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Simulations Plus, Inc. (SLP) is a global leader in biosimulation technology, providing innovative software and consulting services to optimize drug discovery, development, and regulatory processes. The company develops AI-powered biosimulation tools that model drug and disease behavior, and offers scientific consulting to enhance clinical trial design and regulatory submissions. SLP serves pharmaceutical and biotechnology companies, universities, and regulatory agencies worldwide.
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Software Segment - Develops biosimulation software that models drug and disease behavior, supporting drug discovery, preclinical and clinical development, and generic medicine development.
- GastroPlus® - Simulates drug absorption, distribution, metabolism, and excretion in humans and animals.
- MonolixSuite® - Provides tools for population modeling and pharmacokinetics/pharmacodynamics analysis.
- ADMET Predictor® - Predicts chemical properties and biological activity of molecules.
- Other Products - Includes additional software tools for specialized biosimulation needs.
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Services Segment - Offers scientific consulting services to guide drug recovery, clinical development, regulatory submissions, and clinical trial optimization.
| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
Daniel Szot Executive | Chief Revenue Officer (CRO) | Daniel Szot is the Chief Revenue Officer (CRO) at Simulations Plus (SLP) since January 2024, where he leads the sales and marketing teams. He brings over 25 years of strategic sales and go-to-market leadership experience, having held key roles at Dassault Systèmes (BIOVIA) and other leading companies. | ||
Jenna Rouse Executive | President of the Adaptive Learning & Insights business unit | Jenna Rouse is the President of the Adaptive Learning & Insights business unit at SLP since August 2024, having joined SLP in June 2024 as the Chief Markets Officer of a Clinical division. | ||
Jill Fiedler-Kelly Executive | President, Clinical Pharmacology & Pharmacometric Services | Adjunct Professor at University at Buffalo | Jill Fiedler-Kelly has been serving as the President, Clinical Pharmacology & Pharmacometric Services at SLP since 2021. She joined SLP in 2014 through the acquisition of Cognigen Corporation, where she previously held roles as Vice President of Pharmacometric Services and Chief Scientific Officer, and she brings over 30 years of experience in pharmacometrics. | |
John A. DiBella Executive | President, PBPK/Cheminformatics Solutions/Regulatory Services | John A. DiBella has been with Simulations Plus since 2003, serving in key executive roles including Vice President of Marketing and Sales and President of the Simulations Plus Division, and is currently the President, PBPK/Cheminformatics Solutions/Regulatory Services since October 2023. | ||
Jonathan Chauvin Executive | Business Unit President of Clinical Pharmacology & Pharmacometrics Software Solutions (CPP) | Jonathan Chauvin joined SLP in April 2020 as President of Lixoft and was later appointed Business Unit President of Clinical Pharmacology & Pharmacometrics Software Solutions, leveraging his strong background in engineering and applied mathematics, including significant contributions in patents and publications. | ||
Murry Alper Executive | President of the Medical Communications business unit | Murry Alper has nearly 30 years of experience in the life sciences industry, joining SLP in June 2024 as Chief Medical and Commercial Markets Officer before being promoted to President of the Medical Communications business unit in August 2024. | ||
Shawn O’Connor Executive | Chief Executive Officer | Shawn O’Connor is the Chief Executive Officer at Simulations Plus, Inc. since June 2018, bringing over 31 years of high technology executive experience. He previously served as CEO at Entelos Holding Corp. (2011-2018) and Pharsight Corporation (2002-2009), among other key executive roles. | View Report → | |
Steven Chang Executive | President, Quantitative Systems Pharmacology Solutions | Steven Chang is a seasoned technology entrepreneur with over three decades of experience and currently serves as President, Quantitative Systems Pharmacology Solutions at SLP, having joined in August 2024. Previously, he led Immunetrics as President and CEO until June 2023. | ||
Will Frederick Executive | Chief Financial Officer | Will Frederick is the CFO and COO at Simulations Plus since December 2020. He brings over 26 years of financial leadership experience from several reputable companies including Entelos Holding Corp and The Walt Disney Company. | ||
Dr. Daniel Weiner Board | Chairman of the Board | Independent Director of Simmunone, Inc. | Dr. Daniel Weiner has been deeply involved with SLP, joining as a director on May 1, 2017 and serving as Lead Independent Director from October 20, 2022 until December 17, 2024 before being appointed as Chairman of the Board on December 17, 2024. | |
Dr. John K. Paglia Board | Director | Independent Director and Audit Committee Chair at Aeluma, Inc.; Independent Director and Audit Committee Chair at Splash Beverage, Inc.; Independent Director at Impossible Kicks Inc.; Interim Chief Investment Officer at UNest, Inc. | Dr. John K. Paglia has served as a Director and Chair of the Audit Committee at SLP since December 3, 2014, and is recognized as an audit committee financial expert. He has extensive experience in finance and corporate governance, also serving in board and leadership roles at companies such as Aeluma, Inc.; Splash Beverage, Inc.; Impossible Kicks Inc.; and UNest, Inc.. | |
Dr. Lisa LaVange Board | Director | Dr. Lisa LaVange has served as a Director at SLP since May 1, 2019. With an extensive background in biostatistics and regulatory science, she has previously led initiatives at the FDA as Director of the Office of Biostatistics and held key academic roles at UNC. | ||
Dr. Walter S. Woltosz Board | Director | Independent Director at Vulcan Line Tools Corporation | Dr. Walter S. Woltosz is a cofounder and current Director at Simulations Plus. He previously served as CEO until June 26, 2018 and as Chairman of the Board from July 17, 1996 to December 17, 2024, and has extensive experience in aerospace and pharmaceutical industries. | |
Sharlene Evans Board | Director | Partner/People Leader for the Americas | Sharlene Evans has served as a Director at Simulations Plus since December 1, 2021. With over 27 years of experience in operations, human resources, and consulting roles at EFESO Management Consultants, Accenture, and Myrtle Consulting Group, she brings extensive expertise to her board responsibilities. |
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While Services revenue grew 19% this quarter, it declined by 9% on an organic basis, with PBPK down 9%, CPP down 6%, and QSP down 14% ( , ). What are the underlying reasons for these declines in your key Services segments, and what strategies are you implementing to reverse this trend and drive organic growth in your Services business?
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Total gross margin decreased to 54% from 62% in the prior year, with Software gross margin declining from 87% to 75% and Services gross margin from 36% to 26% ( ). Can you explain the factors contributing to this significant margin compression, and what measures are being taken to improve gross margins going forward?
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Despite an increase in backlog to $17.3 million, you cited a year-over-year decline in Services backlog due to a cost-driven pullback by clients during 2024 ( ). Given the ongoing cost constraints and limited funding environment ( ), how confident are you in converting your backlog into revenue, and what indicators give you assurance that client spending will improve?
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Adjusted EBITDA margin was 24% this quarter, below your fiscal 2025 guidance of 31% to 33% and your historical target of 35% to 40% ( , ). Given the current margins, what specific actions are you taking to achieve your adjusted EBITDA margin guidance, and how realistic is it to reach your historical margin targets in the near term?
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You reaffirmed your fiscal 2025 guidance, expecting ALI and MC to contribute $15 million to $18 million in revenue ( , ). Considering these units contributed $3.7 million this quarter, annualizing to the low end of your guidance ( , ), do you anticipate a significant ramp in these businesses to meet your targets, and what risks might impact achieving the projected contributions from these acquisitions?
Competitors mentioned in the company's latest 10K filing.
| Company | Description |
|---|---|
Optibrium | The company competes with established entities providing screening, testing, and research services, as well as software companies whose products are closely related but not directly competitive. Some competitors have larger financial, personnel, research, and marketing resources. |
The company faces competition from other software suppliers, scientific consulting service providers, and contract research organizations, as well as in-house development teams at larger pharmaceutical companies. | |
The company competes with entities offering scientific consulting services and contract research organizations, alongside internal teams at pharmaceutical companies. | |
Metrum Research Group | The company competes with other software suppliers and scientific consulting service providers, including those with larger resources. |
The company competes with software suppliers and consulting service providers, as well as in-house teams at pharmaceutical companies. | |
WCG | The company competes with other software suppliers, scientific consulting service providers, and contract research organizations, as well as internal teams at larger pharmaceutical companies. |
Notable M&A activity and strategic investments in the past 3 years.
| Company | Year | Details |
|---|---|---|
Pro-ficiency Holdings, Inc. | 2024 | Completed on June 11, 2024, this deal involved acquiring 100% of Pro-ficiency for an aggregate purchase price of $100 million in cash with $1 million held in escrow and a $10 million representation and warranty insurance policy, designed to expand Simulations Plus’ capabilities (including clinical trial operations and medical affairs) and effectively double its market opportunity to a $4 billion addressable market, with key non-compete and related covenants for three years. |
Immunetrics, Inc. | 2023 | Completed through a reverse triangular merger on June 16, 2023, this acquisition involved an initial cash payment of $13.7 million, with a $1.8 million holdback and up to $8.0 million in earnout payments (total potential consideration of $23.5 million), strategically enhancing Simulations Plus’ quantitative systems pharmacology (QSP) expertise and expanding its therapeutic focus in oncology, immunology, and autoimmune diseases. |
Recent press releases and 8-K filings for SLP.
- Q2 2025: $22.4M revenue (up 23% YoY) with contributions of $13.5M from software and $8.9M from services
- Earnings details: Reported diluted EPS of $0.15 with adjusted EBITDA at $6.6M and adjusted diluted EPS of $0.31 alongside a net income decline to $3.1M
- The Software segment grew 16% YoY, highlighted by a QSP unit surge of 89% driven by a high-value atopic dermatitis license
- Services revenue increased 34% YoY despite deferred project starts
- FY 2025 Guidance: Expects total revenue of $90M–$93M with adjusted diluted EPS of $1.07–$1.20, and an outlook featuring 28%–33% revenue growth, a software mix of 55%–60%, and an adjusted EBITDA margin of 31%–33%
- Additional highlights include trailing twelve months revenue of $78.6M and a recent $5M project win