, Protalix Ltd. is entitled to payments of up to a maximum of $20.0 million to cover development costs for pegunigalsidase alfa and to receive additional payments of up to a maximum of $760.0 million, in the aggregate, in regulatory and commercial milestone payments. To date, Protalix Ltd. has received the complete amount of development costs to which it is entitled under the Chiesi Agreements.Under the terms of both of the Chiesi Agreements, Protalix Ltd. will manufacture all of the pegunigalsidase alfa needed under the agreements, subject to certain exceptions, and Chiesi will purchase pegunigalsidase alfa from Protalix, subject to certain terms and conditions. Under the Chiesi Ex-US Agreement, Chiesi is required to make tiered payments of 15% to 35% of its net sales, depending on the amount of annual sales outside of the United States, as consideration for product supply. Under the Chiesi US Agreement, Chiesi is required to make tiered payments of 15% to 40% of its net sales, depending on the amount of annual sales in the United States, as consideration for product supply.On May 13, 2021, the Company signed a binding term sheet with Chiesi pursuant to which the Company and Chiesi amended the Chiesi Agreements in order to provide the Company with near-term capital. Chiesi agreed to make a $10.0 million payment to the Company before the end of the second quarter of 2021 in exchange for a $25.0 million reduction in a longer term regulatory milestone payment provided in the Chiesi EX-US Agreement. All other regulatory and commercial milestone payments remain unchanged. The Company received the payment in June 2021. The Company also agreed to negotiate certain manufacturing related matters.Since its approval by the FDA, taliglucerase alfa has been marketed by Pfizer Inc. (“Pfizer”) in accordance with the exclusive license and supply agreement entered into between Protalix Ltd. and Pfizer, which is referred to herein as the Pfizer Agreement. In October 2015, Protalix Ltd. and Pfizer entered into an amended exclusive license and supply agreement, which is referred to herein as the Amended Pfizer Agreement, pursuant to which the Company sold to Pfizer its share in the collaboration created under the Pfizer Agreement for the commercialization of Elelyso. As part of the sale, the Company agreed to transfer its rights to Elelyso in Israel to Pfizer while gaining full rights to it in Brazil. Under the Amended Pfizer Agreement, Pfizer is entitled to all of the revenues, and is responsible for 100% of expenses globally for Elelyso, excluding Brazil where the Company is responsible for all expenses and retains all revenues.On June 18, 2013, the Company entered into a Supply and Technology Transfer Agreement (the “Brazil Agreement”) with Fundação Oswaldo Cruz (“Fiocruz”), an arm of the Brazilian Ministry of Health (the “Brazilian MoH”), for taliglucerase alfa. Fiocruz’s purchases of BioManguinhos alfataliglicerase to date have been significantly below certain agreed-upon purchase milestones and, accordingly, the Company has the right to terminate the Brazil Agreement. Notwithstanding the termination right, the Company is, at this time, continuing to supply BioManguinhos alfataliglicerase to Fiocruz and patients continue to be treated with BioManguinhos alfataliglicerase in Brazil.The novel coronavirus disease (“COVID-19”), which was declared by the World Health Organization to be a global pandemic on March 11, 2020, has had numerous adverse effects on the global economy. To date, the Company’s clinical trials have not been adversely affected by COVID-19, although certain practices the Company adopted during the earlier stages of the pandemic in its offices and facilities in an effort to promote social distancing resulted in minor delays in the performance of administrative activities outside of the clinical programs.The Company expects to continue to incur significant expenditures in the near future due to research and developments efforts with respect to the product candidates. Under the terms of the Company’s outstanding 7.50% Senior Secured Convertible Notes due 2024 (the “2024 Notes”), the Company is required to comply with certain financial covenants, including the maintenance of a minimum cash balance of at least $7.5 million. As of March 31, 2023, the Company is in compliance with all such covenants. The Company believes that its cash and cash equivalents as of March 31, 2023, together with additional funds raised from the sale of ATM Shares under the 2023 Sales Agreement subsequent to March 31, 2023 are sufficient to satisfy the Company’s capital needs for at least 12 months from the date that these financial statements are issued.<table style="border-collapse:collapse;border:0;"><tr><td style="width:36pt;padding:0pt;"/><td style="vertical-align:text-top;white-space:nowrap;width:18pt;padding:0pt;">b.</td><td style="padding:0pt;">Basis of presentation</td></tr></table>The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for annual financial statements. In the opinion of management, all adjustments (of a normal recurring nature) considered necessary for a fair statement of the results for the interim periods presented have been included. Operating results for the interim period are not necessarily indicative of the results that may be expected for the full year.These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements in the Annual Report on Form 10-K for the year ended December 31, 2022, filed by the Company with the U.S. Securities and Exchange Commission (the “Commission”). The comparative balance sheet at December 31, 2022 has been derived from the audited financial statements at that date. There have been no material changes in our significant accounting policies as described in our consolidated financial statements for the year ended December 31, 2022.<table style="border-collapse:collapse;border:0;"><tr><td style="width:36pt;padding:0pt;"/><td style="vertical-align:text-top;white-space:nowrap;width:18pt;padding:0pt;">c.</td><td style="padding:0pt;">Loss per share</td></tr></table>Basic and diluted loss per share (“LPS”) are computed by dividing net loss by the weighted average number of shares of Common Stock attributable to common stockholders outstanding for each period. The calculation of diluted LPS does not include 36,292,208 shares of Common Stock underlying outstanding options and shares of Common Stock issuable upon conversion of the outstanding 2024 Notes and the exercise of outstanding warrants for the three months ended March 31, 2023, and 33,004,217 shares of Common Stock underlying outstanding options and shares of Common Stock issuable upon conversion of the Company’s then outstanding 2024 Notes and the exercise of outstanding warrants for the three months ended March 31, 2022 because their effect would be anti-dilutive.<table style="border-collapse:collapse;border:0;"><tr><td style="width:36pt;padding:0pt;"/><td style="vertical-align:text-top;white-space:nowrap;width:18pt;padding:0pt;">d.</td><td style="padding:0pt;">Revenue recognition</td></tr></table>The Company accounts for revenue pursuant to Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, a contract with a customer exists only when: the parties to the contract have approved it and are committed to perform their respective obligations, the Company can identify each party’s rights regarding the distinct goods or services to be transferred (“performance obligations”), the Company can determine the transaction price for the goods or services to be transferred, the contract has commercial substance and it is probable that the Company will collect the consideration to which it will be entitled in exchange for the goods or services that will be transferred to the customer.Revenues are recorded in the amount of consideration to which the Company expects to be entitled in exchange for performance obligations upon transfer of control to the customer.1. Revenues from selling productsThe Company recognizes revenues from selling goods at a point in time when control over the product is transferred to customers (upon delivery).<table style="border-collapse:collapse;border:0;"><tr><td style="width:54pt;padding:0pt;"/><td style="vertical-align:text-top;white-space:nowrap;width:18pt;padding:0pt;">2.</td><td style="padding:0pt;">Revenues from Chiesi Agreements</td></tr></table>The Company has identified two performance obligations in the Chiesi Agreements as follows: (i) the license and research and development services and (ii) the contingent performance obligation regarding future manufacturing.The Company determined that the license together with the research and development services should be combined into single performance obligation since Chiesi cannot benefit from the license without the research and development services. The research and development services are highly specialized and are dependent on the supply of the drug.The future manufacturing is contingent on regulatory approvals of the drug and the Company deems these services to be separately identifiable from other performance obligations in the contract. Manufacturing services post-regulatory approval are not interdependent or interrelated with the license and research and development services.The transaction price was comprised of fixed consideration and variable consideration (capped research and development reimbursements). Under ASC 606, the consideration to which the Company would be entitled upon the achievement of contractual milestones, which are contingent upon the occurrence of future events, are a form of variable consideration. The Company estimates variable consideration using the most likely method. Amounts included in the transaction price are recognized only when it is probable that a significant reversal of cumulative revenues will not occur. Prior to recognizing revenue from variable consideration, the Company uses significant judgment to determine the probability of significant reversal of such revenue.Since the customer benefits from the research and development services as the entity performs the service, revenue from granting the license and the research and development services is recognized over time using the cost-to-cost method. The Company used significant judgment when it determined the costs expected to be incurred upon satisfying the identified performance obligation.Revenue from additional research and development services ordered by Chiesi is recognized over time using the cost-to-cost method.<table style="border-collapse:collapse;border:0;"><tr><td style="width:54pt;padding:0pt;"/><td style="vertical-align:text-top;white-space:nowrap;width:18pt;padding:0pt;">3.</td><td style="padding:0pt;">Revenue from R&D services</td></tr></table>Revenue from the research and development services is recognized over time using the cost-to-cost method since the customer benefits from the research and development services as the entity performs the service.

<table style="border-collapse:collapse;border:0;"><tr><td style="width:36pt;padding:0pt;"/><td style="vertical-align:text-top;white-space:nowrap;width:18pt;padding:0pt;">a.</td><td style="padding:0pt;">General</td></tr></table>Protalix BioTherapeutics, Inc. (collectively with its subsidiaries, the “Company”) and its wholly-owned subsidiaries, Protalix Ltd. and Protalix B.V. (collectively, the “Subsidiaries”), are biopharmaceutical companies focused on the development and commercialization of recombinant therapeutic proteins based on the Company’s proprietary ProCellEx® protein expression system (“ProCellEx”). To date, the Company has successfully developed taliglucerase alfa (marketed under the name BioManguinhos alfataliglicerase in Brazil and certain other Latin American countries and Elelyso® in the rest of the territories) for the treatment of Gaucher disease that has been approved for marketing in the United States, Brazil, Israel and other markets. The Company has a number of product candidates in varying stages of the clinical development process. The Company’s strategy is to develop proprietary recombinant proteins that are therapeutically superior to existing recombinant proteins currently marketed for the same indications.The most advanced investigational drug in the Company’s product pipeline is pegunigalsidase alfa, or PRX-102, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder, which was the subject of a phase III clinical program. The PRX-102 phase III clinical program included three separate studies, which are referred to as the BALANCE study, the BRIDGE study and the BRIGHT study, each of which has been completed. The studies were designed to evaluate the potential for improved efficacy and better quality of life for adult patients with Fabry disease and to evaluate the safety of the Company’s drug/therapy. The phase III clinical program analyzed two potential dosing regimens: 1 mg/kg every two weeks and 2 mg/kg every four weeks. In addition, the phase III clinical program included two extension studies in which subjects that participated in the Company’s phase I/II clinical trials and phase III clinical trials had the opportunity to enroll and continue to be treated with PRX-102. As of March 1, 2023, sponsorship of the two open-label extension studies was transferred to the Company’s development and commercialization partner for PRX-102, Chiesi Farmaceutici S.p.A. (“Chiesi”).The U.S. Food and Drug Administration (the “FDA”) has indicated that the biologics license application (“BLA”) for PRX-102 for the potential treatment of adult patients with Fabry disease resubmitted on November 9, 2022 by the Company, together with Chiesi, was considered a complete, class 2 response and set a PDUFA action date of May 9, 2023. The initial BLA for PRX-102 was submitted to the FDA on May 27, 2020 under the FDA’s Accelerated Approval pathway, and was subsequently accepted by the FDA and granted Priority Review designation. However, in April 2021, the FDA issued a Complete Response Letter (CRL) in response to the initial BLA. In preparation for the BLA resubmission, the Company and Chiesi participated in a Type A (End of Review) meeting with the FDA on September 9, 2021. As part of the meeting minutes provided by the FDA, which included the preliminary comments and meeting discussion, the FDA, in principle, agreed that the data package proposed to the FDA for a BLA resubmission has the potential to support a traditional approval of PRX-102 for the treatment of Fabry disease. The data package in the BLA resubmission, given the change in the regulatory landscape in the United States, included the final two-year analyses of the Company’s phase III BALANCE clinical trial of PRX-102, which was completed in July 2022, and long-term data from the Company’s open-label extension study of PRX-102 in adult patients treated with a 2 mg/kg every four weeks dosage of PRX-102.On February 7, 2022, the Company, together with Chiesi, submitted a Marketing Authorization Application (“MAA”) for PRX-102 to the European Medicines Agency (“EMA”) which was subsequently validated by the EMA. The submission was made after the October 8, 2021 meeting the Company held, together with Chiesi, with the Rapporteur and Co-Rapporteur of the EMA regarding PRX-102.The MAA submission included a comprehensive set of preclinical, clinical and manufacturing data compiled from the Company’s completed and ongoing clinical studies evaluating PRX-102 as a potential alternative treatment for adult patients with Fabry disease, including data from the Company’s completed 12–month switch–over phase III BRIGHT clinical trial in adult patients with Fabry disease treated with a 2 mg/kg every four weeks dosage to support an additional potential treatment regimen for Fabry patients. As part of the EMA review process, Chiesi and the Company responded to the Day 120 list of questions in September 2022 (following a 3-month clock-stop period) and the list of outstanding issues of Day 180 in December 2022. An essential portion of the Day 120 response included the submission of the final analysis of the two-year BALANCE study (the final Clinical Study Report), and an interim analysis of the Company’s long-term, open-label extension study of PRX-102 in adult patients with Fabry disease treated with the 2 mg/kg every four weeks dosage.On February 24, 2023, the Company, together with Chiesi, announced that the EMA’s Committee for Medicinal Products for Human Use (the “CHMP”) adopted a positive opinion, recommending marketing authorization for PRX-102. The CHMP opinion was referred for final action to the European Commission (the “EC”). A final EC decision on the MAA is expected in the beginning of May 2023.In addition to PRX-102, the Company’s product pipeline currently includes, among other candidates:<table style="border-collapse:collapse;font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:10pt;margin-top:0pt;table-layout:fixed;width:100%;border:0pt;"><tr><td style="width:54pt;"/><td style="font-family:'Times New Roman','Times','serif';font-size:10pt;vertical-align:text-top;white-space:nowrap;width:18pt;padding:0pt;">(1)</td><td style="padding:0pt;">PRX-115, the Company’s plant cell-expressed recombinant PEGylated uricase (urate oxidase) – a chemically modified enzyme to treat severe gout; and</td></tr></table><table style="border-collapse:collapse;font-family:'Times New Roman','Times','serif';font-size:10pt;margin-bottom:0pt;margin-top:0pt;table-layout:fixed;width:100%;border:0pt;"><tr><td style="width:54pt;"/><td style="font-family:'Times New Roman','Times','serif';font-size:10pt;vertical-align:text-top;white-space:nowrap;width:18pt;padding:0pt;">(2)</td><td style="padding:0pt;">PRX-119, the Company’s plant cell-expressed PEGylated recombinant human DNase I product candidate being designed to elongate half-life in the circulation for NETs-related diseases.</td></tr></table><div style="margin-top:10pt;"/>Obtaining marketing approval with respect to any product candidate in any country is dependent on the Company’s ability to implement the necessary regulatory steps required to obtain such approvals. The Company cannot reasonably predict the outcome of these activities.On July 2, 2021, the Company entered into an At The Market Offering Agreement (the “2021 Sales Agreement”) with H.C. Wainwright & Co., LLC, as the Company’s sales agent (the “Agent”) which was amended on May 2, 2022. Pursuant to the terms of the 2021 Sales Agreement, the Company was able to sell, from time to time through the Agent, shares of its common stock, par value $0.001 per share (the “Common Stock”), having an aggregate offering price of up to $20.0 million (the “ATM Shares”). Upon execution of the 2021 Sales Agreement, the Company terminated the ATM Equity OfferingSM Sales Agreement it had entered into on October 1, 2020 with BofA Securities, Inc. (“BofA Securities”). During the term of the sales agreement with BofA Securities, the Company sold a total of 3,296,123 shares of Common Stock for total gross proceeds of approximately $13.8 million.As of March 31, 2023, the Company sold a total of 13,980,060 ATM Shares for total gross proceeds of approximately $20.0 million under the 2021 Sales Agreement, thereby completing the ATM program under said agreement.On February 27, 2023, the Company entered into an At The Market Offering Agreement (the “2023 Sales Agreement”) with the Agent. Pursuant to the terms of the 2023 Sales Agreement, the Company may sell, from time to time through the Agent, ATM Shares having an aggregate offering price of up to $20.0 million. As of March 31, 2023, shares of Common Stock for total gross proceeds of approximately $16.5 million remain available to be sold under the 2023 Sales Agreement.On October 19, 2017, Protalix Ltd. and Chiesi entered into an Exclusive License and Supply Agreement (the “Chiesi Ex-US Agreement”) pursuant to which Protalix Ltd. granted to Chiesi an exclusive license for all markets outside of the United States to commercialize pegunigalsidase alfa. On July 23, 2018, Protalix Ltd. entered into an Exclusive License and Supply Agreement with Chiesi (the “Chiesi US Agreement”) with respect to the commercialization of pegunigalsidase alfa in the United States.Under each of the Chiesi Ex-US Agreement and the Chiesi US Agreement (collectively, the “Chiesi Agreements”), Chiesi made an upfront payment to Protalix Ltd. of $25.0 million in connection with the execution of each agreement. In addition, under the Chiesi Ex-US Agreement, Protalix Ltd. is entitled to additional payments of up to $25.0 million in pegunigalsidase alfa development costs and to receive additional payments of up to $320.0 million, in the aggregate, in regulatory and commercial milestone payments. Under the Chiesi US Agreement, Protalix Ltd. is entitled to payments of up to a maximum of $20.0 million to cover development costs for pegunigalsidase alfa and to receive additional payments of up to a maximum of $760.0 million, in the aggregate, in regulatory and commercial milestone payments. To date, Protalix Ltd. has received the complete amount of development costs to which it is entitled under the Chiesi Agreements.Under the terms of both of the Chiesi Agreements, Protalix Ltd. will manufacture all of the pegunigalsidase alfa needed under the agreements, subject to certain exceptions, and Chiesi will purchase pegunigalsidase alfa from Protalix, subject to certain terms and conditions. Under the Chiesi Ex-US Agreement, Chiesi is required to make tiered payments of 15% to 35% of its net sales, depending on the amount of annual sales outside of the United States, as consideration for product supply. Under the Chiesi US Agreement, Chiesi is required to make tiered payments of 15% to 40% of its net sales, depending on the amount of annual sales in the United States, as consideration for product supply.On May 13, 2021, the Company signed a binding term sheet with Chiesi pursuant to which the Company and Chiesi amended the Chiesi Agreements in order to provide the Company with near-term capital. Chiesi agreed to make a $10.0 million payment to the Company before the end of the second quarter of 2021 in exchange for a $25.0 million reduction in a longer term regulatory milestone payment provided in the Chiesi EX-US Agreement. All other regulatory and commercial milestone payments remain unchanged. The Company received the payment in June 2021. The Company also agreed to negotiate certain manufacturing related matters.Since its approval by the FDA, taliglucerase alfa has been marketed by Pfizer Inc. (“Pfizer”) in accordance with the exclusive license and supply agreement entered into between Protalix Ltd. and Pfizer, which is referred to herein as the Pfizer Agreement. In October 2015, Protalix Ltd. and Pfizer entered into an amended exclusive license and supply agreement, which is referred to herein as the Amended Pfizer Agreement, pursuant to which the Company sold to Pfizer its share in the collaboration created under the Pfizer Agreement for the commercialization of Elelyso. As part of the sale, the Company agreed to transfer its rights to Elelyso in Israel to Pfizer while gaining full rights to it in Brazil. Under the Amended Pfizer Agreement, Pfizer is entitled to all of the revenues, and is responsible for 100% of expenses globally for Elelyso, excluding Brazil where the Company is responsible for all expenses and retains all revenues.On June 18, 2013, the Company entered into a Supply and Technology Transfer Agreement (the “Brazil Agreement”) with Fundação Oswaldo Cruz (“Fiocruz”), an arm of the Brazilian Ministry of Health (the “Brazilian MoH”), for taliglucerase alfa. Fiocruz’s purchases of BioManguinhos alfataliglicerase to date have been significantly below certain agreed-upon purchase milestones and, accordingly, the Company has the right to terminate the Brazil Agreement. Notwithstanding the termination right, the Company is, at this time, continuing to supply BioManguinhos alfataliglicerase to Fiocruz and patients continue to be treated with BioManguinhos alfataliglicerase in Brazil.The novel coronavirus disease (“COVID-19”), which was declared by the World Health Organization to be a global pandemic on March 11, 2020, has had numerous adverse effects on the global economy. To date, the Company’s clinical trials have not been adversely affected by COVID-19, although certain practices the Company adopted during the earlier stages of the pandemic in its offices and facilities in an effort to promote social distancing resulted in minor delays in the performance of administrative activities outside of the clinical programs.The Company expects to continue to incur significant expenditures in the near future due to research and developments efforts with respect to the product candidates. Under the terms of the Company’s outstanding 7.50% Senior Secured Convertible Notes due 2024 (the “2024 Notes”), the Company is required to comply with certain financial covenants, including the maintenance of a minimum cash balance of at least $7.5 million. As of March 31, 2023, the Company is in compliance with all such covenants. The Company believes that its cash and cash equivalents as of March 31, 2023, together with additional funds raised from the sale of ATM Shares under the 2023 Sales Agreement subsequent to March 31, 2023 are sufficient to satisfy the Company’s capital needs for at least 12 months from the date that these financial statements are issued.

0.001

20000000.0

3296123

13800000

13980060

20000000.0

20000000.0 16500000 25000000.0 25000000.0 25000000.0 320000000.0 20000000.0 760000000.0 0.15 0.35 0.15 0.40 10000000.0 25000000.0 1

0.0750

7500000

36292208

33004217

NOTE 2 - INVENTORIESInventories at March 31, 2023 and December 31, 2022 consisted of the following:<table style="border-collapse:collapse;font-size:16pt;height:max-content;margin-left:auto;margin-right:auto;padding-left:0pt;padding-right:0pt;width:80%;"><tr style="height:1pt;"><td style="vertical-align:bottom;width:72.52%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:1.34%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:8.95%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:9.69%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td></tr><tr><td style="vertical-align:bottom;width:72.52%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"> </td><td colspan="2" style="vertical-align:bottom;white-space:nowrap;width:10.3%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">March 31, </td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"> </td><td colspan="2" style="vertical-align:bottom;white-space:nowrap;width:11.26%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">December 31, </td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:72.52%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">(U.S. dollars in thousands)</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"></td><td colspan="2" style="vertical-align:bottom;white-space:nowrap;width:10.3%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">2023</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"></td><td colspan="2" style="vertical-align:bottom;white-space:nowrap;width:11.26%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">2022</td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:72.52%;background:#cceeff;margin:0pt;padding:0pt;">Raw materials</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.34%;background:#cceeff;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:8.95%;background:#cceeff;margin:0pt;padding:0pt;"> 4,308</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;background:#cceeff;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:9.69%;background:#cceeff;margin:0pt;padding:0pt;"> 3,508</td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;background:#cceeff;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:72.52%;margin:0pt;padding:0pt;">Work in progress</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.34%;margin:0pt;padding:0pt;"> </td><td style="vertical-align:bottom;white-space:nowrap;width:8.95%;margin:0pt;padding:0pt;"> 1,533</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:9.69%;margin:0pt;padding:0pt;"> 2,678</td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:72.52%;background:#cceeff;margin:0pt;padding:0pt;">Finished goods</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.34%;background:#cceeff;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"> </td><td style="vertical-align:bottom;white-space:nowrap;width:8.95%;background:#cceeff;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"> 14,462</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;background:#cceeff;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:9.69%;background:#cceeff;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"> 10,618</td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;background:#cceeff;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:72.52%;margin:0pt;padding:0pt;">Total inventory</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.34%;border-bottom:3px double #000000;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:8.95%;border-bottom:3px double #000000;margin:0pt;padding:0pt;"> 20,303</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;border-bottom:3px double #000000;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:9.69%;border-bottom:3px double #000000;margin:0pt;padding:0pt;"> 16,804</td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;margin:0pt;padding:0pt;"></td></tr></table>

<table style="border-collapse:collapse;font-size:16pt;height:max-content;margin-left:auto;margin-right:auto;padding-left:0pt;padding-right:0pt;width:80%;"><tr style="height:1pt;"><td style="vertical-align:bottom;width:72.52%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:1.34%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:8.95%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:9.69%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td></tr><tr><td style="vertical-align:bottom;width:72.52%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"> </td><td colspan="2" style="vertical-align:bottom;white-space:nowrap;width:10.3%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">March 31, </td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"> </td><td colspan="2" style="vertical-align:bottom;white-space:nowrap;width:11.26%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">December 31, </td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:72.52%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">(U.S. dollars in thousands)</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"></td><td colspan="2" style="vertical-align:bottom;white-space:nowrap;width:10.3%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">2023</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"></td><td colspan="2" style="vertical-align:bottom;white-space:nowrap;width:11.26%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">2022</td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:72.52%;background:#cceeff;margin:0pt;padding:0pt;">Raw materials</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.34%;background:#cceeff;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:8.95%;background:#cceeff;margin:0pt;padding:0pt;"> 4,308</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;background:#cceeff;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:9.69%;background:#cceeff;margin:0pt;padding:0pt;"> 3,508</td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;background:#cceeff;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:72.52%;margin:0pt;padding:0pt;">Work in progress</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.34%;margin:0pt;padding:0pt;"> </td><td style="vertical-align:bottom;white-space:nowrap;width:8.95%;margin:0pt;padding:0pt;"> 1,533</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:9.69%;margin:0pt;padding:0pt;"> 2,678</td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:72.52%;background:#cceeff;margin:0pt;padding:0pt;">Finished goods</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.34%;background:#cceeff;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"> </td><td style="vertical-align:bottom;white-space:nowrap;width:8.95%;background:#cceeff;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"> 14,462</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;background:#cceeff;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:9.69%;background:#cceeff;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"> 10,618</td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;background:#cceeff;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:72.52%;margin:0pt;padding:0pt;">Total inventory</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.34%;border-bottom:3px double #000000;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:8.95%;border-bottom:3px double #000000;margin:0pt;padding:0pt;"> 20,303</td><td style="vertical-align:bottom;white-space:nowrap;width:2.17%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;border-bottom:3px double #000000;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:9.69%;border-bottom:3px double #000000;margin:0pt;padding:0pt;"> 16,804</td><td style="vertical-align:bottom;white-space:nowrap;width:1.56%;margin:0pt;padding:0pt;"></td></tr></table>

4308000

3508000

1533000

2678000

14462000

10618000

20303000

16804000

NOTE 3 – FAIR VALUE MEASUREMENTThe Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received from the sale of an asset, or paid to transfer a liability, in an orderly transaction between market participants at the measurement date.The accounting standard establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below:Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data.Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible and considers counterparty credit risk in its assessment of fair value.The fair value of the financial instruments included in the working capital of the Company is usually identical or close to their carrying value.Based on a Level 3 measurement, as of March 31, 2023, the fair value of the $28.75 million aggregate principal amount of the Company’s outstanding 2024 Notes is approximately $41.4 million. The value of these notes was estimated by implementing the binomial model. The liability component was valued based on the Income Approach. The following parameters were used:<table style="border-collapse:collapse;font-size:16pt;height:max-content;margin-left:auto;margin-right:auto;padding-left:0pt;padding-right:0pt;width:80%;"><tr style="height:1pt;"><td style="vertical-align:bottom;width:73.86%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:8.34%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:8.59%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.28%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td></tr><tr><td style="vertical-align:bottom;width:73.86%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"> </td><td style="vertical-align:bottom;white-space:nowrap;width:8.34%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:8.59%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">2024 Notes</td><td style="vertical-align:bottom;white-space:nowrap;width:2.28%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:73.86%;background:#cceeff;margin:0pt;padding:0pt;">Stock price (USD)</td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"> </td><td style="vertical-align:bottom;white-space:nowrap;width:8.34%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:8.59%;background:#cceeff;margin:0pt;padding:0pt;"> 2.10</td><td style="vertical-align:bottom;white-space:nowrap;width:2.28%;background:#cceeff;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:73.86%;margin:0pt;padding:0pt;">Expected term</td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"> </td><td style="vertical-align:bottom;white-space:nowrap;width:8.34%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:8.59%;margin:0pt;padding:0pt;"> 1.42</td><td style="vertical-align:bottom;white-space:nowrap;width:2.28%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:73.86%;background:#cceeff;margin:0pt;padding:0pt;">Risk free rate</td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"> </td><td style="vertical-align:bottom;white-space:nowrap;width:8.34%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:8.59%;background:#cceeff;margin:0pt;padding:0pt;"> 4.19</td><td style="vertical-align:bottom;white-space:nowrap;width:2.28%;background:#cceeff;margin:0pt;padding:0pt;">%</td></tr><tr><td style="vertical-align:bottom;width:73.86%;margin:0pt;padding:0pt;">Volatility</td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"> </td><td style="vertical-align:bottom;white-space:nowrap;width:8.34%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:8.59%;margin:0pt;padding:0pt;"> 62.47</td><td style="vertical-align:bottom;white-space:nowrap;width:2.28%;margin:0pt;padding:0pt;">%</td></tr><tr><td style="vertical-align:bottom;width:73.86%;background:#cceeff;margin:0pt;padding:0pt;">Yield</td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"> </td><td style="vertical-align:bottom;white-space:nowrap;width:8.34%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:8.59%;background:#cceeff;margin:0pt;padding:0pt;"> 12.60</td><td style="vertical-align:bottom;white-space:nowrap;width:2.28%;background:#cceeff;margin:0pt;padding:0pt;">%</td></tr></table>

28750000

41400000

<table style="border-collapse:collapse;font-size:16pt;height:max-content;margin-left:auto;margin-right:auto;padding-left:0pt;padding-right:0pt;width:80%;"><tr style="height:1pt;"><td style="vertical-align:bottom;width:73.86%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:8.34%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:8.59%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.28%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td></tr><tr><td style="vertical-align:bottom;width:73.86%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"> </td><td style="vertical-align:bottom;white-space:nowrap;width:8.34%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:8.59%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">2024 Notes</td><td style="vertical-align:bottom;white-space:nowrap;width:2.28%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:73.86%;background:#cceeff;margin:0pt;padding:0pt;">Stock price (USD)</td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"> </td><td style="vertical-align:bottom;white-space:nowrap;width:8.34%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:8.59%;background:#cceeff;margin:0pt;padding:0pt;"> 2.10</td><td style="vertical-align:bottom;white-space:nowrap;width:2.28%;background:#cceeff;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:73.86%;margin:0pt;padding:0pt;">Expected term</td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"> </td><td style="vertical-align:bottom;white-space:nowrap;width:8.34%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:8.59%;margin:0pt;padding:0pt;"> 1.42</td><td style="vertical-align:bottom;white-space:nowrap;width:2.28%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:73.86%;background:#cceeff;margin:0pt;padding:0pt;">Risk free rate</td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"> </td><td style="vertical-align:bottom;white-space:nowrap;width:8.34%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:8.59%;background:#cceeff;margin:0pt;padding:0pt;"> 4.19</td><td style="vertical-align:bottom;white-space:nowrap;width:2.28%;background:#cceeff;margin:0pt;padding:0pt;">%</td></tr><tr><td style="vertical-align:bottom;width:73.86%;margin:0pt;padding:0pt;">Volatility</td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"> </td><td style="vertical-align:bottom;white-space:nowrap;width:8.34%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:8.59%;margin:0pt;padding:0pt;"> 62.47</td><td style="vertical-align:bottom;white-space:nowrap;width:2.28%;margin:0pt;padding:0pt;">%</td></tr><tr><td style="vertical-align:bottom;width:73.86%;background:#cceeff;margin:0pt;padding:0pt;">Yield</td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"> </td><td style="vertical-align:bottom;white-space:nowrap;width:8.34%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.3%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:8.59%;background:#cceeff;margin:0pt;padding:0pt;"> 12.60</td><td style="vertical-align:bottom;white-space:nowrap;width:2.28%;background:#cceeff;margin:0pt;padding:0pt;">%</td></tr></table>

2.10

1.42

4.19

62.47

12.60

NOTE 4 – REVENUESThe following table summarizes the Company’s disaggregation of revenues:<table style="border-collapse:collapse;font-size:16pt;height:max-content;margin-left:auto;margin-right:auto;padding-left:0pt;padding-right:0pt;width:80%;"><tr style="height:1pt;"><td style="vertical-align:bottom;width:61.3%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:13.27%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:11.78%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.97%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:1.42%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td></tr><tr><td style="vertical-align:bottom;width:61.3%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"> </td><td colspan="5" style="vertical-align:bottom;white-space:nowrap;width:31.45%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">Three Months Ended March 31, </td><td style="vertical-align:bottom;white-space:nowrap;width:2.97%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.42%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:61.3%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">(U.S. dollars in thousands)</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"> </td><td colspan="2" style="vertical-align:bottom;white-space:nowrap;width:15.05%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">2023</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"> </td><td colspan="2" style="vertical-align:bottom;white-space:nowrap;width:13.56%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">2022</td><td style="vertical-align:bottom;white-space:nowrap;width:2.97%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.42%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:61.3%;background:#cceeff;margin:0pt;padding:0pt;">Pfizer</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;background:#cceeff;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:13.27%;background:#cceeff;margin:0pt;padding:0pt;"> 2,266</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;background:#cceeff;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:11.78%;background:#cceeff;margin:0pt;padding:0pt;"> 3,356</td><td style="vertical-align:bottom;white-space:nowrap;width:2.97%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.42%;background:#cceeff;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:61.3%;margin:0pt;padding:0pt;">Brazil</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:13.27%;margin:0pt;padding:0pt;"> 2,800</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:11.78%;margin:0pt;padding:0pt;"> 5,454</td><td style="vertical-align:bottom;white-space:nowrap;width:2.97%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.42%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:61.3%;background:#cceeff;margin:0pt;padding:0pt;">Chiesi</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;background:#cceeff;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:13.27%;background:#cceeff;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"> —</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;background:#cceeff;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:11.78%;background:#cceeff;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"> 218</td><td style="vertical-align:bottom;white-space:nowrap;width:2.97%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.42%;background:#cceeff;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:61.3%;margin:0pt;padding:0pt;">Total revenues from selling goods</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;border-bottom:3px double #000000;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:13.27%;border-bottom:3px double #000000;margin:0pt;padding:0pt;"> 5,066</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;border-bottom:3px double #000000;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:11.78%;border-bottom:3px double #000000;margin:0pt;padding:0pt;"> 9,028</td><td style="vertical-align:bottom;white-space:nowrap;width:2.97%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.42%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:61.3%;background:#cceeff;margin:0pt;padding:0pt;">Revenues from license and R&D services</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;background:#cceeff;border-bottom:3px double #000000;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:13.27%;background:#cceeff;border-bottom:3px double #000000;margin:0pt;padding:0pt;"> 4,522</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;background:#cceeff;border-bottom:3px double #000000;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:11.78%;background:#cceeff;border-bottom:3px double #000000;margin:0pt;padding:0pt;"> 7,057</td><td style="vertical-align:bottom;white-space:nowrap;width:2.97%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.42%;background:#cceeff;margin:0pt;padding:0pt;"></td></tr></table>

The following table summarizes the Company’s disaggregation of revenues:<table style="border-collapse:collapse;font-size:16pt;height:max-content;margin-left:auto;margin-right:auto;padding-left:0pt;padding-right:0pt;width:80%;"><tr style="height:1pt;"><td style="vertical-align:bottom;width:61.3%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:13.27%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:11.78%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:2.97%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td><td style="vertical-align:bottom;white-space:nowrap;width:1.42%;margin:0pt;padding:0pt;"><div style="height:1pt;overflow:hidden;overflow-wrap:break-word;position:relative;"><div style="bottom:0pt;position:absolute;width:100%;"></div></div></td></tr><tr><td style="vertical-align:bottom;width:61.3%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"> </td><td colspan="5" style="vertical-align:bottom;white-space:nowrap;width:31.45%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">Three Months Ended March 31, </td><td style="vertical-align:bottom;white-space:nowrap;width:2.97%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.42%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:61.3%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">(U.S. dollars in thousands)</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"> </td><td colspan="2" style="vertical-align:bottom;white-space:nowrap;width:15.05%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">2023</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"> </td><td colspan="2" style="vertical-align:bottom;white-space:nowrap;width:13.56%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">2022</td><td style="vertical-align:bottom;white-space:nowrap;width:2.97%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.42%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:61.3%;background:#cceeff;margin:0pt;padding:0pt;">Pfizer</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;background:#cceeff;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:13.27%;background:#cceeff;margin:0pt;padding:0pt;"> 2,266</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;background:#cceeff;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:11.78%;background:#cceeff;margin:0pt;padding:0pt;"> 3,356</td><td style="vertical-align:bottom;white-space:nowrap;width:2.97%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.42%;background:#cceeff;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:61.3%;margin:0pt;padding:0pt;">Brazil</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:13.27%;margin:0pt;padding:0pt;"> 2,800</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:11.78%;margin:0pt;padding:0pt;"> 5,454</td><td style="vertical-align:bottom;white-space:nowrap;width:2.97%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.42%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:61.3%;background:#cceeff;margin:0pt;padding:0pt;">Chiesi</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;background:#cceeff;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:13.27%;background:#cceeff;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"> —</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;background:#cceeff;border-bottom:1px solid #000000;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:11.78%;background:#cceeff;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"> 218</td><td style="vertical-align:bottom;white-space:nowrap;width:2.97%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.42%;background:#cceeff;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:61.3%;margin:0pt;padding:0pt;">Total revenues from selling goods</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;border-bottom:3px double #000000;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:13.27%;border-bottom:3px double #000000;margin:0pt;padding:0pt;"> 5,066</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;border-bottom:3px double #000000;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:11.78%;border-bottom:3px double #000000;margin:0pt;padding:0pt;"> 9,028</td><td style="vertical-align:bottom;white-space:nowrap;width:2.97%;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.42%;margin:0pt;padding:0pt;"></td></tr><tr><td style="vertical-align:bottom;width:61.3%;background:#cceeff;margin:0pt;padding:0pt;">Revenues from license and R&D services</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;background:#cceeff;border-bottom:3px double #000000;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:13.27%;background:#cceeff;border-bottom:3px double #000000;margin:0pt;padding:0pt;"> 4,522</td><td style="vertical-align:bottom;white-space:nowrap;width:2.83%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.78%;background:#cceeff;border-bottom:3px double #000000;margin:0pt;padding:0pt;">$</td><td style="vertical-align:bottom;white-space:nowrap;width:11.78%;background:#cceeff;border-bottom:3px double #000000;margin:0pt;padding:0pt;"> 7,057</td><td style="vertical-align:bottom;white-space:nowrap;width:2.97%;background:#cceeff;margin:0pt;padding:0pt;"></td><td style="vertical-align:bottom;white-space:nowrap;width:1.42%;background:#cceeff;margin:0pt;padding:0pt;"></td></tr></table>

2266000

3356000

2800000

5454000

218000

5066000

9028000

4522000

7057000

NOTE 5 – STOCK TRANSACTIONSAt-the-Market (ATM) OfferingDuring the three months ended March 31, 2023, the Company sold, in the aggregate, 8,212,482 shares of Common Stock under the 2023 Sales Agreement and the 2021 Sales Agreement. The Company generated aggregate gross proceeds equal to approximately $14.9 million in connection with such sales.

8212482

14900000

NOTE 6 – SUBSEQUENT EVENTSDuring April 2023, the Company sold, in the aggregate, 3,412,268 shares of Common Stock under the 2023 Sales Agreement. The Company generated aggregate gross proceeds equal to approximately $7.9 million in connection with such sales.

3412268

7900000

Common stock, $0.001 par value; Authorized – as of March 31, 2023 and 2022 – 144,000,000 and 120,000,000 shares, respectively. (1) Includes share-based compensation (2) Includes share-based compensation (3) Includes share-based compensation