AC Immune (ACIU) came out with a quarterly loss of $0.21 per share versus the Zacks Consensus Estimate of a loss of $0.22. This compares to loss of $0.21 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 4.55%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.21 per share when it actually produced a loss of $0.18, delivering a surprise of 14.29%.Over the last four quarters, the company h ...

AC Immune Reports Further Positive Interim Results from Phase 2 Trial of ACI-7104.056 Active Immunotherapy in Early Parkinson's Disease Active immunotherapy with ACI-7104.056 induces high anti-a-synuclein (a-syn) antibody levels on average over 20-fold higher than placebo after 4 immunizationsRepeated immunizations amplify the anti-a-syn antibody response, supporting boostability and the potential to further increase antibody titersACI-7104.056 is well tolerated with no safety issues reported to date Lausan ...

Core Insights - AC Immune SA is set to present its precision medicine pipeline at the International Conference on Alzheimer's and Parkinson's Diseases (AD/PD™ 2025) in Vienna, Austria, from April 1 to 5, 2025, focusing on active immunotherapies for neurodegenerative diseases [1][4] Group 1: Upcoming Presentations - The company will host an industry symposium on April 2, 2025, featuring key opinion leaders discussing advances in clinical development of active immunotherapies [2] - Presentations will cover topics such as disease modification in Parkinson's disease, targeting alpha-synuclein, and precision prevention strategies for Alzheimer's disease [2][3] - The symposium will include a Q&A session and a replay will be available on AC Immune's website [2] Group 2: Research and Development Highlights - AC Immune's pipeline includes Morphomer® small molecules targeting Tau for Alzheimer's disease treatment, with a presentation scheduled for April 5, 2025 [3] - The company is developing Morphomer-antibody drug conjugates, a new class of drugs for neurodegenerative diseases [3] - Research on therapeutic small molecules targeting alpha-synuclein aggregation will also be presented [3] Group 3: Company Overview - AC Immune is a clinical-stage biopharmaceutical company focused on precision prevention for neurodegenerative diseases, leveraging its two technology platforms, SupraAntigen® and Morphomer® [6] - The company has a diversified pipeline featuring candidates in Phase 2 and Phase 3 development, with significant strategic partnerships leading to over $4.5 billion in potential milestone payments and royalties [6]

Core Viewpoint - AC Immune (ACIU) has underperformed the industry, sector, and S&P 500 Index, with shares declining by 18.3% over the past month despite better-than-expected fourth-quarter results [1][4]. Company Overview - AC Immune is a clinical-stage biopharmaceutical company based in Switzerland, focusing on developing drugs for neurodegenerative diseases using its proprietary technology platforms, SupraAntigen and Morphomer [5]. Pipeline Development - The company is advancing multiple therapeutic and diagnostic programs targeting misfolded proteins associated with Alzheimer's disease (AD), Parkinson's disease (PD), and other neurodegenerative disorders [5]. - Key candidates include: - ACI-24.060, an anti-Abeta immunotherapy for AD, currently in phase Ib/II ABATE study [6]. - ACI-7104.056, targeting pathological a-syn, in phase II study (VacSYn) [7]. - ACI-35.030/JNJ-2056, evaluated in preclinical AD in phase IIb ReTain study [7]. - P2620, a Tau-PET imaging agent in late-stage clinical development for AD [8]. Collaborations and Funding - AC Immune has secured strategic collaborations with major pharmaceutical companies, including an exclusive agreement with Takeda for its active immunotherapies, receiving an upfront payment of $100 million and potential total payments of up to $2.1 billion [9][10]. - Collaboration with Janssen Pharmaceuticals has also led to milestone payments due to rapid prescreening in the ReTain trial [11]. Financial Position - As of December 31, 2024, AC Immune reported cash resources of CHF 165.5 million, expected to sustain operations through the first quarter of 2027, assuming no additional milestones are met [12]. Valuation Metrics - ACIU shares are currently trading at a price/sales ratio of 6.15x, which is above its historical mean of 5.30x and the industry average of 1.70x [13]. Earnings Estimates - The loss per share estimate for 2025 has increased to 49 cents over the past 30 days, indicating a downward revision trend [14][15]. Market Outlook - The market for neurodegenerative diseases is anticipated to grow significantly, with potential positive data readouts for key candidates expected to enhance investor sentiment [8][16].

ANNUAL REPORT 2024 Our goal is global leadership in Precision Medicine for the diagnosis and treatment of neurodegenerative diseases we are executing a clear business strategy built on three pillars: alzheimer's disease accelerate development of novel therapeutics in ad with our partners parkinson's and neuro orphans expand our strategic focus in parkinson's disease (pd) and non-ad neurodegenerative diseases, including neuroorphan indications and limbic-predominant age-related tdp-43 encephalopathy (late) d ...

Company Overview - The company is a clinical stage biopharmaceutical entity with no products approved for sale and anticipates incurring losses for the foreseeable future [55]. - The company has no history of commercializing biologics or pharmaceutical products, making it challenging to predict future success [111]. - The company has never generated any revenue from product sales and relies on upfront and milestone payments from collaboration agreements for liquidity [218]. Product Development and Clinical Trials - The company has invested significantly in the development of active immunotherapies and diagnostics, including ACI-35.030, ACI-24.060, and Tau-PET tracer PI-2620, all of which are currently in clinical development [58]. - The company currently generates no revenues from drug or diagnostic sales and does not expect to generate product revenues for several years, if ever [58]. - The success of the company's product candidates heavily relies on achieving clinical and regulatory milestones, which have low probabilities of success in the CNS space [49]. - Patient enrollment in clinical studies is critical; delays could increase costs and hinder product development [85]. - The company has conducted clinical studies outside the U.S., and there is no assurance that data from these studies will be accepted by regulatory authorities [55]. - The company has not yet demonstrated the ability to successfully complete large-scale clinical studies or obtain marketing approval for its product candidates, which may affect future viability [111]. - Regulatory approval is necessary for the commercialization of product candidates, and the company cannot guarantee success in obtaining such approvals [232]. Financial Condition and Funding - The company incurred a net loss of CHF 50.9 million for the year ended December 31, 2024, with accumulated losses totaling CHF 368.2 million as of the same date [215]. - Significant operating losses are expected to continue as the company advances research and development efforts for current and future product candidates [216]. - The company has financed its liquidity requirements primarily through public offerings, share issuances, and contract revenues from collaboration agreements [217]. - The company may require additional capital to develop and commercialize product candidates, with potential significant commercialization expenses depending on the chosen market [224]. - The company expects research and development expenses to continue to increase due to ongoing studies and new studies for product candidates, including ACI-35.030, ACI-24.060, and ACI-7104.056 [222]. - The company holds a significant in-process research and development (IPR&D) asset valued at CHF 50.4 million, which carries a risk of impairment if associated R&D efforts are abandoned [231]. Competition and Market Risks - The company faces intense competition from large biopharmaceutical firms and may not achieve market acceptance for its products even if regulatory approval is obtained [49]. - The company faces potential competition from generic versions of its products, which could lead to a material decline in sales [70]. - If the company's active immunotherapies and diagnostics receive approval, competitors may file ANDAs or 505(b)(2) NDAs for generic versions [71]. - Market acceptance of the company's products is uncertain, and failure to achieve it could adversely affect revenue generation [81]. - The company operates in a highly competitive industry, facing significant challenges from larger competitors with more resources [93]. Intellectual Property and Legal Risks - The company may not successfully secure or maintain patent protection, which could lead to rapid sales declines and potential write-offs of intangible assets [74]. - The company may face challenges regarding inventorship claims that could result in loss of valuable intellectual property rights [176]. - The company is dependent on third-party manufacturers, which poses risks of production delays and quality control issues [155]. - The company may face risks related to potential intellectual property infringement claims that could materially affect its ability to commercialize product candidates [198]. - The company’s ability to protect its intellectual property rights globally is limited, which may allow competitors to use its technologies in jurisdictions without adequate patent protection [204]. Strategic Alliances and Collaborations - The company may seek additional strategic alliances for its product candidates, and failure to realize benefits from these alliances could adversely affect its financial condition [49]. - The company has strategic partnerships with Eli Lilly, Janssen, Life Molecular Imaging, and Takeda, which are crucial for the development and commercialization of its product candidates [141]. - In April 2024, the termination of collaboration agreements with Genentech became effective, allowing the company to regain global rights to certain product candidates [142]. - The company may seek orphan-drug designation for certain product candidates, which could provide market exclusivity but does not guarantee it [118]. Regulatory and Compliance Risks - The company is subject to various risks, including potential delays in obtaining marketing approvals and the possibility of not obtaining approvals at all [65]. - The company faces risks related to compliance with FDA regulations and potential manufacturing defects, which could adversely affect its business and reputation [154]. - The company anticipates increasing regulatory burdens and costs associated with the use of artificial intelligence in its operations [213]. - Compliance with evolving data privacy laws, such as the GDPR, may incur additional costs and operational restrictions, impacting business practices [131]. Economic and Geopolitical Factors - Economic factors such as rising interest rates and high inflation could increase operational costs and affect the company's ability to raise capital [101]. - The ongoing geopolitical conflicts, including those between Russia and Ukraine, may disrupt the company's supply chain and impact clinical trials [100]. - The geopolitical landscape, including conflicts like Russia-Ukraine, may heighten cybersecurity risks for the company and its partners [128]. Technology and Cybersecurity Risks - Rapid technological changes in the industry could render the company's products obsolete, affecting financial performance [94]. - Cybersecurity risks are increasing, with potential vulnerabilities in the company's technology systems that could disrupt operations and affect development programs [123]. - Data privacy and security breaches pose significant risks, with potential exposure of sensitive information leading to financial and reputational harm [124].

Core Insights - AC Immune SA reported significant advancements in its pipeline for neurodegenerative diseases, including a landmark deal with Takeda worth up to $2.1 billion, which includes a $100 million upfront payment [3][5][6] - The company achieved encouraging clinical data from its active immunotherapy programs, particularly ACI-7104.056 and ACI-24.060, and received U.S. FDA Fast Track designation for ACI-35.030 [3][5][6] - Financial results showed an increase in contract revenues to CHF 27.3 million for 2024, up from CHF 14.8 million in 2023, and a cash position of CHF 165.5 million, providing funding into Q1 2027 [14][26] Financial Performance - Total cash resources increased to CHF 165.5 million as of December 31, 2024, compared to CHF 103.1 million in 2023, ensuring operational funding into Q1 2027 [14][26] - Contract revenues for 2024 were CHF 27.3 million, significantly higher than CHF 14.8 million in the previous year, driven by milestone payments from partnerships with Janssen and Takeda [14][26] - The company reported a net loss of CHF 50.9 million for 2024, an improvement from a net loss of CHF 54.2 million in 2023 [14][26] Pipeline and Clinical Developments - ACI-24.060's ABATE Phase 1b/2 trial showed positive interim safety and tolerability data, with further results expected in 2025 [5][6] - ACI-35.030 (JNJ-2056) received U.S. FDA Fast Track designation, and the second milestone payment of CHF 24.6 million was triggered by rapid prescreening rates in the ReTain trial [11][14] - ACI-7104.056 demonstrated positive interim results in the VacSYn Phase 2 trial for Parkinson's disease, with further results anticipated in H1 2025 [5][11] Strategic Partnerships - The exclusive option and license agreement with Takeda for ACI-24.060 includes potential milestone payments of up to approximately $2.1 billion and tiered royalties on sales upon commercialization [5][6] - The partnership with Janssen resulted in a CHF 24.6 million milestone payment, reflecting the rapid progress in the ReTain trial for ACI-35.030 [11][14] Research and Development - R&D expenditures increased to CHF 62.6 million in 2024, primarily due to heightened clinical activities in ongoing trials [14][26] - The company is advancing multiple early-stage assets, including small molecule candidates targeting NLRP3 and Tau, with lead candidates expected to be selected in 2025 [3][14] Future Outlook - The company anticipates significant milestones in 2025, including interim results from the ABATE trial and further developments in its small molecule programs [13][14] - Total cash expenditure for 2025 is expected to be in the range of CHF 75–85 million, reflecting ongoing investment in clinical development [16]

Core Viewpoint - AC Immune (ACIU) has received an upgrade to a Zacks Rank 1 (Strong Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system is based solely on a company's changing earnings picture, with the Zacks Consensus Estimate tracking EPS estimates from sell-side analysts [1][2]. - A positive earnings outlook for AC Immune is expected to create buying pressure and increase its stock price [3][5]. - The correlation between changes in earnings estimates and near-term stock price movements is strong, with institutional investors using these estimates to determine fair value [4][6]. Recent Earnings Estimate Revisions - For the fiscal year ending December 2024, AC Immune is projected to earn -$0.62 per share, reflecting a 12.7% change from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for AC Immune has increased by 71%, indicating a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - The upgrade of AC Immune to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Company Overview - AC Immune SA is a clinical-stage biopharmaceutical company focused on precision medicine for neurodegenerative diseases, including Alzheimer's and Parkinson's diseases, utilizing misfolded proteins as a target [3] - The company has two clinically validated technology platforms, SupraAntigen and Morphomer, which support a diverse pipeline of sixteen therapeutic and diagnostic programs, with five in Phase 2 and one in Phase 3 development [3] - AC Immune has established strategic partnerships with leading global pharmaceutical companies, resulting in over $4.5 billion in potential milestone payments and royalties [3] Upcoming Events - AC Immune management will participate in the Leerink Partners 2025 Global Healthcare Conference on March 10, 2025, and the Barclays 27th Annual Global Healthcare Conference on March 11, 2025 [6]

Core Viewpoint - AC Immune (ACIU) has experienced significant selling pressure, resulting in a 9.7% decline over the past four weeks, but analysts anticipate improved earnings in the near future [1] Group 1: Technical Analysis - The Relative Strength Index (RSI) is utilized to identify oversold stocks, with a reading below 30 indicating oversold conditions [2] - ACIU's current RSI reading of 22.69 suggests that the heavy selling may be exhausting, indicating a potential bounce back towards equilibrium [5] Group 2: Fundamental Analysis - There has been a consensus among sell-side analysts to raise earnings estimates for ACIU, with a 16.7% increase in the consensus EPS estimate over the last 30 days [6] - An upward trend in earnings estimate revisions typically correlates with price appreciation in the near term [6] Group 3: Analyst Ratings - ACIU holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises [7]