Simulations Plus, Inc.

Overview

• Global provider of software and consulting services for the biopharma sector, supporting drug discovery, development, clinical operations, regulatory activities, and commercialization.
• Supports clients across the full drug development lifecycle from early discovery through regulation and post-approval commercialization.
• Offers an integrated platform of scientific software, AI/ML-enabled models, and expert consulting to accelerate timelines, reduce costs, and improve confidence in safety and efficacy.
• Reorganized at the beginning of Q4 fiscal year 2025 into a function-based structure focused on Services, Operations, Product and Technology, Research and Development, Sales and Marketing, and General and Administrative.

Where the company operates

• U.S. headquarters: Research Triangle Park, North Carolina.
• European office: Paris, France.
• Business model emphasizes remote work and an integrated operating platform; maintains a New York colocation facility and uses Amazon Web Services (AWS) for hosting and cloud services.

Core offerings

• End-to-end drug development solutions, combining software and services across:
  • Discovery: Biosimulation tools for predicting molecular properties (AI/ML-based).
  • Development: Mechanistic biosimulation and PK/PD modeling tools.
  • Clinical operations: Education, training, and compliance monitoring software.
  • Commercialization: KOL research and market insights dashboards.

Key products

• Discovery
  • ADMET Predictor®: AI/ML platform predicting more than 175 molecular properties; optional ADMET Modeler for proprietary model building.
  • MedChem Designer™: Chemical sketching tool with integrated ADMET property predictions from ADMET Predictor.
• Development
  • GastroPlus®: Mechanistic simulations of absorption, biopharmaceutics, pharmacokinetics, and pharmacodynamics in humans and animals.
  • DDDPlus™: In vitro dissolution modeling for APIs and excipients under various conditions.
  • MembranePlus™: In vitro permeability and hepatocyte modeling.
• Additional mechanistic/QQT biosimulation products: DILIsym®, NAFLDsym®, ILDsym™, IPFsym®, RENAsym®, MITOsym®, OBESITYsym™, Thales™.
• MonolixSuite™: Integrated suite (Monolix®, PKanalix®, Simulx®) for data visualization, non-compartmental analysis, population modeling, and clinical trial simulations.
• Clinical operations
  • Pro-ficiency®: Adaptive learning and simulation-based training for protocol compliance during trials.
• Commercialization
  • Panorama KOL Insights: Dashboard for current information on key opinion leaders with multiple filters.

Services

• PBPK, QSP, and PK/PD consulting and modeling across discovery, translational science, and clinical development.
• Clinical pharmacology and regulatory support, including dose selection, trial design, and safety/efficacy interpretation.
• Training development, simulation-based education, and compliance monitoring for clinical trials.
• Commercial medical communications strategy and market intelligence support.

Business model and market position

• Focus on model-informed drug development (MIDD) and AI/ML-enabled modeling and simulation to optimize formulations, dosing, trial designs, and regulatory submissions.
• Serves pharmaceutical and biotechnology companies, agrochemical and cosmetics firms, food industry companies, universities, hospitals, and government research and regulatory agencies worldwide.
• Client base is highly fragmented; no single client accounted for a material portion of revenue for the year ended August 31, 2025.
• Competes with software providers, CROs, and in-house teams; emphasizes ongoing R&D investment, proprietary data and resources, and collaborative relationships with industry, academia, and government.

Financial snapshot (year ended August 31, 2025)

• Revenue mix: Software accounted for 58% of total revenue; Services accounted for 42%.
• Employees: 213 total employees as of August 31, 2025 (212 full-time, 1 part-time).
• Workforce qualifications: Over 60% of technical and scientific staff hold advanced degrees; more than 70% have life-sciences software, services, or R&D backgrounds.
• Impairments: A Pro-ficiency impairment charge was recorded in fiscal 2025 due to lower-than-expected performance and a decline in market capitalization.
• Dividend policy: Quarterly dividends were suspended and the company does not expect to pay cash dividends in the foreseeable future.
• Public listing: Common stock trades on the Nasdaq Global Select Market under the symbol SLP (since May 13, 2021).

Other details

• Intellectual property and data security are central to the business; protections include trademarks, copyrights, trade secrets, and contractual safeguards. A Data Protection Officer oversees compliance with personal data regulations (GDPR, UK GDPR, PIPL, and others).
• Cloud and data infrastructure rely on an internal hosting facility plus AWS; the company maintains disaster recovery plans and service-level agreements with clients.
• Environmental, social, and governance (ESG) initiatives include remote work to reduce emissions and a focus on employee well-being, diversity, and data privacy.

Summary

Simulations Plus provides an integrated suite of biosimulation software and specialized consulting services that span the drug development lifecycle. The company combines mechanistic modeling, AI/ML-based prediction tools, and training services with a remote-work enabled, functionally reorganized operating model. As of August 31, 2025, the company employed 213 people and reported a software-led revenue mix.