Simulations Plus (SLP – Free Report) recently announced that the FDA (United States Food and Drug Administration) has renewed its licenses for the DILIsym software for the seventh year in a row.
DILIsym is a modernized quantitative systems toxicology software for the prediction and analysis of drug-induced liver injury (DILI). The software is specifically designed to assess the potential DILI risk in new molecules and offers knowledge of the mechanisms that drive the DILI response at multiple levels of the drug development process. This helps pharmaceutical development teams understand compounds and outlines safe dosing strategies.
Authorized employees in all FDA verticals receive ongoing access to DILIsym by renewing their SLP license for another year. Use of the software is consistent with the FDA’s vision for safe drug evaluation and approval.
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 facilitate the development of the DILIsym platform. The platform is also used to provide advice to the SLP on security issues.
SLP is a leading developer of simulation software for pharmaceutical, chemical and biotechnology companies worldwide. Simulation software is used for drug discovery, development, research and regulatory submissions.
In the last reported quarter, SLP generated revenue of $18.3 million, an increase of 16% year-over-year. The top line, which also beat the Zacks Consensus Estimate of $17 million, saw healthy growth thanks to higher software revenue in the Clinical Pharmacology & Pharmacometrics and Cheminformatics business units.
The growth in revenue from services was driven by the increase in sales of quantitative systems pharmacology (QSP) and physiologically based pharmacokinetics (PBPK) business units. In the observed quarter, QSP achieved a revenue growth of 78% compared to the previous year. The QSP unit is winning more and more projects in the field of immunology and cancer models.
The results have lifted SLP shares by 24% since it reported financial results for the second quarter of fiscal 2024 on April 3, after the closing bell.
Fiscal 2024 is forecast to increase revenue by 10-15% over 2023 levels.
Currently, Simulations Plus has a Zacks Rank #3 (Hold). The company’s stock gained 10% compared to the industry’s 43.1% gain.
Image source: Zacks Investment Research
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