Financial Data and Key Metrics Changes - For the first nine months of 2025, total revenues were $43.6 million, a 24% increase compared to the same period last year [4] - Total revenues for the third quarter were $17.9 million, reflecting a decrease of 1% compared to the same period in 2024 [4] - The net loss for the nine-month period ended September 30, 2025, was $1.1 million, or $0.01 per share, compared to a net loss of $3.6 million, or $0.05 per share for the same period in 2024 [17] - For the three months ended September 30, 2025, net income was approximately $2.4 million, or $0.03 per share, compared to net income of $3.2 million, or $0.04 per share for the same period in 2024 [18] Business Line Data and Key Metrics Changes - Total revenues from selling goods for the nine months ended September 30, 2025, were $43.1 million, an increase of $8.3 million, or 24%, compared to $34.8 million for the same period in 2024 [10] - Revenues consisted of $18.6 million in sales of Elefabrio to Chiesi, $15.4 million in sales of Elelyso to Pfizer, and $9.1 million in sales of Elelyso to Fiocruz in Brazil [10] - For the three months ended September 30, 2025, total revenues from selling goods were $17.7 million, a decrease of $0.1 million, or 1%, compared to $17.8 million for the same period in 2024 [10] Market Data and Key Metrics Changes - The company recognizes revenues from sales to partners, and individual purchases vary from quarter to quarter as each partner controls its own inventories [11] - The company anticipates a significant increase in the overall gout market in the next five to six years, particularly for uncontrolled gout patients requiring uricases [22] Company Strategy and Development Direction - The operating strategy focuses on three pillars: driving commercial success with Elefabrio, advancing PRX-115 and other early-stage pipeline programs, and maintaining financial discipline [7] - The company is preparing for the phase two clinical trial of PRX-115, which is viewed as a strategic investment in the pipeline and long-term growth [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in Elefabrio's long-term potential and is working closely with Chiesi to support the re-examination of the once-in-four-weeks dosing regimen [6] - The company believes that the achievements in 2025 position it for long-term growth and value creation [19] Other Important Information - Research and development expenses for the nine months ended September 30, 2025, totaled $13.9 million, an increase of 58% compared to the prior year period [13] - Selling general and administrative expenses for the nine months ended September 30, 2025, were $8.2 million, down 11% from the same period last year [14] - The company had $29.4 million in cash and cash equivalents at September 30, 2025, sufficient to satisfy capital needs for at least 12 months [18] Q&A Session Summary Question: Timeline for the re-examination of the CHMP opinion on Elefabrio - The company expects to have an answer in Q1 of 2026 regarding the re-examination request [22] Question: Comments on the competitive landscape in treatment refractory gout - The company foresees a significant increase in the overall gout market and believes that if the phase two trial is successful, it could capture a substantial market share [22] Question: Predictability of royalty-based revenue recognition related to Elefabrio sales - The company continues to recognize what it sells to Chiesi's inventory and is optimistic about future revenue [23][24] Question: Cash runway guidance - The cash runway guidance is based on both operating expenditures and continued receipt of royalty-based revenue on Elefabrio [25][26] Question: Anticipated R&D growth during the phase two of PRX-115 - The company is taking into account the expenses associated with the phase two trial and has sufficient cash for more than 12 months to fund this trial [45]

Product Development and Commercialization - The company has successfully developed two commercial products: Elfabrio® (pegunigalsidase alfa) for Fabry disease and Elelyso® (taliglucerase alfa) for Gaucher disease, with Elelyso approved in 23 markets and Elfabrio approved in multiple regions including the US and EU[74]. - The company submitted an Investigational New Drug (IND) application for PRX-115, which has become effective, and plans to initiate a phase 2 clinical trial in Q4 2025[70][79]. - The company has licensed the rights to commercialize Elelyso worldwide (excluding Brazil) to Pfizer and has partnered with Chiesi for the development and commercialization of Elfabrio[75][77]. - The company is developing additional products, including PRX-119 for NETs-related diseases, leveraging its ProCellEx technology for future innovations[79][84]. - The company is focused on expanding its product pipeline to address high unmet needs in rare and orphan diseases, including renal diseases[84]. - The company is currently recruiting for the Pediatric FLY Study to assess the safety and efficacy of pegunigalsidase alfa in patients aged 2 to less than 18 years with confirmed Fabry disease[136]. Clinical Trials and Efficacy - The BALANCE study for PRX-102 showed a favorable tolerability profile, with 90.4% of patients in the PRX-102 arm experiencing at least one treatment-emergent adverse event compared to 96.0% in the agalsidase beta arm[109]. - In the BALANCE study, the number of infusion-related reactions adjusted to 100 infusions was 0.5 for the PRX-102 arm versus 3.9 for the agalsidase beta arm, indicating a better safety profile for PRX-102[111]. - The phase 3 clinical program for PRX-102 included three studies, with the BALANCE study demonstrating comparability in treatment effects to agalsidase beta for primary efficacy renal endpoints[115]. - The FDA determined that substantial evidence of effectiveness for Elfabrio was established through a phase 1/2 clinical trial and the BALANCE study[98]. - The BRIDGE study showed a significant improvement in renal function, with the mean annualized eGFR slope improving from -5.90 mL/min/1.73m²/year on agalsidase alfa to -1.19 mL/min/1.73m²/year on PRX-102[118]. - In the BRIDGE study, male patients' eGFR improved from -6.36 mL/min/1.73m²/year to -1.73 mL/min/1.73m²/year, while female patients improved from -5.03 mL/min/1.73m²/year to -0.21 mL/min/1.73m²/year[118]. - The overall mean eGFR slope at the end of the BRIGHT study was -2.92 mL/min/1.73m²/year, indicating stability in renal function[125]. - Following the transition to PRX-102, none of the patients without ADAs at screening developed treatment-induced ADAs[122]. Financial Performance - Revenues from selling goods for the three months ended September 30, 2025, were $17.7 million, a decrease of 1% from $17.8 million in the same period in 2024, primarily due to a $3.6 million decrease in sales to Chiesi[174]. - Research and development expenses for the three months ended September 30, 2025, were approximately $4.5 million, an increase from approximately $3.0 million in the same period in 2024[177]. - Revenues from selling goods reached $43.1 million for the nine months ended September 30, 2025, an increase of $8.3 million, or 24%, compared to $34.8 million for the same period in 2024[183]. - 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[180]. - The company had $29.4 million in cash and cash equivalents and short-term bank deposits as of September 30, 2025[192]. - Net cash used in operations was $14.0 million for the nine months ended September 30, 2025, with a net loss of $1.1 million[195]. - The company sold 2,775,215 shares of Common Stock under the Sales Agreement, generating gross proceeds of approximately $7.0 million during the nine-month period ended September 30, 2025[193]. Market Insights - The global market for Gaucher disease treatments is projected to be $1.7 billion in 2025, with a CAGR of approximately -1.82% from 2024 to 2030[96]. - The global market for Fabry disease treatments is forecasted to reach approximately $2.2 billion in 2025, growing at a CAGR of 8.19% from 2024 to 2030, potentially reaching $3.4 billion by 2030[102]. - The prevalence of Gaucher disease ranges from 0.70 to 1.75 per 100,000 in the general population, with higher estimates in individuals of Ashkenazi Jewish heritage[95]. - Market research indicates that approximately 25% of the gout population in the US and Western Europe do not have their condition controlled[163]. Research and Development - The company utilizes its proprietary ProCellEx® platform for the production of recombinant therapeutic proteins, being the first to gain FDA approval for a protein produced through plant cell-based expression[72][85]. - The company is committed to enhancing its ProCellEx technology to improve the development and manufacturing of therapeutic proteins[92]. - The company expects to continue incurring significant research and development expenses as it advances its product candidates[188]. - Total research and development expenses for the nine months ended September 30, 2025, were approximately $13.9 million, an increase of $5.1 million, or 58%, compared to $8.8 million for the same period in 2024[186][187]. - The phase 1 clinical trial of PRX-115 demonstrated that 25% of subjects reported drug-related adverse events, with the majority being mild to moderate[159]. - PRX-115 showed a dose-dependent reduction in plasma urate levels, remaining below 6.0 mg/dL for up to 12 weeks at the highest doses[154]. Partnerships and Agreements - The company has received $50 million in upfront payments and $45 million in development cost reimbursements from Chiesi, with potential milestone payments exceeding $1 billion[141]. - Under the Chiesi Ex-US Agreement, the company granted an exclusive license for PRX-102 commercialization outside the U.S., with an upfront payment of $25 million[142]. - The Fill/Finish Agreement with Chiesi includes a 10-year initial term for commercial fill/finish services for PRX-102, with potential extension options[146]. - Protalix Ltd. received an upfront payment of $25.0 million from Chiesi for the exclusive license to develop PRX-102, with potential additional payments of up to $760.0 million in milestone payments[144].

Revenue Performance - Total revenues for the first nine months of 2025 were $43.6 million, an increase of 24% compared to the same period in 2024[2] - Revenues for the third quarter of 2025 were $17.9 million, reflecting a decrease of 1% compared to the same period in 2024[2] - Year-to-date revenues from selling goods for the nine months ended September 30, 2025, were $43.1 million, an increase of 24% from $34.8 million in the same period of 2024[5] - Total revenue for the nine months ended September 30, 2025, was $43.622 million, a 24.4% increase from $35.181 million for the same period in 2024[20] - The company reported revenues from selling goods of $43.108 million for the nine months ended September 30, 2025, compared to $34.820 million for the same period in 2024, a 23.3% increase[20] Research and Development Expenses - Total research and development expenses for Q3 2025 were approximately $4.5 million, a 50% increase compared to approximately $3.0 million in Q3 2024[3] - Total research and development expenses for the nine months ended September 30, 2025, were approximately $13.9 million, a 58% increase from approximately $8.8 million in the same period of 2024[5] - Research and development expenses for the nine months ended September 30, 2025, were $13.934 million, up from $8.846 million for the same period in 2024, reflecting increased investment in R&D[20] Net Income and Loss - Net income for Q3 2025 was approximately $2.4 million, or $0.03 per share, compared to $3.2 million, or $0.04 per share, for the same period in 2024[4] - Net loss for the nine months ended September 30, 2025, was $1.1 million, compared to a net loss of $3.562 million for the same period in 2024, indicating an improvement[20] - Earnings per share for the nine months ended September 30, 2025, were $(0.01) for basic and diluted shares, an improvement from $(0.05) for the same period in 2024[20] Cash and Current Assets - Cash and cash equivalents as of September 30, 2025, were $29.4 million, sufficient to meet capital needs for at least 12 months[7] - Cash and cash equivalents decreased to $13.647 million as of September 30, 2025, down from $19.760 million as of December 31, 2024[18] - Total current assets increased to $66.502 million as of September 30, 2025, compared to $60.078 million as of December 31, 2024[18] Operating Performance - Operating income for the three months ended September 30, 2025, was $2.131 million, compared to an operating loss of $3.292 million for the same period in 2024[20] Future Plans and Risks - The company plans to initiate a phase 2 clinical trial of PRX-115 later in 2025, following the effective IND submission to the FDA[2] - The company expects minimal revenues from license and R&D services now that clinical development of Elfabrio has been completed[3] - The company is facing risks related to clinical trial approvals and potential delays from regulatory authorities, which may impact future product candidates[15]

Core Insights - Protalix BioTherapeutics reported total revenues of $43.6 million for the first nine months of 2025, a 24% increase compared to the same period in 2024, while third-quarter revenues were $17.9 million, reflecting a 1% decrease year-over-year [2][13] - The company is advancing its recombinant PEGylated uricase candidate, PRX-115, for uncontrolled gout, with plans to initiate a phase 2 clinical trial later this year based on promising phase 1 data [2][5] - Protalix's financial results indicate a net income of approximately $2.4 million for the third quarter of 2025, down from $3.2 million in the same quarter of 2024 [6] Financial Highlights - Total revenues for the nine months ended September 30, 2025, were $43.1 million, up from $34.8 million in 2024, with significant contributions from sales of Elfabrio, Elelyso, and alfataliglicerase [13] - Cost of goods sold increased by 10% to $22.4 million for the nine months ended September 30, 2025, primarily due to increased sales to Chiesi and Pfizer [13] - Research and development expenses rose by 58% to approximately $13.9 million for the nine months ended September 30, 2025, driven by preparations for the phase 2 clinical trial of PRX-115 [13][18] Operational Updates - The company submitted an Investigational New Drug (IND) application to the FDA for PRX-115, which became effective after the standard 30-day review period [5] - Protalix is collaborating with Chiesi Global Rare Diseases to address a negative opinion from the EMA regarding Elfabrio's dosing regimen, while the currently approved regimen remains unaffected [5] - As of September 30, 2025, Protalix had $29.4 million in cash and cash equivalents, sufficient to meet capital needs for at least the next 12 months [8]

Core Viewpoint - The Brazilian government's recent changes to the Workers' Food Program (PAT) could jeopardize its long-term sustainability and may lead to increased risks of misuse and non-compliance [2][4]. Group 1: Government Measures - The new measures regarding the merchant discount rate (MDR), reimbursement deadlines, and voucher processing are set to take effect in 90 days [2]. - These measures diverge significantly from prior discussions between the industry association (ABBT) and the government [2]. Group 2: Company Concerns - The changes interfere with private commercial relations and limit issuers' ability to innovate and compete [4]. - The company is considering legal action against the implementation of these measures, both independently and in collaboration with ABBT [4]. Group 3: Historical Context - Since the creation of the PAT over 40 years ago, the company has played a significant role in its expansion by providing innovative solutions and value to various stakeholders [3]. Group 4: Future Actions - Following the publication of the decree, the company will conduct a thorough assessment of the potential financial implications and develop a mitigation plan [4].

Core Insights - Pluxee N.V. disclosed transactions on treasury shares for the period from October 31 to November 7, 2025, indicating ongoing share buyback activities [1][3]. Summary by Category Treasury Share Transactions - On October 31, 2025, Pluxee acquired a total of 43,069 shares across three transactions at weighted average prices of €17.3161, €17.1802, and €17.2366 on different platforms [3]. - On November 3, 2025, the company purchased 35,800 shares at a weighted average price of €17.2350 and €17.1985 [3]. - On November 4, 2025, a total of 40,768 shares were acquired at weighted average prices of €16.6720 and €16.5760 [3]. - On November 5, 2025, Pluxee bought 41,092 shares at prices ranging from €16.5397 to €16.5799 [3]. - On November 6, 2025, the company acquired 46,936 shares at prices between €16.2583 and €16.1604 [3]. - On November 7, 2025, a total of 44,405 shares were purchased at weighted average prices of €15.3456, €15.2952, and €15.2900 [3]. Company Overview - Pluxee operates in the Employee Benefits and Engagement sector, providing solutions in Meal & Food, Well-being, Lifestyle, Reward & Recognition, and Public Benefits across 28 countries [4]. - The company has over 5,600 employees and serves more than 500,000 clients, impacting over 37 million consumers and 1.7 million merchants [4]. - With over 45 years of experience, Pluxee is committed to enhancing employee well-being and supporting local communities [4].

Core Points - Pluxee has announced its Fiscal 2025 Annual General Meeting of shareholders scheduled for December 17, 2025, at 2:00 pm CET in Amsterdam-Schiphol, Netherlands [1] - All relevant documents for the Annual General Meeting, including the agenda and voting instructions, are available on the Pluxee Group website [2] - Pluxee operates in 28 countries, providing a range of Employee Benefits and Engagement solutions, and has over 500,000 clients and 37 million consumers [3] Company Overview - Pluxee is a global player in Employee Benefits and Engagement, focusing on attracting, engaging, and retaining talent through various solutions [3] - The company has been in operation for more than 45 years and employs over 5,600 team members [3] - Pluxee is committed to creating a positive impact on local communities and supporting employee well-being while also focusing on environmental protection [3]

Group 1 - Proactive provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team covers medium and small-cap markets, as well as blue-chip companies, commodities, and broader investment stories [3] - Proactive's content includes insights across various sectors such as biotech, pharma, mining, natural resources, battery metals, oil and gas, crypto, and emerging technologies [3] Group 2 - Proactive is committed to adopting technology to enhance workflows and improve content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Core Viewpoint - Chiesi Global Rare Diseases and Protalix BioTherapeutics have requested a re-examination of the negative opinion from the CHMP regarding the proposed dosing regimen for Elfabrio® (pegunigalsidase alfa) [1][2] Company Overview - Chiesi Global Rare Diseases is a business unit of the Chiesi Group, focused on delivering innovative therapies for rare diseases [16] - Protalix BioTherapeutics specializes in developing recombinant therapeutic proteins using its proprietary plant cell-based expression system, ProCellEx [18] Product Information - Elfabrio® is indicated for the treatment of adults with confirmed Fabry disease [3] - The current approved dosing regimen is 1 mg/kg every 2 weeks, while a new regimen of 2 mg/kg every 4 weeks is under review [2] Clinical Trial Insights - In clinical trials, 14% of patients treated with Elfabrio experienced hypersensitivity reactions, with 3% experiencing anaphylaxis [6] - Infusion-associated reactions were reported in 29% of patients, including symptoms such as nausea, chills, and rash [7][9] Regulatory Context - The existing marketing authorization for Elfabrio remains effective while the re-examination process is ongoing [2] - The outcome of the re-examination will influence the final decision by the European Commission [2] Disease Background - Fabry disease is a rare inherited lysosomal storage disorder caused by mutations in the GLA gene, leading to enzyme deficiency and accumulation of globotriaosylceramide (GL-3) [11][12] - Symptoms include fatigue, chronic pain, and increased risk of serious complications such as kidney failure and stroke [11][12]

Core Viewpoint - Protalix BioTherapeutics, Inc. is currently under investigation for potential fraud, providing an opportunity for investors to join the investigation led by the Schall Law Firm [1] Group 1 - The investigation pertains to allegations of fraud involving Protalix BioTherapeutics, which may impact the company's financial standing and investor confidence [1] - Investors are encouraged to participate in the investigation to explore their legal options regarding potential losses incurred [1]