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]

The biotech industry has been under pressure due to the global uncertainty caused by the tariff war. Though pharmaceuticals have been exempted in the first round of reciprocal tariffs, they could well be Trump’s target in the next round. Though the Trump administration has implemented a 90-day pause on all trading partners, excluding China, when imposed, tariffs on pharmaceutical imports can lead to potential disruptions to global supply chains and increased production costs.Biotech stocks have been under p ...

Aurinia Pharmaceuticals (AUPH) Q4 2024 Earnings Call February 27, 2025 06:27 PM ET Company Participants Andrea Christopher - Head of the Corporate Communications & Investor RelationsPeter Greenleaf - President & Chief Executive OfficerJoe Miller - Chief Financial OfficerGreg Keenan - Chief Medical Officer Conference Call Participants None - AnalystOlivia Brayer - AnalystEd Arce - Managing Director - senior Healthcare Analyst Operator Greetings and welcome to the Aurinia Pharmaceuticals Fourth Quarter and Fu ...

On Thursday, Aurinia Pharmaceuticals Inc AUPH reported fourth-quarter earnings of 1 cent per share, compared to a loss of 19 cents a year ago and the consensus loss of 2 cents.The biopharma company reported fourth-quarter sales of $59.9 million, up 33% year over year, almost in line with the consensus of $59.9 million.Net product sales of LUPKYNIS, the first FDA-approved oral therapy for active lupus nephritis, were $57.6 million, up 36%.License, collaboration, and royalty revenue, which includes manufactur ...

Aurinia Pharmaceuticals (AUPH) came out with quarterly earnings of $0.09 per share, beating the Zacks Consensus Estimate of $0.03 per share. This compares to loss of $0.19 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 200%. A quarter ago, it was expected that this biotechnology company would post earnings of $0.02 per share when it actually produced earnings of $0.10, delivering a surprise of 400%.Over the last four quarters ...

Financial Performance - For the year ended December 31, 2024, net product sales were $216.2 million, up 36% from $158.5 million in 2023[18]. - Total revenue was $235.1 million, a 34% increase from $175.5 million in 2023[1]. - License, collaboration, and royalty revenue was $18.9 million, an 11% increase from $17.0 million in 2023, driven by manufacturing services provided to Otsuka[1][4]. - Gross margin for 2024 was 88%, down from 92% in 2023[1][5]. - Net income for 2024 was $5.8 million, a significant improvement from a net loss of $78.0 million in 2023[1]. - Total operating expenses decreased to $239.8 million from $267.2 million in 2023, a reduction of $27.4 million[1]. - Research and development expenses decreased to $20.8 million from $49.6 million in 2023, primarily due to strategic restructuring efforts[1][6]. - Restructuring expenses for 2024 were $23.1 million, compared to nil in 2023, following a headcount reduction of approximately 25%[1][7]. - The company expects SG&A expenses to decrease in 2025 as it realizes the benefits of its strategic restructuring efforts[1][9]. Cash and Investments - As of December 31, 2024, Aurinia had cash, cash equivalents, restricted cash, and investments of $358.5 million, compared to $350.7 million at December 31, 2023[21]. - The company has cash, cash equivalents, restricted cash, and investments totaling $358.5 million as of December 31, 2024, with LUPKYNIS being the only approved product generating net sales[140]. - A hypothetical 1% increase or decrease in interest rates would have resulted in a $2.8 million fluctuation of annual interest income in the investment portfolio[206]. - The Company recognized a $72.5 million finance lease liability related to the Monoplant agreement, which is denominated in Swiss Francs[207]. - A hypothetical 10% increase or decrease in the Swiss Franc compared to the U.S. dollar would have a $7.5 million fluctuation in the valuation of the lease liability[207]. - The Company maintains cash balances with reputable financial institutions and has not experienced any losses associated with credit risk[209]. - The investment policy limits excess cash investments to certain types of instruments, ensuring a conservative approach to managing financial risk[209]. Product Development and Regulatory Approvals - Aurinia entered into a collaboration and licensing agreement with Otsuka for the development and commercialization of LUPKYNIS in multiple territories, receiving a $50 million upfront cash payment[22]. - Otsuka has obtained regulatory approval for LUPKYNIS in Japan, the EU, the UK, and Switzerland[24]. - AUR200 is being developed as a dual inhibitor of BAFF and APRIL for the potential treatment of autoimmune diseases[43]. - AUR200 has shown high binding affinity for both BAFF and APRIL compared to competitor inhibitors[47]. - The American College of Rheumatology now recommends triple immunosuppressive therapy, including calcineurin inhibitors like LUPKYNIS, as first-line therapy for lupus nephritis[42]. - LUPKYNIS demonstrated a significantly higher rate of complete renal response compared to standard treatments in the pivotal Phase 3 AURORA 1 study[35]. - AUR200 demonstrated an IC50 of 0.02 nM, significantly outperforming Atacicept (0.38 nM, 19.0x) and Telitacicept (1.05 nM, 52.5x) in preclinical testing[52]. - AUR200 resulted in significant and sustained reductions in B cell antibodies IgA and IgM in non-human primates, with no adverse findings reported[52]. - The New Chemical Entity (NCE) exclusivity for LUPKYNIS in the U.S. extends until January 22, 2026, providing 5 to 7.5 years of market exclusivity[56]. - NCE-equivalent exclusivity for voclosporin in certain European countries provides 10 years of exclusivity post-approval, with 8 years in Japan[57]. - The construction of a dedicated manufacturing facility for voclosporin (Monoplant) began in January 2021, with manufacturing commencing in June 2023[65]. - The company pays a quarterly fixed facility fee of approximately $4.0 million for the exclusive right to use the Monoplant through March 31, 2030[65]. Market and Competitive Landscape - LUPKYNIS is the only FDA-approved oral therapy for adult patients with active lupus nephritis, facing competition from injectable treatments and off-label therapies[62]. - The commercial success of LUPKYNIS is heavily dependent on third-party reimbursement policies and pricing regulations in the U.S. and other markets[99]. - The potential market size for LUPKYNIS is based on prescription and sales data, and if the market size is smaller than estimated, commercial prospects may be limited[91]. - LUPKYNIS's commercial prospects may be limited due to unfavorable pricing regulations and third-party reimbursement policies[101]. - The company reported various commercial metrics for LUPKYNIS, including the number of prescriptions and patient persistency rates, but these metrics do not directly correlate to financial performance[104]. - Net product sales are primarily from two specialty pharmacies and a distributor in the U.S., with revenue from collaboration partner Otsuka for the European and Japanese markets[105]. Legal and Regulatory Risks - A paragraph IV notice of certification was received on February 25, 2025, regarding a generic version of LUPKYNIS, alleging invalidity of the 2037 Patents[60]. - The company intends to vigorously defend LUPKYNIS and its intellectual property rights, which may delay FDA approval of any ANDA for 7.5 years from the NDA approval date[61]. - The company faces significant regulatory risks due to various foreign regulations governing clinical studies and commercial sales, which can differ substantially from U.S. FDA approval processes[75]. - The Inflation Reduction Act of 2022 includes drug pricing reforms that could significantly impact the company's future business, including a drug price negotiation program[79]. - The company may face product liability lawsuits, which could incur substantial liabilities and reduce LUPKYNIS sales[92]. - The company may face significant patent litigation costs due to a paragraph IV notice related to a generic version of LUPKYNIS, which could lead to a decline in net product sales[109]. - Compliance with ongoing post-marketing obligations for LUPKYNIS may lead to product recalls or increased regulatory actions, potentially affecting sales and costs[125]. - The company is subject to various federal, state, and foreign laws that could result in substantial penalties for noncompliance, impacting operations[133]. Operational and Strategic Initiatives - The company announced a strategic restructuring that reduced headcount by approximately 25% and later by an additional 45% to focus on LUPKYNIS growth and AUR200 development[117]. - The company relies on sole-source contract manufacturers for LUPKYNIS and AUR200, making uninterrupted supply critical for commercial success[127]. - The company faces risks related to reliance on third parties for distribution and clinical studies, which could delay commercialization efforts[128]. - The company has never paid dividends on common shares, and future dividends will depend on operational results and financial conditions[139]. - The company has not experienced material adverse effects from cybersecurity threats to date[156]. - Aurinia's business continuity program was refreshed in 2024 to enhance resilience against potential threats, including cyber-attacks[155]. - Aurinia's cybersecurity risk management program is part of its overall risk management framework, with regular assessments and updates to ensure security[152][155]. - The company’s Chief Information Officer has over 20 years of experience in information security and has been in the role since 2021[158]. - Management concluded that the disclosure controls and procedures were effective as of December 31, 2024[215]. Employee Relations - As of February 26, 2025, the company had 130 employees and maintains good relations with them, with no employees represented by labor unions[83].

Aurinia Pharmaceuticals Inc.'s (NASDAQ: AUPH ) sole approved product, Lupkynis, for the treatment of lupus nephritis, didn't produce strong product revenue growth going from Q2'24 to Q3'24. The stock is now approaching Q4'24 earnings and a resumption of sales growth could again produce a rallyScientist and trader of biotech stock. Focus on trading around events such as trial results and NDA/BLA approvals. Also covering companies in industries regulated by the FDA. Articles present my opinion on stocks, but ...

Core Viewpoint - Aurinia Pharmaceuticals (AUPH) has received a Zacks Rank 2 (Buy) upgrade, indicating a positive earnings outlook that may lead to increased stock price [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system emphasizes the importance of earnings estimate revisions, which are strongly correlated with stock price movements [4][6]. - Aurinia is projected to earn $0.05 per share for the fiscal year ending December 2024, reflecting a year-over-year increase of 109.3% [8]. - Over the past three months, the Zacks Consensus Estimate for Aurinia has risen by 23.9% [8]. Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating [9][10]. - The upgrade of Aurinia to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Group 1 - The biotech sector has faced challenges, with small biotech stocks experiencing a decline of over 15% in the past ten weeks, as indicated by the SPDR® S&P Biotech ETF (XBI) performance [2] - The Biotech Forum offers a model portfolio featuring 12-20 high upside biotech stocks, along with live chat discussions for trade ideas and weekly market commentary [2] - The community has been focusing on buy-write or covered call strategies on selected biotech stocks, highlighting potential trading opportunities [1] Group 2 - The Biotech Forum provides regular updates on market conditions and portfolio performance every weekend, which is beneficial for investors seeking insights [2] - Analysts within the forum have disclosed beneficial long positions in specific biotech stocks, indicating a vested interest in the sector [3]

Core Insights - Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) has recently released solid Q3 financial results, indicating strong performance and potential for growth [2]. Company Overview - Aurinia Pharmaceuticals is a small biopharma company that has been identified as undervalued, with previous analyses suggesting significant upside potential for its stock [2]. Market Commentary - The Biotech Forum has been actively discussing buy-write or covered call opportunities on selected biotech stocks, including Aurinia, highlighting the interest in trading strategies within the biotech sector [1].