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Overview of Certara, Inc.
Certara, Inc. (symbol: CERT) is a global provider renowned for its biosimulation technology and advanced decision support systems that drive model-informed drug development. Utilizing scientific software and consulting services, Certara empowers biopharmaceutical companies, academic researchers, and regulatory agencies to optimize drug discovery processes and enhance patient care. The company excels in leveraging biosimulation, drug development, and model-informed development techniques to provide robust solutions that transform the way medicines are developed, assessed, and regulated.
Business Focus and Core Offerings
Certara integrates highly specialized simulation software with expert regulatory consulting and technology solutions. Its offerings are designed to streamline various stages of the drug development lifecycle, from early discovery to clinical trial design and regulatory submissions. By bridging complex scientific data and actionable insights, the company assists in reducing the reliance on extensive clinical trials, accelerates regulatory approvals, and enhances patient access to novel therapies.
Advanced Technology and Simulation Capabilities
The company is at the forefront of innovation with its comprehensive suite of software solutions. Certara's offerings include modeling and simulation platforms which incorporate advanced techniques such as quantitative systems pharmacology (QSP) and physiologically-based pharmacokinetics (PBPK). These tools are designed to simulate human physiology and drug interactions, thereby refining dosing strategies and minimizing risk during clinical development phases. The introduction of integrated solutions, such as Certara Cloud, demonstrates the seamless connectivity of different software products, enabling customers to manage licenses, perform detailed analysis, and generate reliable insights within a unified workflow.
Regulatory Science and Consulting Services
Certara's expertise extends into regulatory science and consulting, areas that are critical for navigating the complex frameworks of drug development. By offering detailed regulatory strategies and scientific consulting, the company supports clients in meeting the rigorous requirements of global health authorities. The unique combination of advanced modeling software and regulatory insight helps clients reduce uncertainty and increase the probability of successful regulatory outcomes, offering a significant strategic advantage in the competitive pharmaceutical market.
Market Presence and Competitive Position
Operating across the Americas, EMEA, and Asia Pacific, Certara has cemented its role as a key contributor in the drug development sector. The company’s clientele includes major global biopharmaceutical companies, leading academic institutions, and influential regulatory bodies. Its technology-driven approach to accelerating drug development positions it uniquely within the competitive landscape, providing a robust alternative to traditional clinical trial methodologies and reinforcing its authority in the realm of biosimulation and regulatory strategy services.
Integrated Solutions and Client Benefits
One of the signature aspects of Certara is its integrated platform approach. Products like Certara Cloud offer a centralized portal for accessing multiple software solutions, thus streamlining workflows for users managing diverse aspects of drug development. This integration not only enhances operational efficiency but also provides a scalable and interoperable environment where feedback from users is continually incorporated into the evolution of the company's software suite. By addressing complex drug development challenges with precise and reliable modeling and simulation tools, Certara ensures that scientists and regulators can derive actionable insights more rapidly.
Scientific Expertise and Industry Application
Certara leverages its scientific expertise to address inherent challenges in drug development. The company’s simulation solutions facilitate more informed decision making, improving both the efficiency and safety of clinical trials. Its scientifically advanced models enable the transformation of raw data into strategic insights, thereby streamlining the path from research to patient care. This expertise is critical in an industry where optimizing therapeutic outcomes and meeting regulatory demands are of utmost importance.
Conclusion
In summary, Certara, Inc. stands as a sophisticated confluence of technology, scientific expertise, and regulatory insight. Its comprehensive suite of modeling, simulation, and consulting services provides a concrete foundation for revolutionizing the drug development process. By consistently delivering precise, integrated solutions and employing advanced simulation techniques, Certara plays an instrumental role in bridging the gap between innovative research and the swift, safe delivery of new medicines to patients.
Certara, Inc. (Nasdaq: CERT) reported third-quarter 2021 revenues of $73.9 million, a 23% increase from the previous year. However, the company incurred a net loss of $1.8 million compared to a net income of $1.2 million in Q3 2020. Adjusted EBITDA rose 28% to $26.1 million. Certara announced the completion of its $250 million acquisition of Pinnacle 21 and raised its full-year guidance, forecasting revenue between $288 million and $291 million, adjusted EBITDA of $106 million to $108 million, and adjusted diluted EPS between $0.22 and $0.26.
Certara, Inc. (Nasdaq: CERT) has announced the appointment of James E. Cashman III as Chairman of the Board, effective December 1, 2021. He will succeed Sherilyn McCoy, who is stepping down to focus on other commitments. Cashman, who has served on Certara's Board since 2018, previously led ANSYS, growing its revenue from $50 million to over $1 billion. His expertise in simulation-driven product development is expected to strengthen Certara's innovation and growth strategy. The company specializes in biosimulation technologies enhancing drug development.
Certara, a leader in biosimulation, announced that its CEO, William F. Feehery, and CFO, Andrew Schemick, will participate in a fireside chat at the Piper Sandler 33rd Annual Virtual Healthcare Conference. The event is scheduled for November 22, 2021, at 10:00 am ET. Interested parties can access the webcast through Certara's investor relations website. Certara is known for its proprietary biosimulation software, serving over 1,650 global biopharmaceutical firms, academic institutions, and regulatory agencies across 61 countries.
Certara (Nasdaq: CERT) has secured a five-year contract from the FDA for its Pinnacle 21 Enterprise software, which enhances the agency's ability to review clinical and non-clinical study submission data. This agreement continues a long-standing partnership and follows previous contracts awarded in 2011 and 2015. The software streamlines data validation processes, allowing FDA reviewers to assess data quality more efficiently. This contract also supports the FDA’s DataFit program amid new technical rejection criteria implementation.
Certara, Inc. (Nasdaq: CERT) will release its third-quarter 2021 financial results on November 9, 2021, post-market. A conference call with management to discuss these results will occur at 5:00 p.m. ET. Interested investors can join the call by dialing (833) 360-0946 for domestic and (914) 987-7661 for international participants, using Conference ID: 1968232. The event will also be available via a live and archived webcast on Certara's Investors webpage.
Certara specializes in biosimulation software and technology, assisting over 1,650 clients globally.
Certara, Inc. (Nasdaq: CERT) has appointed Patrick F. Smith, Pharm.D., as the new president of Integrated Drug Development (IDD). He succeeds Craig R. Rayner, Pharm.D., who will transition to a role as a distinguished scientist. Dr. Smith brings extensive experience in drug development, particularly in infectious diseases and oncology, having previously served as senior vice president of IDD strategy and innovation. His leadership aims to enhance Certara's biosimulation and quantitative approaches across the drug development life cycle, positioning the company for continued growth.
Certara Appoints New Chief Commercial Officer
On October 5, 2021, Certara (Nasdaq: CERT) announced the appointment of Drayton T. Virkler as Chief Commercial Officer. With over 20 years of experience in the pharma sector, Virkler's role focuses on enhancing global commercial strategies and business development. Previously at IQVIA, he led sales and marketing, achieving annual revenue growth. Virkler aims to broaden Certara’s reach in biosimulation technologies, ultimately improving drug development processes for clients worldwide.
Certara has successfully acquired Pinnacle 21 for approximately $250 million in cash and 2.24 million shares of restricted common stock. This strategic acquisition aims to enhance Certara's capabilities in clinical data management and regulatory compliance, crucial for expediting drug development. Pinnacle 21's software is already adopted by leading biopharmaceutical companies and regulatory agencies like the FDA. The acquisition is expected to boost Certara's revenue and adjusted EBITDA, with updated financial guidance anticipated in November 2021.
Certara has launched Synchrogenix Writer, a cloud-based regulatory SaaS product aimed at automating and improving the quality of patient narratives critical for clinical study reporting. This innovative solution addresses the inefficiencies of the traditional manual writing process, which is costly and time-consuming. By enabling data-mapping and early drafting, the software ensures consistency, reduces risk, and accelerates the time to regulatory filing. With over 10,000 patient narratives already delivered, Synchrogenix Writer is positioned to meet evolving global regulatory requirements.
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