Protalix BioTherapeutics, Inc. ( PLX ) for FY25 reported a lot weaker-than-expected results. GAAP EPS was a loss of $0.08, missing the consensus by about $0.07, with revenue reaching $52.7 million. Revenue was down just 1% year over year but missedI hold a Master’s degree in Cell Biology and began my career working for several years as a lab technician in a drug discovery clinic, where I gained extensive hands-on experience in cell culture, assay development, and therapeutic research. That scientific founda ...

Regulated information Paris, March 23, 2026 DISCLOSURE FISCAL 2026/20 OF TRANSACTIONS ON TREASURY SHARES Period of: March 16 to March 20, 2026 Issuer: Pluxee N.V. Class of Securities: Ordinary shares (ISIN NL0015001W49) Aggregate presentation by day and by market. Issuer CodeTransaction dateISIN CodeDaily total volume (in number of shares)Daily weighted average price of shares acquiredPlatform213800RQNIQT48SEEO8516-Mar-26NL0015001W4943 50010,5251XPAR213800RQNIQT48SEEO8516-Mar-26<td style="width:102.4px;;t ...

Core Insights - Protalix BioTherapeutics has made significant progress with the European Commission's approval of Elfabrio® for Fabry disease, resulting in a $25 million milestone payment from Chiesi, which enhances the company's financial position [1][6] Financial Performance - For the first quarter of 2026, Protalix reported an earnings per share (EPS) of -$0.07, missing the estimated EPS of $0.04, with revenues of approximately $9.1 million, significantly lower than the expected $18.7 million [2][6] - The company anticipates a cash balance of around $50 million by April 2026, supported by strategic initiatives and milestone payments [2] Revenue Projections - Protalix projects total revenues for 2026 to be between $78 million and $83 million, including the milestone payment [3][6] Clinical Development - The company is actively enrolling participants in a Phase 2 clinical trial for PRX-115, a potential therapy for uncontrolled gout, focusing on expanding its pipeline through innovation and partnerships [3][6] Valuation Metrics - Protalix has a negative price-to-earnings (P/E) ratio of approximately -26.46, indicating current unprofitability, while the price-to-sales ratio is about 3.39, suggesting investors pay $3.39 for every dollar of sales [4] - The enterprise value to sales ratio is 3.27, reflecting a similar valuation when considering debt and cash [4] Financial Health - The company's debt-to-equity ratio is low at 0.17, indicating conservative debt use, and the current ratio is 2.51, suggesting good short-term financial health with more than twice the current assets compared to liabilities [5]

Earnings Call InsightsProtalix targets $78M–$83M 2026 revenue with EU milestone, advancing PRX-115Mar. 18, 2026 10:13 AM ETProtalix BioTherapeutics, Inc. (PLX) StockAI-Generated Earnings Calls InsightsCommentsEarnings Call Insights: Protalix BioTherapeutics (PLX) Q4 2025 Management View Dror Bashan, President and CEO, announced that the European Commission approved the 2 milligram per kilogram every 4-week dosing regimen for Elfabrio for adults with Fabry disease who are stable on enzymeNewsletters for Ever ...

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company operates with a team of experienced and qualified news journalists across key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content delivered by the company includes insights across various sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Utilization - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company employs automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans to maintain quality and best practices in content production [5]

Financial Data and Key Metrics Changes - For the full year 2025, total revenues from selling goods were $51.8 million, a modest decrease compared to 2024, driven by changes in quantities sold to Chiesi's inventory and a change in average net selling price due to increased commercial patients in Europe [8] - The company recorded a net loss of $6.6 million in 2025 compared to a net income of $2.9 million in 2024, reflecting increased investment in the clinical pipeline [10] - As of December 31, 2025, the company held $30.3 million in cash equivalents and short-term bank deposits, with a projected cash balance of approximately $50 million by early April 2026 [10] Business Line Data and Key Metrics Changes - Revenues from Chiesi are projected to be approximately $33 million-$35 million in 2026, representing growth of more than 50% [11] - Revenues from Elelyso are expected to be approximately $20 million-$23 million in 2026 [11] - Revenues from license and R&D services increased to $0.9 million, mainly related to agreements with Chiesi [8] Market Data and Key Metrics Changes - The Fabry market is projected to reach approximately $3.4 billion by 2030, with Elfabrio's differentiated profile enhancing its competitive positioning [5] - The approval of the every four weeks regimen in Europe is expected to significantly enhance Elfabrio's market uptake [5] Company Strategy and Development Direction - The company aims to advance its clinical pipeline, including PRX-115 and PRX-119, while maintaining a strong financial position to support these initiatives [12] - The company is focused on expanding its renal pipeline and expects to provide updates on specific indications and mechanisms of action in the coming months [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's financial flexibility and growth trajectory, projecting revenue growth in 2026 of greater than 50% [12] - The approval of the every four weeks regimen in Europe is seen as a significant competitive edge, with expectations for accelerated approval in the U.S. [17] Other Important Information - The company anticipates top-line results from the PRX-115 RELEASE study in the second half of 2027 [6] - The company is expanding its renal pipeline through collaborations and new candidates [7] Q&A Session Summary Question: Insights on marketing initiatives for Elfabrio in the U.S. and sales trajectory in Europe - Management highlighted ongoing promotional activities by Chiesi, including patient ambassador programs, and noted that the approval of the four-week regimen in Europe is expected to enhance market positioning [16] Question: Positioning of PRX-115 in the gout market - Management discussed the potential competitive advantages of PRX-115, including dosing frequency and safety, and projected a significant market opportunity for uncontrolled gout [18][20] Question: Target indications for PRX-119 and potential commercial opportunities - Management indicated that they are targeting high unmet need renal indications and will provide updates on specific mechanisms of action in the future [22][23] Question: Timeline for rollout of Elfabrio's four-week dosing in Europe - Management stated that availability will vary by country, with expectations for rollout starting in the second half of 2026 [27][30] Question: Physician education efforts accompanying the rollout - Management confirmed that Chiesi is actively engaging with treating physicians and stakeholders to promote the new regimen [31]

Financial Data and Key Metrics Changes - For the full year 2025, total revenues from selling goods were $51.8 million, a modest decrease compared to 2024, driven by changes in quantities sold to Chiesi's inventory and a change in average net selling price due to increased commercial patients in Europe [8] - The company recorded a net loss of $6.6 million in 2025 compared to a net income of $2.9 million in 2024, reflecting increased investment in the clinical pipeline [10] - As of December 31, 2025, the company held $30.3 million in cash equivalents and short-term bank deposits, with a projected cash balance of approximately $50 million by early April 2026 [10] Business Line Data and Key Metrics Changes - Revenues from Chiesi are projected to be approximately $33 million-$35 million in 2026, representing growth of more than 50% [10] - Revenues from Elelyso are expected to be approximately $20 million-$23 million in 2026 [10] - Revenues from license and R&D services increased to $0.9 million, mainly related to agreements with Chiesi [8] Market Data and Key Metrics Changes - The Fabry market is projected to reach approximately $3.4 billion by 2030, with Elfabrio's differentiated profile enhancing its competitive positioning [6] - The approval of the every four weeks dosing regimen in Europe is expected to significantly enhance Elfabrio's market position [5] Company Strategy and Development Direction - The company aims to execute its strategy comfortably, including clinical trials, supported by a strong cash position and projected revenue growth [4][12] - The company is advancing its pipeline with PRX-115 for uncontrolled gout and PRX-119 for renal conditions, targeting high unmet needs [6][7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term trajectory of the Fabry market and the potential for Elfabrio to capture a significant market share [5][12] - The company anticipates a productive 2026, driven by a growing number of patients on Elfabrio and a strong financial position [12] Other Important Information - The European Commission approved the 2 mg/kg every four weeks dosing regimen for Elfabrio, which is expected to enhance long-term management for patients with Fabry disease [3][4] - The company expects to continue increasing R&D investment as its clinical programs advance [9] Q&A Session Summary Question: Insights on marketing initiatives for Elfabrio in the U.S. and the impact of the new dosing regimen in Europe - Management highlighted that Chiesi is implementing various promotional activities to increase patient numbers and that the new dosing regimen provides a competitive edge [15][17] Question: Positioning of PRX-115 in the gout market - Management discussed the potential competitive advantages of PRX-115, including improved dosing frequency and safety, and projected a significant market opportunity for uncontrolled gout [18][22] Question: Target indications for PRX-119 and potential commercial opportunities - Management indicated that they are targeting high unmet need renal conditions and will provide updates on specific indications in the future [23][24] Question: Timeline for rollout of the four-week dosing regimen for Elfabrio in Europe - Management stated that the rollout will vary by country, with expectations for effects to start in the second half of 2026 [27][31]

Financial Data and Key Metrics Changes - For the full year 2025, total revenues from selling goods were $51.8 million, a modest decrease compared to 2024, driven by changes in quantities sold to Chiesi's inventory and a change in average net selling price due to increased commercial patients in Europe [8] - The company recorded a net loss of $6.6 million in 2025 compared to a net income of $2.9 million in 2024, reflecting increased investment in the clinical pipeline [10] - Cash equivalents and short-term bank deposits as of December 31, 2025, were $30.3 million, with a projected cash balance of approximately $50 million by early April 2026 due to a $25 million milestone payment [10] Business Line Data and Key Metrics Changes - Revenues from Chiesi are projected to be approximately $33 million-$35 million in 2026, representing growth of more than 50% [11] - Revenues from Elelyso are expected to be approximately $20 million-$23 million in 2026 [11] - Revenues from license and R&D services increased to $0.9 million, mainly related to agreements with Chiesi [8] Market Data and Key Metrics Changes - The Fabry market is projected to reach approximately $3.4 billion by 2030, with Elfabrio's differentiated profile enhancing its competitive positioning [5] - The company anticipates that the approval of the every four weeks regimen in Europe will significantly enhance Elfabrio's market uptake [5] Company Strategy and Development Direction - The company is focused on advancing its clinical pipeline, including PRX-115 for uncontrolled gout and PRX-119 for renal conditions, with expectations of significant market opportunities [5][6] - The company aims to solidify its revenue mix towards Chiesi, which represents the majority of long-term revenue opportunities [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in entering 2026 with strong business flexibility and a growing commercial foundation through partners [12] - The projected revenue growth in 2026 of greater than 50% is attributed to the increasing number of patients on Elfabrio [12] Other Important Information - The company is expanding its renal pipeline through collaborations and expects to provide updates on specific indications by the end of Q2 [24] - The approval of the every four weeks regimen in Europe is expected to enhance the competitive edge of Elfabrio [17] Q&A Session Summary Question: Insights on marketing initiatives for Elfabrio in the U.S. - Management noted that Chiesi is implementing various promotional activities, including patient ambassador programs, to increase market uptake [16] Question: Positioning of PRX-115 in the gout market - Management highlighted that PRX-115 could offer significant differentiation in dosing frequency and potential safety advantages, targeting a market expected to exceed $2 billion [20] Question: Timeline for rollout of Elfabrio's four-week dosing in Europe - Management indicated that availability will vary by country, with expectations for some markets to see rollout in the second half of 2026 [30]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K FOR ANNUAL AND TRANSITION REPORTS PURSUANT TO SECTIONS 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to 001-33357 (Commission file number) P ...

Revenue Performance - Revenues from selling goods for the fiscal year 2025 were $51.8 million, a decrease of 2% compared to $53.0 million in 2024, primarily due to a $6.8 million decline in sales to Chiesi[12]. - Total revenue for 2023 was $65.494 million, with a projected decrease to $53.399 million in 2024 and further to $52.744 million in 2025[27]. - Full-year 2026 revenues from sales of Elfabrio are expected to range from approximately $33.0 million to $35.0 million[10]. Financial Position - The company has a strong cash position with cash, cash equivalents, and short-term bank deposits totaling $30.3 million as of December 31, 2025[19]. - Cash and cash equivalents decreased from $19.760 million in 2024 to $14.680 million in 2025[26]. - Total current assets increased from $60.078 million in 2024 to $66.673 million in 2025[26]. - The company has no outstanding debt or warrants, positioning it for durable growth and long-term value[8]. Expenses and Losses - Research and development expenses increased by 51% to $19.6 million in 2025, driven by preparations for the RELEASE Phase 2 study of PRX-115[12]. - Research and development expenses are projected to rise from $12.970 million in 2024 to $19.569 million in 2025[27]. - The company reported a net loss of approximately $6.6 million for the year ended December 31, 2025, compared to a net income of $2.9 million in 2024[19]. - Operating income is expected to decline from $3.917 million in 2024 to a loss of $5.500 million in 2025[27]. - Net income for 2023 was $8.312 million, expected to decline to $2.932 million in 2024 and result in a loss of $6.604 million in 2025[27]. Clinical Development - The Phase 2 clinical trial of PRX-115 is actively enrolling, with top-line results anticipated in the second half of 2027[9]. - Management expects total revenues in 2026 to range from approximately $78.0 million to $83.0 million, including the $25.0 million milestone payment[10]. Strategic Focus - The company is focusing on rare renal diseases with PRX-119 and advancing its RNA-based discovery collaboration with Secarna[2]. - The European Commission approved the 2mg/kg every-4-weeks dosing regimen for Elfabrio, which triggered a $25.0 million milestone payment from Chiesi, strengthening the company's cash position[3]. Risks and Challenges - The company anticipates risks related to the commercialization of its product Elfabrio® and potential regulatory challenges[21]. - Total liabilities are expected to rise from $30.206 million in 2024 to $34.116 million in 2025[26]. - Accounts receivable increased significantly from $2.909 million in 2024 to $8.840 million in 2025[26].