AC Immune(US:ACIU)2024-03-13 16:00Financial Position - Cash and cash equivalents totaled CHF 103.0 million as of December 31, 2023[4]. - The company raised USD 50 million in a focused financing transaction in December 2023, extending its cash runway into 2026[11]. - The total value of collaboration agreements is approximately CHF 2,600 million, with upfront payments and milestones received to date totaling CHF 147.4 million[59]. - The company successfully raised USD 50 million through an equity offering in December, strengthening its financial position[94]. Research and Development - Research and development expenditure for the year was CHF 54.6 million[4]. - The company has 9 clinical programs and employs 161 people worldwide[4]. - The company is advancing 16 therapeutic and diagnostic programs, with one in Phase 3 and five in Phase 2 clinical development[22]. - The first-in-class vaccine candidate ACI-35.030 has entered a Phase 2b clinical trial, with an initial CHF 15 million milestone payment and an expected CHF 25 million upon achieving a patient enrollment target[10]. - The company is advancing ACI-24.060, an anti-Abeta active immunotherapy, in a Phase 1b/2 trial, with data expected in H1 2024[52]. - ACI-7104.056, targeting a-synucleinopathies, is currently in a Phase 2 study, with the first patient dosed in July 2023 and cohort 1 enrollment completed in December 2023[53]. - AC Immune received Fast Track designation from the FDA for ACI-24.060 for AD treatment, following the clearance of the Investigational New Drug application in May 2023[53]. - AC Immune's clinical stage pipeline includes multiple product candidates targeting key proteins involved in neurodegenerative diseases[53]. - ACI-35.030 generated a rapid antibody response after the first injection, with a strong response against pathological Tau species observed at mid- and high doses[55]. - A Phase 2b study for ACI-35.030 will randomize approximately 500 participants with confirmed early-stage Tau pathology, with the first patient dosed in H1 2024[55]. - PI-2620 is advancing into late-stage clinical development for Alzheimer's disease, with the first patient imaged in January 2023[55]. - ACI-12589 has been clinically validated as a-a-syn-PET tracer, with IND/CTA-enabling studies for its next-generation candidate ACI-15916 planned to start in Q1 2024[55]. - The company aims to shift the treatment paradigm towards earlier intervention and prevention of neurodegeneration[15]. - Active immunotherapies are designed to stimulate the immune system to produce antibodies against pathological proteins, potentially modifying disease progression[51]. - The company is developing integrated diagnostic and therapeutic strategies to provide tailored treatments for neurodegenerative conditions[50]. - AC Immune's strategy focuses on three pillars: accelerating novel therapeutics development in Alzheimer's disease (AD), expanding into Parkinson's disease (PD) and non-AD neurodegenerative diseases, and enhancing diagnostics for Precision Medicine[41]. - The company aims to address co-pathologies in neurodegenerative diseases through a Precision Medicine approach, potentially increasing treatment success rates[42]. Market Opportunity - The estimated global patient population for dementia is projected to increase from over 50 million in 2020 to 139 million by 2050[25]. - The total healthcare costs for Alzheimer's disease in the U.S. were estimated at USD 321 billion in 2022, with worldwide costs expected to reach approximately USD 2.8 trillion annually by 2030[26]. - Over 400 million people globally could benefit from active immunotherapy, addressing the need for preventive therapies in neurodegenerative diseases[86]. - The global annual cost of treating dementia is estimated at USD 1 trillion, highlighting the economic burden of neurodegenerative diseases[86]. - The population at risk of developing preclinical Alzheimer's disease is estimated at over 300 million, indicating a significant market opportunity[82]. Sustainability and Governance - AC Immune achieved an 11.2% reduction in electricity usage from 2022 to 2023, reflecting targeted environmental strategies[112]. - The company has ambitious recycling targets of 70% as part of its waste management strategies[112]. - AC Immune provides up to a 30% annual subsidy for public transport fares to promote sustainable commuting[113]. - The company actively tracks and aligns with the Sustainable Development Goals (SDGs) among over 3,000 diverse companies[112]. - AC Immune's Board of Directors maintains a majority-independent structure, with 86% independent directors[126]. - The average age of directors on the Board is 61 years, with an average tenure of 4 years[126]. - The company has implemented a Quality Management System (QMS) to ensure compliance and facilitate innovation throughout the product lifecycle[120]. - AC Immune's cybersecurity program is designed based on the COBIT 2019 framework to protect sensitive information and mitigate cyber threats[119]. Executive Compensation and Management - The total executive management compensation for 2023 amounted to CHF 2,603,000, with a cash bonus component of CHF 1,104,000[157]. - The total compensation for the Board of Directors in 2023 was CHF 935,000, a decrease from CHF 1,256,000 in 2022[155][156]. - Andrea Pfeifer, Ph.D., the CEO, received a total compensation of CHF 578,000 in cash, along with CHF 468,000 as a cash bonus[157]. - The company appointed Nuno Mendonça, M.D. as Chief Medical Officer in October 2023, succeeding Johannes Streffer, M.D.[154]. - Madiha Derouazi, Ph.D. will serve as Chief Scientific Officer starting January 1, 2024, following her role as CEO at Speransa Therapeutics[139]. - The Board of Directors consists of six directors and the CEO, with members elected for a renewable one-year term[148]. - The compensation structure for board members includes fixed fees and equity instruments, with annual fixed fees paid semi-annually in Swiss Francs[150]. - The company follows Swiss rules for board governance instead of NASDAQ exchange listing rules, allowing for a non-majority independent board[149]. - The total gross cash compensation for the Board of Directors in 2023 was CHF 500,000, compared to CHF 549,000 in 2022[155][156]. - The company has a focus on expanding its executive team with experienced leaders from the biopharmaceutical industry to enhance its operational capabilities[138][139]. - Total Executive Management Compensation for 2023 was CHF 3,555,000, a decrease from CHF 3,555,000 in 2022[159]. - The company paid CHF 332,000 in social security contributions for Executive Management in 2023, down from CHF 349,000 in 2022[159]. - The Chief Executive Officer, Andrea Pfeifer, received total compensation of CHF 993,000 in 2022, which included CHF 558,000 in cash compensation and CHF 575,000 in equity fair market value[159]. - As of December 31, 2023, the total number of unvested Restricted Share Units held by the Board of Directors was 432,776[164]. - The total number of vested Stock Options for the Chief Executive Officer in 2023 was 894,038, with 683,096 unvested[169]. - AC Immune's compensation philosophy aims to attract and retain top talent by offering a competitive total compensation package[174]. - The company engaged a remuneration expert in 2023 to analyze compensation levels, concluding that adjustments were necessary to remain competitive[175]. - No loans or compensation were provided to members or former members of the Executive Management in 2023 or 2022[163]. - The total number of vested Restricted Share Units for the Chief Executive Officer in 2023 was 131,435[169]. - The maximum compensation for the Board of Directors and Executive Management is approved annually by shareholders, with the latest approval on June 24, 2022[178]. - In 2023, the company granted options for the right to acquire 1,554,281 shares at an exercise price ranging from USD 2.03 to USD 3.11 per share, compared to 633,063 shares at USD 2.76 to USD 3.15 in 2022[189]. - The target bonus for Executive Management in 2023 ranges from 20% to 69% of their base salary, with a median of 35%[185]. - The actual target achievement of corporate goals for 2023 was 104.2%, compared to 90% in 2022[186]. - The company’s pension plan contributions are shared approximately 47% by employees and 53% by the employer[188]. - The annual cash bonus for 2023 and 2022 was based on the achievement of corporate and individual goals, with specific R&D milestones included[185]. - The equity awards for Executive Management continue to be in the lower range of the peer group according to external benchmarking[185]. - The Executive Management team members have an unlimited duration contract with a notice period of twelve months[187]. - The company’s compensation policies are reviewed periodically to ensure alignment with market conditions and performance[177]. - The CNC meets at least four times per year to inform the Board of Directors of its recommendations and decisions[177].