US Market News
1月前
Simulations Plus and NVIDIA Collaborate to Scale GPU-Accelerated, AI-Assisted Modeling WorkflowsMay 6, 2026 7:55 AM
Business Wire Combines validated scientific engines with accelerated computing and AI to enable more scalable, integrated modeling workflows across the drug development lifecycle Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today announced the launch of a technical collaboration with NVIDIA focused on enabling GPU-accelerated simulation and AI-assisted workflows for computationally intensive modeling applications within the drug development lifecycle. The collaboration brings together Simulations Plus’ validated scientific engines across physiologically-based pharmacokinetics (PBPK), pharmacokinetics/pharmacodynamics (PK/PD), and quantitative systems pharmacology (QSP) with NVIDIA AI infrastructure to accelerate and scale simulation cycles, parameter exploration, and virtual population studies. Together, these capabilities address two core constraints in model-informed drug development (MIDD): reducing manual, expertise-driven work and enabling large-scale exploration of model structures and parameters in parallel—shifting modeling from a sequential process to a more iterative, data-informed workflow operating at program-relevant timelines. NVIDIA contributes advanced computing infrastructure and expertise in accelerated inference and GPU-native optimization to improve simulation performance and enable interactive, AI-assisted workflows. NVIDIA also brings access to its life sciences ecosystem, including the NVIDIA BioNeMo platform and a global network of pharmaceutical partners, supporting broader engagement and adoption. “For three decades, Simulations Plus has helped pharmaceutical and biotechnology organizations apply modeling and simulation with confidence across drug development. Our collaboration with NVIDIA brings together validated science, accelerated computing, and AI capabilities in a way that expands what scientific teams are able to explore and accomplish,” said Shawn O’Connor, Chief Executive Officer of Simulations Plus. The collaboration is initially focused on three areas: Next-generation scientific engines Simulations Plus has begun developing GPU-optimized simulation capabilities for QSP and PK/PD applications, reducing runtimes and enabling broader exploration of complex biological systems. This enables scientists to evaluate a broader range of hypotheses without pre-pruning models, increasing confidence in model selection and supporting more robust program decisions. AI-assisted scientific workflows Simulations Plus is applying AI-assisted approaches, informed by NVIDIA’s expertise in accelerated inference and agentic AI, to support model construction, parameter fitting, diagnostics, and refinement—reducing manual effort and accelerating iteration from question to analysis. By reducing manual, time-intensive steps, these workflows will allow scientists to focus more on scientific interpretation and decision-making, significantly accelerating iteration cycles within drug development programs. Advancing quantitative systems pharmacology Simulations Plus is prioritizing QSP workflows—one of the most computationally demanding areas in drug development—by applying GPU acceleration and AI-assisted methods to improve simulation efficiency and expand practical use in pharmaceutical R&D. Current testing shows up to a 75% reduction in time required for end-to-end QSP modeling, enabling faster iteration and expanding the practical use of QSP within program timelines. As part of the collaboration, the companies plan to engage select pharmaceutical partners to evaluate these capabilities in real-world drug development workflows, with initial focus on high-complexity modeling use cases. “Scientific teams are asking for faster iteration, greater scale, and better ways to work across increasingly complex modeling problems. By combining our validated scientific engines with AI-assisted workflows and accelerated computing, we are extending our platform into a more integrated modeling ecosystem—where workflows scale across domains like QSP while remaining grounded in reproducible, scientifically validated outputs,” said Erik Guffrey, Co-Chief Product and Technology Officer of Simulations Plus. “Biopharma teams need platforms that can connect mechanistic modeling, AI, and high-performance simulation into workflows scientists can actually use. By bringing NVIDIA accelerated computing and AI infrastructure together with Simulations Plus’ deep expertise in model-informed drug development, we can help researchers run more complex models, explore larger design spaces, and move from insight to decision faster," said Anthony Costa, Director of Digital Biology and Health, NVIDIA. About Simulations Plus, Inc. Simulations Plus is a global leader in model-informed and AI-accelerated drug development. We create value for our clients by accelerating the discovery, development, and commercialization of pharmaceuticals and other products through innovative science-based software and consulting solutions. For more information, visit www.simulations-plus.com. Forward-Looking Statements Except for historical information, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties. Words like “believe,” “will,” “can,” “expect,” “anticipate” and similar expressions (or the negative of such terms, as well as other words or expressions referencing future events, conditions or circumstances) mean that these are our best estimates as of this writing, but there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Factors that could cause or contribute to such differences include, but are not limited to: effectiveness of our new operational structure, our ability to maintain our competitive advantages, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, market conditions, macroeconomic factors, and a sustainable market. Further information on our risk factors is contained in our quarterly, annual and current reports and filed with the U.S. Securities and Exchange Commission. View source version on businesswire.com: https://www.businesswire.com/news/home/20260506350085/en/ Financial Profiles
Lisa Fortuna
310-622-8251
slp@finprofiles.com Original: Simulations Plus and NVIDIA Collaborate to Scale GPU-Accelerated, AI-Assisted Modeling Workflows
US Market News
1月前
Simulations Plus Announces Collaboration with Lonza and U.S. FDA to Advance Predictive Frameworks for Complex Oral Drug ProductsApril 21, 2026 7:55 AM
Business Wire
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
Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today announced a funded research collaboration with Lonza Group AG (“Lonza”), a leading contract development and manufacturing organization (CDMO) dedicated to serving the healthcare industry, and the U.S. Food and Drug Administration (FDA) to develop and validate a mechanistic, predictive framework for assessing the in vivo performance of amorphous solid dispersion (ASD) drug products.
“Complex oral formulations such as amorphous solid dispersions present significant scientific and regulatory challenges due to their sensitivity to physiological and manufacturing variables,” said Dr. Viera Lukacova, Chief Scientific Officer of Simulations Plus. “Through this funded collaboration, we aim to integrate advanced in vitro systems with mechanistic modeling to improve prediction of in vivo performance, support regulatory decision-making, and enable more efficient development pathways for these high-impact therapies that deliver faster dissolution and more drug absorption.”
Advancing Mechanistic, Model-Informed Approaches for Complex Products
ASDs are among the most powerful yet complex oral drug delivery systems, with performance influenced by factors such as food intake, gastric pH, formulation composition, and manufacturing processes. Current regulatory approaches often require multiple clinical bioequivalence (BE) studies, which can be resource-intensive while still carrying uncertainty.
The collaboration evaluates whether advanced in vitro dissolution systems—particularly those incorporating dynamic gastrointestinal physiology—combined with mechanistic physiologically based biopharmaceutics modeling (PBBM), 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 BE studies while maintaining the rigor and transparency required by regulators.
Integrating Experimental and Mechanistic Modeling Expertise
The collaboration brings together complementary capabilities across experimental science and computational modeling.
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 (CTD), as well as the characterization and, where needed, manufacturing of ASD formulation variants.
Simulations Plus will lead the development and validation of in vitro–in vivo extrapolation (IVIVE) 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 (MIDD).
Francois Ricard, Head of R&D, Lonza Advanced Synthesis, said, “This collaboration reflects Lonza’s commitment to advancing more predictive, science-driven approaches as the leader in the field of bioavailability enhancement. By combining advanced in vitro experimentation with mechanistic modeling, and working closely with Simulations Plus and the FDA, we aim to strengthen the scientific foundation that underpins regulatory decision-making for complex oral drug products. Ultimately, this type of collaboration should help accelerate development for our customers requiring bioequivalence during clinical development.”
Alignment with Regulatory Priorities and Industry Needs
This work is supported in part through FDA funding and includes ongoing engagement with FDA scientists to directly align with regulatory priorities to advance MIDD, 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 ASD products, the initiative is intended to inform future regulatory approaches and support broader adoption of science-based alternatives.
“The industry is moving toward a future where decisions are informed earlier, with greater confidence and scientific transparency,” added Lukacova. “Our role is to ensure those decisions are grounded in validated science—while enabling more efficient ways to connect data, models, and insight.”
About Simulations Plus, Inc.
Simulations Plus is a global leader in model-informed and AI-accelerated drug development. We create value for our clients by accelerating the discovery, development, and commercialization of pharmaceuticals and other products through innovative science-based software and consulting solutions. For more information, visit www.simulations-plus.com.
Forward-Looking Statements
Except for historical information, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties. Words like “believe,” “will”, “can”, “expect,” “anticipate,” and similar expressions (or the negative of such terms, as well as other words or expressions referencing future events, conditions, or circumstances) mean that these are our best estimates as of this writing, but there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Forward-looking statements include but are not limited to statements regarding our fiscal year 2026 guidance, revenue growth, anticipated margins and profitability, demand to software and services, the impact of pricing actions, client spending levels, market conditions, the development, capabilities, regulatory acceptance, regulatory compliance and commercialization of AI-enabled and could-based solutions, the timing and content of product initiatives discussed at Investor Day, and our ability to execute our long-term strategic vision. These forward-looking statements are based on current assumptions and expectations that involve risks and uncertainties that could cause the actual results to differ materially from those expressed or implied. Factors that could cause or contribute to such differences include, but are not limited to: effectiveness of our internal operational structure, our ability to maintain our competitive advantages and commercialize AI and cloud-enabled solutions, evolving regulatory and data privacy standards governing AI technologies, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, market conditions, macroeconomic factors, and a sustainable market. Further information on our risk factors is contained in our quarterly, annual, and current reports and filed with the U.S. Securities and Exchange Commission. No regulatory authority has endorsed, approved, or validated the Company’s products, platforms, or AI-related approaches.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260421564555/en/
Investor Relations Contact:
Lisa Fortuna
Financial Profiles
310-622-8251
slp@finprofiles.com
Original: Simulations Plus Announces Collaboration with Lonza and U.S. FDA to Advance Predictive Frameworks for Complex Oral Drug Products
US Market News
2月前
Simulations Plus Reports Second Quarter Fiscal 2026 Financial ResultsApril 9, 2026 4:05 PM
Business Wire
Revenue grew 8% with increases in both software and services
Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today reported financial results for its second quarter fiscal 2026, ended February 28, 2026.
Second Quarter 2026 Financial Highlights (as compared to second quarter 2025)
Total revenue increased 8% to $24.3 million
Software revenue increased 9% to $14.6 million, representing 60% of total revenue
Services revenue increased 8% to $9.7 million, representing 40% of total revenue
Gross profit was $16.1 million and gross margin was 66%, compared to $13.1 million and 59%
Net income of $4.5 million and diluted earnings per share of $0.22, compared to net income of $3.1 million and diluted EPS of $0.15
Adjusted EBITDA of $8.7 million, representing 36% of total revenue, compared to $6.6 million, representing 29% of total revenue
Adjusted net income of $7.0 million and adjusted diluted EPS of $0.35 compared to adjusted net income of $6.2 million and adjusted diluted EPS of $0.31
Six Months 2026 Financial Highlights (as compared to six months 2025)
Total revenue increased 3% to $42.7 million
Software revenue decreased 3% to $23.5 million, representing 55% of total revenue
Services revenue increased 12% to $19.2 million, representing 45% of total revenue
Gross profit was $27.0 million and gross margin was 63%, compared to $23.3 million and 56%
Net income of $5.2 million and diluted earnings per share of $0.26, compared to net income of $3.3 million and diluted EPS of $0.16
Adjusted EBITDA of $12.3 million, representing 29% of total revenue, compared to $11.1 million, representing 27% of total revenue
Adjusted net income of $9.6 million and adjusted diluted EPS of $0.48, approximately equivalent to the same period last year
Management Commentary
“We delivered solid second quarter results, with revenue increasing by 8%,” said Shawn O’Connor, CEO of Simulations Plus. “Software growth was driven by strong performance in discovery and development solutions, partially offset by an anticipated decline in clinical operations software. We also saw continued success with new logo additions and client upsells. Services revenue growth was primarily driven by development solutions and bookings were strong during the quarter, resulting in an approximately 18% increase in backlog.”
“Market conditions remain favorable. Globally, ongoing most-favored-nation pricing agreements, reduced tariff threats, and an improving funding environment are benefiting our clients. In addition, we believe recent supplemental guidance on new approach methodologies is supporting increased client activity. We are seeing this reflected in strong software renewals, logo activity, and services bookings. Overall, we are pleased with our first-half fiscal 2026 performance and encouraged by the momentum we see across the business,” concluded O’Connor.
Fiscal 2026 Guidance
The Company is adjusting its guidance range for adjusted diluted EPS from a range of $1.03 - $1.10 to $0.75 - $0.85 to reflect an increase in the expected effective tax rate for fiscal 2026 from 12-14% to 23-25%. All other previously issued guidance metrics remain unchanged.
Fiscal 2026
Guidance
Revenue
$79M - $82M
Revenue growth
0 - 4%
Software mix
57 - 62%
Adjusted EBITDA margin
26 - 30%
Adjusted diluted EPS
$0.75 - $0.85
Webcast and Conference Call Details
Shawn O’Connor, Chief Executive Officer, and Will Frederick, Executive Vice President and Chief Financial Officer, will host a conference call and webcast today, April 9 at 5:00 p.m. Eastern Time to discuss the results and certain forward-looking information. The call may be accessed by registering here or by calling 1-877-451-6152 (domestic) or 1-201-389-0879 (international). The webcast can be accessed on the investor relations page of the Simulations Plus website https://www.simulations-plus.com/investorscorporate-profile/corporate-profile/ where it will also be available for replay approximately one hour following the call.
Non-GAAP Financial Measures
This press release contains “non-GAAP financial measures,” which are measures that either exclude or include amounts that are not excluded or included in the most directly comparable measures calculated and presented in accordance with U.S. generally accepted accounting principles (“GAAP”).
A further explanation and reconciliation of these non-GAAP financial measures is included below and in the financial tables in this release.
The Company believes that the non-GAAP financial measures presented facilitate an understanding of operating performance and provide a meaningful comparison of its results between periods. The Company’s management uses non-GAAP financial measures to, among other things, evaluate its ongoing operations in relation to historical results, for internal planning and forecasting purposes, and in the calculation of performance-based compensation. Adjusted EBITDA and Adjusted Diluted EPS represent measures that we believe are customarily used by investors and analysts to evaluate the financial performance of companies in addition to the GAAP measures that we present. Our management also believes that these measures are useful in evaluating our core operating results. However, Adjusted EBITDA and Adjusted Diluted EPS are not measures of financial performance under accounting principles generally accepted in the United States of America and should not be considered an alternative to net income, operating income, or diluted EPS as indicators of our operating performance or to net cash provided by operating activities as a measure of our liquidity. We believe the Company’s Adjusted EBITDA and Adjusted Diluted EPS measures provide information that is directly comparable to that provided by other peer companies in our industry, but other companies may calculate non-GAAP financial results differently, particularly related to nonrecurring, unusual items.
Please note that the Company has not reconciled the adjusted EBITDA or adjusted diluted earnings per share forward-looking guidance included in this press release to the most directly comparable GAAP measures because this cannot be done without unreasonable effort due to the variability and low visibility with respect to costs related to acquisitions, financings, and employee stock compensation programs, which are potential adjustments to future earnings. We expect the variability of these items to have a potentially unpredictable, and a potentially significant, impact on our future GAAP financial results.
Adjusted EBITDA
Adjusted EBITDA represents net income excluding the effect of interest expense (income), provision (benefit) for income taxes, depreciation and amortization, equity-based compensation expense, loss (gain) on currency exchange, impairment charges, change in fair value of contingent consideration, reorganization expense, acquisition and integration expense, and other items not indicative of our ongoing operating performance.
Adjusted Net Income and Adjusted Diluted EPS
Adjusted net income and adjusted diluted earnings per share exclude the effect of amortization, equity-based compensation expense, loss (gain) on currency exchange, impairment charges, change in fair value of contingent consideration, reorganization expense, acquisition and integration expense, and other items not indicative of our ongoing operating performance as well as the income tax provision adjustment for such charges.
The Company excludes the above items because they are outside of the Company’s normal operations and/or, in certain cases, are difficult to forecast accurately.
About Simulations Plus, Inc.
Simulations Plus is a global leader in model-informed and AI-accelerated drug development. We create value for our clients by accelerating the discovery, development, and commercialization of pharmaceuticals and other products through innovative science-based software and consulting solutions. For more information, visit www.simulations-plus.com.
Forward-Looking Statements
Except for historical information, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties. Words like “believe,” “will,” “can,” “expect,” “anticipate,” and similar expressions (or the negative of such terms, as well as other words or expressions referencing future events, conditions, or circumstances) mean that these are our best estimates as of this writing, but there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Forward-looking statements include but are not limited to statements regarding our fiscal year 2026 guidance, revenue growth, anticipated margins and profitability, demand to software and services, the impact of pricing actions, client spending levels, market conditions, the development, capabilities, regulatory acceptance and commercialization of AI-enabled and cloud-based solutions, the timing and content of product initiatives discussed at Investor Day, and our ability to execute our long-term strategic vision. These forward-looking statements are based on current assumptions and expectations that involve risks and uncertainties that could cause the actual results to differ materially from those expressed or implied. Factors that could cause or contribute to such differences include, but are not limited to: effectiveness of our internal operational structure, our ability to maintain our competitive advantages and commercialize AI and cloud-enabled solutions, evolving regulatory and data privacy standards governing AI technologies, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, market conditions, macroeconomic factors, and a sustainable market. Further information on our risk factors is contained in our quarterly, annual, and current reports and filed with the U.S. Securities and Exchange Commission.
SIMULATIONS PLUS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(Unaudited)
(in thousands, except per common share and common share data)
Three Months Ended
Six Months Ended
February 28,
2026
February 28,
2025
February 28,
2026
February 28,
2025
Revenues
Software
$
14,635
$
13,484
$
23,518
$
24,199
Services
9,656
8,948
19,194
17,157
Total revenues
24,291
22,432
42,712
41,356
Cost of revenues
Software
1,648
2,587
3,060
5,225
Services
6,500
6,718
12,618
12,786
Total cost of revenues
8,148
9,305
15,678
18,011
Gross profit
16,143
13,127
27,034
23,345
Operating expenses
Research and development
3,470
2,143
6,450
3,991
Sales and marketing
2,930
3,717
6,109
6,568
General and administrative
4,113
4,555
8,132
9,948
Total operating expenses
10,513
10,415
20,691
20,507
Income from operations
5,630
2,712
6,343
2,838
Other income, net
256
796
513
940
Income before income taxes
5,886
3,508
6,856
3,778
Income tax expense
(1,351
)
(434
)
(1,645
)
(498
)
Net income
$
4,535
$
3,074
$
5,211
$
3,280
Earnings per share
Basic
$
0.22
$
0.15
$
0.26
$
0.16
Diluted
$
0.22
$
0.15
$
0.26
$
0.16
Weighted-average common shares outstanding
Basic
20,160
20,097
20,150
20,082
Diluted
20,243
20,277
20,232
20,262
Other comprehensive income (loss), net of tax
Foreign currency translation adjustments
11
(26
)
5
(68
)
Unrealized gains (losses) on available-for-sale securities
(6
)
—
(6
)
4
Comprehensive income
$
4,540
$
3,048
$
5,210
$
3,216
SIMULATIONS PLUS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(in thousands, except per common share and common share data)
February 28,
2026
August 31,
2025
ASSETS
Current assets
Cash and cash equivalents
$
25,727
$
30,853
Accounts receivable, net of allowance for credit losses of $73 and $187
18,170
9,717
Prepaid income taxes
669
1,777
Prepaid expenses and other current assets
6,885
7,702
Short-term investments
16,109
1,500
Total current assets
67,560
51,549
Long-term assets
Capitalized computer software development costs, net of accumulated amortization of $23,543 and $21,863
11,158
11,117
Property and equipment, net
752
880
Operating lease right-of-use assets
373
407
Intellectual property, net of accumulated amortization of $9,555 and $9,021
5,663
6,197
Other intangible assets, net of accumulated amortization of $4,904 and $4,399
11,327
11,896
Goodwill
43,717
43,717
Deferred tax assets, net
4,589
4,774
Other assets
1,345
1,399
Total assets
$
146,484
$
131,936
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities
Accounts payable
$
803
$
470
Accrued compensation
4,398
2,010
Accrued expenses
1,474
1,343
Operating lease liability - current portion
138
206
Deferred revenue
5,530
2,696
Total current liabilities
12,343
6,725
Long-term liabilities
Operating lease liability - net of current portion
370
410
Total liabilities
12,713
7,135
Commitments and contingencies
Shareholders' equity
Preferred stock, $0.001 par value — 10,000,000 shares authorized; no shares issued and outstanding
$
—
$
—
Common stock, $0.001 par value; 50,000,000 shares authorized, 20,205,482 and 20,137,480 shares issued and outstanding as of February 28, 2026, and August 31, 2025
20
20
Additional paid-in capital
163,176
159,416
Accumulated deficit
(29,153
)
(34,364
)
Accumulated other comprehensive loss
(272
)
(271
)
Total shareholders' equity
133,771
124,801
Total liabilities and shareholders' equity
$
146,484
131,936
SIMULATIONS PLUS, INC.
Reconciliation of Adjusted EBITDA to Net Income (1)
(Unaudited)
Three months ended
Six months ended
(in thousands)
February 28,
2026
February 28,
2025
February 28,
2026
February 28,
2025
Net income
$
4,535
$
3,074
$
5,211
$
3,280
Excluding:
Interest income and expense, net
(288
)
(154
)
(555
)
(313
)
Provision for income taxes
1,351
434
1,645
498
Depreciation and amortization
1,547
2,274
2,893
4,539
Stock-based compensation
1,503
1,557
2,968
3,146
Loss on currency exchange
32
(2
)
42
13
Change in value of contingent consideration
—
(640
)
—
(640
)
Reorganization expense
—
157
—
415
Mergers & Acquisitions expense
55
(122
)
65
133
Adjusted EBITDA
$
8,735
$
6,578
$
12,269
$
11,071
(1) Numbers may not foot due to rounding
SIMULATIONS PLUS, INC.
Reconciliation of Adjusted Diluted EPS to Diluted EPS (1)
(Unaudited)
(in thousands, except Diluted EPS and Adjusted Diluted EPS)
Three months ended
Six months ended
February 28,
2026
February 28,
2025
February 28,
2026
February 28,
2025
Net income
$
4,535
$
3,074
$
5,211
$
3,280
Excluding:
Amortization
1,460
2,130
2,719
4,260
Stock-based compensation
1,503
1,557
2,968
3,146
(Gain) loss on currency exchange
32
(2
)
42
13
Mergers & Acquisitions expense
55
(122
)
65
133
Change in value of contingent consideration
—
(640
)
—
(640
)
Reorganization expense
—
157
—
415
Tax effect on above adjustments
(558
)
41
(1,390
)
(966
)
Adjusted Net income
$
7,027
$
6,195
$
9,615
$
9,641
Weighted-avg. common shares outstanding:
Diluted weighted-avg. common shares outstanding
20,243
20,277
20,232
20,262
Diluted EPS
$
0.22
$
0.15
$
0.26
$
0.16
Adjusted Diluted EPS
$
0.35
$
0.31
$
0.48
$
0.48
(1) Numbers may not foot due to rounding
View source version on businesswire.com: https://www.businesswire.com/news/home/20260409950592/en/
Investor Relations Contact:
Lisa Fortuna
Financial Profiles
310-622-8251
slp@finprofiles.com
Original: Simulations Plus Reports Second Quarter Fiscal 2026 Financial Results
US Market News
2月前
Simulations Plus Announces Strategic Collaboration Programs for AI-Enabled ModelingMarch 26, 2026 7:55 AM
Business Wire
Co-development initiatives to advance next-generation workflows, accelerate adoption, and expand the role of AI within model-informed drug development
Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today announced strategic collaboration programs with three large pharmaceutical companies to advance artificial intelligence (AI) workflows across the drug development lifecycle.
These programs apply AI within scientifically grounded modeling workflows and define how next-generation workflows are deployed at scale. The close collaboration between Simulations Plus and leading pharmaceutical organizations will provide direct insight into how AI will be integrated into real-world environments—informing product direction, workflow standardization, and future commercial models. The programs will utilize Simulations Plus’ major software platforms, including GastroPlus®, MonolixSuite™, ADMET Predictor®, and Thales™.
“Our approach to AI is grounded in how it operates within a complete system, not as a standalone capability,” said Jonathan Chauvin, Co-Chief Product & Technology Officer at Simulations Plus. “These collaborations will allow us to work alongside our partners, leveraging real-time scientific feedback and company data to continuously refine how workflows are orchestrated across our tools, ensuring AI-driven efficiencies translate into reproducible, traceable outcomes. The insights we gain will directly shape how we evolve our platform and deliver value at scale.”
Participating companies will integrate the Company’s internally developed AI agents directly into model-informed drug development (MIDD) workflows, enabling natural language interaction, automation of data processing, coordination of simulations across multiple modeling engines, and generation of interpretable outputs from complex, multi-step pipelines.
Importantly, the collaborations will also serve as a foundation for broader enterprise adoption, including direct alignment with information technology teams to define how AI-enabled capabilities are deployed, governed, and integrated within existing systems. This includes defining standards together for transparency, reproducibility, and governance as AI becomes more deeply embedded in drug development processes.
“As highlighted at our Investor Day presentation in January, AI will only fulfill its potential in drug development when it is delivered responsibly, grounded in validated science, and integrated into real workflows,” said Shawn O’Connor, Chief Executive Officer of Simulations Plus. “Our customers are choosing to work with us because of the strength of our validated scientific engines and depth of our teams who apply them daily within real workflows, enabling us to translate AI into practical, deployable solutions. These strategic collaboration programs represent an important step in moving us and our partners beyond experimentation and into practical implementation as we advance our software and services into a unified modeling ecosystem.”
Companies interested in learning about using AI-enabled workflows in their modeling can request additional information.
About Simulations Plus, Inc.
Simulations Plus is a global leader in model-informed and AI-accelerated drug development. We create value for our clients by accelerating the discovery, development, and commercialization of pharmaceuticals and other products through innovative science-based software and consulting solutions. For more information, visit www.simulations-plus.com.
Forward-Looking Statements
Except for historical information, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties. Words like “believe,” “will”, “can”, “expect,” “anticipate,” and similar expressions (or the negative of such terms, as well as other words or expressions referencing future events, conditions, or circumstances) mean that these are our best estimates as of this writing, but there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Forward-looking statements include but are not limited to statements regarding our fiscal year 2026 guidance, revenue growth, anticipated margins and profitability, demand to software and services, the impact of pricing actions, client spending levels, market conditions, the development, capabilities, regulatory acceptance, regulatory compliance and commercialization of AI-enabled and could-based solutions, the timing and content of product initiatives discussed at Investor Day, and our ability to execute our long-term strategic vision. These forward-looking statements are based on current assumptions and expectations that involve risks and uncertainties that could cause the actual results to differ materially from those expressed or implied. Factors that could cause or contribute to such differences include, but are not limited to: effectiveness of our internal operational structure, our ability to maintain our competitive advantages and commercialize AI and cloud-enabled solutions, evolving regulatory and data privacy standards governing AI technologies, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, market conditions, macroeconomic factors, and a sustainable market. Further information on our risk factors is contained in our quarterly, annual, and current reports and filed with the U.S. Securities and Exchange Commission. No regulatory authority has endorsed, approved, or validated the Company’s products, platforms, or AI-related approaches.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260326658090/en/
Investor Relations Contact:
Lisa Fortuna
Financial Profiles
310-622-8251
slp@finprofiles.com
Original: Simulations Plus Announces Strategic Collaboration Programs for AI-Enabled Modeling
US Market News
3月前
Simulations Plus Convenes Industry and Regulatory Leaders to Define Responsible AI in MIDDMarch 3, 2026 7:55 AM
Business Wire
Expert panel at the 2026 ASCPT Annual Meeting brings together leaders with industry and regulatory experience to explore practical, accountable AI implementation
Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today announced a high-impact panel discussion, “From Debate to Deployment: Responsible, Practical AI in MIDD,” to be held during the upcoming American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meeting on March 5, 2026 at 12:00 PM MST in Denver, CO.
“There is no longer a question of whether artificial intelligence (AI) should be used in drug development, but how to implement it responsibly, defensibly, and with measurable value,” said Dr. Viera Lukacova, Chief Scientific Officer of Simulations Plus and moderator of the panel. “We are excited to bring together leaders who can share perspectives influenced by their industry and regulatory experiences to discuss the cost and impact that should be considered by scientists, stakeholders and leaders involved in AI decision-making and implementation.”
During the session, panelists will discuss how AI is currently being deployed as part of model-informed drug development (MIDD) workflows. The session will focus on:
Where AI is delivering measurable impact today
How organizations are navigating strategic decisions around building, buying, or partnering to enable sustainable implementation
The regulatory principles shaping AI-enabled development strategies
Beyond technology, the session will also address the human dimensions of AI integration, discussing where expert judgment is still central, how scientific roles and workflows are adapting to this technology, and the skills scientists will need to succeed in an increasingly AI-enabled future.
“So much of the conversation around AI revolves around abstract future potential, but we recognize that scientists and stakeholders need practical and operational insights they can put to use now,” said John DiBella, Chief Revenue Officer of Simulations Plus. “Our product strategy is centered on integrating AI directly into our core engines and model-informed workflows where it enhances scientific judgment, improves efficiency, and stands up to regulatory scrutiny. This panel is an extension of that commitment, and we are excited to help the industry move from discussion to disciplined deployment.”
Panelists include:
Rajanikanth Madabushi, Associate Director for Guidance and Scientific Policy, Office of Clinical Pharmacology, CDER/FDA
Jeff Barrett, Vice President, Clinical Pharmacology & Quantitative Science, Genmab
John Mondick, Head of Clinical and Quantitative Pharmacology, Incyte
Mohamed Shahin, AI Strategy Lead, Pfizer
Yue Zhao, Director, Pharmacometrics, Bristol Myers Squibb
Amparo de la Peña, Vice President, Pharmacometric Services, Simulations Plus
Susie Zhang, Vice President, Regulatory Strategies, Simulations Plus
The panel will be held during the ASCPT Annual Meeting in room Summit 9. Interested attendees are encouraged to arrive early as space is limited.
About Simulations Plus, Inc.
Simulations Plus is a global leader in model-informed and AI-accelerated drug development. We create value for our clients by accelerating the discovery, development, and commercialization of pharmaceuticals and other products through innovative science-based software and consulting solutions. For more information, visit www.simulations-plus.com.
Forward-Looking Statements
Except for historical information, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties. Words like “believe,” “will”, “can”, “expect,” “anticipate,” and similar expressions (or the negative of such terms, as well as other words or expressions referencing future events, conditions, or circumstances) mean that these are our best estimates as of this writing, but there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Forward-looking statements include but are not limited to statements regarding our fiscal year 2026 guidance, revenue growth, anticipated margins and profitability, demand to software and services, the impact of pricing actions, client spending levels, market conditions, the development, capabilities, regulatory acceptance, regulatory compliance and commercialization of AI-enabled and could-based solutions, the timing and content of product initiatives discussed at Investor Day, and our ability to execute our long-term strategic vision. These forward-looking statements are based on current assumptions and expectations that involve risks and uncertainties that could cause the actual results to differ materially from those expressed or implied. Factors that could cause or contribute to such differences include, but are not limited to: effectiveness of our internal operational structure, our ability to maintain our competitive advantages and commercialize AI and cloud-enabled solutions, evolving regulatory and data privacy standards governing AI technologies, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, market conditions, macroeconomic factors, and a sustainable market. Further information on our risk factors is contained in our quarterly, annual, and current reports and filed with the U.S. Securities and Exchange Commission. No regulatory authority has endorsed, approved, or validated the Company’s products, platforms, or AI-related approaches.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260303486283/en/
Investor Relations Contact:
Lisa Fortuna
Financial Profiles
310-622-8251
slp@finprofiles.com
Original: Simulations Plus Convenes Industry and Regulatory Leaders to Define Responsible AI in MIDD
US Market News
4月前
Simulations Plus Announces Extensions of U.S. FDA and NIEHS Research CollaborationsFebruary 9, 2026 6:45 PM
Business Wire
Extended projects support ongoing research into computational approaches and new approach methodologies for food and chemical safety assessment
Simulations Plus, Inc. (Nasdaq: SLP) (“Simulations Plus” or the “Company”), a global leader in model-informed and AI-accelerated drug development that advances biopharma innovation, today announced the extension of two separate research collaborations with the U.S. Food and Drug Administration (FDA) and the National Institute of Environmental Health Sciences (NIEHS). The extended projects support ongoing federal research efforts focused on the development of new approach methodologies (NAMs) and advancing computational approaches for food and chemical safety assessments.
Recent guidance from the FDA and other regulatory agencies encourages the use of non-animal based research, including in silico, mechanistic, and data-driven methods intended to support food and chemical safety evaluations. The extended collaborations align with these broader federal initiatives by supporting research into the application, evaluation, and refinement of computational toxicity models.
“We appreciate the opportunity to continue our collaborations with the FDA and NIEHS,” said Viera Lukacova, Chief Scientific Officer of Simulations Plus. “The research being conducted through these projects addresses important challenges, and we are pleased to contribute our scientific engines in support of federal research efforts. We look forward to continued collaboration to advance the scientific foundation for food and chemical safety assessment through AI-enabled and in silico approaches.”
FDA Research Collaboration
The extended agreement with the FDA’s Human Foods Program allows scientists to continue research involving computational models to support chemical safety assessments for food-related substances.
Following the completion of earlier project objectives, the FDA elected to extend the collaboration with Simulations Plus to further expand and refine AI-based safety models for use in regulatory research. New federal funding dedicated to food and chemical safety modernization will provide this collaboration with expanded access to curated toxicological datasets for further training, validation, and benchmarking of Simulations Plus’ AI/ML models.
NIEHS Research Collaboration
The extended collaboration with NIEHS focuses on computational approaches relevant to environmental and exposure-related chemical safety research. This work addresses a broad range of chemicals and exposure scenarios, consistent with NIEHS’s mission to support research on environmental influences on human health.
NIEHS’ collaboration with Simulations Plus is part of a national effort to modernize chemical safety assessment through AI-powered new approach methodologies and will continue the application of the company’s software engines to help with the design, validation, and benchmarking of new experimental systems under evaluation.
Advancing NAM Research
The extensions reflect continued federal interest in evaluating computational and AI-based approaches, areas in which Simulations Plus has longstanding technical expertise.
“For 30 years, our company has helped lay the scientific foundation for what is now known as model-informed drug development,” said Shawn O’Connor, Chief Executive Officer of Simulations Plus. “Our experts helped standardize methods that are now widely accepted by industry and regulators alike, and we are proud to continue pioneering the science and technology that support better-informed decisions across pharmaceutical development, food safety research and chemical risk assessment.”
About Simulations Plus, Inc.
Simulations Plus is a global leader in model-informed and AI-accelerated drug development. We create value for our clients by accelerating the discovery, development, and commercialization of pharmaceuticals and other products through innovative science-based software and consulting solutions. For more information, visit www.simulations-plus.com.
Forward-Looking Statements
Except for historical information, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties. Words like “believe,” “will”, “can”, “expect,” “anticipate,” and similar expressions (or the negative of such terms, as well as other words or expressions referencing future events, conditions, or circumstances) mean that these are our best estimates as of this writing, but there can be no assurances that expected or anticipated results or events will actually take place, so our actual future results could differ significantly from those statements. Forward-looking statements include but are not limited to statements regarding our fiscal year 2026 guidance, revenue growth, anticipated margins and profitability, demand to software and services, the impact of pricing actions, client spending levels, market conditions, the development, capabilities, regulatory acceptance, regulatory compliance and commercialization of AI-enabled and could-based solutions, the timing and content of product initiatives discussed at Investor Day, and our ability to execute our long-term strategic vision. These forward-looking statements are based on current assumptions and expectations that involve risks and uncertainties that could cause the actual results to differ materially from those expressed or implied. Factors that could cause or contribute to such differences include, but are not limited to: effectiveness of our internal operational structure, our ability to maintain our competitive advantages and commercialize AI and cloud-enabled solutions, evolving regulatory and data privacy standards governing AI technologies, acceptance of new software and improved versions of our existing software by our customers, the general economics of the pharmaceutical industry, our ability to finance growth, our ability to continue to attract and retain highly qualified technical staff, market conditions, macroeconomic factors, and a sustainable market. Further information on our risk factors is contained in our quarterly, annual, and current reports and filed with the U.S. Securities and Exchange Commission. No regulatory authority has endorsed, approved, or validated the Company’s products, platforms, or AI-related approaches.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260209178106/en/
Investor Relations Contact:
Lisa Fortuna
Financial Profiles
310-622-8251
slp@finprofiles.com
Original: Simulations Plus Announces Extensions of U.S. FDA and NIEHS Research Collaborations
dickmilde
8年前
SLP Reports Record Second Quarter FY2018 Revenue
( SLP is now a "69 bagger" from the dotcom bust in the early 2000's. I am still holding all my shares.)
Simulations Plus, Inc. (SLP), the premier provider of simulation and modeling software and consulting services for all stages of pharmaceutical discovery and development from the earliest discovery through all phases of clinical trials, today reported financial results for its second quarter of fiscal year 2018, the period ended February 28, 2018 (2QFY18).
2QFY18 highlights compared with 2QFY17:
Revenues were $7.4 million, up $1.7 million, or 28.9%, compared to $5.7 million in 2QFY17
57% of the increase is from DILIsym Services, acquired on June 1, 2017
Gross profit was $5.2 million, up $1.1 million, or 26.2%, compared to $4.2 million in 2QFY17
48% of the increase is from DILIsym Services, acquired on June 1, 2017
Gross margin was 71.2%, down slightly from 72.8% in 2Q17, because more of the new revenues from DILIsym are from consulting rather than software
SG&A expenses were $2.3 million, up $0.4 million, or 20.1%, compared to $1.9 million in 2QFY17
Income from operations was $2.4 million, up $0.6 million, or 34.7%, compared to $1.8 million in 2QFY17
31% of this operating income increase is from DILIsym Services, acquired on June 1, 2017
The Company recorded a benefit for income taxes of $1.1 million in 2QFY18 compared to $589,000 of income tax expense in 2QFY17, due to the effects of a $1.5 million one-time adjustment to deferred taxes based on the new Federal tax law and the lower blended Federal tax rates for the 2nd quarter of this fiscal year
Inclusive of the $1.5 million adjustment, net income was $3.5 million, up $2.3 million, or 190.6%, compared to $1.2 million in 2QFY17; without the adjustment, income would have been $2.0 million for the quarter, up $0.8 million or 65%
Inclusive of the tax benefit, diluted earnings per share increased $0.13 to $0.19 from $0.07; the tax adjustment accounted for $0.08 of the increase in quarterly diluted earnings per share
6MoFY18 highlights compared with 6MoFY17:
Revenues were $14.4 million, up $3.3 million, or 29.7%, compared to $11.1 million for 6MoFY17
62% of the increase is from DILIsym Services, acquired on June 1, 2017
Gross profit was $10.6 million, up $2.34 million, or 28.4%, compared to $8.2 million for 6MoFY17
56% of the increase is from DILIsym Services, acquired on June 1, 2017
Gross margin was 73.3%, down slightly from 74.0% in 2Q17, because more of the new revenues from DILIsym are from consulting rather than software
SG&A expenses were $4.7 million, up $0.94 million, or 24.6%, compared to $3.8 million for 6MoFY17
Income from operations was $5 million, up $1.26 million, or 33.8%, compared to $3.7 million for 6MoFY17
48% of this operating income increase is from DILIsym Services, acquired on June 1, 2017
The non-recurring benefit for income taxes for the six-month period was $289,000, compared to $1.2 million of income tax expense in 6MoFY17, due to the adjustment mentioned above and the lower blended Federal rates for the second quarter of this fiscal year.
Inclusive of the tax benefit, net income was $5.2 million, up $2.63 million, or 103.0%, compared to $2.6 million for 6MoFY17; without the adjustment, income would have been $3.7 million for the quarter, up $1.1 million or 44%
Inclusive of the tax benefit, diluted earnings per share increased $0.14 to $0.29 from $0.15, the tax adjustment accounted for $0.08 of the increase in diluted earnings per share
John Kneisel, chief financial officer of Simulations Plus, said, “We saw another strong quarterly revenue growth in our core divisions in Lancaster and Buffalo coupled with the new revenues and profits from DILIsym Services acquired in the last quarter of our prior fiscal year. Even with the addition of a higher percentage of non-software sales we have seen increases in operating income margins. The Company produced a 28.9% growth in revenues and a 34.7% growth in income from operations.”
https://finance.yahoo.com/news/simulations-plus-reports-record-second-200100996.html
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