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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 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.
Certara, a leader in biosimulation, has appointed Rosemary Crane to its Board of Directors, effective July 21, 2022. This addition increases the board to eleven members. CEO William F. Feehery expressed enthusiasm about Crane's experience in executive leadership and commercialization, which is expected to significantly benefit the company’s growth in the biopharmaceutical sector. Crane brings over 35 years of industry experience, having held leadership positions at several major pharmaceutical companies, including a successful IPO at Epocrates.
Certara, a leader in biosimulation, has appointed Eran Broshy to its Board of Directors, effective July 11, 2022, expanding the board to ten members. Broshy brings over 35 years of experience in healthcare, previously serving as CEO and chairman of inVentiv Health, now part of Syneos Health. His expertise in high-growth healthcare businesses is expected to enhance Certara's strategic direction in drug development. Certara's biosimulation software is used by over 2,000 clients globally, aiming to improve patient outcomes.
Certara, Inc. (Nasdaq: CERT) will release its Q2 2022 financial results on August 9, 2022, after market close. A conference call with management is scheduled for 5:00 p.m. ET to discuss these results. Interested investors must register online. An archived webcast will be available on the Certara website.
Certara has launched the Simcyp Discovery Simulator, designed for small molecule drug discovery and translational research. This advanced software enhances early-stage development decisions using physiologically-based pharmacokinetic (PBPK) modeling, aimed at reducing the high failure rate of preclinical drugs. The simulator includes PBPK models for various species and supports early formulation simulations and drug-drug interaction predictions. Certara's commitment to improving drug development processes is underscored by their technological advancements.
Certara announces enhancements to its biosimulation tools, including new versions of its Immunogenicity (IG), Immuno-oncology (IO), and Vaccine Simulators. These innovations aim to improve drug development predictability across various therapeutic areas. Key advancements in the IG Simulator (Version 5.0) allow for more comprehensive evaluation of biologics, while the IO Simulator (Version 4.0) facilitates optimal cancer therapy combinations. Additionally, the Vaccine Simulator addresses dosing strategies for diverse patient populations, contributing to the development of next-generation mRNA vaccines.
Certara, Inc. (Nasdaq: CERT) reported its Q1 2022 financial results, showcasing a 22% revenue growth to $81.6 million compared to Q1 2021. Net income rose to $2.2 million, reflecting a 110% increase. Adjusted EBITDA was $27.7 million, up 16% year-over-year. The company anticipates FY 2022 revenue guidance between $350 - $360 million and adjusted diluted EPS of $0.48 - $0.53. CEO William F. Feehery emphasized the strong demand for their technology-driven services despite some COVID-related delays.
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