Simulations Plus, Inc. · NASDAQ:SLP
Simulations Plus — Q1 FY2018 Earnings Presentation
34 slides from Simulations Plus's earnings presentation, Jan 10, 2018
Slide 1: Investor Conference Call January 9, 2018
(NASDAQ:SLP) Investor Conference Call January 9, 2018
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 - Walter S. Woltosz
3 Highlights Walter S. Woltosz CEO and Chairman
Slide 4: Overview
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: 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: July 2017
6 FDA Voice blog: July 7 th , 2017
Slide 7: GastroPlus PBPK Consulting: Regulatory Interactions
GastroPlus PBPK Consulting 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: – Preclinical development and Fi
Slide 8: Financial Overview - John Kneisel
8 Financial Overview John Kneisel Chief Financial Officer
Slide 9: Income Statement: 1QFY18 Versus 1QFY17
9 Income Statement: 1QFY18 Versus 1QFY17 (in millions) Lancaster Buffalo North Carolina (ACQ. 6/01/17) 1QFY18 1QFY17 Diff % chg Net sales $ 4.0 $ 1.9 $ 1.1 $ 7.1 $ 5.4 $ 1.7 30.5% Gross profit 3.3 1.2 0.8 5.3 4.1 1.3 30.6% Gross profit margin 82.4% 63.1% 71.2% 75.4% 75.3% 0.1% 0.1% SG&A $ 1.4 $ 0.7
Slide 10: Consolidated Revenues: Fiscal Quarter
10 Consolidated Revenues: Fiscal Quarter ( in millions) 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 7.07 $0 $1 $2 $3 $4 $5 $6 $7 $8 Q1 Q2 Q3 Q4 2014 2015 2016 2017 2018
Slide 11: Consolidated Net Income: Fiscal Quarter
11 Consolidated Net Income: Fiscal Quarter (in millions) $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 $1.72 $- $0.50 $1.00 $1.50 $2.00 $2.50 Q1 Q2 Q3 Q4 2014 2015 2016 2017 2018
Slide 12: Consolidated Diluted Earnings Per Share
12 Consolidated Diluted Earnings Per Share $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 $0.10 $- $0.02 $0.04 $0.06 $0.08 $0.10 $0.12 $0.14 Q1 Q2 Q3 Q4 Quarterly EPS FY14 FY15 FY16 FY17 FY18
Slide 13: Consolidated EBITDA: Fiscal Quarter
13 Consolidated EBITDA: Fiscal Quarter (in millions) 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 3.16 $0 $1 $2 $3 $4 Q1 Q2 Q3 Q4 2014 2015 2016 2017 2018
Slide 14: Cash Position Remains Excellent
14 Cash Position Remains Excellent (in millions) Over $24 million 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 $1.0 $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
Slide 15: Selected Balance Sheet Items
15 Selected Balance Sheet Items (in millions, except where indicated) November 30, 2017 August 31, 2017 Cash and cash equivalents $ 7.046 * $ 6.216* Cash per share ( in Dollars ) $ 0.41 $ 0.36 Total current assets 13.987 12.668 Total assets 39.750 38.512 Total current liabilities 5.654 2.042 Total l
Slide 16: Lancaster Division - John DiBella
16 Lancaster Division John DiBella President, Lancaster Division
Slide 17: Software Product News - Lancaster Division
17 • 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 9.0 scheduled for May 2018 ‒ Updates to HTPK Simulation Module – ne
Slide 18: 1QFY18 Sales Review - Lancaster Division
1QFY18 Sales Review – Lancaster Division • Revenue +9.4% vs. 1QFY17 • Highlights: – Software revenue +3% • 80% renewal rate (accounts) • 88% renewal rate (fees) • 4% increase in license units • 11 new commercial companies – New domestic customers in India, Japan, and China • 10 new nonprofit groups
Slide 19: 1QFY18 Software Revenue by Region
1QFY18 Software Revenue – by Region Europe 27% North America 45% Asia 28% South America <1% Japan = 56% China = 23% India = 21% Korea = <1% 19
Slide 20: 1QFY18 Marketing Activities
1QFY18 Marketing Activities Website Content • Increased production of video content for promotional/branding purposes • Increased focus on SEO performance • Continued migration of content from different division sites to main Simulations Plus domain Workshops and Conferences • PBPK workshops held in
Slide 21: Re-imagining the Future of Science-based R&D - Ted Grasela
21 Re - imagining the Future of Science - based Research and Development Ted Grasela, PharmD , Ph.D. President, Cognigen
Slide 22: Cognigen Growth
Cognigen Growth • 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 – Accelerating KIWI TM development 22
Slide 23: Cognigen Status Report
23 Cognigen Status Report Pharmacometric Services • In FY2018 relationships with 21 companies on 34 drugs, 54 projects – 2 new companies in FY2018 – 14 new projects in FY2018 – 8 projects expanded scope in FY2018 – 3 projects with reduced scope – 37 outstanding proposals with 25 different companies
Slide 24: Leading by Example
24 Leading by Example...... ‘Annual Review of Pharmacology and Toxicology Model-Informed Drug Development for Malaria Therapeutics Kayla Ann Andrews,!* David Wesche,? James McCarthy,** Jorg J. Mohrle, Joel Tarning,?* ‘Luann Phillips,! Steven Kern,’ and Thaddeus Grasela! 4 hs, Bail, New York 1221, US
Slide 25: Cognigen Summary
25 • Increased Marketing and Sales • Pharmacometric services continue to expand ‒ Healthy pipeline of new projects, including global health initiative projects ‒ Bridging global regulatory filings ‒ Embedded client partner opportunities from first - in - human to commercialization of new medicines •
Slide 26: Drug-Induced Liver Injury and Liver Diseases - Brett Howell
26 Drug - Induced Liver Injury and Liver Diseases Brett A. Howell, President DILIsym Services, Research Triangle Park, NC
Slide 27: DILIsym Services, Inc. - Our Vision
DILIsym Services, Inc. – Our Vision 27 • DILIsym Services, Inc. offers comprehensive program services: – DILIsym software licensing, training, development (DILI - sim Initiative) – DILIsym and NAFLDsym simulation consulting projects – Consulting and data interpretation – in vitro assay experimental
Slide 28: DILIsym Services Fiscal Q1 Sales Review
DILIsym Services Fiscal Q1 Sales Review • DILIsym software consulting projects – 17 active consulting projects using our DILIsym software – DILIsym software is focused on helping companies predict drug - induced liver injury probability for drugs and drug candidates – Involve data management and ana
Slide 29: DILIsym Services Software Product News
DILIsym Services Software Product News • DILIsym version 7A was released on Monday, January 8 th to DILI - sim consortium members for internal software use – Includes large number of expanded features and exemplar drugs • NAFLDsym development continues through large pharma company sponsorships – Add
Slide 30: DILIsym Services Marketing Updates
DILIsym Services Marketing Updates • Planning to give scientific talks, training courses, and/or exhibitions at 6 or more venues in 2018, including several national meetings focused on liver and safety • Jointly marketing with Simulations Plus (Lancaster Division) and Cognigen at most shows • Workin
Slide 31: DILIsym Services Summary
DILIsym Services Summary • New, enhanced version of flagship product, DILIsym, just released • Active development across multiple products for expanded applications • Continuing to work with Simulations Plus Lancaster and Cognigen on integrative marketing and other synergies • Number of consulting c
Slide 32: Final Summary - Walter S. Woltosz
32 Final Summary Walter S. Woltosz CEO and Chairman
Slide 33: Final Summary
33 • 1QFY18 • Revenues up $1.7 million (30.5%) to $7.1 million • Net income up $354,000 (26.0%) to $1.7 million • Diluted earnings per share up 22.8% to 10¢ per share • California, Buffalo, and North Carolina divisions all performing well • Expected synergies being realized • Addressing regulatory a
Slide 34: Thank you!
34 Thank you! http://www.simulations - plus.com https://www.linkedin.com/company/95827/ https://www.linkedin.com/company/46152/