Core Insights - Certara, Inc. announced expected revenue and bookings for the first quarter, reflecting a positive outlook for the company [1] - The company reiterated its 2025 guidance, projecting sales between $415 million and $425 million, with an adjusted EBITDA margin of 30-32% and adjusted EPS of 42-46 cents [2] Financial Performance - Certara reported revenue of $106 million for the first quarter, a 10% increase from $96.7 million in the same period last year, exceeding the consensus estimate of $104.42 million [4] - Software revenue reached $46.4 million, up 18%, while services revenue was $59.6 million, up 4% [4] - Interim Q1 bookings totaled $118 million, a 12% increase, including software bookings of $40.6 million and services bookings of $77.4 million [4] - The company expects adjusted EBITDA of approximately $33-$35 million, representing a growth of 13-20% [4] Strategic Initiatives - Certara is pursuing a strategic evaluation of its regulatory services business and has engaged in preliminary discussions with several external parties [3] - The company launched its Non-Animal Navigator solution aimed at assisting biopharmaceutical companies in transitioning from animal testing [3] Market Reaction - Following the announcements, Certara's stock price increased by 9.14%, reaching $14.10 [3]

New offering provides strategic guidance and AI-enabled biosimulation to navigate FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety StudiesRADNOR, Pa., April 14, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced the launch of its Non-Animal Navigator™ solution designed to help biopharmaceutical companies lead the transition ignited by the FDA’s Roadmap to Reducing Animal Testing in Preclinical Safety Studies. The Roadmap m ...

Reiterates Full-Year 2025 Guidance Arsenal Capital Partners agrees to a one-year lock-up RADNOR, Pa., April 14, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced expected revenue and bookings for the first quarter of 2025 based upon a preliminary review of first quarter results. Additionally, the company announced that its Board of Directors has authorized a stock repurchase program under which the company may repurchase up to $100 mil ...

Core Viewpoint - Certara, Inc. has reported strong preliminary financial results for Q1 2025, with significant growth in revenue and bookings, and has reiterated its full-year guidance for 2025 [2][6]. Financial Performance - Expected revenue for Q1 2025 is $106.0 million, a 10% increase from $96.7 million in Q1 2024 [7]. - Software revenue is projected at $46.4 million, up 18% from $39.3 million in the same quarter last year [7]. - Services revenue is expected to be $59.6 million, reflecting a 4% growth from $57.3 million in Q1 2024 [7]. - Total bookings for Q1 2025 are anticipated to be $118.0 million, a 12% increase from $105.8 million in Q1 2024 [7]. - Adjusted EBITDA is estimated to be in the range of $33-$35 million, representing a growth of 13-20% compared to $29.1 million in Q1 2024 [7]. Full-Year Guidance - The company maintains its full-year 2025 revenue guidance in the range of $415 million to $425 million [8]. - Adjusted EBITDA margin for the full year is expected to be between 30-32% [8]. - Adjusted diluted earnings per share is projected to be in the range of $0.42 - $0.46 [8]. Strategic Developments - Arsenal Capital Partners has agreed to a one-year lock-up on shares acquired from EQT, indicating continued support for Certara's growth [3][6]. - Certara is actively pursuing a strategic evaluation of its regulatory services business, engaging in preliminary discussions with external parties [9]. Share Repurchase Program - The Board of Directors has authorized a stock repurchase program allowing for the repurchase of up to $100 million of outstanding common stock, reflecting confidence in the company's strategy [2][3].

Chris Lau is an individual investor and economist with 30 years of experience covering life science, technology, and dividend-growth income stocks. He has degrees in Microbiology and Economics. Chris runs the investing group DIY Value Investing where he shares his top stock picks of undervalued stocks with catalysts for upside, dividend-income recommendations with quant and payment calendar tracking, high upside plays, and research requests to help you become a better do-it-yourself investor. Learn more.Top ...

Certara, Inc. (CERT) shares soared 8% in the last trading session to close at $10.51. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 11.6% loss over the past four weeks.Earlier this month, the company released a new version of the Simcyp Simulator for physiologically-based pharmacokinetic (PBPK) modeling, which forecasts the behavior of drugs in different body tissues. Per management, the latest version cements Certara’s positio ...

Core Insights - Certara, Inc. has launched a new version of the Simcyp™ Simulator, enhancing its capabilities for physiologically-based pharmacokinetic (PBPK) modeling to support data-driven decision-making in drug development [1][2] Company Developments - The Simcyp Simulator Version 24 has been developed with input from a consortium of over 30 leading pharmaceutical companies, reflecting the evolving needs of pharmaceutical collaborators and regulators [2] - The simulator has been instrumental in the approval of over 120 novel drugs by the FDA and has facilitated clinical trial waivers in various areas, including drug-drug interactions (DDI) and pediatric trials [3] Technological Advancements - The latest version includes features for predicting food effects on drug absorption, expanded libraries for drug-drug interactions, and improved modeling for special populations such as pediatrics, pregnancy, and lactation [4] - Enhancements in performance and usability include a modernized user interface, cloud computing capabilities, and AI-enabled help chat [4] Market Impact - Currently, 80% of drugs utilizing PBPK for FDA approval in recent years have employed the Simcyp Simulator, indicating its significant role in the industry [2]

Core Insights - Certara, Inc. has released a new version of the Simcyp™ Simulator, enhancing its position as a leader in physiologically-based pharmacokinetic (PBPK) modeling for drug development [1][2] - The latest version, Simcyp Version 24, addresses the evolving needs of pharmaceutical collaborators and regulators, supporting the growing adoption of PBPK in drug development and regulatory decision-making [2] Company Developments - The Simcyp Simulator has contributed to over 120 FDA-approved novel drugs and has supported clinical trial waivers in various areas, including drug-drug interactions (DDI) and pediatric trials [3] - A consortium of over 30 leading pharmaceutical companies guides the development of the Simcyp Simulator, ensuring that the latest version incorporates their feedback to enhance capabilities and databases [2] Features of Simcyp Version 24 - The new version includes features for predicting food effects, improving drug absorption simulations under various meal conditions [4] - An expanded library for drug-drug interactions now covers a broader range of capabilities, providing qualification evidence for transporter-mediated DDIs in the gut, liver, and kidney [4] - Enhanced modeling for special populations, including pediatric, pregnancy, and lactation groups, has been incorporated [4] - The user interface has been modernized, and new functionalities such as cloud computing and AI-enabled help chat have been added to improve performance and usability [4]

McKemey joins Certara to accelerate growth of its strategic drug development solutionsRADNOR, Pa., March 05, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced the appointment of Adrian McKemey, Ph.D. as President of Drug Development Solutions, effective March 3rd, 2025. In this role, McKemey will lead Certara's global team of drug development scientists. Adrian joins Certara after serving as head of Enterprise Transformation at IQVIA a ...

Financial Data and Key Metrics Changes - Certara reported total revenue of $385.1 million for the full year 2024, representing a 9% increase compared to 2023 [8][30] - Fourth quarter revenue was $100.4 million, reflecting a 14% year-over-year growth [30] - Adjusted EBITDA for the fourth quarter was $33.5 million, up from $29.6 million in the same quarter of 2023, with an adjusted EBITDA margin of 33% [41][42] Business Line Data and Key Metrics Changes - Software revenue for the fourth quarter was $42.3 million, a 26% increase year-over-year, driven by biosimulation software and Pinnacle 21 [32] - Services revenue in the fourth quarter was $58.1 million, up 7% compared to the prior year [36] - Regulatory writing revenue for 2024 was $54.7 million, down from $60.5 million in 2023, indicating a decline in this segment [36] Market Data and Key Metrics Changes - Fourth quarter bookings totaled $144.5 million, a 22% increase from the previous year, with software bookings growing by 38% [9][31] - The software net retention rate was 106% for the fourth quarter and 108% for the full year, consistent with long-term growth profiles [35] Company Strategy and Development Direction - Certara is focused on enabling Model-Informed Drug Development (MIDD) in the biopharmaceutical industry, emphasizing the integration of generative artificial intelligence into existing products [10][14] - The company plans to invest further in software development, particularly for the discovery and lead optimization phases, leveraging Chemaxon's capabilities [21][22] - Certara aims to build an integrated software platform to enhance its competitive positioning in the market [20][22] Management's Comments on Operating Environment and Future Outlook - Management noted that customer sentiment remains cautious due to funding constraints and geopolitical uncertainties, with expectations for 2025 to mirror 2024 in terms of clinical R&D spending [12][13] - The company anticipates total revenue for 2025 to be in the range of $415 million to $425 million, representing growth of 8% to 10% compared to 2024 [46] Other Important Information - Certara expanded its customer base to over 2,400 life sciences companies by the end of 2024, with 431 customers having an annual contract value exceeding $100,000 [18][19] - The company completed the acquisition of Chemaxon in October 2024, which is expected to enhance its capabilities in the discovery biosimulation market [17][26] Q&A Session Summary Question: What drives the 2025 revenue guidance? - Management indicated that the guidance is influenced by spending patterns among Tier 1 and Tier 3 customers, with potential improvements in end markets pushing towards the higher end of the range [55] Question: What are the incremental R&D investments planned for 2025? - The company plans to invest in R&D to maintain momentum in its software portfolio and integrate Chemaxon, which is expected to impact margins [57][58] Question: How is the CoAuthor product performing? - CoAuthor has multiple paying customers and is expected to significantly reduce the time required to create regulatory documents, with revenue expectations in the millions for the year [110][112] Question: What is the outlook for regulatory services? - Regulatory services returned to growth in the fourth quarter, primarily driven by Tier 1 customers, which is expected to positively impact revenue moving into 2025 [106] Question: How does the company view the competitive landscape for Chemaxon? - Chemaxon operates in a fragmented discovery space with unique tools, and the company believes it has a strong competitive position in this area [87]