Welcome to our dedicated page for Certara news (Ticker: CERT), a resource for investors and traders seeking the latest updates and insights on Certara stock.
Certara, Inc. (NASDAQ: CERT) delivers biosimulation solutions and model-informed drug development services that accelerate pharmaceutical innovation. This page provides comprehensive coverage of Certara's latest news, including regulatory milestones, strategic partnerships, and advancements in simulation technology.
Investors and industry professionals will find timely updates on earnings reports, product launches, and scientific developments shaping the drug development landscape. Our curated collection features press releases on regulatory submissions, technology platform enhancements, and collaborations with biopharma leaders.
Key focus areas include Certara's biosimulation software updates, regulatory science achievements, and innovations in quantitative pharmacology. Bookmark this page to stay informed about developments impacting clinical trial optimization and global drug approval processes.
Certara (Nasdaq: CERT) has launched its Non-Animal Navigator™ solution to help biopharmaceutical companies reduce animal testing in drug development, aligning with FDA's new roadmap for preclinical safety studies. The solution focuses particularly on monoclonal antibodies and antibody-drug conjugates (ADCs), where biosimulation models can often predict human outcomes as effectively as traditional animal studies.
The offering includes three key components:
- Strategic Regulatory Advice for future-proof IND submissions
- Integrated Preclinical Development Plan combining various data sources
- Optimized AI-Enabled Modeling Toolkit featuring the Simcyp Simulator® and mAb Quantitative Systems Pharmacology models
The initiative aims to help companies achieve faster development timelines, lower costs, and stronger predictive evidence while ensuring regulatory compliance.
Certara (NASDAQ: CERT) has announced preliminary Q1 2025 financial results and a new $100 million share repurchase authorization. The company reported expected Q1 revenue of $106.0 million, up 10% year-over-year, with software revenue growing 18% to $46.4 million and services revenue increasing 4% to $59.6 million.
Q1 bookings reached $118.0 million, a 12% increase, with software bookings up 22% to $40.6 million and services bookings rising 7% to $77.4 million. Adjusted EBITDA is expected in the range of $33-$35 million, representing 13-20% growth.
The company reiterated its full-year 2025 guidance with revenue projected between $415-425 million and adjusted EBITDA margin of 30-32%. Additionally, Arsenal Capital Partners agreed to a one-year lock-up on shares acquired from EQT in December 2022.
Certara (Nasdaq: CERT) has released Version 24 of its Simcyp™ Simulator, enhancing its physiologically-based pharmacokinetic (PBPK) modeling platform. The update includes significant improvements in biopharmaceutics, drug-drug interactions, and biologics capabilities.
Key updates include enhanced food effect predictions in the Virtual Bioequivalence module, expanded drug-drug interaction libraries, improved biologics modeling, and enhanced trial design support. The platform also features modernized UI, cloud computing capabilities, and AI-enabled assistance.
The Simcyp Simulator, guided by a consortium of over 30 pharmaceutical companies, has contributed to more than 120 FDA-approved novel drugs. Notably, 4 out of 5 drugs using PBPK for FDA approval in recent years utilized the Simcyp Simulator.
Certara (NASDAQ: CERT) has appointed Dr. Adrian McKemey as President of Drug Development Solutions, effective March 3rd, 2025. McKemey, who previously served as head of Enterprise Transformation at IQVIA and Senior VP of R&D Strategy Solutions at Quintiles, brings over 25 years of experience in research and development.
The appointment is part of a planned leadership transition, with Patrick Smith, PharmD, moving to the role of Senior Vice President of Translational Sciences. McKemey holds a BSc and PhD in High Energy Nuclear Particle Physics from the University of London, and previously worked as a Principal at Boston Consulting Group's Life Sciences practice.
The company aims to leverage McKemey's expertise to accelerate growth in its biosimulation and scientific services for life sciences clients globally, focusing on improving drug development processes and portfolio decision-making through in silico models.
Certara (NASDAQ: CERT) reported strong Q4 2024 financial results with total revenue of $100.4 million, up 14% year-over-year. The company's performance was marked by significant growth across segments, with software revenue increasing 26% to $42.3 million and services revenue growing 7% to $58.1 million.
Notable achievements include a net income of $6.6 million, compared to a previous year's loss of $12.5 million, and adjusted EBITDA of $33.5 million, representing 13% growth. Total bookings reached $144.5 million, up 22%, with software bookings growing 38% to $59.7 million.
Looking ahead, Certara provided 2025 guidance projecting revenue between $415-425 million, with adjusted EBITDA margin of 30-32% and adjusted diluted EPS of $0.42-$0.46.
Certara (NASDAQ: CERT) announced it will release its Q4 and full-year 2024 financial results after market close on February 26th, 2025. Management will host a conference call at 5:00 PM ET to discuss the results, with advance registration required for investors.
Additionally, the company's management team will participate in two upcoming investor conferences in March: the Leerink Partners Global Healthcare Conference on March 11th at 1:00 PM ET and the Barclays 27th Annual Global Healthcare Conference on March 12th at 11:30 AM ET. Live and archived webcasts of these events will be available on Certara's investor relations website.
Certara (NASDAQ: CERT) released preliminary Q4 and full-year 2024 financial results, reporting annual revenue of $384.4 million, up 8% from 2023. Q4 revenue reached $99.7 million, showing 13% growth year-over-year.
The company's software segment demonstrated strong performance with Q4 revenue of $41.6 million (+24%) and full-year revenue of $155.0 million (+18%). Services revenue grew more modestly, with Q4 at $58.1 million (+7%) and full-year at $229.4 million (+3%).
Total bookings for 2024 increased 11% to $445.3 million, with software bookings growing 24% to $169.4 million and services bookings up 4% to $275.9 million. The company confirmed its adjusted EBITDA guidance range of $120-124 million for 2024. The results include contribution from Chemaxon, acquired on October 1, 2024, which added $5.9 million in revenue and $11.0 million in bookings.
Certara (CERT), a leader in model-informed drug development, has announced its participation in the upcoming 43rd Annual J.P. Morgan Healthcare Conference. The company's management team is scheduled to present on Wednesday, January 15th, 2025, at 5:15 PM Pacific Time.
Investors and interested parties can access a live webcast of the presentation through Certara's investor relations website at https://ir.certara.com. The presentation recording will remain available for replay on the website for a minimum of 30 days following the event.
Certara (Nasdaq: CERT) highlights its 2024 research achievements with over 100 publications and recognition of 12 company scientists in the Stanford/Elsevier top 2% cited researchers list. The publications cover diverse areas including pediatric oncology, first-in-human dose predictions, exposure-response analyses, and the application of PBPK modeling in global health. Notable research trends focused on biosimulation strategies in drug development and extended model-informed drug development, including the implementation of generative AI in regulatory writing and diversity in clinical trial enrollment.
Certara (NASDAQ: CERT) reported Q3 2024 financial results with revenue of $94.8 million, up 11% year-over-year. Software revenue grew 15% to $35.9 million, while services revenue increased 9% to $58.9 million. The company posted a net loss of $1.4 million, significantly improved from a $49.0 million loss in Q3 2023. Adjusted EBITDA rose 15% to $33.1 million. Total bookings grew 13% to $96.1 million. The company updated its full-year 2024 guidance, expecting revenue between $380-385 million and adjusted EBITDA of $120-124 million.
