Aankondiging • Apr 24
Simulations Plus, Inc. Announces Collaboration with Lonza Group Ag and U.S. Food and Drug Administration to Advance Predictive Frameworks for Complex Oral Drug Products Simulations Plus, Inc. had announced a funded research collaboration with Lonza Group AG and the U.S. Food and Drug Administration to develop and validate a mechanistic, predictive framework for assessing the in vivo performance of amorphous solid dispersion drug products. Mechanistic modeling approach and experimental integration designed to improve early risk identification, strengthen regulatory confidence, and expand AI-enabled workflows connecting data to decision-making. The collaboration evaluates whether advanced in vitro dissolution systems—particularly those incorporating dynamic gastrointestinal physiology—combined with mechanistic physiologically based biopharmaceutics modeling, can reliably predict key in vivo outcomes, including food effects and the impact of elevated gastric pH conditions. By establishing and validating these predictive capabilities, the collaboration aims to provide a scientific foundation for reducing reliance on certain clinical bioequivalence studies while maintaining the rigor and transparency required by regulators. Lonza will lead experimental work, including in vitro dissolution testing under fasted, fed, and elevated gastric pH conditions using advanced systems such as Controlled Transfer Dissolution, as well as the characterization and, where needed, manufacturing of amorphous solid dispersion formulation variants. Simulations Plus will lead the development and validation of in vitro–in vivo extrapolation frameworks using its DDDPlus® and GastroPlus® platforms, translating experimental data into predictions of in vivo pharmacokinetics and supporting virtual bioequivalence assessments. At the same time, it creates new opportunities to extend these capabilities into grounded AI-enabled workflow environments, where data, mechanistic models, and simulation outputs will be more directly connected. The Company will also contribute to interpretation within a regulatory context, ensuring alignment with evolving expectations for model-informed drug development. This work is supported in part through FDA funding and includes ongoing engagement with FDA scientists to directly align with regulatory priorities to advance model-informed drug development, modernize bioequivalence assessment for complex products, and reduce unnecessary reliance on human studies. By combining regulatory collaboration with open, non-proprietary data and validated methods based on real-world, FDA-approved amorphous solid dispersion products, the initiative is intended to inform future regulatory approaches and support broader adoption of science-based alternatives. Aankondiging • Apr 21
Simulations Plus Inc Announces Completion of 2026 Spring School Global Training Initiative Simulations Plus, Inc. announced the successful completion of its 2026 Spring School, a global training initiative designed to expand access to model-informed drug development (MIDD) and strengthen the scientific foundation of the industry’s future workforce. More than 1,400 scientists from industry, academia, and regulatory agencies from over 65 countries participated in the week-long program, reflecting the high demand for expert-led training as modeling and simulation increasingly become standard for drug development strategy, regulatory engagement, and clinical execution. Held from March 23 to 27, 2026, the Spring School program offered two tracks: GastroPlus Spring School: From PBPK Basics to Biopharmaceutics Applications, and MonolixSuite Spring School: High-Impact Pharmacometrics Case Studies. Both tracks included interactive lectures, hands-on exercises, and live Q&A sessions led by Simulations Plus experts. Simulations Plus has a long-standing commitment to education. In addition to its Spring School, the Company has previously offered Summer and Autumn Schools focused on PK/PD modeling. The most recent Autumn School was the first program to offer a second track focused on PBPK modeling. In addition to these programs, Simulations Plus is widely known for its University+ program, which provides free academic access to modeling and simulation software for thousands of students and educators worldwide. Together, these initiatives form a cornerstone of the Company’s global educational outreach—helping expand the adoption of model-informed approaches and strengthening the pipeline of scientists equipped to apply these methods across the drug development lifecycle. Reported Earnings • Apr 10
Second quarter 2026 earnings: EPS and revenues exceed analyst expectations Second quarter 2026 results: EPS: US$0.23 (up from US$0.15 in 2Q 2025). Revenue: US$24.3m (up 8.3% from 2Q 2025). Net income: US$4.54m (up 48% from 2Q 2025). Profit margin: 19% (up from 14% in 2Q 2025). Revenue exceeded analyst estimates by 12%. Earnings per share (EPS) also surpassed analyst estimates by 11%. Revenue is forecast to grow 5.1% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Healthcare Services industry in the US. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 79 percentage points per year, which is a significant difference in performance. Aankondiging • Mar 27
Simulations Plus, Inc. to Report Q2, 2026 Results on Apr 09, 2026 Simulations Plus, Inc. announced that they will report Q2, 2026 results After-Market on Apr 09, 2026 Buy Or Sell Opportunity • Jan 30
Now 24% undervalued after recent price drop Over the last 90 days, the stock has fallen 1.8% to US$16.87. The fair value is estimated to be US$22.06, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 15% over the last 3 years. Meanwhile, the company became loss making. Price Target Changed • Jan 22
Price target increased by 10% to US$24.67 Up from US$22.33, the current price target is an average from 3 analysts. New target price is 19% above last closing price of US$20.74. Stock is down 38% over the past year. The company is forecast to post earnings per share of US$0.54 next year compared to a net loss per share of US$3.22 last year. Reported Earnings • Jan 09
First quarter 2026 earnings: Revenues exceed analysts expectations while EPS lags behind First quarter 2026 results: EPS: US$0.034 (up from US$0.01 in 1Q 2025). Revenue: US$18.4m (down 2.7% from 1Q 2025). Net income: US$676.0k (up 228% from 1Q 2025). Profit margin: 3.7% (up from 1.1% in 1Q 2025). Revenue exceeded analyst estimates by 2.0%. Earnings per share (EPS) missed analyst estimates by 63%. Revenue is forecast to grow 9.1% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Healthcare Services industry in the US. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 90 percentage points per year, which is a significant difference in performance. Aankondiging • Jan 09
Simulations Plus, Inc. Reaffirms Earnings Guidance for Fiscal 2026 Simulations Plus, Inc. reaffirmed earnings guidance for Fiscal 2026. For the period, the company expects Revenue to be in the range of $79 Million to $82 Million. Aankondiging • Dec 30
Simulations Plus, Inc., Annual General Meeting, Feb 12, 2026 Simulations Plus, Inc., Annual General Meeting, Feb 12, 2026. Aankondiging • Dec 17
Simulations Plus, Inc. to Report Q1, 2026 Results on Jan 08, 2026 Simulations Plus, Inc. announced that they will report Q1, 2026 results After-Market on Jan 08, 2026 Reported Earnings • Dec 03
Full year 2025 earnings: EPS misses analyst expectations Full year 2025 results: US$3.22 loss per share (down from US$0.50 profit in FY 2024). Revenue: US$79.2m (up 13% from FY 2024). Net loss: US$64.7m (down US$74.7m from profit in FY 2024). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 1.1%. Revenue is forecast to grow 8.6% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Healthcare Services industry in the US. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 82 percentage points per year, which is a significant difference in performance. Aankondiging • Dec 02
Simulations Plus, Inc. Reaffirms Revenue Guidance for Fiscal 2026 Simulations Plus, Inc. reaffirmed revenue guidance for fiscal 2026. For the year, the company expects revenue of $79 million to $82 million. Recent Insider Transactions Derivative • Oct 02
Director notifies of intention to sell stock Walter Woltosz intends to sell 20k shares in the next 90 days after lodging an Intent To Sell Form on the 1st of October. If the sale is conducted around the recent share price of US$15.07, it would amount to US$301k. Since December 2024, Walter's direct individual holding has decreased from 3.44m shares to 3.31m. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Aankondiging • Jul 29
Simulations Plus, Inc. and Institute of Medical Biology of the Polish Academy of Sciences Partnership Announces Results in Validation of ADMET Predictor Models with Enhanced AI Drug Design Simulations Plus, Inc. announced that experimental results of its artificial intelligence-driven drug design (AIDD) collaboration with the Institute of Medical Biology of the Polish Academy of Sciences (IMB PAS) have been published in the American Chemical Society (ACS) Medical Chemical Letters. Simulations Plus and IMB PAS launched their collaboration in 2023 to use the AIDD module in ADMET Predictor®? to design novel RORg/RORgT ligands, molecules that impact gene expression related to inflammation and immune responses. Within three months, the two teams had developed models to predict RORg/RORg T ligand potency, designed potential ligands simultaneously optimized for potency, in vivo absorption, synthesizability, and ADMET risk, synthesized compounds, and completed initial in vitro potency and toxicity testing. The recently published results show that the vast majority of compounds tested had strong potency for the target that was close to or better than the values predicted by ADMET Predictor. Reported Earnings • Jul 15
Third quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind Third quarter 2025 results: US$3.35 loss per share (down from US$0.16 profit in 3Q 2024). Revenue: US$20.4m (up 9.8% from 3Q 2024). Net loss: US$67.3m (down US$70.5m from profit in 3Q 2024). Revenue exceeded analyst estimates by 4.0%. Earnings per share (EPS) missed analyst estimates. Revenue is forecast to grow 8.3% p.a. on average during the next 3 years, compared to a 9.8% growth forecast for the Healthcare Services industry in the US. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 35 percentage points per year, which is a significant difference in performance. Aankondiging • Jul 15
Simulations Plus, Inc. Updates Earnings Guidance for the Fiscal Year 2025 Simulations Plus, Inc. updated earnings guidance for the fiscal year 2025. For the year, the company expects revenue to be between $76 million to $80 million. Revenue growth to be between 9% to 14%. Major Estimate Revision • Jul 08
Consensus EPS estimates fall by 16% The consensus outlook for earnings per share (EPS) in fiscal year 2025 has deteriorated. 2025 revenue forecast decreased from US$81.7m to US$79.9m. EPS estimate also fell from US$0.363 per share to US$0.307 per share. Net income forecast to grow 39% next year vs 25% growth forecast for Healthcare Services industry in the US. Consensus price target down from US$36.25 to US$32.25. Share price fell 4.4% to US$17.51 over the past week. Recent Insider Transactions Derivative • Jul 02
Director notifies of intention to sell stock Walter Woltosz intends to sell 60k shares in the next 90 days after lodging an Intent To Sell Form on the 1st of July. If the sale is conducted around the recent share price of US$17.45, it would amount to US$1.0m. Since September 2024, Walter's direct individual holding has decreased from 3.50m shares to 3.32m. There has only been one transaction (US$22k purchase) from insiders over the last 12 months. Valuation Update With 7 Day Price Move • Jun 17
Investor sentiment deteriorates as stock falls 33% After last week's 33% share price decline to US$18.32, the stock trades at a forward P/E ratio of 35x. Average trailing P/E is 56x in the Healthcare Services industry in the US. Total loss to shareholders of 58% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at US$30.51 per share. Major Estimate Revision • Jun 13
Consensus EPS estimates fall by 20% The consensus outlook for earnings per share (EPS) in fiscal year 2025 has deteriorated. 2025 revenue forecast decreased from US$90.3m to US$85.8m. EPS estimate also fell from US$0.555 per share to US$0.443 per share. Net income forecast to grow 73% next year vs 25% growth forecast for Healthcare Services industry in the US. Consensus price target down from US$42.00 to US$36.25. Share price fell 31% to US$19.07 over the past week. New Risk • Jun 12
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Profit margins are more than 30% lower than last year (9.2% net profit margin). Buy Or Sell Opportunity • Jun 12
Now 34% undervalued after recent price drop Over the last 90 days, the stock has fallen 23% to US$20.05. The fair value is estimated to be US$30.41, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 15% over the last 3 years. Earnings per share has declined by 12%. Revenue is forecast to grow by 24% in 2 years. Earnings are forecast to grow by 120% in the next 2 years. Aankondiging • Jun 05
Simulations Plus, Inc. Releases ADMET Predictor 13 Simulations Plus, Inc. announced the release of ADMET Predictor 13, its machine learning (ML) modeling platform for the design, optimization, and selection of new molecules during various stages of drug discovery. ADMET Predictor 13 features advancements in three main areas: First-to-invent advantage: clients can harness enhanced high-throughput PBPK (HT-PBPK) simulations--powered by GastroPlus®?--combined with the upgraded AI-driven drug design (AIDD) engine to enable faster, smarter decision-making at the intersection of chemistry and pharmacokinetics. Elevated predictive power: ADMET Predictor 13 offers an expanded suite of next-gen ADMET models, built with updated AI science and premium datasets, which boost accuracy across key endpoints and reinforce scientific rigor and validation. Enterprise-ready automation: with extended APIs, Python scripting support, and IT-friendly deployment capabilities, ADMET Predictor 13 delivers the automation and scalability required by today's data-centric R&D teams. Valuation Update With 7 Day Price Move • Jun 02
Investor sentiment deteriorates as stock falls 20% After last week's 20% share price decline to US$26.37, the stock trades at a forward P/E ratio of 41x. Average trailing P/E is 56x in the Healthcare Services industry in the US. Total loss to shareholders of 46% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at US$40.28 per share. Buy Or Sell Opportunity • May 21
Now 21% undervalued The stock has been flat over the last 90 days, currently trading at US$31.70. The fair value is estimated to be US$40.00, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 15% over the last 3 years. Earnings per share has declined by 12%. Revenue is forecast to grow by 36% in 2 years. Earnings are forecast to grow by 137% in the next 2 years. Aankondiging • May 15
Simulations Plus, Inc. Releases DILIsym 11 Simulations Plus, Inc. announced the release of DILIsym 11, the latest version of its quantitative systems toxicology (QST) platform. DILIsym is a software platform designed to predict potential DILI hazards and provide insight into the mechanisms responsible for observed DILI responses. It is the most widely used QST modeling software for DILI prediction and is utilized as a source of QST modeling-based data assessed by the U.S. Food and Drug Administration's (FDA) DILIsym team. DILIsym 11 offers new pediatric representation for exploratory predictions regarding liver safety to children, and a new T-cell model that allows for better understanding of putative contributions of CD8+ T-cell mediated hepatocellular injury. It also includes improved representation of bile acid and cholestatic liver injury, updated antioxidant adaptation mechanisms, and more. Buy Or Sell Opportunity • May 06
Now 28% undervalued after recent price drop Over the last 90 days, the stock has fallen 20% to US$29.01. The fair value is estimated to be US$40.17, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 15% over the last 3 years. Earnings per share has declined by 12%. Revenue is forecast to grow by 36% in 2 years. Earnings are forecast to grow by 137% in the next 2 years. Price Target Changed • Apr 25
Price target increased by 9.4% to US$46.60 Up from US$42.60, the current price target is an average from 5 analysts. New target price is 31% above last closing price of US$35.50. Stock is down 21% over the past year. The company is forecast to post earnings per share of US$0.56 for next year compared to US$0.50 last year. Aankondiging • Apr 21
Simulations Plus, Inc. Supports New FDA Roadmap for Reducing Animal Testing in Preclinical Safety Studies Simulations Plus, Inc. announced its support of the U.S. Food and Drug Administration's (FDA) recently announced roadmap for reducing animal testing through the use of new approach methodologies (NAMs). Simulations Plus has long provided the software and consulting service expertise to successfully implement the FDA roadmap. The new FDA roadmap outlines a path to incorporate methodologies such as organ-on-a-chip, advanced in vitro assays, and computational modeling in preclinical safety studies, with an initial focus on monoclonal antibody (mAb) testing. Simulations Plus software platforms are utilized by mAb-focused researchers for key decision-making, including: GastroPlus accelerates the assessment of dosing and delivery strategies needed to achieve desired clinical endpoints, enabling researchers to reduce--and in some cases, eliminate--animal testing during non-clinical development. In addition, Simulations Plus' software and consulting services are regularly relied upon by researchers to predict efficacy and safety of compounds and prioritize top drug candidates for further development--contributing to a reduction in animal testing and more focused clinical trials. Simulations Plus' PBPK services team delivers high-value scientific expertise to help clients replace or reduce animal testing by developing and validating predictive PBPK models that integrate standard in vitro and in silico data to simulate human and animal pharmacometrics. Many organizations will need more than new modeling tools and in vitro systems. To follow the FDA roadmap, companies not currently incorporating NAMs into their development processes and timelines may also require consulting services, regulatory guidance and training on new tools. Reported Earnings • Apr 04
Second quarter 2025 earnings: EPS and revenues exceed analyst expectations Second quarter 2025 results: EPS: US$0.15 (down from US$0.20 in 2Q 2024). Revenue: US$22.4m (up 23% from 2Q 2024). Net income: US$3.07m (down 24% from 2Q 2024). Profit margin: 14% (down from 22% in 2Q 2024). The decrease in margin was driven by higher expenses. Revenue exceeded analyst estimates by 2.3%. Earnings per share (EPS) also surpassed analyst estimates by 22%. Revenue is forecast to grow 14% p.a. on average during the next 3 years, compared to a 10.0% growth forecast for the Healthcare Services industry in the US. Over the last 3 years on average, earnings per share has fallen by 12% per year but the company’s share price has fallen by 19% per year, which means it is performing significantly worse than earnings. Aankondiging • Apr 04
Simulations Plus, Inc. Provides Earnings Guidance for the Year 2025 Simulations Plus, Inc. provided earnings guidance for the year 2025. For the year, the company expects revenue of $90 million to $93 million. Revenue growth of 28% to 33%. Aankondiging • Mar 20
Simulations Plus, Inc. to Report Q2, 2025 Results on Apr 03, 2025 Simulations Plus, Inc. announced that they will report Q2, 2025 results After-Market on Apr 03, 2025 Valuation Update With 7 Day Price Move • Feb 25
Investor sentiment deteriorates as stock falls 15% After last week's 15% share price decline to US$30.50, the stock trades at a forward P/E ratio of 59x. Average trailing P/E is 61x in the Healthcare Services industry in North America. Total loss to shareholders of 23% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at US$41.85 per share. Buy Or Sell Opportunity • Feb 06
Now 21% undervalued Over the last 90 days, the stock has risen 16% to US$35.58. The fair value is estimated to be US$44.98, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 14% over the last 3 years. Earnings per share has declined by 7.1%. Revenue is forecast to grow by 41% in 2 years. Earnings are forecast to grow by 102% in the next 2 years. Major Estimate Revision • Jan 15
Consensus EPS estimates fall by 38% The consensus outlook for fiscal year 2025 has been updated. 2025 EPS estimate fell from US$0.763 to US$0.475 per share. Revenue forecast steady at US$90.4m. Net income forecast to grow 38% next year vs 19% growth forecast for Healthcare Services industry in the US. Consensus price target of US$49.00 unchanged from last update. Share price was steady at US$28.76 over the past week. Reported Earnings • Jan 08
First quarter 2025 earnings: EPS misses analyst expectations First quarter 2025 results: EPS: US$0.01 (down from US$0.098 in 1Q 2024). Revenue: US$18.9m (up 31% from 1Q 2024). Net income: US$206.0k (down 89% from 1Q 2024). Profit margin: 1.1% (down from 13% in 1Q 2024). The decrease in margin was driven by higher expenses. Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 86%. Revenue is forecast to grow 14% p.a. on average during the next 3 years, compared to a 9.4% growth forecast for the Healthcare Services industry in the US. Over the last 3 years on average, earnings per share has fallen by 7% per year but the company’s share price has fallen by 16% per year, which means it is performing significantly worse than earnings. Aankondiging • Jan 08
Simulations Plus, Inc. Provides Earnings Guidance for the Fiscal 2025 Simulations Plus, Inc. provided earnings guidance for the fiscal 2025. For the period, the company expects Revenue to be in the range of $90 million to $93 million. Board Change • Jan 02
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Sharlene Evans was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Aankondiging • Dec 24
Simulations Plus, Inc., Annual General Meeting, Feb 13, 2025 Simulations Plus, Inc., Annual General Meeting, Feb 13, 2025. Aankondiging • Dec 20
Simulations Plus, Inc. to Report Q1, 2025 Results on Jan 07, 2025 Simulations Plus, Inc. announced that they will report Q1, 2025 results After-Market on Jan 07, 2025 Valuation Update With 7 Day Price Move • Nov 25
Investor sentiment improves as stock rises 16% After last week's 16% share price gain to US$32.74, the stock trades at a forward P/E ratio of 43x. Average trailing P/E is 57x in the Healthcare Services industry in North America. Total loss to shareholders of 30% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at US$47.71 per share. Aankondiging • Nov 13
Simulations Plus, Inc. and University of Connecticut Receive New FDA Grant to Expand Mechanistic Modeling Approaches for Long-Acting Injectables Simulations Plus, Inc. announced that it has been awarded a newly funded grant from the U.S. Food and Drug Administration (FDA) to use physiologically based pharmacokinetic (PBPK) approaches in GastroPlus to build and validate mechanistic in vitro-in vivo correlations (IVIVCs) for long-acting injectable (LAI) technologies through a joint proposal with the University of Connecticut’s School of Pharmacy, Department of Pharmaceutical Sciences. This project aims to use the GastroPlus PBPK platform to investigate the intricate relationship between LAI formulation critical quality attributes (CQAs) and physiological factors at the injection site to accurately predict in vivo drug release and absorption. Dr. Diane Burgess, Board of Trustees Distinguished Professor of Pharmaceutics and Pfizer Distinguished Endowed Chair of Pharmaceutical Technology at the University of Connecticut and her lab will generate in vitro and in vivo data for marketed LAI suspension products using novel discriminatory systems. The scientific team at Simulations Plus will use this data, along with additional inputs from research collaborators, to develop PBPK models and apply them to validate mechanistic IVIVCs. This effort is expected to lay the groundwork for a practical alternative to in vivo studies in establishing bioequivalence (BE) for additional LAI product technologies. FDA scientific and program staff will actively collaborate with the University of Connecticut, Simulations Plus, and select industry partners. Dr. Silva Ryan, with assistance from scientists at Simulations Plus, will coordinate the contract’s modeling and simulation activities. Funding for this collaboration is made possible by the FDA through grant award 1U01FD008304-01. Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organizations imply endorsement by the United States Government. Valuation Update With 7 Day Price Move • Oct 30
Investor sentiment deteriorates as stock falls 16% After last week's 16% share price decline to US$28.68, the stock trades at a forward P/E ratio of 45x. Average trailing P/E is 49x in the Healthcare Services industry in the US. Total loss to shareholders of 45% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at US$47.73 per share. Price Target Changed • Oct 27
Price target decreased by 7.5% to US$52.75 Down from US$57.00, the current price target is an average from 4 analysts. New target price is 72% above last closing price of US$30.68. Stock is down 9.7% over the past year. The company is forecast to post earnings per share of US$0.64 for next year compared to US$0.50 last year. Reported Earnings • Oct 24
Full year 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2024 results: EPS: US$0.50. Revenue: US$70.0m (up 18% from FY 2023). Net income: US$9.95m (flat on FY 2023). Profit margin: 14% (down from 17% in FY 2023). The decrease in margin was driven by higher expenses. Revenue missed analyst estimates by 1.5%. Earnings per share (EPS) exceeded analyst estimates by 4.3%. Revenue is forecast to grow 15% p.a. on average during the next 3 years, compared to a 9.7% growth forecast for the Healthcare Services industry in the US. Aankondiging • Oct 24
Simulations Plus, Inc. Provides Earnings Guidance for Fiscal Year 2025 Simulations Plus, Inc. provided earnings guidance for Fiscal year 2025. For the period, the company expects Revenue to be in the range of $90 million to $93 million. Aankondiging • Oct 10
Simulations Plus, Inc. to Report Q4, 2024 Results on Oct 23, 2024 Simulations Plus, Inc. announced that they will report Q4, 2024 results After-Market on Oct 23, 2024 Aankondiging • Oct 08
Simulations Plus and the University of Southern California Secure NIH Grant to Develop New AI Drug Discovery Offerings Simulations Plus, Inc. announced the award of a new research grant from the National Institutes of Health (NIH), secured in partnership with the University of Southern California (USC) Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences. The grant will be used to evaluate novel computational methods that account for water-ligand interactions in drug discovery and that integrate with the Artificial Intelligence-driven Drug Design (AIDD) module in ADMET Predictor to offer a first-of-its-kind ligand-based virtual screening (LBVS) solution for pharmaceutical companies. For this award, Dr. Ian Haworth, Associate Professor and Vice Chair of Pharmacology and Pharmaceutical Sciences at the USC Mann School, and his lab will apply their previously developed algorithm (WATGEN) for the prediction of water positions in the unbound protein and protein-ligand complex. With support from the data scientists and software engineers at Simulations Plus, they will apply machine learning (ML) approaches to predict the pharmacophore features that will be used in ADMET Predictor’s proprietary 3D shape and feature matching algorithm. The team at Simulations Plus will productize the updated methods into the ADMET Predictor platform and validate it by designing drugs against defined targets using the AIDD module. Selected compounds will be synthesized and tested experimentally to highlight the technology’s applications. Aankondiging • Aug 23
Simulations Plus, Inc. Announces Executive Changes, Effective August 30, 2024 Simulations Plus, Inc. announced the optimization of its business unit and leadership structure to support future growth following the company’s recent acquisitions. These actions will be effective August 30, 2024. The company announced the following leadership promotions and transitions: Steven Changwill be promoted to President, Quantitative Systems Pharmacology. Mr. Chang joined Simulations Plus in June 2023 with the acquisition of Immunetrics and served as its President and Chief Executive Officer since 2002. He is a successful technology entrepreneur with more than three decades of experience in identifying emerging market needs and combining state-of-the-art technologies and resources to meet those needs. Jenna Rousewill be promoted to President of the newly formed Adaptive Learning & Insights business unit. Ms. Rouse joined Simulations Plus with the acquisition of Pro-ficiency where, as Chief Markets Officer, Clinical, she spent five years driving the growth and engagement with the organization’s simulation-enabled training solutions for clinical trial optimization, competency development, and continuing medical education. Prior to joining Pro-ficiency, she spent 25 years in workforce development in regulated industries, with over 15 years dedicated to professional development and adult learning in clinical trials. Murry Alper will be promoted to President of the newly formed Medical Communications business unit. Mr. Alper joined Simulations Plus with the acquisition of Pro-ficiency. Mr. Alper brings almost 30 years of experience in the life sciences industry, with experience at both major developers, as well as on the agency side. Mr. Alper founded Caravel Group in 2006 after a decade in marketing and sales roles at Bristol-Myers Squibb and Genentech. He has co-founded multiple medical communications agencies and was Managing Partner of Compass Group Partners upon its purchase by Pro-ficiency in June of 2023. Sandra Suarez-Sharp, Ph.D., will transition to President, Regulatory Strategies Center of Excellence. Dr. Suarez-Sharp joined Simulations Plus in 2020 and has been instrumental in facilitating the Company’s regulatory support to clients. Prior to joining Simulations Plus, Dr. Suarez-Sharp had a long and successful career at the Food and Drug Administration, including roles in biopharmaceutics, bioequivalence, and clinical pharmacology. In her new role, she is responsible for expanding the Regulatory Strategies Center of Excellence to accelerate cross-selling opportunities driven by the rapidly growing demand for biosimulation solutions. The company also announced the following departures: Brett Howell, Ph.D., President, Quantitative Systems Pharmacology and Michael Raymer, President, Clinical Simulations & Medical Communications will be leaving Simulations Plus after assisting with the transition process. Buy Or Sell Opportunity • Aug 02
Now 21% undervalued after recent price drop Over the last 90 days, the stock has fallen 17% to US$38.60. The fair value is estimated to be US$49.11, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 12% over the last 3 years. Earnings per share has declined by 3.6%. Revenue is forecast to grow by 53% in 2 years. Earnings are forecast to grow by 51% in the next 2 years. Aankondiging • Aug 02
Simulations Plus, Inc. Releases the latest version of its quantitative systems toxicology (QST) platform, DILIsym version X Simulations Plus, Inc. has released the latest version of its quantitative systems toxicology (QST) platform, DILIsym version X. Branded as DSX™?, the software is designed to support key drug development decisions by predicting potential drug-induced liver injury (DILI) risks. These predictions can guide go/no-go decisions, or the need to modify doses, which are vital to avoiding costly failed clinical trials. DSX offers a completely redesigned interface, tested by clients and consultants, that includes both command line and graphical interface options as well as a licensing option that enables scale-up on local or cloud cluster configurations. Four new exemplar compounds are included in this version of the software, as well as two new simulation populations that include variability in susceptibility to liver injury and biomarker-related parameters (ALT and bilirubin). Upcoming Dividend • Jul 22
Upcoming dividend of US$0.06 per share Eligible shareholders must have bought the stock before 29 July 2024. Payment date: 05 August 2024. The company last paid an ordinary dividend in November 2013. The average dividend yield among industry peers is 1.1%. Major Estimate Revision • Jul 09
Consensus EPS estimates fall by 14% The consensus outlook for fiscal year 2024 has been updated. 2024 EPS estimate fell from US$0.547 to US$0.47 per share. Revenue forecast steady at US$71.2m. Net income forecast to grow 28% next year vs 25% growth forecast for Healthcare Services industry in the US. Consensus price target of US$60.33 unchanged from last update. Share price fell 16% to US$39.57 over the past week. Declared Dividend • Jul 05
Third quarter dividend of US$0.06 announced Shareholders will receive a dividend of US$0.06. Ex-date: 29th July 2024 Payment date: 5th August 2024 Dividend yield will be 0.6%, which is lower than the industry average of 0.9%. Reported Earnings • Jul 05
Third quarter 2024 earnings: EPS in line with analyst expectations despite revenue beat Third quarter 2024 results: EPS: US$0.16 (down from US$0.20 in 3Q 2023). Revenue: US$18.5m (up 14% from 3Q 2023). Net income: US$3.14m (down 22% from 3Q 2023). Profit margin: 17% (down from 25% in 3Q 2023). Revenue is forecast to grow 19% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Healthcare Services industry in the US. Over the last 3 years on average, earnings per share has fallen by 4% per year whereas the company’s share price has fallen by 9% per year. Buy Or Sell Opportunity • Jul 01
Now 12% overvalued after recent price rise Over the last 90 days, the stock has risen 20% to US$46.18. The fair value is estimated to be US$41.15, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 12% over the last 3 years. Earnings per share has declined by 2.8%. Revenue is forecast to grow by 53% in 2 years. Earnings are forecast to grow by 69% in the next 2 years. Buy Or Sell Opportunity • Jun 21
Now 21% overvalued after recent price rise Over the last 90 days, the stock has risen 12% to US$48.15. The fair value is estimated to be US$39.87, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 12% over the last 3 years. Earnings per share has declined by 2.8%. Revenue is forecast to grow by 52% in 2 years. Earnings are forecast to grow by 69% in the next 2 years. Aankondiging • Jun 19
Simulations Plus, Inc. to Report Q3, 2024 Results on Jul 02, 2024 Simulations Plus, Inc. announced that they will report Q3, 2024 results After-Market on Jul 02, 2024 Major Estimate Revision • Jun 18
Consensus EPS estimates fall by 17%, revenue upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$68.1m to US$70.8m. EPS estimate fell from US$0.657 to US$0.547 per share. Net income forecast to grow 29% next year vs 25% growth forecast for Healthcare Services industry in the US. Consensus price target up from US$55.33 to US$60.33. Share price rose 2.5% to US$47.21 over the past week. Price Target Changed • Jun 13
Price target increased by 12% to US$60.33 Up from US$53.67, the current price target is an average from 3 analysts. New target price is 24% above last closing price of US$48.62. Stock is up 3.4% over the past year. The company is forecast to post earnings per share of US$0.59 for next year compared to US$0.50 last year. Aankondiging • Jun 13
Simulations Plus, Inc. (NasdaqGS:SLP) acquired Pro-ficiency, LLC from NovaQuest Capital Management, L.L.C., QHP Capital, L.P. and Pro-ficiency’s minority shareholders for approximately $100 million. Simulations Plus, Inc. (NasdaqGS:SLP) acquired Pro-ficiency, LLC from NovaQuest Capital Management, L.L.C., QHP Capital, L.P. and Pro-ficiency’s minority shareholders for approximately $100 million on June 12, 2024. The transaction is expected to be accretive to fiscal 2025 EPS. The transaction is being funded from existing cash and investment resources. With approximately $119 million in cash and investments available, this acquisition allows Simulations to utilize the capital from August 2020 follow-on public offering. Procopio acted as legal counsel for Simulations Plus and Wyrick Robbins acted as legal counsel for Pro-ficiency and the sellers of Pro-ficiency.
Simulations Plus, Inc. (NasdaqGS:SLP) completed the acquisition of Pro-ficiency, LLC from NovaQuest Capital Management, L.L.C., QHP Capital, L.P. and Pro-ficiency’s minority shareholders on June 12, 2024. Aankondiging • May 16
Simulations Plus Releases GastroPlus® X, The Next Generation PBPK/PBBM Modeling & Simulation Software Simulations Plus, Inc. announced the release of GastroPlus® X. Branded as GPX™, this new platform represents the next generation of physiologically based pharmacokinetics/biopharmaceutics (PBPK/PBBM) modeling and simulation software. Utilizing proven top-rated science, advanced models, refined algorithms and integrated machine learning (ML) technology, GPX offers an entirely updated user experience with an intuitive interface, streamlined workflows, and faster processing. GPX is designed to be a comprehensive PBPK/PBBM modeling and simulation platform, allowing users to handle everything from early discovery high-throughput PK simulations and drug-drug interactions (DDIs) to population predictions and more all in the same place. Utilization of a single PBPK/PBBM platform, with reusable assets and templates, reduces the time spent on tedious tasks like model setup, importing and exporting data, and reformatting plotted modeling results. GPX offers flexible deployment options, allowing for both local installation and seamless integration with cloud environments, providing users with the freedom to choose the best setup for their needs. Recent Insider Transactions Derivative • May 09
lead Independent Director notifies of intention to sell stock Daniel Weiner intends to sell 3k shares in the next 90 days after lodging an Intent To Sell Form on the 7th of May. If the sale is conducted around the recent share price of US$48.21, it would amount to US$157k. Since September 2023, Daniel's direct individual holding has increased from 7.70k shares to 10.01k. Company insiders have collectively sold US$297k more than they bought, via options and on-market transactions in the last 12 months. Upcoming Dividend • Apr 22
Upcoming dividend of US$0.06 per share Eligible shareholders must have bought the stock before 26 April 2024. Payment date: 06 May 2024. Payout ratio is a comfortable 46% and this is well supported by cash flows. Trailing yield: 0.5%. Lower than top quartile of American dividend payers (4.8%). Lower than average of industry peers (1.1%). Declared Dividend • Apr 07
Second quarter dividend of US$0.06 announced Dividend of US$0.06 is the same as last year. Ex-date: 26th April 2024 Payment date: 6th May 2024 Dividend yield will be 0.5%, which is lower than the industry average of 0.9%. Payout Ratios Payout ratio: 46%. Cash payout ratio: 38%. 
