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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) reported Q2 2021 revenue of $70.1 million, a 15% increase year-over-year. Net loss was $2.9 million, contrasting with a net income of $2.8 million in Q2 2020. Adjusted EBITDA rose 1% to $25.5 million. The company announced the acquisition of Pinnacle 21 for $310 million, aimed at enhancing its data standardization capabilities. Full year 2021 guidance was raised to $283-$289 million in revenue, $101-$103 million in Adjusted EBITDA, and $0.21-$0.25 in Adjusted Diluted EPS, excluding Pinnacle 21's impact.
Certara, Inc. (Nasdaq: CERT) has announced a definitive agreement to acquire Pinnacle 21 for $310 million in cash and stock. The acquisition, aimed at enhancing Certara's biosimulation and regulatory software capabilities, is expected to be immediately accretive to revenue and adjusted EBITDA margins. Pinnacle 21's tools ensure compliance with CDISC standards, crucial for FDA and PMDA drug submissions. The deal, which has been unanimously approved, is expected to close by early Q4 2021, subject to regulatory approvals.
Certara (NASDAQ: CERT) has announced a $250 million investment from Mubadala Investment Company, with shares priced at $26 each. The transaction includes the purchase of 9,615,384 shares from existing shareholders, expected to close on August 2, 2021. CEO William F. Feehery expressed enthusiasm for Mubadala's support, highlighting Certara's leadership in biosimulation. Mubadala's investment aims to enhance innovation in clinical needs and improve drug development processes. With over 1,650 clients globally, Certara continues to advance biopharma research and development.
Certara has confirmed through the Pitch study at Oxford University that its Vaccine Simulator predicted an optimal eight-week interval between COVID-19 vaccine doses. This finding challenges the existing dosing schedules of Pfizer-BioNTech and Moderna, which recommend three and four weeks, respectively. Certara's biosimulation technology integrates various data to optimize dosing strategies, aiding in global health efforts amidst the pandemic. The company aims to enhance vaccine efficacy and safety, including future booster recommendations and mixing vaccines.
Certara has appointed Nancy Killefer and Cynthia Collins to its board of directors, effective August 1, 2021, increasing the board to eleven members. Killefer brings over 30 years of executive experience in pharmaceuticals and healthcare, previously serving as a director at McKinsey & Company. Collins, with over 40 years in biotechnology, was CEO at Editas Medicine, where she led significant advancements in gene editing. Both directors aim to leverage their expertise to enhance Certara's drug discovery and development processes.
Certara, Inc. (Nasdaq: CERT) will announce its second quarter 2021 financial results on August 5, 2021, post-market. A conference call with management is scheduled for 5:00 p.m. ET to discuss these results. Investors can join by dialing (833) 360-0946 domestically or (914) 987-7661 internationally, using Conference ID: 2728807. An archived webcast will also be available on the Certara website. Certara specializes in biosimulation technology, assisting over 1,650 clients, which include biopharmaceutical companies and regulatory agencies worldwide.
Certara has appointed Nicolette D. Sherman as Chief Human Resources Officer, bringing over 20 years of HR experience in the biopharmaceutical sector. Previously, she was CHRO at Oyster Point Pharma, where she developed HR strategies for a newly public biotech. Her tenure at Sanofi included roles as Vice President of North American HR Operations and Global Leadership Development. CEO William F. Feehery expressed confidence in Sherman's ability to enhance Certara's capabilities and corporate values, further aligning with the company's mission to transform drug development.
Certara has launched an upgraded version of its BaseCase software, aimed at enhancing the market potential for biopharmaceutical and medical device companies. The new capabilities, which include Data Connect for real-time data updates, aim to improve communications regarding product value. The software is currently utilized in over 60 countries by more than 30,000 users, including leading global firms. This development reflects a strategic move to strengthen Certara’s position in the value-based healthcare sector, providing tools for effective market access and medical affairs.
Certara announced the renewal of its licenses for biosimulation software by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the eighth consecutive year. The PMDA has utilized Certara’s Simcyp™ and Phoenix™ software since 2014. These tools aid in drug development by optimizing dosing regimens and predicting interactions. Certara collaborates with over 130 biopharmaceutical firms in Japan, including the top 10 by R&D expenditure. The continued adoption of biosimulation supports the development of therapies for challenging diseases.
Certara has appointed Carol Gallagher, Pharm.D., to its board of directors, enhancing its governance with her 30+ years of drug development and commercial leadership experience.
Previously a CEO and venture partner, Dr. Gallagher has a notable background in biopharmaceuticals, including her role in developing the cancer drug ZYDELIG. Her experience spans companies like Eli Lilly and Amgen.
Dr. Gallagher's addition is expected to contribute to Certara's mission to accelerate drug development through its biosimulation software, supporting over 1,650 global clients.
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