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Introduction to Simulations Plus Inc
Simulations Plus Inc is a specialized developer of advanced simulation software and consulting services that support pharmaceutical research and regulatory submissions. The company excels in the design and development of tools used in ADMET modeling, PBPK modeling, and overall quantitative systems pharmacology, crucial for enhancing drug discovery and development processes.
Core Business and Operating Segments
The business is primarily divided into two segments: Software and Services. The Software segment offers an extensive suite of simulation tools that integrate data mining, compound library screening, and quantitative structure-activity relationship (QSAR) modeling. These tools are instrumental in providing insights into drug absorption, distribution, metabolism, excretion, and toxicity. The Services segment complements this portfolio by offering consulting and contract research services that guide clients from early discovery phases, through preclinical and clinical development, and up to regulatory submissions.
Technological Expertise and Industry Application
Simulations Plus Inc utilizes state-of-the-art methodologies to bridge complex pharmaceutical science with practical, user-friendly software solutions. Its modeling suite supports a variety of tasks ranging from PBPK/TK modeling in both animal and human studies to quantitative systems pharmacology analyses. This integration of sophisticated algorithms with practical application makes the company a trusted partner for pharmaceutical companies, biotechnology firms, and regulatory agencies worldwide.
Integration of Software Tools and Consulting Services
At the heart of its value proposition is a seamless integration of software products and professional consulting. The software tools, renowned for their ease-of-use and reliability, assist clients in the quantitative evaluation of new chemical entities while optimizing the design of clinical trials. Meanwhile, the consulting services provide bespoke support, leveraging a deep understanding of pharmacokinetics and pharmacodynamics to streamline drug discovery and development processes.
Market Position and Global Reach
Simulations Plus Inc has established itself as a significant participant in the simulation software industry. With a strong market presence in the USA, followed by robust engagements in the EMEA and Asia Pacific regions, the company's technologies are widely recognized for their scientific rigor and practical impact in reducing drug development costs and timelines. This broad geographic footprint underlines its commitment to support regulatory agencies as well as commercial pharmaceutical ventures globally.
Commitment to Scientific Excellence
For over two decades, Simulations Plus Inc has built a reputation based on its methodological approach and deep industry expertise. The company emphasizes continuous improvement in its simulation models, ensuring that they remain robust, scientifically sound, and aligned with current regulatory standards. This unwavering commitment to scientific excellence makes it an invaluable resource for stakeholders involved in every stage of drug development.
Understanding the Competitive Landscape
Operating in an industry characterized by stringent regulatory demands and rapid technological advances, Simulations Plus Inc differentiates itself through its comprehensive suite of integrated solutions and its holistic approach to pharmaceutical modeling. Its dual focus on software development and expert consulting services creates a competitive edge, making it a preferred partner for a wide array of clients who demand precision, efficiency, and regulatory confidence in their simulation tools.
Conclusion
In summary, Simulations Plus Inc stands out in the pharmaceutical simulation software arena by offering a versatile blend of advanced technological solutions and insightful consulting services. Its commitment to high-quality, data-driven methodologies ensures that its offerings remain relevant and reliable, providing indispensable support across every phase of drug development and regulatory review.
Simulations Plus (SLP) reported strong Q2 fiscal 2025 results with total revenue growing 23% year-over-year to $22.4 million. Software revenue increased 16% to $13.5 million (60% of total), while services revenue rose 34% to $8.9 million (40% of total).
The company's Quantitative Systems Pharmacology (QSP) business unit showed exceptional growth of 89%, primarily due to a new model license in atopic dermatitis. Cheminformatics and Clinical Pharmacology & Pharmacometrics revenues grew by 8% and 9% respectively.
However, net income decreased to $3.1 million ($0.15 EPS) compared to $4.0 million ($0.20 EPS) in Q2 2024. The company maintains its full-year 2025 guidance of $90-93 million in revenue and adjusted diluted EPS of $1.07-1.20.
Simulations Plus (Nasdaq: SLP), a provider of cheminformatics, biosimulation, simulation-enabled performance and intelligence solutions, and medical communications to the biopharma industry, has scheduled its second quarter fiscal 2025 earnings release and conference call.
The company will announce its Q2 FY2025 financial results after market close on Thursday, April 3, 2025, followed by a management-hosted conference call at 5:00 p.m. Eastern Time. Investors and shareholders can join the webcast through registration or dial in using 1-877-451-6152 (domestic) or 201-389-0879 (international).
Simulations Plus (Nasdaq: SLP), a leader in cheminformatics, biosimulation, and medical communications for the biopharma industry, has announced its participation in the KeyBanc Capital Markets Virtual Healthcare Investor Forum.
CEO Shawn O'Connor will engage in a fireside chat on Tuesday, March 18, 2025, at 2:15 p.m. Eastern Time. The event will include one-on-one meetings with institutional investors throughout the day. Interested parties can access the fireside chat through a live webcast, which will be available on the Simulations Plus website's Investors page for approximately 90 days after the event.
Simulations Plus (Nasdaq: SLP), a leading provider of cheminformatics, biosimulation, and medical communications solutions to the biopharma industry, has announced its participation in two major healthcare investor conferences in February 2025.
The company will attend the BTIG 12th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference in Snowbird, Utah, where CEO Shawn O'Connor will conduct one-on-one meetings with institutional investors on February 11, 2025.
Additionally, SLP will participate in the Oppenheimer 35th Annual Healthcare Life Sciences Conference, held virtually on February 12, 2025. O'Connor will lead a fireside chat at 12:40 PM ET and host one-on-one investor meetings. The fireside chat will be available via webcast and accessible through the Simulations Plus website's Investors page, with replay options available post-event.
Simulations Plus (Nasdaq: SLP) has announced a strategic collaboration with the Enabling Technologies Consortium (ETC) to enhance its GastroPlus platform. The funded partnership aims to advance in vitro-in vivo correlation approaches for oral drug delivery by improving the GastroPlus advanced compartmental absorption and transit (ACAT™) model.
The collaboration will focus on developing immediate release oral drug products through enhanced predictive capabilities. Key developments include implementing novel product-particle size distribution methodologies and improved food effect modeling features. These advancements aim to improve drug product development, reduce animal studies, and streamline regulatory submissions.
Throughout the project, Simulations Plus will provide ETC members with beta versions for testing. The final enhanced software will be available to all users, with Simulations Plus retaining intellectual property rights from the partnership.
Simulations Plus (Nasdaq: SLP) announced that its technology and expertise supported the development of 100% of FDA-approved drugs in 2024. The company provides cheminformatics, biosimulation, and medical communications solutions to the biopharma industry.
The company's suite of solutions incorporates artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics/biopharmaceutics (PBPK/PBBM), quantitative systems pharmacology/toxicology (QSP/QST), and population PK/PD modeling approaches. These technologies, combined with adaptive learning and medical communications tools, help accelerate drug development processes and support critical advancements in global healthcare.
Simulations Plus (Nasdaq: SLP) announced its significant impact on pharmaceutical development, revealing that its technology supported the majority of FDA-approved drugs in 2024. The company's comprehensive suite of solutions includes artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics/biopharmaceutics (PBPK/PBBM), and quantitative systems pharmacology/toxicology (QSP/QST) modeling approaches.
CEO Shawn O'Connor emphasized the company's 25-year track record in providing mission-critical software and services for therapy development. SLP's offerings encompass drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization support, demonstrating their integral role in advancing global healthcare solutions.
Simulations Plus (Nasdaq: SLP) reported strong Q1 fiscal 2025 results with total revenue increasing 31% year-over-year to $18.9 million. The growth was primarily driven by software revenue, which rose 41% to $10.7 million (57% of total revenue), while services revenue grew 19% to $8.2 million (43% of total revenue).
Key financial metrics include gross profit of $10.2 million (54% margin), net income of $0.2 million, and diluted EPS of $0.01, compared to $1.9 million and $0.10 in Q1 2024. Adjusted EBITDA reached $4.5 million (24% of revenue). The MonolixSuite™ platform showed strong performance with 43% growth, and the QSP business unit grew 40%. The company maintained its fiscal 2025 guidance of $90-93M in revenue (28-33% growth) with adjusted EBITDA margin of 31-33%.
Simulations Plus (Nasdaq: SLP), a provider of biosimulation and medical communications solutions for the biopharma industry, has scheduled its first quarter fiscal 2025 earnings release and conference call for Tuesday, January 7, 2025. The financial results will be announced after market close, followed by a management-hosted conference call at 5:00 p.m. Eastern Time.
Investors and shareholders can join the live webcast through registration or dial in using 1-877-451-6152 (domestic) or 1-201-389-0879 (international). A replay will be available on the company's investor relations website approximately one hour after the call.
Simulations Plus (Nasdaq: SLP), a leading biosimulation and medical communications solutions provider, announces its participation in the upcoming BTIG Digital Health Forum on November 25, 2024. CEO Shawn O'Connor will join a panel discussion on 'Supporting Drug Development, Clinical Trials, and Biopharma' at 2:00 p.m. Eastern Time and conduct one-on-one meetings throughout the day. Interested participants must pre-register through the BTIG website to attend the virtual event.
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