All right, good morning everyone, and welcome to this year's Canaccord Genuity Global Growth Conference. My name is Caitlin Cronin, and I'm on the medical device team here at Canaccord Genuity. KORU Medical is joining us today, and they're a medical device company focused on innovative portable solutions for the drug delivery market. We're very pleased to be joined today by Linda Tharby, President and CEO, as well as Tom Adams, CFO. Before we begin, I want to remind everyone of any relevant disclosures, which can be found on our conference and our firm website. We'll begin with a brief presentation from the KORU team and follow with the fireside chat. With that, I will hand it over to Linda and Tom.
Thank you, Caitlin. Good morning everyone. Today we're going to talk to you about KORU Medical Systems. We are a leader in large volume drug delivery. Think about today, the majority of patients around the globe still go to a hospital to get an IV infusion. What our product does is it allows the patient to get that drug delivered by themselves in their home, giving them the freedom, the name of our system, to live life fully. All forward-looking statements. Today we focus on, if you think about drug delivery, you go all the way from less than 1 ml, which think about diabetes patients that do those drug deliveries every day on their own, to volumes up to 100 ml. KORU would specialize in this niche space of 10 ml +. We're capitalizing on that ongoing shift from IV delivery in the hospital going directly to the home.
Today, we service over 45,000 patients on our system. We were the first to receive an FDA approval for subcutaneous delivery in the home. That happened in 2017, so have close to 10 years of delivering product in the home. That revenue base is a recurring revenue base today. Those are chronic patients, so diagnosis around COVID-19, and they're on it for their entire lives. What we're looking to do is expand beyond that sub-Q base broadly into many different drug therapies. Today, we have about 10 collaborations with pharmaceutical companies to expand into many different areas: nephrology, gastroenterology, and oncology being a few of those drug areas. Just a little bit of a background. We have over 70+ global patents on our Freedom System. Those extend out over the next 20 years. We have eight drugs on our system, rapidly expanding internationally.
We have about 36 countries that were cleared with our drug, with our devices. This year, our guidance just raised that guidance $39.5- $40.5 million, 18%- 25% growth, 75% of it recurring, and also looking to hit cash flow positive this year, about $8 million cash balance. We're headquartered in manufacturing in Mahwah, New Jersey. Today, our business splits between pharma services and clinical trials. This is where we work upfront with pharma companies. Once that drug gets approved for use, it goes into our core business. About 80% of that done in the U.S., about 20% outside internationally. This is our system. We have two different pumps. They're fully mechanical pumps, meaning no batteries, no complex programming needing to be done by the patient. We have both a large volume and a smaller volume, our FreedomEdge. We sell consumables.
That's what connects the pump to the patient body. That controls the flow rate and the delivery of that drug to the body. That can occur anywhere between a 10-minute infusion to an hour and a half infusion. It's very simple, easy to use. Today, over 2 million chronic recurring infusions on that system. We just did a five-year retrospective study, very exciting for us, 97% adherence rate with that system. It's customizable, so it can be used for many large volume drugs. Today, we can, and I'll show you some of the clinical programs that we have going on. What is our overall opportunity? Overall, today we service primarily subcutaneous immunoglobulin. Today, that market is about 20% penetrated with subcutaneous, with IV being the remaining 80%. That's about a $450 million global addressable market. Overall, there are 53 new drugs in development in the future.
Today, with the 10 collaborations we have, we believe our potential is close to $2 billion full total addressable market for those new drugs in development. Three strategic growth pillars, obviously protecting and growing that core IG business, domestically incredibly important. Expanding internationally was about 50% of our growth this past quarter, doing a lot of global growth, and obviously enabling more drugs and reaching more patients with those pharma collaborations. Just a few key highlights from our second quarter. We hit a milestone second quarter, our first $10 million quarter. We grew overall by 21% as a company, 19% within our domestic core business. Doing very well in that area, really being driven by conversions to prefills around the globe.
The underlying market's growing about 8%- 10% per immunoglobulin, but we're seeing a huge boost from that with growth in prefills, which we were the first pump to be indicated for use with prefills on a global basis. We have in total six different partnerships with IG companies, which continues to fuel our market share and growth on a global basis. These are all of the new drugs that are in our pipeline. Overall, 10 new drugs in our pipeline. You see the four that are highlighted here are drugs that will be cleared over the course of the next 6- 12 months. Very exciting opportunity for us.
Those drugs range from one everyone in this room will know or probably been on at one point, vancomycin, used, an IV-infused antibiotic that we're using our pump to infuse, but a very large patient base, to one that we're working on, oncology, which is another big area of growth that we're looking at for the future. Overall, as you see, we anticipate adding over 1 million infusions over the course, the potential for 1 million infusions to our platform at around $10 per infusion. That opens up, as we said, another $5 million- $10 million in opportunity with this full drug pipeline over the next several years. New products that we're looking at, just looking at our total pipeline. The first is a flow controller.
Think about these drugs going into the body, giving the freedom for the patient to dose between a 10-minute infusion and an hour and a half infusion, depending on what's going on with their day. This will open up several new markets for us on a global basis. We've got a new pump. I talked about prefills. This will be the first pump approved on a global basis that's been able to use with all prefill sizes, and then a new consumable set that is geared for convenience and comfort. When you think about the patient doing this in the home, think about this whole portfolio adding comfort and convenience to that patient's experience. I'm going to turn it over to Tom, who's just going to talk you through a couple of the financial slides.
Thanks, Lynn. Yeah, as Linda mentioned in the beginning at the onset of the presentation, we expect to be about $8.1 million, more than $8.1 million in cash by the end of the year. You can see the trending over the last three years or so. We made a conscious decision to invest back into the business for that new product development and those new drugs on label that Linda just went through. You can see our burn has been steadily coming down, and we're at the point right now for the second half to be cash flow positive for the rest of the year from an operational perspective. Looking at our first half highlights, Linda also mentioned that we grew about 19% on revenue, which has been fantastic. Our gross margin is holding steady, even with the tariff impact exposure that's built in.
Our tariff exposure was about 90 basis points, so we've been able to offset that almost by 50% and hold that gross margin from last year. Our OpEx, you can see there, our OpEx is just a 3% increase. This shows the leverage that we're seeing in our business with a top side revenue of 19% and an OpEx of just 3% growth. This is all leading to lower net losses. You can see our net losses are pretty marginal at $1.4 million, which is about a 53% improvement year -over -year. Of course, all into positive adjusted EBITDA. First half of the year, we were actually at zero, so we were flat with adjusted EBITDA, and you can see for the rest of the year, and compared to last year, about 101% improvement. Pretty strong financials in the first half. We expect to continue that trajectory in the second half.
I'll turn it back over to you.
Yeah. Just kind of wrapping up, if you think about the story for the company, what we're really looking at now with the investments, a large majority of the investment behind us, is a sustainable pathway to + 20% growth. That really comes from these four areas that we talked about: the overall IG market growing, that chronic patient base growing, continuing share gains there, the new products, the international expansion, and also the new drugs on our label. Overall, just wrapping up, think about the future as we know it in terms of drug delivery moving from the hospital to the home. We are that essential drug delivery provider that can get the drugs into the body more conveniently. We're one of the first into the space with the largest patient base and large volume around the globe.
You see a business that's growing in that 20% range, sustainable 20% range, with 75% of that revenue being recurring. Great opportunity to expand not only domestically to increase sub-Q penetration, but also on a global basis. 10 new non-SCIG drugs in our pipeline overall, and obviously with the kind of financials, the full P&L and balance sheet. Strong top line revenues, recurring gross margins, looking to get to that 65% + range, had our first quarter EBITDA positive, which is great, and obviously looking to grow our EBITDA over time. That's it. Caitlin, I'll turn it back to you for questions, and maybe I'll just go back to a fun slide we can show people.
Maybe just starting with the Q2 and updates there, and you noted the guidance raised to 18- 20% revenue growth. How do you view this guidance? Do you view it as conservative or more aspirational in light of the 18% growth last year and again the 19% growth in the first half you noted?
Yeah. First, I just want to re-highlight a couple of things from the quarter. First, $10 million quarter, which we're very excited about. This guy to my right's been telling me for several years, as soon as we hit $10 million, magic things start to happen up and down the P&L. As for the overall guidance range around the revenue, I think it's probably we have several opportunities to outperform that. Those would be greater prefill expansion on a global basis, maybe getting some of those new drugs a little bit earlier on our label than what we anticipated. That's also balanced with, you know, we talked about the U.S. market and maybe some destocking happening in the U.S. market. We're incredibly proud that we're now posting our second year of high, you know, 18%, teetering on that 20%, but we hope to end the year with the 20+% number.
Maybe just touch on that disruption from the distributor that you just noted, and a little more color for the audience on the impact of that in Q3.
Yeah. Maybe I'll start and then turn it to Tom. Basically, our business model is we sell to distributors. We write contracts with specialty pharmacies that service the end patient. Those distributors then sell that product directly to all those individual pharmacies. That's where the inventory portion comes in.
From time to time, some of our distributors have inventory initiatives where they carry a certain amount of stock, and for working capital needs, they bring their stocks down. They let us know in Q3 that they were going to be doing a little bit of a reduction to take a week or so out of the chain. We've adjusted our forecasts for that.
You know, I think somewhat contrary to that expectation, OUS. has been particularly strong in the first half. Can you speak to the strength, and then how that translates into your guidance in the second half?
Sure. International, we just did in a quarter what we used to do in a full year a couple of years back. International is a major part of growth for us. If we think about the broad opportunity internationally, it's about a $60 million opportunity. We have ambitions and product launches coming that we believe can take our share from around the 10%- 15% range to closer to where we are in the U.S., which is a 50%- 60% share. The biggest growth driver for us in the quarter was international, and the majority of that growth came from a new device platform called prefills that make it far easier for the patients to dose. That is a multi-year opportunity.
It's probably, in total, I'm going to give a broad range, but probably somewhere between a $2 million and $10 million opportunity for us that we'll recognize over the next several years in close partnership with the pharmaceutical company. That is the reason for raising the guidance. We have converted one market, but as we know, Europe is made up of 15+ countries, and we're just getting started with one, so there are multiple opportunities to penetrate into new markets.
I think related to that was the tender win in the first half, and that led to stocking orders. How do you expect further stocking from this tender, and going forward, any other tenders that you are working towards, as you noted, Linda?
Yeah. Maybe I'll touch and then let Tom hit how that impacts. Overall, we are working with a major pharmaceutical company, and our device and the competitive advantage for us, it's the only device that is cleared by the European authorities to work with their prefill platform. We also will be launching a new pump, which I mentioned in my overview. We expect to file by the end of this year, early next year in Europe, that is custom designed to work with their entire prefill. We see this as being an ongoing story. The first tender that we won was in a market where we displaced the incumbent that was an electronic pump that does not work with prefills. We again see that a lot of legs to come, and they gave us a first order. We anticipate a second order in the back half.
I think that's right. What we saw in the first quarter versus the second quarter was explosive growth internationally, but we did see a sequential decline towards that tender stocking that you mentioned. We have already received pretty firm orders in the back half, so we're pretty much aligned with our plan going forward and our forecast.
Nice. You know, Japan, I think, has been an emerging opportunity for you that you've talked about. When do you expect to launch there? Just talk about how quickly you expect the business to ramp once you do launch.
Sure. Maybe I'll start with Japan, but then paint a broader picture of the international opportunity. Today, Japan would be a top 10 market for IG. It's just getting started in subcutaneous. I mentioned a number, depending on where you are in the world, 20%- 50% penetrated with sub-Q therapy. Japan is probably just getting started around that 10%- 20% level. A new market entry for us. We've got all of the approvals required to enter the market, which we got done over the last several years, a lot of hard work. Now we're working with the pharmaceutical manufacturers to the commercialization plan. It's probably a bigger 2026 story, but we have seven key markets targeted. One's in Europe, for example, Nordics and the U.K. Our share would be 30%- 40%. We're trying to go to 60%- 70%.
You've then got Germany, Italy, France, and Spain, where we're really looking to grow from 10%- 40% share. Then you've got Japan and Canada, which are brand new market entries for us, and we're looking to go from virtually no sales to 20%- 30%. When I talk about that international opportunity, again, we see it as a major opportunity with competitive advantage with our new pump technology.
Great. I'm just turning to the new pump and then new products in the pipeline more broadly. I think you noted on the earnings call that you pushed back your next-gen consumables launch. Maybe just explain the rationale for the pushback of this launch and then also why you don't expect that it should impact your top line expectations.
Sure. Maybe two broad messages that you heard Caitlin say. Number one is we're focused on top line revenue and how do we grow that top line revenue as quickly as possible and keep it sustainably above that 20%. Then how do we ensure also that we are cash flow positive? We run a very disciplined capital allocation process in the company. As part of pushing back consumables, we looked at two products, the new pump and our flow controller, that could, if we got them out a little bit sooner, add incremental revenues faster. We chose to, so new market access and new drug access, that those would allow us to. We prioritize those in our portfolio, made sure we're going to hit those timelines in all of the geographies we want to get into.
We then made the choice to say, okay, our consumable set, we already have one on the market. This was a next generation, so an incremental share gain opportunity. We just said we'll delay that for a little bit. We're going to refine the product a little bit in working with our pharma companies. I think the overall message is, you know, think about the growth we've seen to date of, you know, 15%- 20% that we've done three of the last four years. That's been without any new products or any new drugs on our label. Now you have a company where we'll launch three new products over the course of the next, you know, 6- 12 months, and we'll launch four new drugs on our label. That's why that sustainable opportunity to go now above 20% we feel is in our sights.
You know, maybe just turning to the new drugs that you're working to get on label, talk about the oncology opportunity. Where are you guys with the U.S. trial sites, and when do you see this expanding more broadly as an opportunity for you?
Sure. As I showed in the pipeline slide, we have 10 new drug opportunities. One of the larger ones, unfortunately, as we all know, oncology is a huge space. Today, if someone is on chemotherapy, they take adjunct drugs, protein inhibitors. There's a whole class of these seven drugs that have been launched and approved by the FDA. That's why we love oncology so much, because the drugs are already approved. That risk is gone. Seven drugs have been approved. Today, the standard of care is a nurse that is standing over a patient who's already having a tough experience and has to stand there between five and 10 minutes and manually push a syringe with about five pounds of force with just their thumb. They are pushing that into the patient.
It's painful for the patient because they're pushing it with a great amount of force to make sure they're doing it. I'm watching a clock to make sure I'm doing it in the five to seven minutes the label requires. The opportunity came about for us the way we love it, which is a nurse said, "This is a struggle. I'm not going to do this." The hospital then was using our Freedom System for IG drugs and said, "Why don't I use this system for oncology?" We did that product for them in an off-label, regulated clinical trial experience for them. Here's what we found. 97% of patients preferred our system. They reported a significant reduction in patient pain. That was a great outcome. Their own experience was great. The best part about it was the efficiency part of it.
They were able to see more patients or spend more time in quality interactions with the patients. We now have a trial that we then extended. We've just been asked to present at a major European oncology conference, presenting the results there. When we talked to the U.S. healthcare system, everybody wanted to see U.S. results. We are now in seven trial sites dosing four different oncology drugs. When they use it for one drug, they say, "Why can't I use it for all of them?" which was what we hoped would happen. Four drugs, and we anticipate these trials will do three things. Number one is, do they love it as much as nurses in Europe do? That answer thus far has been a big check yes. Number two is, how do the reimbursement and payment work? You know, can we charge $5?
Do we charge $50 for this device? What is the economic benefit for those sites, and how do we capitalize on that? Finally, how do we sell it? Oncology centers are new for us. Do we stay? Many of them are dosed at the infusion centers we call on today, or do we go to big hospital centers? Those are the decisions we're trying to make. Obviously, at this point, really excited for the value proposition playing out. Now it's just, is it a $5 million opportunity? Is it a $10 million+ opportunity for us? What kind of investment profile goes along with that?
You know, talking about drugs that are already approved, that would be easy wins for you guys. You've also begun pursuing additional indications for iron chelation, antibiotics. Just speak to those opportunities and any other ones that you've kind of found that you can maybe pursue as easy additions to your on-label usage.
Yeah. As I talked about, working with pharmaceutical companies to get new drugs on our label or get new drugs on our label independent of the pharmaceutical company support is what we're trying to do, is get as many new drugs on the platform as we can. Several of our specialty pharmacies began to use the drug off-label. When we start to see 10s, 20s, 30s coming in on a monthly, quarterly basis, we look at that data and say, "There's something here. There's an unmet need that needs to be filled." That's what happened. Vancomycin and deferoxamine are two drugs today that we're able to administer. We're going to get those on our label. There are several others that we're thinking about. Too early for prime time, but we expect to make this a part of our business.
They're great base hits, $0.5 million- $1 million a year between those opportunities. They're great opportunities to add another point of growth to our platform and a low-risk way to do that.
Of the opportunities in your pipeline, maybe just highlight which are nearest term and also maybe the largest incremental opportunities for you guys.
For the new drugs?
Yeah, just overall the new drugs in the pipeline.
Yeah. Overall, I would say the closest to home are the ones I just spoke about that we'll put those on over the next two quarters. There are two new drugs that we are just adding, a rare disease candidate, two rare disease, but one that just got approved for expanded indications. Those will add another $0.5 million or so. The big one, obviously, is oncology. It just, by nature, it's a huge growing area for us. We've got a couple others coming into 2027 that are around 1 million infusions overall. I think once you get the cycle going, and we've been talking about this for about three years now about getting new drugs on our label, it's great to see now four drugs we think we'll get approval for over the course of the next 6- 12 months. We've got another six.