Simulations Plus, Inc. · NASDAQ:SLP
Simulations Plus — Shareholder Meeting (February 2016)
30 slides from Simulations Plus's shareholder meeting presentation, Feb 26, 2016
Slide 1: Annual Shareholders' Meeting February 25, 2016
Simulations Plus, Inc. (NASDAQ:SLP) Annual Shareholders’ Meeting February 25, 2016
Slide 2: Agenda
• Welcome and Introductions • Discussion of Voting Issues • Chairman’s Remarks • Financial presentation • Products and Services • Questions & Answers • Adjournment of Official Meeting Agenda
Slide 3: Safe Harbor Statement
Safe Harbor Statement With the exception of historical information, the matters discussed in this presentation are forward - looking statements that involve a number of risks and uncertainties . The actual results of the Company could differ significantly from those statements . Factors that could c
Slide 4: Management & Directors
Management & Directors • Board of Directors: – David Z. D’Argenio, Ph.D., Director • Professor, Biomedical Engineering, USC • Director, Co - Director, Biological Simulation Resource Center, USC since 1985 – Thaddeus H. “Ted” Grasela, Ph.D., Director and President • Founder of Cognigen Corporation –
Slide 5: Auditors, Tax Specialists and Legal Counsel
• Registered Independent Auditors • Rose, Snyder & Jacobs, Encino, CA • Tax Specialists • Rose, Snyder & Jacobs, Encino, CA • Legal Counsel • Procopio, Cory, Hargreaves, & Savitch LLP Outside Counsels
Slide 6: Voting Issues/Proxy Proposals
6 • Through this morning 92% of outstanding share votes have been cast • Proposal 1: Election of Directors • Result: All elected with ~98+% voting for • Proposal 2: Ratify Rose, Snyder & Jacobs CPA’s as Independent Registered Public Accounts • Result: Ratified with 99+% voting to ratify • With these
Slide 7: Simulations Plus, Inc. Overview
• Major software provider for pharmaceutical research and development • Consulting services for problem drugs and formulations • Expertise and software tools span from earliest drug discovery through clinical trials and beyond patent life to supporting generic companies • New applications being expl
Slide 8: Financial Presentation
• FY2015 ended August 31, 2015 vs FY2014 • 1QFY2016 vs 1QFY2015 • Balance Sheet Highlights • Financial Charts FINANCIAL PRESENTATION
Slide 9: Income Statement FY15 Compared to FY14
9 Income Statement FY15 Compared to FY14 (in millions) California Buffalo FY15 FY14 Diff % chg Net sales $13.086 $5.228 $18.314 $ 11.461 $6.853 59.8% Gross profit 10.855 3.144 13.999 $ 9.832 4.167 42.4% Gross profit margin 82.95% 60.14% 76.44% 85.79% - 9.35% - 10.9% SG&A 4.783 2.030 6.813 $ 4.440 2.
Slide 10: Income Statement 1QFY16 Compared to 1QFY15
10 Income Statement 1QFY16 Compared to 1QFY15 (in millions) Lancaster Buffalo 1QFY16 1QFY15 Diff % chg Net sales $ 3.410 $ 1.428 $ 4.838 $ 4.086 $0.752 18.4% Gross profit 2.853 0.902 3.755 3.088 0.667 21.6% Gross profit margin 83.67% 63.17% 77.61% 75.58% 2.04% 2.7% SG&A 1.099 0.577 1.676 2.079 - 0.4
Slide 11: Selected Balance Sheet Items
Selected Balance Sheet Items ($ millions) *Cash as of 2/24/16 is $6.9 million 11 August 31, 2015 August 31, 2014 Cash and cash equivalents $8.551* $8.614 Cash per share 0.50 0.52 Accounts Receivable 4,042 1,593 Total current assets 12.364 11.533 Total assets 27.344 20.981 Total current liabilities 3
Slide 12: Revenues by Fiscal Year
Revenues by Fiscal Year - Simulations Plus, Inc. (pro forma prior to 2012) 3.2 5.7 6.1 6.3 7.62 8.74 9.45 10.07 11.46 13.08 5.23 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Lancaster Buffalo
Slide 13: Consolidated Revenues, by Fiscal Quarter and YTD
13 Consolidated Revenues, by Fiscal Quarter and YTD (pro forma prior to 2012; in millions) 4.01 4.57 5.99 3.71 4.84 $0 $1 $2 $3 $4 $5 $6 $7 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 2015 2016
Slide 14: Consolidated Net Income, by Fiscal Quarter and YTD
14 Consolidated Net Income, by Fiscal Quarter and YTD (pro forma prior to 2012; in millions) $0.53 $0.97 $1.85 $0.49 $1.11 $ - $0.50 $1.00 $1.50 $2.00 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 2015 2016
Slide 15: Returning Cash to Shareholders
15 Returning Cash to Shareholders (in millions) 1.6 0.8 0.8 2.2 0 0.5 0.5 0.6 0.81 0.81 0.81 0.84 0.84 0.84 0.85 0.85 0.85 13.2 12.9 12.7 11.4 9.3 9.8 10 10.1 10.6 11 7.8 8.6 5.8 6.1 6.4 8.6 7.2 6.9 $0 $1 $1 $2 $2 $3 $0 $2 $4 $6 $8 $10 $12 $14 Dividend Paid Cash on Hand Cash paid $2.5M TSRL Cash pai
Slide 16: Products & Services
Products & Services
Slide 17: Products and Services
Products and Services • Modeling and Simulation Software • Related consulting services Technology • Molecule design • QSAR • PBPK/PD Markets • Pharmaceutical and Bio Tech Research (pre - clinical and clinical) • [Aerospace, Healthcare ] Users • Chemists • Pharmacokinetic & Formulation Scientists • T
Slide 18: Overview of Products and Services
Simulations Plus, Inc. Overview of Products and Services 18 N H O OH O CH 3 CH 3 CH 3 ADMET Predictor ™ GastroPlus ™ Population PK/PD Modeling & Simulations Regulatory Submission MedChem Studio ™ MedChem Designer™ DDDPlus ™ MembranePlus ™ Consulting Services and Collaborations Buffalo PKPlus ™ (new)
Slide 19: The Science Behind the Software: What happens when I swallow a pill?
The Science Behind the Software What happens when I swallow a pill? GI Tract Chemical Degradation Dissolution
Slide 20: The Science Behind the Software: after the medicine is absorbed
What happens after the medicine is absorbed? The Science Behind the Software
Slide 21: Software Product Developments
21 • Version 9.5 scheduled for spring 2016 ‒ Intramuscular dosing model – optional add - on model ‒ Antibody - drug conjugate (ADC) models for biologics • Version 8.0 scheduled for early 2016 ‒ Significant refresh of the graphical user interface ‒ New ‘Chemistry’ module – optional add - on incorpora
Slide 22: PBPK Modeling and Simulation Increasingly Common in Regulatory Submissions
22 PBPK Modeling and Simulation is Becoming More Common in Regulatory Submissions Figure 1. The number of PBPK applications contained in IND/NDA submissions or developed by US FDA reviewers from 2008 to 2012. Huang, Shiew - Mei, et al, The utility of modeling and simulation in drug development and r
Slide 23: Modeler Overview
Application of artificial neural network ensemble (ANNE) technology used to build predictive models from complex input data for various industries • ADMET Modeler ™ (embedded in ADMET Predictor ™) – Predicts large number of important drug properties without the need to synthesize and test molecules
Slide 24: Strong Relationships with Regulators Driving Applications
• FDA Center for Food Safety and Applied Nutrition (modeling of toxicity endpoints) • FDA Office of Testing and Research (mechanistic absorption and IVIVCs) • NIEHS National Toxicology Program (screening of the Tox21 database using QSAR and PBPK modeling) • FDA Office of Generic Drugs (ocular absorp
Slide 25: Buffalo Division (Cognigen) - Overview
• Provides modeling & simulation support for Pharma and Biotech companies – Primary focus on pharmacokinetic, biomarker, and outcome data from preclinical and clinical studies – 30 - 40 drugs per year; >100 different compounds over the last 5 years • Track record of successful regulatory submissions
Slide 26: SLP - Customers Highlights
SLP – Customers Highlights • FY15 Renewal rates (in line with historical performance): • Accounts = 91% • Fees = 95% • 690 license “units” in FY15 • 17% increase vs. FY14 • Over 200 organizations licensing the technology, including 19 of the top 20 pharmaceutical companies
Slide 27: Additional Growth Opportunities
• Of 2,500 companies registered with FDA, both foreign and domestic, we have ~10% penetration with Simulations Plus products – http://www.fda.gov/Drugs/NewsEvents/ucm339912.htm • Continued enhancement of current software products to expand application space • Dermal and improved oral cavity dosing m
Slide 28: Marketing and Sales Program
• Conferences/scientific meetings continue to be primary source of leads • In 4Q14, we presented at our first aerospace conference • In 1Q15 we presented at our first MRI conference • Trainings and workshops • Strategic digital marketing initiatives • Active updates of LinkedIn, YouTube, Facebook ,
Slide 29: Summary
29 Summary • For FY2015: - Financial performance continues our 8 - year profitable trend - Successful acquisition of Cognigen Corporation increasing revenues by $5.2 Million - Continuing to Expand our team : - Cognigen acquisition doubled the employee count of the consolidated entity • Expanding Sal
Slide 30: & @B SimulationsPlus
& 30 @B SimulationsPlus
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