Aurinia Pharmaceuticals(AUPH)

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Aurinia Pharmaceuticals (AUPH) Update / Briefing Transcript
2025-06-30 13:30
Summary of Aurinia Pharmaceuticals (AUPH) Conference Call Company Overview - **Company**: Aurinia Pharmaceuticals - **Product**: Aretinirecept (previously referred to as AUR200) - **Focus**: Development of treatments for autoimmune diseases Key Points from the Conference Call Phase One Study Results - Aretinirecept is a dual BAF and APRIL inhibitor designed to modulate immune responses in autoimmune diseases [3][4] - The Phase one study involved 61 healthy subjects with a standard single ascending dose design [7] - Doses tested: 5 mg, 25 mg, 75 mg, 150 mg, 225 mg, and 300 mg [7] - Aretinirecept was well tolerated with no treatment-related grade three or higher adverse events [7][9] - Injection site reactions occurred in 24% of subjects receiving Aretinirecept compared to 13% for placebo [9] - Significant reductions in immunoglobulins were observed: IgA (up to 76%), IgM (up to 67%), and IgG (up to 43%) [6] Pharmacokinetics and Pharmacodynamics - Aretinirecept demonstrated a half-life of 6 to 8 days after a single dose [9] - Mean reductions from baseline to day 28 for immunoglobulins were: IgA (48%), IgM (55%), and IgG (20%) [10] - The drug's pharmacodynamic effects support the potential for once-monthly dosing [10] Future Plans - Aurinia plans to initiate further clinical studies in at least two autoimmune diseases in the second half of the year [13][16] - Specific details on future studies and indications were not disclosed for competitive reasons [13][16] Competitive Landscape - The BAF and APRIL inhibitor space is becoming increasingly competitive, with many potential targets identified [24] - Aurinia is focusing on a range of B cell-mediated autoimmune diseases, with an internal review identifying over 20 potential targets [24] Intellectual Property and Development Strategy - Aurinia continues to file for intellectual property related to Aretinirecept, although specific details on the IP life were not disclosed [20] - The company intends to conduct further studies independently without seeking external funding [21] Safety and Administration - No dose-dependent effects were observed for upper respiratory infections or back pain, which were mild and transient [30] - Future formulations are expected to allow for self-administration at home via prefilled syringes or auto-injectors [32] Additional Insights - The study's design included a higher number of patients in the 150 mg dose group to better understand pharmacodynamic impacts [25][26] - Aretinirecept's binding affinity is significantly higher than that of competitor drugs, indicating a potential advantage in efficacy [5][6] This summary encapsulates the key findings and strategic directions discussed during the conference call, highlighting Aurinia Pharmaceuticals' advancements and future plans in the autoimmune disease treatment landscape.
Aurinia Pharmaceuticals (AUPH) Earnings Call Presentation
2025-06-30 07:07
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]
Aurinia (AUPH) Surges 7.5%: Is This an Indication of Further Gains?
ZACKS· 2025-06-27 14:01
Company Overview - Aurinia Pharmaceuticals (AUPH) shares increased by 7.5% to $8.63 in the last trading session, with a notable trading volume that exceeded the average [1] - The stock has shown a modest gain of 0.6% over the past four weeks [1] Product Performance - The rise in stock price is linked to positive investor sentiment regarding Lupkynis, the company's only marketed drug for treating adults with active lupus nephritis (LN) [2] - Sales of Lupkynis grew by 25% year-over-year, reaching $60 million in the first quarter of 2025 [2] Earnings Expectations - Aurinia is projected to report quarterly earnings of $0.18 per share, reflecting an 800% increase year-over-year [3] - Expected revenues for the upcoming quarter are $64.23 million, which is a 12.3% increase from the same quarter last year [3] - The consensus EPS estimate has remained stable over the last 30 days, indicating no recent revisions in earnings estimates [4] Industry Context - Aurinia holds a Zacks Rank of 3 (Hold), indicating a neutral outlook [5] - In the same medical-drugs industry, Corcept Therapeutics (CORT) also holds a Zacks Rank of 3 (Hold) and has seen a 0.5% increase in its stock price, but has returned -4.7% over the past month [5][6]
Aurinia shares rise ahead of key autoimmune therapy data
Proactiveinvestors NA· 2025-06-26 18:26
Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced news journalists who produce independent content across various financial markets [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content includes insights into sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is committed to adopting technology to enhance its content creation and workflow processes [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all published content is edited and authored by humans [5]
Is the Options Market Predicting a Spike in Aurinia Pharmaceuticals (AUPH) Stock?
ZACKS· 2025-05-30 13:51
Investors in Aurinia Pharmaceuticals Inc. (AUPH) need to pay close attention to the stock based on moves in the options market lately. That is because the July 18, 2025 $2.00 Call had some of the highest implied volatility of all equity options today.What is Implied Volatility?Implied volatility shows how much movement the market is expecting in the future. Options with high levels of implied volatility suggest that investors in the underlying stocks are expecting a big move in one direction or the other. I ...
Aurinia Pharmaceuticals(AUPH) - 2025 Q1 - Earnings Call Transcript
2025-05-12 13:32
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]
Aurinia Pharmaceuticals(AUPH) - 2025 Q1 - Earnings Call Transcript
2025-05-12 13:30
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]
Aurinia Pharmaceuticals (AUPH) Surpasses Q1 Earnings and Revenue Estimates
ZACKS· 2025-05-12 12:10
Company Performance - Aurinia Pharmaceuticals reported quarterly earnings of $0.16 per share, exceeding the Zacks Consensus Estimate of $0.08 per share, compared to a loss of $0.03 per share a year ago, representing an earnings surprise of 100% [1] - The company posted revenues of $62.47 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 2.63%, and showing an increase from year-ago revenues of $50.3 million [2] - Over the last four quarters, Aurinia has consistently surpassed consensus EPS and revenue estimates [2] Stock Performance and Outlook - Aurinia shares have declined approximately 10.9% since the beginning of the year, while the S&P 500 has decreased by 3.8% [3] - The company's future stock performance will largely depend on management's commentary during the earnings call and the trends in earnings estimate revisions [3][4] - The current consensus EPS estimate for the upcoming quarter is $0.09 on revenues of $64.76 million, and for the current fiscal year, it is $0.44 on revenues of $258.28 million [7] Industry Context - The Medical - Drugs industry, to which Aurinia belongs, is currently ranked in the top 27% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]
Aurinia Pharmaceuticals(AUPH) - 2025 Q1 - Quarterly Report
2025-05-12 10:05
Financial Performance - For the three months ended March 31, 2025, net product sales were $60.0 million, up 25% from $48.1 million in the same period of 2024[66]. - Total revenue for the three months ended March 31, 2025, was $62.5 million, an increase of 24% from $50.3 million in the same period of 2024[69]. - Gross margin for the three months ended March 31, 2025, was 86%, compared to 85% in the same period of 2024[78]. Cash Flow and Position - Cash flow provided by operating activities was $1.3 million for the three months ended March 31, 2025, compared to $(18.6) million in the same period of 2024[67]. - As of March 31, 2025, the cash position was $312.9 million, down from $358.5 million at December 31, 2024[68]. - Excluding restructuring payments, cash flow generated from operations was $12.4 million for the three months ended March 31, 2025[88]. - Future operations are expected to be funded by existing cash or cash generated from operations[89]. - Additional capital may be raised through equity or debt financings if necessary, but favorable terms are not guaranteed[90]. Expenses - Selling, general and administrative (SG&A) expenses decreased to $20.3 million for the three months ended March 31, 2025, from $47.7 million in the same period of 2024[80]. - Research and development (R&D) expenses increased to $5.7 million for the three months ended March 31, 2025, compared to $5.6 million in the same period of 2024[83]. - Restructuring expenses were $1.5 million for the three months ended March 31, 2025, down from $6.7 million in the same period of 2024[86]. - The company expects SG&A expenses to remain low in 2025 as it realizes the benefits of strategic restructuring efforts[81]. - The company anticipates an increase in R&D expenses as it advances the AUR200 program through clinical development[84]. Share Repurchase - The company repurchased 5.8 million common shares for $47.4 million during the three months ended March 31, 2025[88]. Accounting Policies - There have been no material changes to critical accounting policies or market risk disclosures since the Annual Report for the year ended December 31, 2024[91][94].
Aurinia Pharmaceuticals: Shareholder Pressure And Sales Growth
Seeking Alpha· 2025-04-26 14:54
Core Insights - Aurinia Pharmaceuticals has experienced management changes, but activist investors believe these changes are insufficient despite the upward trend in Lupkynis sales [1] Company Overview - Aurinia Pharmaceuticals is focused on the sales performance of its product Lupkynis, which continues to show growth [1]