Financial Data and Key Metrics Changes - The company recorded revenues from selling goods of $10 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 [10] - The cost of goods sold was $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 [11] - The net loss for the quarter ended March 31, 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 the three months ended March 31, 2025, consistent with the same period in 2024 [10] - Total research and development expenses were approximately $3.5 million for the three months ended March 31, 2025, an increase of $600,000 or 21% compared to $2.9 million for the same period in 2024 [12] Market Data and Key Metrics Changes - The company noted an increase in sales to Pfizer by $5.9 million and an increase of $400,000 in sales to Fearcruz in Brazil, contributing to the overall revenue growth [10] Company Strategy and Development Direction - The company is focused on initiating a Phase II clinical trial for its gut product candidate PRX-115 later this year, building on the momentum from promising Phase I results [4][6] - The company continues to evaluate additional pipeline candidates, including PRX-119 and other early-stage clinical assets, to strengthen its product development pipeline [8] 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 management highlighted strong sales efforts and recruitment of commercial patients, which are exceeding expectations [21][56] 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 license and R&D services going forward, primarily from potential regulatory milestone payments [11][51] Q&A Session Summary Question: Any visibility on an El Fabrio milestone? - Management indicated that Kiese's sales efforts are strong, and the pace of recruitment of commercial patients is above expectations, but specific numbers cannot be disclosed due to confidentiality [20][22] Question: Is there any effort for a similar dosing frequency approach in the U.S.? - Management stated that the application with Kiese is ongoing, and updates will be provided as they become available [23][24] Question: Will U.S. patients be enrolled in the Phase II trial for gout? - Management confirmed that the majority of patients will be enrolled in the U.S. [36] Question: Any increase in the list price of El Fabrio in response to U.S. tariffs? - Management stated that there are no current plans for a price increase, but this could change depending on future tariff impacts [45] Question: What is the approximate value of the contract left to be paid out by Kiese? - Management explained that future revenues from Kiese will primarily consist of regulatory milestones, with potential milestones estimated up to $75 million, but this is minimal at this point [51][52]