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Item 1. Business

2025-12-01 compared with 2024-10-30 · 179 added, 182 removed, 146 unchanged (71% of the section changed)

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was incorporated in California on July 17, 1996.

We are a global leader and premier provider in the biopharma sector, offering advanced software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization.

With the June 2024 acquisition of Pro-ficiency Holdings, Inc.

and its subsidiaries (collectively, “Pro-ficiency”), the Company extended its reach across the drug development value chain from the initial protocol stage through all phases of clinical research and development (“R&D”) to product commercialization.

Simulations Plus now has a one-of-a-kind platform to serve its clients at every step in the drug development process.

This optimizes efficiency, costs and time-to-market for our clients and enhances our competitive position.

The Company is a global leader and premier provider in the biopharma sector, offering advanced software and consulting services that enhance drug discovery and development, clinical trial operations, and commercialization.

The Company supports its clients across the drug development lifecycle from early discovery through all phases of clinical research and development (“R&D”), including clinical operations, to product commercialization.

The Company serves clients as a strategic partner throughout the entire drug development lifecycle, offering solutions that integrate scientific software platforms, artificial intelligence-augmented insights, and expert consulting.

This optimizes efficiency, costs, and time-to-market for our clients, thereby enhancing our competitive position.

Our clients face many challenges.

Developing new therapies is time-consuming and expensive, requiring an average of 10-15 years and an average cost of $6.16 billion to develop a single drug.

Drug sponsors must prioritize not only efficacy of the drug, but also issues like drug-drug interactions, inclusion of diverse populations, regulatory approvals, reduction of animal testing, safety and compliance during clinical trials, and commercial success.

Our model-informed drug development (“MIDD”) software and services allow clients to use modeling and simulation to accelerate the drug development timeline, reduce the costs of R&D, comply with regulatory guidance and best practices, and increase confidence in the safety and efficacy of their drugs.

Our adaptive learning solutions support the success of clinical trials by increasing the diversity and retention of participants and driving competency and compliance with trial protocols, while our medical communications solutions provide support in obtaining regulatory approval and post regulatory commercialization of drugs.

Through these offerings, we fulfill our mission to create value for our customers by accelerating and reducing the costs of R&D through innovative science-based software and consulting solutions that optimize treatment options and improve patient lives.

At the beginning of fiscal year 2024, the Company reorganized its internal structure to create a more integrated and cohesive operating platform based on key product and services offerings rather than separate divisions based on its prior acquisitions.

This business unit restructuring is engendering greater scientific collaboration and knowledge sharing within the Company that leads to identifying new opportunities that both advance the Company’s business objectives and deepen client relationships.

Continuing with our strategic plan of aligning our business units around products and services, the Pro-ficiency acquisition resulted in two new business units, Adaptive Learning & Insights and Medical Communications, giving the Company six business units that include:

• Cheminformatics (“CHEM”);

• Physiologically Based Pharmacokinetics (“PBPK”);

• Clinical Pharmacology and Pharmacometrics (“CPP”);

• Quantitative Systems Pharmacology (“QSP”);

• Adaptive Learning & Insights (“ALI”);

• Medical Communications (“MC”).

The Company is headquartered in Southern California, with offices in Buffalo, NY;

Research Triangle Park, NC;

Pittsburgh, PA;

and Paris, France.

Developing new therapies is time-consuming and expensive, requiring an average of 10-15 years at an average cost of $2.2 billion to develop a single drug according to Drug Discovery Today.

Drug sponsors must prioritize not only the safety and efficacy of the drug, but also navigate issues such as drug-drug interactions, inclusion of diverse populations, evolving regulatory policies, increasing compliance during clinical trials, and achieving commercial success.

Our model-informed drug development (“MIDD”) software and services solutions allow clients to use modeling and simulation to accelerate the drug development timeline, minimize animal testing, reduce the costs of R&D, comply with regulatory guidance and best practices, and increase confidence in the safety and efficacy of their drugs.

Our clinical operations solutions support the success of clinical trials by enhancing participant diversity and retention of participants and driving competency and compliance with trial protocols.

Meanwhile, our commercialization solutions provide support in obtaining regulatory approval and post-regulatory commercialization of new treatments.

Through these offerings, we fulfill our mission to create value for our clients by accelerating and reducing the costs of R&D through innovative science-based software and consulting solutions that optimize treatment options and improve patient lives.

At the beginning of the fourth quarter of fiscal year 2025, the Company reorganized its internal structure to create a more integrated and cohesive operating platform based on product and service solutions.

This reorganization reflects a shift from a business unit to a function-based organizational structure including:

• Operations;

• Product and Technology;

• Research and Development;

• Sales and Marketing;

• General and Administrative

The Company's U.S.

headquarters is in Research Triangle Park, NC and its European office is in Paris, France.

Our common stock has traded on the Nasdaq Global Select Market under the symbol “SLP” since May 13, 2021, prior to which it traded on the Nasdaq Capital Market under the same symbol.

We provide end-to-end offerings across the drug development continuum, including guiding early drug discovery, establishing pre clinical protocols, developing clinical programs, enabling clinical trial operations, facilitating regulatory submissions for product approval, and supporting commercial market launches.

We are a premier developer of modeling and simulation software for drug discovery and development, including the prediction of properties of molecules utilizing both artificial intelligence (“AI”) and machine-learning technologies.

Our software and consulting services are provided to major pharmaceutical, biotechnology, agrochemical, cosmetics, and food industry companies and academic and regulatory agencies worldwide for use in the conduct of industry-based research.

Our customers use our software programs and scientific consulting services to enhance their understanding of the properties of potential new therapies and to use emerging data to improve formulations, select and justify dosing regimens, support generic pharmaceutical product development, optimize clinical trial designs, and simulate outcomes in special populations, such as in elderly and pediatric patients.

SEGMENT INFORMATION

During the fiscal year ended August 31, 2024, our business was organized into two reportable segments, software and services.

We currently offer software products for pharmaceutical research, development, and commercialization, as follows:

• Three simulation products that provide time-dependent results based on solving large sets of mechanistic differential equations:

◦ GastroPlus ®

◦ MembranePlus™

• Two products that predict and analyze static properties of chemicals utilizing both AI and machine-learning technologies:

We provide end-to-end offerings across the drug development lifecycle, including guiding early drug discovery, establishing pre-clinical protocols, contributing to the design of clinical programs, enabling clinical trial operations, facilitating regulatory submissions for product approval, and supporting commercial market launches.

Our clients use our software programs and scientific consulting services during the drug discovery and development stages to enhance their understanding of the properties of potential new therapies and to use emerging data to improve formulations, select and justify dosing regimens, support generic pharmaceutical product development, optimize clinical trial designs, and simulate outcomes in special populations, such as elderly and pediatric patients.

Our clients also leverage our software and consulting services to optimize their clinical trial operations and commercial market launches.

We currently offer software products for discovery, development, clinical operations, and commercialization, as follows:

• Two biosimulation products that predict and analyze static properties of chemicals utilizing both AI and ML technologies:

◦ ADMET Predictor ® :

AI/ML software for absorption, distribution, metabolism, excretion, and toxicity (ADMET) modeling, with extended capabilities for data analysis, extensive metabolism predictions, AI-driven drug design, integrated HT-PBPK simulations, and rapid mechanistic liver safety risk assessments.

◦ MedChem Designer™ :

• Seven products that are based on mechanistic, mathematical models and differential equations:

free chemical sketching software tool that combines innovative molecule drawing features with some of the fast and accurate ADMET property predictions from ADMET Predictor.

• Three biosimulation products that provide time-dependent results based on solving large sets of mechanistic differential equations:

◦ GastroPlus ® :

mechanistically based simulation software that predicts absorption, biopharmaceutics, pharmacokinetics, and pharmacodynamics in humans and animals.

software for modeling the in vitro dissolution of active pharmaceutical ingredients (APIs) and formulation excipients under various experimental conditions.

◦ MembranePlus™ :

software for in vitro permeability and hepatocyte modeling.

• Eight biosimulation products that are based on mechanistic, mathematical models and differential equations:

◦ DILIsym ® :

software for predicting potential drug-induced liver injury (DILI) hazards and providing insight into mechanisms responsible for observed DILI responses.

◦ NAFLDsym ® :

software for predicting efficacy for treatment modalities developed for metabolic dysfunction-associated steatotic liver disease (MASLD), formerly known as nonalcoholic fatty liver disease (NAFLD), and metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH).

software for predicting efficacy of treatment modalities developed for interstitial lung disease (ILD) associated with systemic sclerosis (SSc).

software for predicting efficacy of treatment modalities developed for idiopathic pulmonary fibrosis (IPF) and other lung diseases.

◦ RENAsym ® :

software for predicting the likelihood of renal injury and providing insight into the biological mechanisms behind observed renal safety signals.

◦ MITOsym ® :

software focused on representing in vitro experimental assessment of mitochondrial function.

◦ OBESITYsym™ :

• One product designed for modeling and simulation that allows for population analyses, rapid clinical trial data analyses, and regulatory submissions:

software for predicting drug efficacy for weight loss and nausea side effects.

end-to-end quantitative systems pharmacology (QSP) software for building models, optimizing simulated populations to reported clinical efficacy, and visualizing and analyzing simulation results.

• One biosimulation product designed for modeling and simulation that supports clinical trial simulations and trial design, as well as population analyses, rapid clinical trial data analyses, and regulatory submissions:

◦ MonolixSuite™ (the combination of Monolix ® , PKanalix ® , and Simulx ® ).:

• One product for education and compliance training:

◦ Pro-ficiency Performance Management

fully interoperable software suite for a modeling workflow that includes data visualization, non-compartmental analysis, and population modeling and simulations.

Clinical Operations

• One product for education, training, and compliance monitoring:

◦ Pro-ficiency® :

adaptive learning/simulation-based training software supporting protocol compliance during clinical trials.

Commercialization

• One product for key opinion leader (“KOL”) research in the medical community:

◦ Panorama KOL Insights :

an easy-to-use dashboard for accessing current information about key opinion leaders (KOLs) based on filters including but not limited to therapeutic expertise, geographic location, affiliations, publications, and clinical trials.

Our software business represented 58% of our total revenue during the fiscal year ended August 31, 2025, primarily generated by the following products:

Our flagship product, initially introduced in 1998, and currently our largest single source of software revenue, is GastroPlus.

GastroPlus mechanistically simulates the absorption and drug interactions of compounds administered to humans and animals.

It is currently one of the most widely used commercial software products of its type by industry and regulatory agencies in the U.S.

and globally.

Our goal with GastroPlus is to integrate the most advanced science into user-friendly software to enable researchers and regulators to perform sophisticated analyses of complex compound behaviors in humans and laboratory animals.

We work to release updated versions of the program on an ongoing basis.

ADMET Predictor®

ADMET Predictor is a top-ranked, chemistry-based computer program that takes molecular structures as inputs and uses AI/ML technology to predict more than 175 different properties for them.

This capability allows chemists to generate estimates for many important molecular properties without the need to synthesize and test the molecules.

A chemist can then assess the likely success of many existing molecules in a company’s chemical library, as well as generate new ideas for virtual molecules still being designed.

The optional ADMET Modeler™ Module in ADMET Predictor enables scientists to use their own experimental data to quickly create proprietary high-quality predictive models using the same powerful AI engine we use to build our top-ranked property predictions.

Version 13 of ADMET Predictor was released in June 2025, which added many new features, including:

• New Models:

New models offer increased accuracy and granularity of our clients' predictions, including areas such as liver microsomal and hepatocyte intrinsic clearance for monkeys and dogs, plasma protein binding (Fup) for monkeys and dogs, melting point, Gibbs free energy of self-solvation and hydration, and more.

• Enhanced Models:

Updates to our trusted models offer improved understanding around aqueous solubility, volume of distribution, blood-brain barrier (BBB) penetration, and more.

• Updated Modules:

The high-throughput pharmacokinetic ("HTPK") and Artificial Intelligence-driven Drug Design ("AIDD") modules have been expanded to provide more detail to our clients' predictions and promote novelty and synthetic feasibility.

• Expanded Representation State Transfer ("REST") API:

The latest version of our REST API supports image generation in Linux, easier property prioritization, and more.

• General Usability and Informatics Improvements

We have made significant investments in three key areas with recent versions:

improving integration of our top-ranked ADMET Predictor and GastroPlus models to leverage our novel HTPK simulation approaches for chemists and safety researchers, enhancing our best-in-class AI/ML engine to assist with drug discovery, and advancing our innovative AIDD Module to apply generative AI technology to design, optimize, and evaluate up to 10 million lead molecules overnight for any combination of properties.

Recent collaborations include:

• Validation of ADMET Predictor models with enhanced AI drug design :

in July 2025 and with the Institute of Medical Biology of the Polish Academy of Sciences (IMB PAS), we announced the publication of results that showed the validation of our models and on the ADMET Predictor platform.

With IMB PAS, we used our models to design and optimize molecules for RORγ/RORγT ligand potency, in vivo absorption, synthesizability, and ADMET risk;

the vast majority of compounds tested had strong potency for the target.

• Development of new AI drug discovery offering:

in October 2024 and in partnership with the University of Southern California (USC) Alfred E.

Mann School of Pharmacy and Pharmaceutical Sciences, we were awarded a research grant from the National Institutes of Health ("NIH") to evaluate and integrate novel computational methods that account for water-ligand interactions into the AIDD module for a first-of-its-kind ligand-based virtual screening solution.

In May 2024, GastroPlus version 10 (branded as GPX™) was released.

This version was the culmination of a long-term collaboration with our partners to understand how we can better support their program needs and enable critical scientific thinking.

This resulted in a completely redesigned, intuitive, and flexible platform which incorporated the proven top-rated science, advanced models, refined algorithms, and integrated machine learning (“ML”) technology that has been validated over 26 years.

Because of the widespread use of GastroPlus, we have been able to enter both funded and unfunded collaborations with industry and government agencies to drive advances in modeling and simulation science.

This version was the culmination of a long-term collaboration with our scientific partners to understand how we can better support their needs, and resulted in a completely redesigned platform that incorporated the proven top-rated science, advanced models, refined algorithms, and integrated ML technology that has been validated over 27 years.

In September 2025, GastroPlus version 10.2 (branded as GPX.2) was released with new and expanded models, as well as new AI and automation functionality designed to support complex simulations and workflows.

Because of the extent of the use of GastroPlus, we have been able to enter both funded and unfunded collaborations with industry and government agencies to drive advances in modeling and simulation science.

In all such collaborations, we own the intellectual property developed within the GastroPlus program, and updates are integrated into future versions and made available to all clients.

In the fiscal year ended August 31, 2024, we participated in nine funded grants from the U.S.

Food and Drug Administration (“FDA”) to enhance PBPK modeling science.

Recent collaborations include:

• Virtual bioequivalence studies:

in September 2023, we entered into a funded collaboration with the FDA to validate and define best practices for PBPK modeling workflows to simulate virtual bioequivalence (“VBE”) studies in support of regulatory bio-waivers.

• Modified-release (“MR”) product development model:

in January 2024, through a joint proposal with Northeastern University and InnoGI Technologies, we were awarded a newly funded contract from the FDA to advance the development and approval of generic oral MR drug products through the combination of novel in vitro testing and mechanistic modeling and simulation.

• Enhancement of advanced compartmental absorption and transit (ACAT™) model:

in January 2025, we partnered with the Enabling Technologies Consortium to enhance the predictive capabilities of our ACAT model to support the development of immediate-release oral drug products.

• Expansion of mechanistic modeling approaches for long-acting injectables:

in November 2024 and in partnership with the University of Connecticut’s School of Pharmacy, Department of Pharmaceutical Sciences, we were awarded a funded grant from the U.S.

Food and Drug Administration (FDA) to use Physiologically Based Pharmacokinetics ("PBPK") approaches in GastroPlus to build and validate mechanistic in vitro-in vivo correlations for long-acting injectables.

DILIsym is the leading quantitative systems toxicology ("QST") platform for predicting and explaining drug-induced liver injury ("DILI").

It is designed for use during drug development to provide an indication of the potential DILI hazard posed by individual molecules as well as to provide deeper insight into the mechanisms responsible for observed DILI responses at various stages of the development process.

It is the most widely used software for DILI prediction and is utilized as a source of QST modeling-based data assessed by the FDA’s DILI team.

In May 2025, DILIsym version 11 was released with new and enhanced models, as well as the addition of new pediatric and post-menopausal women (PMW) simulated populations.

Thales is an end-to-end quantitative systems pharmacology (QSP) platform for building models, optimizing simulated populations to reported clinical efficacy, and visualizing and analyzing simulation results.

It is designed to support scientists in developing models to understand biological complexities, evaluate drug candidates for clinical efficacy and/or toxicity potential, and guide clinical trial designs and optimal dosing protocols.

Licensable models are available in the areas of metabolism, oncology, inflammation, and immunology.

MonolixSuite™

The MonolixSuite is a unique solution for modeling and simulation for pharmaceutical companies, biotechnology enterprises, and hospitals.

MonolixSuite is a specialized solution for modeling and simulation for pharmaceutical companies, biotechnology enterprises, and hospitals.

It supports nonparametric analyses, population analyses and modeling, and clinical trial simulation.

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The products are used by pharmaceutical companies across the globe at each step of drug development, from preclinical to first-in-human, clinical, and post-approval.

ADMET Predictor®

ADMET (Absorption, Distribution, Metabolism, Excretion, and Toxicity) Predictor is a top-ranked, chemistry-based computer program that takes molecular structures as inputs and uses AI/machine-learning technology to predict different properties for them.

This capability allows chemists to generate estimates for many important molecular properties without the need to synthesize and test the molecules.

A chemist can then assess the likely success of many existing molecules in a company’s chemical library, as well as molecules that have never been made.

Version 12 of ADMET Predictor was released in July 2024, which added many new features including:

• Enhanced Models :

New and expanded models offer greater predictive accuracy, with an average 30% increase in training set sizes, for microsome and hepatocyte clearance, protein binding, bio relevant solubilities, MDCK-LE/PAMPA permeability, and more

• High-Throughput Pharmacokinetics (“HTPK”) :

New options for solution dosing, adjusted free fraction outputs, and species-specific simulations enhance the flexibility and precision of HTPK studies

• Artificial Intelligence-Driven Drug Design (“AIDD”) :

Integration of 3D shape matching and tissue sensitivities (based on tissue Kp values) as new objectives, facilitating innovative lead optimization processes

• New DILI Module :

Introduction of the first drug-induced liver injury (“DILI”) endpoint models to support high-throughput (“HT”) DILIsym® predictions in early drug development

• Boosted ANN Regression Models and added 37 new descriptors in ADMET Modeler™

• General Usability and Informatics Improvements

We have made significant investments in three key areas with recent versions:

improving integration of our top-ranked ADMET Predictor and GastroPlus models to leverage our novel high-throughput pharmacokinetic (“HTPK”) simulation approaches for chemists and safety researchers, enhancing our best-in-class AI/ML engine to assist with drug discovery, and advancing our innovative AIDD Module to apply generative AI technology to design and optimize lead molecules for any combination of properties.

Recent collaborations include:

• Qualification of in silico methods for risk assessment of chemicals:

in February 2024, we extended a collaboration with the Translational Toxicology Division at the National Institute of Environmental Health Sciences (“NIEHS”) to support the rapid safety assessment of chemicals in animals and humans.

• Drug design collaboration using the AIDD Module:

in March 2023, we entered into a collaborative research agreement with the Polish Academy of Sciences (“PAS”) to jointly design new compounds for the RORγ/RORγT nuclear receptors using our cutting-edge AI/ML technology in the ADMET Predictor® software platform.

Emerging intellectual property, in the form of encouraging lead compounds, will be jointly owned by the Company and PAS for further development opportunities.

• Strategic collaboration to discover anticancer therapies using the AIDD Module:

in March 2023, we entered into a strategic research collaboration with the Sino-American Cancer Foundation (“SACF”) to leverage our staff and AIDD Module to support the discovery and design of novel inhibitors of methylenetetrahydrofolate dehydrogenase 2 (“MTHFD2”), an emerging cancer target.

SACF will provide upfront funding to the Company to design a set number of compounds for efficacy against MTHFD2, which will be exclusive to SACF.

Subsequent milestone payments will be made to the Company as key research and development goals are met.

Pro-ficiency Performance Management

Pro-fiency Performance Management is an adaptive learning platform that uses lifelike simulation and detailed data tracking to increase recruitment, retention, and protocol compliance during clinical trials.

In simulations of complex real-world scenarios, learners are asked to make decisions and practice implementation of the trial protocol.

The generated data provides insight into areas of the trial protocol that are unclear to healthcare practitioners, enabling clarification and further education prior to start of clinical trials.

Panorama KOL Insights

Panorama KOL Insights is a platform for KOL research in the life sciences industry.

It provides current information about influential industry leaders, which can be filtered by criteria including but not limited to therapeutic expertise, professional affiliation(s), and geographic location.

Our scientists and engineers have extensive expertise in drug absorption via various dosing routes, pharmacokinetics, pharmacodynamics, drug-drug interactions, and other areas related to the drug development process.

We conduct contracted consulting studies for large customers with complex problems who recognize our expertise in solving them, as well as for smaller customers.

We also offer services supporting marketplace insight and medical communications for clinical and commercial drug development.

The demand for our consulting services has been steadily increasing, and we have expanded our consulting teams to meet the increased workload.

Pro-ficiency®

Pro-ficiency is an adaptive learning/simulation-based training platform that delivers bespoke education underpinned by a proprietary software foundation that allows for rapid content development with multi-language and cultural adaptability, with insights derived from learned behavior that highlight performance/execution risk areas and allow them to be addressed before trials or projects begin.

Our scientists and engineers have extensive expertise, including, but not limited to initial molecule design using molecular design tools, and AI and ML;

modeling pharmacokinetics, pharmacodynamics, drug-drug interactions, dosing paradigms, exposure-response, and potential toxicity;

developing and conducting effective site/investigator training and compliance monitoring;

and medical communications and commercialization strategies.

We partner with clients who have complex problems and recognize our expertise in solving them.

Our services business represented 42% of our total revenue during the fiscal year ended August 31, 2025, primarily generated by the following service offerings:

Our clinical-pharmacology-based consulting services include population pharmacokinetic and pharmacodynamic (“PKPD”) modeling, exposure-response analyses, clinical trial simulations, data programming, and technical writing services in support of regulatory submissions.

In addition to modeling and simulation consulting services, we provide expertise and assistance with development-related decision making and support for regulatory interactions related to dose selection, clinical trial design, and understanding of the determinants of safety and efficacy for new medicines.

We provide creative and insightful consulting services to support our quantitative systems pharmacology, QSP, modeling focused on NAFLD, and NASH, idiopathic pulmonary fibrosis (“IPF”), heart disease, and liver and kidney safety, as well as other areas.

In 2014, the FDA began to emphasize the need to encourage mechanistic PBPK modeling and simulation in clinical pharmacology, with final guidance documents completed in 2018.

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This has resulted in an increased need for our scientific consulting staff to draw upon its extensive experience across multiple therapeutic areas of modeling and simulation to provide consulting-related services utilizing these sophisticated techniques.

We support MIDD throughout the entire product lifecycle, from discovery through translational research and clinical development, when an organization does not have the time or resources to use our software directly.

We support PBPK modeling throughout the entire product lifecycle, from discovery through translational research and clinical development, when an organization lacks the time or resources to use our software directly.

More specifically, our clients seek out our consulting services to acquire scientific, therapeutic-area-related modeling and simulation expertise that they do not have in-house.

Early Drug Discovery ( “ EDD ” )

At Simulations Plus, we have a team of experts, including computational and medicinal chemists, cheminformatics specialists, and drug development professionals with decades of experience, all able to facilitate small and large companies’ drug discovery and development journeys.

With our EDD services offering, we provide end-to-end in silico drug design and optimization services, as well as help with individual steps in the process, including:

• AIDD enabled drug discovery and optimization

• High-throughput screening (“HTS”) library design and hit visualization and analysis

• Quantitative Structure-Activity Relationship (“QSAR”)/Quantitative Structure-Property Relationship (“QSPR”) modeling and simulation

Adaptive Learning & Insights

Our expert content creation team delivers programming that is focused on the development of engaging, adaptive learning solutions independent of individualized analytics.

Our team of experts supports clients in developing training materials for complex procedures, providing insight derived from learner data, and optimizing learning in life sciences.

Medical Communications

We provide creative and insightful consulting services to support our quantitative systems pharmacology (“QSP”) modeling focused on liver and kidney safety, metabolic and cardiac conditions, inflammatory disease, and immuno-oncology, as well as other areas.

Our clinical-pharmacology-based consulting services span the entire clinical development phase, and includes population pharmacokinetic and pharmacodynamic (“PKPD”) modeling, exposure-response analyses, clinical trial simulations, data programming, and technical writing services in support of regulatory submissions.

In addition to modeling and simulation consulting services, we provide expertise and assistance with development-related decision-making and support for regulatory interactions related to dose selection, clinical trial design, and understanding of the determinants of safety and efficacy for new medicines.

Clinical Operations

Our training development consulting services provide a unique blend of instructional design and clinical operations expertise, designing simulation-based programs that allow learners to practice complex concepts from clinical trial protocols in a risk-free virtual environment, thereby facilitating and accelerating study launch, and that provide Sponsors with performance-based analytics to mitigate risk and optimize study and project quality.

Commercialization

Our experienced medical communications consultants provide strategy, positioning, messaging, and tactical support for our clients in support of their market intelligence and commercial endeavors.

Below is a summary of revenue percentages by each of our software and services businesses for the fiscal years ended August 31:

Below is a summary of percentage of total revenues for each of our software and services businesses for the fiscal years ended August 31:

2025 2024 2023

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SALES AND MARKETING

We market our software and services globally through attendance and presentations at scientific meetings, exhibits at trade shows, seminars at pharmaceutical companies and government agencies, online presentations, our website, and various communication channels to our database of prospects and customers.

At various scientific meetings worldwide, research accomplishments using our software are reported through numerous presentations and posters.

Many of these presentations are from industry and FDA scientists;

some are from our staff.

Numerous peer-reviewed scientific journal articles are published, and conference presentations are delivered each year using our software, primarily by our customers, further supporting its use in a wide range of preclinical and clinical studies.

Our sales and marketing efforts are handled primarily internally by sales and marketing staff, with our scientific team and several senior management staff assisting our marketing and sales staff with trade shows, seminars, and customer training both online and on-site.

During fiscal year 2024, the Company invested in marketing automation tools to increase customer insights and engagement.

In addition, enhancements were made to our customer relationship management software, providing insights about our targeted markets and customers.

while others are from our staff.

Numerous peer-reviewed scientific journal articles are published, and conference presentations are delivered each year using our software, primarily by our clients, further supporting its use in a wide range of preclinical and clinical studies.

Our sales and marketing efforts are handled primarily internally by our sales and marketing staff, with our scientific team and several senior management staff assisting with trade shows, seminars, and client training both online and on-site.

We also have independent distributors in Japan, China, India, South Korea, and Brazil, who sell and market our products with support from our scientists and engineers.

We compete against a number of established companies that provide screening, testing, and research services, and products that are not based on simulation software.

During the fourth quarter of fiscal year 2025, the Company pivoted to an account-based solution selling business model, where the focus is on identifying and solving client pain points across the drug development lifecycle rather than selling discrete products or services.

This is an opportunity to align business development activities with the Company reorganization and design the sales organization for strategic growth, client-centricity, and scalability.

We compete against a number of established companies;

some of our competitors provide screening, testing, and research services, and products that are not based on biosimulation software.

Other competitors provide both consulting services and biosimulation software.

There are also software companies whose products do not compete directly with ours but are sometimes closely related.

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Smaller companies generally need to outsource a greater percentage of this effort.

Thus, we compete not only with other software suppliers, scientific consulting service providers, and contract research organizations ("CROs"), but also with the in-house development and scientific consulting teams at some of the larger pharmaceutical companies.

Thus, we compete not only with other software suppliers, scientific consulting service providers, and contract research organizations ("CROs"), but also with in-house development and scientific consulting teams at some of the larger pharmaceutical companies.

Our competitors include, but are not limited to, Optibrium, Certara, ICON, Metrum Research Group, Veeva, and WCG.

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(i) to acquire scientific, therapeutic-area-related modeling expertise that they do not have in-house, (ii) to address a need for modeling and simulation efforts beyond the capacity of in-house resources, (iii) to fulfill their modeling requirements more efficiently than they could do in-house, and (iv) to utilize our software when they do not have the in-house expertise to do so.

We apply our software and assist companies in such areas as MIDD, PKPD, PBPK, and QSP.

We apply our software and assist companies in such areas as AIDD, MIDD, PKPD, PBPK, and QSP.

We believe the key factors in our ability to successfully compete in this field are our ability to:

(i) continue to invest in research and development, and develop and support industry-leading simulation and modeling software and related products and services, (ii) develop and maintain a proprietary database of results of physical experiments that serve as a basis for simulated studies and empirical models, (iii) continue to attract and retain a highly-skilled scientific and engineering team, (iv) aggressively promote our products and services to our global market, and (v) develop and maintain relationships with research and development departments of pharmaceutical companies, universities, and government agencies.

(i) continue to invest in research and development, and develop and support industry-leading simulation and modeling software and related products and services, (ii) develop and maintain a proprietary database of results of physical experiments that serve as a basis for simulated studies and empirical models, (iii) continue to attract and retain a highly-skilled scientific and engineering team, (iv) aggressively promote our products and services to the global market, and (v) develop and maintain collaborative relationships with research and development departments of pharmaceutical companies, universities, and government agencies.

In addition, we are actively seeking strategic acquisitions to expand both our pharmaceutical software portfolio and services offerings.

TRAINING AND TECHNICAL SUPPORT

The acquisition of Pro-ficiency expanded our software and services portfolio to include customer-facing professional development and medical communications capabilities within the clinical trial and commercial space.

The adaptive learning/simulation-based training approach delivers bespoke education underpinned by a proprietary software foundation that allows for rapid content development with multi-language and cultural adaptability, with insights derived from learned behavior that highlight performance/execution risk areas and allow them to be addressed before trials or projects begin.

The medical communications team delivers a customer-centric approach to supporting sponsors in their endeavors to drive intelligent clinical development, from medical affairs to commercialization, with programming such as advisory boards, focus groups and medical education.

These new solutions address the previously untapped clinical research and medical communications markets for Simulations Plus.

Customer training and technical support are important factors in customer satisfaction for our modeling and simulation products, and we believe we are an industry leader in providing strong customer training and technical support in our business areas.

We provide in-house seminars at customers’ and potential customers’ sites, as well as at selected universities to train students who will soon be industry scientists.

These seminars often serve as initial training in the event the potential customer decides to license or evaluate our software.

Technical support is provided after the sale of any software in the form of on-site training (at the customer’s expense), web meetings and telephone, fax, and e-mail assistance to the customers’ users during customers’ license periods.

Technical support for our software is provided by our life sciences teams and our inside sales and support staff.

Client training and technical support are important factors in client satisfaction for our modeling and simulation products in discovery and development, and we believe we are an industry leader in providing strong client training and technical support in our business areas.

We provide in-house seminars at clients’ and potential clients’ sites, as well as at selected universities to train students who will soon be industry scientists.

These seminars often serve as initial training in the event the potential clients decide to license or evaluate our software.

Technical support is provided after the sale of any software in the form of on-site training (at the client’s expense), web meetings, and e-mail assistance to the clients’ users during the clients’ license periods.

Technical support for our software is provided by our sales operations and support staff.

We have found that most clients need minimal technical support for our software products.

RESEARCH AND DEVELOPMENT

The development of our software is focused on expanding our product portfolio, designing enhancements to our core technologies, and integrating existing and new products into our principal software architecture and platform technologies.

The development of our software is focused on the convergence of AI, cloud computing, and our validated science to expand our product portfolio and integrate existing and new products into our principal software architecture and platform technologies.

We intend to continue to offer regular updates to our products and to continue to look for opportunities to expand our existing suite of products and services.

To date, we have developed products internally, sometimes also licensing or acquiring products, or portions of products, from third parties.

In certain instances, these arrangements have required that we pay royalties to third parties;

we paid no royalties during the fiscal year ended August 31, 2024.

We intend to continue to license or otherwise acquire technology or products from third parties when we believe that it makes business sense to do so.

Our software products are designed and developed by our development teams, which work remotely using collaboration software.

Our products and services are delivered electronically.

Our software products are designed and developed by our product and technology team in close partnership with other departments.

Our products and services are delivered electronically and deployed through on-premise and cloud-hosted models.

INTELLECTUAL PROPERTY AND OTHER PROPRIETARY RIGHTS

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The expertise of our staff is a considerable asset closely related to intellectual property and attracting and retaining highly qualified scientists and engineers is essential to our business.

Our customers include companies involved in pharmaceuticals, biotechnology, agrotechnology, and cosmetics, as well as universities, hospitals, and government research organizations.

We concentrate on serving the needs of our customers in drug discovery, development, clinical trials, post-patent generic formulation development, and post-approval drug commercialization.

Our current customer base is highly fragmented, and we did not derive a material portion of our revenues from any single client for the fiscal year ended August 31, 2024.

Our revenues exhibit seasonal fluctuations, with the first fiscal quarter (September-November) generally having the lowest revenues for biosimulation software and services, while clinical trial and commercial activity tends to be slow during the last fiscal quarter (June-August).

This is due to pharmaceutical industry buying patterns, consulting service slowdowns due to summer vacations in the previous quarter, and lower customer and employee conference attendance in those periods.

Our clients include companies involved in pharmaceuticals, biotechnology, agriculture, and consumer goods, as well as universities, hospitals, and government research and regulatory agencies.

We concentrate on serving the needs of our clients in drug discovery, development, clinical trials, post-patent generic formulation development, and post-approval drug commercialization.

Our current client base is highly fragmented, and we did not derive a material portion of our revenues from any single client for the fiscal year ended August 31, 2025.

Our revenues exhibit seasonal fluctuations, with the first and fourth fiscal quarters generally having the lowest revenues.

This is due to pharmaceutical industry buying patterns, consulting service slowdowns due to summer vacations in the previous quarter, and lower client and employee conference attendance in those periods.

Revenues for any quarter are not necessarily indicative of revenues for any future period;

however, because our pharmaceutical software is licensed on an annual basis, renewals are usually within the same quarter year after year, even though there are certain instances in which the license renewal term may not immediately follow the initial license term, and therefore result in a shift of certain customer revenues to a subsequent quarter.

ENVIRONMENTAL REGULATORY MATTERS

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HUMAN CAPITAL

We are committed to our people, and embrace a culture of engagement, empowerment, and equity.

Over 98% of our global employees are employed full-time, and more than 68% work within our life sciences software or consulting business units.

Given the specialized nature of our business, candidates for our open positions are strategically selected for their unique education and skills.

The majority of our employees have advanced degrees, with over 65% of our technical and scientific staff holding doctoral degrees in mathematics, chemistry, biomedical engineering, and/or the pharmaceutical sciences.

As of August 31, 2024, we employed a total of 247 persons, including 243 full-time employees and 4 part-time employees.

We believe that our continued success depends on our ability to continue to attract, hire, and retain qualified personnel.

To support the endeavor, we have continued to focus heavily on our total rewards program, which includes components of compensation, health and wellness benefits, training, time off, recognition and support for business travel.

Over the past year, the Company was recognized by Comparably as Best Company for Diversity, Best Company for Women, Best Company Culture and a Best Company Compensation awards winner, as determined based on direct feedback from our employees.

We had a voluntary turnover rate of less than 4% during fiscal year 2024, further exemplifying our good relations with employees.

Diversity, Equity, and Inclusion

We embrace diversity with the knowledge that it can lead to greater innovation, and in our workplace, we foster inclusion, so all employees feel they are a part of our team with equal access to all opportunities.

One of our goals is to always continue expanding our focus on diversity, equity, and inclusion.

We are dedicated to our people and foster a culture of engagement, empowerment, and equity.

Over 99% of our global workforce is full-time, with more than 70% having life sciences software, services, and R&D backgrounds.

Due to the specialized nature of our work, we recruit candidates with advanced education and skills-over 60% of our technical and scientific staff hold advanced degrees with focuses inclusive of mathematics, chemistry, biomedical engineering, or pharmaceutical sciences.

As of August 31, 2025, we employed 213 people, including 212 full-time and one part-time employee.

Our continued success depends on attracting and retaining top talent.

To support this, we focus on a comprehensive total rewards program encompassing compensation, benefits, wellness, training, time off, recognition, and travel support.

In 2025, according to employee feedback collected by the workplace-culture platform Comparably, the Company was included on that site's lists for Best Company for Diversity, Best Company for Women, Best Company for Leadership, and Best Company for Benefits.

Our voluntary turnover rate was under 6% in fiscal year 2024, reflecting strong continued employee engagement.

In fiscal 2025, we hosted an all-company summit that brought our global team together to align on company strategy, strengthen in-person connections, and give back to the community.

As part of the event, employees volunteered to assemble and donate over 100 STEM backpacks to support a local underserved community.

We are committed to fostering an inclusive environment where all employees feel valued, respected, and supported in reaching their full potential.

Our goal is to ensure that everyone has equal access to opportunities and is empowered to contribute meaningfully to our shared success.

In terms of gender equity, women currently comprise 46% of our workforce and 47% of our scientific staff.

Our ADP Workforce Now platform, allows us to access and better understand trends in our staff and hiring relative to diversity.

We regularly track our metrics to ensure we are aligning our recruitment efforts and continue to refine our policies and benefits to be inclusive of all employees.

We continue to pay parental leave to all employees for birth or adoption, and have a flexible time off and remote-first work culture that supports the ability to work globally and allows us to hire the best fit for the role regardless of location.

Through our ADP Workforce Now platform, we actively monitor workforce trends and hiring data to guide continuous improvements in our policies and practices.

We regularly review these metrics to align our recruitment efforts and refine benefits to support all employees.

We offer paid parental leave for all employees, whether for birth or adoption, and maintain a flexible time-off and remote-first work culture that enables collaboration across the globe and allows us to hire the best talent, regardless of location.

Compensation, Training, and Awareness Programs

We continue to refine career paths for the different functions within our organization.

We use these career paths as a basis for promoting employee career development and growth within the organization, as well as in recruiting and hiring new talent.

We have implemented a new performance platform within our ADP Workforce Now system that allows for better performance management processes.

We plan to use the features to continue to focus on performance, goal tracking, and succession planning as part of our future personnel growth strategies.

This past year, we implemented a training program that allowed all employees access to company-paid technical, leadership or skills training opportunities in an area that they selected with management support.

In the coming year, we intend to focus even more training efforts on leadership development.

In addition to these recently implemented employee training and development initiatives, we continue to offer an ongoing program of cross-specialty training consisting of presentations by expert modelers from each business unit.

These monthly sessions serve to familiarize all business units with the applications and techniques unique to each business unit and, in so doing, create opportunities to find synergies, and cross-selling opportunities, expand the knowledge base across all business units, identify cross-selling opportunities, and build a shared sense of purpose.

We continue to refine our career paths across all functions, using grade-level benchmarking to guide internal development, promotion, and recruitment.

These structured pathways ensure transparency and consistency while supporting employee growth and organizational excellence.

Our ADP Workforce Now platform further enhances performance management, goal tracking, and succession planning.

In the coming year, we intend to place greater emphasis on identifying and growing future leaders by strengthening leadership development and succession planning.

We continue to provide company-funded opportunities for employees to advance their technical, leadership, and professional skills.

Our ongoing cross-specialty training program—featuring monthly presentations by expert modelers from different departments—fosters collaboration, expands shared knowledge, and builds a unified, innovative workforce.

Health & Safety

We place a high value on maintaining a clean, safe, and healthy environment for our employees.

Our Human Rights Policy confirms our commitment to basic human rights worldwide and our Code of Conduct requires our employees and vendors to work within our established principals of ethics.

Our Human Rights Policy confirms our commitment to basic human rights worldwide and our Code of Conduct requires our employees and vendors to work within our established principles of ethics.

The well-being of our employees, whether they are working in our offices or remotely from home offices, is one of our highest priorities.

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We continue to provide very competitive health and wellness benefits, and each year we host a wellness challenge for all employees with monetary incentives to encourage a healthy and less sedentary lifestyle.

We also host regular “coffee breaks” to encourage, even in a remote environment, interacting with colleagues outside of work meetings or topics.

We also host regular "coffee breaks" and other virtual engagement opportunities to encourage, even in a remote environment, interacting and sharing with colleagues outside of work meetings or topics.

We also consider open and transparent channels of communication to be a critical component of our employee health and wellness program.

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Our pharmaceutical software products and platforms are tools used in research and/or development and are neither approved nor approvable by the FDA or other government agencies.

No significant pollution or other types of hazardous emission result from our operations and it is not anticipated that our operations will be materially affected by federal, state, or local provisions concerning environmental controls.

No significant pollution or other types of hazardous emissions result from our operations and it is not anticipated that our operations will be materially affected by federal, state, or local provisions concerning environmental controls.

Our costs of complying with environmental, health, and safety requirements have not been material.

Furthermore, compliance with federal, state, and local requirements regulating the discharge of materials into the environment, or otherwise relating to the protection of the environment, have not had, nor are they expected to have, any material effect on the capital expenditures, earnings, or competitive position of the Company.

Furthermore, compliance with federal, state, and local requirements regulating the discharge of materials into the environment, or otherwise relating to the protection of the environment, has not had, nor are they expected to have, any material effect on the capital expenditures, earnings, or competitive position of the Company.

ENVIRONMENTAL, SOCIAL, GOVERNANCE

We are committed to providing consistent and excellent return to our shareholders, all while maintaining a strong sense of good corporate citizenship that places a high value on the welfare of our employees, the communities in which we operate, and the world as a whole.

We are committed to creating sustainable and excellent returns to our shareholders, all while maintaining a strong sense of good corporate citizenship that places a high value on the welfare of our employees, the communities in which we operate, and the world as a whole.

We believe that effectively prioritizing and managing our Environmental, Social, and Governance (“ESG”) factors will help create long-term value for our investors.

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The topics covered in this section are identified through third-party ESG reporting frameworks, standards, and metrics, such as the Sustainability Accounting Standards Board (“SASB”), and United Nations Sustainable Development Goals ("SDGs").

More information regarding our key ESG programs, goals and commitments, and key metrics can be found on our website and within our 2023 ESG Update, 2022 ESG Update, and 2020 ESG Report.

More information regarding our key ESG programs, goals and commitments, and key metrics can be found on the ESG Reports and Updates section of our website.

Our ESG highlights include the following:

Environmental Matters

We participate in recycling programs through local waste management facilities to divert all recyclable materials away from landfills, including but not limited to bottles, cans, plastics, paper, and cardboard.

Our electronic waste is sent to approved local e-waste recycling centers.

We have a policy of using IT hardware vendors that embrace environmental sustainability.

We continue in our commitment to remote work;

with most employees working from home, which reduces emissions from commuting to workplaces.

We continue in our commitment to remote work, with most employees working from home, which reduces emissions from commuting to workplaces.

As part of our ongoing commitment to environmentally sustainable business operations, we recently consolidated the servers in our U.S.

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We have identified electricity as our source that produces GHG scope 2 emissions.

Scope 3 encompasses emissions that are not produced by the company itself and are not the result of activities from assets owned or controlled by them, but by those entities with which it engages up and down its value chain.

Scope 3 encompasses emissions that are not produced by the company itself and are not the result of activities from assets owned or controlled by it, but by those entities with which it engages up and down its value chain.

An example of this is when we buy, use, and dispose of products from suppliers.

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• Our commitment to our people lies in our continued efforts to support and value our most important asset - our employees.

• We conduct an annual employee engagement survey to ensure cultural alignment and success of internal programs and to further support our employees' needs.

• We maintain a remote-first philosophy that supports the needs and priorities our employees have outside of work and contributes to work-life balance.

• We have a paid parental leave program to support working parents and a recognition system to encourage peer- to-peer and leader-to-employee recognition.

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• We continue to engage with our employees and listen to their feedback in order to work toward building a culture of trust, collaboration, and transparency.

• We conducted a compensation benchmarking study with an external compensation consultant, and have made efforts to better align our compensation practices with market salary ranges.

Customer Privacy & Data Security

• We value customer privacy, and we endeavor to collect data only to the extent needed to deliver company information, software products, and consulting services.

Client Privacy & Data Security

• We value client privacy, and we endeavor to collect data only to the extent needed to deliver company information, software products, and consulting services.

Our website includes a copy of our comprehensive Privacy Notice, which details what and how data are collected, how data are used and stored, and the options for controlling personal data, including opting out, accessing, updating, or deleting it.

• In recognition of the critical importance of data security to our operations, including cybersecurity, data protection, and customer privacy, our leadership team conducts a thorough examination of all elements of data security.

• In recognition of the critical importance of data security to our operations, including cybersecurity, data protection, and client privacy, our leadership team conducts a thorough examination of all elements of data security.

Our objective is to ensure the security, confidentiality, and privacy of our systems and information assets, and to follow and be compliant with all applicable laws, regulations, and guidelines, including, but not limited to:

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◦ The EU’s General Data Protection Regulation (the "EU GDPR")

◦ The U,K Data Protection Act 2018 (the “UK GDPR”)

◦ The UK Data Protection Act 2018 (the "UK GDPR")

◦ Pharmaceutical Good Practice Quality Guidelines, including FDA 21 CFR Part 11

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Our Quality and Compliance department is also responsible for ensuring that corporate IT policies are aligned and compliant with all applicable regulatory provisions and current best practices.

• We have engaged a third-party consulting firm, VeraSafe, as our Data Protection Officer ("DPO").

The DPO is responsible for ensuring that we have a Personal Data Protection program in place that is compliant with data privacy laws such as the EU GDPR, UK GDPR, China’s PIPL, and data privacy laws enacted at the state level, as applicable to us.

• Margaret Richardson, Executive Director of Quality and Compliance, is the Data Protection Officer (“DPO”) for the Company.

Our corporate Personal Data Protection program includes policies, practices, and training directed to protecting personal data.

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• In addition to abiding by all applicable laws, all management and employees are required to comply fully with our Code of Conduct, which sets forth the Company’s values, business culture, and practices.

The Code of Conduct also governs conduct between our employees and our customers and vendors with whom we do business.

Because many of our customers are companies in the pharmaceutical and biotech industries, we have incorporated in our Code of Conduct the principles of the Pharmaceutical Supply Chain Initiative, including Leadership, Partnering, Presence, Consistency & Quality, Learning, and Innovation & Discovery.

The Code of Conduct also governs conduct between our employees and our clients and vendors with whom we do business.

Because many of our clients are companies in the pharmaceutical and biotech industries, we have incorporated into our Code of Conduct the principles of the Pharmaceutical Supply Chain Initiative, including Leadership, Partnering, Presence, Consistency & Quality, Learning, and Innovation & Discovery.

• The Company was founded on the belief that our software technologies could lead to important advances in healthcare, thereby improving patient outcomes, advancing and improving global health, and bettering the lives of humankind.

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In addition, all our employees, contractors, and vendors are required to follow our Code of Conduct as a part of our good governance practice.

Our Board of Directors is gender and racially diverse and we have appointed a lead independent director.

Our Board of Directors is gender and racially diverse.

Our ESG steering committee oversees and executes matters related to ESG.

More information about our corporate governance features will be included in our Proxy Statement for the 2026 Annual Meeting of Shareholders (the "Proxy Statement"), which we intend to file with the Securities and Exchange Commission within 120 days after August 31, 2025, the close of our fiscal year covered by this Report.

These ESG initiatives reflect our approach to managing long-term operational and reputational risks.

They are not intended to imply that we have adopted, or are required to comply with, any particular third-party standard.

We will continue to evaluate our ESG disclosures as regulatory expectations evolve.

COMPANY WEBSITE

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business