Certara, Inc. Stock Price, News & Analysis

Certara, Inc. (Nasdaq: CERT) reported its Q1 2022 financial results, showcasing a 22% revenue growth to $81.6 million compared to Q1 2021. Net income rose to $2.2 million, reflecting a 110% increase. Adjusted EBITDA was $27.7 million, up 16% year-over-year. The company anticipates FY 2022 revenue guidance between $350 - $360 million and adjusted diluted EPS of $0.48 - $0.53. CEO William F. Feehery emphasized the strong demand for their technology-driven services despite some COVID-related delays.

Certara, Inc. (Nasdaq: CERT), a leader in biosimulation, announced participation in several upcoming investor conferences. Key events include the Bank of America 2022 Healthcare Conference on May 10, Citi’s Biopharma Virtual Co-Panel Day on May 18, Jefferies Healthcare Conference from June 8-10, and William Blair’s Annual Growth Stock Conference on June 9. Live webcasts will be available on Certara's investor relations website, with replays accessible for 90 days. Certara specializes in accelerating drug discovery using proprietary biosimulation software.

Certara, Inc. (Nasdaq: CERT) will announce its financial results for Q1 2022 on May 5, 2022, after market close. A conference call to discuss these results will take place at 5:00 p.m. ET. Interested investors can participate by calling specific numbers for domestic and international audiences. Certara utilizes proprietary biosimulation software to enhance drug discovery and development, serving over 2,000 clients worldwide.

Certara, Inc. (Nasdaq: CERT) reported Q4 2021 revenue of $75.3 million, a 17% increase from Q4 2020. Excluding Pinnacle 21, revenue grew 7%. The net loss narrowed to $9.7 million from $54.5 million year-over-year, while adjusted EBITDA rose 27% to $28.2 million. For 2021, total revenue reached $286.1 million, up 17% year-over-year. However, 2022 revenue guidance was revised down to $350-$360 million. The company is confident in its mid-teens growth target despite challenges from the Omicron variant.

Certara announces FDA licensing of its Immunogenicity (IG) Simulator, enhancing drug development capabilities. The simulator predicts immune responses in protein therapeutics, crucial for clinical and regulatory decisions. With over five years of rigorous development, Certara aims to address immunogenicity risks, which can significantly impact drug projects. This technology is validated through 20 clinical studies, facilitating virtual patient trials. Certara serves over 2,000 clients globally, underscoring its role as a leader in biosimulation.

Certara announced that in 2021, 90% of new drug approvals from the FDA’s CDER were achieved by its customers, marking the eighth consecutive year of success in drug approval for clients utilizing its biosimulation software. The company’s Simcyp™ Simulator played a significant role in providing prescribing information for 13 new drugs, thereby reducing clinical trial costs and durations. Certara's technology has been instrumental in supporting the approval process for various therapeutic areas including oncology and orphan diseases, reinforcing its position as a leader in drug development.

Certara, Inc. (Nasdaq: CERT) will announce its fourth quarter and full year 2021 financial results after market close on March 1, 2022. A conference call hosted by company management will take place at 5:00 p.m. ET to discuss these results. Investors can join the call by dialing (833) 360-0946 for domestic calls or (914) 987-7661 for international calls, using Conference ID: 4688502. Additionally, a live and archived webcast of the call will be available on Certara's investor relations website.

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.