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 Inc. (NASDAQ:AUPH) Q4 2024 Earnings Conference Call February 27, 2025 8:30 AM ET Company Participants Andrea Christopher - Head, Corporate Communications and Investor Relations Peter Greenleaf - President, Chief Executive Officer and Director Joe Miller - Chief Financial Officer Greg Keenan - Chief Medical Officer Conference Call Participants Vishwesh Shah - TD Cowen Olivia Brayer - Cantor Fitzgerald Farzin Haque - Jefferies Will Soghikian - Leerink Partners Ed Arce - H.C. Wainwright ...

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].

Financial Data and Key Metrics Changes - For Q3 2024, total net revenue was $67.8 million, a 24% increase from $54.5 million in Q3 2023 [6][16] - Net product revenue for Q3 2024 was $55.5 million, up 36% from $40.8 million in Q3 2023 [6][17] - Cash flow from operations was approximately $17 million in Q3 2024, compared to a cash outflow of $13.3 million in Q3 2023 [7][16] - The company recorded a net income of $14.4 million, or $0.10 per share, compared to a net loss of $13.4 million, or $0.09 per share, in Q3 2023 [22] Business Line Data and Key Metrics Changes - The company added 364 PSFs and 146 new patients in Q3 2024, totaling 510, a 17% increase from 436 PSFs in Q3 2023 [8] - Total patients on LUPKYNIS therapy grew by 25%, reaching approximately 2,422 patients as of September 30, 2024, compared to 1,939 patients a year earlier [8] Market Data and Key Metrics Changes - The Japanese regulatory approval of LUPKYNIS triggered a $10 million milestone payment, with expectations of low double-digit royalties on net sales once launched in Japan [11] - Presentations at the American Society of Nephrology Kidney Week highlighted LUPKYNIS's role in treating lupus nephritis, particularly in affected populations [11][12] Company Strategy and Development Direction - The company is restructuring operations to enhance commercial and R&D efforts, aiming for a more focused operational strategy [13] - The restructuring will involve a workforce reduction of approximately 45%, with expected annualized cash-based operating expense savings of over $40 million [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business despite the restructuring, reaffirming 2024 revenue guidance [25] - The company anticipates continued growth driven by patient restarts and hospital-based sales, with a focus on maintaining high persistency rates [31] Other Important Information - The gross margin for Q3 2024 was 91%, compared to 88% in Q3 2023, while the gross margin for the first nine months of 2024 was 87%, down from 93% in the same period of 2023 [20] - Research and development expenses significantly decreased due to headcount reductions and the cessation of the AUR300 development program [21] Q&A Session Summary Question: Insights on restructuring and competitive positioning for AUR200 - Management clarified that the restructuring is based on a thorough review of business drivers and is not a sign of lack of confidence in the business [25][26] Question: Commentary on fourth quarter sales and guidance - Management feels comfortable with the current guidance range and noted potential factors affecting sales, including year-end insurance changes and holiday impacts [30] Question: Insights from the ENLIGHT-LN study on lupus nephritis treatment - Management indicated that the restart phenomenon is influenced by physician practices and guidelines, with expectations for increased persistency in treatment [31][32] Question: Dose levels and safety considerations for AUR200 - Management stated that dosing strategies will be determined through ongoing clinical studies, with a focus on balancing efficacy and safety [34] Question: Commentary on PSFs and sales environment - Management acknowledged the importance of PSFs but emphasized the need to consider restarts and hospital sales as part of the overall growth strategy [39]

分组1 - Aurinia Pharmaceuticals reported quarterly earnings of $0.10 per share, exceeding the Zacks Consensus Estimate of $0.02 per share, compared to a loss of $0.09 per share a year ago, representing an earnings surprise of 400% [1] - The company posted revenues of $67.77 million for the quarter ended September 2024, surpassing the Zacks Consensus Estimate by 14.74%, and compared to year-ago revenues of $54.52 million [2] - Aurinia has surpassed consensus EPS estimates three times over the last four quarters and topped consensus revenue estimates four times in the same period [2] 分组2 - The stock has underperformed the market, losing about 16.4% since the beginning of the year, while the S&P 500 gained 24.3% [3] - The current consensus EPS estimate for the coming quarter is $0.11 on revenues of $68.33 million, and for the current fiscal year, it is $0.04 on revenues of $235.59 million [7] - The Zacks Industry Rank for Medical - Drugs is currently in the top 33% of over 250 Zacks industries, indicating that the industry outlook can significantly impact stock performance [8]