Core Insights - Pluxee demonstrated strong performance in Fiscal 2025, achieving sustained growth, significant margin expansion, and record cash generation, setting a solid foundation for Fiscal 2026 [1][6][7] Financial Performance - Total Revenues reached €1,287 million, reflecting a 10.6% organic growth and a 6.4% reported growth compared to Fiscal 2024 [2][14] - Recurring EBITDA increased to €471 million, marking a 22.2% organic growth and a 9.4% reported growth, with a recurring EBITDA margin of 36.6%, up 230 basis points organically [2][24][25] - Operating profit (EBIT) grew by 34.3% to €335 million, while net profit for the year attributable to the Group increased by 48.6% to €197 million [2][29][32] - Adjusted net profit attributable to the Group reached €221 million, an 8.4% increase year-on-year, with adjusted earnings per share of €1.52, up 9.1% [2][34][35] Cash Flow and Financial Position - Recurring free cash flow generation was €417 million, up 10.0%, resulting in a recurring cash conversion rate of 89%, exceeding the 75% target [2][36][41] - The net financial cash position improved to €1,163 million, an increase of €108 million year-on-year, supported by strong cash flow generation [2][42] Business Segments and Growth Drivers - Employee Benefits business volumes issued reached €18.7 billion, reflecting a 7.6% organic growth, with a net retention rate maintained at 100% [11][12] - Other Products & Services business volumes remained stable at €5.8 billion, impacted by the discontinuation of large Public Benefits programs [13][19] - The Group's strategic acquisitions, including Cobee and Benefício Fácil, contributed to growth and market position enhancement [46][47][49] Shareholder Returns and Future Outlook - A dividend of €0.38 per ordinary share was proposed, representing a 9% increase year-on-year, alongside a €100 million share buyback program [52][54] - For Fiscal 2026, Pluxee aims for high single-digit organic growth in Total Revenues, a 100 basis points increase in Recurring EBITDA margin, and an average recurring cash conversion above 80% [6][60]

Core Opinion - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion regarding the revised dosing schedule for Elfabrio, a treatment for Fabry disease, proposed by Protalix BioTherapeutics and Chiesi Group [1][2]. Company Overview - Protalix BioTherapeutics and Chiesi Group are facing selling pressure following the CHMP's decision [2][5]. - The companies had requested approval for a new dosing regimen of 2 mg/kg body weight infused every 4 weeks, in addition to the currently approved regimen of 1 mg/kg body weight infused every 2 weeks [2]. Clinical Data - The CHMP review was based on data from the BRIGHT trial and an ongoing open-label extension study, which collectively provided a median exposure of almost six years [3][4]. - The data from these studies, along with modeling and exposure-response analyses from prior trials, were deemed insufficient to demonstrate similar efficacy for the new dosing schedule [4]. Market Impact - Following the negative opinion, Protalix BioTherapeutics' stock price decreased by 29.83%, closing at $1.68 [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 is committed to adopting technology 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]

Core Insights - Chiesi Global Rare Diseases and Protalix BioTherapeutics received a negative opinion from the CHMP of the EMA regarding the approval of a new dosing regimen for Elfabrio (pegunigalsidase alfa) [1][2] - The proposed regimen of 2 mg/kg every 4 weeks was not deemed to have sufficient efficacy compared to the currently approved regimen of 1 mg/kg every 2 weeks [1][2] Company Overview - Chiesi Global Rare Diseases is a unit of the Chiesi Group focused on innovative therapies for rare diseases [1][16] - Protalix BioTherapeutics specializes in developing recombinant therapeutic proteins using its proprietary ProCellEx® plant cell-based expression system [1][19] - Both companies are committed to reducing the treatment burden for patients with Fabry disease [2][20] Clinical Trial Insights - The CHMP review was based on data from the BRIGHT trial and its extension study, which had a median exposure of almost six years [2] - The data from these studies, along with modeling and exposure-response analyses from prior trials, were insufficient to demonstrate similar efficacy for the new dosing regimen [2] Fabry Disease Context - Fabry disease is a rare lysosomal storage disorder caused by mutations in the GLA gene, leading to serious health complications [11][12] - Early detection and access to treatment are critical for managing symptoms and slowing disease progression [12] Safety Information - Elfabrio is indicated for adults with confirmed Fabry disease and has been associated with hypersensitivity reactions, including anaphylaxis [3][4] - In clinical trials, 14% of patients experienced hypersensitivity reactions, with 3% experiencing anaphylaxis [6][9]

Company Overview - Protalix BioTherapeutics, Inc. is a New Jersey-based biopharmaceutical company specializing in recombinant therapeutic proteins [4] - The company develops innovative plant-based biologics, including products like Elelyso, Elfabrio, PRX-115, and PRX-119 [4] Investment Activity - Goldman Sachs Group Inc. increased its holdings in Protalix BioTherapeutics by 482.3% during the first quarter, acquiring 239,751 shares, bringing its total ownership to 289,461 shares valued at approximately $741,000 [1] Product Development - Protalix is expanding its ProCellEx platform into drug delivery optimization, targeting specific tissue requirements, which is considered a "game-changer" for the company [3] - The ProCellEx platform is noted for its cost efficiency and ability to express complex protein capabilities, positioning it as a leader in future biopharmaceutical developments [3] Market Position - The company is recognized as a hidden penny stock with potential for growth, likened to planting a tree that requires time and patience to flourish [2]

Summary of Protalix BioTherapeutics Conference Call Company Overview - Protalix BioTherapeutics is a publicly traded company listed on NYSE American, with a unique technology for expressing complex human proteins through plant cells rather than mammalian cells [4][3] - The company has been operational for approximately 30 years [4] Core Products - Protalix has two FDA-approved drugs: - **El Eliza** for the treatment of Gaucher disease, licensed to Pfizer [8][10] - **El Fabrio** for the treatment of Fabry disease, licensed to Kiesi [8][18] - Both drugs are sold through partnerships, with annual sales to Pfizer and Brazil estimated at $22 to $24 million [13][12] Financial Performance - The manufacturing agreement with Pfizer for El Eliza expires in October 2030, with hopes to renegotiate for potential return of the drug [15] - The market for El Fabrio is expected to grow from $2.2 billion last year to $3.2 billion by the end of the decade, with Protalix potentially earning $100 to $120 million in royalties from Kiesi [17][20] - Protalix is currently well-capitalized with approximately $34 million in cash and zero debt [46] Pipeline and Future Prospects - The most advanced pipeline asset is **PRX-115**, targeting uncontrolled severe gout, with a significant patient population in the U.S. [9][36] - The company is exploring additional dosing regimens for its drugs, including a once-a-month option for El Fabrio, which is under review by the EMA [29][30] - Protalix aims to leverage its core competencies in rare renal diseases and is open to collaborations in this area [44] Market Dynamics - The competitive landscape includes other enzyme replacement therapies (ERTs) like Fabrazyme and Replagal, which require more frequent infusions compared to El Fabrio [27][41] - The agreement with Kiesi includes royalties of 15-40% on U.S. sales and 15-35% on international sales, along with potential milestone payments [18][20] Key Takeaways - Protalix's unique plant-based technology offers cost advantages and manufacturing flexibility [5][6] - The company is focused on maintaining operational stability while exploring growth opportunities in its pipeline [14][46] - Upcoming catalysts include the EMA's decision on the new dosing regimen and the initiation of Phase 2 trials for PRX-115 [53]

Core Viewpoint - Pluxee has signed an agreement to acquire 100% of ProEves, enhancing its multi-benefit offerings in the Indian market and reinforcing its leadership position in the employee benefits sector [2][8]. Group 1: Acquisition Details - The acquisition of ProEves, a leading corporate childcare benefit player in India, is part of Pluxee's strategic growth plan [2][4]. - ProEves provides a digital platform for parents to select caregivers, addressing preschool and daycare needs, and currently collaborates with over 100 companies [6][4]. - The transaction will be fully funded from existing financial resources, with no material impact on Pluxee's leverage [4][8]. Group 2: Market Position and Impact - Pluxee serves over 3.5 million consumers in India and aims to strengthen its leadership by promoting gender equality and work-life balance through enhanced childcare benefits [3][4]. - The acquisition is expected to be accretive to total revenue organic growth and recurring EBITDA by Fiscal 2026, indicating a positive financial outlook [4][8]. - ProEves partners with over 7,000 childcare centers across India, supporting thousands of working parents each month [6].

Core Viewpoint - Protalix BioTherapeutics, Inc. is set to present its growth strategies and market opportunities at the upcoming Investor Summit Virtual on September 16, 2025, led by former Sr. Vice President and Chief Financial Officer Eyal Rubin [1] Company Overview - Protalix BioTherapeutics focuses on the development, production, and commercialization of recombinant therapeutic proteins [1] - The company utilizes its proprietary ProCellEx® plant cell-based protein expression system for its biopharmaceutical products [1] Event Details - The Q3 Investor Summit presentation is scheduled for September 16, 2025, at 10:30 a.m. [1]

Core Viewpoint - Pluxee has completed the acquisition of 100% of Skipr, enhancing its employee mobility benefits offerings in Belgium and France, and reinforcing its strategic growth plan in Continental Europe [2][3][11] Group 1: Acquisition Details - The acquisition of Skipr, a fast-growing Belgian company specializing in employee mobility solutions, is a strategic move for Pluxee to increase market share and broaden its product portfolio [2][3][4] - Skipr offers a state-of-the-art SaaS solution that allows employees to choose their mobility options while providing HR teams with tools for expense management and carbon footprint tracking [4][8] - The transaction is fully funded from existing financial resources, ensuring limited impact on Pluxee's leverage [6][11] Group 2: Market Position and Growth Potential - By acquiring Skipr, Pluxee is positioned to capture market share in the emerging benefit segment focused on sustainable mobility, which is increasingly important to employers and employees [5][11] - The acquisition is expected to be accretive to Pluxee's Group Organic Growth and Recurring EBITDA starting from Fiscal 2026 [6][11] - This move will expand Pluxee's revenue through an increased client base and create new cross-selling opportunities [5][11] Group 3: Company Background - Pluxee operates in 29 countries and offers a wide range of employee benefits solutions, including Meal & Food, Well-being, Lifestyle, Reward & Recognition, and Public Benefits [7] - The company has over 5,400 team members and serves more than 500,000 clients, impacting over 37 million consumers and 1.7 million merchants [7]

Company Overview - Protalix BioTherapeutics (PLX) is a commercial-stage biotech company focused on recombinant therapeutic proteins [1] - The company utilizes its proprietary plant cell-based ProCellEx technology [1] Product Portfolio - Protalix has two approved enzyme replacement therapies: 1) Elfabrio for Fabry disease 2) Elelyso for Gaucher disease [1]