Financial Data and Key Metrics Changes - For Q1 2025, total revenue was $62.5 million, up 24% from $50.3 million in Q1 2024 [7][10] - Net product sales of Lupkinus were $60 million, a 25% increase from $48.1 million in the same period of 2024 [7][8] - Cash flow generated from operations was $1.3 million compared to a negative $18.6 million in Q1 2024; excluding restructuring payments, cash flow was $12.4 million [8][10] - The company had cash, cash equivalents, restricted cash, and investments of $312.9 million as of March 31, 2025, down from $358.5 million at the end of 2024 [9][10] - Net income was $23.3 million or $0.17 per share, compared to a net loss of $10.7 million or $0.07 per share in Q1 2024 [12] Business Line Data and Key Metrics Changes - The increase in net product sales of Lupkinus was primarily due to a rise in the number of cartons sold to specialty pharmacies and greater penetration in the lupus nephritis market [8][9] - Cost of revenue for Q1 2025 was $8.6 million, up from $7.8 million in Q1 2024, while gross margin improved to 86% from 85% [11][12] - Total operating expenses decreased to $40.6 million from $63.6 million in the same period of 2024, attributed to lower personnel expenses and reduced R&D costs [11][12] Market Data and Key Metrics Changes - The company is focused on educating rheumatologists about the benefits of initiating Lupkinus earlier in treatment, following updated guidelines from the American College of Rheumatology [9] - The company anticipates continued growth in the lupus nephritis market, supported by recent guideline updates that favor earlier diagnosis and treatment [26][52] Company Strategy and Development Direction - The company is maintaining a focus on commercial execution and operational efficiency, with a strong emphasis on the growth of Lupkinus [6][9] - The company reiterated its total revenue guidance for 2025 in the range of $250 million to $260 million and net product sales guidance of $240 million to $250 million [9][10] - The company is on track to report initial results from the Phase 1 study of AUR-200, a dual BAP inhibitor, later in the quarter [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory of Lupkinus, citing improvements in patient adds and rheumatology prescribing [17][18] - The company is closely monitoring potential impacts from government policies and tariffs, with minimal expected impact on costs due to existing stockpiles in the U.S. [31][32] - Management emphasized the importance of maintaining a competitive profile against new entrants in the lupus nephritis market [52][53] Other Important Information - The company has repurchased $5.8 million of its common shares in Q1 2025, part of a broader share repurchase program [9][10] - The company is actively defending its patents against ANDA filers and is committed to maintaining its revenue stream from Lupkinus [26][56] Q&A Session Summary Question: Can you discuss the quarterly cadence for Lupkinus sales and what is driving current sales? - Management indicated that sales are driven by a combination of new patient adds and persistency, with historical patterns suggesting a rise in sales in the latter half of the year [15][17] Question: What are the expectations for the second quarter compared to the first? - Management noted that Q1 is not typically the lowest quarter, with historical trends indicating a soft summer followed by a rise in Q4 [23][24] Question: Can you elaborate on the ANDA filers challenging the dosing protocol patent? - Management confirmed that they are vigorously defending their patents and that the process includes a 30-month stay for the filers [26] Question: What is the company's exposure to potential new federal government policies? - Management stated that they are monitoring the situation closely, with minimal expected impact on costs due to existing stockpiles in the U.S. [29][31] Question: What endpoints are anticipated to differentiate AUR-200 from other inhibitors? - Management indicated that the Phase 1 results will provide critical pharmacokinetic and pharmacodynamic data, which will help assess AUR-200's competitive profile [59]

Financial Data and Key Metrics Changes - For Q1 2025, total revenue was $62.5 million, up 24% from $50.3 million in Q1 2024 [5] - Net product sales of Lupkinus were $60 million, up 25% from $48.1 million in the same period of 2024 [5] - Cash flow generated from operations was $1.3 million compared to a negative $18.6 million in Q1 2024; excluding restructuring payments, cash flow was $12.4 million [5][6] - Net income was $23.3 million or $0.17 per share, compared to a net loss of $10.7 million or $0.07 per share in Q1 2024 [10] Business Line Data and Key Metrics Changes - The increase in net product sales of Lupkinus was primarily due to a rise in the number of cartons sold to specialty pharmacies and greater penetration in lupus nephritis treatment [5] - Cost of revenue for Q1 2025 was $8.6 million, up from $7.8 million in Q1 2024, while gross margin improved to 86% from 85% [9] Market Data and Key Metrics Changes - The company has seen improvements in rheumatology prescribing, indicating early diagnosis and treatment trends [16] - The American College of Rheumatology updated guidelines recommending the incorporation of drugs like Lupkinus into first-line therapy, which is expected to drive further growth [6] Company Strategy and Development Direction - The company is focused on commercial execution and operational efficiency, aiming for continued growth in Lupkinus sales and advancing the AUR 200 clinical program [6][11] - Total revenue guidance for 2025 is maintained in the range of $250 million to $260 million, with net product sales guidance of $240 million to $250 million [6][7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth trajectory for Lupkinus, citing historical performance patterns and ongoing improvements in patient treatment initiation [15][16] - The company is closely monitoring potential impacts from new federal government policies and tariffs, with minimal expected impact on operations due to existing stockpiles in the U.S. [29][30] Other Important Information - The company repurchased $5.8 million of its common shares in Q1 2025, part of a broader share repurchase program [6][9] - The company is on track to report initial results from the Phase 1 study of AUR 200 later in the quarter [7] Q&A Session Summary Question: Can you discuss the quarterly cadence for Lupkinus sales and what is driving sales? - Management indicated that sales are driven by a combination of new patient additions and persistency, with historical patterns suggesting a rise in sales in the latter half of the year [15] Question: What are the expectations for the second quarter compared to the first? - Management clarified that Q1 is not typically the lowest quarter, with historical trends indicating a soft summer followed by a rise in Q4 [21][22] Question: Can you elaborate on the ANDA filers challenging the dosing protocol patent? - The company is actively defending its patents and has filed infringement lawsuits against ANDA filers, with ongoing litigation expected [24] Question: What is the company's exposure to potential tariffs and government reimbursement policies? - The company has several years of product stockpiled in the U.S. and does not anticipate significant impact from tariffs on overall costs [29][30] Question: What endpoints are expected to differentiate AUR 200 from other inhibitors? - The Phase 1 results will provide insights into pharmacokinetics and pharmacodynamics, which will help assess AUR 200's competitive profile [60]