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Aurinia Pharmaceuticals(AUPH) - 2025 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q1 2025, total revenue was 62.5million,up2462.5 million, up 24% from 50.3 million in Q1 2024 [5] - Net product sales of Lupkinus were 60million,up2560 million, up 25% from 48.1 million in the same period of 2024 [5] - Cash flow generated from operations was 1.3millioncomparedtoanegative1.3 million compared to a negative 18.6 million in Q1 2024; excluding restructuring payments, cash flow was 12.4million[5][6]Netincomewas12.4 million [5][6] - Net income was 23.3 million or 0.17pershare,comparedtoanetlossof0.17 per share, compared to a net loss of 10.7 million or 0.07pershareinQ12024[10]BusinessLineDataandKeyMetricsChangesTheincreaseinnetproductsalesofLupkinuswasprimarilyduetoariseinthenumberofcartonssoldtospecialtypharmaciesandgreaterpenetrationinlupusnephritistreatment[5]CostofrevenueforQ12025was0.07 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 7.8millioninQ12024,whilegrossmarginimprovedto867.8 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 260million,withnetproductsalesguidanceof260 million, with net product sales guidance of 240 million to 250million[6][7]ManagementsCommentsonOperatingEnvironmentandFutureOutlookManagementexpressedconfidenceinthegrowthtrajectoryforLupkinus,citinghistoricalperformancepatternsandongoingimprovementsinpatienttreatmentinitiation[15][16]Thecompanyiscloselymonitoringpotentialimpactsfromnewfederalgovernmentpoliciesandtariffs,withminimalexpectedimpactonoperationsduetoexistingstockpilesintheU.S.[29][30]OtherImportantInformationThecompanyrepurchased250 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]