Regulated information Half-year report on Pluxee N.V.’s liquidity contract as of June 30, 2025 Pursuant to the liquidity contract entered into by Pluxee N.V. with BNP Paribas, the following assets appeared on the liquidity account as of June 30, 2025: 198,165 Pluxee N.V. ordinary shares€6,347,475 During the period from January 1, 2025 to June 30, 2025, the following transactions were performed: Purchasing of 718,910 ordinary shares amounting to €14,773,178 (4,467 transactions).Disposal of 719,962 ordinary s ...

Core Insights - Pluxee demonstrated solid organic growth performance in Q3 Fiscal 2025, achieving total revenues of 310 million euros, which represents an 11.1% organic growth year-on-year [2][6][9] - The company confirmed its full-year financial objectives, reflecting strong execution and performance over the first nine months of the fiscal year [5][24] Financial Performance - Total revenues for Q3 Fiscal 2025 reached 310 million euros, up from 297 million euros in Q3 Fiscal 2024, marking an 11.1% organic growth and a 4.3% reported growth [2][9] - Operating revenue was 270 million euros, reflecting an 11.1% organic growth and a 5.4% reported growth [10][12] - Float revenue amounted to 39 million euros, growing 10.8% organically but declining 2.2% in reported terms [11][12] Regional Performance - Continental Europe generated 134 million euros in revenues, up 6.5% organically, while Latin America saw revenues of 121 million euros, growing 13.8% organically [2][15] - The Rest of the World reported revenues of 55 million euros, with a 15.2% organic growth despite a decline in reported terms [2][18] Business Segments - Employee Benefits segment generated 270 million euros in operating revenue, up 12.3% organically, driven by strong client acquisition and improved retention rates [7][12] - Other Products & Services reported 40 million euros in operating revenue, showing a modest 0.5% organic growth [14][36] M&A Activity - The company signed the acquisition of MyBenefits in Romania, which is expected to enhance technological capabilities and generate sustainable growth synergies [20][21][22] - Integration efforts for Cobee in Spain and Benefício Fácil in Brazil are ongoing, alongside a fully operational partnership with Santander [23][24] Outlook - Pluxee maintains its financial objectives for Fiscal 2025, expecting low double-digit organic growth in total revenues and float revenue [24][27] - The company anticipates a recurring EBITDA margin expansion of +150 basis points at Fiscal 2024 constant rates for Fiscal 2025 [27]

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]

Financial Data and Key Metrics Changes - The company reported revenues of $53 million for the fiscal year 2024, indicating a strong cash-generating position for a biotech firm [6][29] - Cash at the end of the last quarter was $34.7 million, with projections to approach cash flow positive by the end of 2024 [29][30] Business Line Data and Key Metrics Changes - The first product, El Eliza, has generated approximately $12 million in Brazil, while global sales through Pfizer are only $50 million out of a $1 billion market, indicating commercialization challenges [9][34] - The second product, El Fabrio, is expected to capture 15% to 20% of a $3.1 billion market, potentially generating $130 million to $150 million in sales for Protalix [13][19] Market Data and Key Metrics Changes - The Fabry market was valued at $2.2 billion last year, with expectations for growth to $3.1 billion by 2030 [12][13] - The gout treatment market is projected to be $5.6 billion with a 6.4% CAGR, highlighting significant potential for the PRX-115 product [25] Company Strategy and Development Direction - The company aims to enhance its platform and explore rare renal diseases, while also focusing on the development of PRX-115 for gout treatment [28][30] - A strategic partnership with Chiesi is crucial, with a tiered royalty agreement that could yield significant revenue based on sales performance [14][18] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges in commercialization for El Eliza but remains optimistic about future partnerships to improve market penetration [10][34] - The company believes that by 2030, total sales could reach between $120 million to $230 million, contingent on successful product launches and market acceptance [35] Other Important Information - The company has no debt and has cleaned its balance sheet, positioning itself for a fresh start [30] - Management noted that the share price drop following the first quarter results was disproportionate and attributed it to market reactions rather than operational failures [31][34] Q&A Session Summary Question: Is it reasonable to liken the competitive advantage of PRX-115 to that of El Fabrio? - Management believes PRX-115 could represent an even stronger competitive advantage due to its potential dosing regimen, which could significantly reduce treatment frequency compared to existing therapies [37] Question: What are the implications of sales fluctuations? - Sales are highly dependent on shipment logistics, and even minor delays can impact revenue recognition, but the company remains optimistic about profitability [38] Question: What are the expected costs for the upcoming trials? - The projected costs for the trials are manageable, estimated at around $24 million over two and a half years, which is significantly lower than previous trials [39]

Financial Data and Key Metrics Changes - The company recorded revenues from selling goods of $10 million for Q1 2025, an increase of $6.3 million or 170% compared to $3.7 million for Q1 2024, primarily due to increased sales to Pfizer and Fearcruz in Brazil [11][12] - Cost of goods sold was $8.2 million for Q1 2025, an increase of $5.6 million or 215% from $2.6 million for Q1 2024 [12] - 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 [16] Business Line Data and Key Metrics Changes - Revenues from license and R&D services were $100,000 for both Q1 2025 and Q1 2024, with expectations for minimal future revenues from this line [11][12] - Total research and development expenses were approximately $3.5 million for Q1 2025, an increase of $600,000 or 21% compared to $2.9 million for Q1 2024, driven by advancements in the clinical pipeline [12][13] - Selling, general, and administrative expenses decreased to $2.6 million for Q1 2025, a decrease of $500,000 or 16% compared to $3.1 million for Q1 2024 [13] Market Data and Key Metrics Changes - The company is focused on the clinical development of PRX-115, with plans to initiate a Phase II study in patients with gout later this year [4][7] - The European Medicines Agency (EMA) has validated a submission to reduce the dosing frequency for PEGUNIGARCID, which is expected to be reviewed in Q4 2025 [8] Company Strategy and Development Direction - The company aims to build on the momentum from its first-in-human study of PRX-115 and is evaluating additional pipeline candidates for further development [4][9] - The focus remains on early-stage development assets and leveraging the Procedex platform to enhance the product development pipeline [9][10] 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 revenue will support the next phase of pipeline development [17] - The company anticipates a promising year ahead, with ongoing efforts to drive innovation and create long-term value for patients and shareholders [17] Other Important Information - Cash, cash equivalents, and short-term bank deposits were approximately $34.7 million as of March 31, 2025 [15] - The company expects minimal revenues from R&D services going forward, primarily from potential regulatory milestone payments [12][51] Q&A Session Summary Question: Visibility on El Fabrio milestone - Management noted that Kiese's sales efforts are strong, with recruitment of commercial patients exceeding expectations, but specific numbers cannot be disclosed due to confidentiality [20][21][22] Question: Dosing frequency changes in the US - Management confirmed that an application has been submitted to Kiese, and updates will be provided as they become available [23][24] Question: Comparison with other gout medications - Management indicated that more information will be available after the Phase II trial, which is designed to have high statistical power [25][26][27] Question: Options close to expiration - The majority of warrants from the 2020 PIPE transaction expired, with a minimal amount exercised [30][31] Question: U.S. patients in Phase II trial - The majority of patients will be enrolled in the U.S., with hopes for a good safety and immunogenicity profile [36][37] Question: Effects of U.S. pharmaceutical tariffs - Management clarified that the relationship with Kiese is not expected to be impacted by the tariffs, as sales are made to Kiese, not directly to the U.S. market [42][44][45] Question: Remaining value of the contract with Kiese - Management explained that future revenues from Kiese will primarily consist of regulatory milestones, with potential milestones estimated up to $75 million, depending on sales performance [49][51][53]

Protalix BioTherapeutics (PLX) Q1 2025 Earnings Call May 09, 2025 08:30 AM ET Company Participants Mike Moyer - Managing DirectorDror Bashan - President, CEO & DirectorEyal Rubin - SVP and CFODaniel Smith - Equity Research Associate Conference Call Participants John Vandermosten - Senior AnalystDan Akschuti - Equity Partner - Biotech AnalystNone - Analyst Operator Good morning, ladies and gentlemen, and welcome to the Protalix Biotherapeutics First Quarter twenty twenty five Financial and Business Results C ...

Financial Data and Key Metrics Changes - The company recorded revenues from selling goods of $10 million for Q1 2025, an increase of $6.3 million or 170% compared to $3.7 million in Q1 2024, primarily due to increased sales to Pfizer and Fearcruz in Brazil [11][12] - Cost of goods sold was $8.2 million for Q1 2025, an increase of $5.6 million or 215% from $2.6 million in Q1 2024 [12] - 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 in the same period in 2024 [16] Business Line Data and Key Metrics Changes - Revenues from license and R&D services were $100,000 for both Q1 2025 and Q1 2024, indicating minimal change [11][12] - Total research and development expenses increased to approximately $3.5 million in Q1 2025, up $600,000 or 21% from $2.9 million in Q1 2024, primarily due to advancements in the clinical pipeline [12][13] - Selling, general, and administrative expenses decreased to $2.6 million in Q1 2025, down $500,000 or 16% from $3.1 million in Q1 2024 [13] Market Data and Key Metrics Changes - The company is focused on the European market with a submission to the EMA to reduce dosing frequency for PEGUNIGARCID, expecting feedback in Q4 2025 [7][8] - The company plans to initiate a Phase II clinical trial for PRX-115 in patients with gout later in 2025, with a focus on the U.S. market for patient enrollment [6][10] Company Strategy and Development Direction - The company aims to build on the momentum from its Phase I study of PRX-115 and is evaluating additional pipeline candidates for further development [4][10] - The strategy includes leveraging the Procedex platform and focusing on early-stage development assets in renal rare diseases [9][10] - The management expressed confidence in the company's strategy and balance sheet to support future pipeline development [17] Management's Comments on Operating Environment and Future Outlook - Management highlighted strong sales efforts and recruitment of commercial patients, exceeding expectations [21][22] - The company is optimistic about the potential approval of dosing frequency changes in the U.S. and Europe, with no current red flags in the application process [23][24] - The management is excited about the progress in R&D efforts and the foundation being laid for future developments [17] Other Important Information - Cash, cash equivalents, and short-term bank deposits were approximately $34.7 million as of March 31, 2025 [15] - The company expects minimal revenues from license and R&D services going forward, primarily from potential regulatory milestone payments [12][51] Q&A Session Summary Question: Visibility on El Fabrio milestone - Management indicated strong sales efforts and recruitment of commercial patients, with improvements noted every quarter [21][22] Question: Dosing frequency application in the U.S. - Management confirmed that the application is ongoing and they are encouraged by the process [23][24] Question: Comparison with other gout medications - Management expressed optimism about the Phase II trial outcomes and potential competitive advantages, but refrained from discussing specific competitors [27][30] Question: Options close to expiration - Most warrants from the 2020 PIPE transaction expired, with minimal amounts exercised [32] Question: Phase II trial enrollment in the U.S. - Majority of patients will be enrolled in the U.S., with hopes for a good safety and immunogenicity profile [38] Question: Effects of U.S. pharmaceutical tariffs - Management clarified that their relationship with Chiesi is not expected to be impacted by the tariffs [44] Question: Remaining value of the contract with Kiese - Management explained that future revenues from Kiese will primarily be regulatory milestones, with potential milestones estimated up to $75 million [52][53]

Company Overview - Proactive is a publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The news team operates from key finance and investing hubs including London, New York, Toronto, Vancouver, Sydney, and Perth [2] Expertise and Focus Areas - The company specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - Proactive delivers news and insights across various sectors including biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for being a forward-looking technology adopter, utilizing decades of expertise and experience among its content creators [4] - The company employs automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Product Development and Approval - The company has successfully developed two commercial products: Elfabrio® for Fabry disease and Elelyso® for Gaucher disease, with Elelyso approved in 23 markets including the US and Brazil[62] - Elfabrio has received marketing approval in multiple regions including the US, EU, and Russia, indicating a broad market acceptance[62] - The FDA determined that substantial evidence of effectiveness for Elfabrio was established through a well-controlled study, with the BALANCE study meeting its primary efficacy endpoint[86] - The company has licensed the rights to commercialize Elelyso worldwide (excluding Brazil) to Pfizer and in Brazil to Fiocruz[62] - The company is focused on developing treatments for rare and orphan diseases, leveraging its proprietary ProCellEx technology for new product candidates[66] - The company is currently in advanced stages of preparations for a Phase II clinical trial of PRX-115, expected to commence in the second half of 2025[64] - The company plans to submit a Variation Submission to the EMA to add a new dosing regimen of 2 mg/kg every four weeks for adult patients with Fabry disease[93] Market Analysis - The global market for Gaucher disease treatments was valued at $1.7 billion in 2024 and is forecasted to grow at a compound annual growth rate (CAGR) of approximately -0.46% from 2024 to 2030[83] - The global market for Fabry disease treatments is projected to reach approximately $2.3 billion by 2025, growing at a CAGR of 6.6% to about $3.1 billion by 2030[90] - Elelyso is the only alternative enzyme replacement therapy (ERT) for Gaucher disease besides Cerezyme and Vpriv, highlighting its unique market position[84] Clinical Trials and Efficacy - The clinical development program for PRX-102 included three pivotal studies: BALANCE, BRIDGE, and BRIGHT, focusing on safety and efficacy compared to existing treatments[95] - The BALANCE study demonstrated a favorable tolerability profile for PRX-102, with 90.4% of patients experiencing at least one treatment-emergent adverse event (TEAE) compared to 96.0% in the agalsidase beta arm[97] - In the BRIDGE study, the mean annualized eGFR slope improved from -5.90 mL/min/1.73m²/year on agalsidase alfa to -1.19 mL/min/1.73m²/year on PRX-102, indicating substantial renal function improvement[106] - The BRIGHT study evaluated the safety and efficacy of a 2 mg/kg dosage of PRX-102 administered every four weeks, although this regimen has not yet received regulatory approval[108] - Following the switch to PRX-102 in the BRIDGE study, there was a decrease in patients with progressing or fast-progressing kidney disease, aligning with therapeutic goals for Fabry disease[106] - The phase I/II study demonstrated a 90% reduction in lyso-Gb3 levels from baseline after 24 months[120] - The Mainz Severity Score Index (MSSI) showed an improvement of over 40% in disease severity across various parameters[120] - The BRIGHT study showed that 2 mg/kg of PRX-102 administered every four weeks was well tolerated, with no serious treatment-related adverse events reported[110] - Approximately 75% of study participants reported improvement or no change in average pain severity at Week 52[116] - Plasma lyso-Gb3 concentrations remained stable with a mean change of 3.01 nM from baseline to Week 52, indicating treatment stability[114] - Mean eGFR values were stable during the 52-week treatment period, with a mean change from baseline of -1.27 mL/min/1.73 m²[114] - Out of 30 patients, 29 completed the one-year study, with 28 receiving the intended regimen of 2 mg/kg every four weeks[111] Financial Performance - Revenues from selling goods increased to $10.0 million for the three months ended March 31, 2025, a rise of $6.3 million, or 170%, compared to $3.7 million for the same period in 2024[163] - Cost of goods sold rose to $8.2 million for the three months ended March 31, 2025, an increase of $5.6 million, or 215%, from $2.6 million for the same period in 2024[165] - Research and development expenses totaled approximately $3.5 million for the three months ended March 31, 2025, an increase of $0.6 million, or 21%, compared to $2.9 million for the same period in 2024[166][167] - Selling, general and administrative expenses decreased to $2.6 million for the three months ended March 31, 2025, a decrease of $0.5 million, or 16%, compared to $3.1 million for the same period in 2024[168] - Net cash used in operations for Q1 2025 was $5.1 million, with a net loss of $3.6 million[174] - Net cash provided by operations for Q1 2024 was $4.2 million, with a net loss of $4.6 million[175] - Significant research and development expenditures have been incurred without offsetting revenues, particularly for the products Elelyso and Elfabrio[176] - The company expects to continue incurring significant expenditures for research and development, with no anticipated revenues sufficient to cover these costs[178] Strategic Focus and Future Outlook - The corporate strategy includes developing treatments for rare diseases, focusing on early-stage product candidates with high unmet needs[136] - The company is exploring novel platform technologies and enhancing its ProCellEx capabilities to address high unmet needs in various diseases[66] - Future financing needs may arise from costs associated with clinical trials, employee salaries, and operational expenses[178] - The company has not engaged in hedging transactions to mitigate currency risk but may consider this in the future[184] - As of March 31, 2025, the company had $34.7 million in cash and cash equivalents and short-term bank deposits[171] - The company generated gross proceeds of approximately $3.0 million from the sale of 1,325,179 shares of Common Stock during the quarter ended March 31, 2025[172] - As of March 31, 2025, approximately $19.7 million in gross proceeds from Common Stock sales remain available under the Sales Agreement[179] - Approximately 44% of the company's costs are incurred in NIS, with potential inflation in Israel affecting U.S. dollar costs[184] - The average exchange rate of the U.S. dollar to NIS for Q1 2025 was 3.613, compared to 3.662 for Q1 2024[184] - The company has no off-balance sheet arrangements as of March 31, 2025[181]

Protalix BioTherapeutics Reports First Quarter 2025 Financial and Business Results Company to host conference call and webcast today at 8:30 a.m. EDT CARMIEL, Israel, May 9, 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 reported financial results for the quarter ended M ...