Certara Stock is a key biosimulation game

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Biosimulation software and technology firm Certara (NASDAQ: CERT) the stock grants withdrawals to cautious investors to gain exposure. The company provides biosimulation for drug discovery, research, regulatory submissions and market access using its predictive data analytics. It enables customers to speed up drug development and regulatory processes by claiming that 90% of their drug submissions have resulted in FDA approvals since 2014. In fact, the FDA is an additional customer of Certara. 1,650 customers in 61 countries with an average over 10 years. mandate for its 30 main clients using its proprietary technology. Biosimulation can replace human trials in some situations to speed up the time it takes for a drug to hit the market, which is traditionally 10 years and $ 2 billion. Biosimulation increases the likelihood of success in human trials, which is the most expensive factor in drug development. His immuno-oncology simulator correctly predicted treatment outcomes for various types of blood tumors and cancers using certain drugs. Essentially, Certara saves considerable time and cost in the drug discovery and development process, thereby improving efficiency. Cautious investors looking for a catalyst in the biosimulation segment can watch for pullbacks in Certara shares.

Publication of results for the second quarter of fiscal 2021

On July 21, 2021, Certara released its second quarter 2021 tax results for the quarter ending June 2021. The company reported earnings per share (EPS) of $ 0.03 excluding non-recurring items compared to analyst estimates. consensus for a profit of $ 0.05. , one (- $ 0.02) missed. Revenue increased just over 15% year-on-year to $ 70.1 million, beating analysts’ estimates of $ 69.52 million. Company released FY2021 forecast for EPS of $ 0.21 to $ 0.25 vs. $ 0.23 according to analysts’ estimates and future revenue of $ 283 to 289 million vs. $ 282.7 millions of dollars. The company also announced that it will acquire Pinnacle 21, a leader in pharmaceutical clinical data standardization software, for $ 310 million in cash and in stock closing early in the fourth quarter of 2021.

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Comments from the CEO and CFO

Certara CEO William Feehery said, “Our second quarter results reflect the continued momentum of increased adoption of our proprietary end-to-end platform and the launch of new software features to expand use cases. of biosimulation around the world. Earlier today, we announced the strategic and accretive agreement to acquire Pinnacle 21, our largest to date. This extension of Certara’s quantitative tools and solutions will further help researchers and regulators answer critical questions throughout the drug development lifecycle. Certara CFO Andrew Schermick added: “In the second quarter, Certara’s differentiated portfolio of technology-driven software and services delivered strong financial performance. Going forward, we remain well positioned to meet our long-term goals of growing teen revenue and expanding the Adjusted EBITDA margin. With a 12-month growth in bookings of 26%, we have a high level of visibility on the achievement of our commercial and financial plans for the year ”

Take-out conference call

CEO Feehery set the tone: “Overall, we are satisfied with our performance since the start of the year, which has exceeded expectations at the start of the year. In line with our goal of expanding biosimulation use cases and increasing adoption of our end-to-end platform, we were delighted to announce earlier today the acquisition of Pinnacle 21, the largest acquisition in our history, for $ 310 million in cash. and stock. Pinnacle 21 is a privately held company providing industry leading data standardization software for clinical pharmaceutical data. Their SaaS solutions are used to manage compliance with CDISC standards and increase the quality of preclinical and clinical data. The CDISC, also known as the Clinical Data Interchange Standards Consortium, has developed a set of global data standards for regulatory submissions. Compliance with these standards is required for regulatory submissions to the US FDA and Japanese pharmaceutical and medical device agencies, so that these agencies can effectively understand the data they have received and evaluated during the process. review process. CDISC standards are also the preferred standards for electronic data submissions in China. Interestingly, CEO Feehery also noted, “Pinnacle’s software is used by the FDA and PMDA to validate all incoming submission data. This acquisition is a perfect fit for Certara on several levels. First, Pinnacle 21’s proprietary validation software perfectly complements our biosimulation and regulatory software. Global regulatory submissions require consistent and compliant datasets to minimize costly delays. “

Synergy Pinnacle 21

CEO Feehery spoke about the synergistic importance of his Pinnacle 21 acquisition. Additionally, data standardization advances scientific research as data is collected and combined from increasingly diverse sources, then organized and analyzed with biosimulation and other methods. Second, Certara’s drug development and regulatory science consulting teams will be able to expand our data standardization and CDISC compliance service offerings powered by Pinnacle 21 software, as we are already collaborating with our customers on the data collection, integration, analysis and preparation. And last but not least, the cultural fit is remarkable, as we are both passionate about innovation and efficiency throughout the lifecycle of drug development using technology. Working together, we will integrate and develop features and tools to accelerate life-saving therapies for patients.

Pinnacle 21 has taken incredible steps with a leading team of software developers and CDISC experts who have designed user-friendly software to help biopharmaceutical companies manage complex data standards. Their Pinnacle 21 community-based open source software is used by more than 1,000 organizations and helps remove barriers to entry and promote innovation, especially among small biopharmaceutical companies and start-ups, while meeting standards. complex data that can be intimidating and take up a lot of time and resources. This large user base also creates a strong community of committed data scientists and biostatisticians who provide feedback that feeds the development of new features. As businesses become more familiar with the significant benefits of Pinnacle 21 tools, many find it helpful to upgrade to the enterprise version in order to get the most out of their data, ensure standards compliance, and minimize risk. regulatory delays. He continued, “Pinnacle 21 has more than 130 corporate customers, including 22 of the top 25 biopharmaceutical companies in terms of R&D spending, as well as the FDA and PMDA. They rapidly increased the number of customers with annual customer value above $ 100,000 from 19 customers in 2018 to 44 in 2020. When we close, Pinnacle 21 will immediately contribute to revenue growth and Adjusted EBITDA of Certara. We expect the acquisition to be completed early in the fourth quarter.

Certara Stock is a key biosimulation game

CERT opportunistic withdrawal levels

Using the gun charts over the weekly and daily periods provides an accurate view of the price action playing field for CERT stocks. The weekly rifle chart is trending upward with a 5-period moving average (MA) rising to $ 33.97 and a 15-period MA rising to $ 29.62 Fibonacci level (fib). The weekly upper Bollinger Bands are at $ 37.81. The Weekly Stochastic is trying a mini puppy to high band above the 80 band. The Weekly has a sell high market structure (MSH) trigger on a breakdown below $ 33.25. The Daily Shooting Board is in a make or break setup. The daily 5 period MA is $ 35.07 and the 15 period MA is $ 35.01. The Daily Stochastic has a mini reverse puppy attempt. The bullish case is if the Daily Stochastic crosses for a daily puppy breakout towards the daily upper BBs of $ 40.26. The bearish case is that the 5 period MA crosses the 15 period MA as the mini stochastic reverse puppy forms a full swing towards the daily lower BBs of $ 27.38. The daily has an MSH sell trigger on an outage below $ 34.52 and a weak market structure (MSL) buy trigger that formed when breaking above $ 27.93. Cautious investors can watch for opportunistic withdrawal levels at $ 33.34 fib, $ 32.16 fib, $ 31.14 fib, $ 29.62 fib, $ 28.50 fib, $ 28.04 fib, and 27.38 $ fib. Bullish trajectories range from the $ 39.11 level to the $ 48.58 level.

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