New Risk • May 22
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 8.7% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. This is currently the only risk that has been identified for the company. Reported Earnings • May 12
First quarter 2026 earnings released: US$0.056 loss per share (vs US$0.029 profit in 1Q 2025) First quarter 2026 results: US$0.056 loss per share (down from US$0.029 profit in 1Q 2025). Revenue: US$106.9m (flat on 1Q 2025). Net loss: US$8.76m (down 285% from profit in 1Q 2025). Revenue is forecast to stay flat during the next 3 years compared to a 13% growth forecast for the Healthcare Services industry in Europe. Over the last 3 years on average, earnings per share has increased by 23% per year but the company’s share price has fallen by 39% per year, which means it is significantly lagging earnings. Announcement • May 12
Certara, Inc. Updates Earnings Guidance for the Full Year 2026 Certara, Inc. updated earnings guidance for the full year 2026. For the period, revenue is expected to be $395 million - $405 million, including Regulatory and Medical Writing revenue of approximately $18 million. Fully diluted shares are expected to be in the range of 157 million - 159 million. Announcement • Apr 10
Certara, Inc. to Report Q1, 2026 Results on May 11, 2026 Certara, Inc. announced that they will report Q1, 2026 results Pre-Market on May 11, 2026 Announcement • Apr 06
Certara, Inc., Annual General Meeting, May 14, 2026 Certara, Inc., Annual General Meeting, May 14, 2026. Announcement • Apr 02
Certara, Inc. Announces Resignation of Director Cynthia Collins, Effective May 14, 2026 Certara, Inc. announced that on March 27, 2026, Cynthia Collins, a member of the Board of Directors and the Audit Committee of the Board, notified the Company of her intention to resign as a Class II director on the Board, effective as of May 14, 2026, the date of the Company's 2026 annual meeting of stockholders. Announcement • Mar 03
Certara Inc Announces Simcyp Simulator Results Replace Ten Human Trials For Chronic Myeloid Leukemia Therapy Asciminib Certara, Inc. enabled physiologically-based pharmacokinetic (PBPK) modeling predictions accepted by the U.S. FDA in lieu of clinical studies to support the new drug application (NDA) for asciminib (Scemblix®). PBPK modeling uses virtual biological systems to predict how drugs are absorbed, distributed, metabolized, and eliminated by the body, and is increasingly being applied in place of certain clinical studies where appropriate. The results published in “Physiologically Based Pharmacokinetic Modeling and Simulations in Lieu of Clinical Pharmacology Studies to Support the New Drug Application of Asciminib” (Loisios-Konstantinidis et al.), highlight the growing impact and business benefits of model-informed drug development approaches for regulatory decision-making. Asciminib is the first-in-class allosteric inhibitor that specifically binds the BCR::ABL1 myristoyl pocket used to treat patients with Chronic Myeloid Leukemia (CML). The global incidence rate of CML was close to one case in 100,000 population in 2018, and it accounts for approximately 15% of newly diagnosed cases of leukemia in adults. Given its potential for drug-drug interactions and the need to evaluate multiple dosing regimens, PBPK modeling with the Simcyp Simulator enabled a mechanistic assessment of asciminib’s pharmacokinetics across diverse patient populations, dosing regimens and clinical scenarios. These simulations provided evidence that complemented and, in some cases, replaced clinical pharmacology studies in the NDA. Key results from the PBPK modeling included: Bridging between clinically tested and untested scenarios; Replacement of at least ten dedicated clinical pharmacology studies; Accurate characterization of asciminib pharmacokinetics across healthy volunteers and cancer patients; Predicting how medicines work in real-life patients taking other medications. The modeling work for asciminib evolved over a decade and contributed to richer understanding its optimal dosing regimen and drug interaction profile, ultimately supporting regulatory approval and an important new treatment for patients with CML. Breakeven Date Change • Mar 02
Forecast breakeven date pushed back to 2027 The 13 analysts covering Certara previously expected the company to break even in 2026. New consensus forecast suggests the company will make a profit of US$14.0m in 2027. Average annual earnings growth of 80% is required to achieve expected profit on schedule. Reported Earnings • Feb 27
Full year 2025 earnings released: US$0.01 loss per share (vs US$0.075 loss in FY 2024) Full year 2025 results: US$0.01 loss per share (improved from US$0.075 loss in FY 2024). Revenue: US$418.8m (up 8.7% from FY 2024). Net loss: US$1.60m (loss narrowed 87% from FY 2024). Revenue is forecast to grow 5.9% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Healthcare Services industry in Europe. Over the last 3 years on average, earnings per share has increased by 4% per year but the company’s share price has fallen by 32% per year, which means it is significantly lagging earnings. Announcement • Feb 26
Certara, Inc. Provides Earnings Guidance for the Full Year 2026 Certara, Inc. provided earnings guidance for the full year 2026 . For the year, company revenue is expected to grow in the range of 0% to 4%. Announcement • Jan 29
Certara, Inc. to Report Q4, 2025 Results on Feb 26, 2026 Certara, Inc. announced that they will report Q4, 2025 results at 9:30 AM, US Eastern Standard Time on Feb 26, 2026 Board Change • Dec 17
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 11 experienced directors. 1 highly experienced director. Independent Director Eran Broshy was the last director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Announcement • Nov 07
Certara, Inc. Provides Earnings Guidance for the Year 2025 Certara, Inc. provides earnings guidance for the year 2025. For the year, the company expects revenue to be in the range of $415 million to $420 million. Announcement • Nov 05
Certara, Inc. Announces the Launch of TFL Studio Certara, Inc. announced the launch of TFL Studio, the first cloud-native module of its Phoenix Cloud solution. TFLs (Tables, Figures, and Listings) present data on study participants, treatments, and outcomes visually for clear interpretation. They are critical components of regulatory submissions and scientific publications. TFL Studio lets pharmacokinetic (PK) and pharmacodynamic (PD) scientists create these components with greater speed and collaboration. Traditional TFL workflows are often hindered by manual processes, fragmented tools, and the challenges of maintaining visual quality and consistency across studies. Phoenix Cloud is designed to accelerate these and related PK workflows through AI and cloud technology. A complementary module, AI PK Reports, will be released this quarter. AI PK Reports leverages GenAI to turnables, figures, and listings into draft PK reports, reducing a process that typically takes scientists days to complete down to minutes. AI PK Reports are powered by CoAuthor™?, Certara's GenAI software for regulatory and medical writing. TFL Studio delivers a user-friendly, no-code environment where scientists can: Build TFLs Faster with Reusable Templates: Create, maintain, and apply standardized templates, reducing setup time and ensuring consistency. Generate Dynamic, Editable Outputs: Easily fine-tune TFLs from source data without intermediate preparation, streamlining the editing and review process. Lower Training Burden: Intuitive tools and transparent workflows make it easier for new users to quickly become proficient, fostering broader adoption across teams. As the inaugural cloud-native module of Phoenix Cloud, TFL Studio sets the stage for future innovations, including the AI PK Reports module described above. It integrates with Integral™?, Certara's data repository, providing a single source of truth for PK/PD data, models and visualizations. TFL Studio is available now as part of the Phoenix Cloud solution. Announcement • Oct 31
Certara, Inc. Expands Biosimulation Market with AI-Driven QSP Platform Certara, Inc. announced the launch of Certara IQ, a scalable, AI-powered Quantitative Systems Pharmacology (QSP) solution. QSP has rapidly become a cornerstone of modern drug discovery and development with QSP-based FDA submissions having nearly doubled every 1.4 years since 2013.1 QSP combines computational modeling and experimental data to examine how a drug interacts with biological systems and disease processes, enabling scientists to predict critical outcomes such as optimal dosing, therapeutic window, and ideal patient populations. These capabilities are especially critical for novel or complex modalities. Certara IQ removes many of the computational and workflow challenges that have historically limited QSP adoption including minimal model reuse, long simulation times, complex coding environments, and a lack of standardization. Its AI-driven software reduces manual work and enhances reproducibility, making QSP modeling faster, easier, and more impactful. Certara IQ: Enhances model reproducibility and reusability through an intuitive, generative-AI supported interface for building and visualizing QSP models; Accelerates model creation with a deep repository of scientifically validated and pre-built QSP models, workflows and report templates; Reduces computational bottlenecks with a high-performance simulation engine that runs simulations thousands of times faster than traditional tools; Empowers decision making with a no-code interface for "what-if" analysis to assess feasibility, identify data gaps, and optimize dosing and drug properties quickly. Announcement • Oct 10
Certara, Inc. to Report Q3, 2025 Results on Nov 06, 2025 Certara, Inc. announced that they will report Q3, 2025 results After-Market on Nov 06, 2025 Announcement • Sep 04
Certara Launches Pinnacle 21 Enterprise Plus to Deliver Regulatory Submissions Faster Certara, Inc. announced the availability of Pinnacle 21 Enterprise Plus. The solution enables clinical and statistical programmers to efficiently create, reuse, and manage required data specifications for creating the CDISC Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets. These datasets are required when sponsors present their study safety and efficacy results and analysis to regulators. Traditional, spreadsheet-based methods of managing specifications are prone to errors, lack version control, andinder collaboration. Pinnacle 21 Enterprise Plus directly addresses these challenges by offering a unified, collaborative workspace that accelerates the journey from source data to submission-ready datasets. The no-code interface is set to deliver a 50% reduction in time spent drafting mapping specifications, according to internal measurements. Benefits of Pinnacle 21 Enterprise Plus: Support for industry and proprietary standards: Configurable columns ensure compliance with both CDISC and company-specific standards for maximum flexibility. Seamless Integration for programmers: The platform facilitates the export of mapping specifications via application programming interfaces (APIs) for seamless integration with downstream programming tools likeAS and R. Faster Submission Cycle Times: Earlier and easier creation of SDTM and ADaM mapping specifications provides submission-ready data sooner, mitigating end-of-study delays. Pinnacle 21 Enterprise Plus is purpose-built for clinical and statistical programmers, the same professionals who rely on Pinnacle 21 Foundational Enterprise for critical data validation. Most teams can go live with Pinnacle 21 in less than a month. Announcement • Aug 07
Certara, Inc. Reiterates Its Earnings Guidance for the Full Year 2025 Certara, Inc. reiterated its earnings guidance for the full year 2025. For the full year company expects Full year 2025 revenue to be in the range of $415 million to $425 million. Announcement • Aug 04
Certara Simcyp Simulator Becomes First and Only Software Platform to Receive EMA Qualification Opinion for PBPK Modeling Certara, Inc. announced that the European Medicines Agency (EMA) has formally qualified the Simcyp®? Simulator for use in regulatory submissions across the EU. Certara is the first company to receive EMA qualification for a PBPK modeling platform, and Simcyp is the only software to hold this designation. The recognition follows a rigorous multi-year, collaborative engagement between Certara and the EMA. With this qualification in place, sponsors can now use the Simcyp Simulator in regulatory submissions across the EU to assess drug-drug interaction (DDI) risk without needing to re-establish the platform's credibility for the specified context of use (COU) scenarios. Simcyp has long been the leading biosimulation software used in submissions to the EU and other regulatory agencies, and this qualification makes the drug submission process easier and faster. Drug-drug interaction (DDI") studies typically involve the co-administration of two or more drugs, where one acts as a substrate and the other as a perpetrator. The qualification opinion covers various scenarios (3 COUs) where Simcyp simulations can replace clinical DDI studies using a range of verified substrates and perpetrators integrated within the platform. The COUs span 6 CYP enzymes and 2 inhibition mechanisms, thereby significantly reducing the number of clinical studies a sponsor has to conduct. Announcement • Aug 01
Certara, Inc. Appoints Christopher Bouton as Chief Technology Officer Certara, Inc. announced the appointment of Christopher Bouton, Ph.D., as Chief Technology Officer. In this role, Bouton will lead technology strategy and development of a next-generation integrated model-informed drug development (MIDD) platform, which is enabled by generative AI and advances in biosimulation technology.Dr. Bouton was the founder and CEO of Vyasa Analytics, acquired by Certara in 2022. Vyasa provided scalable deep-learning software, which allows Certara software to make new predictions and answer complex questions across structured and unstructured data sources. Chris has led the development of several new Certara AI-based products, including CoAuthor ™, a generative AI product for regulatory and medical writing. Earlier in his career, Chris founded and led Entagen, an enterprise analytics software provider acquired by Thomson Reuters, and started his work in drug development as a computational biologist at Pfizer. Certara’s next-generation modeling platform integrates its scientific expertise, broad portfolio of solutions, and AI approaches to increase the efficiency and effectiveness of discovering and developing novel therapeutics. Announcement • Jul 10
Certara, Inc. to Report Q2, 2025 Results on Aug 06, 2025 Certara, Inc. announced that they will report Q2, 2025 results After-Market on Aug 06, 2025 Announcement • May 06
Certara, Inc. Reiterates Earnings Guidance for the Full Year 2025 Certara, Inc. reiterated earnings guidance for the full year 2025. Full year 2025 revenue to be in the range of $415 million to $425 million. Announcement • Apr 10
Certara, Inc., Annual General Meeting, May 21, 2025 Certara, Inc., Annual General Meeting, May 21, 2025. Announcement • Apr 02
Certara Expands the Simcyp™ Simulator Platform Advancing Biopharmaceutics, Drug-Drug Interaction & Biologic Capabilities Certara, Inc. has released a new version of the Simcyp Simulator for physiologically-based pharmacokinetic (PBPK) modeling. Simcyp PBPK models describe and predict the behavior of drugs in different body tissues. The latest version includes numerous advancements to further support data-driven decision-making at every stage of development. A consortium of more than 30 leading pharmaceutical companies guides the development of the Simcyp Simulator. Version 24 incorporates their feedback, which enhances and expands existing capabilities and databases. Simcyp Simulator V24 features numerous updates, including: Biopharmaceutical capabilities and the Virtual Bioequivalence (VBE) module now include features for predicting food effects that improve the simulation of drug absorption under various meal conditions. Expanded library for drug-drug interactions (DDI): New and upgraded compound files for enzymes and transporters cover a broader range of DDI capabilities. These capabilities provide qualification evidence for transporter-mediated DDIs in the gut, liver, and kidney. More precise characterization of the behavior of membrane-bound targets across various tissues and plasma in biologics models. These include soluble target movement and drug-target complex dynamics throughout the body, and refinements to the target shedding model. Further, nonlinear protein and plasma binding, and target-mediated drug disposition are incorporated for small molecules. Expanded Trial Design support: Enhanced speed and ease of use for designing and simulating clinical trials. Special Populations modeling: Enhanced and expanded capabilities for pediatric, pregnancy, and lactation populations. Performance and Usability: Modernized UI, cloud computing add-on, 'Ask Simcyp' AI-enabled help chat, and chemical structure-based parameter predictors. Routes of Administration: Improved functionality for long-acting injectables, inhalation, and ocular routes. Announcement • Mar 08
Certara, Inc. Announces Step Down of Patrick F. Smith as President, Certara Drug Development Solutions On March 5, 2025, Certara, Inc. announced that Dr. Patrick F. Smith, President, Certara Drug Development Solutions, stepped down from that role as of March 3, 2025, but will remain employed by the Company in a senior advisory and scientific role. Announcement • Mar 06
Certara, Inc. Appoints Adrian Mckemey as President of Drug Development Solutions Certara, Inc. announced the appointment of Adrian McKemey, Ph.D. as President of Drug Development Solutions, effective March 3, 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 and Senior Vice President and Head of the R&D Strategy Solutions at Quintiles. He has over 25 years of experience in research and development roles where he focused on business transformation, portfolio management and R&D strategies. Before IQVIA, he was a Principal with the Boston Consulting Group (BCG) working in the Life Sciences practice in New York. He holds a BSc (First Class) and a PhD in High Energy Nuclear Particle Physics from the University of London. The change is part of a planned leadership transition. Patrick Smith, PharmD. will continue to support Certara’s growth in science and innovation as Senior Vice President of Translational Sciences. Patrick and his leadership team successfully led and integrated the Certara services team building a unified offering of comprehensive scientific services for life sciences clients across the globe. Announcement • Feb 27
Certara, Inc. Provides Earnings Guidance for the Full Year 2025 Certara, Inc. provided earnings guidance for the full year 2025. For the year, the company expects revenue to be in the range of $415 million to $425 million. Announcement • Jan 30
Certara, Inc. to Report Q4, 2024 Results on Feb 26, 2025 Certara, Inc. announced that they will report Q4, 2024 results After-Market on Feb 26, 2025 Announcement • Jan 16
Certara, Inc. Provides Preliminary Financial Guidance for the Fourth Quarter and Full Year Ended December 31, 2024 Certara, Inc. provided preliminary financial guidance for the fourth quarter and full year ended December 31, 2024. Preliminary financials for the fourth quarter of 2024 are expected to be: revenue of $99.7 million, compared to $88.0 million in the fourth quarter of 2023, representing growth of 13%.
Preliminary financials for the full year of 2024 are expected to be: Revenue of $384.4 million, compared to $354.3 million in 2023, representing growth of 8%. Reported Earnings • Nov 07
Third quarter 2024 earnings released: US$0.009 loss per share (vs US$0.31 loss in 3Q 2023) Third quarter 2024 results: US$0.009 loss per share (improved from US$0.31 loss in 3Q 2023). Revenue: US$94.8m (up 11% from 3Q 2023). Net loss: US$1.37m (loss narrowed 97% from 3Q 2023). Revenue is forecast to grow 9.5% p.a. on average during the next 3 years, compared to a 8.3% growth forecast for the Healthcare Services industry in Europe. Over the last 3 years on average, earnings per share has fallen by 35% per year whereas the company’s share price has fallen by 33% per year. Announcement • Nov 07
Certara, Inc. Updates Earnings Guidance for the Year 2024 Certara, Inc. updated earnings guidance for the year 2024. For the year, revenue to be in the range of $380 million to $385 million. Announcement • Oct 17
Certara, Inc. Appoints John Reynders as Independent Board Member Certara, Inc. announced the appointment of John Reynders, PhD, to its Board of Directors, effective October 15, 2024. Dr. Reynders has over 25 years of experience in the pharmaceutical and tech industries. He was the founding CIO of Moderna where he led the data-sciences capabilities to design mRNA therapies. Most recently, he was Chief Data Sciences Officer at Neumora, a biotech focused on brain diseases. Before that, he held various executive positions leading data-sciences, informatics, and technology organizations at Alexion Pharmaceuticals, AstraZeneca, Johnson & Johnson, Eli Lilly, and Celera. Announcement • Oct 10
Certara, Inc. to Report Q3, 2024 Results on Nov 06, 2024 Certara, Inc. announced that they will report Q3, 2024 results After-Market on Nov 06, 2024 Announcement • Oct 04
Certara, Inc. (NasdaqGS:CERT) completed the acquisition of ChemAxon Kft. Certara, Inc. (NasdaqGS:CERT) signed a definitive agreement to acquire ChemAxon Kft. on July 9, 2024. The transaction is subject to approval by regulatory and other customary closing conditions. The transaction is expected to close in the second half of 2024.
Certara, Inc. (NasdaqGS:CERT) completed the acquisition of ChemAxon Kft. on October 2, 2024. Announcement • Aug 16
Certara, Inc. Launches Phoenix™ Version 8.5 Drug Development Software Certara, Inc. announced the launch of Phoenix™ version 8.5. Phoenix is the pharmaceutical industry's gold standard in pharmacokinetic/pharmacodynamic (PK/PD) and toxicokinetic modeling and simulation software. The Phoenix Platform is used by more than 75 of the top 100 pharmaceutical companies worldwide. Eleven regulatory agencies, including the U.S. FDA, Japan PMDA, and China NMPA, rely on Phoenix to evaluate life-saving drug candidates. Version 8.5 is the latest release from Certara’s Phoenix Platform, available as a hosted solution for maximum performance and lower total cost of ownership. Today, 88% of new medicines that enter clinical trials fail, indicating a need for improved processes. Certara’s Phoenix platform expedites everything from data preparation to report generation – a time-consuming process that drug developers rely on. Version 8.5 delivers new features driven by customer demand. These features improve the efficiency, quality, and speed of PK/PD workflows within Phoenix. Sign-in via Certara Cloud - Phoenix 8.5 introduces user sign-in via Certara Central Admin, offering Single Sign-On and centralized authentication. This simplifies license management, streamlines assignments, enhances access control, and improves the user experience by providing easier access to resources, training and support. Reporting Enhancements for Tables, Plotting, Reporting: Updates are designed to offer increased customization and efficiency in data presentation in tables and plots, along with advancing capabilities for visual data analysis. These improvements aim to streamline the reporting process and enable more detailed and readily interpretable reports. NLME (Non-linear mixed effects) Enhancements: Phoenix NLME is a population modeling and simulation software solution for scientists with varying levels of experience—from novice PK/PD scientists to the most advanced modelers. The 8.5 update improves the precision of modeling, increases the adaptability for users, and provides tools to enhance the interpretability of models. Announcement • Aug 07
Certara, Inc. Reiterates Earnings Guidance for the Year 2024 Certara, Inc. reiterated earnings guidance for the year 2024. For the year, the company expects full year 2024 revenue to be in the range of $385 million to $400 million. Announcement • Jul 10
Certara, Inc. (NasdaqGS:CERT)signed a definitive agreement to acquire ChemAxon Kft. Certara, Inc. (NasdaqGS:CERT)signed a definitive agreement to acquire ChemAxon Kft. on July 9, 2024. The transaction is subject to approval by regulatory and other customary closing conditions. The transaction is expected to close in the second half of 2024. Announcement • Jul 04
Certara, Inc. to Report Q2, 2024 Results on Aug 06, 2024 Certara, Inc. announced that they will report Q2, 2024 results After-Market on Aug 06, 2024 Announcement • Jun 18
Certara Launches Next Generation CoAuthor™ Generative AI Regulatory Writing Software Certara, Inc. unveiled its next-generation CoAuthor regulatory writing software. CoAuthor is an advanced writing platform designed for medical writers. It combines generative AI, document templates, Microsoft Word integration, and structured content authoring tools. CoAuthor accelerates the creation of regulatory documents while maintaining a “human in the loop” approach to the use of generative AI. Medical writing is a critical part of drug development. It relies on manual processes which have not changed significantly over the past two decades. Drug development pipelines increasingly comprise precision medicine therapies that depend on advanced biomedical knowledge. Today’s medical writers must translate complex study designs and data into documents that contextualize research results for different audiences. They need better ways to synthesize numerous sources of knowledge and securely connect them to their data and documents. Built by writers, for writers, CoAuthor is easy to use and combines a life science specialized, secure, client-specific GPT with structured content authoring and comprehensive eCTD regulatory writing templates. With CoAuthor, medical writers can streamline the document drafting process, allowing more time for content curation, collaboration, and quality control. Fully integrated with Microsoft Word, CoAuthor enables writing teams to use familiar tools, systems, and processes while ensuring consistency and quality. Certara clients will have the flexibility to work with CoAuthor as part of a comprehensive regulatory writing solution, at the program level and across the enterprise. Announcement • May 22
Certara, Inc Appoints Rona Anhalt as Chief Human Resources Officer and Daniel Corcoran as General Counsel Certara, Inc. has appointed Rona Anhalt as Chief Human Resources Officer and Daniel Corcoran as General Counsel. Ms. Anhalt will drive Certara’s human capital management strategy. She will lead the company’s global Human Resources function supporting Certara’s 1,400 team members including more than 400 scientists across the globe. She has over 20 years of experience supporting strategic growth and building high-performing teams in life sciences. In her prior role at EQRx, Ms. Anhalt led HR from start-up through acquisition and championed a mission-oriented culture. Daniel Corcoran will oversee Certara’s legal affairs. He has over 20 years of experience in publicly traded and privately held global technology companies. Previously, he was the Senior Vice President of Legal and General Counsel at Nexthink where he led legal and compliance teams and helped the company prepare for its IPO. Announcement • May 09
Certara, Inc. Reiterates Earnings Guidance for the Year 2024 Certara, Inc. reiterated earnings guidance for the year 2024. For the year, the company expects revenue to be in the range of $385 million to $400 million. Announcement • Apr 16
Certara, Inc. Launches Cloud Platform to Further Unify Its End-To-End Scientific Software Platform Certara, Inc. announced the launch of Certara Cloud, the unifying platform that integrates its many scientific software solutions. Customers log into Certara Cloud using a single ID to access and manage their licensed software, linking predictive solutions to modeling and analysis of clinical trial results. Certara Cloud delivers value and unique capabilities across several areas of immediate benefit and lays the foundation for future advanced operations, including: Real-time collaboration across internal teams and external partners with reduced friction in deployment, licensing, and technical implementation. Centralized security and IT administration, leveraging Single Sign On and cross-product user management and auditing functions. Best practices documentation and media-rich educational resources from thought leaders spanning all stages of drug development including complimentary access to the gold standard PK/PD e-book, Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications. Cross-functional insights and benchmarks for clients, derived from following their drug candidate across its various stops in the Certara ecosystem. Certara Cloud is following a phased roll-out over 2024 with over 1,500 client-specific portals already prepared and is currently in use by fifteen of the top 30 biopharmaceutical companies. Announcement • Apr 11
Certara, Inc., Annual General Meeting, May 21, 2024 Certara, Inc., Annual General Meeting, May 21, 2024, at 09:00 US Eastern Standard Time. Agenda: To consider election of Class I directors; to approve two separate proposals to amend our Amended and Restated Certificate of Incorporation ; to Amend our Certificate of Incorporation to limit the liability of certain officers of Certara as permitted pursuant to the Delaware General Corporation Law; to Amend our Certificate of Incorporation to make certain technical changes, including to remove inoperative provisions related to our former majority stockholder and other immaterial changes; to Ratification of the appointment of independent registered public accounting firm for the fiscal year ending December 31, 2024; and to conduct a non-binding advisory vote to approve the compensation of our named executive officers. Announcement • Apr 10
Certara, Inc. to Report Q1, 2024 Results on May 07, 2024 Certara, Inc. announced that they will report Q1, 2024 results at 4:00 PM, US Eastern Standard Time on May 07, 2024 Announcement • Mar 01
Certara, Inc. Provides Earnings Guidance for the Year 2024 Certara, Inc. provided earnings guidance for the year 2024. For the year, the company expects revenue to be in the range of $385 million to $400 million. Announcement • Feb 02
Certara, Inc. to Report Q4, 2023 Results on Feb 29, 2024 Certara, Inc. announced that they will report Q4, 2023 results After-Market on Feb 29, 2024 Announcement • Dec 14
Certara, Inc. (NasdaqGS : CERT) acquired Applied BioMath, LLC. Certara, Inc. (NasdaqGS : CERT) acquired Applied BioMath, LLC on December 13, 2023.Certara, Inc. (NasdaqGS : CERT) completed the acquisition of Applied BioMath, LLC on December 13, 2023. Announcement • Nov 22
Certara, Inc. Announces the Introduction of Simcyp Biopharmaceutics Software Certara, Inc. announced the introduction of Simcyp™? Biopharmaceutics software. It is designed for use by biopharmaceutic, formulation, and CMC scientists to aid in formulating complex novel and generic small molecule medicines quickly and cost effectively. Simcyp Biopharmaceutics software is part of the Simcyp Simulator biosimulation platform, which has supported label claims for more than 100 approved novel therapies. Simcyp Biopharmaceutics software also helps sponsors develop the evidence needed to attain biowaivers which are used in lieu of conducting clinical studies. It is available as a standalone product and is designed for life sciences companies of all sizes looking to optimize their therapies’ formulations to maximize safety, efficacy, and patient convenience. Simcyp Biopharmaceutics software delivers value and unique capabilities across several areas that are critical to achieving formulation success, including: Replace Costly Clinical Bioequivalence Studies - With growing encouragement from regulators, virtual bioequivalence studies (VBE) leverages physiologically based pharmacokinetic (PBPK) modeling to demonstrate bioequivalence (BE) between test and reference drugs. Simcyp Biopharmaceutics software includes a VBE module that automates elements of trial design significantly enhancing opportunities for attaining biowaivers. Optimize Formulation for Complex Drugs: Biopharmaceutical Classification System (BCS) Class II-IV drugs are challenging to create oral formulations for because of their poor solubility and/or absorption. Simcyp Biopharmaceutics software facilitates developing these drugs, which constitute 90% of new drug candidates. Inform Drug Labels - Recent FDA guidance recognizes physiologically-based pharmacokinetic (PBPK) models as a valuable technology for identifying and optimizing the impact of gastrointestinal effects such as meal type and pH. Simcyp Biopharmaceutics software advances these capabilities for optimizing dosing strategies and providing label guidance to clinicians. Announcement • Nov 10
Certara, Inc. Provides Revenue Guidance for the Year 2023 Certara, Inc. provided revenue guidance for the year 2023. For the year, the company expects revenue to be in the range of $345 million to $360 million. Reported Earnings • Nov 10
Third quarter 2023 earnings released: US$0.31 loss per share (vs US$0.025 profit in 3Q 2022) Third quarter 2023 results: US$0.31 loss per share (down from US$0.025 profit in 3Q 2022). Revenue: US$85.6m (up 1.0% from 3Q 2022). Net loss: US$49.0m (down US$52.9m from profit in 3Q 2022). Revenue is forecast to grow 8.4% p.a. on average during the next 3 years, compared to a 7.5% growth forecast for the Healthcare Services industry in Europe. Announcement • Oct 12
Certara, Inc. to Report Q3, 2023 Results on Nov 08, 2023 Certara, Inc. announced that they will report Q3, 2023 results After-Market on Nov 08, 2023 Announcement • Aug 10
Certara, Inc. Updates Earnings Guidance for the Year 2023 Certara, Inc. updated earnings guidance for the year 2023. The company is updating its previously reported guidance for full year 2023. The company expects full year 2023 revenue to be in the range of $345 million to $360 million. Reported Earnings • Aug 10
Second quarter 2023 earnings released: EPS: US$0.03 (vs US$0.004 loss in 2Q 2022) Second quarter 2023 results: EPS: US$0.03 (up from US$0.004 loss in 2Q 2022). Revenue: US$90.5m (up 9.3% from 2Q 2022). Net income: US$4.71m (up US$5.30m from 2Q 2022). Profit margin: 5.2% (up from net loss in 2Q 2022). The move to profitability was driven by higher revenue. Revenue is forecast to grow 10% p.a. on average during the next 3 years, compared to a 7.7% growth forecast for the Healthcare Services industry in Europe. New Risk • Aug 05
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 9.6% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. This is currently the only risk that has been identified for the company. Announcement • Jul 14
Certara, Inc. to Report Q2, 2023 Results on Aug 09, 2023 Certara, Inc. announced that they will report Q2, 2023 results After-Market on Aug 09, 2023 Reported Earnings • May 09
First quarter 2023 earnings released: EPS: US$0.009 (vs US$0.014 in 1Q 2022) First quarter 2023 results: EPS: US$0.009 (down from US$0.014 in 1Q 2022). Revenue: US$90.3m (up 11% from 1Q 2022). Net income: US$1.36m (down 39% from 1Q 2022). Profit margin: 1.5% (down from 2.7% in 1Q 2022). The decrease in margin was driven by higher expenses. Revenue is forecast to grow 15% p.a. on average during the next 3 years, compared to a 8.8% growth forecast for the Healthcare Services industry in Europe. Announcement • May 09
Certara, Inc. Provides Revenue Guidance for the Year 2023 Certara, Inc. provided revenue guidance for the year 2023. For the full year 2023, the company expects revenue to be in the range of $370 million to $385 million. Reported Earnings • Mar 03
Full year 2022 earnings released: EPS: US$0.094 (vs US$0.089 loss in FY 2021) Full year 2022 results: EPS: US$0.094 (up from US$0.089 loss in FY 2021). Revenue: US$335.6m (up 17% from FY 2021). Net income: US$14.7m (up US$28.0m from FY 2021). Profit margin: 4.4% (up from net loss in FY 2021). The move to profitability was driven by higher revenue. Revenue is forecast to grow 12% p.a. on average during the next 3 years, compared to a 9.7% growth forecast for the Healthcare Services industry in Europe. Announcement • Feb 02
Certara, Inc. to Report Q4, 2022 Results on Mar 01, 2023 Certara, Inc. announced that they will report Q4, 2022 results After-Market on Mar 01, 2023 Announcement • Jan 05
Certara, Inc. (NasdaqGS:CERT) acquired VYASA Analytics LLC. Certara, Inc. (NasdaqGS:CERT) acquired VYASA Analytics LLC on January 4, 2023,Certara, Inc. (NasdaqGS:CERT) completed the acquisition of VYASA Analytics LLC on January 4, 2023, Breakeven Date Change • Dec 31
Forecast breakeven date pushed back to 2023 The 8 analysts covering Certara previously expected the company to break even in 2022. New consensus forecast suggests the company will make a profit of US$21.3m in 2023. Average annual earnings growth of 59% is required to achieve expected profit on schedule. Announcement • Dec 26
Certara, Inc. Announces the Resignation of Mason Slaine as Director of the Company On December 23, 2022, Mr. Mason Slaine, a member of the Board of Directors of Certara, Inc., and a member of the Nominating and Corporate Governance Committee notified the Company of his intention to resign as a director of the Company for personal reasons, effective December 23, 2022. Announcement • Dec 09
Certara, Inc. Appoints David Spaight to the Board of Directors Certara, Inc. announced that Arsenal Capital Partners closed its previously announced $449 million new investment in Certara. David Spaight, an Operating Partner at Arsenal, has been appointed to Certara’s Board of Directors, effective immediately. Stephen McLean, a Senior Partner at Arsenal, will continue to serve on Certara’s Board of Directors. Prior to joining Arsenal in 2016, Mr. Spaight served as the Chairman and CEO of WIL Research Laboratories, a leading pre-clinical CRO acquired by Charles River Laboratories, and, before that, as President of MDS Pharma Services, a global CRO serving all phases of pharmaceutical research and development. Mr. Spaight has also held senior leadership positions in Fisher Scientific and PerkinElmer. Buying Opportunity • Nov 24
Now 21% undervalued after recent price drop Over the last 90 days, the stock is down 11%. The fair value is estimated to be €18.93, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 16% over the last 3 years. Earnings per share has declined by 8.0%. Recent Insider Transactions • Nov 16
Independent Director recently sold €172k worth of stock On the 14th of November, Matthew Walsh sold around 12k shares on-market at roughly €14.26 per share. This transaction amounted to 6.7% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of €22m more than they bought in the last 12 months. Reported Earnings • Nov 09
Third quarter 2022 earnings released: EPS: US$0.025 (vs US$0.012 loss in 3Q 2021) Third quarter 2022 results: EPS: US$0.025 (up from US$0.012 loss in 3Q 2021). Revenue: US$84.7m (up 14% from 3Q 2021). Net income: US$3.94m (up US$5.70m from 3Q 2021). Profit margin: 4.6% (up from net loss in 3Q 2021). Revenue is forecast to grow 13% p.a. on average during the next 3 years, compared to a 9.8% growth forecast for the Healthcare Services industry in Europe. Announcement • Oct 20
Japan's Pharmaceuticals and Medical Devices Agency Renews Licenses of Certara's Software for Evaluating Regulatory Submissions Certara, Inc. announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has renewed its licenses of Certara's Simcyp(TM) Simulator, Phoenix(TM) biosimulation software, and Pinnacle 21(TM) Enterprise software. The PMDA also performs independent validation of clinical study data which CDISC compliance is required as part of sponsors' regulatory submissions in their Pinnacle 21 Enterprise environment. Pinnacle 21 Enterprise software supports the PMDA's new validation rules, which were introduced at the end of 2021. Announcement • Oct 14
Certara, Inc. to Report Q3, 2022 Results on Nov 07, 2022 Certara, Inc. announced that they will report Q3, 2022 results at 4:00 PM, US Eastern Standard Time on Nov 07, 2022 Recent Insider Transactions • Aug 18
Insider recently sold €3.1m worth of stock On the 16th of August, Mason Slaine sold around 182k shares on-market at roughly €17.08 per share. In the last 3 months, they made an even bigger sale worth €4.6m. Insiders have been net sellers, collectively disposing of €22m more than they bought in the last 12 months. Buying Opportunity • Aug 13
Now 21% undervalued Over the last 90 days, the stock is up 8.4%. The fair value is estimated to be €22.66, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 20% over the last year. Earnings per share has grown by 84%. Announcement • Aug 13
Certara, Inc. Announces Resignation of Justin Edge as President of Regulatory and Access, Effective September 1, 2022 On August 12, 2022, Certara, Inc. announced the resignation from the Company of Justin Edge, President of Regulatory and Access. Mr. Edge’s last day with the Company is planned to be September 1, 2022. Reported Earnings • Aug 10
Second quarter 2022 earnings released: US$0.004 loss per share (vs US$0.019 loss in 2Q 2021) Second quarter 2022 results: US$0.004 loss per share (up from US$0.019 loss in 2Q 2021). Revenue: US$82.8m (up 18% from 2Q 2021). Net loss: US$589.0k (loss narrowed 79% from 2Q 2021). Over the next year, revenue is forecast to grow 22%, compared to a 16% growth forecast for the industry in Germany. Announcement • Aug 10
Certara, Inc. Revises Its Full Year Earnings Guidance of 2022 Certara, Inc. revised its full year guidance for the full year 2022. For the year, the company is adjusting its previously reported guidance for full year 2022 to a new full year guidance of $325 million to $335 million for revenue. Announcement • Aug 06
Certara, Inc. Introduces Update of Pinnacle 21(Tm) Enterprise and New Pinnacle 21(Tm) Data Exchange Module Certara, Inc. announced the feature release 5.2.0 of Pinnacle 21 Enterprise, the Company’s software for validating clinical trial data for biosimulation and regulatory submissions. It also introduced the new Pinnacle 21 Data Exchange product, an integrated module that streamlines the process of ingesting clinical trial data from external sources. Pinnacle 21 Enterprise validates data quality and compliance with regulatory standards, enabling a clean data pipeline from sponsors to health authorities. The new Pinnacle 21 Data Exchange module ensures data integrity and regulatory compliance while empowering sponsors to maintain executive oversight to drive objective decisions. This release of Pinnacle 21 Enterprise 5.2.0 includes: Analytics features to monitor progress in adherence to the FDA’s Technical Rejection Criteria, which came into effect in September 2021, Improved workflow and in-app communication to facilitate collaboration among teams, vendors, and sponsors, Actionable, searchable real-time notifications to keep users informed, Enhanced security with additional role-specific permissions. Announcement • Jul 26
Certara, Inc. Appoints Rosemary A. Crane, as a Class III Director, Effective July 21, 2022 Certara, Inc. announced that the Board elected Rosemary A. Crane, as a Class III director, effective July 21, 2022. The Board has appointed Ms. Crane to serve as a member of the Compensation Committee. Ms. Crane will receive compensation as a non-employee director in accordance with the Company’s non-employee director compensation policy described in “Board and Governance Practices - Director Compensation - Compensation Element” of the Company’s Proxy Statement on Schedule 14A filed with the Securities and Exchange Commission on April 7, 2022. The Company intends to enter into an indemnification agreement with Ms. Crane substantially similar to the indemnification agreements the Company has entered into with other members of the Board. Announcement • Jul 14
Certara, Inc. Appoints Eran Broshy as New Independent Board Member, Effective July 11, 2022 Certara, Inc. announced the appointment of Eran Broshy to its Board of Directors, effective July 11, 2022. His appointment brings the company’s board of directors to ten members. Mr. Broshy is an accomplished veteran board director and private equity operating executive with more than 35 years of experience working broadly across healthcare. Mr. Broshy also served for over a decade as chief executive officer and chairman of inVentiv Health (now part of Syneos Health), and under his leadership the company transformed into the leading global provider of clinical and commercialization services. Earlier in his career, he spent 15 years at The Boston Consulting Group (BCG), where he was a managing director and partner responsible for the firm’s healthcare practice across the Americas. Mr. Broshy currently serves on the boards of Theravance Biopharma (Nasdaq: TBPH), a respiratory-focused biotech company, and Thirty Madison, a digital healthcare company. He is also a member of the Corporation of the Massachusetts Institute of Technology. Announcement • Jul 13
Certara, Inc. to Report Q2, 2022 Results on Aug 09, 2022 Certara, Inc. announced that they will report Q2, 2022 results After-Market on Aug 09, 2022 Announcement • Jun 29
Certara Introduces New Simcyp™ Discovery Simulator for Early-Stage and Translational Drug Development Certara announced the release of Simcyp Discovery Simulator, a new software designed for scientists working in small molecule drug discovery and translational research. Derived from the industry-leading Simcyp Simulator, Simcyp Discovery increases confidence in early-stage development decisions using physiologically-based pharmacokinetic (PBPK) modeling and simulation. Simcyp Discovery includes PBPK models for mouse, rat, dog, monkey and humans, enabling researchers to predict first-in-human (FIH) pharmacokinetics and understand how investigational drugs may behave before going into clinical trials, a regulatory requirement. The software also supports early formulation simulations and flags potential drug-drug interactions (DDI) with a new static DDI calculator informed by regulatory guidelines from the U.S. Food and Drug Administration, European Medicines Agency, and Japan’s Pharmaceuticals and Medical Devices Agency. Additionally, Simcyp Discovery supports rapid batch processing and screening of drug candidates. Announcement • Jun 22
Certara, Inc. Announces New Versions of Biosimulation Software for Development of Novel Biologics Certara Inc. announced the release of new versions of its Immunogenicity Immuno-oncology and Vaccine Simulators to help predict how drugs work and address key questions in the development of novel biologic therapies. Developed in partnership with eight leading pharmaceutical companies, Certara's IG Simulator is used to assess, predict and manage the immunogenicity of a wide range of biologic therapies in development. The latest version allows for the evaluation of many different types of biologics, including monoclonal antibodies, bi-and multi-specifics, complex proteins, cell, and gene therapies. The latest version of the IO Simulator expands the number of targets in blood cancers and solid tumors to include 20 different cell types, such as cytotoxic, helper, regulatory T-cells and B-cells, and 10 immunomodulatory cytokine targets. The IO Simulator enables researchers to assess combination therapies, design trials, select patients, and link dosing regimens to biomarkers, which aligns well with Project Optimus, the FDA's initiative to reform the dose optimization and dose selection paradigm in oncology drug development. Certara's Vaccine Simulator answers 'what-if' scenarios to determine the best vaccine dosing strategies for variouspatient populations, including children and the elderly. Version 1.0 of the Vaccine Simulator incorporates a novel lipid nanoparticle administration module and is being used to support the development of next-generation mRNA vaccines and gene therapies. Recent Insider Transactions • Jun 04
Insider recently sold €4.6m worth of stock On the 2nd of June, Mason Slaine sold around 250k shares on-market at roughly €18.23 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of €19m more than they bought in the last 12 months. Reported Earnings • May 06
First quarter 2022 earnings released: EPS: US$0.014 (vs US$0.007 in 1Q 2021) First quarter 2022 results: EPS: US$0.014 (up from US$0.007 in 1Q 2021). Revenue: US$81.6m (up 22% from 1Q 2021). Net income: US$2.21m (up 110% from 1Q 2021). Profit margin: 2.7% (up from 1.6% in 1Q 2021). Over the next year, revenue is forecast to grow 23%, compared to a 25% growth forecast for the industry in Germany. Announcement • May 06
Certara, Inc. Reiterates Earnings Guidance for the Year 2022 Certara, Inc. reiterated earnings guidance for the year 2022. For the year, the company reiterates revenues of $350 million to $360 million. Announcement • Apr 21
Certara, Inc. to Report Q1, 2022 Results on May 05, 2022 Certara, Inc. announced that they will report Q1, 2022 results After-Market on May 05, 2022 Announcement • Apr 14
Certara, Inc. Announces Committee Changes Certara, Inc. announced that the Nominating and Corporate Governance Committee recommended and the Board approved the appointment of Nancy Killefer as Chair of the Compensation Committee. In connection with her appointment, Ms. Killefer resigned as a member of the Audit Committee and will continue to remain a member of the Nominating and Corporate Governance Committee. Recent Insider Transactions • Mar 21
Insider recently sold €4.5m worth of stock On the 17th of March, Mason Slaine sold around 250k shares on-market at roughly €18.18 per share. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of €14m more than they bought in the last 12 months. Announcement • Mar 03
Certara, Inc. Revises Earnings Guidance for the Year 2022 Certara, Inc. revised earnings guidance for the year 2022. The company expects revised revenue to be in the range of $350 million to $360 million. The company is reducing the top end of the revenue range from $370 million to $360 million. Note that revenue guidance assumes 22% - 26% year over year growth, and excluding Pinnacle 21 assumes 15%-18% year over year growth. Reported Earnings • Mar 03
Full year 2021 earnings: EPS in line with expectations, revenues disappoint Full year 2021 results: US$0.089 loss per share (up from US$0.37 loss in FY 2020). Revenue: US$286.1m (up 18% from FY 2020). Net loss: US$13.3m (loss narrowed 73% from FY 2020). Revenue missed analyst estimates by 2.5%. Over the next year, revenue is forecast to grow 26%, compared to a 41% growth forecast for the industry in Germany. Announcement • Feb 24
U.S. Food and Drug Administration Licenses Certara, Inc.’s Immunogenicity Simulator Certara, Inc. announced that the U.S. Food and Drug Administration has licensed Certaras Immunogenicity Simulator to research and evaluate immunogenicity in protein-based therapeutics. Certaras IG Simulator predicts the immune response of therapeutics in development, which is important to guide clinical and regulatory decision-making. Immunogenicity, or the tendency of a molecule to trigger an immune response, is a major problem with protein-based therapeutics such as antibody-based drugs or biological medicines that are engineered versions of naturally occurring human proteins. Immunogenicity has long been an area of keen research interest by the FDA and biopharmaceutical companies as it can be challenging to predict and can negatively impact drug development projects late in the process that may be costly to rectify. As a part of its pilot model-informed drug development program, the FDA held a workshop on immunogenicity in June of 2021 with more than 2,000 registrants, where Certara scientists and partners presented on the rapid advances of the IG Simulator and its use cases. 
