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Simulations Plus, Inc. provides model-informed and AI-accelerated drug development software, training, and consulting services for biopharmaceutical research. News about the company centers on its software and services segments, scientific modeling engines, ADMET and other modeling workflows, and financial results tied to software renewals, services bookings, and customer activity.
Recurring developments also include collaborations with pharmaceutical companies, technology providers, and regulatory or public-health agencies. These updates cover GPU-accelerated simulation, AI-assisted modeling, predictive frameworks for complex oral drug products, computational toxicology, new approach methodologies, and education programs that expand use of model-informed drug development practices.
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Simulations Plus, Inc. (NASDAQ: SLP) announced the renewal of FDA licenses for its DILIsym® software, a leading tool in predicting drug-induced liver injury (DILI). This one-year renewal allows FDA employees continued access to DILIsym across all divisions. Dr. Paul B. Watkins emphasized that this endorsement underscores DILIsym's value in assessing liver safety during drug development, especially after the FDA Modernization Act 2.0 signing. Dr. Brett A. Howell remarked on the growing importance of simulation technologies to enhance drug development efficiency amid rising healthcare costs. DILIsym's predictive modeling aids crucial decisions in drug development by identifying potential DILI risks and guiding go/no-go decisions. Simulations Plus has provided biosimulation solutions for over 25 years, employed by major stakeholders in the pharmaceutical industry.
Simulations Plus, a leader in pharmaceutical modeling software, reported Q2 fiscal 2023 revenues of $15.8 million, a 6% increase year-over-year. Software revenue rose 7% to $10.5 million, while services revenue saw a 4% increase to $5.3 million. Gross profit grew 10% to $13.1 million, achieving an impressive gross margin of 83%. However, net income decreased to $4.2 million with diluted EPS at $0.20, down from $4.4 million or $0.21 last year. Year-to-date, revenues climbed 2% to $27.7 million, with diluted EPS at $0.26, down from $0.36. The company maintains its full-year revenue guidance of $59.3 - $62.0 million and diluted EPS of $0.63 - $0.67.