LANCASTER, Calif. - Simulations Plus , Inc. (NASDAQ:SLP), a provider of simulation software and services for the pharmaceutical industry, has announced a collaboration with the University of Strathclyde and InnoGI Technologies, funded by a grant from the U.S. Food and Drug Administration. The project aims to advance the understanding and prediction of amorphous solid dispersion (ASD) formulations under various conditions, including the impact of food and pH-dependent drug-drug interactions (DDIs).
The collaboration will leverage the University of Strathclyde's expertise in analyzing ASD drug products, while InnoGI Technologies will conduct tests using their tiny-TIMsg, part of the SurroGUT™ Platform. The initiative will develop physiologically based pharmacokinetic (PBPK) models on the GastroPlus® platform to connect in vitro dissolution with in vivo pharmacokinetic data, leading to virtual bioequivalence (VBE) trial simulations. These advancements are expected to facilitate formulation adjustments, reduce costs, and accelerate the time-to-market for ASD products.
Dr. Maxime Le Merdy, Director of PBPK Collaborations at Simulations Plus and principal investigator for the grant, expressed enthusiasm about the project's potential to significantly advance PBPK science and improve predictions of drug product performance. Professor Hannah Batchelor from the University of Strathclyde highlighted the benefits of the industry-academia-regulatory collaboration in driving greater efficiency and confidence in drug development decisions.
The FDA will actively collaborate with the project partners, and Simulations Plus will coordinate the modeling and simulation activities. The collaboration is funded by the FDA through grant award 1U01FD008388-01, but the views expressed in the press release do not necessarily reflect the official policies of the Department of Health and Human Services.
The project is part of Simulations Plus's broader commitment to enhancing drug discovery and development processes. The company's work in this field is complemented by its focus on Environmental, Social, and Governance (ESG) efforts to maximize positive impact.
This news is based on a press release statement and should not be seen as an endorsement of the company or its products by the U.S. Government.
In other recent news, Simulations Plus reported robust financial results for fiscal year 2024, with total revenue up by 18% to $70 million and a fourth-quarter revenue rise of 19% to $18.7 million. The company's fourth-quarter results revealed a revenue increase of 19% year-over-year but fell short of the $19.7 million expected by BTIG and the consensus estimate. Despite this, Simulations Plus issued financial guidance for fiscal year 2025 that included revenue projections aligning with initial estimates and an adjusted earnings per share (EPS) forecast between $1.07 and $1.20.
Simulations Plus's strategic acquisitions of Pro-ficiency and Immunetrics have expanded its total addressable market and enhanced its software offerings. Despite facing renewal delays and challenges in the Asian market, Simulations Plus remains optimistic, projecting a revenue of $90 million to $93 million for fiscal year 2025. This projection indicates a growth of 28% to 33% year-over-year, with anticipated organic growth consistent with the previous year at 10% to 15%.
BTIG has adjusted the financial outlook for Simulations Plus, reducing the price target to $50.00 from the previous $60.00 while still holding a Buy rating on the stock. The guidance for adjusted EBITDA margin was set at 31-33%, surpassing BTIG's projection of 27%. These recent developments reflect the company's ongoing financial performance and market expectations.
InvestingPro Insights
Simulations Plus's recent collaboration with the University of Strathclyde and InnoGI Technologies, backed by FDA funding, aligns well with the company's strong market position and financial performance. According to InvestingPro data, Simulations Plus boasts a market capitalization of $596.52 million, reflecting its significant presence in the pharmaceutical simulation software industry.
The company's revenue growth is particularly noteworthy, with a 17.52% increase over the last twelve months and a 19.65% quarterly growth as of Q4 2024. This robust growth trajectory supports the company's ability to invest in innovative projects like the ASD formulation research.
InvestingPro Tips highlight that 3 analysts have revised their earnings upwards for the upcoming period, suggesting positive expectations for the company's financial performance. This optimism may be linked to Simulations Plus's involvement in cutting-edge pharmaceutical research projects, such as the one described in the article.
It's worth noting that Simulations Plus operates with a moderate level of debt, which could provide financial flexibility for research and development initiatives. The company's strong gross profit margin of 61.63% in the last twelve months indicates efficient operations and potential for reinvestment in growth opportunities.
For investors interested in a deeper analysis, InvestingPro offers 9 additional tips for Simulations Plus, providing a more comprehensive view of the company's financial health and market position.
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