Simulations Plus, Inc. - SLP STOCK NEWS

Simulations Plus (Nasdaq: SLP) announced that its technology and expertise supported the development of 100% of FDA-approved drugs in 2024. The company provides cheminformatics, biosimulation, and medical communications solutions to the biopharma industry.

The company's suite of solutions incorporates artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics/biopharmaceutics (PBPK/PBBM), quantitative systems pharmacology/toxicology (QSP/QST), and population PK/PD modeling approaches. These technologies, combined with adaptive learning and medical communications tools, help accelerate drug development processes and support critical advancements in global healthcare.

Simulations Plus (Nasdaq: SLP) announced its significant impact on pharmaceutical development, revealing that its technology supported the majority of FDA-approved drugs in 2024. The company's comprehensive suite of solutions includes artificial intelligence/machine learning (AI/ML), physiologically based pharmacokinetics/biopharmaceutics (PBPK/PBBM), and quantitative systems pharmacology/toxicology (QSP/QST) modeling approaches.

CEO Shawn O'Connor emphasized the company's 25-year track record in providing mission-critical software and services for therapy development. SLP's offerings encompass drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization support, demonstrating their integral role in advancing global healthcare solutions.

Simulations Plus (Nasdaq: SLP) reported strong Q1 fiscal 2025 results with total revenue increasing 31% year-over-year to $18.9 million. The growth was primarily driven by software revenue, which rose 41% to $10.7 million (57% of total revenue), while services revenue grew 19% to $8.2 million (43% of total revenue).

Key financial metrics include gross profit of $10.2 million (54% margin), net income of $0.2 million, and diluted EPS of $0.01, compared to $1.9 million and $0.10 in Q1 2024. Adjusted EBITDA reached $4.5 million (24% of revenue). The MonolixSuite™ platform showed strong performance with 43% growth, and the QSP business unit grew 40%. The company maintained its fiscal 2025 guidance of $90-93M in revenue (28-33% growth) with adjusted EBITDA margin of 31-33%.

Simulations Plus (Nasdaq: SLP), a provider of biosimulation and medical communications solutions for the biopharma industry, has scheduled its first quarter fiscal 2025 earnings release and conference call for Tuesday, January 7, 2025. The financial results will be announced after market close, followed by a management-hosted conference call at 5:00 p.m. Eastern Time.

Investors and shareholders can join the live webcast through registration or dial in using 1-877-451-6152 (domestic) or 1-201-389-0879 (international). A replay will be available on the company's investor relations website approximately one hour after the call.

Simulations Plus (Nasdaq: SLP), a leading biosimulation and medical communications solutions provider, announces its participation in the upcoming BTIG Digital Health Forum on November 25, 2024. CEO Shawn O'Connor will join a panel discussion on 'Supporting Drug Development, Clinical Trials, and Biopharma' at 2:00 p.m. Eastern Time and conduct one-on-one meetings throughout the day. Interested participants must pre-register through the BTIG website to attend the virtual event.

Simulations Plus (Nasdaq: SLP) and the University of Connecticut have received a new FDA grant to expand mechanistic modeling for long-acting injectable (LAI) technologies. The collaboration will use GastroPlus® PBPK platform to investigate relationships between LAI formulation and physiological factors at injection sites. The project aims to develop models that could serve as alternatives to in vivo studies for establishing bioequivalence. Dr. Diane Burgess's lab will generate vital data for marketed LAI suspension products, while Simulations Plus will develop PBPK models for validation. The initiative seeks to reduce development time and costs while streamlining regulatory processes for both innovator and generic formulations.

Simulations Plus (Nasdaq: SLP), a leading biosimulation and medical communications solutions provider for the biopharma industry, announced its participation in the Stephens Annual Investment Conference in Nashville. CEO Shawn O'Connor will engage in a fireside chat on November 20, 2024, at 12:00 p.m. Eastern Time and conduct one-on-one investor meetings throughout the day. The presentation will be available via live audio webcast, with a 90-day replay accessible on the company's Investors page.

Simulations Plus (Nasdaq: SLP) has secured a new FDA grant in partnership with the University of Strathclyde and InnoGI Technologies. The collaboration aims to improve understanding of amorphous solid dispersion (ASD) formulations and predict food and pH-dependent drug-drug interactions through in vitro testing and simulation. The project will utilize GastroPlus® platform for physiologically based pharmacokinetic modeling to link in vitro dissolution with in vivo data. The research is expected to accelerate formulation adjustments, reduce costs, and speed up time-to-market for both innovator and generic ASD products.

Simulations Plus (Nasdaq: SLP) reported strong fiscal 2024 results with total revenue growing 18% to $70.0 million. Software revenue increased 12% to $41.0 million (59% of total), while services revenue rose 26% to $29.0 million (41% of total). The company reported net income of $10.0 million with diluted EPS of $0.49. The acquisition of Pro-ficiency in June doubled their total addressable market to $8 billion. For fiscal 2025, the company provides revenue guidance of $90-93 million (+28-33%) and adjusted diluted EPS guidance of $1.07-1.20.