Simulations Plus' (SLP) CEO Walt Woltosz on Q2 2018 Results - Earnings Call Transcript

Simulations Plus, Inc. (NASDAQ:SLP) Q2 2018 Results Earnings Conference Call April 9, 2018 4:15 PM ET

Executives

Cameron Donahue - IR

Walt Woltosz - Chairman and CEO

John Kneisel - CFO

Ted Grasela - Cognigen, Division President

Brett Howell - DILIsym, Division President

Analysts

Cameron Donahue

Good afternoon. It’s Monday, April 9, 2018. On behalf of Simulations Plus, I welcome you to our Second Quarter Fiscal Year 2018 Financial Results Conference Call and Webinar. Presenting this afternoon will be CEO and Chairman, Walt Woltosz; Chief Financial Officer, John Kneisel; and Division Presidents, Ted Grasela of Cognigen and Brett Howell of DILIsym.

An opportunity to ask questions will follow today’s presentations. You may send your written questions using the questions pane on your control panel or you may use the hand-raising icon on your control panel to ask your question directly. Please be sure to enter unique audio PIN displayed when you join the call. This call is being recorded for playback at our website, www.simulations-plus.com.

Before we get started with the presentation, we’ll begin with the Safe Harbor Statement slide.

It is now my pleasure to introduce Walt Woltosz, CEO and Chairman of Simulations Plus. Walt?

Walt Woltosz

Thank you, Cameron and Renee. And hopefully everybody was able to read that Safe Harbor slide. I assume everyone on the call is familiar with the Safe Harbor. So, if I say expect or anticipate or words to that effect, please understand that that is our best understanding of how things are going at this time but there are no guarantees. So, as our attorneys like to say, there can be no assurances.

So, I’ll review outstanding news to report. Revenues for the second quarter up almost 29%, $1.7 million to $7.4 million; income from operations, up almost 35% to $2.4 million; net income, up 190.6% to $3.5 million, which includes a one-time non-cash $1.5 million deferred tax adjustment as a result of the new 2018 tax law.

Diluted earnings per share increased to $0.19 per share, up $0.13, $0.08 of that is due to the deferred tax. So, it still would be up $0.05 a share from the original $0.06 a share last year.

Software renewal rates 89%, based on number of accounts and 94% based on fees and 15 new software clients added. For the six months, first half of 2018, revenues up again just under 30%, $3.3 million to $14.4 million. Income from operations -- it’s not accounting -- not including the deferred tax benefit, up $1.3 million or almost 34% to $5 million. Net income up $2.6 million or 103% to $5.2 million including the one-time non-cash $1.5 million deferred tax adjustment. And diluted earnings per share increased to $0.29 a share, up $0.14. That does include the deferred tax benefit.

Software renewal rates 85% for accounts and 91% based on fees for the six months and 30 new -- 36 new software clients added. Our consulting pipeline has been -- it’s beautiful. Consulting demand and the industry since they just keep increasing and so we’ve seen a significant increase in our consulting revenues.

And now, I will turn it over to John Kneisel, our Chief Financial Officer for his report. John?

John Kneisel

Thank you, Walt. I appreciate it.

As Walt said, our net revenues increased 28.5%, about $1.7 million for the second quarter of the fiscal year. Lancaster was up 12.6%, Buffalo was up 12.2%, and North Carolina or DILIsym recorded $939,000 worth of revenues in this quarter. This is their first second quarter of our fiscal year. They came on, on June 1, 2017. So, they mark part of the numbers in the prior year. So, they are $900,000 of that $1.7 million increase, the 28%.

Our consolidated software revenues increased 10.6%, up $400,000, and our analytical study revenues up of $1.3 million. Our cost of revenues increased by $562,000. Of that, about $413,000 was the new costs that were at DILIsym for the quarter. Consolidated labor increased about $288,000 and other significant increases in costs were $182,000 of direct expenses on contracts, most of that coming from the North Carolina division on consulting contracts where they have to pay for lab testing costs.

Software amortization was up about $46,000 and amortization expense associated with the acquired technologies -- the division was about $79,000. Our cost of revenues as a percentage of revenue increased by about 1.6% during this period compared to the prior year.

Our consolidated gross margin increased about $1.9 million, to $5.2 million; DILIsym was $525,000 of that. They had about 56% gross margin this last quarter. The overall margin as a percentage of revenue decreased by about 1.6%. And decrease comes mainly from this higher blend of consulting revenues compared with the new division. Consulting revenues, if you can look at Buffalo and with North Carolina, they have a lower margin for those revenues because the higher percentage of labor costs associated with those consulting revenues, and in North America with the lab costs when we have a chunk of lab costs that go into a contract, that will come down. Last quarter, we didn’t have that as much; it just will fluctuate a little bit in that division.

Our selling and G&A increased $392,000, [ph] $306,000 of that was from North Carolina. So, it really wasn’t that big of a increase relatively, they -- just the new divisional cost. And as a percentage, SG&A was about 32% compared to 34% in the prior year.

Research and development, we incurred about $1.1 million of research and development costs; $640,000 was capitalized; about $500,000 was expensed. Total research and development increased about $360,000 in the quarter over the prior year and $76,000 of that was an increase in expense. Income from operations increased $600,000 or 35% in 2018 -- second quarter of 2018, compared to the prior year. And as a percentage of income, that was actually up 1.4%.

I’m going to talk about the income taxes a little bit now. We had a large benefit of 1.9 -- $1.1 million, not $1.9 million, sorry about that, compared to a tax expense of $600,000 the prior year. We finished our assessment of the deferred taxes based on the new taxes, tax rates enacted by Congress as of January 1st this year.

Going through those, we ended up booking about $1.5 million one-time tax benefit adjustment to our deferred tax liabilities, which comes in as one-time adjustment as we went from statutory tax rate for federal purposes of 34% to a 21% rate for our estimated future liabilities on taxes. That gave us this effective rate for the quarter, which was basically a negative tax expense of about 46% compared to rate of about 33% the prior year. That means that’s not going to continue obviously with the 1% or with a one-time hit like that.

So, on an ongoing basis, we do expect to have the effect of the new tax law on us. And in the past, we’ve been running in the -- anywhere from a 29% to 33% tax rate in a quarter. But we expect that to go down with the new rates. And so, we can probably this year expect to be somewhere in the low 20% range for the year and even in 2019, we may see that go down a little bit. It all depends on the amount of our permanent differences in tax credits and other stock-based compensation however those come out.

Our net income for the year increased $2.28 million -- or for the six -- three months was $2.28 million, which was like Walt said was up 190%, but 1.5 of that was related to this one-time charge. And without that, deferred tax benefit, we still would have been up $800,000 or 44% for the quarter.

Moving at the six months. Revenues were up 29.7%, $3.3 million. North Carolina recorded revenues of $2.1 million. All those are new revenues for us in the fiscal year compared to the prior year. The Lancaster division was up 11.1% to $8.6 million; Buffalo was up 11.6% to $3.8 million, all great gains in our core divisions. And consolidated software and software related sales were up 10%, by about $700,000 and while our study revenues and consulting revenues were up 66% and that does include revenues from the new division.

The costs of revenues were up 33%; two-thirds of that increase came from the new division. Most of the costs our labor-related costs and those costs are the increases from the direct contract costs and amortization costs for newly acquired technologies associated with the acquisition. Overall cost of revenues as a percentage increased by about 0.7% as compared to the prior year.

Our gross margin increased $2.3 million or about 28% in the six-month period. DILIsym showed about a $1.3 million gross margin, added 64%. Gross margin rate, $700,000 came from our California division, which showed an 82% margin. That one is more heavily software-related. And the Buffalo division increased $300,000 or 15.8% with the gross margin of 58%.

Overall, our margin as a percentage of revenue decreased by 0.7% for the year, holding pretty steady, even though the increase in the -- the large increase in the consulting work in that period.

SG&A expenses over the time period were up about $900,000, about $650,000 of that was from DILIsym group. And as a percentage of revenues SG&A was about 33% for this time period, which was actually down about 1.4%. The majority of that was just decrease in legal expenses associated with the acquisition and other related items.

Our research and development, we continue to put money back into the business, was about $1.9 million or $2 million total during the period; and of that amount, about $1.1 million was capitalized, the $800,000 was expensed. Total research and development increased $700,000 and the expense portion of that actually increased by about $146,000.

Our income from operations increased by $1.3 million or about 34% in the six months, and as a percentage of revenues from operations, increased about 1% over the period. Again, we’ve talked about the provision for income taxes for this period, for the six months. It was a benefit of about $300,000 compared to last year as an expense. The majority of that again is difference of $1 million -- $1.5 million. We saw a little bit of tax rate help in this quarter because we had blended rates between the statutory 34% and 21% rates as they cut off on December first, we got new rates in that time period. And our effective rate was just a small benefit of about 6%. And last year we had about 32% rate, it was 31.8% in the period. And again, we sort of talked about on a go forward basis, this year it’ll probably in the -- in that low 20% and next year we could even see a better rate than that.

Net income during the period, $2.6 million for the six months, which is including the $1.5 million, which represented about 57% of that change. Without that, we’d still have about $1.3 million profit.

Looking at diluted earnings per share, were $0.29, it would be about $0.21 and still would have been about $0.06 for the time period. EBITDA still remains strong that that would not have been affected by the $1.5 million because would have drawn the tax into it and still strong as up 1.4% or 30% over last year.

Moving on the chart. We can see the consolidated revenue. We can see the progressive growth we had. Since the fourth quarter of last year, you can see the big jump from $4 million to $6.3 million last year. Chunk of that was the acquisition of DILIsym, but you can see we’ve had progressive growth throughout this entire time period.

The next one, next chart is income from operations. We’ve added this chart this time. So, it is before taxes and will not be impacted by the $1.5 million adjustment as we go forward. We can just see the movement of the numbers, again sort of in upward direction. In the third quarter, you can see there is a little bit of a beginning anomaly there for 2015. I went back and looked at that. We had had a large software sale carry into that 2015 year that’s where it was total decrease there at the beginning. But consistently, we’ve seen revenue growth over the last several years and the years before that.

Going to the next slide. In this quarter, we had -- if you look at the dark purple bands there, you’d see what would be sort of a normalized income for the fiscal quarter in comparison to the large jump, just makes it a little bit easier to see where numbers would have been without the tax deferred adjustment. And that still shows the growth and the progression that we’ve consistently seen as a company.

Moving to next slide. And taking out $0.08 of the effect of that same tax benefit, see where the numbers are, actually pretty happy with this and that we’re showing $0.11 for our second quarter, which is close to where we’ve been in our third quarter most years, going forward. So, the effect of our acquisitions is showing as really just really pleased with the numbers that we see; they’re coming out company here.

Moving on. Consolidated EBITDA, our cash position is strong, consistently putting money back into the Company to build our software products and stable Company from investor standpoint, always feel good talking to people about the Company.

This next slide, no, go back please. The cash position, for those of you who’ve never maybe seen this slide before. There is three components to this slide, one is our quarterly cash position, which is the line here above the red line. Today, we’re sitting with -- or as of last week, we’re about $8.5 million in cash. The blue bar is our dividends. We’ve been just about 4.5 years on this chart here. We’ve been paying $0.05 a share, increased that at the beginning of ‘18 to $0.06 a share. And the red lines are the uses of our cash where we’ve made strategic buys of Company’s acquisitions or uses of cash buyout, in the one pace of TSRL a royalty agreement or restructure that royalty agreement, ultimately buy it out. So, we no longer have any royalty payments on that agreement.

In the end, I went back and looked at the stock price at the beginning of this chart. It was $5 a share. Today, I believe it closed just year 16. So, we’re still in the same cash position and making payments out to shareholders and making acquisitions to grow the Company. So, very pleased.

Next slide, please. Just some of the highlights. We’ve got -- just going back to August, last audited balance sheet. We’ve maintained the cash balance, our cash balances and cash balances per share, our current assets, our stable solid going into -- even into our third quarter real solid. And our current liabilities are mostly efficient related liabilities or we’ve got some payouts coming up later on in the year and which also is that increase in those, when they split from total -- from long-term liabilities to current, actually dropped our current ratio a little bit, but really everything is very stable and ready for the future.

Walt, back to you.

Walt Woltosz

Okay. John DiBella, the President of the Lancaster division is traveling. I think he is over in Asia somewhere this week. So, I will present his presentation for the Lancaster division.

So, our software products, we have three upgrades coming out in the next few months. Version 9.6 GastroPlus, a flagship product that generates the largest share of the software revenues is scheduled for this month. This has been a lot of work on this one, going on in parallel with complete rewrite of GastroPlus into C++ at the same time, so, very, very busy group here doing some outstanding work. We’ve got some new special population, physiologies that are going in that will be enhancing one of our option that on modules. [Ph] Also, we’re improving all of our mechanistic absorption models in a variety of ways, again enhancements to an option right on margin. So, hopefully generate more sales in those optional modules.

ADMET Predictor is our program that uses artificial intelligence to predict properties, molecules from their molecular structure. So, it’s been top rated and time-after-time in publications that compare various software programs and in various modeling challenges that come out every few years, we consistently perform, we have the top of all of the 100 or so competitors that go into those. Version 9 is scheduled for release next month. This will update our high throughput pharmacokinetics HTPK simulations module. This is unique capability to actually predict blood concentration versus time, bioavailability [indiscernible] for different dose levels, just for molecular structure. So, this is a new optional add-on module.

We’re also improving the ADMET Modeler module. This is our artificial intelligence engine that we use to build our models. And we’ve applied that not only to pharmaceutical chemistry, but to some applications in some other industries that we would like to try to monetize and get into it.

DDDPlus version 6.1 scheduled for summer 2018. In our FDA grant for long-acting injectable microspheres, we expanded DDDPlus to deal with the in vitro experiments that along with that type of dosage form, so that expands our potential user base. We have also added some new abilities to use for different precipitation assays in bi-phase [ph] of dissolution models where we have a rapid dissolution phase followed by a slower dissolution phase typically.

MembranePlus, we released Version 2.0 in September of last year that included new models to analyze data from liver cells hepatocytes, which expands the user base. And we improved the integration with the ADMET Predictor module, so that we can generate inputs for MembranePlus from molecular structure and that is an actual add-on module for MembranePlus.

We finally released Version 2 of PKPlus in January. This is a program that we released first in about September of 2016, Version 1, and tremendous amount of feedback from users that liked a lot of what they saw, what they said, we also needed to do this and that, so we spent a year and a half making it do this and that. And now, we have it out there being evaluated by a significant number of customers. This new version handles the 21 CFR Part 11 requirements. It adds a non-parametric superposition, which is just a fancy set of words for dealing with multiple doses over a period of time [indiscernible] pharmacokinetics.

Next slide, please. So, for Lancaster, revenue for the second quarter, up 12.6%; software revenue up 7%. You see the renewal rates are 89%, based on the number of accounts but 94% based on actual fees. Some of the accounts that we lose our academic accounts when a Ph.D. student graduates, for example, who was using the program for their thesis and no one else in the department needs it, so their fees are extremely lower, sometimes even free. But, the renewal rate for paying customers you can see is very nice, 94%. 8% increase in license unit, eight new commercial companies and seven new non-profit groups were added to our customer base.

Consulting and training revenue is -- as you can see is growing at a remarkable rate, up 83% with projects ongoing with 26 companies plus our two FDA funded collaborations. The bar chart you can see up there shows a number of software license units sold per quarter. And you can see the trend is very nice trend, very similar to the financial trends that John K showed a few minutes ago. And you can see our revenue breakdown in the pie chart. So, about 75% of our revenues are from renewals, 12% of new sales -- about 12% software sales and about 12% consulting and 1% training [ph].

Next slide please. For the six months, similar numbers, don’t need to read all of these to you. You can see the trends are pretty well, the same across a number of new groups. It’s about double what it is for one quarter, since we have two quarters here. Percentages remain fairly similar, about 72% from renewals, 14% from new sales for software, 13% for consulting and 1% for training [ph].

Next slide please. As far as the distribution of customers, it seems to remain pretty close to these numbers quarter-over-quarter and year-over-year, around 41% or so North America; Europe, about a third; and Asia, around 25%, 26% with more than half of that out of Japan, which is our largest single country considering Europe to be a variety of countries; Europe of course would be bigger out in the whole. But as a single country, Japan is actually the second largest pharmaceutical industry in the world.

Next slide, please. Marketing activities. We do a lot with website, with social media. So, we’ve been increasing our production of video content. We’ve increased the focus on search engine optimization performance, and continuing migration content from our different division sites to our main corporate site, the Simulations Plus. We held a PDPK workshop at University of Maryland. That’s physiologically based pharmacokinetics -- the thing that GastroPlus does so well. We hosted 6 onsite trainings at individual companies and we attended two scientific conferences during the first quarter and delivered three poster and podium presentations. First quarter of course is over the winter holidays and so there is not quite as much conference activity that goes on during the quarter.

Strategic digital marketing initiatives. We did host three webinars on modeling simulation applications and we do continue with our very active social media campaigns through Tweeter, LinkedIn, YouTube, and the number of followers increased 20% versus February as a year ago. And our GastroPlus user group membership increased 8% versus the previous year.

Next slide, please. I’ll now turn it over to Ted Grasela, President and Director of the Cognigen division. Ted?

Ted Grasela

Thanks, Walt. It’s a real pleasure actually to see how these numbers all add up to the performance of the Company. And it’s very rewarding to myself and our staff to see the responses that we’ve been getting from clients for our services.

In 2018, we had relationships with 25 companies, working on a total of 38 drugs and 62 projects overall. So far in this fiscal year, we’ve started to work with two new companies. We have two new projects that are just starting. Of the old projects that we had, 11 of them expanded in scope. There were 30 projects with reduced scope, primarily because the drugs didn’t respond as they were expected to as part of the development program. And our pipeline is very healthy with 41 outstanding proposals with 28 different companies.

Picking up on the theme that Walt talked about before about marketing of our services, really being based on interactions with our clients and communicating with both our clients and people we hope are going to be clients about the quality and the diversity of the work that we do. So, so far at scientific meetings, we’ve had 7 posters and 5 peer reviewed publications. One of our posters actually won a Blue Ribbon at a recent clinical pharmacology conference for the specification of the material that was presented.

And while we’re -- when we’re not working on consulting projects, we’re working 20 publications and five conference abstracts for presentations of material at upcoming meetings. The PAGE meeting is the pharmacometrics meeting in Europe and we’ll be presenting two posters on new functionality that we’ve incorporated into the KIWI platform during that meeting.

For a while now, the most common area that we work in has been oncology and that’s followed by neurology, endocrinology, infectious disease, and actually also global health. Overall, the really important part of our deliverables are the way that they’re incorporated into regulatory filings. And it’s been a constant theme that nearly half of the projects that we work on, end up being incorporated into a regulatory interaction or submission of some sort in any given year.

Next slide. So, the way that we’ve been continuing to develop our pipeline and ensure constant flow of business has been increasing marketing and sales activities, primarily through the use of posters and presentations at scientific meetings. We’ve been continuing to recruit new scientific talent and then have been quite successful at that so that we’re able to handle the increasing in work that we have. The nature of our services continued to expand. And as I mentioned, we have healthy pipeline of new projects, including a number of global health projects that we continue to expand on.

Global regulatory filings where the information from one region is used to justify regulatory approval, and another is an important part of our work. And we continue to look for opportunities to embed our services into our client partners so that we’re involved in those compounds as they move through the lifecycle from first in human to commercialization of new medicines. We’ve been working on developing cross-selling opportunities with both Simulations Plus and DILIsym. Of course, we’ve been at this now for a little over three years. So, we have really good relationships with any number of the scientists with Simulations Plus. We’re still feeling our way with our colleagues in DILIsym, but actually right now, we’re in the process of finalizing a proposal and dealing with some questions from a potential client that would involve the use of all three of our services.

So, this is enabling us to create and continue to create broader spectrum of business models for our clients and expanding scientific synergies across the scientists and letting us to be more creative and innovative in bringing solutions to our clients. And of course, in the back all of this is the work that we’re doing on the KIWI communication platform. And we continue to identify new functionality and/or as a result of some of the hires that we’ve had in this past six months able to accelerate deployment of some of that functionality. Thank you.

Brett Howell

All right. Thanks, Ted. This is Brett Howell, President of the DILIsym Services division. I just want to take a few moments to comment on our quarter as well. So, if you go to the next slide please.

Since we are relatively new to the group, I’ll take a moment just to mention again who we are as a division and how we fit into the overall picture. We focus on safety, primarily through the use of our DILIsym platform or drug-induced liver injury prediction software platform. We also focus on evaluating treatment for non-alcoholic fatty liver disease, it’s NAFLD, our NAFLDsym program and also NASH another related liver disease. So, we do both pharmacology, but also safety.

Next please. Just a quick review of our fiscal Q2 sales. In terms of our breakdown, we did about 67% of our revenue from DILIsym related consulting projects, about 19% from software licensing, and 14% from NAFLDsym projects. Over time, we expect the NAFLDsym portion of that to grow as we expand that platform.

We had 18 active consulting projects related to DILIsym, and we were using the software through all these projects to help companies predict drug induced liver injury or understand issues that they were having in those areas. These projects often involve data management, collection as well as analysis using our software.

For NAFLDsym, we had two active consulting projects going, one of which is a very significant development project which will increase the scope and our capabilities with software. And again, NAFLDsym is focused on helping companies evaluate targets and the effectiveness of potential drugs for those targets.

Finally, in terms of licensing, our DILIsym platform, we have non-active consortium members who are licensing the software. That’s the vehicle through which we make it available for companies to use internally. And we are continuing to work through the avenue of the consortium to add new science and new features to DILIsym. We are actually completing the process right now of giving the FDA additional licenses and software or in the past they’ve already licensed.

Next slide, please. In terms of our products, we have -- Version 7A was released in January of our all accounts running smoothly. We have received good feedback. We also are working on Version 8A for release in early 2019. In the meantime, we are working on an exciting project refactoring and recoding the software to be very tightly integrated with GastroPlus, so that will be coming in the future. And we are also as I said adding some features in NAFLDsym including fibrosis and inflammation to make it more capable that will be coming at the end of 2018. Finally, we are looking to expand into the safety of the kidney. And we have currently put forth a grant proposal to fund this that we’re waiting on final funding decision.

Next slide, please. From a marketing and sales front, just a few quick notes. We had a very successful three-day workshop in San Diego, which is one of our first; that was in parallel with the GastroPlus workshops. That is very good example of synergies across the divisions. We had some great interest at the Society of Toxicology meeting in San Antonio where we exhibited with both Cognigen and Simulations Plus Lancaster and we had a nice joint presentation with John DiBella and myself had a joint presentation focused on DILIsym plus GastroPlus and the power of these tools together.

And finally, we continue to make website revisions that will allow customers to see [indiscernible] improved work in terms of their look and feel on the web for the three divisions coming together.

Next slide, please. So, just to summarize, the product is currently out there working well. We are continuing to expand and looking to move into new area. We continue to find synergies, as you’ve heard from the other speakers with Lancaster and Cognigen and Buffalo division. Our number of consulting clients is thrilling. We are now well over 30 companies that use the software for various development purposes. And we also continue to grow the number of licenses overall. We now have 19 companies licensed DILIsym throughout the life of the consortium. Of course, we look to continue to move that number forward as well.

So that concludes my points. Walt?

Walt Woltosz

So, just to summarize, the next slide, please. Second quarter, again outstanding numbers. Revenues up almost 29%, income from operations 35%. Neither of those are affected by the tax rates but the net income certainly is with the $2.3 million, 190 plus percent including the deferred tax, but even still around 44%, even without deferred tax benefit. From the six months, revenues up almost 30%, income from operations 34% and net income just over 100% with the deferred tax. Diluted earnings per share increased to $0.29 per share for the six months, up $0.14 and about $0.08 of that is from the deferred tax benefit. So, $0.06 was due to just normal operations, which includes DILIsym acquisition. So, very nice comparison for the quarter and six months.

All three divisions performing well, California, Buffalo, and North Carolina. We are realized the synergies. We’ve gotten now a nice intermediate connection between GastroPlus and the DILIsym software. The DILIsym software needs he output of PBPK Simulations, which GastroPlus provides as inputs to the DILIsym. And so, we’ve now made that much more convenient. With integration, we’ll continue to be improved as refactor GastroPlus and reprogram the DILIsym software, C++.

There are new guidance documents issued by the FDA and EMA. The new Commissioner o the FDA, Scott Gottlieb is a very strong proponent of modeling simulation. And we think that that may be one of the reasons our consultant work is going up so quickly. Many companies don’t have the expertise to run these very sophisticated software programs in-house, and so they contract for that work and we’re benefitting from that. As we do that for them, they learn. So very often what we’ve seen over 20 plus years is that our consulting customers eventually become software customers. And so, they finally get to the point where they realize they would actually save money by licensing the software and hiring someone internally to run it with our support of course. And for us that means a higher margin sale. The software margins are very high compared to -- that gives our consulting team the opportunity to go and work with new potential customers. So, we definitely believe that Simulations Plus continues to lead the trend towards the more use of modeling, simulation and pharmaceutical, food products, cosmetics and general chemistry industry in research and development.

With that, we’ll open it up for questions. Renee, are you going to moderate the questions?

Question-and-Answer Session

A - Cameron Donahue

This is Cameron. I’ll be reading to the questions. We’ll start up with some questions from Howard Halpern. [Ph] What do you believe consulting services for the industry seem to be doing? What is your pipeline of consulting revenue within each division?

Walt Woltosz

Okay. Well, I comment on that -- I just did actually briefly. I think several reasons. Software is one of the, if not the highest productivity tool out there. What you can do something with the software that either replaces an in vitro experiment, an animal experiment or a clinical trial, you save tremendous amounts of time and money, but that doesn’t happen every day. But very often what it also does is guide you to choose which experiment you’re going to run and in what order. And so, as is commonly known, most molecules fail to become drugs. The winner is a needle in the haystack almost out of all the molecules that are examined every year. And we have the ability now to examine millions and millions of molecules a year, at least with software, very few of them will ever make it all the way through the cycle to become drugs. So that if you could eliminate any of those in software without even having to make the molecule, you save the tremendous amount of time and money.

And I was like to say, the drug that fails out there in the Phase 3 clinical trial, was bad 15 years before when the chemist first drew it. They just didn’t know it. So more that we can eliminate upfront, the fewer those failures that we can experience in very expensive clinical trials, a better it is. So, I think that’s why, the consulting services [indiscernible] as I say because these are sophisticated programs that require quite a bit of expertise to use properly. And I think the industry has not been able to get employees who are tackled [ph] with these tools as rapidly as they have need to see the results. Pipeline of consulting revenue, I’m not able to answer that. Maybe John K, could you answer for Lancaster?

John Kneisel

I think John -- from my understanding, John’s just gone and there has been a back -- sort of back-loaded -- sorry, back-loaded section just opened up when we hired more employees back and we’re filling in stuff that’s been out there, pent up demand for some of our services out there. We’re now going after the business that was out there.

Walt Woltosz

Okay. Thanks. I think Ted, you do the most consulting at Cognigen. Do you want to address that one?

Ted Grasela

The way that I’d like to answer that is simply say that we keep track of the outstanding proposals as we send them out. And of course, we keep records of which ones we’re successful with and which ones we aren’t and why. But right now, we have 41 outstanding proposals with 28 different companies. So for us that represents a really robust pipeline in terms of incoming projects.

Cameron Donahue

And Ted, this is Cameron. One follow-up question, I guess on the Cognigen side. Within the industry, how is KIWI viewed and how solid is the growth pipeline in that segment of your business?

Ted Grasela

Yes. So, we’ve been continuing to add functionality that we believe will make the platform more attractive to a variety of different types of users. We’ve been experimenting with different groups from different environments. And everyone has very positive things to say about the software and the way that it’s been design and intended to be used. One of the great things about the project that we’re working on for the Gates Foundation is that we’re actually getting to use it into developing of some specific projects, specific drugs. And so, not only are we able to test out different functionality but we are also able to show how that can serve as a prototype for its use in a variety of different environments and different sectors of the industry. So, we continue to be at a place where we are developing and testing new functionalities continuing to demonstrate software at different scientific meetings and doing what we can to encourage people to share our vision for the platform.

Cameron Donahue

Great. Next question has to do on the Lancaster side is, where does your current penetration of the commercial customer stand and how do you anticipate future growth within the software sales?

Walt Woltosz

Commercial customers…

Cameron Donahue

Large blue chip customers or even the pharmaceutical companies for the software sales.

Walt Woltosz

Yes. Most of our customers are commercial customers. Our best guesstimate sometime ago was based on the FDA registry of about 2,500 companies, and we probably are in the order of 10% to 15% of that number of companies. The fact that we keep adding at a pretty aggressive rate new customers every quarter I think is an indication of the increasing sophistication in the industry for one thing to learn, to use simulation and modeling where 20 years ago or 21 years ago when we started, determined, some of them didn’t even exist in the computer as opposed to in vitro, in the lab or in vivo. So, I think the trend is going to continue, I feel quite optimistic about it. But, again, as my attorney would say, there could be no assurances, but 10 or 15 years ago, we wondered where will this begin to plateau, and it just hasn’t happened yet.

So, I think as we continue to expand the capabilities of the software, the knowledge base, the underlying science keeps growing. We learn more and more for example about how to model different populations going from premature babies more and upto 16 weeks premature; we couldn’t do that 10 years ago, now we do it routinely. Looking at Asian populations and other populations, how you change, what happens in the intestinal track for different populations, different ages and genders and ethnic groups.

So, all of these things are built on a knowledge base that continues to grow. And as we understand more about enzymes and transporter proteins that affect many drugs, the better we can model those. I don’t see this ending any time soon. It’s just going to continue to grow.

Cameron Donahue

Okay. One quick follow-up on that. As far as the current I guess penetration with our existing customers of the top pharma companies and with the India growth we showed on the slide, is that from I guess stemming all from the new contract we established there last year?

Walt Woltosz

John DiBella would have to answer that but it makes sense to me the fact that we do have a distributor in India now that is promoting the product and we’ve had our scientists go to India to do workshops and training. That certainly -- that market, Asia, in general India, China, Korea, some of the other countries in that region certainly have come on where probably five or six years ago we hardly had a customer in those countries.

Cameron Donahue

Okay. Next question, how are the synergistic opportunities between DILIsym and the two other divisions progressing?

Walt Woltosz

Well, I mentioned part of that. The DILIsym software needs the outputs for population simulations from physiologically based pharmacokinetics, PBPK software, and that’s where GastroPlus does so well. And these simulations can be pretty complicated. And what we have done as an initial integration of the two is to provide an output file from GastroPlus that can be loaded directly into those without having to do a lot of hand manipulation reorganize things and get them into a format that DILIsym could input. So, that part is done; it’s working.

We still have to run each program separately. What we would like to do eventually is to be able to fire up the DILIsym software from within GastroPlus and have all of the information that’s needed just pass through memory, so that you don’t have to do anything other than start program and set up the parameters you want to run the simulation. So, that has progressed well. I heard Ted mentioned a proposal with Cognigen and DILIsym working together. I don’t know the technical details of that one. But, we’ve been working now with DILIsym for three quarters, fourth quarter of last year and the first two of this year. A lot of work has been done; a lot of nice things are working already. And I just need to put the integration continuing to improve as we go forward.

Cameron Donahue

Great. Next question would be for Ted and Brett. Could the presidents of both Cognigen and DILIsym discuss the scalability of their business on a high level basis? Top-line growth…

Brett Howell

Yes. I can start, Ted. This is Brett for DILIsym. Certainly, be happy to discuss in a general sense. We have two different lines of revenue that’s discussed clearly today. One is our consulting side and one is our licensing side for the DILIsym platform and our potential future products. So, as you might imagine, on the licensing side, the scalability is very high. And really the only limitation there is acquiring these customers. We can make that software available and sell those licenses as customers want to use them.

Our software is a little bit specialized. And so, we do often times use it for customers through consulting. And on the consulting side, we’ve we do have the barrier of leading to add additional trained scientists who can use the software internally for consulting. So, that’s always going to be a concern with any consulting activities is that with any companies that you need to scale that by adding trained individuals to use it. However, we’ve been working hard at getting in place over the last few years processes and procedures and report formats and styles and presentation, milestones goals, styles et cetera to really facilitate the use of employees with the software and doing these consulting projects. So, I actually feel quite positive about our ability to scale as our consulting demand continues to grow. We have on the order 14 to 15 proposals currently outstanding for consulting, both in terms of model use and also model construction and mutual development. And all total, that’s well over $5 million of new proposals. Again, those are over a long period of time or certain different periods of time and at various places in the proposal processes. So, not saying that all of that is eminent, but that’s certainly our pipeline currently. So I think, fell positive about our ability to scale both on the consulting side and certainly on the software side. Ted?

Ted Grasela

Thanks, Brett. Yes. So, the nature of the business at Cognigen is primarily consulting revenue. And there over the years we’ve spent a lot of time and effort in streamlining our processes and getting them down, so that we deliver a consistently high quality product in a timely way. So, I feel really very good about all of that work that has been done. And we’re leveraging that now as our consulting pipeline continues fill up. But as you imagine, our consulting business can only scale so far. So, as you continue to bring in projects, we have to continue to bring in new scientists. And we’ve been successful at both of those requirements and are feeling really good about the consulting side.

The KIWI platform is the opportunity to really scale up in a rather large way. And that is still in the process of being developed and flushed out. So, I don’t know what to say about that particular part of it. But I feel really good about having created a system for the consulting that is as sufficient as it could be.

Cameron Donahue

Great. Two quick questions for John. What do you expect your effective tax rate to be for all of fiscal 2018 and 2019? I know you have touched on that already. And the second question, will there be any material impact from the new revenue recognition accounting rule 606?

John Kneisel

Okay. I’ll handle. The 2018, I’m expecting it to be somewhere in the low-20s. I mean, it’s little, like I said earlier in the call, little hard to estimate some of the effects of the permanent differences and what’s going to hit during that time period. But clearly, the rates are lower. I don’t have any concerns that it’s going to affect us this year substantially, but I just can’t -- I can’t really quite get there in all the estimates I have to do, because there are some moving parts there. But it should be in the low-20s somewhere. And 2019 should be a few points lower than 2018, again all for the same reasons.

And the second question was related to 606. All indications are that there will be some effect, not sure how big it’s going to be, I’m not seeing a lot of effect based on the analysis that’s being done right now. So, I’ll know more at the next call that we have, we should be done with most of the analysis by that time. But not really seeing any real big hits based on the way we sell our software here. On an annual renewal model, there really doesn’t seem to be anything there. And we’re on a percentage completion on our consulting revenues and that really isn’t concerning a lot at this point.

Cameron Donahue

Right. We two more questions, one is a follow-up. You mentioned that there was some pent up demand that you’re able to take advantage of by hiring talent. Any sense of where that pent up demand level is at now?

John Kneisel

I don’t want to finish that question much farther than. And I was answering for John, who’s not on the call. He would be at better sense of answering that. I just felt that we’re able to really flex up really quickly once we have the personnel in place at this point and we’re just seeing some really good results of that at this point here in Lancaster?

Cameron Donahue

And the final question, any indication as the launch of Version 2.0 of PKPlus and how those sales have started to ramp up?

Walt Woltosz

Again, John DiBella will be the person to answer that in detail. It’s only been up here for, what, eight or 10 weeks in the sales cycle, for software it tends to run probably on average three to six months, sometimes longer. And for a product like this where there is a competitive product already out there that people license typically on an annual license and sometimes on a three-year license, it may be that we have to wait for those annual licenses to expire, which is probably happening every month somewhere before we might be able to get some market share away from the competitive product. So, I don’t have a good solid answer for you on that. And John DiBella would be the one that would know the details how many companies are actually evaluating right now, what sort of feedback they gave.

Cameron Donahue

That does conclude the questions that have been submitted. Walt, you wanted to say quick closing remarks, and then I will finalize the conclusion of the conference call.

Walt Woltosz

Yes. I think, you know that Company continues to grow. We are always shopping. John showed you our cash with the outlays that we’ve had, I think somewhere on the order of $13 million in acquisition costs and the buyout of the TSRL agreement, altogether and another -- I don’t know, it’s almost a similar amount in dividends that we paid out since we started paying a dividend. Yet our cash still seems to stay right in that same range and we saw the growth in the last three data points there where we saw nice upwards growth in all. We will have some cash going out as we pay back the earnout portion of the DILIsym acquisition. But, we are generating cash at a healthier rate. And I see a bright future so far, I see no reason to think otherwise.

Cameron Donahue

Great. Thank you everyone for joining the call. One final note, the management will be presenting at several upcoming investor conferences, the Needham Emerging Technology Conference on May 15th and 16th in New York City as well as the LD Micro Invitational on June 5th and that is in LA.

This concludes today’s conference call and webinar. If you missed any part of today’s call, the replay will be available at our website, simulations-plus.com. Thank you for joining us today.