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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) has launched D360 version 21.5, enhancing its scientific informatics software for biomedical research. This update improves efficiency in analyzing small molecules and biologic drugs, facilitating quicker, higher-confidence decision-making in drug development. Key new features include support for biologic drug sequence clustering, transformation analysis for small molecules, accelerated workflows, and advanced data visualization. D360 is utilized by over 6,000 scientists at top biopharmaceutical firms, reaffirming Certara's commitment to optimizing drug discovery processes.
Certara, Inc. (Nasdaq: CERT) has closed its public offering of 10,000,000 shares at $31.00 each, undertaken by existing stockholders. The underwriters were granted a 30-day option for an additional 1,500,000 shares. Certara will not receive any proceeds from this sale. The offering was led by Jefferies, Morgan Stanley, and BofA Securities, with other firms participating. A registration statement relating to these securities was approved by the SEC. Full prospectus details are available upon request from the underwriting firms.
Certara, a leader in biosimulation, announced the pricing of an underwritten public offering of 10 million shares at $31.00 each, solely by existing stockholders. The underwriters have a 30-day option to purchase an additional 1.5 million shares. Certara will not receive proceeds from this offering, which is expected to close on November 22, 2021. This offering is managed by Jefferies, Morgan Stanley, and BofA Securities, among others. A registration statement has been declared effective by the SEC.
Certara has announced a proposed underwritten public offering of 10 million shares of its common stock by certain selling stockholders, as per the registration statement filed with the Securities and Exchange Commission. The underwriters will have a 30-day option to purchase an additional 1.5 million shares. Certara will not receive any proceeds from this offering. The underwriting group includes Jefferies, Morgan Stanley, and BofA Securities. A preliminary prospectus has been filed but is subject to completion and will not be effective until registration formalities are met.
Certara, Inc. (Nasdaq: CERT) reported third-quarter 2021 revenues of $73.9 million, a 23% increase from the previous year. However, the company incurred a net loss of $1.8 million compared to a net income of $1.2 million in Q3 2020. Adjusted EBITDA rose 28% to $26.1 million. Certara announced the completion of its $250 million acquisition of Pinnacle 21 and raised its full-year guidance, forecasting revenue between $288 million and $291 million, adjusted EBITDA of $106 million to $108 million, and adjusted diluted EPS between $0.22 and $0.26.
Certara, Inc. (Nasdaq: CERT) has announced the appointment of James E. Cashman III as Chairman of the Board, effective December 1, 2021. He will succeed Sherilyn McCoy, who is stepping down to focus on other commitments. Cashman, who has served on Certara's Board since 2018, previously led ANSYS, growing its revenue from $50 million to over $1 billion. His expertise in simulation-driven product development is expected to strengthen Certara's innovation and growth strategy. The company specializes in biosimulation technologies enhancing drug development.
Certara, a leader in biosimulation, announced that its CEO, William F. Feehery, and CFO, Andrew Schemick, will participate in a fireside chat at the Piper Sandler 33rd Annual Virtual Healthcare Conference. The event is scheduled for November 22, 2021, at 10:00 am ET. Interested parties can access the webcast through Certara's investor relations website. Certara is known for its proprietary biosimulation software, serving over 1,650 global biopharmaceutical firms, academic institutions, and regulatory agencies across 61 countries.
Certara (Nasdaq: CERT) has secured a five-year contract from the FDA for its Pinnacle 21 Enterprise software, which enhances the agency's ability to review clinical and non-clinical study submission data. This agreement continues a long-standing partnership and follows previous contracts awarded in 2011 and 2015. The software streamlines data validation processes, allowing FDA reviewers to assess data quality more efficiently. This contract also supports the FDA’s DataFit program amid new technical rejection criteria implementation.
Certara, Inc. (Nasdaq: CERT) will release its third-quarter 2021 financial results on November 9, 2021, post-market. A conference call with management to discuss these results will occur at 5:00 p.m. ET. Interested investors can join the call by dialing (833) 360-0946 for domestic and (914) 987-7661 for international participants, using Conference ID: 1968232. The event will also be available via a live and archived webcast on Certara's Investors webpage.
Certara specializes in biosimulation software and technology, assisting over 1,650 clients globally.
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