Certara, Inc. - CERT STOCK NEWS

Certara's Leadership in Drug Approvals

On April 27, 2023, Certara, Inc. (Nasdaq: CERT) announced that its clients achieved a remarkable milestone, with 90% of new drug approvals from the FDA's CDER in 2022. This marks the ninth consecutive year of significant FDA approvals for Certara’s clients, using its innovative biosimulation software across multiple therapeutic areas, including oncology and rare diseases.

Certara's Simcyp™ and Phoenix™ software have been instrumental in informing drug label claims and evaluating drug applications, respectively. Notably, these tools aided in the approval of eight oncology drugs among other critical treatments, reflecting Certara's commitment to enhancing drug development efficiency and safety for patients worldwide.

Certara, Inc. (Nasdaq: CERT) announced it will release its financial results for Q1 2023 after market close on May 8, 2023. A conference call is scheduled for 5:00 PM ET the same day, where company management will discuss the results. Investors can register for the call online, with an early registration recommended. Additionally, Certara will participate in the BofA Securities 2023 Healthcare Conference, presenting on May 10, 2023, at 8:40 AM PT. Live and archived webcasts from both events will be accessible on the Certara Investors website.

Certara specializes in biosimulation, providing software and services for drug discovery and development, with a client base exceeding 2,000 organizations globally.

Xentria, Inc. has announced a peer-reviewed publication in Frontiers in Pharmacology, detailing a biosimulation model for its treatment candidate, XTMAB-16, aimed at pulmonary sarcoidosis. Partnering with Certara, Inc., the model aids in estimating safe and effective dosing for upcoming clinical trials slated for early 2023. XTMAB-16, an anti-TNF monoclonal antibody, has shown promise in reducing granuloma formation. The publication represents a significant collaboration in sarcoidosis research, potentially marking the first use of an in vitro model to guide dosing in clinical trials. Xentria aims to launch its first patient trial soon.

Certara has announced the integration of deep learning capabilities into its scientific informatics software platform, D360. This enhancement aims to improve data-driven decision-making in drug discovery by allowing users to predict properties of chemical structures and access unstructured data. The new features include Automated Property Prediction, Novel Structure Generation, and enhanced access to literature-based insights. Certara acquired these advanced capabilities from Vyasa and will showcase them at the Lab of the Future Congress in Boston.

Certara, Inc. (CERT) announced the launch of Simcyp Simulator Version 22, enhancing its capabilities for drug development. This advanced platform has been utilized to support over 300 label claims for more than 90 FDA-approved novel drugs, allowing for comprehensive analysis without human clinical trials. Key upgrades include enhanced subcutaneous dosing predictions, expanded compound libraries, and additional ethnic populations for improved therapeutic applications. Certara aims to facilitate faster medicine delivery through its continuing commitment to advanced biosimulation technologies.

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.