PLX

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Revenue growth was primarily driven by increased Elfabrio sales to Chiesi, reflecting deeper global market penetration and inventory management strategies. Management attributes the strong first-half performance to the combination of commercial scaling and a $25 million milestone payment recognized in Q1 2026. The company is strategically focused on the rare renal disease market, leveraging its proprietary platform to maintain a competitive advantage in specialized therapeutic areas. Profitability is being sustained through a business model designed to limit downside risks while preserving upside through clinical program advancements. Operational efficiency was bolstered by a $2.1 million reduction in R&D expenses resulting from a new ongoing grant available under the R&D law. Management views the recent European approval of Elfabrio's once-every-4-weeks dosing regimen as a key strengthener of their partnership with Chiesi. Protalix projects the global Fabry market will reach approximately $3.2 billion by 2031, with a target to capture 15% to 20% of this market share. Top-line results for the RELEASE study evaluating PRX-115 in uncontrolled gout are expected in the second half of 2027. Management expects to finalize enrollment for the PRX-115 Phase 2 study by the end of 2026, with nearly all clinical sites currently active. Future revenue is expected to remain 'lumpy' on a quarter-to-quarter basis due to the timing of partner shipments and inventory cycles, necessitating a full-year evaluation approach. The company maintains a strong cash position of $40.7 million with no outstanding debt, providing the financial flexibility required to fund ongoing clinical and preclinical programs. Taxes on income increased to $1.1 million due to GILTI tax limitations under IRC Section 174. The company secured a patent term extension for Elfabrio and received new regulatory approval in South Korea, expanding its commercial footprint. R&D expenses are expected to rise in future periods as the RELEASE study progresses and additional pipeline programs advance. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management is evaluating four arms in the Phase 2 RELEASE study, including every-4-weeks without methotrexate and every-8-weeks with methotrexate. The decision on which regimen advances will depend on the totality of evidence regarding immunogenicity, infusion-related reactions (IRR), and patient convenience. Eliminating methotrexate or extending dosing frequency are both considered significant potential competitive advantages. The 36-milligram dose was selected based on PK/PD data from Phase 1 and the goal of achieving the most convenient patient dosing schedule. Phase 2 will provide a clearer picture of anti-drug antibodies (ADAs) against the enzyme across different treatment arms compared to the single ascending dose Phase 1 study. Management noted the growth of the uncontrolled gout market, citing Krystexxa's revenue trend toward $1.6 billion as an encouraging sign for PRX-115's potential. While acknowledging competitor price increases, management focused on the overall market expansion as the primary indicator of the opportunity for their differentiated uricase.

Company to host conference call and webcast today at 8:00 a.m. EDT Revenues from selling goods increased to $19.8 million in the second quarter of 2026, up $4.4 million from the second quarter of 2025, driven primarily by sales of Elfabrio® Total revenue climbed to $53.6 million, year to date, from $25.8 million for the same period in 2025, which includes the previously reported $25.0 million Chiesi milestone payment Year-to-date, the Company achieved profitability with a net income of $22.1 million The Company reiterates full-year 2026 guidance of $78.0 million to $83.0 million in total revenue PRX-115 Phase 2 study continues to advance as planned, with top-line results anticipated in the second half of 2027 Cash, cash equivalents, and short-term bank deposits were $40.7 million as of June 30, 2026, providing sufficient capital to fund ongoing operations including the Phase 2 RELEASE clinical trial of PRX-115 CARMIEL, Israel, Aug. 12, 2026 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the discovery, development, production, and commercialization of innovative therapeutics for rare diseases with significant unmet needs, today reported financial results for the second quarter ended June 30, 2026, and provided a business and clinical update. During the second quarter, Protalix grew revenues from selling goods, driven primarily by continued penetration of Elfabrio® globally, advanced enrollment in the PRX-115 Phase 2 RELEASE clinical trial, and reaffirmed its strategic priorities and financial outlook for 2026. "We enter the second half of 2026 in a position of strength, driven by the continued penetration and growth of Elfabrio® through our partnership with Chiesi, a trend toward achieving our financial goals for 2026," said Dror Bashan, President and Chief Executive Officer of Protalix BioTherapeutics. "Total revenue climbed to $53.6 million from $25.8 million for the same period in 2025. With $40.7 million in cash and short-term deposits, we are well-positioned to fund execution across our operations. We remain focused on continued enrollment in our PRX-115 Phase 2 RELEASE study and our pipeline addressing rare renal indications." Second Quarter 2026 Operational Update Elfabrio® for Fabry Disease On May 4, 2026, the U.S. Patent and Trademark Office (USPTO) issued a Patent Term Extension certificate for U.S. Patent No. 9,194,011, covering Elfabrio® (pegunigalsidase alfa–iwxj). The extension adds five years to the patent term, moving the U.S. expiration date to November 17, 2035. Elfabrio® received orphan drug designation and Marketing Authorization in South Korea in May 2026, with Kwangdong Pharmaceutical Co., Ltd. as the local marketing authorization holder. PRX-115 for Uncontrolled Gout – RELEASE Phase 2 continues enrollment On July 7, 2026, the USPTO issued U.S. Patent No. 12,674,146, "Modified Uricase and Uses Thereof," to Protalix Ltd., strengthening the Company's intellectual property position around PRX-115. Patient enrollment continues in the Company's RELEASE Phase 2 clinical trial (NCT07280156) of PRX–115, a recombinant PEGylated uricase, for the treatment of uncontrolled gout. The Company continues to anticipate top–line results in the second half of 2027. Focus on Rare Renal Indications (Preclinical Programs) The Company continues to advance PRX–119, its long–acting DNase I program, as part of a broader strategic focus on rare renal indications, as well as other research collaborations. Financial Outlook: Building Durable Growth and Long–Term Value The Company operates a profitable growing commercial business through its partnerships, and a focused pipeline aligned to areas of high unmet need. The Company has a strong balance sheet, with no outstanding debt or warrants. The Company believes that its current business model limits downside risk while preserving significant upside potential as the Company progresses its clinical and preclinical programs, expands its commercial footprint, and pursues strategic partnerships to accelerate impact and scale. Priorities remain consistent: Support our commercial partners through the manufacture and supply of our products Advance PRX–115 as a potential best–in–class therapy for patients with uncontrolled gout Advance rare renal programs leveraging the Company's R&D strengths The Company reaffirms its previously stated 2026 revenue expectations: Total revenue in 2026 to range from approximately $78.0 million to $83.0 million including the $25.0 million milestone which the Company has received from Chiesi. This outlook is not a guarantee of future performance, and stockholders should not rely on such forward-looking statements. These estimates are based on management's current estimates, which are subject to change and may be updated accordingly. See "Forward-Looking Statements" for additional information. Second Quarter and Year-to-Date 2026 Financials highlights Revenues from selling goods were $19.8 and $27.2 million for the three and six months ended June 30, 2026, respectively compared to $15.4 and $25.4 million for the same periods in 2025, respectively, an increase of $4.4 and $1.8 million, respectively. The increase was driven primarily by higher sales to Chiesi and Fiocruz (Brazil), partially offset by lower Pfizer purchases mainly due to Pfizer's manufacturing issues in the previous year. Revenues from license and R&D services were $0.1 and $26.4 million for the three and six months ended June 30, 2026, respectively, compared to $0.2 and $0.3 million for the same periods in 2025, the decrease in the second quarter was due to a lower amount of services provided to Chiesi in the second quarter of 2026. The increase in the first half of 2026 resulted from the $25.0 million milestone payment received from Chiesi in connection with the E4W dosage approval in the EU in the first quarter of 2026. Other than potential regulatory milestone payments, the Company expects to generate minimal revenues from license and R&D services going forward, having completed the clinical development of Elfabrio®. Cost of revenues were $7.8 and $11.9 million for the three and six months ended June 30, 2026, respectively, an increase of $1.9 million (32%) and a decrease of $2.2 million (15%) compared to $5.9 and $14.1 million for the same periods in 2025. The increase in the second quarter was driven primarily by higher sales to Chiesi and Fiocruz (Brazil), partially offset by lower sales to Pfizer. The decrease in the first half of 2026 resulted primarily from a decrease in sales to Pfizer which was partially offset by an increase in sales to Chiesi and to Fiocruz (Brazil). Research and development (R&D) expenses were $4.4 and $9.8 million for the three and six months ended June 30, 2026, respectively, a decrease of $1.6 million and an increase of $0.3 million compared to $6.0 and $9.5 million for the same periods in 2025. Both periods reflect a $2.1 million grant receivable recorded under the new R&D law as a reduction of R&D expenses. The Company expects to continue to incur R&D expenses as the RELEASE study progresses and additional preclinical and clinical programs advance. Selling, general, and administrative (SG&A) expenses were $3.1 and $6.2 million for the three and six months ended June 30, 2026, respectively, an increase of $0.5 and $1.0 million, respectively, compared to $2.6 and $5.2 million for the prior-year periods, driven primarily by $0.3 and $0.7 million in higher salary and related expenses, respectively, and of $0.2 million higher selling expenses for the three and six months ended June 30, 2026. Financial income, net was $0.2 million for the three and six months ended June 30,2026, compared to financial expenses, net of $0.5 and $0.1 million for the same periods in 2025. The change resulted primarily from exchange rate fluctuations between the U.S. dollar and the New Israeli Shekel. Taxes on income were $1.1 and $3.9 million for the three and six months ended June 30, 2026, respectively, compared to $0.5 and $0.4 million for the same periods in 2025 an increase of $0.6 and $3.5 million, respectively. The increase resulted primarily from taxes on income derived from global intangible low-taxed income (GILTI) resulting from limitations under IRC Section 174 and from taxes related to the Company's receipt of the $25 million milestone payment in the first quarter of 2026. Cash, cash equivalents, and short–term bank deposits were $40.7 million at June 30, 2026. Net income for the three months ended June 30, 2026 was $3.8 million or $0.05 per share, basic and diluted, compared to net income of $164,000 or $0.00 per share, basic and diluted, for the same period in 2025. Net income for the six months ended June 30, 2026 was $22.1 million, or $0.28 per share, basic, and $0.27 per share, diluted, compared to a net loss of $3.5 million, or $0.04 per share, basic and diluted, for the same period in 2025. Conference Call and Webcast Information The Company will host a conference call today, August 12, at 8:00 am EDT, 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: August 12, 2026 Time: 8:00 a.m. Eastern Daylight Time (EDT) Toll Free: 1-877-423-9813 International: 1-201-689-8573 Israeli Toll Free: 1-809-406-247 Conference ID: 13761985 Call me™: https://bit.ly/4w2OverThe 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: http://bit.ly/4h4mqOYConference ID: 13761985 Participants 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 discovery, development, production, and commercialization of innovative therapeutics for rare diseases. Protalix has researched, developed, and currently manufactures two enzyme replacement therapies that are currently available in multiple markets. These therapies are recombinant therapeutic proteins expressed through Protalix's proprietary plant cell-based expression system, ProCellEx®. ProCellEx is a unique plant cell-based system that enables Protalix to produce recombinant proteins in an industrial-scale manner with no exposure to mammalian cells. Protalix 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. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa, Elelyso®, for the treatment of Gaucher disease, excluding in Brazil where Protalix retains full rights. Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio® which was approved by both the FDA and the European Medicines Agency (EMA) in May 2023. Protalix's development pipeline includes, among others, two proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; and PRX–119, a plant cell-expressed long-acting DNase I for the treatment of NETs-related diseases. To learn more, please visit www.protalix.com. 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. These statements generally relate to future events or the Company's future financial or operating performance, including the 2026 financial outlook described above. Actual outcomes and results may differ materially from what is expressed or forecast in such forward-looking statements. 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 of 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; 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; and/or inability to monitor patients adequately during or after treatment; the risk that the results of our clinical trials of our product candidates will not support the applicable claims of safety or efficacy and that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; the possible disruption of our operations due to the regional conflict in Iran and the military actions between Israel and Iran, the Hamas terrorist organization located in the Gaza Strip, Hezbollah, the Houthis terrorist group that controls parts of Yemen, and others, including as a result of the disruption of the operations of certain regulatory authorities and of certain of our suppliers, collaborative partners, licensees, clinical trial sites, distributors, and customers, and the risk that the current hostilities will result in increased regional conflict; delays in the approval or potential rejection of any applications we file with the FDA, European Medicines Agency or other health regulatory authorities for our other product candidates and other risks relating to the review process; risks associated with global conditions and developments such as new or increased tariffs, treaties, trade policies, taxes, and other limitations on cross-border operations, which may adversely impact our business, results of operations, and financial condition; risks associated with global conditions and developments such as new or changed trade restrictions, supply chain challenges, the inflationary environment and tight labor market, and instability in the banking industry, which may adversely impact our business, results of operations, and financial condition, and our 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; risks relating to our ability to manage our relationship with our collaborators, distributors, and partners, including, but not limited to, Pfizer Inc. and Chiesi Farmaceutici S.p.A.; 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, or Fiocruz, an arm of the Brazilian Ministry of Health with its purchase obligations under our supply and technology transfer agreement that we entered into with Fiocruz in June 2013, which may have a material adverse effect on us and may result in our terminating 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. You are cautioned not to place undue reliance on these forward-looking statements. Investor Contact Mike Moyer, Managing DirectorLifeSci [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/protalix-biotherapeutics-reports-second-quarter-2026-financial-and-business-results-302849539.html

This article first appeared on GuruFocus. Total Revenues (Q2 2026): $19.9 million, compared to $15.7 million in Q2 2025. Total Revenues (H1 2026): $53.6 million, compared to $25.8 million in H1 2025. Revenues from Selling Goods (Q2 2026): $19.8 million, up from $15.4 million in Q2 2025. Revenues from Selling Goods (H1 2026): $27.2 million, compared to $25.4 million in H1 2025. Cost of Revenues: $7.8 million in Q2 2026, up from $5.9 million in Q2 2025. R&D Expenses: $4.4 million in Q2 2026, down from $6.0 million in Q2 2025. SG&A Expenses: $3.1 million in Q2 2026, up from $2.6 million in Q2 2025. Financial Income (Net): $0.2 million income in Q2 2026, compared to $0.5 million expense in Q2 2025. Taxes on Income: $1.1 million in Q2 2026, up from $0.5 million in Q2 2025. Net Income: $3.8 million, or $0.05 per share basic and diluted, in Q2 2026, compared to $164,000, or $0 per share, in Q2 2025. Cash Position: Cash equivalents and short-term bank deposits totaled $40.7 million as of June 30, 2026. Warning! GuruFocus has detected 3 Warning Signs with PLX. Is PLX fairly valued? Test your thesis with our free DCF calculator. Release Date: August 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Total revenues for Q2 2026 increased to $19.9 million, up from $15.7 million in Q2 2025, driven by higher Elfabrio sales to Chiesi. Net income for Q2 2026 was $3.8 million, a significant improvement from $164,000 in the same period last year. The company maintains a strong cash position of $40.7 million with no outstanding debt, providing financial flexibility for pipeline advancement. Elfabrio's global market penetration is growing, supported by the recent approval of a once-every-four-weeks dosing regimen in Europe. PRS-115, a long-acting treatment for uncontrolled gout, is advancing as planned, with top-line results expected in the second half of 2027, targeting a market projected to reach $3.2 billion by 2031. Revenues from selling goods for the first half of 2026 increased only modestly by $1.8 million, indicating slower growth compared to the prior year. Cost of revenues increased by $1.9 million in Q2 2026, driven by higher sales volumes to Chiesi and fuel cruise, partially offset by lower Pfizer sales. R&D expenses decreased due to a $2.1 million grant under the new R&D law, but the company expects expenses to rise as the release study progresses. Taxes on income increased by $0.6 million due to GILTI and limitations under IRC Section 174, impacting net income. Revenue from Elfabrio sales can be lumpy due to Chiesi's inventory management, making quarterly results volatile and less predictable. Q: What totality of evidence framework will determine which PRS-115 regimen advances to Phase III, and could a modest month-six responder rate difference be outweighed by eliminating methotrexate or extending dosing to every eight weeks? A: Dror Bashan (President and CEO) and Gilad Mamlok (CFO) explained that the decision will be based on the outcomes of the ongoing Phase II multiple-dose study. They noted that while the four active arms (excluding placebo) could all be viable, the final choice will depend on a comprehensive assessment of immunogenicity, infusion-related reactions (IRR), and efficacy. The company will weigh the benefits of dosing frequency (every four weeks without methotrexate vs. every eight weeks with methotrexate) against the overall safety and efficacy profile, but a definitive decision cannot be made until the data is available. Q: How did the combined PK, PD, and immunogenicity data from Phase I support selecting the fixed 36-milligram dose, and what ADA profile would support every-four-week dosing without methotrexate? A: Dror Bashan (President and CEO) stated that the 36-milligram dose was selected based on the PK/PD profile from the single ascending dose Phase I study. He emphasized that the Phase II multiple-dose study will provide a clearer picture of the different types of anti-drug antibodies (ADAs) against the PEG and the enzyme, and their correlation with outcomes across the different arms. The company believes this regimen could offer the most convenient and beneficial profile for patients, potentially achieving high efficacy with a favorable dosing schedule. Q: Is there any benefit to having lumpy purchases of Elfabrio, and is the strong Q2 increase due to new approvals in certain geographies or other reasons? A: Gilad Mamlok (CFO) clarified that the company prefers to evaluate performance on a year-to-date basis rather than quarterly, as revenues can be lumpy. The strong Q2 performance from Chiesi reflects their business growth but is primarily driven by their inventory management strategies. Dror Bashan (CEO) added that Chiesi operates logically based on global demand, inventory levels, and manufacturing schedules, ensuring adequate stock of both drug substance and drug product. Q: How is the site activation and enrollment progressing for the PRS-115 Phase II study, and how many more sites might be opening in 2026? A: Dror Bashan (President and CEO) confirmed that all planned sites are now signed and activated, with only one site potentially missing. The company expects to complete enrollment within the next five months, by year-end, as planned. He noted that progress is on track and "so far, so good." Q: What does Amgen's significant price increase on Krystexxa (over 20% in Q1 and Q2) indicate about the market, and does it make the space more attractive for PRS-115? A: Dror Bashan (President and CEO) stated he had no direct insights into Amgen's pricing strategy but acknowledged that the market is growing, with revenues increasing from $1.3 billion in 2025 to a projected $1.6 billion. He agreed that this trend is very encouraging for the potential of PRS-115, as it validates the market's willingness to accept higher prices and underscores the significant unmet need in uncontrolled gout. Q: Can you provide more detail on the financial results for Q2 2026, specifically regarding revenue breakdown and expense drivers? A: Gilad Mamlok (CFO) reported total revenues of $19.9 million for Q2 2026, up from $15.7 million in Q2 2025, driven by higher sales of Elfabrio to Chiesi. Cost of revenues increased to $7.8 million due to higher sales volumes. R&D expenses decreased to $4.4 million, primarily due to a $2.1 million grant recorded under the new R&D law, which is now available on an ongoing basis. SG&A expenses rose slightly to $3.1 million due to higher salaries. The company reported a net income of $3.8 million for the quarter. Q: What is the company's cash position and financial flexibility going forward? A: Gilad Mamlok (CFO) confirmed that cash, cash equivalents, and short-term bank deposits totaled $40.7 million as of June 30, 2026. The company has no outstanding debt, providing substantial financial flexibility to support continued pipeline advancements and operations. Q: Can you reiterate the full-year 2026 revenue guidance and the factors supporting it? A: Dror Bashan (CEO) and Gilad Mamlok (CFO) reaffirmed confidence in the full-year 2026 revenue guidance. They highlighted that the positive revenue trends, driven by continued growth of Elfabrio sales through Chiesi and the $25 million milestone payment recognized in Q1, keep the company firmly on track. They emphasized that while quarterly revenues can vary due to shipment timing, the full-year outlook remains strong. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Company to host conference call and webcast at 8:00 a.m. EDT CARMIEL, Israel, Aug. 5, 2026 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the discovery, development, production, and commercialization of innovative therapeutics for rare diseases with significant unmet needs, today announced that it will release its financial results for the quarter ended June 30, 2026 and provide a business update on August 12, 2026. Management will host a conference call to discuss the financial results and provide an update on recent corporate and regulatory developments. Conference Call Details: The 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: Participants are requested to access the call 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 Company's website, at the above link. About Protalix BioTherapeutics, Inc. Protalix is a biopharmaceutical company focused on the discovery, development, production, and commercialization of innovative therapeutics for rare diseases. Protalix has researched, developed, and currently manufactures two enzyme replacement therapies that are currently available in multiple markets. These therapies are recombinant therapeutic proteins expressed through Protalix's proprietary plant cell-based expression system, ProCellEx®. ProCellEx is a unique plant cell-based system that enables Protalix to produce recombinant proteins in an industrial-scale manner with no exposure to mammalian cells. Protalix 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. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa, Elelyso®, for the treatment of Gaucher disease, excluding in Brazil where Protalix retains full rights. Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio® which was approved by both the FDA and the European Medicines Agency (EMA) in May 2023. Protalix's development pipeline includes, among others, two proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; and PRX–119, a plant cell-expressed long-acting DNase I for the treatment of NETs-related diseases. To learn more, please visit www.protalix.com. Investor Contact Mike Moyer, Managing DirectorLifeSci [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/protalix-biotherapeutics-to-announce-second-quarter-2026-financial-results-and-business-update-on-august-12-2026-302843662.html

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Performance in Q1 was primarily driven by a $25 million milestone payment from Chiesi following the European Commission's approval of Elfabrio's every 4 weeks dosing regimen. The new every 4 weeks dosing flexibility in Europe is expected to reduce treatment burden for patients, strengthening Elfabrio's competitive position and supporting broader adoption over time. Management attributes the decrease in selling goods revenue to timing and inventory dynamics regarding Elelyso purchases by Pfizer and Fiocruz, rather than a shift in underlying demand. The company is focusing its long-term strategy on rare renal diseases, believing its platform offers a clear advantage and a business model that limits downside risk while preserving clinical upside. Management maintains a long-term target of 15% to 20% global market share for Elfabrio by 2031, supported by a projected $3.2 billion total addressable market. Reaffirmed 2026 total revenue guidance of approximately $78 million to $83 million, which includes the $25 million milestone already received. The company expects Elfabrio product revenues to range between $33 million and $35 million for the full year, with growth weighted toward the second half of 2026. The Phase II RELEASE study for PRX-115 is expected to complete enrollment by the end of 2026, with top-line results anticipated in the second half of 2027. Management intends to provide specific indication details for the PRX-119 program by the end of the current quarter to clarify the clinical development path. The company ended the quarter with $51 million in cash and no outstanding debt or warrants, which management states provides sufficient funds for the Phase II RELEASE study. R&D expenses increased to $5.4 million from $3.5 million year-over-year, reflecting a deliberate capital allocation shift toward the PRX-115 clinical program. Net income reached $18.3 million for the quarter, a significant shift from a prior year loss, though this was heavily influenced by the one-time milestone revenue. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management expects the second half of 2026 to be stronger for Elfabrio sales as Chiesi navigates country-by-country local reimbursement approvals for the new dosing regimen. The company is sticking to its current guidance for now, suggesting it is too early to raise outlooks based on the March approval. Management believes the segment for uncontrolled gout patients will remain robust despite next-generation competitors, providing ample room for their Uricase-based treatment. Management noted it is too early for specific uptake data, but reported that partner Chiesi remains optimistic about the progress and expects visible results in the second half of the year. Chiesi is pursuing several additional geographic targets over the next 12 months, with management committing to report new approvals as they occur.

This article first appeared on GuruFocus. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Protalix BioTherapeutics Inc (PLX) received a $25 million milestone payment following the European Commission's approval of El Fabrio's every four weeks dosing regimen. The company ended the first quarter with $51 million in cash, providing a strong balance sheet and substantial financial flexibility. Protalix BioTherapeutics Inc (PLX) reaffirmed its 2026 revenue guidance, expecting total revenue to range from $78 million to $83 million. The company is actively enrolling for the PRX-115 Phase II release study, with top-line results expected in the second half of 2027. Protalix BioTherapeutics Inc (PLX) operates a profitable commercial business, with net income for the quarter at $18.3 million, compared to a net loss in the prior year period. Revenues from selling goods decreased to $7.4 million from $10 million in the first quarter of 2025, reflecting lower purchases by Pfizer. R&D expenses increased to $5.4 million, up from $3.5 million in the prior year period, driven by the PRX-115 Phase 2 release study. SG&A expenses rose to $3.1 million, reflecting modest growth year-over-year, largely due to personnel-related costs. The company has not provided specific updates on the progress of enrollment for the PRX-115 Phase II release study. Initial data or insights into the market uptake of El Fabrio's every four weeks dosing regimen are not yet available, with expectations of seeing results in the second half of the year. Warning! GuruFocus has detected 5 Warning Signs with PLX. Is PLX fairly valued? Test your thesis with our free DCF calculator. Q: Can you comment on the expected revenue cadence from Chiesi regarding El Fabrio's sales and the likelihood of increasing the full-year 2026 guidance for El Fabrio-related royalty-based revenue? A: We received approval for the four-week dosing regimen on March 5th, and Chiesi is now working on obtaining local reimbursement approvals country by country. We expect to see the impact mostly in the second half of the year and are maintaining our current guidance. Q: How is enrollment progressing in the PRX-115 release trial, and when do you expect to complete enrollment? A: Enrollment is progressing with many sites open. We aim to complete enrollment by the end of 2026 and expect top-line results in the second half of 2027. Q: Do you expect the positioning of PRX-115 in the gout market to change with the advent of next-generation URAP1 inhibitors? A: We believe the segment of uncontrolled gout patients will remain, providing enough room for growth even with new URAP1 inhibitors entering the market. Q: Do you have any initial insights into the market uptake of the four-week dosing regimen for El Fabrio? A: It's too early to provide data, but Chiesi is optimistic about the progress. We expect to see actual results in the second half of the year. Q: Can you update us on Chiesi's global regulatory efforts and any new geographies for El Fabrio? A: Chiesi has several targets for the next 12 months. We will report new approvals as they occur, continuing to expand patient exposure to El Fabrio. Q: What is the next milestone for PRX-119, and when can we expect it to enter the clinic? A: We are preparing to determine the specific indication for PRX-119's mechanism of action. We hope to update on this by the end of the quarter and detail when we expect to start Phase I. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Protalix BioTherapeutics (AMEX:PLX) released first-quarter financial results and hosted an earnings call on Wednesday. Read the complete transcript below. Benzinga APIs provide real-time access to earnings call transcripts and financial data. Visit https://www.benzinga.com/apis/ to learn more. View the webcast at https://viavid.webcasts.com/starthere.jsp?ei=1762414&tp_key=330c698581 Protalix BioTherapeutics reported a $25 million milestone payment from Chiesi due to European Commission approval of a new dosing regimen for El Fabrio, ending the quarter with $51 million in cash. The company reaffirmed its 2026 revenue guidance of $78 to $83 million, with key revenue drivers being El Fabrio and PRX115's Phase 2 study and ongoing partnerships. The company plans to capture 15-20% of the global Fabry market by 2031, with strategic focus on expanding El Fabrio's presence in Europe and advancing PRX115 for uncontrolled gout. First-quarter revenue was $33.8 million, with an increase in R&D expenses to $5.4 million due to the PRX115 Phase 2 study, while maintaining a strong financial position with no debt. Management expressed confidence in achieving long-term growth through strategic partnerships and pipeline advancement, with expectations for significant revenue growth in the second half of 2026. OPERATOR . Good morning ladies and gentlemen and welcome to Protalix BioTherapeutics First Quarter 2026 Financial and Business Results Conference Call. As a reminder, this conference is being recorded. I will now turn the conference over to our host, Mr. Mike Moyer of LASCI Advisors, Investor Relations for Protalix. Thank you. Please go ahead. Mike Moyer (Investor Relations) Thank you Operator and welcome to Protalix BioTherapeutics Q1 2026 financial results and Business Update Conference Call. With me today are Dror Bashan, President and CEO of Protalix, and Gilad Mamlach, Senior Vice President and Chief Financial Officer. A press release announcing the financial results and corporate updates were issued this morning and are available now on the Protalix website. Please take a moment to read the disclaimer about forward looking statements in the press release. The earnings release and this teleconference include forward looking statements. These forward looking statements are subject to known and unknown risks and uncertainties. They may cause actual results to differ materially from the statements made. Factors that could cause actual results to differ are described in the disclaimer and in Protalix's filings with the U.S. securities and Exchange Commission. I will now turn the call over to Mr. Dror Bashan. Dror Bashan Thank you Mike and thank you everyone for joining our Q1 2026 financial results and Business Update for I want to begin by highlighting two points that underscore the strength of our business today. First, during the quarter we received the $25 million milestone from Chiesi following the European Commission approval of a Elfabrio every four weeks dosing regimen. As a result, we ended the first quarter of this year with $51 million in cash, providing us with a strong balance sheet and substantial financial flexibility and sufficient funds to support our ongoing operations as well as our phase two release study with PRX115. Second, we are reaffirming our 2026 guidance. We continue to expect total revenue for the year to range from approximately 78 to 83 million dollars inclusive of the 25 million dollar milestones received from Chiesi. Within that outlook, we anticipated Elfabrio revenues excluding milestones of approximately 33 to 35 million and PRX-102 revenues of approximately 20 to 23 million. Taken together, this guidance reflects the strength of our commercial partnerships and our confidence in execution across our business for the year ahead. We entered 2026 with a good momentum with the regulatory progress for in Europe which triggered the $25 million milestone payment, the continued enrollment of our PRX115 Phase 2 release study and a growing focus on our rare renal disease preclinical pipeline, we remain confident in our strategy for the years ahead. Our partner Chiesi continues to execute well with Elfabrio across approved markets. Following the European Commission recent approval of every four weeks regiment, we believe Elfabrio is well positioned to meaningfully reduce treatment burden for eligible patients in the European Union without compromising efficacy. This added dosing flexibility strengthens the Elfabrio competitive position and supports broader adoption over time. In the United States, the FDA approved dosing regimen remains unchanged. Looking longer term with the global Fabry market projected to approach approximately 3.2 billion by 2031, we believe Elfabrio has the potential to achieve a meaningful 15 to 20% market share globally supported by its differentiated profile. We believe our revenue mix, particularly the continued expansion of El Fablo, positions us well for substantial long term value creation. On our clinical side, PRX115 continues to move forward as planned. The Phase 2 release study is actively evolving and we remain encouraged by the program profile. Based on the Phase one data, we believe it has the potential to improve outcomes for patients with uncontrolled gout. We continue to expect top line results in the second half of 2027. Beyond 115, our strategy remains centered on rare renal diseases where we believe our capabilities and platform offer a clear advantage. In our view, our business model limits downside risk while preserving meaningful upside as we advance our clinical programs and continue our commercial partnership. With that, I will turn the call over to Gilad for a detailed review of our financial results and outlook. Gilad Mamlach (Senior Vice President and Chief Financial Officer) Thank you Dror. For the first quarter of 2026, total revenue was 33.8 million, driven mainly by the 25 million milestone payment received from Chiesi following approval of the every four weeks dosing regimen for Elfabrio in Europe. This milestone underscores the value embedded in our commercial partnerships. Revenues from selling goods was 7.4 million compared to 10 million in the first quarter of 2025. This change reflects lower Fabry purchases by Pfizer and Fuel crews mainly due to timing and inventory dynamics, and was partially offset by sales to Kiese. As we have noted previously, quarterly product revenues can fluctuate based on party purchasing patterns and we encourage investors to focus on full year performance rather than quarter to quarter viability. Cost of revenues was 4.1 million compared to 8.2 million for the same period in 2025. The decrease was mainly attributable to lower sales volumes to Pfizer and Pfizer, partially offset by increased sales to Chiesi R&D expenses increased to 5.4 million, up from 2.5 million in the prior year period, driven mainly by preparations for an Initiation of the PRX115 phase 2 release study. This increase reflects a deliberate allocation of capital toward advancing PRX115, which remains our top clinical priority. SGA expenses were 3.1 million up 0.5 million, reflecting modest growth year over year, largely attributable to personnel related costs. As a result of the milestone revenues and ongoing cost discipline, net income for the quarter was 18.3 million or $0.23 per share and $0.22 on a fully diluted basis, compared to a Net loss of 3.6 million or $0.05 per share in the prior year period. Importantly, the company continues to operate a profitable commercial business. profitable commercial business and milestone provide additional upside without changing our underlying expense base. Turning to the balance sheet cash, cash equivalent and short term bank deposits total 51 million as of March 31, 2026. We have no outstanding debt or warrants providing us with substantial financial flexibility to support our continued pipeline advancement. In summary, we remain in a strong financial position and well capitalized to advance our key programs to the next set of clinical and commercial milestones. With that, I will turn the call back over to Dror Bashan Dror Bashan thank you Gilant. To conclude, as we look ahead, we do so from a position of strength. With the $25 million milestone triggered by the EC approval, we hold approximately $51 million in cash as 31st of this year, giving us the financial flexibility to continue investing in programs and partnerships that will drive our next stage of growth. We are reaffirming our 2026 guidance and our expectation that Elfabrio can achieve 15 to 20% market share of the Fabri market by 2031. This reflects our confidence in the product, our partnership with Chiesi and the continued expansion of Elfabrio globally. Now I will turn. I would like to ask the operator to open the call for questions. OPERATOR Thank you. If you would like to ask a question, please press Star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press Star two if you would like to remove your question from the queue. And for participants using speaker equipment, it may be necessary to pick up your handset before pressing the Star key. Our first question is from Ram Sirvaju with HC Wainwright. Please proceed. Ram Sirvaju (Analyst) Thank you so much for taking our questions and congratulations on a good quarter. I wanted to ask if you could comment on the core determinants of the cadence with which you expect to receive revenue from Chiesi Regarding El Fabrio sales and what you think the likelihood is, if any of increases to the full year 2026 guidance for El Fabrio related royalty based revenue. Thank you. Dror Bashan So. Thank you. So I think as we mentioned last time, we just Chiesi, we received the approval for every four weeks on 5th of March. And Chiesi is now in the process of going country by country and getting the local reimbursement approval. So I think we are going to see the effect mostly in the second half of the year. And we expect the second half of the year to be much stronger with regards to Kez sales at that point of time. We still stick to the same guidelines we provided. Ram Sirvaju (Analyst) And secondly, can you provide any commentary on how enrollment is going in the release trial and if you can potentially provide us with timing for completion of enrollment? Dror Bashan As we said before, we are not updating regarding the continuing progress of the enrollment. It does progress. As we mentioned, we have many sites open. Our target is to finish enrollment by the end of 2026 and have the top end results in the second half of 2027. Ram Sirvaju (Analyst) And then lastly, with respect to the positioning of 115 in the overall gout market, do you expect this to change meaningfully with the advent of next generation URAT1 inhibitors or do you anticipate that the treatment, refractory gout, the refractory gout market segment is more or less likely to remain the same. Goro So Ram, this is Goro. Thank you. We believe, I would say this segment of uncontrolled gout patients will stay and there will be, I would say, enough room and growing even for patients qualified for Uricas. Thank you. Ram Sirvaju (Analyst) Thank you. OPERATOR Our next question is from John Vandermeuyen with Saks. Please proceed. John Vandermeuyen (Analyst) Good morning, Dror Bashan and Gilad Mamlach, or good afternoon. I know you mentioned that it's only the very first initial stages of the launch of El Fabrio for every four weeks, but do you have any initial data or initial insight into the, you know, the uptake in the market on that, on that approach? Dror Bashan It's too early for dad. Joan, good morning and thank you. But we do see, I mean, when we talk with Chiesi, I mean they're optimistic about the progress and they expect to make to see the progress. But again, in terms of seeing the actual results, I don't think we're going to see them before the second half of the year. John Vandermeuyen (Analyst) Understood. And there was a mention in the press release about TAZ continuing launches and regulatory efforts around the globe. And can you give us an update on how things are going in that respect. Any new geographies and any geographies that we should expect in the next few months or next quarters in terms of expanding exposure of patients to El Fabria. Dror Bashan So there are a few targets from CHIES in the next 12 months. I would say some are more significant, some are less. But we are going to report them immediately once there's approval. But it's a continuous route of getting more approvals, and we see what they have in the pipeline and we will update as soon as they receive the approval. John Vandermeuyen (Analyst) And then there's also mention of PRX119. And I was wondering, what's the next milestone for PRX119? And I'm thinking also, you know, in terms of like, getting into the clinic or IND submission or something like that, how does. How do we. How does that look, that program? Dror Bashan You know, we are developing and, you know, putting together different activities, if I may say, to make sure that we have, you know, we are on the right path. If I may say, we will update soon, I believe, I hope by the end of this quarter to which specific indication this mechanism of action works. And then we will, of course, detail when we expect to start Phase one. John Vandermeuyen (Analyst) Okay. All right. Thank you for taking my questions. OPERATOR Thank you. There are no further questions at this time. I would like to turn the floor back over to Dror Bashan for closing remarks. Dror Bashan So thank you everybody for joining us today and we are looking forward to talk to you next quarter. Thank you. Disclaimer: This transcript is provided for informational purposes only. While we strive for accuracy, there may be errors or omissions in this automated transcription. For official company statements and financial information, please refer to the company's SEC filings and official press releases. Corporate participants' and analysts' statements reflect their views as of the date of this call and are subject to change without notice. Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga: PROTALIX BIOTHERAPEUTICS (PLX): Free Stock Analysis Report This article Transcript: Protalix BioTherapeutics Q1 2026 Earnings Conference Call originally appeared on Benzinga.com ﾩ 2026 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Company to host conference call and webcast today at 8:00 a.m. EDT Elfabrio commercial execution continues following European Commission approval of the 2 mg/kg every–4–weeks (E4W) dosing regimen; $25 million milestone received from Chiesi PRX–115 Phase 2 study continues to advance as planned with top–line results anticipated in the second half of 2027 The Company reaffirms its previously stated 2026 revenue guidance of $78.0 – $83.0 million including the $25.0 million milestone received from Chiesi Cash, cash equivalents, and short–term bank deposits were $51 million as of March 31, 2026, providing sufficient capital to fund ongoing operations including the Phase 2 RELEASE clinical trial of PRX-115 CARMIEL, Israel, May 13, 2026 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the discovery, development, production, and commercialization of innovative therapeutics for rare diseases with significant unmet needs, today reported financial results for the first quarter ended March 31, 2026, and provided a business and clinical update. During the first quarter, the Company continued to execute against its commercial partnerships, advance its clinical and preclinical development programs, and reaffirm its strategic priorities and financial outlook for 2026. "Protalix entered 2026 with positive momentum," said Dror Bashan, President and Chief Executive Officer of Protalix BioTherapeutics. "With the recent regulatory progress for Elfabrio in Europe which triggered the $25 million milestone payment, the continued enrollment of our PRX–115 Phase 2 RELEASE study, and a growing focus on rare renal diseases, we believe the company is entering a pivotal period of growth and clinical advancement. We are confident in our strategy and reaffirm our guidance for 2026. We believe our business model positions us well to generate long–term value while advancing therapies that meaningfully address unmet needs." First Quarter 2026 Operational Update Elfabrio® for Fabry Disease Protalix and its partner, Chiesi Farmaceutici, continue to support the launch and expansion of Elfabrio across approved markets. Following the previously announced European Commission approval of the 2 mg/kg every–4–weeks (E4W) dosing regimen, Protalix believes Elfabrio is well-positioned to reduce treatment burden for patients with Fabry disease in the European Union without compromising efficacy. The E4W option enhances Elfabrio's competitive positioning in the European Union and supports broader adoption by providing increased dosing flexibility. The FDA-approved dosing regimen for Elfabrio in the United States remains 1 mg/kg every 2 weeks. With the global Fabry market projected to reach approximately $3 billion by 2031, Elfabrio® is positioned as a leading therapy with the potential to achieve a meaningful 15% to 20% global market share, supported by strong execution through Protalix's partnership with Chiesi. PRX-115 for Uncontrolled Gout – RELEASE Phase 2 continues enrollment The RELEASE Phase 2 clinical trial (NCT07280156) of PRX–115, a recombinant PEGylated uricase, for the treatment of uncontrolled gout continues to enroll patients. The Company continues to anticipate top–line results in the second half of 2027. PRX–115 is designed as a potential best–in–class, long–acting uricase therapy, which is supported by favorable Phase 1 data, with a possible E4W dosing schedule with or without an immunomodulator, or less frequent dosing with an immunomodulator, aiming to improve adherence and durability of response for patients with uncontrolled gout. By addressing immunogenicity challenges and enabling more flexible dosing intervals, the Company believes PRX–115 is well-positioned to capture a meaningful share of the uncontrolled gout segment, where even modest penetration represents significant commercial opportunity. Focus on Rare Renal Indications (Preclinical Programs) The Company continues to advance PRX–119, its long–acting DNase I program, as part of a broader strategic focus on rare renal indications. The Company also continues to collaborate with Secarna to identify RNA–based therapeutic candidates that may complement its proprietary ProCellEx® platform. Financial Outlook: Building Durable Growth and Long–Term Value The Company operates a profitable growing commercial business through its partnerships, and a focused pipeline aligned to areas of high unmet need. The Company has a strong balance sheet, with no outstanding debt or warrants. The Company believes that its current business model limits downside risk while preserving significant upside potential as the Company progresses its clinical and preclinical programs, expands its commercial footprint, and pursues strategic partnerships to accelerate impact and scale. Priorities remain consistent: The Company reaffirms its previously stated 2026 revenue expectations: Total revenue in 2026 to range from approximately $78.0 million to $83.0 million including the $25.0 million milestone which the Company has received from Chiesi. Full–year 2026 revenues from sales of Elfabrio without milestones to range from approximately $33.0 million to $35.0 million. Full–year 2026 revenues from sales of Elelyso to range from approximately $20.0 million to $23.0 million. This outlook is not a guarantee of future performance, and stockholders should not rely on such forward-looking statements. These estimates are based on management's current estimates, which are subject to change and may be updated accordingly. See "Forward-Looking Statements" for additional information. First Quarter 2026 Financial Highlights Revenues from selling goods were $7.4 million for the three months ended March 31, 2026, compared to $10.0 million for the same period in 2025. The change was primarily due to a timing shift in Pfizer's purchases this past quarter, following elevated Elelyso orders in the same period during 2025 to address unexpected manufacturing issues on their end. This timing related impact was partially offset by $3.5 million in sales to Chiesi, which did not occur in the prior–year period. Revenues from license and R&D services were $26.3 million for the first quarter of 2026, compared to $0.1 million for the first quarter of 2025. The increase resulted primarily from a $25.0 million milestone payment received from Chiesi in connection with the approval of the E4W dosage in the European Union. The Company expects to generate minimal revenues from license and R&D services, having completed the clinical development of Elfabrio, other than potential regulatory milestone payments. Cost of revenues were $4.1 million for the first quarter of 2026, a decrease of $4.1 million (50%) compared to $8.2 million for the same period in 2025. The decrease was primarily attributable to lower sales volumes to Pfizer and Fiocruz, partially offset by increased sales to Chiesi. Research & development (R&D) expenses totaled $5.4 million for the first quarter of 2026, compared to $3.5 million for the first quarter of 2025, representing an increase of $1.9 million (56%). The increase was driven primarily by preparations for and initiation of the Phase 2 RELEASE clinical trial of PRX–115. The Company expects to continue to incur R&D expenses as the RELEASE study progresses, and additional preclinical and clinical programs advance. Selling, general, and administrative (SG&A) expenses were $3.1 million for the first quarter of 2026, an increase of $0.5 million (17%) compared to $2.6 million for the prior-year period. The increase was driven primarily by higher salary and related expenses. Financial income (expenses), net was approximately $(0.0) million for the first quarter of 2026, compared to income of $0.4 million for the first quarter of 2025. The change resulted primarily from a $0.3 million exchange rate influence and $0.1 million lower interest income. Taxes on income were approximately $2.8 million for the first quarter of 2026 and tax benefit was approximately $(0.1) million for the first quarter of 2025. Income tax expense primarily reflects taxes on income derived from global intangible low-taxed income (GILTI), including the impact of capitalization requirements under Internal Revenue Code Section 174. Cash, cash equivalents, and short–term bank deposits were $51.1 million on March 31, 2026. Net income for the three months ended March 31, 2026 was $18.3 million, or $0.23 per share - basic and $0.22 per share – diluted, compared to a net loss of $3.6 million, or $(0.05) per share - basic and diluted, for the same period in 2025. The net income was driven primarily by the milestone revenue recognized from Chiesi. Conference Call and Webcast Information The Company will host a conference call today, May 13, at 8:00 am EDT, 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: May 13, 2026 Time: 8:00 a.m. Eastern Daylight Time (EDT) Toll Free: 1-877-423-9813 International: 1-201-689-8573 Israeli Toll Free: 1-809-406-247 Conference ID: 13760475 Call me™: https://tinyurl.com/yjww2vxn The 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://tinyurl.com/ykmy9jmr Conference ID: 13760475 Participants 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 discovery, development, production, and commercialization of innovative therapeutics for rare diseases. Protalix has researched, developed, and currently manufactures two enzyme replacement therapies that are currently available in multiple markets. These therapies are recombinant therapeutic proteins expressed through Protalix's proprietary plant cell-based expression system, ProCellEx®. ProCellEx is a unique plant cell-based system that enables Protalix to produce recombinant proteins in an industrial-scale manner with no exposure to mammalian cells. Protalix 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. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights to taliglucerase alfa, Elelyso®, for the treatment of Gaucher disease, excluding in Brazil where Protalix retains full rights. Protalix has partnered with Chiesi Farmaceutici S.p.A. for the global development and commercialization of Elfabrio® which was approved by both the FDA and the European Medicines Agency (EMA) in May 2023. Protalix's development pipeline includes, among others, two proprietary versions of recombinant therapeutic proteins that target established pharmaceutical markets: PRX–115, a plant cell-expressed recombinant PEGylated uricase for the treatment of uncontrolled gout; and PRX–119, a plant cell-expressed long-acting DNase I for the treatment of NETs-related diseases. To learn more, please visit www.protalix.com. 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. These statements generally relate to future events or the Company's future financial or operating performance, including the 2026 financial outlook described above. Actual outcomes and results may differ materially from what is expressed or forecast in such forward-looking statements. 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 of 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; 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; and/or inability to monitor patients adequately during or after treatment; the risk that the results of our clinical trials of our product candidates will not support the applicable claims of safety or efficacy and that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; the possible disruption of our operations due to the regional conflict in Iran and the military actions between Israel and Iran, the Hamas terrorist organization located in the Gaza Strip, Hezbollah, the Houthis terrorist group that controls parts of Yemen, and others, including as a result of the disruption of the operations of certain regulatory authorities and of certain of our suppliers, collaborative partners, licensees, clinical trial sites, distributors, and customers, and the risk that the current hostilities will result in increased regional conflict; delays in the approval or potential rejection of any applications we file with the FDA, European Medicines Agency or other health regulatory authorities for our other product candidates and other risks relating to the review process; risks associated with global conditions and developments such as new or increased tariffs, new or changed trade restrictions, supply chain challenges, the inflationary environment and tight labor market, and instability in the banking industry, which may adversely impact our business, operations and ability to raise additional financing if and as required and on terms acceptable to us; 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; risks relating to our ability to manage our relationship with our collaborators, distributors, and partners, including, but not limited to, Pfizer Inc. and Chiesi Farmaceutici S.p.A.; 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, or Fiocruz, an arm of the Brazilian Ministry of Health with its purchase obligations under our supply and technology transfer agreement that we entered into with Fiocruz in June 2013, which may have a material adverse effect on us and may result in our terminating 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. You are cautioned not to place undue reliance on these forward-looking statements. Investor Contact Mike Moyer, Managing Director LifeSci Advisors +1-617-308-4306 [email protected] Logo: https://mma.prnewswire.com/media/999479/Protalix_Biotherapeutics_Logo.jpg View original content:https://www.prnewswire.com/news-releases/protalix-biotherapeutics-reports-first-quarter-2026-financial-and-business-results-302770790.html