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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), a leader in biosimulation, announced its participation in the BofA Securities 2021 Virtual Health Care Conference. The presentation will be led by CEO William Feehery and CFO Andrew Schemick on May 11, 2021, at 2:45 p.m. ET. A live webcast will be available on Certara’s investor relations website, with a replay option for 90 days. Certara specializes in accelerating drug discovery and development through innovative biosimulation technology, serving over 1,650 clients globally, including major biopharmaceutical firms and regulatory agencies.
Certara, Inc. (Nasdaq: CERT) announced it will release preliminary financial results for Q1 2021 on May 6, 2021, after market close. A conference call will follow at 5:00 p.m. ET for management to discuss these results. Investors can participate via phone or listen to the archived webcast on Certara's website. Certara specializes in biosimulation software, serving over 1,650 biopharmaceutical companies and regulatory agencies worldwide, enhancing drug discovery and development processes.
Certara announced the successful closing of its underwritten public offering of 11,500,000 shares of common stock at $25.00 per share. This includes 1,500,000 shares sold due to the full exercise of underwriters’ options. Notably, Certara and its management did not sell any shares and received no proceeds from this offering. The transaction was conducted by leading underwriters including Jefferies, Morgan Stanley, and BofA Securities. The offering was registered under the SEC with an effective registration statement on Form S-1.
Certara, Inc. (Nasdaq: CERT) has announced the pricing of its underwritten public offering of 10 million shares of common stock by existing stockholders at $25.00 per share. The underwriters have a 30-day option to purchase up to an additional 1,500,000 shares. Certara will not receive any proceeds from this offering. The closing is anticipated around March 29, 2021, subject to customary conditions. The offering is managed by Jefferies, Morgan Stanley, and BofA Securities.
Certara, Inc. announced a proposed underwritten public offering of 17 million shares of its common stock by selling stockholders, with an additional 2,550,000 shares available for purchase by underwriters. Certara will not receive proceeds from this offering. The underwriting team includes Jefferies, Morgan Stanley, and BofA Securities. A preliminary registration statement has been filed with the SEC but is not yet effective, meaning no sales can occur until it is approved. This initiative supports Certara's ongoing role in biosimulation technology for drug development.
Certara (Nasdaq: CERT) has licensed TrialAssure's ANONYMIZE software to enhance anonymization of clinical data. This collaboration allows Certara's regulatory science division, Synchrogenix, to offer tailored anonymization services as a SaaS model to over 1,650 global biopharmaceutical clients. The ANONYMIZE tool enables full configurability to sponsor specifications, leveraging machine learning for efficient data processing. This partnership aims to strengthen compliance with increasing regulatory demands for data transparency in clinical trials.
Certara, a leader in biosimulation, is set to join the Russell 1000® Index effective March 22, 2021. This inclusion is based on its strong financial performance and reflects the growing adoption of its biosimulation platform. The Russell 1000 Index tracks the 1,000 largest companies in the U.S., and membership can enhance visibility among institutional investors, with approximately $9 trillion in assets benchmarked to these indexes. Certara aims to leverage this milestone to increase stock awareness within the investment community.
Certara, a leader in biosimulation, reported its preliminary results for Q4 and the full year 2020. Q4 revenue reached $64.6 million, with a full-year total of $243.5 million, reflecting growths of 20% and 17% year-over-year, respectively. However, the company recorded a net loss of ($54.4 million) in Q4 and ($49.4 million) for the full year, an increase from previous losses. Adjusted EBITDA grew by 36% in Q4 and 28% for the year. Certara anticipates 2021 revenue between $272 million and $285 million.
Certara, Inc. (Nasdaq: CERT) reported that 2020 was the seventh consecutive year where 90% of new drug and biologic approvals by the FDA were by its customers. In total, the FDA approved 54 new medicines in 2020, many of which received orphan and breakthrough designations. Certara’s biosimulation platforms, including Simcyp™, Phoenix™, and GlobalSubmit™, have been pivotal for drug development, enabling the provision of drug label claims without extensive clinical studies. CEO William Feehery highlighted the company's role in transforming drug development through advanced modeling techniques.
Certara, Inc. (Nasdaq: CERT) will announce its preliminary financial results for Q4 and the full year of 2020 post-market on March 4, 2021. A conference call to discuss these results will take place at 5:00 p.m. ET, accessible to investors through specific dialing options and a live webcast. Certara specializes in biosimulation technologies for drug discovery and development, serving over 1,650 biopharmaceutical companies and regulatory agencies in 61 countries.