Intelligent Bio Solutions Inc. Common StockINBS
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Intelligent Bio Solutions Inc. Common Stock Fireside chat

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Period 0Duration31 minParticipants3

Transcript

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Walter PintoManaging Director

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.

Walter PintoManaging Director

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 30, 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.

Walter PintoManaging Director

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 24, 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 SimeonidisPresident and CEO

Harry? Yeah. Thanks, Walter. Thanks everyone for joining.

Harry SimeonidisPresident and CEO

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.

Harry SimeonidisPresident and CEO

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.

Harry SimeonidisPresident and CEO

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. 5 seconds per digit, and then within a space of 1 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.

Harry SimeonidisPresident and CEO

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 7 days up, maybe 10, 12 days, depending on how each individual metabolizes the drug and metabolizes in the individual.

Harry SimeonidisPresident and CEO

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.

Harry SimeonidisPresident and CEO

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.

Harry SimeonidisPresident and CEO

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.

Harry SimeonidisPresident and CEO

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 Passaris 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?

Harry SimeonidisPresident and CEO

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.

Harry SimeonidisPresident and CEO

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.

Walter PintoManaging Director

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?

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