Company Highlights - Aurinia Pharmaceuticals Inc. (AUPH) has seen solid growth for its product LUPKYNIS, with expected net product sales for 2025 ranging from $250 million to $260 million, up from $216.2 million last year [2][3] - Arrowhead Pharmaceuticals Inc. (ARWR) is preparing for its first commercial launch in 2025, with its lead drug candidate Plozasiran under FDA review, decision expected on November 18, 2025 [4][5] - Beta Bionics Inc. (BBNX) reported a 54% growth in second-quarter net sales, with expectations for full-year 2025 net sales to range between $88 million and $93 million, compared to $65.1 million last year [7][8] - Kiniksa Pharmaceuticals International plc (KNSA) anticipates net product revenue for its drug Arcalyst to be between $625 million and $640 million for 2025, up from $417 million in 2024 [10][11] - Ionis Pharmaceuticals Inc. (IONS) generated net product sales of $19 million in Q2 2025, with a supplemental new drug application expected by year-end [12][14] - Stoke Therapeutics Inc. (STOK) is developing Zorevunersen for Dravet syndrome, with a 52-week high of $24.60 reached recently, representing an 82% gain in less than two months [16][17] - Fortress Biotech Inc. (FBIO) is awaiting an FDA decision on its investigational drug CUTX-101 for Menkes disease, expected on September 30, 2025 [18][21] Stock Performance - AUPH stock increased by 168% over 1.5 years, reaching a 52-week high of $12.87 [3] - ARWR stock gained 65% in less than 9 months, hitting a 52-week high of $31.13 [5] - BBNX stock rose nearly 55% in less than 4 months, reaching a 52-week high of $26.66 [8] - KNSA stock saw a 46% increase in less than four months, touching a 52-week high of $37.34 [11] - IONS stock gained 52% in less than two months, reaching a 52-week high of $64.72 [15] - STOK stock increased by 82% in less than two months, achieving a 52-week high of $24.60 [17] - FBIO stock rose by 61% in less than a month, reaching a 52-week high of $3.97 [21]

Core Viewpoint - Aurinia Pharmaceuticals reported strong second-quarter 2025 earnings, exceeding revenue and earnings expectations, and raised full-year guidance, indicating positive business momentum and effective cost management [1][13]. Financial Performance - Q2 2025 revenue reached $70.0 million, surpassing the $63.8 million estimate by 9.7%, and increased by 22.2% from $57.2 million in Q2 2024 [2][5]. - Diluted EPS (GAAP) was $0.16, slightly above the $0.15 estimate, and a significant increase from $0.01 in Q2 2024, reflecting a 1,500% year-over-year growth [2][7]. - Net income (GAAP) rose to $21.5 million from $0.7 million in the prior year, marking a 2,971.4% increase [2][7]. - Operational cash flow for the first half of 2025 was $45.5 million, a turnaround from an outflow in the same period of 2024 [8]. Product and Market Focus - Aurinia specializes in therapies for autoimmune diseases, particularly lupus nephritis, with its main product being LUPKYNIS, which is now recommended as a first-line treatment [3][5]. - The company’s revenue growth is primarily driven by LUPKYNIS, supported by updated treatment guidelines from the American College of Rheumatology [5]. - LUPKYNIS is approved in multiple regions, including the U.S., Europe, and Japan, with a notable 55% increase in license and collaboration revenue to $3.4 million [6]. Cost Management and Efficiency - Selling, general, and administrative expenses decreased significantly from $44.9 million in Q2 2024 to $26.0 million in Q2 2025, attributed to lower personnel costs and improved operational efficiency [7]. - The company is on track for approximately $40 million in annualized savings following a restructuring in November 2024 [8]. Shareholder Returns - In the first half of 2025, Aurinia repurchased 11.2 million shares for $90.8 million, with a total of 18.3 million shares repurchased since the buyback program began [10]. - The board authorized a $150 million increase in the buyback plan, reflecting a commitment to returning capital to shareholders [10]. Future Outlook - Management raised full-year revenue guidance to between $260 million and $270 million, up from the previous range of $250 million to $260 million, indicating confidence in ongoing commercial trends [13]. - The lead candidate AUR200 is progressing with positive Phase 1 data and plans for further clinical trials later in 2025 [9].

LUPKYNIS Commercialization and Growth - The company aims to accelerate LUPKYNIS commercialization by improving screening, diagnosis, and treatment rates[4, 5] - The company also aims to continue LUPKYNIS commercial growth[4] - LUPKYNIS is the first FDA-approved oral therapy for the treatment of lupus nephritis[7] - In AURORA 1, 408% of patients on LUPKYNIS achieved a complete renal response at Week 52, compared to 225% on placebo, MMF, and corticosteroids, representing an 81% increase[32] - In AURORA 1, patients treated with LUPKYNIS were 64% more likely to achieve complete renal response at Week 24 than those on MMF + corticosteroids alone[32] - LUPKYNIS reduced proteinuria in a median of 169 days compared to 372 days for placebo, MMF, and corticosteroids[35] AUR200 Development - The company is advancing the AUR200 development program, a dual BAFF/APRIL inhibitor for autoimmune diseases[5, 43] - AUR200 has high binding affinity for both BAFF and APRIL compared to competitor dual BAFF/APRIL inhibitors[51] - In non-human primates, AUR200 lowered IgA by up to 76% and IgM by up to 67% after 4 weekly doses[56, 57] Financial Performance and Guidance - Total revenue increased by 34% from $1755 million in 2023 to $2351 million in 2024[62] - Net product sales increased by 36% from $1585 million in 2023 to $2162 million in 2024[62] - The company projects 2025 total revenue between $2500 million and $2600 million, representing a 6% to 11% increase from 2024[63] - The company projects 2025 net product sales between $2400 million and $2500 million, representing an 11% to 16% increase from 2024[63]

Financial Data and Key Metrics Changes - For Q4 2024, total revenue was $59.9 million, up 33% from $45.1 million in Q4 2023 [8][16] - For the full year 2024, total revenue was $235.1 million, up 34% from $175.5 million in 2023 [8][16] - Net product sales of LUPKYNIS for Q4 2024 were $57.6 million, up 36% compared to $42.3 million in Q4 2023 [9] - For the full year 2024, net product sales were $216.2 million, up 36% from $158.5 million in 2023 [9] - Cash flow from operations for Q4 2024 was $30.1 million, compared to $14.3 million in Q4 2023 [10] - As of December 31, 2024, cash and investments totaled $358.5 million [11] Business Line Data and Key Metrics Changes - The increase in LUPKYNIS sales was driven by greater market penetration and an increase in the number of cartons sold to specialty pharmacies [9] - Gross margin for Q4 2024 was 91%, compared to 88% in Q4 2023 [20] - Total operating expenses for Q4 2024 were $61.5 million, down from $74.8 million in Q4 2023 [20][21] - Net income for Q4 2024 was $1.4 million, compared to a net loss of $26.9 million in Q4 2023 [21] Market Data and Key Metrics Changes - The company is focusing on expanding its business at academic medical centers and lupus centers, targeting key rheumatology prescriber segments [12] - The new ACR lupus nephritis treatment guidelines are expected to drive positive momentum for LUPKYNIS [13] - The company aims to improve continuity of care for lupus nephritis patients by growing its hospital business [14] Company Strategy and Development Direction - The company has a commercial strategy focused on four key growth drivers: expanding business at academic centers, leveraging new treatment guidelines, reinforcing clinical data, and improving patient care continuity [12][13][14] - The company expects total revenue for 2025 to be in the range of $250 million to $260 million and net product sales to be between $240 million and $250 million [14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth of LUPKYNIS and the overall business, citing a solid position entering 2025 [14] - The company is advancing the development of AUR200, with initial results expected in Q2 2025 [15] Other Important Information - The company has repurchased approximately 9.7 million shares for about $70 million since the launch of its share repurchase program [18] - The increase in cost of revenue for the full year 2024 was primarily due to the amortization of the finance right-of-use lease asset [19] Q&A Session Summary Question: Maximizing LUPKYNIS Opportunity - Management highlighted a focus on high-prescribing rheumatology offices and the importance of the new ACR guidelines in driving treatment urgency [30][31] Question: AUR200 Data Expectations - Management expects to disclose pharmacodynamics and pharmacokinetic data from the ongoing study, which will inform the next steps in development [32] Question: LUPKYNIS Growth Beyond 2025 - Management refrained from providing long-term guidance but indicated that historical trends would inform future projections [38] Question: Guidance and Commercial Outlook - Management stated that the guidance for 2025 is based on current market conditions and historical performance [48] Question: AUR200 Dosing Frequency - Management indicated that the potency of AUR200 may allow for less frequent dosing, but specifics will be determined after the ongoing studies [62]

Financial Data and Key Metrics Changes - For Q4 2024, total revenue was $59.9 million, up 33% from $45.1 million in Q4 2023 [8][16] - For the full year 2024, total revenue was $235.1 million, up 34% from $175.5 million in 2023 [8][16] - Net product sales of LUPKYNIS for Q4 2024 were $57.6 million, up 36% from $42.3 million in Q4 2023 [9] - For the full year 2024, net product sales were $216.2 million, up 36% from $158.5 million in 2023 [9] - Cash flow from operations for Q4 2024 was $30.1 million, compared to $14.3 million in Q4 2023 [10] - Cash flow from operations for the full year 2024 was $44.4 million, compared to cash flow used in operations of $33.5 million in 2023 [10] - As of December 31, 2024, cash, cash equivalents, restricted cash, and investments totaled $358.5 million [11][17] - Gross margin for Q4 2024 was 91%, compared to 88% in Q4 2023; for the full year 2024, gross margin was 88%, down from 92% in 2023 [20] Business Line Data and Key Metrics Changes - The increase in net product sales of LUPKYNIS was primarily due to an increase in the number of cartons sold to specialty pharmacies [9] - Cost of revenue for Q4 2024 was $5.6 million, compared to $5.4 million in Q4 2023; for the full year 2024, cost of revenue was $28.2 million, up from $14.1 million in 2023 [19] Company Strategy and Development Direction - The company has a commercial strategy focused on four key growth drivers: expanding business at academic medical centers, targeting key rheumatology prescriber segments, leveraging new ACR lupus nephritis treatment guidelines, and improving continuity of care for lupus nephritis patients [12][13] - The company expects total revenue for 2025 to be in the range of $250 million to $260 million and net product sales in the range of $240 million to $250 million [14] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth of LUPKYNIS, citing a strong sales growth of 36% in 2024 and a solid position to start 2025 [12][14] - Management noted that historical financial results provide sufficient insight into the health of the business for projecting future results [11][58] Other Important Information - The company initiated a Phase 1 study for AUR200 in September 2024, with initial results expected in Q2 2025 [14][15] - The company has repurchased approximately 9.7 million common shares for about $70 million since the launch of the share repurchase program in Q1 2024 [18] Q&A Session Summary Question: Details on maximizing LUPKYNIS opportunity with current sales force - Management highlighted a focus on high prescribing rheumatology offices and the importance of the new ACR guidelines for early diagnosis and treatment [25][30] Question: Expectations for AUR200 data in Q2 - Management indicated that normal pharmacodynamics and pharmacokinetic data are expected, which will inform the next steps in the study [26][32] Question: Growth expectations for LUPKYNIS beyond 2025 - Management refrained from providing long-term guidance but emphasized historical trends as a basis for future projections [36][38] Question: Initial two months of 2025 and commercial outlook - Management stated that the guidance range is based on current market observations and historical financial results [46][49] Question: Decision to stop reporting PSS metrics - Management explained that after five years on the market, historical results provide sufficient insight for future projections [54][58] Question: Impact of ACR treatment guidelines on prescriber behavior - Management noted that over 50% of prescriptions come from rheumatologists, with expectations for gradual improvement in treatment behaviors [65][70] Question: Timeline for AUR200 studies - Management indicated that timelines will be clearer after the completion of the single-ascending dose study [66][72]