Certara, Inc. Stock Price, News & Analysis

Certara, a leader in biosimulation, announced on December 21, 2021, that the FDA has renewed and expanded its licenses for more than 400 user licenses of Certara's Simcyp and Phoenix software across 12 divisions. This software plays a critical role in drug development, helping the FDA analyze investigational therapies, new drug applications, and generic applications. The renewal indicates the FDA's growing reliance on Certara's tools, which are used by 37 of the top 40 biopharmaceutical companies. This expansion reflects Certara's influential position in ensuring the safety and efficacy of medicines.

Certara has announced the release of Pinnacle 21 Enterprise 5.1.0, enhancing its capabilities for biopharmaceutical clients. This update focuses on improving clinical trial data preparation for regulatory submissions, aligning with CDISC standards. The new features include support for the Define-XML 2.1 standard and an analytics module for summarizing portfolio performance. Major biopharmaceutical companies and regulatory bodies, such as the US FDA, utilize this software, indicating its critical role in accelerating time-to-market for medical products.

Certara, a leader in biosimulation, will host an Investor Day on December 15, 2021, from 3:00 PM to 6:00 PM ET in New York City. During this event, the management team will share updates on the company's strategy, software, and financial guidance for 2022. A demonstration of the Simcyp™ Simulator will also take place. The event will be available via a live video webcast on Certara's Investor Relations website, and a replay will be accessible for two weeks post-event.

Certara, a leader in biosimulation, announced the release of Simcyp Simulator Version 21, enhancing its population-based modeling platform. This tool aids in drug development by predicting dosing and drug-drug interactions without extensive clinical trials. The simulator has informed over 250 label claims for 85+ novel drugs approved by the FDA. New features include updates for renal and hepatic models, expanded brain models, and a broadened compound library. These advancements align with FDA guidance, facilitating faster drug approvals.

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.