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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) announced it will release its financial results for Q1 2023 after market close on May 8, 2023. A conference call is scheduled for 5:00 PM ET the same day, where company management will discuss the results. Investors can register for the call online, with an early registration recommended. Additionally, Certara will participate in the BofA Securities 2023 Healthcare Conference, presenting on May 10, 2023, at 8:40 AM PT. Live and archived webcasts from both events will be accessible on the Certara Investors website.
Certara specializes in biosimulation, providing software and services for drug discovery and development, with a client base exceeding 2,000 organizations globally.
Xentria, Inc. has announced a peer-reviewed publication in Frontiers in Pharmacology, detailing a biosimulation model for its treatment candidate, XTMAB-16, aimed at pulmonary sarcoidosis. Partnering with Certara, Inc., the model aids in estimating safe and effective dosing for upcoming clinical trials slated for early 2023. XTMAB-16, an anti-TNF monoclonal antibody, has shown promise in reducing granuloma formation. The publication represents a significant collaboration in sarcoidosis research, potentially marking the first use of an in vitro model to guide dosing in clinical trials. Xentria aims to launch its first patient trial soon.
Certara has announced the integration of deep learning capabilities into its scientific informatics software platform, D360. This enhancement aims to improve data-driven decision-making in drug discovery by allowing users to predict properties of chemical structures and access unstructured data. The new features include Automated Property Prediction, Novel Structure Generation, and enhanced access to literature-based insights. Certara acquired these advanced capabilities from Vyasa and will showcase them at the Lab of the Future Congress in Boston.
Certara, Inc. (CERT) announced the launch of Simcyp Simulator Version 22, enhancing its capabilities for drug development. This advanced platform has been utilized to support over 300 label claims for more than 90 FDA-approved novel drugs, allowing for comprehensive analysis without human clinical trials. Key upgrades include enhanced subcutaneous dosing predictions, expanded compound libraries, and additional ethnic populations for improved therapeutic applications. Certara aims to facilitate faster medicine delivery through its continuing commitment to advanced biosimulation technologies.
Certara, a leader in biosimulation, reported a strong financial performance for Q4 and full-year 2022. Q4 revenue grew by 15% to $86.6 million, with net income of $9.2 million, reversing a loss from the previous year. For the full year, revenue reached $335.6 million, up 17%, with a net income of $14.7 million. Adjusted EBITDA also saw an increase, totaling $31.9 million for Q4 and $120.2 million for the year. Looking ahead, Certara projects 2023 revenues between $370 million and $385 million, with adjusted EBITDA expectations of $131 million to $137 million. The acquisition of Vyasa Analytics is positioned to strengthen its market position.
Certara, Inc. (Nasdaq: CERT) announced that John Gallagher will replace Andrew Schemick as Chief Financial Officer effective April 1, 2023. Gallagher brings nearly 25 years of experience, including his recent role as CFO of Cue Health and various positions at Becton Dickinson. Schemick transitions to Senior Vice President of Corporate Operations, focusing on operational excellence during Certara's growth. CEO William Feehery expressed excitement about Gallagher’s expertise to drive growth and thanked Schemick for his leadership over the past nine years, which included an IPO and significant capitalizations.
Certara (Nasdaq: CERT) announced its participation in the Barclays Global Healthcare Conference on March 15, 2023, at 11:15 AM ET. This event highlights the company's leadership in biosimulation technology aimed at transforming drug discovery and development. A live webcast will be hosted on Certara’s investor relations website, with a replay available for 90 days. Certara serves over 2,000 clients, including biopharmaceutical companies and regulatory agencies across 62 countries. The company continues to accelerate medicine development through its proprietary software and services.
Certara, Inc. (Nasdaq: CERT), renowned for its biosimulation expertise, has announced it will disclose its financial results for the fourth quarter and full year of 2022 post-market on March 1, 2023. The company will host a conference call at 5:00 p.m. ET to discuss these results. Interested investors can register in advance to listen live, with an archive available afterward. Certara provides innovative biosimulation software and services to a global clientele that includes over 2,000 biopharmaceutical firms, academic institutions, and regulatory bodies.
Certara has announced the acquisition of Vyasa Analytics, enhancing its software capabilities with advanced deep-learning technology aimed at the life sciences sector. This acquisition will integrate Vyasa's AI-driven solutions, including the LAYAR data platform, into Certara's biosimulation software, broadening its product offerings and improving decision-making in drug development. Certara serves over 2,000 clients globally, leveraging proprietary software to accelerate drug discovery and development.
Certara, Inc. (Nasdaq: CERT) has completed a $449 million stock purchase from funds controlled by EQT Private Equity, marking a significant investment by Arsenal Capital Partners. As part of this deal, David Spaight, an Operating Partner at Arsenal, has been appointed to Certara’s Board of Directors. Arsenal has committed to a two-year lock-up period, reflecting its long-term commitment as a shareholder. Spaight's extensive experience in the biopharmaceutical sector is expected to enhance Certara’s strategic direction and growth prospects.
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