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Protalix BioTherapeutics Says With Debt Fully Repaid, It's Well-Positioned To Execute Strategy Through 2025 And Beyond
PLXProtalix BioTherapeutics(PLX) Benzinga·2025-03-17 15:56

Financial Performance - Protalix BioTherapeutics reported fiscal 2024 earnings of 4 cents, exceeding the consensus estimate of 1 cent [1] - The company recorded sales of 53.40millionfor2024,representinga3153.40 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 11.8millionriseinsalestoChiesi,a11.8 million rise in sales to Chiesi, a 0.6 million increase in sales to Brazil, and a 0.1millionincreaseinsalestoPfizer[1]ProductDevelopmentandPipeline−ProtalixfocusesondevelopingrecombinanttherapeuticproteinsusingitsProCellExplantcell−basedexpressionsystem,beingthefirsttogainFDAapprovalforsuchaproduct[2]−ThecompanyhaslicensedworldwiderightsfortaliglucerasealfatoPfizerforGaucherdiseasetreatment,whileretainingfullrightsinBrazil[3]−Protalix′ssecondproduct,Elfabrio,receivedFDAandEuropeanMedicinesAgencyapprovalinMay2023[3]−Thecompanyisoptimisticaboutitsgoutcandidate,PRX−115,andplanstoinitiateaphaseIIclinicaltrialinthesecondhalfof2025[5]FinancialHealthandStrategy−Protalixrepaidits7.500.1 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]