Core Insights - Certara, Inc. announced that its Simcyp Simulator's physiologically-based pharmacokinetic (PBPK) modeling predictions were accepted by the U.S. FDA to support the new drug application (NDA) for asciminib, demonstrating the effectiveness of model-informed drug development approaches in regulatory decision-making [1][2] Group 1: Drug Development and Regulatory Impact - PBPK modeling utilizes virtual biological systems to predict drug absorption, distribution, metabolism, and elimination, increasingly replacing certain clinical studies [1] - The results from the PBPK modeling for asciminib provided evidence that complemented and, in some cases, replaced clinical pharmacology studies in the NDA process [2] - The collaboration on asciminib's modeling evolved over a decade, enhancing understanding of its optimal dosing regimen and drug interaction profile, ultimately supporting regulatory approval [3] Group 2: Asciminib and Chronic Myeloid Leukemia (CML) - Asciminib is a first-in-class allosteric inhibitor targeting the BCR::ABL1 myristoyl pocket, used for treating Chronic Myeloid Leukemia (CML) [2] - The global incidence rate of CML was approximately one case per 100,000 population in 2018, accounting for about 15% of newly diagnosed leukemia cases in adults [2] - PBPK modeling enabled a mechanistic assessment of asciminib's pharmacokinetics across diverse patient populations and dosing regimens [2] Group 3: Company Overview - Certara accelerates medicine development using biosimulation software and services, serving over 2,600 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries [4]

Core Viewpoint - Certara, Inc. will release its financial results for Q4 and the full year of 2025 on February 26, 2026, before market open, followed by a conference call at 8:30 AM ET to discuss these results [1]. Group 1 - The financial results announcement is scheduled for February 26, 2026, before market open [1]. - A conference call will be hosted by company management at 8:30 AM ET to discuss the financial results [1]. - Investors interested in the conference call must register online, with a recommendation to do so at least one day in advance [2]. Group 2 - Certara is a global leader in model-informed drug development, utilizing biosimulation software and technology to enhance drug discovery and development [3]. - The company serves over 2,600 clients, including biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries [3].

Summary of Simulations Plus Investor Day - January 21, 2026 Company Overview - **Company**: Simulations Plus (NasdaqGS:SLP) - **Industry**: Biopharmaceutical modeling and simulation - **Focus**: Drug development, commercialization, and scientific consulting Core Points and Arguments Industry Transformation - The biopharma industry is undergoing significant changes, including: - Adoption of AI - Shift towards cloud-native scientific computation - Move away from animal testing - Increased reliance on model-informed drug development [2][12][50] Company Vision and Mission - **Vision**: Improve quality of life through innovative solutions - **Mission**: Create value for clients by accelerating the discovery, development, and commercialization of pharmaceuticals through science-based software and consulting solutions [3][2] Unique Value Proposition - Simulations Plus differentiates itself through: - A combination of scientific excellence and technological innovation - A robust suite of software products including GastroPlus, MonolixSuite, ADMET Predictor, DILIsym, and Thileys [4][5] - The company is evolving from point solutions to an integrated cloud-enabled ecosystem [5] Market Opportunity - Total Addressable Market (TAM) is approximately $12.5 billion: - $4 billion in traditional biosimulation - $8.5 billion in clinical trial training and medical communications [6] Client Needs and Industry Pressures - Clients face pressures from: - Economic factors increasing the cost and complexity of drug development - Scientific complexity requiring advanced modeling techniques - Technological expectations for integrated digital infrastructure [10][11][12] Regulatory Environment - Regulatory agencies are pushing for broader use of model-informed drug development and non-animal methodologies, which aligns with Simulations Plus's offerings [12][56] Strategic Shift - The company is transitioning from a tool provider to an ecosystem partner, focusing on integrated workflows and AI-assisted solutions [14][28] Additional Important Insights Product Strategy and Roadmap - The company is building a unified AI-orchestrated ecosystem that connects various aspects of drug development [20][25] - The architecture includes: - Validated modeling engines - Composition layer for data standardization - Grounded intelligence layer with AI copilots - Orchestration layer for automating workflows [21][22][24] Services and Consulting - Simulations Plus's services complement its product offerings by providing scientific consulting that informs software enhancements and optimizes workflows [33][34] - The consulting teams help clients navigate complex drug development decisions, reducing uncertainty and costs [34][35] Case Studies - Case studies illustrate the effectiveness of Simulations Plus's approach in reducing development timelines and costs while improving clinical trial success rates [41][43] Future Growth and Revenue Opportunities - The acquisition of Pro-ficiency has doubled the TAM and is expected to contribute to future growth [54][55] - The company anticipates increased demand for simulation and modeling services driven by FDA's NAMs guidance [56][58] Pricing Evolution - The company is evolving its pricing strategy to reflect the added value of its integrated ecosystem, with new monetization opportunities expected as the ecosystem matures [29][30] Conclusion - Simulations Plus is well-positioned to lead in the evolving landscape of model-informed drug development, leveraging its scientific expertise, technological innovations, and strategic partnerships to create a cohesive platform that meets the industry's growing demands [53]

Core Insights - Certara, Inc. has appointed Jon Resnick as the new CEO effective January 1, 2026, succeeding William Feehery, who will transition to an advisory role [1][3] - The company reaffirms its financial outlook for the full year 2025 as previously disclosed [4] Leadership Transition - Jon Resnick brings over 20 years of experience from IQVIA, where he held various leadership roles, including President of the U.S. and Canada regional business [2][3] - William Feehery has been credited with guiding Certara through its successful IPO and reinforcing its position as a global leader in biosimulation [4] Company Strategy and Vision - Resnick expressed enthusiasm about leading Certara, emphasizing the company's unique position in drug discovery and development through AI, data, and simulation technologies [3] - The company serves over 2,400 clients, including biopharmaceutical companies and regulatory agencies across 70 countries, highlighting its extensive market reach [5]

Core Viewpoint - Certara, Inc. will release its financial results for Q2 2025 on August 6, 2025, after market close, followed by a conference call at 5:00 PM ET to discuss the results [1]. Company Overview - Certara is a global leader in model-informed drug development, utilizing biosimulation software, technology, and services to enhance traditional drug discovery and development [3]. - The company serves over 2,400 clients, including biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries [3]. Investor Information - Investors interested in the conference call must register online, with a recommendation to do so at least one day in advance [1]. - A live and archived webcast of the conference call will be available on the "Investors" section of Certara's website [2]. Contact Information - Investor Relations contact is David Deuchler from Gilmartin Group [4]. - Media contact is Alyssa Horowitz [4].

Core Insights - Certara, Inc. has launched the Non-Animal Navigator™ solution to assist biopharmaceutical companies in adapting to the FDA's Roadmap aimed at reducing animal testing in preclinical safety studies, marking a significant shift in drug development practices [1][3] Group 1: Company Overview - Certara is a global leader in model-informed drug development, providing biosimulation software and services to enhance drug discovery and development processes [5] - The company has over 2,400 clients, including biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries [5] Group 2: Industry Context - The FDA's Roadmap is a pivotal moment for the industry, encouraging the adoption of model-informed drug development approaches that are predictive, efficient, and ethical [3] - Monoclonal antibodies and antibody-drug conjugates (ADCs) are in the preclinical phase across various therapeutic areas, with biosimulation models showing predictive capabilities comparable to traditional animal studies [2] Group 3: Product Features - The Non-Animal Navigator offers strategic regulatory advice to design preclinical programs that align with regulatory requirements and utilize new approach methodologies (NAMs) [5] - It includes an integrated preclinical development plan that combines various evidence types, including in vitro, in vivo, and biosimulation data, supported by expert toxicology input [5] - The solution provides access to advanced AI-enabled modeling tools, such as the Simcyp Simulator, to accelerate development timelines [5]

Core Insights - Certara, Inc. has appointed Adrian McKemey, Ph.D. as President of Drug Development Solutions to enhance its strategic drug development solutions [1][2] - McKemey brings over 25 years of experience in R&D roles, focusing on business transformation and portfolio management [2] - The leadership change is part of a planned transition, with Patrick Smith continuing as Senior Vice President of Translational Sciences [3] Group 1 - Adrian McKemey's leadership is expected to scale Certara's biosimulation and scientific services, supporting the development of next-generation therapies [4] - Certara's expertise in biosimulation is crucial for addressing challenges in clinical development and improving success rates in drug portfolios [4] - The company serves over 2,400 clients, including biopharmaceutical companies and regulatory agencies across 66 countries [5]