Slide 1: Investor Conference Call January 14, 2016
( NASDAQ:SLP ) Investor Conference Call January 14, 2016
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: 1QFY16 Highlights
4 • Software renewal rates: 89% (accounts); 94%(fees) • 23 new software client sites added • Product development • Announced development of PKPlus ™ • new software product for noncompartmental analysis and compartmental analysis for regulatory submissions • potential to become significant contributo
Slide 5: FDA Office of Generic Drugs (OGD) Funded Collaboration
5 • Completed first year of 3 - year, $200,000/year collaboration and contract was renewed for second year) • Met all milestones during first full year • Consortium of leading pharmaceutical companies established to ensure the scientific integrity of the improved model and maximize the impact on the
Slide 6: Exploring Business Opportunities Outside of Pharmaceutical Industry
6 • 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 and other objects from radar tracking data • Discriminate between warheads and decoys
Slide 7: Overview
7 • 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 8: Summary
8 • Continued Growth • Seven - year - plus profitable trend • Successful strategic acquisition • Customer base increased: • 23 new software customers in 1QFY16 • 94 percent renewal rate (fees) • Expecting continued compounded growth • 1 ST Quarter earnings per share increased 107% ($0.034) • Strong
Slide 9: Financial Overview
9 Financial Overview John Kneisel Chief Financial Officer
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: Consolidated Revenues, by Fiscal Quarter and YTD
11 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 12: Consolidated Gross Profit, by Fiscal Quarter & YTD
12 Consolidated Gross Profit, by Fiscal Quarter & YTD (pro forma prior to 2012; in millions) 3.09 3.45 4.83 2.64 3.76 $0 $1 $2 $3 $4 $5 $6 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 2015 2016
Slide 13: Consolidated Net Income, by Fiscal Quarter and YTD
13 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 14: Consolidated Diluted Earnings Per Share
14 Consolidated Diluted Earnings Per Share 0 0.02 0.04 0.06 0.08 0.1 0.12 Q1 Q2 Q3 Q4 $0.03 $0.06 $0.11 $0.03 $0.06 Quarterly EPS FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16
Slide 15: Consolidated EBITDA, by Fiscal Quarter & YTD
15 Consolidated EBITDA, by Fiscal Quarter & YTD (in millions) 1.22 1.97 3.33 1.19 2.2 $0 $1 $2 $3 $4 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 2015 2016
Slide 16: Returning Cash to Shareholders
16 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 7.2 7.9 $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 paid $2.
Slide 17: Selected Balance Sheet Items
17 Selected Balance Sheet Items (in millions) November 30, 2015 August 31, 2015 Cash and cash equivalents $7.155* $8.551 Cash per share 0.42 0.50 Total current assets 12.364 11.533 Total assets 27.958 27.344 Total current liabilities 3.897 3.613 Total liabilities 8.023 7.812 Current ratio 3.17 3.19
Slide 18: Marketing and Sales
18 Marketing and Sales John DiBella VP of Marketing and Sales
Slide 19: Overview of Products and Services
19 Overview of Products and Services N H O OH O CH 3 CH 3 CH 3 ADMET Predictor™ GastroPlus ™ MedChem Studio™ MedChem Designer™ DDDPlus ™ MembranePlus™ Consulting Services and Collaborations Discovery Preclinical C linical COMING SOON: PKPlus™ KIWI™
Slide 20: Software Product News
20 • 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 21: 1QFY16 Sales Review
21 1QFY16 Sales Review • Highlights: – Software revenue +12% – PBPK consulting +129% – 89% renewal rate (accounts) – 94% renewal rate (fees) – 29% increase in license units – 10 new commercial clients – 13 new nonprofit groups – 50 - license pack ordered by U.S. FDA 51% 14% 34% 1% Consolidated Sales
Slide 22: 1QFY16 Software & PBPK Consulting: Revenue by Region
22 1QFY16 Software & PBPK Consulting: Revenue by Region Europe 27% North America 43% Asia 30% South America <1% Japan = 53% India = 25% China = 21% Korea = 1%
Slide 23: Marketing Activities – 1QFY16
23 Marketing Activities – 1QFY16 • Company rebranding – Launched company rebrand – work continuing on website refresh • Conferences and scientific meetings – 14 scientific meetings attended; co - authors on 19 presentations • Trainings and workshops – Hosted GastroPlus workshops in US, Japan, and Eu
Slide 24: Buffalo Office Update
24 Buffalo Office Update Expanding Our Reach in Consulting Services and Product Offerings Ted Grasela President
Slide 25: Buffalo Growth Opportunities
25 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 26: Status Report - Consulting
26 Status Report - Consulting • Working with 19 companies on 32 drugs, 56 projects of which 15 projects started FY16Q1 • Expanded scope of projects with 3 companies • 26 outstanding proposals • Worked with 7 new companies over the past year; continuing to build relationships • Most common therapeuti
Slide 27: Cutting Edge Scientific Projects
27 Cutting Edge Scientific Projects • Redesigning R&D processes to improve interdisciplinary communications • Modeling and simulation results being used to support client patent applications for new formulations – multiple sclerosis and gout • Emerging applications of systems pharmacology to R&D dec
Slide 28: Coping with Complexity and Chaos
28 • 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 29: KIWI – A Software Platform for Accessing Validated Cloud Processing
29 KIWI™ – A Software Platform for Accessing Simulations Plus’ Validated Cloud Processing Capabilities
Slide 30: KIWI Update
30 • Successful ACCP, ACOP, and AAPS meetings in FY2016 • ~ 20 demonstrations • Targeting release of KIWI ™ Version 1.5 in February 2016 • Improved data visualization tools • Improved metadata labeling • Implementing “agile” methodology for testing and validation that will speed up release of future
Slide 31: Summary
31 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 g
Slide 32: Final Summary
32 Final Summary Walt Woltosz Chairman and Chief Executive Officer
Slide 33: Summary
33 Summary 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 +