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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, a leader in biosimulation, reported a strong financial performance for Q4 and full-year 2022. Q4 revenue grew by 15% to $86.6 million, with net income of $9.2 million, reversing a loss from the previous year. For the full year, revenue reached $335.6 million, up 17%, with a net income of $14.7 million. Adjusted EBITDA also saw an increase, totaling $31.9 million for Q4 and $120.2 million for the year. Looking ahead, Certara projects 2023 revenues between $370 million and $385 million, with adjusted EBITDA expectations of $131 million to $137 million. The acquisition of Vyasa Analytics is positioned to strengthen its market position.
Certara, Inc. (Nasdaq: CERT) announced that John Gallagher will replace Andrew Schemick as Chief Financial Officer effective April 1, 2023. Gallagher brings nearly 25 years of experience, including his recent role as CFO of Cue Health and various positions at Becton Dickinson. Schemick transitions to Senior Vice President of Corporate Operations, focusing on operational excellence during Certara's growth. CEO William Feehery expressed excitement about Gallagher’s expertise to drive growth and thanked Schemick for his leadership over the past nine years, which included an IPO and significant capitalizations.
Certara (Nasdaq: CERT) announced its participation in the Barclays Global Healthcare Conference on March 15, 2023, at 11:15 AM ET. This event highlights the company's leadership in biosimulation technology aimed at transforming drug discovery and development. A live webcast will be hosted on Certara’s investor relations website, with a replay available for 90 days. Certara serves over 2,000 clients, including biopharmaceutical companies and regulatory agencies across 62 countries. The company continues to accelerate medicine development through its proprietary software and services.
Certara, Inc. (Nasdaq: CERT), renowned for its biosimulation expertise, has announced it will disclose its financial results for the fourth quarter and full year of 2022 post-market on March 1, 2023. The company will host a conference call at 5:00 p.m. ET to discuss these results. Interested investors can register in advance to listen live, with an archive available afterward. Certara provides innovative biosimulation software and services to a global clientele that includes over 2,000 biopharmaceutical firms, academic institutions, and regulatory bodies.
Certara has announced the acquisition of Vyasa Analytics, enhancing its software capabilities with advanced deep-learning technology aimed at the life sciences sector. This acquisition will integrate Vyasa's AI-driven solutions, including the LAYAR data platform, into Certara's biosimulation software, broadening its product offerings and improving decision-making in drug development. Certara serves over 2,000 clients globally, leveraging proprietary software to accelerate drug discovery and development.
Certara, Inc. (Nasdaq: CERT) has completed a $449 million stock purchase from funds controlled by EQT Private Equity, marking a significant investment by Arsenal Capital Partners. As part of this deal, David Spaight, an Operating Partner at Arsenal, has been appointed to Certara’s Board of Directors. Arsenal has committed to a two-year lock-up period, reflecting its long-term commitment as a shareholder. Spaight's extensive experience in the biopharmaceutical sector is expected to enhance Certara’s strategic direction and growth prospects.
Certara, Inc. (Nasdaq: CERT) reported significant growth for Q3 2022, achieving $84.7 million in revenue, a 15% increase year-over-year. This growth was complemented by a net income of $3.9 million, a notable turnaround from a net loss of $1.8 million in the same quarter last year. Adjusted EBITDA rose 25% to $32.7 million. The company reiterated its full-year revenue guidance of $325 million to $335 million. Additionally, Arsenal Investment Partners is set to acquire 30 million shares at $15 per share, strengthening shareholder support.
Certara (Nasdaq: CERT) has announced a significant investment from Arsenal Capital Partners, acquiring approximately 30 million shares at $15 each, totaling around $449 million. Once completed, Arsenal's stake will rise to about 22% of diluted shares outstanding. This investment is subject to HSR regulatory approval and includes a two-year lock-up on share sales. Arsenal is a long-time investor in Certara, which specializes in biosimulation for drug development.
Certara, Inc. (Nasdaq: CERT) has announced its participation in two upcoming investor conferences. The first is the Jeffries London Healthcare Conference on November 15 at 4:25 PM GMT, followed by the Stephens Annual Investment Conference on November 17 at 9:00 AM CT. Live webcasts will be available on Certara's investor relations website and can be replayed for 90 days. Certara specializes in biosimulation software and services that enhance drug discovery and development for over 2,000 clients worldwide.
Certara has announced the renewal of its software licenses with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the ninth consecutive year.
Certara's Simcyp™ Simulator, Phoenix™, and Pinnacle 21™ Enterprise software will continue to support PMDA in drug development and regulatory submissions.
The PMDA has utilized Certara’s software since 2014, significantly enhancing its data validation processes, including new compliance rules introduced in 2021.
Certara collaborates with over 140 biopharmaceutical companies in Japan, including the top 20 by R&D spending.