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Certara, Inc. (NASDAQ: CERT) is a leading provider of decision support technology and consulting services designed to optimize drug development and improve health outcomes. The company's suite of solutions spans the entire drug development and patient care lifecycle, employing advanced modeling and simulation technologies along with cutting-edge regulatory strategies. Certara's services are pivotal in increasing the probability of both regulatory and commercial success for their clients, which include over 2,300 global biopharmaceutical companies, leading academic institutions, and major regulatory agencies across 70 countries.
Certara's core business revolves around leveraging biosimulation software and technology to transform traditional drug discovery and development processes. By using its innovative modeling and simulation tools, the company aids clients in reducing the need for extensive clinical trials, thereby accelerating regulatory approvals and enhancing patient access to new therapies. Their product suite includes regulatory science, assessment software, and a range of consulting services, all aimed at streamlining drug development.
One of Certara's notable achievements is its collaboration with the FDA on physiologically-based pharmacokinetic (PBPK) modeling for virtual bioequivalence (VBE) and predicting drug absorption of topical formulations. These initiatives aim to replace costly and time-consuming clinical bioequivalence studies with efficient virtual simulations, thus speeding up the development process and reducing costs. The Simcyp Simulator, a key component of Certara's technology, has already proven its utility in replacing clinical studies in VBE and dermal absorption scenarios.
Certara's business operations are primarily concentrated in the Americas, generating significant revenue from this region, with additional market presence in EMEA and the Asia Pacific. The company continues to expand its software portfolio with innovations like the Simcyp™ Biopharmaceutics software, which helps drug developers optimize formulations for complex therapies, and the recently launched Certara Cloud, a unified platform that integrates their scientific software solutions for seamless workflow management.
Financially, Certara has reiterated its full-year guidance for 2024, showcasing a stable outlook and ongoing commitment to delivering high-quality, innovative solutions. Their recent acquisition of Applied BioMath underscores their growth strategy, enhancing their capabilities in quantitative systems pharmacology (QSP) to de-risk and accelerate therapeutic R&D. The combined expertise positions Certara as the largest QSP center of excellence, further strengthening their role in the life sciences industry.
For more information, visit www.certara.com.
Certara (Nasdaq: CERT) highlights its 2024 research achievements with over 100 publications and recognition of 12 company scientists in the Stanford/Elsevier top 2% cited researchers list. The publications cover diverse areas including pediatric oncology, first-in-human dose predictions, exposure-response analyses, and the application of PBPK modeling in global health. Notable research trends focused on biosimulation strategies in drug development and extended model-informed drug development, including the implementation of generative AI in regulatory writing and diversity in clinical trial enrollment.
Certara (NASDAQ: CERT) reported Q3 2024 financial results with revenue of $94.8 million, up 11% year-over-year. Software revenue grew 15% to $35.9 million, while services revenue increased 9% to $58.9 million. The company posted a net loss of $1.4 million, significantly improved from a $49.0 million loss in Q3 2023. Adjusted EBITDA rose 15% to $33.1 million. Total bookings grew 13% to $96.1 million. The company updated its full-year 2024 guidance, expecting revenue between $380-385 million and adjusted EBITDA of $120-124 million.
Certara (Nasdaq: CERT), a global leader in model-informed drug development, has announced its participation in the Stephens Annual Investment Conference. The company's management will deliver a presentation on Thursday, November 21st, 2024, at 10:00 AM CT. Investors and interested parties can access a live webcast of the presentation through Certara's investor relations website at https://ir.certara.com. The presentation recording will remain available for replay for a minimum of 90 days following the event.
Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, has appointed John Reynders, PhD, to its Board of Directors, effective October 15, 2024. Dr. Reynders brings over 25 years of experience in the pharmaceutical and tech industries, with expertise in artificial intelligence, data science, and life science.
Dr. Reynders' career highlights include serving as the founding CIO of Moderna, where he led data-sciences capabilities for mRNA therapy design, and as Chief Data Sciences Officer at Neumora. He has also held executive positions at Alexion Pharmaceuticals, AstraZeneca, Johnson & Johnson, Eli Lilly, and Celera.
Certara's CEO, William F. Feehery, PhD, expressed excitement about the appointment, emphasizing the value Dr. Reynders' expertise will bring to the company's ongoing development of transformational software and services for accelerating new medicines and increasing pharma R&D productivity.
Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, has announced it will release its financial results for the third quarter of 2024 after the market close on Wednesday, November 6th, 2024. The company management will host a conference call to discuss the financial results at 5:00PM ET. Investors interested in participating in the conference call are required to register online, with registration recommended at least one day in advance. A live and archived webcast of the event will be available on the "Investors" section of Certara's website at https://ir.certara.com/.
Certara, Inc. (Nasdaq: CERT), a leader in model-informed drug development, has completed the acquisition of Chemaxon, a developer of scientific informatics software for in-silico research in the life sciences industry. The combined organization aims to offer improved predictive biosimulation and scientific informatics capabilities to enhance decision-making from discovery through commercialization.
Key points:
- Integration plans include incorporating Chemaxon's chemistry structures, calculators, and predictors into Certara's D360 applications and Simcyp™ PBPK Simulator.
- Long-term plans involve leveraging Certara.AI's specialized GPT capabilities and expanding pharmacokinetics and pharmacodynamics knowledge in drug discovery processes.
- Chemaxon is expected to generate software revenue exceeding $20 million in 2024.
- Certara will update its 2024 guidance to include Chemaxon's contribution in its third-quarter earnings report in November.
Certara (Nasdaq: CERT) celebrates the 25th anniversary of its Simcyp Consortium, a pre-competitive scientific research group comprising 35 leading biopharmaceutical companies. The consortium has become a global authority on physiologically-based pharmacokinetic (PBPK) modeling and simulation.
The Simcyp Simulator, used by pharmaceutical companies, academia, and regulatory agencies, has informed dosing decisions for over 375 label claims across 115+ drugs. It accurately predicts drug behavior in the human body, aiding various stages of drug development.
The consortium has awarded grants totaling $1.4 million to support 13 PhD and postdoctoral researchers. Simcyp provides academic licenses to more than 110 universities worldwide, and its publications have been cited over 8,000 times in scientific literature.
Certara (Nasdaq: CERT) and Ichnos Glenmark Innovation (IGI) collaborated on optimizing the first-in-human dosing strategy for ISB 2001, a trispecific T-cell engager for cancer treatment. The research, published in Nature Cancer, used virtual trials to select a higher starting dose, increasing it by 50-100 fold over conventional methods. This approach, approved by the FDA and Australian HREC, aims to reduce costs, minimize ineffective dosing, and accelerate drug development.
The collaboration leveraged Certara's expertise in quantitative systems pharmacology and physiologically-based pharmacokinetics to develop a virtual clinical trial platform. This innovative method not only enhances patient safety and efficacy but also aligns with regulatory goals to reduce animal studies. The optimized dosing strategy for ISB 2001 showcases the potential of virtual patient technology in drug development, particularly for complex biologics like T-cell engagers.
Certara (Nasdaq: CERT), a leader in model-informed drug development, has announced its participation in two upcoming investor conferences. The company will be present at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 4 at 4:05 p.m. ET and the Baird Global Healthcare Conference on September 11 at 10:15 a.m. ET.
Both conference presentations will be available via live webcasts on Certara's investor relations website at https://ir.certara.com. These webcasts will remain accessible for replay for at least 90 days after the events. This participation provides investors with opportunities to gain insights into Certara's operations and future prospects directly from the company's management.
Certara (Nasdaq: CERT) has launched Phoenix™ version 8.5, an upgraded drug development software used by top pharmaceutical companies and regulatory agencies worldwide. This release aims to improve the efficiency, quality, and speed of pharmacokinetic/pharmacodynamic (PK/PD) workflows. Key features include:
1. Sign-in via Certara Cloud for simplified license management and enhanced access control
2. Reporting enhancements for better data presentation and analysis
3. NLME improvements for more precise modeling and interpretation
Phoenix 8.5 was developed based on customer feedback to streamline drug development processes and potentially reduce the high failure rate of new medicines in clinical trials. The software is available as a hosted solution for improved performance and cost-effectiveness.
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