Protalix BioTherapeutics Reports Third Quarter 2025 Financial and Business Results | PLX Stock News

Company to host conference call and webcast today at 8:00 a.m. EST , /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, today reported financial results for the quarter ended September 30, 2025, and provided a financial and business update. "We are pleased to report total revenues of $43.6 million for the first nine months of 2025, an increase of 24%, compared to the same period in 2024. Our total revenues for the third quarter were $17.9 million which reflects a decrease of 1%, compared to revenues for the same period of 2024," said Dror Bashan, Protalix's President and Chief Executive Officer. "We recognize revenues from sales of our products to Chiesi, Pfizer, and Fiocruz in Brazil, and their purchases vary from quarter to quarter as they control their own inventories. Overall, these revenues reflect the continued commercial success of our enzyme replacement therapies and provide a strong foundation to support our research and development efforts." "We are particularly excited about PRX-115, our recombinant PEGylated uricase candidate under development for the treatment of uncontrolled gout, which we believe has the potential to be a differentiating treatment for uncontrolled gout," continued Mr.Bashan. "Based on encouraging first-in-human data from our phase 1 clinical trial of PRX-115, we believe it has the potential to be a best-in-class therapy with a long-acting profile that could improve patient compliance and outcomes. We are planning to initiate a phase 2 clinical trial of PRX-115 later this year." Corporate Highlights In October 2025, we submitted an Investigational New Drug (IND) to the US Food and Drug Administration in connection with our planned phase 2 clinical trial of PRX-115 for the potential treatment of uncontrolled gout. The IND has become effective following the FDA's standard 30-day review period. In November 2025, Chiesi Global Rare Diseases, a business unit of the Chiesi Group, with our collaboration requested a re-examination of the recent negative opinion issued in October 2025by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on Chiesi's request for a Variation Submission covering the 2 mg/kg body weight infused every 4 weeks (E4W) dosing regimen for Elfabrio (pegunigalsidase alfa), in addition to the currently approved 1 mg/kg body weight infused every 2 weeks (E2W) dosing regimen. The 1 mg/kg E2W regimen is unaffected and remains approved as a dosing regimen of Elfabrio in the EU. Third Quarter 2025 Financial Highlights We recorded revenues from selling goods of $17.7 million during the three months ended September 30, 2025, a decrease of $0.1 million, or 1%, compared to revenues of $17.8 million for the three months ended September 30, 2024. These revenues consist of $8.8 million in sales of Elfabrio to Chiesi, $2.8 million in sales of Elelyso to Pfizer and $6.1 million in sales of alfataliglicerase (Elelyso) to Fiocruz (Brazil). We recorded revenues from license and R&D services of $0.2 million for the three months ended September 30, 2025, an increase of $0.1 million, or 100%, compared to $0.1 million for the same period in 2024. Revenues from license and R&D services are comprised primarily of revenues we recognized in connection with our license and supply agreements with Chiesi. Other than potential regulatory milestone payments that may become payable, we expect to generate minimal revenues from license and R&D services now that we have completed the clinical development of Elfabrio. Cost of goods sold was $8.3 million for the three months ended September 30, 2025, a decrease of $0.1 million, or 1%, from $8.4 million for the same period in 2024. The decrease was primarily the result of the decrease in sales to Chiesi and Pfizer, partially offset by the increase in sales to Fiocruz (Brazil). For the three months ended September 30, 2025, our total research and development expenses were approximately $4.5 million comprised of approximately $2.6 million of salary and related expenses, approximately $0.5 million of subcontractor-related expenses, approximately $0.5 million of materials-related expenses and approximately $0.9 million of other expenses. For the same period in 2024, our total research and development expenses were approximately $3.0 million comprised of approximately $1.6million of salary and related expenses, approximately $0.6 million of subcontractor-–related expenses, approximately $0.2 million of materials-related expenses and approximately $0.6 million of other expenses. The increase of $1.5 million, or 50%, compared to the same period of 2024 resulted primarily from preparations for the planned phase2 clinical trial of PRX-115. We expect to continue to incur significant research and development expenses as we enter into a more advanced stage of preclinical and clinical trials, including the initiation of the phase 2 clinical trial of PRX-115 and as we develop additional research stage programs. Selling, general and administrative expenses were $2.9 million for the three months ended September 30, 2025, an increase of $0.3 million, or 12%, compared to $2.6 million for the same period in 2024. The increase resulted primarily from an increase of $0.1million in salary and related expenses and an increase of $0.2 million in selling expenses. Financial income, net was $0.1 million for the three months ended September 30, 2025, compared to financial expenses, net of $0.1 million for the same period in 2024. The difference resulted primarily from lower notes interest expenses due to the September 2024 repayment in full of all the outstanding principal and interest payable under our then outstanding convertible promissory notes, or the 2024 Notes. We recorded a tax benefit of approximately $0.1 million for the three months ended September 30, 2025, compared to tax expenses of approximately $0.6 million for the same period in 2024. The tax benefit resulted primarily from taxes on income mainly derived from GILTI income in respect of Section 174 of the U.S. Tax Cuts and Jobs Act of 2017, or the TCJA. On July 4, 2025, tax reform legislation was enacted in the United States through the passage of H.R.1, One Big Beautiful Bill Act, or HR1, which includes significant corporate tax changes, including a restoration of the current deductibility for domestic research expenditures beginning in 2025, with transition options for previously capitalized amounts. Net income for the three months ended September 30, 2025 was approximately $2.4million, or $0.03 per share, basic and diluted, compared to net income of $3.2million, or $0.04 per share, basic and $0.03 per share, diluted, for the same period in 2024. Year-to-Date 2025 Financial Highlights We recorded revenues from selling goods of $43.1 million for the nine months ended September 30, 2025, an increase of $8.3 million, or 24%, compared to revenues of $34.8million for the same period in 2024. These revenues consist of $18.6million in sales of Elfabrio to Chiesi, $15.4 million in sales of Elelyso to Pfizer and $9.1 million in sales of alfataliglicerase (Elelyso) to Fiocruz (Brazil). We recorded revenues from license and R&D services of $0.5 million for the nine months ended September 30, 2025, an increase of $0.1 million, compared to $0.4million for the same period in 2024. Revenues from license and R&D services are comprised primarily of revenues we recognized in connection with our license and supply agreements with Chiesi. Other than potential regulatory milestone payments that may become payable, we expect to generate minimal revenues from license and R&D services now that we have completed the clinical development of Elfabrio. Cost of goods sold was $22.4 million for the nine months ended September 30, 2025, an increase of $2.0 million, or 10%, from $20.4 million for the same period in 2024. The increase was primarily the result of increased sales to Chiesi and Pfizer, partially offset by a decrease in sales to Fiocruz (Brazil). For the nine months ended September 30, 2025, our total research and development expenses were approximately $13.9 million, comprised of approximately $6.5 million of salary and related expenses, $4.3 million of subcontractor-related expenses, $0.9 million of materials-related expenses, and $2.2 million of other expenses. For the same period in 2024, R&D expenses were approximately $8.8 million comprised of approximately $4.8million of salary and related expenses, approximately $1.6million of subcontractor-related expenses, approximately $0.5million of materials-related expenses and approximately $1.9million of other expenses. The $5.1 million, or 58%, increase compared to the same period of 2024 resulted primarily from preparations for the planned phase2 clinical trial of PRX-115. Selling, general and administrative expenses were $8.2 million for the nine months ended September 30, 2025, a decrease of $1.0 million, or 11%, compared to $9.2 million for the same period in 2024. The decrease resulted primarily from lower salary and selling expenses. Financial income, net was $0.01 million for the nine months ended September 30, 2025, compared to financial income, net of $0.1 million for the same period in 2024. The decrease resulted primarily from exchange rate costs and lower interest income on bank deposits, partially offset by lower notes interest expenses due to the September 2024repayment in full of all the outstanding principal and interest payable under the 2024Notes. We recorded tax expenses of approximately $0.3 million for the nine months ended September 30, 2025, compared to tax expenses of approximately $0.4 million for the same period in 2024. The tax expenses resulted primarily from taxes on income mainly derived from GILTI income in respect of the TCJA. HR1 which includes significant corporate tax changes, including a restoration of the current deductibility for domestic research expenditures beginning in 2025, with transition options for previously capitalized amounts. Net loss for the nine months ended September 30, 2025 was approximately $1.1 million, or $(0.01) per share, basic and diluted, compared to a net loss of $3.6 million, or $(0.05) per share, for the same period in 2024. At September 30, 2025, we had $29.4 million in cash and cash equivalents and short-term bank deposits, which we believe are sufficient to satisfy our capital needs for at least 12 months from the date we issue our quarterly report for the quarter ended September 30, 2025. Conference Call and Webcast Information We will host a conference call today, November13, 2025, at 8:00am EST, to review the financial results and provide a business update. To participate in the conference call, please dial the following numbers prior to the start of the call: Conference Call Details: Date: Thursday, November13, 2025Time: 8:00a.m. Eastern Standard Time(EST)Toll Free: 1-877-423-9813International: 1-201-689-8573Israeli Toll Free: 1-809-406-247Conference ID: 13757080Call me™: http://bit.ly/4qJnnhYThe Call me™ feature allows you to avoid the wait for an operator; you enter your phone number on the platform and the system calls you right away. Webcast Details: The conference will be webcast live from the Protalix website and will be available via the following links: Company Link: https://ir.protalix.com/news-events/events Webcast Link: https://bit.ly/4nJBRM1 Conference ID: 13757080Participants are requested to access the websites at least 15 minutes ahead of the conference to register, download and install any necessary audio software. A replay of the call will be available for two weeks on the Events Calendar of the Investors section of the Protalix website, at the above link. About Protalix BioTherapeutics, Inc.Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx. It is the first company to gain U.S. Food and Drug Administration (FDA) approval of a protein produced through plant cell-based in suspension expression system. This unique expression system represents a new method for developing recombinant proteins in an industrial-scale manner. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa for the treatment of Gaucher disease, Protalix's first product manufactured through ProCellEx, excluding in Brazil, where Protalix retains full rights. Protalix's second product, Elfabrio®, was approved by both the FDA and the European Medicines Agency in May 2023. Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio. Protalix's development pipeline consists of proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets, including the following product candidates: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; PRX–119, a plant cell-expressed long acting DNaseI for the treatment of NETs-related diseases; and others. Forward-Looking Statements To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. 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 are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk and the final results of a clinical trial may be different than the preliminary findings for the clinical trial. Factors that might cause material differences include, among others: risks related to the commercialization of Elfabrio® (pegunigalsidase alfa-iwxj), our approved product for the treatment of adult patients with Fabry disease; risks relating to Elfabrio's market acceptance, competition, reimbursement and regulatory actions, including as a result of the boxed warning contained in the FDA) approval received for the product; the possible disruption of our operations due to military actions conducted by Israel with the Hamas terrorist organization located in the Gaza Strip, theHezbollahin Lebanon, the Houthis which control parts of Yemen, Iran 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 a greater regional conflict; risks related to the regulatory approval and commercial success of our other product and product candidates, if approved; risks related to our expectations with respect to the projected market of our products and product candidates; 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; inability to monitor patients adequately during or after treatment; and/or lack of sufficient funding to finance our clinical trials; delays in the approval or potential rejection of any applications we file with the FDA, EMA or other health regulatory authorities for our other product candidates, including the requested a re-examination of the negative opinion issued by the CHMP regarding the proposed dosing regimen of 2 mg/kg body weight infused E4W for Elfabrio, and other risks relating to the review process; risks associated with global conditions and developments such as new or increased tariffs, new 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; 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; risks relating to our evaluation and pursuit of strategic partnerships; the risk that the results of our clinical trials 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; risks relating to our ability to manage our relationship with our collaborators, distributors or partners, including, but not limited to, Pfizer and Chiesi; risks related to the amount and sufficiency of our cash and cash equivalents and short-term bank deposits; risks relating to changes to interim, top-line or preliminary data from clinical trials that we announce or publish; risks relating to the compliance by Fundação Oswaldo Cruz, an arm of the Brazilian Ministry of Health,with its purchase obligations under our supply and technology transfer agreement, which may have a material adverse effect on us and may also result in the termination of such agreement; risk of significant lawsuits, including stockholder litigation, which is common in the life sciences sector; our dependence on performance by third-party providers of services and supplies, including without limitation, clinical trial services; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies; risks related to our supply of drug products to Pfizer; potential product liability risks, and risks of securing adequate levels of related insurance coverage; 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; risks relating to changes in healthcare laws, rules and regulations in the United States or elsewhere; and other factors described in our filings with the U.S.Securities and Exchange Commission.The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law. Investor ContactMike Moyer, Managing DirectorLifeSci Advisors+1-617-308-4306mmoyer@lifesciadvisors.com PROTALIX BIOTHERAPEUTICS,INC. CONDENSED CONSOLIDATED BALANCE SHEETS (U.S. dollars in thousands) (Unaudited) September30,2025 December31,2024 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 13,647 $ 19,760 Short-term bank deposits 15,723 15,070 Accounts receivable 14,425 2,909 Other assets 1,452 1,096 Inventories 21,255 21,243 Total current assets $ 66,502 $ 60,078 NON-CURRENT ASSETS: Funds in respect of employee rights upon retirement $ 549 $ 462 Property and equipment, net 4,724 4,591 Deferred income tax asset 2,679 2,856 Operating lease right of use assets 7,810 5,430 Total assets $ 82,264 $ 73,417 LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable and accruals: Trade $ 5,375 $ 4,533 Other 15,173 19,588 Operating lease liabilities 1,397 1,500 Total current liabilities $ 21,945 $ 25,621 LONG TERM LIABILITIES: Liability for employee rights upon retirement $ 631 $ 559 Operating lease liabilities 6,780 4,026 Total long term liabilities $ 7,411 $ 4,585 Total liabilities $ 29,356 $ 30,206 COMMITMENTS STOCKHOLDERS' EQUITY 52,908 43,211 Total liabilities and stockholders' equity $ 82,264 $ 73,417 PROTALIX BIOTHERAPEUTICS,INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (U.S. dollars in thousands, except share and per share data) (Unaudited) Nine Months Ended Three Months Ended September30,2025 September30,2024 September30,2025 September30,2024 REVENUES FROM SELLING GOODS $ 43,108 $ 34,820 $ 17,673 $ 17,839 REVENUES FROM LICENSE AND R&D SERVICES 514 361 178 120 TOTAL REVENUE 43,622 35,181 17,851 17,959 COST OF GOODS SOLD (22,374) (20,433) (8,324) (8,375) RESEARCH AND DEVELOPMENT EXPENSES (13,934) (8,846) (4,467) (2,998) SELLING, GENERAL AND ADMINISTRATIVE EXPENSES (8,156) (9,194) (2,929) (2,595) OPERATING INCOME (LOSS) (842) (3,292) 2,131 3,991 FINANCIAL EXPENSES (808) (1,056) (180) (299) FINANCIAL INCOME 818 1,186 288 151 FINANCIAL INCOME (EXPENSES), NET 10 130 108 (148) INCOME (LOSS) BEFORE TAXES ON INCOME (832) (3,162) 2,239 3,843 TAXES ON INCOME (TAX BENEFIT) 268 400 (116) 607 NET INCOME (LOSS) $ (1,100) $ (3,562) $ 2,355 $ 3,236 EARNINGS (LOSS) PER SHARE OF COMMON STOCK: BASIC $ (0.01) $ (0.05) $ 0.03 $ 0.04 DILUTED $ (0.01) $ (0.05) $ 0.03 $ 0.03 WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING EARNINGS (LOSS) PER SHARE: BASIC 78,225,112 73,301,091 79,281,685 73,549,745 DILUTED 78,225,112 73,301,091 80,814,564 81,217,068 Logo: https://mma.prnewswire.com/media/999479/5618153/Protalix_Biotherapeutics_Logo.jpg SOURCE Protalix BioTherapeutics, Inc.