Core Insights - The market has experienced volatility due to unexpected tariff policy changes, leading to uneven recovery among firms, with some stocks emerging as high-momentum plays [1][2] Group 1: Software-Based Drug Development - Certara Inc. has seen a 30% year-to-date increase in stock price, driven by strong outlook and a $100 million share buyback program [3][6] - Certara's revenue guidance for 2025 is projected between $415 million and $425 million, with adjusted earnings per share expected to be between 42 cents and 46 cents [4] - Schrödinger Inc. has also experienced a 25% year-to-date increase, attributed to FDA policy shifts favoring human-relevant testing and a legal settlement [9][10] Group 2: Modular Furniture Industry - The Lovesac Co. reported a 23% increase in stock price following an earnings beat and the launch of new product platforms, with EPS exceeding expectations by 33 cents [12][14] - Lovesac's modular design allows for increased supply chain flexibility, enabling the company to adapt to geopolitical changes [14] - Analysts project a 57.86% upside for Lovesac's stock, with a current price of $20.06 and a 12-month forecast of $31.67 [13][14]

Core Insights - Certara, Inc. announced expected revenue and bookings for the first quarter, reflecting a positive outlook for the company [1] - The company reiterated its 2025 guidance, projecting sales between $415 million and $425 million, with an adjusted EBITDA margin of 30-32% and adjusted EPS of 42-46 cents [2] Financial Performance - Certara reported revenue of $106 million for the first quarter, a 10% increase from $96.7 million in the same period last year, exceeding the consensus estimate of $104.42 million [4] - Software revenue reached $46.4 million, up 18%, while services revenue was $59.6 million, up 4% [4] - Interim Q1 bookings totaled $118 million, a 12% increase, including software bookings of $40.6 million and services bookings of $77.4 million [4] - The company expects adjusted EBITDA of approximately $33-$35 million, representing a growth of 13-20% [4] Strategic Initiatives - Certara is pursuing a strategic evaluation of its regulatory services business and has engaged in preliminary discussions with several external parties [3] - The company launched its Non-Animal Navigator solution aimed at assisting biopharmaceutical companies in transitioning from animal testing [3] Market Reaction - Following the announcements, Certara's stock price increased by 9.14%, reaching $14.10 [3]

Core Insights - Certara, Inc. has launched the Non-Animal Navigator™ solution to assist biopharmaceutical companies in adapting to the FDA's Roadmap aimed at reducing animal testing in preclinical safety studies, marking a significant shift in drug development practices [1][3] Group 1: Company Overview - Certara is a global leader in model-informed drug development, providing biosimulation software and services to enhance drug discovery and development processes [5] - The company has over 2,400 clients, including biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries [5] Group 2: Industry Context - The FDA's Roadmap is a pivotal moment for the industry, encouraging the adoption of model-informed drug development approaches that are predictive, efficient, and ethical [3] - Monoclonal antibodies and antibody-drug conjugates (ADCs) are in the preclinical phase across various therapeutic areas, with biosimulation models showing predictive capabilities comparable to traditional animal studies [2] Group 3: Product Features - The Non-Animal Navigator offers strategic regulatory advice to design preclinical programs that align with regulatory requirements and utilize new approach methodologies (NAMs) [5] - It includes an integrated preclinical development plan that combines various evidence types, including in vitro, in vivo, and biosimulation data, supported by expert toxicology input [5] - The solution provides access to advanced AI-enabled modeling tools, such as the Simcyp Simulator, to accelerate development timelines [5]

Core Viewpoint - Certara, Inc. has announced its preliminary financial results for Q1 2025, highlighting strong revenue growth and a stock repurchase program of up to $100 million, reflecting confidence in its long-term strategy and AI investments [2][3][6]. Financial Performance - Expected revenue for Q1 2025 is projected at $106.0 million, a 10% increase from $96.7 million in Q1 2024 [6]. - Software revenue is anticipated to be $46.4 million, up 18% from $39.3 million in Q1 2024 [6]. - Services revenue is expected to reach $59.6 million, a 4% increase from $57.3 million in Q1 2024 [6]. - Total bookings for Q1 2025 are projected at $118.0 million, representing a 12% growth compared to $105.8 million in Q1 2024 [6]. - Adjusted EBITDA is expected to be in the range of $33-$35 million, reflecting a growth of 13-20% from $29.1 million in Q1 2024 [6]. Full-Year Guidance - Certara reiterates its full-year 2025 revenue guidance of $415 million to $425 million [7]. - The adjusted EBITDA margin for the full year is expected to be between 30-32% [7]. - Adjusted diluted earnings per share is projected to be in the range of $0.42 - $0.46 [7]. - Fully diluted shares are expected to be between 162 million to 164 million [7]. Strategic Initiatives - The company is conducting a strategic review of its regulatory services business and is in preliminary discussions with external parties [8]. - Arsenal Capital Partners has agreed to a one-year lock-up on shares acquired in a December 2022 transaction, indicating ongoing support for Certara's growth [3][6]. Upcoming Events - Certara will host a conference call on May 5, 2025, to discuss its Q1 2025 financial results, with registration required for investors [9].

Core Viewpoint - Certara, Inc. has reported strong preliminary financial results for Q1 2025, with significant growth in revenue and bookings, and has reiterated its full-year guidance for 2025 [2][6]. Financial Performance - Expected revenue for Q1 2025 is $106.0 million, a 10% increase from $96.7 million in Q1 2024 [7]. - Software revenue is projected at $46.4 million, up 18% from $39.3 million in the same quarter last year [7]. - Services revenue is expected to be $59.6 million, reflecting a 4% growth from $57.3 million in Q1 2024 [7]. - Total bookings for Q1 2025 are anticipated to be $118.0 million, a 12% increase from $105.8 million in Q1 2024 [7]. - Adjusted EBITDA is estimated to be in the range of $33-$35 million, representing a growth of 13-20% compared to $29.1 million in Q1 2024 [7]. Full-Year Guidance - The company maintains its full-year 2025 revenue guidance in the range of $415 million to $425 million [8]. - Adjusted EBITDA margin for the full year is expected to be between 30-32% [8]. - Adjusted diluted earnings per share is projected to be in the range of $0.42 - $0.46 [8]. Strategic Developments - Arsenal Capital Partners has agreed to a one-year lock-up on shares acquired from EQT, indicating continued support for Certara's growth [3][6]. - Certara is actively pursuing a strategic evaluation of its regulatory services business, engaging in preliminary discussions with external parties [9]. Share Repurchase Program - The Board of Directors has authorized a stock repurchase program allowing for the repurchase of up to $100 million of outstanding common stock, reflecting confidence in the company's strategy [2][3].

Chris Lau is an individual investor and economist with 30 years of experience covering life science, technology, and dividend-growth income stocks. He has degrees in Microbiology and Economics. Chris runs the investing group DIY Value Investing where he shares his top stock picks of undervalued stocks with catalysts for upside, dividend-income recommendations with quant and payment calendar tracking, high upside plays, and research requests to help you become a better do-it-yourself investor. Learn more.Top ...

Certara, Inc. (CERT) shares soared 8% in the last trading session to close at $10.51. The move was backed by solid volume with far more shares changing hands than in a normal session. This compares to the stock's 11.6% loss over the past four weeks.Earlier this month, the company released a new version of the Simcyp Simulator for physiologically-based pharmacokinetic (PBPK) modeling, which forecasts the behavior of drugs in different body tissues. Per management, the latest version cements Certara’s positio ...

Core Insights - Certara, Inc. has launched a new version of the Simcyp™ Simulator, enhancing its capabilities for physiologically-based pharmacokinetic (PBPK) modeling to support data-driven decision-making in drug development [1][2] Company Developments - The Simcyp Simulator Version 24 has been developed with input from a consortium of over 30 leading pharmaceutical companies, reflecting the evolving needs of pharmaceutical collaborators and regulators [2] - The simulator has been instrumental in the approval of over 120 novel drugs by the FDA and has facilitated clinical trial waivers in various areas, including drug-drug interactions (DDI) and pediatric trials [3] Technological Advancements - The latest version includes features for predicting food effects on drug absorption, expanded libraries for drug-drug interactions, and improved modeling for special populations such as pediatrics, pregnancy, and lactation [4] - Enhancements in performance and usability include a modernized user interface, cloud computing capabilities, and AI-enabled help chat [4] Market Impact - Currently, 80% of drugs utilizing PBPK for FDA approval in recent years have employed the Simcyp Simulator, indicating its significant role in the industry [2]

Core Insights - Certara, Inc. has released a new version of the Simcyp™ Simulator, enhancing its position as a leader in physiologically-based pharmacokinetic (PBPK) modeling for drug development [1][2] - The latest version, Simcyp Version 24, addresses the evolving needs of pharmaceutical collaborators and regulators, supporting the growing adoption of PBPK in drug development and regulatory decision-making [2] Company Developments - The Simcyp Simulator has contributed to over 120 FDA-approved novel drugs and has supported clinical trial waivers in various areas, including drug-drug interactions (DDI) and pediatric trials [3] - A consortium of over 30 leading pharmaceutical companies guides the development of the Simcyp Simulator, ensuring that the latest version incorporates their feedback to enhance capabilities and databases [2] Features of Simcyp Version 24 - The new version includes features for predicting food effects, improving drug absorption simulations under various meal conditions [4] - An expanded library for drug-drug interactions now covers a broader range of capabilities, providing qualification evidence for transporter-mediated DDIs in the gut, liver, and kidney [4] - Enhanced modeling for special populations, including pediatric, pregnancy, and lactation groups, has been incorporated [4] - The user interface has been modernized, and new functionalities such as cloud computing and AI-enabled help chat have been added to improve performance and usability [4]

McKemey joins Certara to accelerate growth of its strategic drug development solutionsRADNOR, Pa., March 05, 2025 (GLOBE NEWSWIRE) -- Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, today announced the appointment of Adrian McKemey, Ph.D. as President of Drug Development Solutions, effective March 3rd, 2025. In this role, McKemey will lead Certara's global team of drug development scientists. Adrian joins Certara after serving as head of Enterprise Transformation at IQVIA a ...