RADNOR, Pa. - Certara, Inc. (NASDAQ: NASDAQ:CERT), known for its model-informed drug development services, announced today the release of its new CoAuthor regulatory writing software. This advanced platform is designed to aid medical writers by integrating generative AI with document templates and Microsoft (NASDAQ:MSFT) Word.
Medical writing, an essential facet of drug development, has been predominantly manual and unchanged for decades. With the increasing complexity of precision medicine therapies, there is a greater need for efficient synthesis of expansive biomedical knowledge into understandable documents.
CoAuthor aims to expedite the creation of regulatory documents, while still involving a "human in the loop" to oversee the generative AI's contributions. According to Certara CEO William Feehery, Ph.D., the software is tailored for the drug development sector, providing a secure and specialized AI solution.
Developed with input from medical writers, CoAuthor is user-friendly and equipped with eCTD regulatory writing templates, structured content authoring, and integration with Microsoft Word. Christopher Bouton, Ph.D., Senior Vice President, Artificial Intelligence at Certara, highlighted that CoAuthor can improve the time to first draft by at least 30%, enhancing consistency and reducing drafting time.
Certara will showcase CoAuthor at the DIA Annual Meeting in San Diego, CA, and will also present the platform during an Innovation Theatre session today. This announcement is based on a press release statement.
In other recent news, Certara revealed promising Q1 2024 results, reflecting a 6% year-over-year increase in revenue to $96.7 million, surpassing estimates. The firm's software segment, responsible for a significant portion of its revenue, experienced a 19.1% year-over-year increase.
Despite these positive results, Certara's earnings were challenged by ongoing investments and the effects of mergers and acquisitions, resulting in an adjusted EBITDA for Q1 2024 of $29.1 million, slightly below consensus.
Certara's management maintains its guidance for the full year 2024, indicating confidence in a second-half performance uptick, partly driven by a recovery in bookings. The company's strategic initiatives, including the launch of Certara Cloud and engagement with top biopharmaceutical companies, emphasize its commitment to innovation and market expansion.
Still, recent declines in service bookings and modest capital markets activity in the biopharma sector during 2022-2023 have raised concerns among analysts. Barclays (LON:BARC) has given Certara an "Equal Weight" rating with a price target of $18.00, while JMP Securities rates it as "Market Perform". Despite these challenges, Certara's management remains confident in the company's resilience and potential for a bookings recovery in the latter half of the year.
InvestingPro Insights
Amid the launch of its innovative CoAuthor software, Certara (NASDAQ: CERT) continues to navigate the complex landscape of drug development with its financial metrics indicating a blend of challenges and growth potential. According to InvestingPro, the company's revenue has seen a modest uptick, with a 4.73% growth over the last twelve months as of Q1 2024. This aligns with the company's efforts to innovate and streamline the drug development process.
InvestingPro data also reveals that Certara's market capitalization stands at $2.39 billion, reflecting the market's valuation of the company in light of its industry position and future prospects. Despite not being profitable over the last twelve months, with a negative P/E ratio of -38.68, analysts predict that the company will turn a profit this year. This optimistic outlook may be buoyed by the company's gross profit margin of 59.68%, suggesting that Certara can effectively convert revenue into gross profit.
InvestingPro Tips indicate that while the stock price has shown volatility, with a 1-month price total return of -7.4%, Certara's liquid assets exceed its short-term obligations, providing some financial stability. Moreover, the company operates with a moderate level of debt, which could be a strategic lever for growth or a point of caution for risk-averse investors.
For those considering an investment in Certara, there are additional insights available on InvestingPro, with the opportunity to use coupon code PRONEWS24 for an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
As Certara showcases its CoAuthor platform, investors and industry watchers will be keen to see how this integration of AI into regulatory writing will impact the company's operational efficiency and financial performance in the dynamic biotech sector.
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