AbCellera Biologics FY Conference Summary Company Overview - **Company Name**: AbCellera Biologics - **Ticker**: NasdaqGS:ABCL - **Founded**: 2012, from the University of British Columbia - **Headquarters**: Vancouver, Canada, with additional facilities in Sydney, Australia, and Montreal, Canada - **Employees**: Approximately 500 in Vancouver and 50 in Sydney - **Public Offering**: Went public in 2020, raising over $600 million Financial Highlights - **Total Liquidity**: Approximately $680 million as of Q3 2023 - **Funding**: Secured about $1.5 billion in non-dilutive funding, including $1 billion from a partnership with Eli Lilly for COVID-19 antibody development and $400 million from Canadian government support Business Model Transition - Shifted from a partnership-focused model to internal development of clinical assets - Over 100 therapeutic antibody programs worked on since 2014, with 16 molecules moving into clinical stages - New strategy emphasizes building a pipeline of first-in-class and differentiated molecules Pipeline Development - **Lead Asset**: AbCell 635, an antibody for treating vasomotor symptoms associated with menopause, currently in Phase 2 trials - **Additional Candidates**: - AbCell 575: A half-life extended OX40 ligand in Phase 1 - AbCell 386: New oncology candidate - AbCell 688: Targets GPCRs and ion channels for autoimmune conditions - **Clinical Readouts**: Anticipated data readout for AbCell 635 in Q3 2026 and for AbCell 575 at the end of 2026 Market Opportunity - Significant market for menopause treatments, with approximately 6 million women in the U.S. experiencing moderate to severe hot flashes - Differentiation from existing therapies includes a more convenient dosing regimen (once-monthly injection) and a potentially better safety profile compared to oral therapies Competitive Landscape - Current competitors include small molecules like fezolinetant and elinzanetant, which have safety concerns such as liver toxicity - AbCell 635 aims to avoid these issues by not metabolizing in the liver and not antagonizing NK1R, potentially leading to a better safety profile Clinical Development Strategy - Focus on high unmet medical needs and strong scientific rationale for selecting targets - Emphasis on indication-agnostic development, seeking to leverage technology for various therapeutic areas - Plans to initiate late-stage studies for AbCell 635 and other candidates based on positive clinical data Operational Insights - Established a GMP manufacturing facility to enhance bioresilience and reduce reliance on external CDMOs - Recruitment of skilled labor for manufacturing has been a challenge but has been successfully addressed Future Outlook - Anticipated continued investment in the pipeline with a focus on advancing clinical candidates - Expected cash burn of approximately $120 million annually, with sufficient liquidity to support operations for the next three years Key Takeaways - AbCellera is transitioning to a clinical-stage company with a robust pipeline and significant financial backing - The company is well-positioned to capitalize on unmet medical needs in women's health, particularly in menopause treatment - Upcoming clinical readouts are critical for the company's future trajectory and potential market impact

Core Insights - Amgen is optimistic about 2026, viewing it as a pivotal year with significant clinical data expected to be generated [2] Group 1: Company Overview - Amgen operates in four general therapeutic areas, focusing on diseases with high unmet medical needs [3] - The company offers first-in-class and best-in-class innovative medicines, including branded biosimilars [4] Group 2: Financial Performance - Over the past decade, Amgen has achieved consistent revenue and earnings growth, reflecting the success of its product offerings [4]

Financial Data and Key Metrics Changes - The company ended Q1 2025 with cash and cash equivalents of $257.9 million, indicating a robust balance sheet [23] - Recognized revenue for the quarter was $9.9 million, which includes $6.6 million in cost reimbursements from collaboration with Chiesi [23] - R&D expenses increased to $38 million from $32.4 million in the same period of 2024, while G&A expenses decreased to $8.7 million from $9.6 million [24] - The net loss for Q1 2025 was $36.6 million, or $0.16 per share, compared to a net loss of $41.9 million, or $0.19 per share, in Q1 2024 [24] Business Line Data and Key Metrics Changes - The company is focused on the development of saralutinib for pulmonary hypertension, with significant progress in the PROCERA study, which is nearing completion of patient enrollment [5][6] - The PROCERA study has enrolled 343 patients, with expectations to complete enrollment by early June 2025 [8][9] - The baseline characteristics of enrolled patients indicate a more severe population compared to previous studies, which may enhance the likelihood of a successful treatment outcome [10][12] Market Data and Key Metrics Changes - The company is expanding its global footprint for patient enrollment in the PROCERA study, with significant participation expected from regions like Latin America and Asia Pacific [36] - The company anticipates that the broader global reach will yield a patient population with lower comorbidities, potentially leading to a greater magnitude of treatment effect [36][39] Company Strategy and Development Direction - The company aims to position saralutinib as a first-in-class treatment for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PHILD) [5][17] - The strategic partnership with Chiesi Group is crucial for the global registrational phase III study in PHILD, highlighting the commitment to innovation and addressing unmet medical needs [19][27] - The company is focused on generating comprehensive and differentiated outcomes in both phase III trials to establish saralutinib as a backbone therapy in PAH [26][28] Management's Comments on Operating Environment and Future Outlook - Management emphasized the substantial unmet need in PAH and PHILD, with a commitment to developing safe and effective therapies [25] - The management expressed optimism about the likelihood of achieving positive results in the PROCERA study, given the targeted patient population and the treatment's potential [9][10] - The company is preparing for the potential launch of saralutinib in early 2027, anticipating a market reset as patients transition from existing therapies [115] Other Important Information - The company has achieved a significant milestone with the closure of new patient screening in the PROCERA study [6] - The primary endpoint for the PROCERA study is the change in six-minute walk distance at 24 weeks, which is a critical measure for evaluating treatment efficacy [20] Q&A Session Summary Question: Have you considered stopping enrollment in PROCERA to report data this year? - Management decided to continue enrollment due to high demand and a commitment to patients and physicians, ensuring the right patient population is included [30][32] Question: How does the global recruitment impact results? - The broader global footprint is expected to yield a patient population with lower comorbidities, potentially leading to a greater magnitude of treatment effect [36][39] Question: What are the powering assumptions for PROCERA? - The study is powered based on a 30-meter treatment effect on six-minute walk distance, with over 90% power given the sample size [49][87] Question: What is the expected clinical meaningful effect for six-minute walk distance? - A clinically meaningful effect is considered to be an improvement of 20 meters or more, given the safety profile and potential for long-term progression prevention [75] Question: What are the implications of the open-label extension data? - The open-label extension data suggests a potential for continued improvement over time, which could position saralutinib favorably in the market [100][101]