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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) announced participation in upcoming virtual investor conferences featuring CEO William Feehery and CFO Andrew Schemick. They will speak at William Blair's 41st Annual Growth Stock Conference on June 1 at 11:40 a.m. ET and the Jefferies Virtual Healthcare Conference on June 4 at 10:00 a.m. ET. Live webcasts will be available on Certara's investor relations website and can be replayed for 90 days. Certara specializes in biosimulation software to enhance drug discovery and development for over 1,650 global clients.
Certara has launched new versions of its Immunogenicity and Immuno-oncology Quantitative Systems Pharmacology (QSP) Simulators to tackle challenges in developing biologics and cancer therapies. The updates enhance the simulators' capabilities, allowing for better predictions of clinical outcomes and the testing of therapy combinations. Certara's tools are now critical in regulatory submissions, highlighting the growing importance of QSP in pharmaceutical R&D. The simulators have successfully predicted outcomes for various cancer treatment scenarios, including solid tumors and blood cancers.
Certara reported Q1 fiscal 2021 results with revenue of $66.7 million, a 16% increase from Q1 2020. Net income rose to $1.1 million, with adjusted EBITDA climbing 20% to $23.9 million. The company updated its full-year guidance, projecting revenue between $277 million and $285 million, and adjusted EBITDA of $100 million to $102 million. First quarter bookings grew 34% year-over-year, indicating strong demand for its biosimulation platform.
Certara has launched its innovative Secondary Intelligence™ software, designed to predict off-target safety issues that could affect drug development. This software is the first of its kind, providing critical data on secondary pharmacology and enhancing decision-making for drug developers. With safety issues contributing to around 25% of candidate failures, this tool aims to improve the efficiency and precision of safety assessments, potentially accelerating clinical success. Certara serves over 1,650 clients in 61 countries, highlighting its significant role in the biopharmaceutical sector.
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.
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