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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), 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.
Certara (Nasdaq: CERT) reported its Q2 2024 financial results, showing mixed performance. Revenue increased 3% year-over-year to $93.3 million, driven by 13% growth in software revenue to $38.2 million. However, services revenue declined 3% to $55.1 million. The company reported a net loss of $12.6 million, compared to a net income of $4.7 million in Q2 2023. Adjusted EBITDA decreased to $26.3 million from $32.4 million last year.
Despite challenges in services due to cautious spending among large biopharma customers, Certara reiterated its full-year 2024 guidance. The company expects revenue between $385-400 million, adjusted EBITDA margin of 31-33%, and adjusted diluted EPS of $0.41-$0.46.
Certara, a leader in model-informed drug development, has signed a definitive agreement to acquire cheminformatics software provider Chemaxon. The acquisition is expected to close in the second half of 2024, pending regulatory approvals. This deal aims to enhance Certara's drug discovery capabilities by integrating Chemaxon's software, which is important for chemical structure drawing, property prediction, and analysis.
Chemaxon is projected to generate over $20 million in software revenue in 2024 and is expected to align with Certara’s EBITDA margin by the end of 2025. The combined entity will offer a comprehensive data and predictive analytics platform, expected to improve decision-making and reduce costs in drug development.
Certara has reiterated its full-year 2024 financial outlook, excluding Chemaxon, and will update its guidance post-transaction, maintaining an adjusted EBITDA margin of 31-33%.
Certara (Nasdaq: CERT), a global leader in model-informed drug development, will announce its Q2 2024 financial results after market close on August 6th, 2024. The announcement will be followed by a conference call at 5:00 PM ET to discuss the results. Investors are advised to register online for the call at least a day in advance. The event will be broadcast live and archived on Certara's investor relations website.
Certara (Nasdaq: CERT) has launched its next-generation CoAuthor regulatory writing software, enhancing the medical writing process using generative AI. Unveiled on June 17, 2024, CoAuthor integrates AI, document templates, and Microsoft Word, aiming to expedite the creation of regulatory documents while maintaining a 'human in the loop' approach. The software allows medical writers to efficiently synthesize complex biomedical data, providing a secure and specialized GPT for the drug development sector.
The platform promises to improve drafting times by at least 30%, enhancing content curation and quality control. Certara’s CEO, William Feehery, emphasized the company's expertise in maximizing AI’s potential in drug development. CoAuthor will be presented at the DIA Annual Meeting in San Diego, featuring a dedicated session on June 17th.
Certara (Nasdaq: CERT), a global leader in biosimulation, announced its participation in the Jefferies Global Healthcare Conference.
The event will take place on June 5th, 2024, at 11:30AM ET.
Company management will present at the conference, and a live webcast will be available on Certara’s investor relations website.
The webcast replay will be accessible for at least 90 days.
On May 21, 2024, Certara (Nasdaq: CERT), a global leader in model-informed drug development, announced the appointment of Rona Anhalt as Chief Human Resources Officer and Daniel Corcoran as General Counsel.
CEO William F. Feehery expressed confidence in their ability to enhance Certara's mission to accelerate medicine development. Anhalt, previously with EQRx, will lead human capital management for Certara's 1,400 employees, including 400 scientists. Corcoran, coming from Nexthink, will oversee legal affairs, bringing over 20 years of experience from technology companies.
Certara, Inc. reported its first quarter 2024 financial results, with revenue reaching $96.7 million, a 7% increase from the previous year. Software revenue grew by 19% to $39.3 million, while services revenue remained flat. The net loss was $4.7 million, with adjusted EBITDA at $29.1 million. The company reiterated its full-year 2024 financial guidance, expecting revenue between $385 million to $400 million.
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