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RADNOR, Pa. - Certara, Inc. (NASDAQ:CERT), a $1.59 billion market cap company generating $385 million in annual revenue, known for its expertise in model-informed drug development, announced the release of an updated version of its Simcyp Simulator, a tool utilized for physiologically-based pharmacokinetic (PBPK) modeling. According to InvestingPro data, the company has maintained solid 8.7% revenue growth over the last twelve months. The latest iteration, Version 24, offers several enhancements aimed at refining data-driven decision-making throughout the drug development process.
The Simcyp Simulator is designed to predict how drugs behave in various body tissues. Its development is guided by a consortium of over 30 leading pharmaceutical companies whose input has been instrumental in the enhancements of Version 24. These improvements are expected to support the growing use of PBPK in both drug development and regulatory decision-making.
Rob Aspbury, President of Certara Predictive Technologies, emphasized the tool’s evolution to meet the changing needs of both pharmaceutical partners and regulators. The new version extends its applications from the discovery phase through to clinical development.
Masoud Jamei, Ph.D., Senior Vice President of Simcyp R&D at Certara, highlighted the simulator’s role in regulatory approvals, noting that "4 out of 5 drugs leveraging PBPK for FDA approval in recent years used the Simcyp Simulator."
Key updates in Simcyp Simulator V24 include improved biopharmaceutical capabilities and the Virtual Bioequivalence (VBE) module, now with features to predict the impact of food on drug absorption. The expanded library for drug-drug interactions covers a wider range of capabilities, providing evidence to support transporter-mediated DDIs in the gut, liver, and kidney.
The update also offers more accurate characterization of membrane-bound targets, enhancements for clinical trial design simulation, and expanded modeling for special populations such as pediatric, pregnant, and lactating individuals. Users can expect a modernized user interface, cloud computing options, AI-enabled support, and improved parameter prediction based on chemical structures.
The Simcyp Simulator has contributed to the approval of over 120 novel drugs by the FDA and has played a role in clinical trial waivers for DDI and pediatric trials. Certara is hosting a webinar to provide further insights into the new features of Simcyp V24. While the company’s stock currently trades near its 52-week low of $9.41, InvestingPro analysis suggests the stock is undervalued, with analysts maintaining positive earnings forecasts for the upcoming year.
Certara is a global entity that provides biosimulation software, technology, and services to expedite the drug discovery and development process. Its clientele spans more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries. The company maintains a healthy financial position with a current ratio of 2.13 and operates with moderate debt levels. For detailed insights into Certara’s financial health and growth prospects, including 12 additional ProTips and comprehensive valuation metrics, visit InvestingPro. This announcement is based on a press release statement from Certara.
In other recent news, Certara Inc. reported its fourth-quarter earnings for 2024, surpassing market expectations with an earnings per share (EPS) of $0.15, compared to the forecast of $0.12. The company’s revenue reached $100.4 million, exceeding the anticipated $97.92 million, marking a 14% year-over-year increase. This strong financial performance was driven by a 22% growth in total bookings, with software bookings experiencing a significant 38% rise. KeyBanc Capital Markets maintained an Overweight rating on Certara shares, setting a $15 price target, citing confidence in the company’s growth potential and noting a robust software backlog. Meanwhile, TD Cowen initiated coverage with a Buy rating and a $16 price target, emphasizing the potential of Certara’s Model-Informed Drug Discovery and Development platform. In leadership news, Certara announced that Dr. Patrick F. Smith stepped down as President of Certara Drug Development Solutions, although he will continue in a senior advisory role. These developments underscore Certara’s ongoing efforts to expand its market presence and enhance its financial performance.
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