Protalix BioTherapeutics(PLX)

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Protalix BioTherapeutics(PLX) - 2025 FY - Earnings Call Transcript
2025-05-20 21:30
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]
Protalix BioTherapeutics(PLX) - 2025 Q1 - Earnings Call Transcript
2025-05-09 13:32
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 ...
Protalix BioTherapeutics(PLX) - 2025 Q1 - Earnings Call Transcript
2025-05-09 13:30
Protalix BioTherapeutics (PLX) Q1 2025 Earnings Call May 09, 2025 08:30 AM ET Speaker0 Good morning, ladies and gentlemen, and welcome to the Protalix Biotherapeutics First Quarter twenty twenty five Financial and Business Results Conference Call. As a reminder, this conference is being recorded. I will now turn the conference over to our host, Mike Moyer of LifeSci Advisors, Investor Relations for Potalix. Thank you. Please go ahead. Speaker1 Thank you, operator, and welcome to the Potalix Biotherapeutics ...
Protalix eyes Phase II gout trial later this year following solid Q1 revenue growth
Proactiveinvestors NA· 2025-05-09 12:41
About this content About Angela Harmantas Angela Harmantas is an Editor at Proactive. She has over 15 years of experience covering the equity markets in North America, with a particular focus on junior resource stocks. Angela has reported from numerous countries around the world, including Canada, the US, Australia, Brazil, Ghana, and South Africa for leading trade publications. Previously, she worked in investor relations and led the foreign direct investment program in Canada for the Swedish government ...
Protalix BioTherapeutics(PLX) - 2025 Q1 - Quarterly Report
2025-05-09 11:04
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(PLX) - 2025 Q1 - Quarterly Results
2025-05-09 10:57
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 ...
Protalix BioTherapeutics Reports First Quarter 2025 Financial and Business Results
Prnewswire· 2025-05-09 10:50
Company to host conference call and webcast today at 8:30 a.m. EDTCARMIEL, 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 March 31, 2025, and provided a business and clinical update."We had another solid qua ...
Pluxee continues to deliver solid business and financial performance in H1 and raises its Fiscal 2025 Recurring EBITDA margin objective
GlobeNewswire· 2025-04-17 05:30
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 Is A Strong Buy With Increasing Revenues And A Promising Pipeline
Seeking Alpha· 2025-04-10 13:54
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 ...
Protalix BioTherapeutics to Present at the iAccess Alpha Virtual Best Ideas Spring Conference 2025
Prnewswire· 2025-03-24 10:50
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 ...