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]

[CEO Statement](index=1&type=section&id=CEO%20Statement) The CEO highlighted a solid quarter with increased revenues from selling goods compared to the prior year, focusing on advancing PRX-115 to Phase II in late 2025 and evaluating other pipeline candidates - Revenues from selling goods **increased** compared to the same quarter in the previous year[2](index=2&type=chunk) - The primary focus is on initiating a Phase II clinical trial for the gout candidate, PRX-115, in the **latter half of 2025**[2](index=2&type=chunk) - The company continues to evaluate additional pipeline candidates, including PRX-119 and other early-stage assets[2](index=2&type=chunk) [Business and Clinical Highlights](index=1&type=section&id=First%20Quarter%202025%20and%20Recent%20Business%20and%20Clinical%20Highlights) The company provided updates on its clinical pipeline, focusing on PRX-115 for gout and recent presentations on pegunigalsidase alfa for Fabry Disease by its partner, Chiesi [Pipeline Development: PRX-115 (Gout)](index=1&type=section&id=PRX-115) Protalix is preparing for a Phase II clinical trial for PRX-115 in H2 2025, following successful Phase I results indicating effective uric acid reduction and potential for wide dosing - Successfully completed the First-in-Human (FIH) Phase I clinical trial of PRX-115 in **2024**[3](index=3&type=chunk) - The company is in advanced stages of preparation for a Phase II clinical trial expected to commence in the **second half of 2025**[3](index=3&type=chunk) - Preliminary FIH study results indicate PRX-115 has the potential for effective uric acid reduction with a potentially wide dosing interval, which could enhance patient compliance[4](index=4&type=chunk) [Pipeline Development: Pegunigalsidase alfa (Fabry Disease)](index=2&type=section&id=Pegunigalsidase%20alfa) Partner Chiesi Global Rare Diseases presented multiple findings on pegunigalsidase alfa and Fabry Disease at the WORLDSymposium™ in March 2025 - Partner Chiesi Global Rare Diseases presented multiple findings on pegunigalsidase alfa at the WORLDSymposium™ in **March 2025**[6](index=6&type=chunk) [Q1 2025 Financial Highlights](index=2&type=section&id=First%20Quarter%202025%20Financial%20Highlights) Protalix reported a 170% increase in Q1 2025 revenues from selling goods to $10.0 million, narrowing net loss to $3.6 million, and ending the quarter with $34.7 million in cash and equivalents Q1 2025 vs Q1 2024 Key Financial Metrics | Financial Metric | Q1 2025 (USD) | Q1 2024 (USD) | Change (USD) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenues from Selling Goods | $10.0M | $3.7M | +$6.3M | +170% | | Cost of Goods Sold | $8.2M | $2.6M | +$5.6M | +215% | | R&D Expenses | $3.5M | $2.9M | +$0.6M | +21% | | SG&A Expenses | $2.6M | $3.1M | -$0.5M | -16% | | Net Loss | ($3.6M) | ($4.6M) | +$1.0M | -21.7% | | Loss Per Share (basic & diluted) | ($0.05) | ($0.06) | +$0.01 | -16.7% | - The increase in revenues from selling goods was primarily due to a **$5.9 million** increase in sales to Pfizer Inc. and a **$0.4 million** increase in sales to Fiocruz (Brazil)[7](index=7&type=chunk) - Cash, cash equivalents, and short-term bank deposits totaled approximately **$34.7 million** as of March 31, 2025[15](index=15&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) The financial statements detail the company's financial position as of March 31, 2025, showing total assets of $73.9 million, total liabilities of $28.7 million, and a net loss of $3.6 million for the quarter Condensed Consolidated Statements of Operations (Unaudited) | (U.S. dollars in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | **REVENUES FROM SELLING GOODS** | **$9,995** | **$3,677** | | REVENUES FROM LICENSE AND R&D SERVICES | 118 | 71 | | **TOTAL REVENUE** | **10,113** | **3,748** | | COST OF GOODS SOLD | (8,180) | (2,602) | | RESEARCH AND DEVELOPMENT EXPENSES | (3,475) | (2,887) | | SELLING, GENERAL AND ADMINISTRATIVE EXPENSES | (2,603) | (3,115) | | **OPERATING LOSS** | **(4,145)** | **(4,856)** | | FINANCIAL INCOME, NET | 413 | 123 | | LOSS BEFORE TAXES ON INCOME | (3,732) | (4,733) | | TAX BENEFIT | 113 | 138 | | **NET LOSS** | **$(3,619)** | **$(4,595)** | | **LOSS PER SHARE - BASIC AND DILUTED** | **$(0.05)** | **$(0.06)** | Consolidated Balance Sheets (Unaudited) | (U.S. dollars in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total current assets** | **$60,514** | **$60,078** | | Cash and cash equivalents | 19,458 | 19,760 | | Short-term bank deposits | 15,285 | 15,070 | | **Total assets** | **$73,892** | **$73,417** | | **Total current liabilities** | **$24,322** | **$25,621** | | **Total liabilities** | **$28,684** | **$30,206** | | **STOCKHOLDERS' EQUITY** | **$45,208** | **$43,211** | | **Total liabilities and stockholders' equity** | **$73,892** | **$73,417** | [Corporate Information](index=3&type=section&id=Corporate%20Information) This section outlines conference call details, the company's ProCellEx® technology-based business model, key products, partnerships, and standard forward-looking statements regarding business risks - Protalix is a biopharmaceutical company using its proprietary ProCellEx® plant cell-based expression system to develop recombinant therapeutic proteins[19](index=19&type=chunk) - Key partnerships include licensing taliglucerase alfa to Pfizer for Gaucher disease and partnering with Chiesi for the global commercialization of Elfabrio® for Fabry disease[19](index=19&type=chunk)[20](index=20&type=chunk) - The development pipeline includes PRX–115 for uncontrolled gout and PRX–119 for NETs-related diseases[20](index=20&type=chunk)

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]

Company Overview - Protalix BioTherapeutics (PLX) is a biotechnology company that has two marketed therapies: Elelyso for Gaucher disease and Elfabrio for Fabry Disease [1] - The company is actively developing a clinical pipeline that may present future opportunities [1] Market Position - The presence of two marketed therapies positions Protalix BioTherapeutics as a player in the biotechnology sector focused on rare diseases [1]

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]