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Simulations Plus (SLP) DILIsym Software Licenses Renewed by FDA

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Simulations Plus (SLP - Free Report) recently announced that the FDA (United States Food and Drug Administration) has renewed its DILIsym software licenses for the seventh year in a row.

DILIsym is a modernized Quantitative Systems Toxicology software for forecasting and analyzing drug-induced liver injury (DILI). The software is specifically engineered to evaluate the potential of DILI risk in new molecules and offer knowledge on the mechanisms that fuel DILI response at multiple levels of the drug development process. This aids pharmaceutical development teams in the understanding of compounds and outlines safe dosing strategies.

Authorized employees across all FDA verticals gain continuous access to the DILIsym by renewing SLP’s license for another year. The use of the software aligns with FDA’s vision of safe evaluation and approval of drugs.

SLP has been part of the DILI-sim Initiative for the past 14 years. DILI-sim is a public-private consortium between DILIsym Services, Inc. and numerous pharmaceutical companies to cushion the development of the DILIsym platform. The platform is also used for providing consultancy on safety-related concerns to the SLP.

SLP is a leading-edge developer of simulation software for pharmaceutical, chemical and biotechnology companies across the globe. The simulation software is used for drug discovery, development, research and regulatory submissions.

In the last reported quarter, SLP posted revenues of $18.3 million, increasing 16% year over year. The top line, which also beat the Zacks Consensus Estimate of $17 million, registered healthy growth owing to higher software revenues in the Clinical Pharmacology & Pharmacometrics and Cheminformatics business units.

Growth in services revenues was driven by increasing sales from Quantitative Systems Pharmacology (QSP) and Physiologically Based Pharmacokinetics (PBPK) business units. QSP posted 78% year-over-year revenue growth in the quarter under review.  QSP unit is gaining from increasing immunology and cancer model projects.

The results have boosted the shares of SLP by 24% since it announced second-quarter fiscal 2024 financial results on Apr 3, after the closing bell.

For fiscal 2024, it anticipates a revenue increase of 10-15% from the 2023 levels.

Currently, Simulations Plus carries a Zacks Rank #3 (Hold). Shares of the company have gained 10% compared with the industry’s growth of 43.1%.

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