Slide 1: Investor Conference Call November 18, 2015
( NASDAQ:SLP ) Investor Conference Call November 18, 2015
Slide 2: Safe Harbor Statement
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 . Factors that could cause or contribute t
Slide 3: Highlights
3 Highlights Walt Woltosz Chairman and Chief Executive Officer
Slide 4: Company Highlights
4 • Major provider of software and consulting services for pharma R&D • Earliest drug discovery – when a chemist first draws a molecule • Preclinical development (lab and animals) through first - in - human trials • Phase 2 and 3 clinical trials • Beyond patent life to supporting generic companies •
Slide 5: 4QFY15 Highlights
5 • Software renewal rates 99%(fees) • 21 new software client sites added • Product releases • GastroPlus 9.0: • Biologics Module • Dermal Module • Enhanced oral cavity dosing • Enhanced ADMET Predictor integration • ADMET Predictor 7.2: • New property predictions • Retrained metabolism models • Gre
Slide 6: FDA Office of Generic Drugs Funded Collaboration
6 • Completed first 9 months of 3 - year, $200,000/year collaboration (full year completed in 1QFY16 and contract was renewed for second year) • Met all milestones due during FY15 • Consortium of leading pharmaceutical companies established to ensure the scientific integrity of the improved model an
Slide 7: Exploring Business Opportunities Outside of Pharmaceutical Industry
7 • 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 • Classify missiles from radar tracking data • Discriminate between warheads and decoys from sensor data •
Slide 8: Summary
8 • Continued Growth • Seven - year - plus profitable trend • Successful strategic acquisition • Customer base increase: • 22 new software customers in 4QFY15, 86 in FY15 • 90 + percent renewal rate • Expecting continued compounded growth • 4 th Quarter earnings per share increase 114% ($0.015) • St
Slide 9: Financial Overview
9 Financial Overview John Kneisel Chief Financial Officer
Slide 10: Income Statement 4QFY15 Compared to 4QFY14
10 Income Statement 4QFY15 Compared to 4QFY14 (in millions) California Buffalo 4QFY15 4QFY14 Diff % chg Net sales $ 2.291 $ 1.421 $ 3.712 $ 1.998 $ 1.714 85.8% Gross profit 1.732 0.903 2.635 1.537 1.098 71.4% Gross profit margin 75.60% 63.55% 70.99% 76.93% - 5.94% - 7.7% SG&A 1.038 0.472 1.510 1.061
Slide 11: Income Statement FY15 Compared to FY14
11 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 12: Consolidated Revenues, by Fiscal Quarter and YTD
12 Consolidated Revenues, by Fiscal Quarter and YTD (pro forma prior to 2012; in millions) 4.01 4.57 5.99 3.71 $0 $1 $2 $3 $4 $5 $6 $7 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 2015 18.31 $0 $5 $10 $15 $20 2009 2010 2011 2012 2013 2014 2015
Slide 13: Consolidated Gross Profit, by Fiscal Quarter & YTD
13 Consolidated Gross Profit, by Fiscal Quarter & YTD (pro forma prior to 2012; in millions) 3.09 3.45 4.83 2.64 $0 $1 $2 $3 $4 $5 $6 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 2015 14.00 $0 $5 $10 $15 Year end 2009 2010 2011 2012 2013 2014 2015
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 $- $0.50 $1.00 $1.50 $2.00 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 2015 $3.84 $- $1.00 $2.00 $3.00 $4.00 $5.00 YTD 2009 2010 2011 2012 2013 2014 2015
Slide 15: Consolidated Diluted Earnings Per Share
15 • Consolidated Diluted Earnings Per Share 0 0.02 0.04 0.06 0.08 0.1 0.12 Q1 Q2 Q3 Q4 Quarterly EPS FY09 FY10 FY11 FY12 FY13 FY14 FY15 0.08 $0.13 $0.17 $0.18 $0.18 $0.18 $0.23 $0.00 $0.05 $0.10 $0.15 $0.20 $0.25 Q4 YTD EPS FY09 FY10 FY11 FY12 FY13 FY14 FY15
Slide 16: Consolidated EBITDA, by Fiscal Quarter & YTD
16 Consolidated EBITDA, by Fiscal Quarter & YTD (in millions) 7.68 $0 $1 $2 $3 $4 $5 $6 $7 $8 $9 YTD 2009 2010 2011 2012 2013 2014 2015 1.45 1.97 3.33 1.19 $0 $1 $2 $3 $4 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 2015
Slide 17: Returning Cash to Shareholders
17 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 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 7.3 $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 paid $2.1M f
Slide 18: Selected Balance Sheet Items
18 Selected Balance Sheet Items (in millions) August 31, 2015 August 31, 2014 Cash and cash equivalents $8.551* $8.614 Cash per share 0.50 0.52 Total current assets 11.533 11.533 Total assets 27.344 20.981 Total current liabilities 3.613 1.391 Total liabilities 7.812 5.545 Current ratio 3.19 8.29 Sh
Slide 19: Marketing and Sales
19 Marketing and Sales John DiBella VP of Marketing and Sales
Slide 20: Overview of Products and Services
20 Overview of Products and Services 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 Discovery Preclinical C linical COMING SOON: PKP
Slide 21: Software Product News
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: FY15 Sales Review
22 FY15 Sales Review • Highlights: – Software revenue +11.5% vs. FY14 – 91% renewal rate (accounts) – 95% renewal rate (fees) – 17% increase in license units – 31 new commercial companies – 38 new nonprofit groups – PBPK consulting +105%* vs. FY14 • * Does not include FDA grant revenue 54% 13% 32% 1
Slide 23: New Software Customers
23 New Software Customers Annual Quarterly 0 5 10 15 20 25 Q1 Q2 Q3 Q4 2012 2013 2014 2015 0 10 20 30 40 50 60 70 80 90 100 FY12 FY13 FY14 FY15
Slide 24: FY15 Software/PBPK Consulting Revenue by Region
24 FY15 Software/PBPK Consulting Revenue by Region Europe 28% (+22% vs. FY14) North America 48% (+11% vs. FY14) Asia 24% (+12% vs. FY14) South America <1% (No change vs. FY14) Japan = 63% China = 17% Korea = 8% India = 7%
Slide 25: Marketing Activities – 4QFY15
25 Marketing Activities – 4QFY15 • Logo Redesign – Redesigned corporate logo – will work on website refresh in FY16 • Conferences and scientific meetings – 14 scientific meetings attended; co - authors on 8 presentations • Trainings and workshops – Hosted 7 onsite training workshops at client sites;
Slide 26: Buffalo Office Update
26 Buffalo Office Update Expanding Our Reach in Consulting Services and Product Offerings Ted Grasela President
Slide 27: Buffalo Growth Opportunities
27 Buffalo Growth Opportunities • Strategic and synergistic benefits of the Buffalo (Cognigen) acquisition are being realized • Strong collaborations between Buffalo and Lancaster scientists have identified new and innovative ways of using modeling and simulation to bring valuable insights to our cl
Slide 28: Status Report - Consulting
28 Status Report - Consulting • Working with 20 companies on 49 projects of which 15 projects started FY16Q1 • Expanded scope of projects with 3 companies • Worked with 7 new companies over the past year • Most common therapeutic area is oncology, followed by neurology and immunology – ~25% of proje
Slide 29: Cutting Edge Scientific Projects
29 Cutting Edge Scientific Projects • Investigating feasibility of designing formulations to match clinical therapeutic needs • Designing clinical programs for inhaled therapies to improve data input into GastroPlus to improve predictive performance • Leveraging GastroPlus ability to predict intrace
Slide 30: Brookings Health Policy Event
B Health Policy at BROOKINGS Improving Productivity in Pharmaceutical Research and Development: The Role of Clinical Pharmacology and Experimental Medicine Center for Health Policy The Brookings Institution The Embassy Row Hotel ¢ Washington, DC July 28, 2015 SimulationsPlus 30 ssl
Slide 31: The Pink Sheet: Drug Approvals Might Skip 2nd Trial
34 “The Pink Sheet.’ Text Size Email Print Share Drug Approvals Might Skip 2" Trial, Rely More On Clinical Pharmacology By Sue Sutter Email the Author View Full Issue Regulatory Update | Word Count: 1653 | Article #00150810002 | Posted: August 10 2015 12:01 AM Executive Summary FDA looks to expand 1
Slide 32: Coping with Complexity and Chaos
32 • Analysis in R&D can be messy • Data and inputs coming from many groups • Careful synthesis and communication is essential • The industry has enormous computing power • The industry lacks tools for harnessing that power Behind the scenes in R&D Coping with complexity and chaos
Slide 33: KIWI – A Software Platform for Validated Cloud Processing
33 KIWI™ – A Software Platform for Accessing Simulations Plus’ Validated Cloud Processing Capabilities
Slide 34: KIWI Update
34 • Current KIWI ™ prospects: 6 • Successful PAGE meeting in June 2015 • 10 demonstrations • Successful ACOP meeting in October 2015 • 12 demonstrations • Targeting release of KIWI ™ Version 1.5 in December 2015 • Next release – July 2016 KIWI Update
Slide 35: Summary
35 Summary • Buffalo office strong and growing • Revenues and earnings up and contributing to overall growth of Simulations Plus • Consulting expanding through enhanced marketing and sales and through synergies with Lancaster office for PBPK modeling in clinical pharmacology • KIWI software platform
Slide 36: Final Summary
36 Final Summary Walt Woltosz Chairman and Chief Executive Officer
Slide 37: Final Summary
37 • California and Buffalo divisions both performing well • Expected synergies being realized • Addressing regulatory agency interests in applying PBPK modeling in clinical pharmacology • Software sales continue strong growth trend • New releases expected to further enhance product offerings • Trad