EX-99.2 4 simulations_8k-ex9902.htm INVESTOR CONFERENCE CALL APRIL 13, 2016

Exhibit 99.2

 

( NASDAQ:SLP ) Investor Conference Call April 13, 2016

 
 

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 to such differences include, but are not limited to : continuing demand for the Company’s products, competitive factors, the Company’s ability to finance future growth, the Company’s ability to produce and market new products in a timely fashion, the Company’s ability to continue to attract and retain skilled personnel, and the Company’s ability to sustain or improve current levels of productivity . Further information on the Company’s risk factors is contained in the Company’s quarterly and annual reports and filed with the Securities and Exchange Commission . Safe Harbor Statement

 
 

3 Highlights Walt Woltosz Chairman and Chief Executive Officer

 
 

4 • Software renewal rates: 85% (accounts); 91%(fees) • 20 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 contributor to revenues and earnings • Working on Version 9.5 of GastroPlus ™ • Intramuscular dosing and enhanced ocular dosing model (2 FDA RCAs helping) • Antibody - drug conjugates (ADCs) • New animal physiologies for Additional Dosing Routes • Working on version 8.0 of ADMET Predictor ™ • major overhaul of user interface and code refactoring • greater integration with MedChem Studio™ • Finalized version 5.0 of DDDPlus ™ • several new dosage forms • tablet disintegration addition • biorelevant solubilities • tablet compression model • Consulting services continue to grow • (3 rd quarter announcement of $4.7MM/5 - year contract) 2 QFY16 Highlights

 
 

5 • Completed first year of up to 3 - year, $200,000/year collaboration for improved ocular dosing simulations – contract renewed for 2nd year • Met all milestones during first full year • Established consortium of leading pharmaceutical companies • The global ophthalmic drugs market was valued at $16 billion in 2012, and was expected to reach an estimated value of $21.6 billion in 2018 • Prevalence of eye disorders is increasing, such as diabetic retinopathy and macular degeneration FDA Office of Generic Drugs (OGD) Funded Collaborations • Began first year of up to 3 - year, $200,000/year collaboration for simulation of long - acting injectable microspheres • Formed consortium of industry partners, FDA scientists, and Simulations Plus • Added intramuscular dosing to GastroPlus • Developing enhancements to DDDPlus to simulate in vitro dissolution/release from polymer microspheres

 
 

6 • AEROModeler™ • Application of our artificial neural network ensemble (ANNE) technology to: • Predict aerodynamic force coefficients for missiles • Classify missiles from radar tracking data • Discriminate between warheads and decoys from sensor data • Exploring several government and industry contacts with interest expressed at each meeting to date • Put on temporary hold to allow development team to focus on PKPlus • MRIModeler™ • Application of our ANNE technology to analysis of magnetic resonance imaging (MRI) data to classify patients as healthy or likely to experience various disease states • Put on temporary hold to allow development team to focus on PKPlus Exploring Business Opportunities Outside of Pharmaceutical Industry

 
 

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 • Enhancing every existing software product. • Finalizing PKPlus – exciting new product • Developing new applications in aerospace and general healthcare based on our machine - learning technologies (on temporary hold) • 2 QFY16 revenues were up by $590,000 (12.9%) to $5.16 million • 2QFY16 net income was up by $175,000 (18.0%) to $1.15 million • 2QFY16 diluted EPS up 16.9% to $ 0.066 (7¢) per share compared to $0.057 (6¢) in 2QFY15. • 6moFY16 revenues were up by $1.34 Million(15.5%) to $10.0 Million • 6mo FY16 net income was up by $ 753,000 ( 50.2%) to $2.25 million • 6moFY16 diluted EPS up 49.0% to $ 0.131 (13¢) per share compared to $ 0.088 (9¢) in 2QFY15. Overview

 
 

8 • Continued Growth • Eight - year - plus profitable trend • Successful strategic acquisition • Customer base increased: • 20 new software customers in 2QFY16 • 91 percent renewal rate (fees) • Expecting continued compounded growth • 2nd Quarter earnings per share increased 17% • Strong cash position; returning cash to shareholders • Company has continued to pay dividend of $0.05 per quarter • Over $15 million in cash dividends distributed since 2012, yet cash remains at $8.8 million as of yesterday Summary

 
 

9 Financial Overview John Kneisel Chief Financial Officer

 
 

10 Income Statement 2 QFY16 Compared to 2QFY15 (in millions) Lancaster Buffalo 6moQFY16 6moFY15 Diff % chg Net sales $ 3.648 $ 1.516 $ 5.164 $ 4.574 $ 0.590 12.9% Gross profit 3.058 0.842 3.900 3.443 0.457 13.3% Gross profit margin 83.83% 55.54% 75.52% 75.27% 0.25% 0.3% SG&A 1.146 0.577 1.723 1.607 0.116 7.2% R&D 0.442 0.020 0.462 0.361 0.101 28.0% Total operating expenses 1.588 0.596 2.184 1.968 0.216 11.0% Income from operations 1.470 0.246 1.716 1.475 0.241 16.3% Other income (expense) ( 0.024) - (0.024) (0.030) 0.006 - 20.0% Income from operations before income taxes 1.446 0.246 1.692 1.445 0.247 17.1% Net income $ 0.994 $ 0.152 $ 1.146 $ 0.970 0.176 18.% Diluted earnings per share (in dollars) $ 0.066 $ 0.057 $ 0.010 16.9% EBITDA 1.841 0.336 2.177 1.966 0.211 10.7%

 
 

11 Income Statement 6moFY16 Compared to 6moFY15 (in millions) Lancaster Buffalo 2QFY16 2QFY15 Diff % chg Net sales $ 7.058 $ 2.944 $ 10.002 $ 8.660 $ 1.342 15.5% Gross profit 5.911 1.744 7.655 $ 6.485 1.17 18.0% Gross profit margin 83.75% 59.24% 76.53% 74.88% 1.65% 2.2% SG&A 2.245 1.154 3.399 $ 3.627 - 0.228 - 6.3% R&D 0.772 0.041 0.813 $ 0.633 0.18 28.4% Total operating expenses 3.017 1.195 4.212 $ 4.260 - 0.048 - 1.1% Income from operations 2.894 0.549 3.443 2.224 1.219 54.8% Other income (expense) ( 0.035) - (0.035) (0.033) - 0.002 6.1% Income from operations before income taxes 2.860 0.549 3.409 2.191 1.218 55.6% Net income $ 1.912 $ 0.339 $ 2.251 $ 1.499 0.752 50.2% Diluted earnings per share (in dollars) $ 0.131 $ 0.088 $ 0.043 49.0% EBITDA 3.649 0.731 4.38 2.804 1.576 56.2%

 
 

12 Consolidated Revenues, by Fiscal Quarter and YTD (pro forma prior to 2012; in millions) 4.01 4.57 5.99 3.71 4.84 5.16 $0 $1 $2 $3 $4 $5 $6 $7 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 2015 2016

 
 

13 Consolidated Gross Profit, by Fiscal Quarter & YTD (pro forma prior to 2012; in millions) 3.09 3.45 4.83 2.64 3.76 3.9 $0 $1 $2 $3 $4 $5 $6 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 2015 2016

 
 

14 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 $1.15 $- $0.50 $1.00 $1.50 $2.00 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 2015 2016

 
 

15 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 $0.07 Quarterly EPS FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16

 
 

16 Consolidated EBITDA, by Fiscal Quarter & YTD (in millions) 1.22 1.97 3.33 1.19 2.2 2.18 $0 $1 $2 $3 $4 Q1 Q2 Q3 Q4 2009 2010 2011 2012 2013 2014 2015 2016

 
 

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 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 7.1 8.8 $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 for Cognigen

 
 

18 Selected Balance Sheet Items (in millions, except where indicated) February 29, 2016 August 31, 2015 Cash and cash equivalents $ 7.155* $ 8.551 Cash per share ( in Dollars ) $ 0.42 $ 0.50 Total current assets 12.514 11.533 Total assets 27.903 27.344 Total current liabilities 3.537 3.613 Total liabilities 7.591 7.812 Current ratio 3.54x 3.19x Shareholders’ equity 20.311 19.532 Total liabilities and shareholders’ equity 27.903 27.344 Shareholders’ equity per diluted share( in Dollars ) $1.18 $1.15 * Cash as of April 12, 2016 was ~$8.8 million

 
 

19 Marketing and Sales John DiBella VP of Marketing and Sales

 
 

20 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™

 
 

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 spring 2016 ‒ Significant refresh of the graphical user interface ‒ New ‘MedChem Studio™’ module – optional add - on incorporating items from MedChem Studio • Version 4 .0 still licensed by clients ‒ Many features merged into ADMET Predictor 8.0 as optional add - on to consolidate under one GUI Software Product News • Version 5.0 released in April 2016 ‒ Integration of models from ADMET Predictor™ – optional add - on ‒ New dosage form options for immediate & controlled release formulations • Version 1.5 scheduled for 2016 ‒ Ability to model multiple compounds to optimize in vitro drug - drug interaction parameters • New product: v ersion 1.0 scheduled for spring 2016 ‒ Validated software for noncompartmental (NCA) & compartmental PK modeling ‒ Reports in user - customized formats for regulatory submission ‒ Large potential market

 
 

22 2 QFY16 Sales Review • Highlights: – Software revenue +15% – C onsulting +9% – 85% renewal rate (accounts) – 91% renewal rate (fees) – 16% increase in license units – 12 new commercial clients – 8 new nonprofit groups 54% 14% 32% 0% Consolidated Sales Breakdown Renewal New Consulting Training 0 50 100 150 200 250 1st Quarter 2nd Quarter 3rd Quarter 4th Quarter Software License Units – per Quarter FY13 FY14 FY15 FY16

 
 

23 6moFY16 Sales Review • Highlights: – Software revenue +14% – C onsulting +20% – 87% renewal rate (accounts) – 92% renewal rate (fees) – 25% increase in license units – 20 new commercial clients – 19 new nonprofit groups – Significant expansion of licenses at US and China FDA 53% 13% 33% 1% Consolidated Sales Breakdown Renewal New Consulting Training 0 50 100 150 200 250 1st Quarter 2nd Quarter 3rd Quarter 4th Quarter Software License Units – per Quarter FY13 FY14 FY15 FY16

 
 

24 2 QFY16 Software Revenue by Region Europe 29% North America 55% Asia 16% South America <1% Japan = 71% India = 15% China = 8 % Korea = 5%

 
 

25 Marketing Activities – 2QFY16 • Website redesign – Kicked off website redesign project in February; live launch in July • Conferences and scientific meetings – 4 scientific meetings attended; co - authors on 2 presentations • Trainings and workshops – Hosted first GastroPlus workshop in India – overflow crowd – W orkshops scheduled for US, Europe, China, Korea, and Japan in calendar 2016 • Strategic digital marketing initiatives – Hosted 3 webinars on our software updates and applications – Active updates: LinkedIn, Twitter, YouTube, and Facebook accounts – Continued web - based advertising for all programs – 28 peer - reviewed publications citing use of software

 
 

26 Buffalo Division Update Re - imagining the future of science - based research and development Ted Grasela President

 
 

27 Consulting Services • 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 bringing value to our clients • Consulting projects help shape management and regulatory decision - making process • Successful projects help drive additional consulting and software sales

 
 

28 Cutting Edge Scientific Projects • Emerging applications of systems pharmacology and PBPK – O ncology (ongoing) – Diabetes (ongoing) – Nonalcoholic steatohepatitis (new) – Ophthalmology (new) • Working to develop “platform” opportunities (same model; different drugs) – Successful ongoing project shaping early clinical research

 
 

29 Status Report - Consulting • In FY2016 working with 22 companies on 43 drugs, 72 projects of which 2 projects started FY16Q2 • Expanded scope of projects with 5 companies • 32 outstanding proposals • Worked with 7 new companies over the past year; continuing to build relationships • Most common therapeutic area is oncology, followed by neurology and immunology – ~25% of projects result directly in regulatory interaction. • First - time presentation of ADMET Predictor™ at clinical pharmacology meeting opened up conversations with new community of users.

 
 

30 • 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

 
 

31 KIWI™ – A Software Platform for Accessing Simulations Plus’ Validated Cloud Processing Capabilities

 
 

32 • Signed a $4.7 million contract with a major foundation to implement a KIWI platform for global teams engaged in model - based drug development; 5 - year term contingent on satisfactory completion of milestones • KIWI will become an integral driver of the foundation’s efforts to accelerate the eradication of underserved diseases • This initiative provides much - needed support in terms of computer processing power and organizational and communication tools for complex modeling and simulation projects • Ultimately, the goal is to reduce the risks and cost of drug development and speed the delivery of new life - saving medicines KIWI Update

 
 

33 • Project builds on our extensive process - related research; enables substantial enhancements to the KIWI platform • Enhancements will provide a scaffold with broad applicability and will be available to academic and industry clients of KIWI • Our long - term goal is to creating an innovative framework for collaboration that increases the value of emerging scientific research KIWI Update - Continued

 
 

34 Summary Buffalo division is strong and growing • Revenues and earnings up and contributing to overall growth of Simulations Plus • Consulting activities continuing to expand, and realizing synergies with Lancaster division for PBPK modeling in clinical pharmacology • New contract to enhance the KIWI platform is a major step forward in our long - term vision for the product

 
 

35 Final Summary Walt Woltosz Chairman and Chief Executive Officer

 
 

36 • 2QFY16 revenues were up by 12.9% • 2QFY16 net income was up by 18.0% • Diluted EPS for 2QFY16 up 16.9% to $0.07 from $0.06 in 2QFY15 • 6moFY16 revenues were up by 15.5% • 6moFY16 net income was up by 50.0% • Diluted EPS for 6moFY16 up 49.0% to $0.13 from $0.09 in 6moFY15 • California and Buffalo divisions both performing well • Expected synergies being realized and are resulting in expanded consulting activities • Addressing regulatory agency interests in applying PBPK modeling in clinical pharmacology • 5 - year, $4.7 million contract with research foundation is largest in Simulations Plus’ history • Offers potential for additional such contracts with other organizations • Software sales continue strong growth trend • Recent report by Grandview Research indicates: • Global market for computational biology to reach $4.285 billion by 2020 • North America largest regional market at 58.0% in 2013 • Asia Pacific seen as fastest growth market – estimated CAGR of 28% • 5 key players listed: Accelrys , Certara , Entelos , Schrodinger, and Simulations Plus • We believe Simulations Plus continues to lead the trend toward greater use of modeling and simulation in drug development Summary