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 ...