KORU Medical Systems, Inc.

but with fairly low penetration and we see the opportunity in pre-fills to really grow that market significantly. So what we see today is that we have our second market. We started our year off strong in 26 with our second market that's really going live now with this pre-fill launch and we expect to see likely a new market being added one to two every quarter as we move through the year. I think the last part of the question was just the Freedom 60 and the new approval. Very excited about that because now we have two pumps, both our 60 and our Edge that are both approved. We required some slight modifications to our Freedom 60 and an update to our IFU We just received approval on that in the fourth quarter of 26. So great news for us. We've now just started distributing that new product into the market today. And of course, what comes at the back end of the year is our Freedom 360, which is our pump that will work for all pre-fills. So hopefully that got all of those questions.

Perfect. Thank you. Maybe just for my second one, Tom, a little more composition of the guide would be good color. I heard ramping revenue throughout the year as some of these initiatives progress, but maybe how much contribution from U.S., how should we think about that growth rate, OUS, and then any cadence in color you'd like to provide would be great, too. Thanks.

Yeah. Hi, Frank. Thanks for the question. Yeah, great. So we're continuing to see momentum coming into Q1 after a record Q4. So that's very strong for us, particularly on the international side. So as mentioned earlier, pre-fill still is a driver of that market. So we continue to see that progress. I would say from the international side, you will see a step up in the back half of the year based on what Linda just mentioned in some of those countries. going online for pre-fills. And then on the U.S. side, I think that's slow and steady. I mean, you've seen the last couple years a pretty steady growth rate on the U.S. side. And then, of course, as we get further along into the year, you will see more growth from some of those 510 approvals that are upcoming. And then, yeah, then we'll just continue to grow off of there. And then on the PST side, you'll see consistent growth

consistent revenue trajectory like you've seen the last couple of years.

Okay, that's helpful. Thanks for taking the questions. Our next question is from Chase Knickerbocker with Craig Hallam Capital Group.

Good afternoon. I just want to echo Frank's comments. Obviously, we wish you the best uh linda and all your future endeavors appreciate everything you've done here which is which is quite a bit um so and obviously congrats adam on the new role as well uh maybe just first for me on the domestic side you know 18 growth is that is obviously substantially above the market uh can you give us some sense for what's happening in the markets allowing you to take so much share and maybe one and then and then two on that front um you know how should we think about the opportunity for further share gains in 2026 after a pretty strong year in 25.

So thanks, Chase, for the well wishes. Appreciate it. And you and the Craig Hallam team have been great. So first, yes, very proud of the U.S. growth in the fourth quarter. We continue to see new account gains overall on that business. And of course, we had the return happen of the distributor in international that moved back to the U.S. So as we projected, all that business is now back, which is great news. I'll give it to Tom, maybe to add some specifics on the U.S. and what we might see in 26.

Yeah, so in 26, as I mentioned, we continue to see a strong SCIG market, and we expect that to continue to grow throughout the course of the year. And then as I just mentioned to Frank, as we continue to receive approvals for new drugs on label throughout the year, we expect some growth off of that as well.

So we will continue to see that revenue grow sequentially in the U.S. market.

Maybe on that front, on the novel therapies that we're adding, particularly in the second half, can you give us a sense for kind of the magnitude of impact there? And then just second for you, Tom, you know, if we think about EBITDA in a year, obviously a little bit kind of open-ended on guidance. Can you give us a sense for, you know, how much operating leverage we should kind of expect from you guys in 26? Obviously, you know, low single-digit OPEX growth in 25 was quite a bit of operating leverage. Can you just give us some goalposts as far as what we should be expecting for OPEX growth in 26?

So maybe I'll just start with novel therapies and the overall impact that we're thinking about. And what I would say is we have changed this name to Pharmaceutical Services and Clinical Trials. So we're still figuring that out here, but now we're calling that our PSD business. So obviously, in terms of overall revenues, these revenues are Milestone-based, based upon the overall innovations and clinical trials that we're servicing. So that number, I would suggest, has always been around where it's been historically. So not to expect anything new there, but obviously very excited about the two new deals that we signed this past quarter. And maybe I'll turn it over to Adam just to talk a little bit more about that.

Yeah. Thanks, Linda. quarter, we signed two new deals with pharmaceutical companies. One of them is a nephrology drug that's in phase three. We're really excited about that. The other one's a molecule in early phase one. It's a multi-indication drug. In total, this represents approximately 3 million annual infusions between the two of them. So really excited to add those into our pipeline and get the work going on the feasibility side to keep these moving through the pharmaceutical pipeline and into our future prospects.

Thanks, Adam. And I think before I just turn it over, I think what you were looking for as well here, Chase, was the new drugs on label and what we see in the near term with Ristigo and then the other two drugs, mancomycin and Deporoxamine. Overall, I think a couple of things. First of all, that many of these drugs are administered in infusion clinics. So that is a new entry point for us, and we've already started to hear some of our customers say, hey, can we try these other drugs? So we see that as a broader opportunity, one which I'm not going to put a number on today. But I think the numbers that we've mentioned in the past for these three drugs in total, somewhere between a half a million upwards of a half a million dollar of opportunities. We've got a modest number today, knowing that two of those drugs are not approved yet. And so, you know, we'll refresh the models as time goes on and we learn more and see how many new accounts we can gain. I would also say on Ristigo, we already had a large portion of that business off-label. So excited for the entry. We're already hard at work there, and we'll have more to report as quarters go on. And Tom, question on the operating leverage.

Yeah, just on the EBITDA case, we continue. Last year was a great year for us. You know, we hit adjusted EBITDA positive. We're excited about that. We're excited to hit cash flow positivity. And as I mentioned in the guidance, you know, we will be positive adjusted EBITDA once again and continuing to grow from there, as well as, you know, cash flow positive for the full year, not just in operations, but for the full year. So we're excited about that again. We will continue to see leverage because our business model allows it with the way our SG&A is set up in our business. So we'll get more specific on that as the year runs through, but we expect to continue to progress on those fronts.

Understood. Thank you. Our next question is from Caitlin Roberts with Canaccord Genuity.

Great. Thanks so much for taking the questions. And Linda, I'm so sad to see you go, but you're truly an inspiration to women and men alike in the industry. So thank you so much. I guess just starting with first to go, how are you thinking about the go-to-market model here in infusion clinics? And how does this really position you to penetrate the oncology opportunity more quickly when cleared?

Right. So first, Caitlin, thank you so much. The Canaccord team has been great. And you personally, you know, right back at you in terms of women in leadership. And thank you to all the men who support us in doing what we do. So getting to the overall Ristigo opportunity and how that entry into infusion clinics, I would say broadly what we discussed in the presentation earnings was that Ristigo we see is about 20,000 infusions in the U.S. here today going to about 100,000 infusions over the course of the next five years and even a bigger opportunity globally which we're at early stages of looking at today. In terms of infusion clinics and our entry strategy fortunately for us this channel today is many of the same specialty pharmacies we deal with are dealing with this channel. I'm going to let Adam say a few words in a moment relative to if he's thinking about anything broader relative to our infusion clinic entry, but I would certainly say that oncology infusion centers, which I understand can be a little confusing, but oncology infusion centers are different than ambulatory infusion centers, and sometimes there's an overlap. So we see this as good for our pending oncology opportunity. It gives us a leap and head start and then a broader opportunity once we get approval in oncology. Adam, I don't know if you want to add anything.

Thanks, Linda. Hi, Caitlin. You know, I'll start by saying, you know, this is our first collaboration with UCB and it diversifies our revenue beyond just SCIG in a meaningful way. On the strategic side, it's significant because as you mentioned, it opens up a new commercial channel for us beyond the home. and that's into the infusion clinics. We see there's a lot more opportunity there in the future beyond Restigo. As Linda mentioned, we do have off-label sales there today. We look forward to continuing to grow that now that we have the product on label and we can be promoting it. You know, I want to highlight UCB's reported over 65% year-on-year growth in global Restigo sales.

So we see this drug has a lot of momentum, and we're really looking forward to continuing helping to bring value there.

Awesome.

And Adam, while I have you, just curious what your vision for the company is as you take the helm, you know, coming from the seat that you're currently in.

You know, so... Acknowledging we've had some really great success over the last few years here under Linder's leadership. The strategic priorities don't change. We have a proven strategy really built around three pillars, protecting and growing the core domestic business, expanding internationally, and enabling more drugs to reach more patients. So I focus really on accelerating the execution against those pillars.

I see it as we have a lot of runway in front of us, and my job is to make sure we're running as fast and sufficiently as possible towards those opportunities.

Awesome. Thanks so much.

As a reminder, if you'd like to ask a question, please press star 1.

Our next question is from Joseph Dowling with Piper Sandler.

Hey, Lynda and Tom. First and foremost, Lynda, I wanted to congratulate you on your retirement. It's been a pleasure working with you and wishing you all the best in the future. Yeah, I just wanted to touch on the guidance range here. It was pretty much in line with what we expected. Just looking at, you know, kind of the high end and low end, how you get to each. Curious if you could walk through that. I'm curious if on the low end, it's a scenario kind of where the new drug clearances and OUS pre-fill conversions slip into 2027 a little bit. And then the high end is more of, you know, you execute everything on schedule in 26. Just curious if you could walk through a little bit more detail there.

Right. Hi, Joe. Thank you. And you and your Piper colleagues have been great. And congratulations to you on your recent promotion as well. So referring to the guidance range, I think you have it right. Prefills and the new drugs on label would be, those are the things that vary. If we get prefill conversions faster, the markets get going faster. That's a great thing. And also new drugs, we get further traction or we get them on our label sooner. There's another big opportunity. The other third piece would be a little bit about the Middle East, which we've got a little bit of a factor in here. And depending on the timing of that. And then finally, I would just say, you know, oncology is something we do not have today, a big number in here at all, a very small number. So if we get a bigger head start, an oncology or we're looking at new drugs now, I think that could be a meaningful area for us as well.

Thanks, Linda. I appreciate that and for your comments.

One more just on Japan. I know it's been a kind of a de-emphasized piece of the business with all the great stuff going on in some of the other U.S. markets, but just curious like where you're looking at that for 2026 guidance or expectations there just at a higher level. And is there a point there where the pharma-driven pre-fill opportunity kind of opens up and makes Japan kind of move back up the list? Yeah, just any color there would be helpful.

Yeah, I'll start and then turn it over to Adam. So Japan, we see, again, being one of the larger IG markets overall, we see that this could be half a million to a million-dollar total opportunity. We know that today that's very much a – a hospital, but moving to the home opportunity and lots of exciting stuff that I'm going to let Adam talk through.

Yeah, thanks, Linda. You know, in Japan, I'll start with good news, right? So both pumps are approved. Consumables are approved as well. So we're pretty well positioned to continue to grow in that market. You know, at the time, we're seeing pre-filled syringes there as being important, just as we kind of see in these other international markets. So As those pre-fills continue to grow, we expect that we're going to be growing with them.

So it's a pretty exciting opportunity for us.

Great. Thank you all. And I'm looking forward to working with you a little closer moving forward. Likewise. Thanks, Joe.

Thank you. There are no further questions at this time. I would like to hand the floor back over to Linda Tharby for any closing remarks.

Great. Thank you, Operator. I just want to say thank you to all of you again. I have so appreciated all of your support, your guidance, and most of all, your partnership in working with everyone on the call. Thank you all for taking some time with us this afternoon. Incredibly proud. I want to say my last thanks to this entire Coru team, to my daughters, who actually listened in to an earnings call for a change. I told them there was some big news today, so I think they listened in. So thank you to my daughters. Thank you to our board. Thank you to our investors. I'm not gone yet. I am a big investor and will remain so. And I look forward to working with all of you as this retirement goes on. But I'm here, as I said, to the end of June, looking forward to supporting Adam and the team and through the end of the year. Have a great rest of your day. And thank you so much.

This concludes today's conference. You may disconnect your lines at this time. Thank you again for your participation.