Core Viewpoint - Protalix BioTherapeutics reported strong financial results for Q1 2025, with significant revenue growth driven by increased sales, and is advancing its clinical pipeline, particularly focusing on the gout treatment candidate PRX-115 [2][7][14]. Financial Highlights - Revenues from selling goods reached $10.0 million for the three months ended March 31, 2025, an increase of $6.3 million, or 170%, compared to $3.7 million for the same period in 2024 [7]. - Revenues from license and R&D services were $0.1 million for both Q1 2025 and Q1 2024, primarily from agreements with Chiesi [7]. - Cost of goods sold was $8.2 million for Q1 2025, up $5.6 million, or 215%, from $2.6 million in Q1 2024 [7]. - Total research and development expenses were approximately $3.5 million for Q1 2025, a 21% increase from $2.9 million in Q1 2024 [8][13]. - The net loss for Q1 2025 was approximately $3.6 million, or $0.05 per share, compared to a net loss of $4.6 million, or $0.06 per share, for the same period in 2024 [13][20]. Clinical and Pipeline Developments - Protalix is preparing to initiate a phase II clinical trial for PRX-115, a treatment for uncontrolled gout, later in 2025, following promising results from a phase I trial completed in 2024 [2][6]. - The preliminary results of the phase I trial indicated that PRX-115 has the potential for effective uric acid-lowering treatment with a wide dosing interval [6]. - The company is also evaluating additional pipeline candidates, including PRX-119 and various early-stage clinical assets [2]. Partnerships and Collaborations - Protalix has partnered with Chiesi Global Rare Diseases for the global development and commercialization of its products, including Elfabrio® [4][15]. - The company has licensed worldwide development and commercialization rights for taliglucerase alfa to Pfizer Inc. for the treatment of Gaucher disease [14]. Market Presence - Protalix is recognized for its proprietary ProCellEx® plant cell-based protein expression system, which is a novel method for developing recombinant proteins at an industrial scale [14]. - The company has achieved FDA approval for its products, marking significant milestones in its commercialization efforts [14].

Core Insights - Pluxee reported solid financial performance in the first half of Fiscal 2025, achieving a total revenue of €635 million, representing a 10.8% organic growth and a 7.2% reported growth year-on-year [2][12] - The company has upgraded its Fiscal 2025 Recurring EBITDA margin objective to +150 basis points, reflecting strong execution and performance in the first semester [4][48] - The Group's strategic growth plan is on track, with significant progress in key initiatives, including M&A activities that have positively contributed to its market position [4][5] Financial Performance - Total Revenues reached €635 million in H1 Fiscal 2025, with organic growth of +10.8% and reported growth of +7.2% [2][12] - Recurring EBITDA was €225 million, up +22.5% organically, with a Recurring EBITDA margin of 35.4%, expanding by +151 basis points on a reported basis [2][22] - Net Profit attributable to the Group increased by +47.3% to €97 million, with Adjusted Net Profit at €107 million, reflecting a +10.5% year-on-year growth [27][32] Revenue Breakdown - Operating revenue amounted to €552 million, growing +10.1% organically, while Float revenue reached €83 million, up +16.2% organically [13][14] - Employee Benefits generated €464 million in Operating revenue, reflecting an organic growth of +11.8% [17] - Other Products and Services saw a return to growth with €88 million in Operating revenue, driven by trends in Reward & Recognition solutions [18] Regional Performance - Continental Europe reported Operating revenue of €248 million, growing +5.0% organically, while Latin America achieved €204 million, with a +12.3% organic growth [19][20] - The Rest of the World segment showed strong performance with €99 million in Operating revenue, reflecting +18.5% organic growth [21] Cash Flow and Financial Position - Recurring free cash flow stood at €171 million, with a Recurring cash conversion rate of 76% [33][36] - The net financial cash position was €1,045 million as of February 28, 2025, reflecting a strong cash generation capability [37][39] Strategic Initiatives - The acquisition of Cobee has strengthened Pluxee's position in the Spanish employee benefit market, enhancing its technology capabilities [46] - The Group also completed the acquisition of Benefício Fácil in Brazil, expanding its mobility benefit offerings [49][50] Sustainability and Recognition - Pluxee received multiple awards for its commitment to sustainability and was recognized for its strong employee engagement practices [41][44] - The company achieved a 'B' score from the Carbon Disclosure Project for its climate management efforts [42]

Protalix BioTherapeutics ( PLX ) is a biotechnology company with two marketed therapies: Elelyso, for Gaucher disease, and Elfabrio for Fabry Disease. As well, the company is actively developing a clinical pipeline that, in our view, may open upAnalyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, but may initiate a beneficial Long position through a purchase of the stock, or the purchase of call options or similar derivatives in PLX over the next ...

CARMIEL, Israel, March 24, 2025 /PRNewswire/ -- Protalix BioTherapeutics, Inc. (NYSE American: PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell–based protein expression system, today announced that its management will be participating in the iAccess Alpha Virtual Best Ideas Spring Investment Conference 2025, to be held virtually March 25-26, 2025. iAccess Alpha hosts virtual in ...

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 has a strong focus on technology adoption to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

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 has a strong focus on technology adoption to enhance workflows and content production [4] - The company utilizes automation and software tools, including generative AI, while ensuring all content is edited and authored by humans [5]

Financial Performance - Protalix BioTherapeutics reported fiscal 2024 earnings of 4 cents, exceeding the consensus estimate of 1 cent [1] - The company recorded sales of $53.40 million for 2024, representing a 31% year-over-year increase, although slightly below the consensus of $53.94 million [1] - The sales increase was primarily driven by an $11.8 million rise in sales to Chiesi, a $0.6 million increase in sales to Brazil, and a $0.1 million increase in sales to Pfizer [1] Product Development and Pipeline - Protalix focuses on developing recombinant therapeutic proteins using its ProCellEx plant cell-based expression system, being the first to gain FDA approval for such a product [2] - The company has licensed worldwide rights for taliglucerase alfa to Pfizer for Gaucher disease treatment, while retaining full rights in Brazil [3] - Protalix's second product, Elfabrio, received FDA and European Medicines Agency approval in May 2023 [3] - The company is optimistic about its gout candidate, PRX-115, and plans to initiate a phase II clinical trial in the second half of 2025 [5] Financial Health and Strategy - Protalix repaid its 7.50% Senior Secured Convertible Promissory Notes in September 2024, fully financed with available cash [5] - The repayment of debt and absence of outstanding warrants have strengthened the company's balance sheet, positioning it well for future strategies through 2025 and beyond [6] Regulatory Developments - In December, Protalix and Chiesi announced that the European Medicines Agency validated a submission for a less frequent dosing regimen of pegunigalsidase alfa for Fabry disease [7] Stock Performance - Following the earnings report, PLX stock increased by 17.4%, reaching $2.630 [7]

Financial Data and Key Metrics Changes - Protalix recorded revenues from selling goods of $53 million for the year ended December 31, 2024, an increase of $12.6 million or 31% compared to $40.4 million for the year ended December 31, 2023 [18] - Revenues from license and R&D services decreased to $0.4 million for the year ended December 31, 2024, a decrease of $24.7 million or 98% compared to $25.1 million for the year ended December 31, 2023 [18] - Net income for the year ended December 31, 2024, was approximately $2.9 million or $0.04 per share, compared to $8.3 million or $0.12 per share for the same period in 2023 [24] Business Line Data and Key Metrics Changes - The increase in revenues from selling goods was primarily due to an increase of $11.8 million in sales to Chiesi, $0.6 million in sales to Brazil, and $0.1 million in sales to Pfizer [18] - Cost of goods sold was $24.3 million for the year ended December 31, 2024, an increase of $1.3 million or 6% compared to $23 million for the year ended December 31, 2023 [20] - Total research and development expenses decreased to approximately $13 million for the year ended December 31, 2024, a decrease of $4.1 million or 24% compared to $17.1 million for the year ended December 31, 2023 [21] Market Data and Key Metrics Changes - The company expects minimal revenues from license and R&D services going forward, primarily due to the completion of the Fabry clinical program and the regulatory process related to Elfabrio [19] - The company reported cash, cash equivalents, and short-term bank deposits of approximately $34.8 million at December 31, 2024 [24] Company Strategy and Development Direction - Protalix is focusing on R&D efforts on early-stage candidates such as PRX-115 and PRX-119, with plans to initiate a Phase 2 clinical trial for PRX-115 in the second half of 2025 [7][14] - The company aims to leverage its ProCellEx platform and pegylation capabilities to expand its product development pipeline, particularly in renal rare diseases [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strategy and balance sheet, indicating that the three streams of revenues will support the next phase of pipeline development [26] - The management highlighted a positive outlook for the collaboration with Chiesi, expecting a steady stream of higher-margin revenues from Elfabrio in the coming years [34][37] Other Important Information - The company fully repaid all outstanding principal and interest under its 7.5% senior secured convertible promissory notes in September 2024, strengthening its balance sheet [15] - Protalix issued 908,000 shares of common stock in connection with the exercise of warrants, generating proceeds of approximately $2.1 million [15] Q&A Session Summary Question: Long-term revenue guidance based on Elfabrio royalties - Management indicated that they cannot provide specific revenue guidance for 2025 due to the nature of sales to Chiesi, a private company, but they expect a growing revenue stream from this collaboration [34][37] Question: Differences between PRX-119 and historical program PRX-110 - PRX-119 is a long-acting DNase, while PRX-110 was an acute treatment. The company is finalizing indication selection and will provide updates on market size in the coming quarters [40] Question: Cost and timeline for Phase 2 study of PRX-115 - The estimated cost for the Phase 2 study is expected to be north of $20 million, with top-line results anticipated in approximately two years, depending on patient enrollment [42]

Product Development and Commercialization - The company has successfully developed two commercial products: Elfabrio® for Fabry disease and Elelyso® for Gaucher disease, with Elfabrio generating $29.3 million in sales in 2024[42]. - Elelyso is approved in 23 markets globally, with $12.6 million generated from sales to Pfizer and $11.0 million from sales in Brazil in 2024[41]. - The FDA approved Elfabrio on May 9, 2023, for adult patients with Fabry disease, covering a dosage of 1 mg/kg every two weeks[22]. - The company has licensed Elelyso's commercialization rights worldwide to Pfizer, excluding Brazil, where it is marketed as BioManguinhos alfataliglicerase[18]. - The company’s first commercial product, Elelyso, is now approved in 23 markets including the United States, Brazil, and Israel[51]. - The company’s second commercial product, Elfabrio, was approved for marketing in the EU and the United States in May 2023 for adult patients with Fabry disease[55]. Clinical Trials and Research - The company is developing PRX-115, a PEGylated uricase for uncontrolled gout, with an estimated 25% of the gout population in the US and Western Europe not having their condition controlled[44]. - PRX-119, a PEGylated recombinant human DNase I, is being designed for the treatment of NETs-related diseases, targeting the excessive formation of neutrophil extracellular traps[45]. - In May 2024, the company announced the expansion of its phase I First-in-Human clinical trial of PRX-115 by adding an eighth cohort with eight new patients and preparations for a phase II clinical trial[46]. - The phase I clinical trial of PRX-115 for uncontrolled gout included 64 randomized subjects, with 48 receiving PRX-115 and 16 receiving placebo[108]. - The company is conducting a clinical trial in Japan to evaluate the safety and efficacy of PRX-102 in Fabry disease patients, aiming to enroll approximately 18-20 patients[103]. - The BALANCE study demonstrated a favorable tolerability profile for PRX-102, with 90.4% of patients in the PRX-102 arm experiencing at least one treatment-emergent adverse event (TEAE) compared to 96.0% in the agalsidase beta arm[71]. - The BRIDGE study reported that 20 out of 22 patients completed the 12-month treatment duration, demonstrating high treatment adherence[80]. - The BRIGHT study reported that 75% of participants experienced improvement or no change in average pain severity at Week 52[92]. Financial Performance and Market Analysis - The global market for Gaucher disease was $1.7 billion in 2024 and is forecasted to grow at a compound annual growth rate (CAGR) of approximately -0.46% from 2024-2030[53]. - The global market for Fabry disease is forecasted to be approximately $2.3 billion in 2025, growing at a CAGR of 6.6% from 2024-2030, reaching approximately $3.1 billion in annual sales by 2030[61]. - In September 2024, the company fully repaid all outstanding principal and interest under its 2024 Notes, financed entirely with available cash[49]. Regulatory and Compliance - The Biologics License Application for Elfabrio was resubmitted to the FDA on November 9, 2022, after an initial Complete Response Letter[21]. - The FDA requires substantial time and financial resources for regulatory approvals, with potential sanctions for non-compliance, including product recalls and clinical holds[160]. - The IND application must include preclinical test results, manufacturing information, and analytical data, becoming effective 30 days after submission unless placed on clinical hold by the FDA[161]. - The FDA review process for a BLA or NDA typically takes one to three years, with potential delays if additional data is required[172]. - The FDA may withdraw product approval if regulatory compliance is not maintained or if new problems arise post-approval[188]. Intellectual Property and Licensing - The company holds a robust patent portfolio of approximately 75 patents globally, with about 50 pending applications[125]. - New patents have been granted in the U.S., Australia, Chile, and Mexico for the treatment of Fabry disease using stabilized alpha-galactosidase[128]. - Protalix Ltd. has entered into two exclusive global licensing agreements with Chiesi for PRX-102, receiving $50 million in upfront payments and development cost reimbursements of $45 million, with potential milestone payments exceeding $1 billion[146]. - Under the Chiesi US Agreement, Protalix Ltd. is eligible for up to $760 million in regulatory and commercial milestone payments, with tiered payments of 15% to 40% of net sales depending on annual sales[148]. Manufacturing and Supply Chain - The manufacturing facility in Carmiel, Israel, has approximately 14,700 sq/ft of clean rooms and has been approved by the FDA as a multi-product facility since 2017, capable of meeting all current and expected commercial and clinical needs[152][153]. - Protalix Ltd. relies on a single approved supplier for certain materials but has identified additional suppliers for most raw materials required for production[155]. - The company is committed to identifying alternative approved suppliers to ensure an uninterrupted supply of necessary raw materials for drug development[156]. Taxation and Financial Incentives - The corporate tax rate in Israel is 23% for income not derived from "Approved Enterprises" as of 2018[205]. - Under the Investment Law, an Approved Enterprise may be exempt from corporate tax for a period of 2 to 10 years depending on its geographic location[209]. - The company has an Approved Enterprise program, allowing for tax benefits for a 10-year period if it qualifies as a foreign investors' company[210]. - A foreign investors' company with over 25% foreign ownership can benefit from a reduced corporate tax rate ranging from 10% to 23%[211].

Revenue Performance - Protalix recorded revenues from selling goods of $53.0 million for the year ended December 31, 2024, an increase of $12.6 million, or 31%, compared to $40.4 million in 2023[8] - Revenues from license and R&D services decreased by $24.7 million, or 98%, to $0.4 million in 2024, primarily due to the absence of a $20.0 million regulatory milestone payment received in 2023[8] - Total revenue increased to $65.494 million in 2023, up 37.4% from $47.638 million in 2022[22] - Revenues from selling goods reached $40.418 million in 2023, a 59.9% increase compared to $25.292 million in 2022[22] - The company anticipates total revenue of $53.399 million for 2024, reflecting a decrease from 2023[22] Expenses - Total research and development expenses decreased by $4.1 million, or 24%, to approximately $13.0 million in 2024, attributed to the completion of the Fabry clinical program[9] - Selling, general and administrative expenses were $12.2 million in 2024, a decrease of $2.8 million, or 19%, from $15.0 million in 2023[9] - Research and development expenses decreased to $17.093 million in 2023 from $29.349 million in 2022[22] Net Income - Protalix's net income for the year ended December 31, 2024, was approximately $2.9 million, or $0.04 per share, compared to $8.3 million, or $0.12 per share, in 2023[14] - Net income for 2023 was $8.312 million, a significant turnaround from a net loss of $14.927 million in 2022[22] Clinical Trials and Developments - The company successfully completed the First-in-Human phase I clinical trial of PRX-115, demonstrating its potential as an effective uric acid-lowering treatment[3] - Protalix plans to initiate a phase II clinical trial for PRX-115 in patients with gout during the second half of 2025[2] - The European Medicines Agency validated the Variation Submission for pegunigalsidase alfa to label a less frequent dosing regimen of 2 mg/kg every four weeks for Fabry disease[5] Financial Position - Cash, cash equivalents, and short-term bank deposits were approximately $34.8 million at December 31, 2024[14] - The company repaid all outstanding principal and interest under its 7.50% Senior Secured Convertible Promissory Notes in September 2024, strengthening its balance sheet[8] - Cash and cash equivalents decreased to $19.760 million in 2024 from $23.634 million in 2023[21] - Total current assets decreased to $60.078 million in 2024 from $69.932 million in 2023[21] - Total liabilities decreased to $30.206 million in 2024 from $50.865 million in 2023[21]