Protalix BioTherapeutics(PLX) - 2025 Q1 - Quarterly Results

CEO Statement 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] - The primary focus is on initiating a Phase II clinical trial for the gout candidate, PRX-115, in the latter half of 2025[2] - The company continues to evaluate additional pipeline candidates, including PRX-119 and other early-stage assets[2] Business and Clinical Highlights 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) 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] - The company is in advanced stages of preparation for a Phase II clinical trial expected to commence in the second half of 2025[3] - 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] Pipeline Development: Pegunigalsidase alfa (Fabry Disease) 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] Q1 2025 Financial Highlights 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] - Cash, cash equivalents, and short-term bank deposits totaled approximately $34.7 million as of March 31, 2025[15] Financial Statements 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 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] - 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][20] - The development pipeline includes PRX–115 for uncontrolled gout and PRX–119 for NETs-related diseases[20]