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5 Small Drug Stocks to Buy as Tariff-Related Uncertainty Looms
ZACKS· 2025-04-23 14:35
Industry Overview - The biotech industry is facing pressure due to global uncertainties, particularly from the tariff war, which may target pharmaceuticals in future rounds [1] - The Zacks Medical-Drugs industry consists of small to medium-sized drug companies that produce medicines for human and veterinary use, often relying on a limited portfolio of marketed drugs [4] Current Trends - Despite challenges, the Zacks Medical-Drugs industry is showing promising trends due to positive pipeline news and regulatory successes, with expectations for increased innovation and M&A activity [3] - The industry has outperformed the S&P 500 but slightly underperformed the Zacks Medical sector, with a year-to-date decline of 7.3% compared to the S&P 500's decline of 12.3% [11] Key Factors Influencing the Industry - Pipeline success is crucial, as the outcomes of clinical studies can significantly impact stock prices [5] - Strong collaboration with larger drugmakers is a positive indicator for small pharma companies, with M&A activity signaling growth [6] - Investment in technology and personalized medicine is essential for smaller companies to adapt to the evolving healthcare landscape [7] Company Highlights - **Heron Therapeutics**: Key drug Zynrelef saw a 44.1% sales increase in 2024, with expectations for transformational growth in 2025. The stock has risen 40.5% year-to-date [17][18] - **Esperion Therapeutics**: The company has two approved drugs with improving prescription trends, although its stock has declined 57.7% year-to-date [21][22] - **Pyxis Oncology**: Focused on next-generation cancer therapeutics, the stock has declined 34.6% year-to-date, but the consensus estimate for 2025 losses has narrowed [24][26] - **Plus Therapeutics**: Developing targeted radiotherapeutics for CNS cancers, the stock has declined 31.5% year-to-date, with improving loss estimates for 2025 [28][30] - **Aurinia Pharmaceuticals**: The company reported a 36% sales growth for Lupkynis in 2024, with ongoing studies for expanded patient populations. The stock has declined 12.1% year-to-date [32][33]
Aurinia Pharmaceuticals(AUPH) - 2024 Q4 - Earnings Call Transcript
2025-02-27 22:27
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]
Autoimmune Disease-Focused Aurinia Pharmaceuticals Reports Quarterly Profit, Revenue Outlook Below Expectations
Benzinga· 2025-02-27 19:11
Financial Performance - Aurinia Pharmaceuticals reported fourth-quarter earnings of $0.01 per share, an improvement from a loss of $0.19 per share a year ago and better than the consensus loss of $0.02 [1] - Fourth-quarter sales reached $59.9 million, reflecting a 33% year-over-year increase, aligning with the consensus estimate [1] - For the full year 2024, net product sales were $216.2 million, up 36%, within the management guidance of $210 million to $220 million [2] - The company reported an operating loss of $1.67 million, significantly reduced from a loss of $29.7 million in the previous year [2] - Aurinia achieved a net income of $1.43 million, a notable improvement from a loss of $26.9 million [2] Product Performance - Net product sales of LUPKYNIS, the first FDA-approved oral therapy for active lupus nephritis, amounted to $57.6 million, marking a 36% increase [4] - License, collaboration, and royalty revenue, which includes manufacturing services revenue and royalties from collaboration partner Otsuka, totaled $2.3 million, down 18% [4] Future Outlook - The CEO of Aurinia anticipates 2025 to be a pivotal year for increasing the adoption of LUPKYNIS and advancing AUR200, which has potential applications in treating various autoimmune diseases [3] - The company expects fiscal year revenue guidance of $250 million to $260 million, compared to the consensus estimate of $274.4 million [3] Stock Performance - Following the earnings report, Aurinia's stock declined by 6.35%, trading at $7.45 [3]
Aurinia Pharmaceuticals(AUPH) - 2024 Q4 - Earnings Call Transcript
2025-02-27 15:32
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]
Aurinia Pharmaceuticals (AUPH) Beats Q4 Earnings and Revenue Estimates
ZACKS· 2025-02-27 13:10
Core Viewpoint - Aurinia Pharmaceuticals reported quarterly earnings of $0.09 per share, exceeding the Zacks Consensus Estimate of $0.03 per share, and showing a significant improvement from a loss of $0.19 per share a year ago, indicating strong performance in the biotechnology sector [1][2] Financial Performance - The company achieved revenues of $59.87 million for the quarter ended December 2024, surpassing the Zacks Consensus Estimate by 0.25%, and reflecting a year-over-year increase from $45.1 million [2] - Over the last four quarters, Aurinia has consistently surpassed consensus EPS estimates, achieving an earnings surprise of 200% in the latest quarter and 400% in the previous quarter [1][2] Stock Performance and Outlook - Aurinia shares have underperformed the market, losing approximately 11.5% since the beginning of the year, while the S&P 500 has gained 1.3% [3] - The current consensus EPS estimate for the upcoming quarter is $0.11 on revenues of $63.6 million, and for the current fiscal year, it is $0.55 on revenues of $281.87 million [7] Industry Context - The Medical - Drugs industry, to which Aurinia belongs, is currently ranked in the top 50% of over 250 Zacks industries, suggesting a favorable environment for stock performance [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5][6]
Aurinia Pharmaceuticals(AUPH) - 2024 Q4 - Annual Report
2025-02-27 11:12
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: There's Still Time For Sales Growth
Seeking Alpha· 2025-02-21 21:09
Core Insights - Aurinia Pharmaceuticals Inc.'s sole approved product, Lupkynis, for lupus nephritis treatment, did not show strong revenue growth from Q2'24 to Q3'24 [1] - The stock is nearing Q4'24 earnings, and a potential resumption of sales growth could lead to a rally [1] Company Overview - Aurinia Pharmaceuticals focuses on the development and commercialization of therapies for kidney diseases, particularly lupus nephritis [1] Market Context - The biotech sector is influenced by events such as trial results and NDA/BLA approvals, which can significantly impact stock performance [1]
Aurinia (AUPH) Upgraded to Buy: Here's Why
ZACKS· 2025-01-22 18:00
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].
3 Biotech Stocks With Notable Insider Buying
Seeking Alpha· 2025-01-22 17:29
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]
Aurinia Pharmaceuticals: A Potential Buyout Looms On The Horizon
Seeking Alpha· 2024-11-08 17:15
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].