Afternoon, everyone, and welcome to the Intelligent Bio Solutions Fireside chat. Thank you all for joining us today. My name is Walter Pinto, Managing Director at KCSA Strategic Communications, and today I am joined by Harry Simeonidis, President and CEO, and Peter Passaris, Vice President of Product Development. Earlier this month, the company submitted its 510(k) pre-market notification package to the FDA for its Intelligent Fingerprinting Drug Screening System, seeking clearance from the FDA to enter the U.S. market. We are hosting today's call for management to have an opportunity to provide investors with more detail as to where we stand in the FDA process, more information regarding the data submitted to the FDA, and provide a look ahead as to what to expect next.
Before we begin, quickly, I would like to remind everyone that statements made during today's fireside chat may contain forward-looking statements within the meaning of the Safe Harbor of the Private Securities Litigation Reform Act of 1995. Actual results may differ materially due to a variety of risks, uncertainties, and other factors. For a detailed discussion of some of the ongoing risks and uncertainties in the company's business, I refer you to the company's reports, both periodically with the SEC, including its annual report on Form 10-K and for the fiscal year ended June 30th, 2026, and the investor materials under the company's investor relations website. The company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. I want to thank everyone again for joining our call today.
At the conclusion of our discussion, we will have a live Q&A. Please submit your questions via the Q&A function at any time. We will do our best to get to as many questions as we can today. If for some reason we do not get to your question, please email our team at INBS@kcsa.com. Please note this call is being recorded today, Thursday, September 24th, 2026 at 4:30 P.M. Eastern. The recording will be available on the company's investor relations website under past events at the conclusion of this call. Before we get into our questions, I would like to turn the call over to Harry to provide a brief overview on the company. Harry?
Yeah. Thanks, Walter. Thanks everyone for joining. Look, let me first start with an opportunity just explaining who we are again for a lot of people that do not know. Intelligent Bio Solutions, we are listed on the Nasdaq, ticker code INBS. What I am going to be showing today is our product and our business and what we have been doing for the last few months. A very exciting period for us right now. Let me just talk to you about what we do have. So we have got a product. It is a commercially available product, and it is a drug screening system. As you can see here, I am holding it in front. This is what we call the reader for the drug screening system, and we have what is the consumable, which is a cartridge that goes with it
What this does is we have the ability to test drugs which is in your system via sweat. A lot of people probably understand that either via urine test or a saliva test, but we use the tips of your fingertips to actually collect a sample of sweat that we can actually detect what kind of drugs you have in your system within a space of 10 minutes. Some of the typical drugs that we do screen for is opiates, cocaine, methamphetamines, and cannabis. What I'd like to do right now is just show you how simple this test is. Let me take you to the traditional way. Traditionally, if you want a drug test, you would ask the individual to urinate in a cup. You would have to witness them. They would have to want to urinate. That can take time.
You have to find a place for the actual individual to be able to fill the cup. Once you've got that sample, then that sample is then analyzed, and that could take from several, half an hour, an hour, 2 hours to do that whole process. For us, it's a simple three-step process. What we do is we get our cartridge here, and we ask the individual just to take a fingertip and place it on the collection of our cartridge. Five seconds per digit, and then within a space of one minute, we have all the sample that we need. We then get this lovely cartridge, and we put it inside the reader, as you can see down here on the bottom.
Within 10 minutes, we get the result, and the result will come back either you are positive or negative for those drugs that we actually screen for. The one advantage is obviously it's a very non-invasive way. You can actually see the individual providing the sample, and it's easy and simple, as you saw. It's 10 minutes, non-invasive, very easy. The other key factor of our system is we have what is called a very short window of detection. What that means is, typically, when you take drugs, it can remain in your system. If you have a urine test, you can actually see what's been in your system for seven days up, maybe 10, 12 days, depending on how each individual metabolizes the drug and metabolizes in the individual.
What that means is I could be having cannabis on the weekend and then have a drug screening test on a Wednesday or a Thursday and come back positive. Even though I'm not high, I can work, and it's safe for me to work. With our drug screening test, we can only detect what's been in your system for the last 24 hours. What you can see is the shorter window of detection shows how likely you've had the drug within that 24-hour period. The closer you can get from the time of ingesting the drug, the more it shows if you are impacted in terms of are you high? Can you work? Can you drive that bus, fly that plane, drive that forklift? The shorter window of detection infers or implies that you are impacted on the drug.
A lot of our customers actually enjoy that shorter window because you are truly testing an individual to see if they actually are affected by drugs. This product has been in the market commercially available outside of the U.S., and we are pleased to, as you probably saw from our financial statements, we are continuing to grow year-on-year, and our revenues, we closed our financial year above $4 million. We closed at $4.2 million. And that was up from $3 million the previous year. Significant growth on the top line. The other key factor is we are not only growing the top-line revenue, but we are also growing the overall margin. So we are getting leverage both from the ability of scale, but also we have done a lot of key things on our manufacturing side to reduce the actual cost.
We are making better margins and a stronger growth period. A very exciting period for us as we continue to grow. Three years ago, when I was having a discussion, we were doing $1 million worth of revenue. We are now over $4 million, and we continue to do that. Our revenue comes from two factors, two key factors. One is the actual reader itself, which is a one-off buy for the customer, but the key is our consumable, which is our cartridge. This is a reoccurring revenue for us, and every time you do a test, you need a new cartridge. As you can see, the more readers or the more install base you have out there, the more consumables, and that continues to grow. So we are seeing both growth in our overall install base and our overall consumable business.
The other key factor for us, as you can see, we are doing good revenues outside of the U.S., but we want to get back in, and we want to be in the U.S. And for us to be in the U.S., we require 510(k) clearance. We have done a lot of work, and Peter will go into it a lot more in detail on what we have done. But we were finally able to submit our 510(k) submission early September. And there were multiple steps that we needed to do to complete to ensure we have what we consider one of the best submissions we have ever had. Why the U.S. is important for us?
The overall drug screening market, depending on what kind of research papers that you look at, we take the average, and it is approximately a $10 billion market, and half of that market comes out of the U.S. So U.S. is close to a $5 billion worth of market on drug screening. One is the size, and we understand this, it is a huge opportunity for us, but drug screening is becoming more, it is increasing more and more, and the reason for that is more and more drugs are becoming legalized. And people are really concerned about employee safety, so they are testing more and more people at work to ensure that they are not affected by some of the legal drugs that we have. For example, cannabis, not only in the U.S. but globally, it is becoming legalized. So people are taking more and more cannabis.
That's fine if they require to take it, but they should not be taking it or being affected by cannabis if they're driving, flying a plane, that bus taking our kids to school, or that person driving the Amazon delivery down the street should not be high. What people are doing now, companies are screening more and more. The best way to screen is a non-invasive, fast way with a shorter window and detection, and we're the only one in the market that can provide that. On that one, I would like to hand it back to Walter. Thanks, Walter, for the opportunity for both of us, both myself and Peter, to be able to present.
Well, thank you, Harry. I think that was great. Peter, perhaps a question for you first. We talked about on this call the FDA submission, the 510(k) package that was submitted on September 9th. I guess from your point of view, if you could give our audience an idea what it took to get to that point where you were ready for the submission, and what, if anything, can you say about the review process for people to expect from now that we have submitted the package to the FDA?
Sure. Yeah. Thank you, Walter. The 510(k) submission that we put together is very detailed and very comprehensive, and we could not be prouder of our team. With the efforts of our team and our extended consultants, believe it or not, we put over 18,000 hours it took to get this across the line. 18,000 hours is a lot of time. What did we do over those work hours? Let me give you a high-level view of the major aspects of our 510(k) submission. That would include a cutoff study, a precision study, an interference study, a method comparison study, a usability study, and then we did a lot of cybersecurity work around our reader. It was necessary for us to start with a cutoff study, and the reason is it allowed us to fine-tune the needle when it came to our coding threshold.
Then we were able to take that new cutoff, apply it to our other studies, and they all lined up beautifully and looked great. Another study that's important to note is the interference study, which demonstrates that regardless of what your hands may have on it, right, in different environments, different workplaces, if you have dirt, oil, if you have hand lotion, that our product remained robust and remained accurate throughout the interference testing. The method comparison study is kind of the highlight, I would say, or the golden star of the submission, and for good reason. Because what the method comparison study shows is that our product is greater than 98% accurate on our screening device, which is absolutely incredible. We could not be more thrilled with that. Then we can't forget about the cybersecurity aspect, right?
Cybersecurity software is all around our reader that Harry held up. We had to ensure that this cannot be hacked, this cannot be compromised in any way. We used a third-party group to do extensive penetration testing and EMC testing. They identified a list of vulnerabilities. They gave it to us. We addressed every single one of those vulnerabilities before we finished this portion of the 510 and added it to our package. Overall, a lot of aspects, a lot of hard work in individual areas you can see has been put together in this whole package. We did submit it on September 9, as you mentioned, and it is currently with FDA, and they are currently reviewing it. We are on standby to answer any questions they may have with an overall anticipated response of H1 next year.
Thank you, Peter. Obviously, a lot of work went into that package, including the method comparison study. These are requirements to submit the package to the FDA, but for the investors on the call, what does the accumulation of all this data tell from an investor's point of view? What does it all mean?
Right. I will focus on the method comparison, what the important part of the method comparison study is that it gave us Let me step back. What does the method comparison study tell us? It determines the accuracy, the sensitivity, and the specificity of a product. Right? When we were building our method comparison study and building every aspect of this study, we were building the protocol, how we were going to execute each aspect. We purposely built this to be very robust, which is why in the method comparison, we executed it across three independent U.S. clinical sites. We had 135 participants and nine operators, which gave a representative diverse demographic of the United States population.
We could not be happier with the results, giving us, like I mentioned, a greater than 98% accuracy, a greater than 94% sensitivity, and 100% specificity. What that means is 100% specificity tells us that we did not have a single false positive result across our entire study. Right? That is huge and very important for our customers too, because a false positive result can lead to somebody being wrongfully terminated. We cannot play around with this. Having 100% specificity is a huge strength when it comes to our method comparison. As I mentioned, every aspect of our submission was started from the protocol of how are we designing this to be robust, to be very strong, all coming off of the new cutoff and creating a very, very strong 510 submission.
Very interesting. I appreciate that, Peter. Harry, again, regards on the FDA submission, we know the undertaking that comes along with it. I realize that there may be limitations on what you can and can't say, but for the investors on the call, what happens now? What should investors expect now that we have had the submission, the timeline starts? What can you disclose to investors about what happens from here?
Yeah, great question, Walter. Look, a couple aspects. First of all, as you can understand, it's key for us, the FDA submission was key for us. It was a major milestone. What happens here is virtually when they have the FDA, they're going to be reviewing it, and they'll be coming back with any questions. I expect from my experience, while everyone quotes a 90-day window on when they come back to you, there's a bit of back and forth in terms of questions and answers. So I expect sometime in the first half of 2024 with an answer from the FDA aspect. Now, that's what we submitted, but we're not sitting down and doing nothing, right? In the meantime. So one thing that we'll continue to do is grow our revenues and to be strong commercially.
We are starting to get a lot. We're preparing our distribution network in the U.S. So when we get final answer from the FDA, and hopefully once we get clearance, so we can start selling, there's a couple key aspects that we need to do for us to be successful in the U.S. One is we want to build out our distribution network, and we're already commencing that on talking to individuals on who's going to sell it for us. We won't be doing it direct. We will be going via distributors. The reason for that is, simple fact is distributors already are playing in the industry. They know the customer install base. They know the lay of the land. So they're the best people to go hit the ground running very, very fast. So we are in talks with multiple distributors in the U.S.
The other thing is that we're preparing to get ready is once we get this first phase of FDA clearance, which will be cleared, our reader, our back-to-lab method, our whole system and how it works, but only one indication of drugs. We've got multiple drugs that we want to add on to this panel, and the first one we're going to be hitting with is cannabis. In fact, what we're going to be doing is we're going to do a side-by-side approval, and we're going with three key drugs. We're going to go cannabis, methamphetamines, and cocaine straight off the bat. So what we expect is once we get cleared for our codeine right now, we're going to go hard with the other ones.
As you can see is our commercial, we'll keep on going on that one, get our distribution ready for the U.S., then once we get that FDA clearance, we're off and getting those other drugs very, very fast approved. Because what we need to do is have a comprehensive test for the U.S. market. Unless we get these other three indications approved fast, we won't have the ultimate product for the U.S. market.
We appreciate that. A question came in from our audience, and it was a question that I had as well. As you're preparing for U.S. commercialization, and obviously you have a massive footprint outside of the U.S., how do you think about the differences or things to be prepared for when you're commercializing in the U.S. versus outside the U.S.? Are there a lot of similarities or are there things that you're finding where you're getting yourself prepared for the differences in those two markets?
The one thing is, we've been in the market, as we said, and most of our revenues right now is coming out of the U.K., which is a very strong drug screening market for us. We do have some international sales and growing on the international sales. But one thing that we have learned is we've done our proof of concept. We understand how to sell this product. We understand what works, what doesn't work, how to mine your install base, how to grow your install base. That is key for us. Once we get into the U.S., we have all those scars that we have had to have this product in the market. Being able to sell it to the U.S., we've got that experience going through. So I would pretty much say it's kind of the same.
You might have to tweak it here and there, and the messaging a little bit here and there, but pretty much we have the know-how of how to sell it. But when it comes down to then manufacturing and supplying this product, we'll be doing it out of the U.S. While we can support the U.S. outside and manufacturing, which we have been doing outside of the U.K., we need to get close to the customers in the U.S. So we will be manufacturing both our readers and our cartridges, manufacturing facility out of the U.S. for a couple of reasons. One is we're closer to the customer, which is key because it is a high-demand and fast-moving product. Second of all, it's cost-effective for us. We have been doing some modeling, and we have got pricing, and we know how much it's going to cost.
Manufacturing out of the U.S. won't be that much more expensive than what we're currently doing. In fact, some aspects might be more productive. Last but not least, we need to ensure that we don't have all the logistics costs and freight and shipping overseas and duties and customs and all the complexity that goes around that as well. If you want to hit a product hard in the market, you have to have the product close to the customer and to be able to fulfill that demand. The worst thing that we can do is have product outside of the U.S. and customers waiting for the delivery of that. Customers don't wait. They want it here and there. That's key for us to get ready for the U.S. market.
Yeah, that makes total sense. We received a lot of questions from our audience, so appreciate that. Just one last question from me before we open up the call for you, Harry and Peter, would love your point of view. Harry, in your presentation, you did talk about the size of the U.S. market, obviously a large multi-billion dollar opportunity. More specifically, when you think about the competitive landscape in the U.S., we understand the alternatives, but how do you think about competition? How do you give an idea to investors? Obviously, we have this new technology coming into a new market. How do you think about competition in the competitive landscape?
No, it's a great question. We deal with competitors every single day outside of the U.S. Look, the alternative from us is the traditional way of people have been doing it, is a urine test or a saliva test. From a urine test, it is so archaic, it's not funny. First of all, having to watch a person urinate to ensure that it is their sample. There's so much gaming in urine, as we know. Handling warm samples, the risks to going around urine, it's just not the way to do it. The other aspect is that shorter window of detection. Being able to have a shorter window of detection is key, especially now that cannabis is becoming legalized. The way that I always say it is, and I'll compare it to an alcohol test.
An alcohol test does not test to see if you drink, right? It's legal to drink, so everyone drinks. An alcohol test right now is to see if you're drunk, right? It's the same thing with us, our product. Our product does not test to see if you take drugs. There are better tests to do that, to see if you take drugs. If you want to see if someone takes drugs, the best test out there is a hair follicle test to see if you've ever taken drugs in the last three months. That's not where we are. We are out to see if you are impaired. Are you high? Are you affected by any way with drugs in your system? The only way you can do that at this day is ensuring that you've got the shortest window of detection.
Again, from our standpoint, our key competitive advantage is, one, we are super fast and super simple. 10 minutes from go to whoa. We are actually looking at, we have done some announcements, is we are validating now to actually speed up that test. Currently, it takes 10 minutes. We could be potentially down to sub five minutes in terms of our test. We have announced that we are doing a validation study. First of all is our speed. Second of all is the ease and simplicity to do it. I can do a urine test right now on screen within 10 minutes by just using my digits, of the sweat of my fingers. Really fast, really simple to use, and that short window of detection. Then put that all together and our price in terms of how cost-effective it is.
We are as affordable or sometimes less when you take into consideration lost productivity, how long it takes. All the other PPE that you need. If you are doing a urine test, you need to have gloves, a proper vial. We do not need all of that stuff. When you look at it in the holistic standpoint is, we are faster, easier, surer in our detection and sometimes cheaper. For me, it is an easy sell.
I do not know if you have any point of view, Peter.
I am sorry?
If you have any point of view on that.
No, I think Harry summed it up quite well. He answered all the major aspects as to what differentiates our products from our competitors. I think he did a good job.
Great. Harry, the questions coming in from our audience in the last few minutes that we have. You talked about faster results. You get this question a lot. Clearly you are going down that path. Potentially, could this be a roadside testing for law enforcement or some other vertical like that, just given the time frame in which you can get your real data? Is that a potential as well?
Well, this is why the direction why we went down this pathway. We have been doing some trials. Look, we have, I think currently there are three trials and a potentially fourth one, of trialing with law enforcement or police doing roadside testing. Today there is an alcohol test that you can do for an alcohol test, but there is no fast way to do a roadside test. We have been testing it in Dubai, we have been testing it in Italy, and there are a couple of other places in Asia that we are testing it, and the biggest feedback was, it takes too long. You cannot keep someone on the side of the road for 10 minutes.
If you can get it down sub five, three to four minutes, you've opened up the opportunity to pull someone over and quickly test within three to four minutes, and then they're on their way. That changes the game. We're very strongly competitive advantage. Waiting 10 minutes on a work site, that's fine, right? But roadside testing, for us to crack this one, we really need a sub five minute. That's the biggest reason. That market alone, that opens up huge possibilities in that market. Not only the fact that you can do it actually makes the road a lot safer. I think there was an article that we saw that an individual, a famous sports person or golfer in the U.S., was affected by drugs, but they didn't have that ability to drug screen him right there and then.
You can do that with ours if you can be able to do sub five minutes. So very excited with that, and there'll be more on that. We should be able to update the market with our validation study by the end of the year and inform people how we're going with that.
Interesting. A comment just came through that I think is worth notating. Just speaking about the large market verticals, the insurance industry, and specifically for construction projects. Not really a question, but a comment, but I guess it gets to the heart of the potential opportunity with all these large verticals that clearly need innovative technology that's non-invasive, that's safe, that's right?
Correct. Well, look, unfortunately, people are taking more drugs, and unfortunately, we're getting more and more accidents with drugs on the work site. The only way we can prevent this, is by screening and being more preventative, and the ability for us, again, to provide that solution for industries. We play in every single vertical, from oil and gas to logistics, construction, manufacturing, anything around where we call blue collar kind of industries. We play in every single vertical, and the demand is increasing day on day on that one.
I appreciate that, Harry. Just one last question. We talked a little bit about the full list of drugs that we screen for. How do you think about rolling out the opportunity for screening for more drugs? How do you think about the timeline? What are the steps that are required to do that?
Yeah. Look, this is one question I get all the time. The thing is, these drugs hit the market every single day. Where it comes for us is, anything you can do in urine or saliva, we can do. The limitation there, we are not limited by what we are doing. It is where you have to validate it and prove it and do tests and clinical trials and et cetera to get the confidence of the thing. Just because a drug enters the market does not mean that the customers actually want to screen for it in the workplace. We get it driven from our customers. If our customers turn around and say, "Listen, there is more and more people using a certain drug," can you actually add it to the panel? We can add it to the panel very, very fast. That does not take long.
It is that validation and screening on all the clinical trials. We are looking at ways to fast-track that, but that typically takes anywhere from six to nine months to get all that information, then submit it to a regulatory body. That is kind of where that one sits. No limitation, it is just time and clinical trial.
Interesting. Well, really appreciate it. We are at the 30-minute mark. Really appreciate everyone's participation. We had a great audience. Harry, Peter, really appreciate your time today. Harry, before we conclude the call, any last statements before we head out?
No. Thank you, and appreciate everyone's time in joining. I would just encourage everyone to keep an eye on this as we power through this one. Our goal is to get into the U.S. This FDA submission is the first stage of that. Once we get into the U.S., we have got a solution that the U.S. market needs. Watch us. That's all I ask.
Thanks again, Harry. Peter, really appreciate your time. Thank you everybody for joining. As a reminder, if you have any questions, please always email us, INBS@kcsa.com, and the recording will be available on the investor relation website. Again, thank you, everybody.