Simulations Plus, Inc. · NASDAQ:SLP
Simulations Plus — Investor Meetings New York City January 12-13, 2015
32 slides from Simulations Plus's conference presentation, Jan 12, 2015
Slide 1: Simulations Plus, Inc. and Cognigen Corp. Investor Meetings New York City
Copyright (c) 2015 Simulations Plus, Inc. 1 Simulations Plus, Inc. and Cognigen Corp. (NASDAQ:SLP ) Investor Meetings New York City January 12 - 13, 2015
Slide 2: Safe Harbor Statement
Copyright (c) 2015 Simulations Plus, Inc. 2 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.
Slide 3: Simulations Plus, Inc. Overview
Copyright (c) 2015 Simulations Plus, Inc. 3 • 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 gen
Slide 4: Overview of Products and Services
Copyright (c) 2015 Simulations Plus, Inc. 4 Simulations Plus, Inc. Overview of Products and Services 4 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 Service
Slide 5: The Science Behind the Software: What happens when I swallow a pill?
Copyright (c) 2015 Simulations Plus, Inc. 5 The Science Behind the Software What happens when I swallow a pill? GI Tract Chemical Degradation Dissolution
Slide 6: The Science Behind the Software: What happens after the medicine is absorbed?
Copyright (c) 2015 Simulations Plus, Inc. 6 The Science Behind the Software What happens after the medicine is absorbed?
Slide 7: PBPK Modeling and Simulation is Becoming More Common in Regulatory Submissions
Copyright (c) 2015 Simulations Plus, Inc. PBPK Modeling and Simulation is Becoming More Common in Regulatory Submissions 7 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
Slide 8: Strong Relationships With Regulators Driving Applications
Copyright (c) 2015 Simulations Plus, Inc. 8 • 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)
Slide 9: Cognigen Division - Overview
Copyright (c) 2015 Simulations Plus, Inc. 9 • Provide modeling & simulation support for Pharma and Biotech companies • Primary focus on data from clinical studies • 30 - 40 drugs per year; >100 different compounds over the last 5 years • Track record of successful regulatory submissions utilizing ph
Slide 10: Cognigen Division - Calendar Year 2014
Copyright (c) 2015 Simulations Plus, Inc. 10 • Worked with 22 clients on 62 projects covering 38 different compounds • Average length of current client relationship is 6 years ranging from 1 - 14 years • 6 new clients • 6 regulatory submissions • Typically work on 4 to 8 submissions per year Cognige
Slide 11: Cognigen Division Infrastructure
Copyright (c) 2015 Simulations Plus, Inc. 11 • Significant investment in IT infrastructure and workflow processes • Recently upgraded computer systems, implemented automated offsite backup storage, and installed green technology to reduce computer cooling costs • KIWI ™ - proprietary software provid
Slide 12: Additional Growth Opportunities
Copyright (c) 2015 Simulations Plus, Inc. 12 • Cognigen • Penetration of clinical pharmacology departments to provide more detailed mechanistic modeling for clinical trial data analysis – regulatory agencies want this • Expand marketing effort for KIWI ™ • Expand marketing effort for modeling & simu
Slide 13: Additional Growth Opportunities, cont'd.
Copyright (c) 2015 Simulations Plus, Inc. 13 • 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 spa
Slide 14: Additional Growth Opportunities, cont'd.
Copyright (c) 2015 Simulations Plus, Inc. 14 • AEROModeler ™ • Application of our artificial neural network ensemble (ANNE) technology to predict aerodynamic force coefficients for missiles at arbitrary Mach number and angle of attack - much faster than conventional methods ‒ Presented at our first
Slide 15: Marketing and Sales Program
Copyright (c) 2015 Simulations Plus, Inc. 15 • Conferences/scientific meetings continue to be primary source of leads • During FY14, we participated in 48 scientific meetings and conferences in the US, Europe, and Asia with 30 scientific posters and presentations • In 4Q14, we presented at our first
Slide 16: Marketing and Sales Program
Copyright (c) 2015 Simulations Plus, Inc. 16 • Strategic digital marketing initiatives • Hosted 7 webinars on our new software updates and applications - over 1100 registrations • Active updates of LinkedIn, Facebook, and Twitter accounts help with outreach programs • We believe fundamental industry
Slide 17: FY15.1 Sales By Region
Copyright (c) 2015 Simulations Plus, Inc. 17 FY15.1 Sales By Region Europe 19% North America 56% Asia 25% South America <1% Japan = 50% India = 15% China = 28% Korea = 7%
Slide 18: New Customers By Quarter
Copyright (c) 2015 Simulations Plus, Inc. 18 New Customers By Quarter 10 11 9 9 14 17 12 14 15 21 13 10 18 18 16 9 15 22 20 18 Q1 Q2 Q3 Q4 2010 2011 2012 2013 2014 2015 23
Slide 19: FQY15.1 Highlights Fiscal Quarter Ended 11/30/14
Copyright (c) 2015 Simulations Plus, Inc. 19 • FQY15.1 compared to FQY14.1 • Sales increased by $1.5 million to $4.1 million from $2.6 million ‒ Cognigen revenues were $1.1 million ‒ Simulation Plus revenue increased $310,000 or 11.7% in FQY15.1 vs. FQY 14.1 • Cost of revenues increase by $537,000.
Slide 20: FQY15.1 Highlights
Copyright (c) 2015 Simulations Plus, Inc. 20 • FQY15.1 compared to FQY14.1( Con’t ) • Consolidated Gross margin decreased to 75.6% from 82.5% ‒ Cognigen gross margin for the quarter was 52.9% ‒ Simulations Plus margin for the quarter was 84.3% up from 82.5% the prior year • SG&A increased $1.0 milli
Slide 21: FQY15.1 Highlights Fiscal Quarter Ended 11/30/14
Copyright (c) 2015 Simulations Plus, Inc. 21 • FQY15.1 compared to FQY14.1( Con’t ) • R&D expense increased 60.3% to $260,000 from $162,000 the prior year ‒ This increase resulted from a higher mix of expensed R&D in FQY15.1 compared to FQY14.1 • Other income(expense) decrease by $36K in FQY15.1 vs.
Slide 22: FQY15.1 Highlights Fiscal Quarter Ended 11/30/14
Copyright (c) 2015 Simulations Plus, Inc. 22 • FQY15.1 compared to FQY14.1( Con’t ) • Diluted earnings per share was $ 0.03 in FQY15.1, a decrease of $ 0.01 from $ 0.04 in FQY14.1 • Without one - time charges, diluted earnings per share would have been approximately $0.05 per share, up 58% • Cash di
Slide 23: Income Statement FQY15.1 Versus QY14.1
Copyright (c) 2015 Simulations Plus, Inc. 23 Income Statement FQY15.1 Versus QY14.1 ($ millions) FQY15.1 FQY14.1 Net sales 4.086 2.641 Gross profit 3.088 2.193 Gross profit margin 75.6% 83.0% SG&A 2.079 1.071 R&D 0.260 0.162 Total operating expenses 2.339 1.233 Income from operations 0.749 0.959 Oth
Slide 24: Income Statement FQY15.1 by division
Copyright (c) 2015 Simulations Plus, Inc. 24 Income Statement FQY15.1 by division ($ millions) SLP Cognigen Eliminations FQY15.1 Net sales 2.951 1.135 0.00 4.086 Gross profit 2.488 0.600 0.00 3.088 Gross profit margin 84.3% 52.9% 0.00 75.6% SG&A 1.541 0.537 0.00 2.079 R&D 0.260 0.000 0.00 0.260 Tota
Slide 25: Selected Balance Sheet Items
Copyright (c) 2015 Simulations Plus, Inc. 25 Selected Balance Sheet Items ($ millions) November 30, 2014 November 30, 2013 Cash and cash equivalents* $5.791 $10.555 Cash per share 0.34 0.64 Total current assets 10.686 13.136 Total assets 27.108 16.405 Total current liabilities 1.784 0.791 Total liab
Slide 26: Revenues by Quarter
Copyright (c) 2015 Simulations Plus, Inc. 26 Revenues by Quarter (pro forma prior to 2012) $1.4 $1.8 $2.0 $1.1 $1.7 $2.2 $2.3 $1.3 $2.1 $2.6 $2.6 $1.4 $2.2 $2.8 $2.8 $1.6 $2.3 $3.1 $3.1 $1.6 $2.6 $3.1 $2.0 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 2015 $3.7 $4.01 Included $1.135 million from Cognige
Slide 27: Gross Profit by Fiscal Quarter
Copyright (c) 2015 Simulations Plus, Inc. 27 $1.24 $1.53 $1.75 $0.71 $1.45 $1.93 $1.97 $1.07 $1.70 $2.21 $2.21 $1.12 $1.90 $2.39 $2.33 $1.32 $1.90 $2.62 $2.64 $1.26 $2.19 $2.59 $1.54 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 2015 Gross Profit by Fiscal Quarter (pro forma prior to 2012 ) $3.5 $3.09
Slide 28: EBITDA by Fiscal Quarter
Copyright (c) 2015 Simulations Plus, Inc. 28 EBITDA by Fiscal Quarter $0.55 $0.73 $0.93 $0.20 $0.73 $1.28 $1.23 $0.36 $1.00 $1.48 $1.48 $0.27 $1.23 $1.38 $1.48 $0.58 $1.09 $1.76 $1.73 $0.44 $1.20 $1.35 $0.67 1.45 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 2015 $2.1
Slide 29: Net Income by Quarter
Copyright (c) 2015 Simulations Plus, Inc. 29 Net Income by Quarter (pro forma prior to 2012) $ 0.33 $ 0.47 $ 0.53 $ 0.17 $ 0.44 $ 0.85 $ 0.74 $ 0.21 $ 0.56 $ 0.91 $ 1.05 $ 0.17 $ 0.76 $ 0.84 $ 0.87 $ 0.35 $ 0.59 $ 1.06 $ 0.99 $ 0.24 $ 0.69 $ 0.81 $ 1.31 $ 0.22 $ 0.53 Q1 Q2 Q3 Q4 2009 2010 2011 2012
Slide 30: tas of
tas of $10.9 11872015 2 gs = $6.40 a mm TSRL $2.50 i f 0 | S 1 $0161 $HlB2 siib2 ANAT > ND nD RD NDE nde nde nde ey ES Ss ae CEE CEES ate? eo FEF S F FS pes meiaions Fie ™COGNIGEN* Copyright () 2015 Simulations Plus, Inc. Sence Sofware Suess 39
Slide 31: Summary
Copyright (c) 2015 Simulations Plus, Inc. 31 • For FQY15.1 - Revenues and earnings continued seven - year - plus profitable trend - Cognigen acquisition increases revenues, expands offerings into clinical pharmacology - Earnings for quarter lower due to one - time charges associated with the Cognige
Slide 32: Q&A
Copyright (c) 2015 Simulations Plus, Inc. 32 Q&A
Simulations Plus — Investor Meetings New York City January 12-13, 2015 on 6ix