Simulations Plus, Inc. · NASDAQ:SLP
Simulations Plus — FY2017 Earnings Presentation
35 slides from Simulations Plus's earnings presentation, Nov 15, 2017
Slide 1: Investor Conference Call November 14, 2017
(NASDAQ:SLP) Investor Conference Call November 14, 2017
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 Walter S. Woltosz CEO and Chairman
Slide 4: Company overview and 4QFY17 / FY17 highlights
4 • Global provider of software and consulting solutions for R&D • Earliest drug discovery – when a chemist first draws a molecule • Preclinical development (lab and animals) through first - in - human trials • Safety research and risk assessment • Phase 2 and 3 clinical trials • Beyond patent life
Slide 5: Simulations Plus: Your end-to-end M&S solutions provider
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 Clinical PKPlus™ KIWI™ Simulations Plus: Your end - to - end M&S solutions provider DILIsym ® NAFLDsym™ 5
Slide 6: FDA Voice blog
6 FDA Voice blog: July 7 th , 2017
Slide 7: GastroPlus PBPK Consulting: Regulatory Interactions
GastroPlus PBPK C onsulting from Simulations Plus: Regulatory Interactions • Since 2015, our consulting team has built PBPK models and written reports for internal review and submissions to various regulatory agencies for the following types (and numbers) of projects: – Formulation optimization (14)
Slide 8: Two-year stock performance compared to DOW, NASDAQ, S&P 500
* Yahoo! Data 11/13/2017 Close Two - year stock performance compared to DOW, NASDAQ, & S&P 500 * 8
Slide 9: Financial Overview
9 Financial Overview John Kneisel Chief Financial Officer
Slide 10: Income Statement: 4QFY17 Versus 4QFY16
10 Income Statement: 4QFY17 Versus 4QFY16 (in millions) Lancaster Buffalo North Carolina (ACQ. 6/01/17) 4QFY17 4QFY16 Diff % chg Net sales $ 2.92 $ 2.11 $ 1.24 $ 6.27 $ 3.96 $ 2.31 58.3% Gross profit 2.37 1.24 0.68 4.29 2.90 1.40 48.2% Gross profit margin 81.3% 58.7% 55.2% 68.5% 73.2% - 4.7% - 6.4%
Slide 11: Income Statement: FY17 Versus FY16
11 Income Statement: FY17 Versus FY16 (in millions) Lancaster Buffalo North Carolina (ACQ. 6/01/17) FY17 FY16 Diff % chg Net sales $ 15.60 $ 7.30 $ 1.24 $ 24.14 $ 19.97 $ 4.17 20.9% Gross profit 12.96 4.19 0.68 17.83 15.37 2.46 16.0% Gross profit margin 83.0% 57.4% 55.2% 73.9% 77.0% - 3.1% - 4.0% SG
Slide 12: Consolidated Revenues: Fiscal Quarter
12 Consolidated Revenues: Fiscal Quarter ( in millions) 2.29 3.12 3.09 1.58 2.64 3.08 3.74 2.00 4.01 4.57 5.94 3.71 4.84 5.16 6.01 3.96 5.42 5.71 6.75 6.26 $0 $1 $2 $3 $4 $5 $6 $7 $8 Q1 Q2 Q3 Q4 2013 2014 2015 2016 2017
Slide 13: Consolidated Net Income: Fiscal Quarter
13 Consolidated Net Income: Fiscal Quarter (in millions) $0.59 $1.06 $0.99 $0.24 $0.69 $0.81 $1.31 $0.22 $0.53 $0.97 $1.85 $0.49 $1.11 $1.15 $1.91 $0.79 $1.36 $1.20 $2.08 $1.15 $- $0.50 $1.00 $1.50 $2.00 $2.50 Q1 Q2 Q3 Q4 2013 2014 2015 2016 2017
Slide 14: Consolidated Diluted Earnings Per Share
14 Consolidated Diluted Earnings Per Share $0.04 $0.06 $0.06 $0.01 $0.04 $0.05 $0.08 $0.01 $0.03 $0.06 $0.11 $0.03 $0.06 $0.07 $0.11 $0.05 $0.08 $0.07 $0.12 $0.06 $- $0.02 $0.04 $0.06 $0.08 $0.10 $0.12 $0.14 Q1 Q2 Q3 Q4 Quarterly EPS FY13 FY14 FY15 FY16 FY17
Slide 15: Consolidated EBITDA: Fiscal Quarter
15 Consolidated EBITDA: Fiscal Quarter (in millions) 1.09 1.76 1.73 0.44 1.20 1.35 2.30 0.67 1.22 1.97 3.33 1.19 2.22 2.18 3.28 1.51 2.48 2.30 3.60 1.99 $0 $1 $2 $3 $4 Q1 Q2 Q3 Q4 2013 2014 2015 2016 2017
Slide 16: Cash Position Remains Excellent
16 Cash Position Remains Excellent (in millions ) Over $23MM cash paid out over last three FYs $0.5 $0.6 $0.8 $0.8 $0.8 $0.8 $0.8 $0.8 $0.9 $0.9 $0.9 $0.9 $0.9 $0.9 $0.9 $0.9 $0.9 $2.5 $2.1 $0.8 $0.7 $0.8 $1.0 $5.1 $10.1 $10.6 $11.0 $7.8 $8.6 $5.8 $6.1 $6.4 $8.6 $7.2 $7.1 $8.8 $8.0 $8.8 $7.4 $8.2 $6
Slide 17: Selected Balance Sheet Items
17 Selected Balance Sheet Items (in millions, except where indicated) August 31, 2017 August 31, 2016 Cash and cash equivalents $ 6.216* $ 8.030* Cash per share ( in Dollars ) $ 0.36 $ 0.47 Total current assets 12.668 12.700 Total assets 38.512 27.814 Total current liabilities 2.042 2.126 Total liab
Slide 18: Lancaster Division
18 Lancaster Division John DiBella President
Slide 19: Software Product News – Lancaster Division
19 • Version 9.6 scheduled for January 2018 ‒ New special population physiology models – enhancement to optional add - on module ‒ Improvements to all mechanistic absorption models – enhancement to optional add - on module • Version 8.5 released in November 2017 ‒ New HTPK Simulation Module brings n
Slide 20: 4QFY17 Sales Review – Lancaster Division
4QFY17 Sales Review – Lancaster Division • Revenue +8.1% vs. 4QFY16 • Highlights: – Software revenue +4% • 90% renewal rate (accounts) • 88% renewal rate (fees) • 8% increase in license units • 14 new commercial companies • 11 new nonprofit groups – Continued expansion of licenses at China FDA – Con
Slide 21: FY17 Sales Review – Lancaster Division
FY17 Sales Review – Lancaster Division • Revenue +8.2% vs. FY16 • Highlights: – Software revenue +6% • 88% renewal rate (accounts) • 94% renewal rate (fees) • 8% increase in license units • 44 new commercial companies • 44 new nonprofit groups – Consulting revenue +47% • 23 projects + 2 FDA collabor
Slide 22: FY17 Software Revenue – by Region
FY17 Software Revenue – by Region Europe 26% North America 47% Asia 27% South America <1% Japan = 57% China = 19% India = 16% Korea = 4% 22
Slide 23: FY17 Marketing Activities
FY17 Marketing Activities Website Content • Continued production of video content for promotional/branding purposes • Increased focus on SEO performance • Began migration of content from different division sites to main Simulations Plus domain Workshops and Conferences • 10 PBPK and/or population PK
Slide 24: Cognigen: Re-imagining the Future of Science-based R&D
24 Cognigen Re - imagining the Future of Science - based Research and Development Ted Grasela, PharmD , Ph.D. President, Cognigen
Slide 25: FY2017 Cognigen Growth
FY2017 Cognigen Growth • Sales Growth 31 % • Net Income Growth 97% • Activities supporting continued growth – Successful recruiting and on - boarding of software engineers and scientists – New marketing initiatives and business/sales models – Increasing synergy and cross - selling between divisions
Slide 26: Cognigen Status Report: Pharmacometric Services
26 Cognigen Status Report Pharmacometric Services • In FY2017 relationships with 27 companies on 41 drugs, 74 projects – 9 new companies in FY2017 – 36 new projects in FY17 – 40 projects expanded scope in FY17 – 3 projects with reduced scope – 32 outstanding proposals with 20 different companies • E
Slide 27: Cognigen Status Report: KIWI Pharmacometric Communication Platform
27 • Continue to work on 4 - year contract to design, develop, and implement KIWI TM Pharmacometric Communication Platform for individuals and global teams engaged in model - informed drug development • Deploying KIWI 2 in November 2017 – Pharmacometric - centric data repository to bridge inter - or
Slide 28: Cognigen Summary
28 • Increased Marketing and Sales • Pharmacometric services continue to expand; healthy pipeline of new projects, including global health initiative projects, bridging global regulatory filings, and embedded client partner opportunities from first - in - human to commercialization of new medicines
Slide 29: North Carolina (DILIsym) Division
29 North Carolina (DILIsym) Division Drug - Induced Liver Injury Brett Howell, Ph.D. President, DILIsym Division
Slide 30: Acquisition of DILIsym Services, Inc.
Acquisition of DILIsym Services, Inc. • DILIsym ® is a mechanistic, mathematical model that has been constructed to support pharmaceutical risk assessment and decision - making – Intersection of compound distribution and metabolism (PBPK), hepatotoxicity mechanisms, and patient variability • DILIsym
Slide 31: The DILI-sim Initiative
The DILI - sim Initiative : P artnership between DILIsym Services and p harmaceutical c ompanies to m inimize DILI • Overall Goals – Improve patient safety – Reduce the need for animal testing – Reduce the cost and time necessary to develop new drugs • History – Officially started in 2011 – 17 major
Slide 32: DILIsym Services Status Report
DILIsym Services Status Report • The DILI - sim Initiative is moving into Stage 3 of its lifecycle – Contracts cover years 2018 - 2020 – Focused on adding new science and features to DILIsym including adaptive immune components, new simulated populations, and advanced integration with GastroPlus • C
Slide 33: Final Summary
33 Final Summary Walter S. Woltosz CEO and Chairman
Slide 34: Final Summary: results and outlook
34 • 4QFY17 • Revenues up $2.3 million (58.3% ) to $ 6.3 million • Net income up $362,000 (45.9% ) to $1.15 million * • FY17 • Revenues up $4.17 million (20.9%) to $ 24.1 million • Net income up $ 837,000 (16.9%) to $ 5.79 million* • Diluted earnings per share up 14.9% to 33¢ per share* • California
Slide 35: Thank you!
35 Thank you! http://www.simulations - plus.com https://www.linkedin.com/company/95827/ https://www.linkedin.com/company/46152/