Protalix BioTherapeutics Reports Third Quarter 2025 Financial and Business Results

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 HighlightsIn 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 2025 by 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 HighlightsWe 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 $1.6 million 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 phase 2 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 $0.1 million 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 $2.4 million, or $0.03 per share, basic and diluted, compared to net income of $3.2 million, or $0.04 per share, basic and $0.03 per share, diluted, for the same period in 2024.Year-to-Date 2025 Financial HighlightsWe 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 $34.8 million for the same period in 2024. These revenues consist of $18.6 million 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 $0.4 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 $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 $4.8 million of salary and related expenses, approximately $1.6 million of subcontractor-related expenses, approximately $0.5 million of materials-related expenses and approximately $1.9 million of other expenses. The $5.1 million, or 58%, increase compared to the same period of 2024 resulted primarily from preparations for the planned phase 2 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 2024 repayment in full of all the outstanding principal and interest payable under the 2024 Notes. 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 InformationWe will host a conference call today, November 13, 2025, at 8:00 am 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, November 13, 2025Time: 8:00 a.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.

Protalix BioTherapeutics Reports Third Quarter 2025 Financial and Business Results

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