All right. Good morning, everyone. Can you hear me okay? Yes. Okay, good. Is it better without the microphone? No, use the microphone. Use the microphone. It's a big webcast. Oh, that's right. Yeah. That's right. Okay. All right. Good morning, everyone. Great to be here. Thank you to the MicroCapClub for inviting us to present here today. I'll give you all a second to read the disclaimer, because we're going to be tested on it, hopefully everyone can read that ridiculous size one and a half font. Let's jump in. Just to cover a few milestones for 2025. As you can see, good revenue growth, nice share appreciation. One of the most important things for us as the company to achieve in 2025 was to become profitable. A couple of years ago, we did a capital raise.
It wasn't the prettiest one. Our team sat around and said, "That's it. We're done. We're not doing any of the more ugly raises anymore. We're going to become financially independent." We did. We are profitable as of Q3 of 2025. If you look back at our history, you'll see that we had an ATM. We canceled that, and that was an important signal to our shareholders that we're not going to pull that stuff anymore that a lot of microcap companies do. What does our business do? This is a pretty bold statement. We develop products that save lives, and I'm going to share with you an example of one of our products that is related to acute leukemia. Acute leukemia is probably one of the most deadliest cancers that exist.
About 30% of patients are at risk of dying within a week of diagnosis. When the patients are diagnosed with acute leukemia, there's really two types of treatment options. One is what's called conventional chemotherapy, and the other is called targeted therapy. The idea of targeted therapy, I'm sure you guys have heard of personalized medicine and personalized therapy. The idea is that you do a genetic profile on the patient to identify or look for certain mutations, and if the patient has a mutation in a certain gene, there's a targeted therapy that kind of blocks that gene from misbehaving. They're very effective. That's kind of the holy grail of being able to do that. The problem is those tests takes between 10 and 15 days to achieve results.
Some of you guys are doing the math and say, "Wait a second, you just told us there's a chance of dying within a week. This doesn't work." That's part of the problem of the diagnostic world, is that it doesn't always serve the clinical purpose of the patient. What happens? Patient's been diagnosed. Doctor says, "We're going to do some genetic tests." The results are going to come back in 10 to 15 days, and now there's two options, neither of which are great. Option number 1 is you say, "Crap, the patient isn't doing well. We're not going to wait for the results. We're going to put them on standard chemotherapy," which oftentimes can be less effective. At that point, you have foregone the option of doing the call it better, personalized medicine. That option is gone now. Not great.
The second option, I think is even worse, is let's wait and see. I don't know about you guys. If someone told me that I had acute leukemia, waiting and seeing doesn't sound very good. Neither of those options are attractive. We face that in our clinical lab with patients, with samples coming in, diagnosed with acute leukemia and now we got to tell a doctor we're going to have a result in 10 days, and we know that that's not a good option. In our lab, we decided we're going to fix that and create what we call a rapid AML, which is a four-hour test. We are the only company in the world that has this test. Our lab and our customers are the only one that can deliver these results in four hours.
Typically, what happens in our lab, a sample comes in in the morning. By lunchtime, we know the patient has acute leukemia through various other tests. We run our panel, and we can tell the doctor, "This patient is IDH1 positive. You can put him on an IDH1 inhibitor on the same day." This saves patients' lives. This is just one example of what we call ineffective diagnosis, and this is a plague throughout the industry. There's various impacts to that. Either the test is too late, the test isn't accurate enough, the test fails to capture the patient's clinical situation. There's a plethora of problems that kind of fall into this bucket of ineffective diagnosis, which is what we're trying to solve. You can see the magnitude of the problem depending on which publications you read. Anywhere between 25%-40% of patients experience that.
I'm sure there's people here in the room who have family, friends who have gone through that. I am no doubt about that. This is a $100 billion problem in the industry. What happens is, of course, when you have ineffective diagnosis, you have ineffective treatment, you're putting the patient on the wrong therapy, they get worse instead of better. They're more time in the hospitals, and all the costs of skyrocket that you know about in healthcare. This is a massive problem. People ask me, "How do you build a moat around your business?" I like to call it an unfair advantage, and this is what we've developed in our business. We have two divisions in our lab. The first is our Pathology Services Division. We operate a clinical lab just like all of our customers, and we'll get to that in a second.
We operate a clinical lab that has what you would imagine in a lab. We have a facility. We have a lot of boxes on benches. We have reagents that run on those boxes. We have a staff, and most importantly, we have samples of patients coming in every day. This is a business that today is profitable, generates revenue. We bill insurance, we collect, and it's a profitable business. That is our core, kind of our legacy business. What we built on top of that is our Diagnostic Services Division. Like an example, AML, we were providing kind of the old tests that we were running. We realized it wasn't good enough, developed our own assay, and we run it in our lab. I want you to think for a second, what does it take to develop an assay?
It takes three things, and they happen to be listed on the left. You need a facility with equipment. You need staff who will run it and test it. The most important thing is you need patient samples. We pay for none of those. They come in as part of our business. We essentially have a free R&D platform. That is our unfair advantage in our business. Number one, when I go to a customer, I can tell them we use our products, and there's no other manufacturer that does that. We use our product every day. We started with it. We've been using it for several years. We know that it works well. It gives the clinician what it wants. The workflow is optimized. We can bill and get paid for it with confidence, which no other manufacturer can provide.
It gives us a really big advantage over any other product manufacturer. We have hands-on experience obviously, which we can help train our customers and help them bring the test up on live. Maybe not the most important thing is we can develop these products quickly and in a very cost-effective manner. One of the problems with biotech companies is the ongoing need for capital for innovation. In biotech, especially healthcare, especially in cancer diagnostics, you don't develop an assay, and that's the same assay for 10 years, because science changes. New genes are discovered to be relevant to this disease or another, you constantly to update your products, change them, modify them, make them more sensitive, extend coverage areas, and a whole bunch of things.
This is something that requires a lot of capital in the things that we talked about. You need the equipment, you need the staff, you need the samples. Those are the ingredients that you need in order to develop it. All of those are free in our lab because it's part of our clinical division. What we've done is created a situation where our clinical lab and our R&D division are constantly collaborating together and we want to develop a panel for CML. Our R&D team will say, "Hey, lab, when you have CML samples coming in, throw a few our way so that we can test our new assay on them, and it doesn't cost us anything." Some of these samples are either super expensive or impossible to come by.
It really gives us an advantage and one example I like to talk about is a recent product release of our BCR-ABL assay. BCR-ABL is what's called the Philadelphia chromosome. It's for chronic leukemia, and this is a test for monitoring patients that have chronic leukemia. We have probably the most advanced assay in the market. We recently came out with a study that we published with Memorial Sloan Kettering, citing its advantages. The beauty of it took us three months and less than $100,000 to develop. That's unheard of in this business. Any other company would take three to five years and probably $5 million or north of that to develop because they don't have the infrastructure that we have. We hit on the three elements that for a customer are important in the lab.
If you're managing a lab, the first thing that's important is the workflow. How long does it take? Am I going to be able to deliver the turnaround time? Do I have lab staff that is properly skilled for that? That's point number one. Number two is the economics. What kind of equipment do I need to invest in? Most of our competing tests, $1 billion or more to purchase all the capital equipment that's required and what do the margins look like? Economics are important. A lab is a business that needs to make money. The third thing that labs are always measured by ultimately is how quickly we can get the results. I know this sounds like a benign kind of factor, but I want you to stop and think for a second.
If someone in your family has been told they have cancer, but we're going to have to run some tests before we decide what treatment we're going to put them on, and now you got to wait for a week or two weeks or three weeks, and those three weeks are eternity. Turnaround time is really an important factor in our business. How do we scale this up? We've partnered with the four main distributors, to get us into the customers. The reason is that the hardest part of our business is getting in front of the right person in the lab manager. We're a small biotech company out of New Haven, Connecticut. Our relationships are limited. If you go to McKesson or Thermo Fisher or some of the other ones, these guys have been selling into those labs for 15 years. They have relationships.
They can say, "Hey, I want to get in front of Arkansas Pathology Group. Thermo Fisher, you guys sell to them all the time. Get me in for a meeting." That's worth the 20% margin that we give them. Thermo Fisher has a 200 sales force, 200 reps that have been there an average of 12 years. There's no money in the world that I can replicate that. Being able to leverage those relationships and those distributors to get in, we believe is the right model, and it's starting to show its fruits. Where does this company go? Currently, we're focused on blood-related cancers. That's about a half a billion market in the U.S. and about equivalent overseas. For the next two to three years, that's going to be our focus. We have a full product suite for blood-related cancers.
Our tests cover about 85% of blood cancer diseases. We've got a pretty good offering that our customers like. For the next two years, our focus is growing into that market. Down the line, we do see ourselves expanding and duplicating the model in solid tumors. What just happened? Did I do that? Okay. Duplicating that into solid tumors and going into other molecular tests outside of cancer. There's a lot of opportunities to take this model and really expand it far beyond that. In terms of our financial kind of outlook and product and resulting margin mix, we end the 2025 at about a $25 million run rate. About 90% are legacy business, our laboratory services business, about 10% are products business. That's going to change.
There was a clever investor who said, "Oh, well, you're just going to drop your services." No, we're not going to do that. That's going to grow at probably about a 10% a year, although we're not focusing any resources on that because if you think about it, the services division is not the alpha of the business. That's not the growth engine, but it does what it needs. It's profitable, and it delivers samples for the R&D team to develop what they need the next generation of products. We're good with that. That'll grow kind of at a small clip, but really all of our resources of growth are focused on the products business. As we see the balance change and in the next three to five years, I expect it to go from 90/10 to 60/40. That's kind of the goal.
Our margin mix will change as well because the products have a much, much higher margin. We see at scale, and it doesn't take much, we'll be at around 80% margin for the products. It's a really good business that we want to be in. There's some numbers on market share and where we think we can be in the future. Our focus, as I've said, in the near term is to capture significant market share on the blood-related cancers. This is a half a billion dollar market in the U.S. I see no reason why we can't have 20% of that in a few years. It doesn't take that much, and our products are certainly superior than anything the alternative has. This is our good-looking team. Lots of experience in the diagnostic field. We just hired Stephen Miller, our Chief Commercial Officer, been 35 years in the field.
I mention him because he's going to be the driver of the growth on the product side, and that's his focus. In summary, five key points. I think this is a disruptive business that really takes a personal look at what's going on in the laboratory and says, "We can fix it. We can do better based on our own experience and our exposure to the market." We live this world ourselves. We've got a really good platform that enables us to innovate in a very capital-efficient manner. We're not going to have to, for every product, raise another $5 million to get the product into the market and dilute our investors. Big opportunity. I think it's extremely scalable.
Just an example, and some of you may heard me say this, on the product side, we currently have capacity to produce about $50 million of product annually. We did three last year, plenty of room to grow with no further investment. If we had to go beyond that, if we had to double that capacity, it's about $700,000 to double our capacity from $50 million to $100 million. Extremely scalable in our business. Which is much more attractive than the Pathology Services Division. That's a much more stepwise way to scale it up. That's part of the reason why we like this business. Last of all, as being profitable at this level, and continue to operate a very cash-efficient business, I think it can create a very attractive business model. With that, I'm done. I'll hand it over to questions.
10 minutes. Yes, sir.
You mentioned that you're superior to some of your competitors in blood testing. As a layman, can you help me understand why that's the case, and what are the reasons why your competitors can't make it or don't want to make a product as good as yours?
I'll answer the first part of your question, going back to the example of acute leukemia. Go to any hospital website, any reference lab website, and do a search for turnaround time for acute leukemia genetic testing. You'll see 10 to 15 days. Ours is the same day. We're better. It's just as simple as that. We give answers. Remember, diagnostics are here to serve the clinician, to give the doctor information to treat the patient. A delay in information means they can't treat the patient properly. It's as simple as that. The reasons they don't do it, I think for the most part, I don't know what's going on in their head, but I think for a large part, the market accepts what is there.
We go to labs all the time and we ask them, "What's your turnaround time for acute leukemia?" "10 to days." "How do you think about that?" "Well, pretty good. That's what the rest of the market does." Inside I'm thinking, "No, you suck." I'm not going to tell them that, of course. That's terrible. They know that for the patient, that's not good. There's a lot of inertia in the lab, and that's part of the challenge of growing this business. Labs are creatures of habit. Every other lab manager, like, "Oh, we've been doing for 25 years. Our doctors never complain." Well, that's not the indication, right? Of whether the customer complains or not. That's not how you measure if you're giving the right product. That make sense? Yes. You mentioned margins at scale could be 80%.
The question was what drives the difference between our turnaround time that our products can deliver and the competitors. It's all about economics. When you have an expensive test that is complicated, what a lab does is batches. Think about an airplane, right? If they had the choice, they want to fill every seat because they've got the fixed cost of the pilot and the crew and the fuel and all that stuff, and that's critical to them. Our assay, because it's more economically attractive and it's easier, we reduce the threshold for batches. Instead of with other competing tests, they have to run 25 tests in order for it to make economic sense, ours can run five tests.
Think about a lab with a workflow where every day you have five patient samples coming in, you can run the test every day, as opposed to if you're locked into the other product that requires 25 samples, you now have to wait five business days or a week in order for the bus to be filled so it can leave the station. That make sense? Okay. Yes, sir.
If you're selling through distributors that they own the customer relationship, how do you get a sense of demand? How do you fulfill that demand, and how predictable is that view that you don't own the relationship?
Excellent. I'm not sure I would agree that we don't own the relationship. The distributor largely makes introduction and gets our foot in the door. We have significant interaction with our customers, we're there for the first meeting. They're not pitching. This is a complex sale. No offense to a rep from McKesson, but they don't know our business. They don't know our product. They don't know how to answer the next level down of questions. We tell them, "Your job is to get us in the door." That is absolutely worth the 20%, but from there, we take it from there. We develop a relationship with all of our customers. We help onboard them. We have a whole lab implementation team that comes in and helps set them up. As part of that discussion, we understand complete with what their volume.
That's part of the initial discussions. I was talking to someone last night about how do we create our pipeline. What we do is Thermo Fisher will open the door, we go see customer X. Okay. Then we walk them through our product line, and we say, "Okay, which panels do you want?" "Well, we want this one, this one, and this one." "Okay. Can you share with us your volume from last year?" Lab volumes don't change that much. They're pretty stable. Now we know the price we sell to the customer, and we multiply that by the volume, and we know exactly what the value of that customer is, and that's when it goes into our pipeline. Okay. I think we have much more of a deeper relationship than other distributors where they never talk to the customer. Yes, sir.
You mentioned your products pipeline in the last earnings call. More about that products pipeline and the confidence level of it and the duration for that pipeline into revenue.
Yeah. Sure. One of the things I mentioned that was a big change for us is this year we hired three commercial folks, Steve and two other guys. Before that, there was one person in a, call it 50% role, doing sales. We've kind of 6x'd our sales force, and they now start to build the relationship with the distributors and with the customers. With every customer that we're introduced, we go through the process I just described to assess the dollar value of that customer, and only then that comes in. At that point, you've had a pretty good discussion, probably two or three discussions, both on a technical, clinical, and economic discussion. There's a pretty good buy-in. Based on our experience, from that point, it's always been a when, never an if.
We've gotten that far with a customer, they've said, "Well, we want this, and this product." They've looked at what they have in the lab and which ones they want to change or which one they want to bring in-house. They're committed to that, then it's just a matter of timeline of how long it takes. That's a challenge in terms of the pipeline. I want to be very clear, I've said several times we have now about a $10 million pipeline. That doesn't equate to $10 million this year because we're bringing on board next quarter a large customer, a large academic center out of California, which we first pitched to in November of 2024. They wanted it. They were in.
We went through the numbers, everything. They had to buy one of the machines, which we plug into the internet. They need IT approval. You've heard me tell this story about Shane for the benefit of everyone else. They needed IT approval. That took 11 months for them to get IT approval. No one could've predicted that. That's the challenge. I think over time we'll get better in predicting and converting that pipeline to more concrete guidance. I don't think we're there yet. Yes.
Who are your customers?
We have three customer segments, hospital laboratories, reference laboratories, small regional and large reference laboratories, and physician office laboratories, which basically means a large oncology group that is big enough that they've built a lab in their practice and they want to run these tests in-house.
Is that whom your salespeople are-
All three.
When they purchase, they purchase through McKesson?
If it's through a distributor. We have direct customers as well, so it depends. Yeah. If the distributor brought us in, it's theirs, and now they'll purchase through McKesson, and basically we give McKesson a price, and they mark it up whatever they want for whatever margin they want.
How many customers are there of the three combined, total?
Probably about 15 right now.
Say again?
15.
15?
15, one, five. How many customers do we have or available?
How many customers are available?
Oh, hundreds of each.
Hundreds.
Yeah. We did $3 million last year.
Out of 15 customers.
Yes, out of $500 million a year TAM. Yeah. We haven't even scratched the surface.
You have a new COO. Is he running sales?
Yes.
His objective is to turn that 15 into 150?
That's right. Yes.
Mine's an educational question. For the four-hour test, well, there are two things you're really testing for. One, yes, that person has AML. Two, we have a genetic mixed presentation, I guess.
No, just a second. At that point, we know they have AML, and we want to help the clinician decide which therapy they want.
Okay, anyone who has this type of cancer, it's a genetic cause that's the case.
Yes, it's a genetic cause. Not every genetic cause has a targeted therapy. We don't test for their entire genome. We test for the ones that we know there's a bingo. If you have a mutation gene X, drug X will work. You have a mutation gene Y, drug Y will work. If you have a mutation gene W, but there's no therapy to it, there's no point in doing the test. Right? A test is only worth it if there's an action to it afterwards. That make sense?
Yeah. Thank you.
Yes.
What's the feedback been from those 15 clients you're currently selling?
We've never lost one of them.
Great.
We've never lost a customer. They've been with us, some of them, for four years now. That's the nice thing about the business. It's a tough sell, but once you're in, you're in till death do us part. They don't go away. It's a routine. They've got it. They've now shrunk the turnaround time from 10 days to one. The doctors are not going back. Yeah.
Just a couple things. Can you talk about the pertinent economics of the assays in the lab that you're using?
Can you also talk about from your client customer's perspective of they're treating this patient, how does the price of your services compare to the total cost of treating the patient? I guess what I'm trying to get at.
Yeah
Do you have pricing power there?
No. Okay, let me ask you the first question. In terms of economics, and you're talking about the customer economics, right?
Yep.
Okay. Our assays sell on between $200 and $450 per test, depending on which test they do. The reimbursement to the customer is about double. We ensure that our customers have a 50% margin, which makes it attractive for them. They make money, they don't leave me. All right? That's them. Your second question is far more complicated because it depends on the therapy, and you know that, of course. The other thing is there's no price control because reimbursement is set by the payers. If we're testing for AML, the reimbursement is $1,250. Nobody controls that. That's just set. That's based on CPT codes and reimbursement. Now the game is to create a product that leaves the customer margin and that leaves us margin, and we've accomplished that. You've heard our margin, we do very well.
The customer does 50% margin, that's very attractive for them as well. Yes.
Can you talk about how to see the insurance companies, how to make sure that they work and cover your products? Also just to get an idea of how they see Precipio whether the multiple paths
Do you ever see them down-weighting you benefits?
Right. It's not an individual product. The way you develop an assay is you look at the testing codes that exist, which typically exist because of clinical relevance, right? A payer's not going to pay for a gene W that doesn't give any therapy. They know when a new drug comes on board, there's a new CPT code established for that test. We play into that. It's not defined by us, we don't influence that. That's the downside. The upside is it's guaranteed reimbursement because the code exists and a rate exists for it. We don't really have an influence. I don't think Medicare knows who Precipio is, quite frankly. As far as the reimbursement from the payers, all they look for is the matching of the codes to the clinical situation, and then they pay. Does that answer your question? Okay.
Yes, sir.
What happens do you expect that the people who are doing more assay, [inaudible] days, may look at you and say, "These are the company take business away from us.
Yeah.
Therefore, we're going to change our legacy model to follow you.
Right.
Have you seen any of that kind?
No, quite frankly, we're too small to really move the needle for anyone. We're talking about behemoths of companies like Qiagen and Abbott Diagnostics. They're huge companies. This is a fraction of a fraction of a percentage. I think, I hope it'll take a long time for them to wake up. That's good for us. I also think that going into our business model is not easy. It took us 15 years to build a successful laboratory. It's a pain-in-the-ass business, I'll be honest with you. There's a reason we're focusing on the products. It's a tough business, capital intensive. We've made it work, but you look at other competitors 20 times our size, and they're not making money. We've been able to figure out operationally how to really make an efficient business, but it's not easy.
I think that large manufacturers, it would behoove them to jump into that business. I'm getting the wrap-up, but I'm around. Thank you all, and happy to speak to anyone afterwards.