Simulations Plus, Inc. - SLP STOCK NEWS

Simulations Plus reports Q3 fiscal 2023 financial results with total revenue of $16.2 million and diluted EPS of $0.20. They maintain their full-year revenue guidance of $59.3 - $62.0 million (+10-15%) and EPS guidance of $0.63 - $0.67.

Simulations Plus acquires Immunetrics, a modeling and simulation company focused on drug development in oncology, immunology, and autoimmune diseases. The acquisition strengthens Simulations Plus' QSP expertise and expands the range of therapeutic areas addressed by its software and services. The deal includes a cash consideration of $15.5 million, with potential earn-out payments of up to $8 million based on revenue performance.

Simulations Plus, Inc. (NASDAQ: SLP) announced the renewal of FDA licenses for its DILIsym® software, a leading tool in predicting drug-induced liver injury (DILI). This one-year renewal allows FDA employees continued access to DILIsym across all divisions. Dr. Paul B. Watkins emphasized that this endorsement underscores DILIsym's value in assessing liver safety during drug development, especially after the FDA Modernization Act 2.0 signing. Dr. Brett A. Howell remarked on the growing importance of simulation technologies to enhance drug development efficiency amid rising healthcare costs. DILIsym's predictive modeling aids crucial decisions in drug development by identifying potential DILI risks and guiding go/no-go decisions. Simulations Plus has provided biosimulation solutions for over 25 years, employed by major stakeholders in the pharmaceutical industry.

Simulations Plus, a leader in pharmaceutical modeling software, reported Q2 fiscal 2023 revenues of $15.8 million, a 6% increase year-over-year. Software revenue rose 7% to $10.5 million, while services revenue saw a 4% increase to $5.3 million. Gross profit grew 10% to $13.1 million, achieving an impressive gross margin of 83%. However, net income decreased to $4.2 million with diluted EPS at $0.20, down from $4.4 million or $0.21 last year. Year-to-date, revenues climbed 2% to $27.7 million, with diluted EPS at $0.26, down from $0.36. The company maintains its full-year revenue guidance of $59.3 - $62.0 million and diluted EPS of $0.63 - $0.67.

Simulations Plus recently hosted a virtual panel discussion focused on advancing gender equity for women in science, attended by over 150 participants. The session, part of the Model-Informed Drug Development (MIDD+) conference, featured a diverse group of speakers emphasizing the importance of male involvement in the conversation. Jill Fiedler-Kelly, President of Cognigen, highlighted the need for policy changes to support women, including flexible hours and parental leave. Current statistics show that 52% of Simulations Plus scientists are women, but more work is needed for equity, particularly for women of color in STEM. The panel emphasized creating supportive environments and critically examining existing policies.