Company Overview

Simulations Plus, Inc. is a publicly traded biotechnology and software company that develops modeling and simulation software and provides consulting services to support drug discovery, development, regulatory approval, and commercialization. The company primarily operates within the pharmaceutical, biotechnology, and regulatory science industries, focusing on quantitative methods that predict drug behavior in humans. Its core value proposition lies in reducing development timelines, costs, and clinical risk through advanced computational modeling.

The company’s primary revenue drivers include proprietary software platforms for pharmacokinetics and pharmacodynamics modeling, physiologically based pharmacokinetic (PBPK) modeling, population PK/PD analysis, and specialized regulatory and clinical pharmacology consulting services. Simulations Plus serves a global customer base that includes large pharmaceutical companies, emerging biotechnology firms, academic institutions, and government agencies. Founded in 1996, the company initially focused on chemical modeling and cheminformatics before evolving into a leader in pharmacometric and systems-based modeling through organic development and targeted acquisitions.

Business Operations

Simulations Plus generates revenue through two primary operating segments: Software and Services. The Software segment includes licensed and subscription-based products used for drug absorption, distribution, metabolism, excretion, and toxicity modeling, as well as population-based and nonlinear mixed-effects modeling. The Services segment provides scientific consulting, regulatory strategy support, clinical pharmacology analysis, and model-informed drug development services, often complementing the company’s software offerings.

Operations are conducted both domestically and internationally, with a strong emphasis on intellectual property developed in-house and through acquired technologies. The company operates through several wholly owned subsidiaries, including Lixoft, Cognigen Corporation, DILIsym Services, Nuventra Pharma Sciences, and SCIPharm, each contributing specialized expertise in pharmacometrics, systems toxicology, regulatory consulting, and clinical development strategy. These subsidiaries function as integrated business units while maintaining domain-specific focus.

Strategic Position & Investments

Strategically, Simulations Plus positions itself as a comprehensive provider of model-informed drug development solutions, integrating software platforms with high-value scientific consulting. Growth initiatives emphasize expanding the use of PBPK modeling in regulatory submissions, increasing adoption of subscription-based software, and incorporating artificial intelligence and machine learning into predictive modeling workflows. The company also targets cross-selling opportunities between its software customers and consulting services.

Major investments have centered on acquisitions that deepen technical capabilities and expand service offerings. Notable acquisitions include Lixoft (population modeling software), Cognigen Corporation (pharmacometric services), DILIsym Services (liver safety modeling), Nuventra Pharma Sciences (regulatory and clinical pharmacology consulting), and SCIPharm (UK-based pharmacometric consultancy). These investments have broadened Simulations Plus’ end-to-end coverage across the drug development lifecycle and strengthened its competitive position with regulators and global pharmaceutical sponsors.

Geographic Footprint

Simulations Plus is headquartered in North America, with its corporate headquarters in the United States. The company maintains a strong domestic presence supporting U.S.-based pharmaceutical and biotechnology clients, including interactions with U.S. regulatory agencies. Its operations and customer base extend across Europe and Asia-Pacific, reflecting the global nature of pharmaceutical development.

Internationally, the company’s footprint is reinforced through subsidiaries such as Lixoft in Europe and SCIPharm in the United Kingdom, as well as through distributed scientific teams and long-term client relationships in Asia, including Japan, China, and South Korea. This global reach enables Simulations Plus to support multinational clinical programs and regulatory submissions across multiple jurisdictions.

Leadership & Governance

Simulations Plus was founded by scientists with expertise in computational modeling and has continued to be led by executives with strong technical and industry backgrounds. The leadership team emphasizes scientific rigor, regulatory credibility, and long-term value creation through innovation and disciplined capital allocation. Governance practices align with U.S. public company standards, with oversight by an independent board of directors.

Key executives include:

• Shawn E. O’Connor – Chief Executive Officer
• Daniel G. O’Connor – Chief Financial Officer
• John E. DiLillo – President and Chief Operating Officer
• Roderick J. Morrison – Chief Scientific Officer
• Ying Wu – Chief Technology Officer

The leadership’s strategic vision centers on advancing model-informed drug development as a standard across the pharmaceutical industry while maintaining strong relationships with global regulators and scientific stakeholders.