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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 significant growth for Q3 2022, achieving $84.7 million in revenue, a 15% increase year-over-year. This growth was complemented by a net income of $3.9 million, a notable turnaround from a net loss of $1.8 million in the same quarter last year. Adjusted EBITDA rose 25% to $32.7 million. The company reiterated its full-year revenue guidance of $325 million to $335 million. Additionally, Arsenal Investment Partners is set to acquire 30 million shares at $15 per share, strengthening shareholder support.
Certara (Nasdaq: CERT) has announced a significant investment from Arsenal Capital Partners, acquiring approximately 30 million shares at $15 each, totaling around $449 million. Once completed, Arsenal's stake will rise to about 22% of diluted shares outstanding. This investment is subject to HSR regulatory approval and includes a two-year lock-up on share sales. Arsenal is a long-time investor in Certara, which specializes in biosimulation for drug development.
Certara, Inc. (Nasdaq: CERT) has announced its participation in two upcoming investor conferences. The first is the Jeffries London Healthcare Conference on November 15 at 4:25 PM GMT, followed by the Stephens Annual Investment Conference on November 17 at 9:00 AM CT. Live webcasts will be available on Certara's investor relations website and can be replayed for 90 days. Certara specializes in biosimulation software and services that enhance drug discovery and development for over 2,000 clients worldwide.
Certara has announced the renewal of its software licenses with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the ninth consecutive year.
Certara's Simcyp™ Simulator, Phoenix™, and Pinnacle 21™ Enterprise software will continue to support PMDA in drug development and regulatory submissions.
The PMDA has utilized Certara’s software since 2014, significantly enhancing its data validation processes, including new compliance rules introduced in 2021.
Certara collaborates with over 140 biopharmaceutical companies in Japan, including the top 20 by R&D spending.
Certara, a leader in biosimulation, will release its Q3 2022 financial results on November 7, 2022, after market close. A conference call with management will follow at 5:00 p.m. ET to discuss the results. Interested investors must register online, ideally a day in advance. The event will be accessible via a live and archived webcast on the Certara website. The company aids over 2,000 clients globally in drug discovery and development through its innovative software and services.
Certara, Inc. (Nasdaq: CERT), a leader in biosimulation, will participate in two upcoming investor conferences. The first is the Morgan Stanley 20th Annual Global Healthcare Conference on September 13 at 11:45 a.m. ET. The second is the Baird Global Healthcare Conference on September 14 at 12:15 p.m. ET. Live webcasts will be available on Certara’s investor relations website and can be replayed for 90 days. Certara uses advanced biosimulation software to enhance drug discovery and development for over 2,000 clients in 62 countries.
Certara, Inc. (Nasdaq: CERT) announced an underwritten secondary offering of 7,000,000 shares of common stock by certain stockholders, including EQT Avatar Parent L.P. The offering allows for a 30-day option for the underwriter to purchase an additional 1,050,000 shares. No shares are being sold by Certara, and the proceeds will go entirely to the Selling Stockholders. The last reported stock price was $20.19, with the closing expected around August 16, 2022. Morgan Stanley is the underwriter for this offering.
Certara reported a strong second quarter of fiscal year 2022, achieving $82.8 million in revenue, an 18% increase compared to the prior year. Revenue excluding Pinnacle 21 was $75.8 million, up 8%. Net loss decreased to $0.6 million from $2.9 million, marking a significant improvement. Adjusted EBITDA rose to $28.0 million, reflecting 9% growth. While full-year guidance has been adjusted to $325-$335 million due to currency fluctuations and slow regulatory market recovery, Certara remains optimistic about its biosimulation and Pinnacle 21 services.
Certara, Inc. recently announced the release of Pinnacle 21 Enterprise version 5.2.0, enhancing biosimulation software for validating clinical trial data. This update includes new analytics features to ensure compliance with FDA regulations, improved team collaboration tools, and enhanced security measures. The new Pinnacle 21 Data Exchange module streamlines data ingestion from external sources, promising significant time savings in clinical studies, as evidenced by a recent pilot with a major pharmaceutical client.
Certara has announced a two-year collaboration with Memorial Sloan Kettering Cancer Center (MSK) to develop a new biosimulation platform aimed at enhancing CAR T-cell therapies for multiple myeloma. The initiative will utilize de-identified clinical data from MSK to optimize dosing strategies and evaluate combination therapies. Dr. Sham Mailankody emphasized the need for improved treatments for relapsed patients. This partnership aims to accelerate innovative solutions to improve cancer therapy outcomes.
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