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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. 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.
Certara, a leader in biosimulation, is set to join the Russell 1000® Index effective March 22, 2021. This inclusion is based on its strong financial performance and reflects the growing adoption of its biosimulation platform. The Russell 1000 Index tracks the 1,000 largest companies in the U.S., and membership can enhance visibility among institutional investors, with approximately $9 trillion in assets benchmarked to these indexes. Certara aims to leverage this milestone to increase stock awareness within the investment community.
Certara, a leader in biosimulation, reported its preliminary results for Q4 and the full year 2020. Q4 revenue reached $64.6 million, with a full-year total of $243.5 million, reflecting growths of 20% and 17% year-over-year, respectively. However, the company recorded a net loss of ($54.4 million) in Q4 and ($49.4 million) for the full year, an increase from previous losses. Adjusted EBITDA grew by 36% in Q4 and 28% for the year. Certara anticipates 2021 revenue between $272 million and $285 million.
Certara, Inc. (Nasdaq: CERT) reported that 2020 was the seventh consecutive year where 90% of new drug and biologic approvals by the FDA were by its customers. In total, the FDA approved 54 new medicines in 2020, many of which received orphan and breakthrough designations. Certara’s biosimulation platforms, including Simcyp™, Phoenix™, and GlobalSubmit™, have been pivotal for drug development, enabling the provision of drug label claims without extensive clinical studies. CEO William Feehery highlighted the company's role in transforming drug development through advanced modeling techniques.
Certara, Inc. (Nasdaq: CERT) will announce its preliminary financial results for Q4 and the full year of 2020 post-market on March 4, 2021. A conference call to discuss these results will take place at 5:00 p.m. ET, accessible to investors through specific dialing options and a live webcast. Certara specializes in biosimulation technologies for drug discovery and development, serving over 1,650 biopharmaceutical companies and regulatory agencies in 61 countries.
Certara, a leader in biosimulation, announced the launch of version 20 of its Simcyp™ Physiologically-based Pharmacokinetic (PBPK) Simulator. This version includes new models for maternal health, virtual bioequivalence, and long-acting injectable drugs. The simulator has informed the FDA approval of over 75 drugs, enhancing clinical trial efficiency. The expanded Simcyp Biologics Simulator aids in predicting pharmacokinetics for biologic drugs, crucial for their development. This software is pivotal for optimizing drug safety and efficacy in a vibrant biopharmaceutical R&D landscape.
Certara, a global leader in biosimulation, announced the closing of its upsized IPO on December 15, 2020, selling 33,413,250 shares at $23.00 each, raising approximately $336.5 million. Out of this, Certara itself sold 14,630,000 shares while certain stockholders sold 18,783,250 shares. Shares started trading on Nasdaq under the ticker symbol 'CERT' on December 11, 2020. The underwriters included Jefferies, Morgan Stanley, and BofA Securities, among others. This offering was registered under an effective Form S-1 with the Securities and Exchange Commission.
Certara has priced its upsized initial public offering (IPO) of 29,055,000 shares of common stock at $23.00 per share, aiming to raise approximately $336.5 million before expenses. The offering, scheduled to close on December 15, 2020, involves 14,630,000 shares from Certara and 14,425,000 from selling stockholders. Shares will trade on Nasdaq under the ticker 'CERT' starting December 11, 2020. A 30-day option for underwriters to purchase an additional 4,358,250 shares is also part of the offering.
Certara, known for its biosimulation technology, has announced the launch of its initial public offering (IPO) of 24,390,000 shares of common stock, with prices expected between $19.00 and $22.00 per share. The offering comprises 14,630,000 shares from Certara and 9,760,000 shares from selling stockholders, who will also give underwriters a 30-day option for an additional 3,658,500 shares. Certara's shares will be listed on Nasdaq under the symbol "CERT." The company will not receive proceeds from shares sold by selling stockholders.
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