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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, Inc. (Nasdaq: CERT), a leader in biosimulation, announced participation in several upcoming investor conferences. Key events include the Bank of America 2022 Healthcare Conference on May 10, Citi’s Biopharma Virtual Co-Panel Day on May 18, Jefferies Healthcare Conference from June 8-10, and William Blair’s Annual Growth Stock Conference on June 9. Live webcasts will be available on Certara's investor relations website, with replays accessible for 90 days. Certara specializes in accelerating drug discovery using proprietary biosimulation software.
Certara, Inc. (Nasdaq: CERT) will announce its financial results for Q1 2022 on May 5, 2022, after market close. A conference call to discuss these results will take place at 5:00 p.m. ET. Interested investors can participate by calling specific numbers for domestic and international audiences. Certara utilizes proprietary biosimulation software to enhance drug discovery and development, serving over 2,000 clients worldwide.
Certara, Inc. (Nasdaq: CERT) reported Q4 2021 revenue of $75.3 million, a 17% increase from Q4 2020. Excluding Pinnacle 21, revenue grew 7%. The net loss narrowed to $9.7 million from $54.5 million year-over-year, while adjusted EBITDA rose 27% to $28.2 million. For 2021, total revenue reached $286.1 million, up 17% year-over-year. However, 2022 revenue guidance was revised down to $350-$360 million. The company is confident in its mid-teens growth target despite challenges from the Omicron variant.
Certara announces FDA licensing of its Immunogenicity (IG) Simulator, enhancing drug development capabilities. The simulator predicts immune responses in protein therapeutics, crucial for clinical and regulatory decisions. With over five years of rigorous development, Certara aims to address immunogenicity risks, which can significantly impact drug projects. This technology is validated through 20 clinical studies, facilitating virtual patient trials. Certara serves over 2,000 clients globally, underscoring its role as a leader in biosimulation.
Certara announced that in 2021, 90% of new drug approvals from the FDA’s CDER were achieved by its customers, marking the eighth consecutive year of success in drug approval for clients utilizing its biosimulation software. The company’s Simcyp™ Simulator played a significant role in providing prescribing information for 13 new drugs, thereby reducing clinical trial costs and durations. Certara's technology has been instrumental in supporting the approval process for various therapeutic areas including oncology and orphan diseases, reinforcing its position as a leader in drug development.
Certara, Inc. (Nasdaq: CERT) will announce its fourth quarter and full year 2021 financial results after market close on March 1, 2022. A conference call hosted by company management will take place at 5:00 p.m. ET to discuss these results. Investors can join the call by dialing (833) 360-0946 for domestic calls or (914) 987-7661 for international calls, using Conference ID: 4688502. Additionally, a live and archived webcast of the call will be available on Certara's investor relations website.
Certara, a leader in biosimulation, announced on December 21, 2021, that the FDA has renewed and expanded its licenses for more than 400 user licenses of Certara's Simcyp and Phoenix software across 12 divisions. This software plays a critical role in drug development, helping the FDA analyze investigational therapies, new drug applications, and generic applications. The renewal indicates the FDA's growing reliance on Certara's tools, which are used by 37 of the top 40 biopharmaceutical companies. This expansion reflects Certara's influential position in ensuring the safety and efficacy of medicines.
Certara has announced the release of Pinnacle 21 Enterprise 5.1.0, enhancing its capabilities for biopharmaceutical clients. This update focuses on improving clinical trial data preparation for regulatory submissions, aligning with CDISC standards. The new features include support for the Define-XML 2.1 standard and an analytics module for summarizing portfolio performance. Major biopharmaceutical companies and regulatory bodies, such as the US FDA, utilize this software, indicating its critical role in accelerating time-to-market for medical products.
Certara, a leader in biosimulation, will host an Investor Day on December 15, 2021, from 3:00 PM to 6:00 PM ET in New York City. During this event, the management team will share updates on the company's strategy, software, and financial guidance for 2022. A demonstration of the Simcyp™ Simulator will also take place. The event will be available via a live video webcast on Certara's Investor Relations website, and a replay will be accessible for two weeks post-event.
Certara, a leader in biosimulation, announced the release of Simcyp Simulator Version 21, enhancing its population-based modeling platform. This tool aids in drug development by predicting dosing and drug-drug interactions without extensive clinical trials. The simulator has informed over 250 label claims for 85+ novel drugs approved by the FDA. New features include updates for renal and hepatic models, expanded brain models, and a broadened compound library. These advancements align with FDA guidance, facilitating faster drug approvals.
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