Shawn O'Connor
Analyst · Craig-Hallum. Please proceed with your question
Thank you, Jeff. This was another strong quarter for Simulations Plus, and a solid first half to our fiscal year. We delivered 27% year-over-year revenue growth, bolstered particularly by the software side of our business. The solid growth, the inherent leverage of our business model, and the greater mix of higher margin software revenue led to improved profitability. One of the highlights of the quarter was the successful launch of our MIDD+ scientific conference in early March, a two-day event focused on delivering customized modeling and simulation content, specifically for pharmaceutical scientists and their organizations. This event, our first Simulations Plus sponsored event, demonstrated our leadership in the industry. More than 500 commercial and academic professionals participated with tracks including dedicated sessions covering all stages of the drug development process including discovery, pre-clinical, first in human, Phase-I, proposed approval, and generics. In addition, this conference included a strong presence and active participation from regulatory agencies, including representatives from the U.S. FDA, Offices of Clinical Pharmacology, New Drug Products, Research and Standards, Translational Sciences, Center for Drug Evaluation and Research, and the National Center for Toxicological Research, as well as ANVISA and Health Canada. Another highlight was the release of our inaugural ESG report which you can find on our IR website. This report demonstrates our commitment to good governance, diversity, transparency, and our shareholders. I'm proud of this report, something still rare for companies of our size as the ESG movement continues to find its form. We have adopted the mission of achieving our long-term goals for growth, profitability, and industry leadership through innovative science-based software and consulting solutions to optimize treatment options that will both save and improve the quality of patients' lives. In summary, this was a strong and productive quarter with excellent revenue growth and important initiatives that solidify our leadership position. The strong software growth and especially the software mix puts our results a bit ahead of our full year plan and we expect this to normalize as we move through the second half of the year. Turning to our revenue mix for the second quarter, as I mentioned we delivered 27% consolidated growth for the quarter. Organic growth was 12% versus the same quarter last year. Lixoft continued to outperform expectations with the revenue contribution of $1.6 million for the quarter. Software revenue was 60% of total revenues compared to 52% last year. Our second fiscal quarter software revenue growth was 45% compared to 13% last year. Excluding the addition of revenue sourced from Lixoft, software revenue growth was 15% compared to 13% last year. We are seeing accelerated organic growth in addition to Lixoft's contribution resulting in excellent overall software growth performance. Our Service revenue increased 7% compared to 35% last year. As a reminder, our DILIsym business experienced some accelerated projects in the second quarter last year driving that 34% growth rate, and we indicated at the time that performance was likely not sustainable. Our Service revenue growth in the quarter improved sequentially from Q1 fiscal year '21 but still reflects this difficult DILIsym year-over-year comparison in addition to the conclusion of the client-funded software development project at Cognigen. Year-to-date, our consolidated year-over-year revenue growth was 21%. If you exclude the DILIsym division with its challenging year-over-year comparison, our growth was 28% for the six-month period compared to last year. Year-to-date, our software revenue was 59% of total revenue compared to 51% last year, again the Lixoft acquisition being the driving factor. Our year-to-date software revenue growth was 40% compared to 13% last year. Excluding our Lixoft division, our year-to-date software revenue growth was 13%. Our year-to-date Services revenue increased 1% compared to 37% last year, again the DILIsym comparison is the primary driver of this growth rate. Over the last couple of years, we have accelerated revenue growth both organically and through acquisition. At the same time, we remain very focused on profitability, and in that regard we are performing well across these metrics. For the second quarter of fiscal year '21, overall gross margin has increased from 74% the last two years to 78% this quarter. EBITDA as a percentage of revenue has remained consistent in the mid-30s coming in this quarter at 33%. Diluted earnings per share continues to grow year-over-year coming in at $0.15 this quarter and would have been 42% growth to $0.17 without the dilutive effects of last year's follow-on offering. And finally, the Rule of 40 metric that has been widely adopted by many to measure revenue growth in combination with profitability is also a positive one for us coming in at 60% this quarter. For year-to-date fiscal '21, overall year-to-date gross margin has increased from 73% the last two years to 78%. EBITDA as a percentage of revenue has remained consistent in the mid-30s, coming in at 34% year-to-date. Diluted earnings per share continues to grow year-over-year coming in at $0.27 year-to-date and would have been 30% growth to $0.30 without the dilutive effects of last year's follow-on offering. And finally, the Rule of 40 metric is also a positive one for us for year-to-date coming in at 55%. In summary, these metrics demonstrate our ability to balance revenue growth and profitability to deliver continued increases in earnings per share to our shareholders. We enjoyed a diverse mix of software revenue in the quarter with solid growth across our entire portfolio of platforms. GastroPlus represented 57% of total revenue for the quarter. Monolix Suite was -- from Lixoft was 20% of Q2 software revenue, and ADMET Predictor represented 16%. Other software contributed 7% to software revenue in the quarter. On the year-to-date perspective, GastroPlus represented 56% of total revenue and Monolix Suite was 19%. ADMET Predictor represented 17% of total software revenue and other software was 7% of year-to-date software revenue. With regard to software highlights during the quarter, our AIDD lead optimization collaboration with a large pharma partner recently achieved a significant milestone. After being synthesized and assayed by the pharma partner, 80% of the candidate molecules tested exhibited sub-micromolar activity and acceptable ADMET properties. These results are excellent and demonstrate the unique value of the ADMET Predictor, machine learning models coupled with powerful AIDD technology, which required only activity data to optimize lead molecules across a wide spectrum of properties. These results are contributing to a growing sales pipeline for this product category. We released version 9.8.1 of our flagship PBPK modeling platform, GastroPlus in anticipation of the GastroPlus 10 or GPX release scheduled for later this year. Version 9.8.1 of GastroPlus includes more mechanisms, verification, and guidance for our validated drug-drug interaction models, a validated column in the drug-drug interaction perpetrator table to clearly identify the values that have been validated by our DDI experts for use in simulations, a new option to include variability in lung deposition in the Population Simulator and many other key enhancements. In addition, we also established a relationship with the South America distributor expanding our presence in this emerging region. The agreement is with the Institute of Pharmaceutical Sciences or ICF. Founded in 2002, ICF is one of the largest pharmaceutical research centers in Latin America and the first commercial Brazilian laboratory to be fully certified by the Brazilian health regulatory agency and visa to conduct bioavailability and bioequivalence trials. ICF will provide marketing, sales, and technical support to organizations throughout South America. Turning to Monolix, our Monolix Suite R 2020 was released in the first quarter and we are encouraged with the market reaction and the resulting lead generation. We completed a five-day Monolix virtual training workshop in March with daily attendance in excess of 500 participants. Finally, we announced a new distributor in China for Monolix with Mosim, one of Chinese leading biopharmaceutical services companies. Founded in 2015 Mosim was the first clinical CRO providing clinical pharmacology services in China with a staff of over 100 qualified scientists, Mosim will provide extensive connections throughout industry, academia, and regulatory agencies to increase awareness of Monolix Suite including PKanalix, Monolix, and Simulx. Overall our Monolix Suite has seen a 28% increase in customers year-over-year. For the quarter, our renewal rates were in line with historical rates at 93% based on fees and 86% based upon customers. We continue to see improvement in our average revenue per customer at around 84,000 for commercial customers and 66,000 for customers including nonprofits. During the quarter we signed six multiyear renewals for GastroPlus and ADMET Predictor. We also successfully renewed a large pharma merger situation for Monolix, a scenario which often results in a decrease seat license removal by the combined client entity. Three agent renewals including two in India and one in Japan were delayed, but we anticipate renewals from these entities in the coming quarters. Year-to-date, our renewal rate was also in line with historical rates at 93% based upon fees, and 86% based on customers. We see continued improvement year-to-date as well in our average revenue per customers at around 97,000 for commercial customers and 71,000 for all customers, including non-profits. Let me shift now to our service business. Our services revenue grew 7% for the quarter compared to 37% growth last year. For the quarter, our service revenues were sourced 50% from PKPD services, which are primarily delivered by our Cognigen division, 32% from QSP, QST services, primarily delivered by our DILIsym division and 18% from PBPK services primarily delivered by our Simulations Plus division. Year-to-date, service revenues were similarly dispersed by type and division. Service revenue growth and momentum is good, but continues to be impacted by the difficult year-over-year revenue comparisons at DILIsym that we've previously discussed. We were also challenged by the completion at the end of last year of a client funded software development collaboration. Absent these two factors, service revenue growth is more in line with historical growth. Turning to service highlights for the quarter, we signed a significant large pharma customer for PKPD project during the quarter in support of regulatory interactions. In addition, more than a dozen projects were performed utilizing Monolix as the primary analysis platform. We secured seven new PKPD clients during the quarter and three large project contracts with ongoing existing clients. Finally, we secured a large QSP contract with a large pharma client in a new disease area. Another significant event during the quarter was the formation of a Scientific Advisory Board to provide guidance and direction for DILIsym’s, RENAsym quantitative systems, toxicology, kidney injury software platform, this board called the RENAsym Consortium consists of six renowned experts in the field and is chaired by Dr. Paul Watkins. The Howard Q. Ferguson Distinguished Professor and Director of the Institute for Drug Safety Sciences at the University of North Carolina. DILIsym also received a Phase I NIH-funded SBIR grant, together with the University of Pittsburgh Drug Discovery Institute's vLAMPS experimental liver model and the micro physiology systems database to predict the safety of large molecules such as proteins that are increasingly used to treat diseases. The first phase of development funded by the grant will include beta version software construction and vLAMPS testing of several large molecules. Successful completion of the objectives will lead to an application for a larger Phase II grant, which would fully fund the development of the joint commercial offering. The software uses properties of drugs to predict their risk of causing liver injury in patients and is now widely used to support the e-drug development decisions. We also entered into a new funded collaboration with a large pharmaceutical company to develop machine learning models and enhance physiologically based pharmacokinetics, pharmacodynamics approaches for potential treatments of pulmonary infections. Our plan is to apply our ADMET Predictor platform to build these machine learning models for key endpoints to serve two purposes, to aid scientists and discovery as they screen candidate libraries and to inform the mechanistic GastroPlus models as lead compounds progress through development. Additionally, we entered into a new funded collaboration with a large pharmaceutical company to add novel mechanisms for oral peptide formulations within the GastroPlus advanced compartmental absorption and transit or ACAT mechanistic model. This partner is a frequent user of the GastroPlus platform across multiple research sites worldwide. A growing portion of this Pharma’s development pipeline is focused on therapeutic peptides and proteins. And part of their strategy involves designing oral delivery systems to complement the traditional invasive routes for these bio molecules. This collaborative effort plans to expand the applicability of GastroPlus to simulate intestinal absorption of large molecules and the effect of permeation enhancers within oral formulations. And finally, our Cognigen division awarded a grant to the Department of Pharmacology and therapeutics and Makerere University in Kampala, Uganda. The country’s largest and oldest institution of higher learning. This grant will fund upgraded internet capabilities and ensure access to Cognigen’s KIWI platform. The goal is to accelerate the university's pharmaceutical research efforts in quantitative approaches, including modeling and simulation, supporting future research and mentorships opportunities. As [Indiscernible] users, researchers, faculty, students at the University will gain access to a state-of-the-art platform to dynamically build, compare, refine and evaluate pharmacometric models. The Cognigen team will provide training and oversight to ensure KIWI is optimally leveraged to support the university's initiatives. Overall, a very busy and productive quarter for our services group, providing momentum as we enter the back half of our fiscal year. With regard to a couple of key service metrics, total service projects increased 19% during the quarter, with excellent growth in our PKPD and PBPK service offerings. This offset a reduction in projects and QSP and QST reflecting the accelerated project and revenue growth in fiscal year ‘20 previously discussed. We closed the quarter with $11 million in service backlog, which has improved after taking a fall since its peak at the end of Q2 fiscal year ‘20 prior to the impact of COVID-19 around this time last year. Finally, with regard to our fiscal year ‘21 outlook, we continue to expect 15% to 20% total revenue growth for fiscal year 21. As we enter the back half of the year, we will see fiscal year ‘20 revenue comparables that include Lixoft, which we acquired in April 2020, and began contributing revenue in Q3 and Q4 of fiscal year ‘20. This was anticipated in our fiscal ‘21 outlook provided at the beginning of the fiscal year and remains unchanged. Our software revenue is likely to perform at the high end or above the outlook provided due to accelerating software growth rates and the stronger than expected contribution from Lixoft. Conversely, our service revenues are likely to perform at the low end or perhaps slightly below the outlook provided due to difficulty overcoming year-over-year comparisons. On balance, our outlook for fiscal year ‘21 remains unchanged. And if anything, profitability is enhanced by the richer mix of software revenues for the year. We continue to be very active on the M&A front that we're maintaining our rigor in the evaluation of opportunities. With that, let me turn the call over to our CFO Will Frederick to discuss the financial results.