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RESEARCH TRIANGLE PARK, N.C. - Simulations Plus, Inc. (NASDAQ:SLP), a provider of simulation software and consulting services to the pharmaceutical industry with a market capitalization of $618 million and impressive revenue growth of 21.5% over the last twelve months, has announced the launch of DILIsym® 11, the newest iteration of its quantitative systems toxicology (QST) software. According to InvestingPro data, the company maintains a strong financial position with a current ratio of 4.37, indicating robust liquidity. The update introduces capabilities for predicting drug-induced liver injury (DILI) in pediatric populations, a significant advancement in the field of predictive toxicology.
DILIsym is recognized as a leading QST model for DILI prediction, widely used for its insights into liver injury mechanisms and for its data which is evaluated by the U.S. Food and Drug Administration’s (FDA) DILI team. The latest version, DILIsym 11, includes a new pediatric module that allows researchers to assess liver safety risks in children, which is a critical step towards safer therapies for this vulnerable group.
Additionally, DILIsym 11 features an improved T-cell model to better understand CD8+ T-cell mediated hepatocellular injury, updated mechanisms for antioxidant adaptation, and enhanced representation of bile acid and cholestatic liver injury. These advancements are expected to refine the predictive accuracy of DILI risks and contribute to the development of safer drug dosing strategies.
Shawn O’Connor, CEO of Simulations Plus, emphasized the importance of improving the prediction of DILI to develop safer treatments. Dr. Scott Q. Siler, Chief Scientific Officer of QSP Solutions at Simulations Plus, also highlighted the significance of the software’s new pediatric capabilities in advancing the safety of treatments for children globally.
Simulations Plus has been serving the biopharma industry for over 25 years, offering a range of software and consulting services that support drug discovery, development, and regulatory submissions. The company integrates artificial intelligence and machine learning with various pharmacokinetic and pharmacodynamic modeling approaches in its solutions.
The company also maintains a commitment to Environmental, Social, and Governance (ESG) initiatives, details of which can be found in their 2024 ESG update.
This announcement contains forward-looking statements and reflects the company’s projections and expectations as of the release date. However, actual results may differ due to various factors, including market conditions and the ability to maintain competitive advantages. For comprehensive analysis of Simulations Plus and over 1,400 other US stocks, including detailed Fair Value assessments and expert insights, visit InvestingPro. The information is based on a press release statement.
In other recent news, Simulations Plus reported strong financial results for the second quarter of fiscal year 2025, with revenue reaching $22.4 million, a 22.5% increase from the previous year. This figure exceeded both BTIG’s and consensus estimates, which were $22 million and $21.9 million, respectively. Despite the revenue growth, the company’s adjusted EBITDA fell to $6.6 million, representing a 7.8% decline from the previous year and missing the estimates from BTIG and consensus. In a related development, BTIG adjusted its price target for Simulations Plus, reducing it from $50.00 to $41.00, while maintaining a Buy rating. Citizens JMP also maintained a Market Perform rating on the company’s stock following the financial report. Additionally, Simulations Plus announced a change in its independent registered public accounting firm, appointing Grant Thornton LLP as its new auditor. This decision follows a competitive process and was not due to any disagreements with the previous auditor, Rose, Snyder & Jacobs LLC.
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