Financial Data and Key Metrics Changes - For the first nine months of 2025, total revenues were $43.6 million, a 24% increase compared to the same period last year [4] - Total revenues for the third quarter were $17.9 million, reflecting a decrease of 1% compared to the same period in 2024 [4] - The net loss for the nine-month period ended September 30, 2025, was $1.1 million, or $0.01 per share, compared to a net loss of $3.6 million, or $0.05 per share for the same period in 2024 [17] - For the three months ended September 30, 2025, net income was approximately $2.4 million, or $0.03 per share, compared to net income of $3.2 million, or $0.04 per share for the same period in 2024 [18] Business Line Data and Key Metrics Changes - Total revenues from selling goods for the nine months ended September 30, 2025, were $43.1 million, an increase of $8.3 million, or 24%, compared to $34.8 million for the same period in 2024 [10] - Revenues consisted of $18.6 million in sales of Elefabrio to Chiesi, $15.4 million in sales of Elelyso to Pfizer, and $9.1 million in sales of Elelyso to Fiocruz in Brazil [10] - For the three months ended September 30, 2025, total revenues from selling goods were $17.7 million, a decrease of $0.1 million, or 1%, compared to $17.8 million for the same period in 2024 [10] Market Data and Key Metrics Changes - The company recognizes revenues from sales to partners, and individual purchases vary from quarter to quarter as each partner controls its own inventories [11] - The company anticipates a significant increase in the overall gout market in the next five to six years, particularly for uncontrolled gout patients requiring uricases [22] Company Strategy and Development Direction - The operating strategy focuses on three pillars: driving commercial success with Elefabrio, advancing PRX-115 and other early-stage pipeline programs, and maintaining financial discipline [7] - The company is preparing for the phase two clinical trial of PRX-115, which is viewed as a strategic investment in the pipeline and long-term growth [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in Elefabrio's long-term potential and is working closely with Chiesi to support the re-examination of the once-in-four-weeks dosing regimen [6] - The company believes that the achievements in 2025 position it for long-term growth and value creation [19] Other Important Information - Research and development expenses for the nine months ended September 30, 2025, totaled $13.9 million, an increase of 58% compared to the prior year period [13] - Selling general and administrative expenses for the nine months ended September 30, 2025, were $8.2 million, down 11% from the same period last year [14] - The company had $29.4 million in cash and cash equivalents at September 30, 2025, sufficient to satisfy capital needs for at least 12 months [18] Q&A Session Summary Question: Timeline for the re-examination of the CHMP opinion on Elefabrio - The company expects to have an answer in Q1 of 2026 regarding the re-examination request [22] Question: Comments on the competitive landscape in treatment refractory gout - The company foresees a significant increase in the overall gout market and believes that if the phase two trial is successful, it could capture a substantial market share [22] Question: Predictability of royalty-based revenue recognition related to Elefabrio sales - The company continues to recognize what it sells to Chiesi's inventory and is optimistic about future revenue [23][24] Question: Cash runway guidance - The cash runway guidance is based on both operating expenditures and continued receipt of royalty-based revenue on Elefabrio [25][26] Question: Anticipated R&D growth during the phase two of PRX-115 - The company is taking into account the expenses associated with the phase two trial and has sufficient cash for more than 12 months to fund this trial [45]