Greetings. And welcome to KORU Medical Systems third quarter 2025 earnings conference call.

At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please note this conference is being recorded. I will now turn the conference over to Louisa Smith, Head of Investor Relations. Thank you. You may begin.

Thank you, operator, and good afternoon, everyone. Joining me on the call today are Linda Tharby, President and CEO of KORU Medical Systems, and Tom Adams, Chief Financial Officer. Earlier today, KORU released financial results for the third quarter ended 09/30/2025. A copy of the press release is available on the company's website. I encourage listeners to have our press release in front of them, which includes our financial results and commentary on the quarter. Additionally, we will use slides to support further commentary in today's call, which are also available on the Investor Relations section of our website. During this call, we will make certain forward-looking statements regarding our business plans and other matters. These comments are based on our predictions and expectations as of today. Actual events or results could differ materially due to risks and uncertainties, including those mentioned in the associated press release and our most recent filings with the SEC. We assume no obligation to update any forward-looking statements. During the call, management will also discuss certain non-GAAP financial measures. You will find additional disclosures, including reconciliations of these non-GAAP measures with comparable GAAP measures in our press release, the accompanying investor presentation, and SEC filings. For the benefit of those listening to the replay, this call was held and recorded on Wednesday, 11/12/2025, at approximately 04:30 PM Eastern Time. Since then, the company may have made additional comments related to the topics discussed. I'd now like to turn the call over to Linda Tharby, President and CEO. Linda, please go ahead.

Thank you, Louisa. Good afternoon, everyone. Thank you for joining today's earnings call. I'll begin with some commentary on our third-quarter highlights and strategic progress, and then Tom will review our financial results before we open the call for questions. During the third quarter, we delivered strong results. Accelerating revenue growth, outstanding performance in our core immunoglobulin business, new additions to our PST pipeline, and continued progress towards sustained profitability. We achieved our second consecutive quarter with more than $10 million in revenue, representing 27% year-over-year growth. The key growth driver was our core subcutaneous immunoglobulin or SCIG business, which grew 30% driven by international expansion, continued global share gains, and strong underlying patient growth. While we saw some quarterly shifts in purchasing patterns between domestic and international markets, both underlying businesses remain robust. Tom will provide additional details on the shift in geographic mix. From a strategic standpoint, we advanced several important initiatives this quarter. We recently announced two new PST collaborations underscoring our commitment to expanding our pipeline, broadening our label, and reaching additional patient populations. I'll share more detail on those collaborations during our pipeline discussion. We also made meaningful progress toward our goal of expanding into oncology infusion centers, successfully completing a US-based oncology study that validated Core's value proposition in this market. We remain on track for a 510(k) filing by the 2026. On the financial front, we delivered gross profit growth of 21% year-over-year, achieved positive adjusted EBITDA, and generated positive cash flow. To reflect our confidence in the business and continued execution, we are raising our full-year revenue guidance to $40,541,000, representing growth of approximately 20% to 22%, and we are reaffirming our guidance for gross margins and cash flow from operations. Now turning to our US SCIG business, which represents our largest…

Thanks, Linda. Starting with revenue, we are pleased to report our second consecutive quarter of revenue above $10 million with 27% year-over-year growth, which is a record high for KORU. We delivered 30% growth in our overall core business, reflecting the fundamental strength of the underlying demand for our products and KORU's growing market position. The geographic mix this quarter does require some context, for which I'll provide some additional commentary. Our reported domestic revenues declined 5% while international revenue grew by 230%. There were three specific factors that drove this geographic shift in revenue imbalance across our businesses. First, in the domestic core business, as we discussed and anticipated on our previous call, one of our US distributors reduced their on-hand inventory levels this quarter, which temporarily impacted their order volume and moderated our domestic growth. Second, in the international core business, we had some outsized stocking orders to support the exceptionally strong demand we're seeing with prefilled conversions in Europe. We're encouraged by this momentum in PFS and believe that it will continue to be a meaningful driver of international growth moving forward. And third, one of our international distributors sold product to a US distributor, and that transaction had a dual effect. It inflated our international revenue figures while simultaneously reducing our domestic revenue growth. We have since corrected for this dynamic and do not anticipate it occurring again. Altogether, we estimate that these three factors had an underlying impact of approximately $1,200,000 between the two businesses. The bar chart on the right provides a visual to normalize for the imbalance we saw from these factors in the quarter. The bottom line here is that our core business is solid, end-market demand is robust, we continue to grow our market position, and we are really pleased to…

Thank you, Tom. We are making strong strides across our strategic priorities, setting the stage for accelerated revenue growth. In our efforts to expand the number of drugs on our Freedom system, this year to date, we have advanced four new pharmaceutical collaborations and submitted a 510(k) for our rare disease infusion drug. Upcoming 510(k) filings in early 2026, including opportunities in oncology, position us for meaningful pipeline and commercial growth. In our international expansion efforts, we launched commercial sales in Japan and rolled out our Phase I flow controller. Growth in our top 10 markets will be further driven by prefilled conversions, expanding our global footprint and patient reach. Our core domestic SCIG franchise continues to outpace the market's 8% to 10% growth. With key submissions ahead, including the Phase II flow controller and NextGen IG pump, we are poised to expand our SCIG leadership. Overall, these achievements combined with upcoming milestones reinforce our confidence in meeting 2025 financial targets and sustaining long-term momentum. In summary, I'll leave you with some of the core elements we believe make KORU an attractive opportunity not only now but also in the future. Market dynamics continue to support a shift towards subcutaneous delivery, and our technology is well-positioned to capture the benefits of that shift. Each quarter, we make great strides in executing against our plan. We achieved another excellent quarter with revenue expansion exceeding 25%, driven by steady recurring revenue from our core IG franchise, ongoing patient base expansion, with a compelling opportunity for growth acceleration internationally with prefilled conversions. Additionally, we have a robust and growing pipeline, including 11 new opportunities to bring new drugs outside of IG onto our label in the coming years. And finally, our updated guidance underscores our confidence in continuing to accelerate revenue growth in 2025 and beyond, while maintaining a healthy P&L and improving balance sheet to optimize flexibility and support our growth strategies moving forward. Before closing, I'd like to thank the entire KORU team for their continued efforts and passionate work to further our mission and treat even more patients worldwide. Operator, please open the line for questions.

Thank you. We will now be conducting the question and answer session with selected analysts. The format will be for one question and one follow-up. If you would like to ask a question, please press 1 on your telephone keypad. You may press 2 if you would like to remove your question from the queue. It may be necessary to pick up your handset before pressing the star keys. Our first question comes from Frank Takkinen with Lake Street Capital Market. You may proceed with your question.

Great. Thanks for taking the questions. Congrats on all the progress. I was hoping to start with the oncology setting. Happy to hear the pilot's done, and you had some great outcomes there. I think I heard you comment on the nurse feedback. Has been particularly positive, with the ability to service a few patients at once. Maybe a little bit deeper into that would be helpful to understand how that feedback has been. And then as a second part in the oncology setting, can you maybe talk about the reimbursement model, any work that needs to be done there? Or is there currently a structure in place that'd be conducive to adoption in that setting?

Thanks, Frank. Obviously, we're very excited about oncology being a major expansion into a new market for KORU. So the clinical study that we did was really based in five clinics in the US. We had very large centers and much smaller regional centers. We had good diversity in terms of that. But the outcomes across all the clinics were fairly synonymous. So, you know, a glide quickly past nursing and patient satisfaction, you know, very, very high in the 90 plus percent range. Obviously, the safe dosing of all of those drugs. Your specific question on workflow efficiency was the one that we were really excited about, where 70% of nurses reported the ability to multitask. So right now, they are completely wed to that patient with the manual syringe push administration. So what we were hoping to validate was that by using our pump, the clinic could see improved throughput of patients. And indeed, what we saw was that many nurses were comfortable being able to leave that patient and attend to other patients, do administrative duties, etcetera. So really, huge opportunities for these clinics. On your last part around reimbursement, the great news is we don't have anything to do on the reimbursement front. The reimbursement codes that exist today cover for the administration of these drugs in infusion clinics using a pump. So that reimbursement coverage exists for the products, and so we're very excited about the opportunity. Know, charging ahead now to we've been doing the work to get the submission completed. Provided that everything gets passed, we hope that the FDA will be receiving that submission confident by the end of this year, and we're looking forward to what's ahead for us in the oncology market.

That's great. Thanks for that. And then maybe a clarifier on guidance for Q4. Any color you can provide on that?

So overall, if you look at our front half performance for the business, we grew 19% overall for the business, with back half growth implied at the midpoint of our guidance at 23%. So that's the first thing as everybody should feel comfortable about the acceleration revenues between the front and the back half. As for the splits between business and what you can expect, given the dynamics of the Q3, I'll let Tom go ahead.

Yes. Thanks, Frank, for the question. If you look at our first half of the year and you look at that split, we split around 70% or so for the US business and around 23% to 24% for the international business. So you can assume that's that sort of split for the Q4, the expectation on revenue, with the remainder of that obviously being the PST business.

Thanks, Tom. And then regarding 2026 guidance, so the first thing I want to say is, obviously, when you post two 20 plus percent quarters in a row, we feel great and excited about the position that we're in. So if you look back over what we've been talking about for pretty much the course of the last year, it's taken the company to this new level of sustainable plus 20% growth. So while I'm not comfortable giving exact guidance for 2026, what I can say is that a number that starts with a two is something we're feeling good about at this moment in time. Obviously, we're looking for those accelerations, which opportunities from pre fills, more international expansion, oncology, those new drugs, all of those things, the 20 plus percent you're seeing today is being done without those things. So, obviously, acceleration, whether that comes in '26 later in '26, early in '27. But that's what I would say that the number starting in the '2 is what is what we're comfortable with. Today. Given what we know today.

Yep. Got it. Makes a lot of sense. Thank you. Our next question comes from Caitlin Roberts with Canaccord Genuity.

Hi. Thanks for taking the questions, and congrats on a great quarter. You know, just starting with the EU, I think you noted that several countries are, you know, preparing for the change to PFS. I mean, any more color on the size of those opportunities and potentially the timing of those?

So thank you, Caitlin. And congratulations on the new last name. Thank you, though, for the course. We're very excited about the international expansion opportunity. As I mentioned on the call, we see international taking our share position pretty much doubling it over the next little bit, and we see that as a $10 million to $20 million opportunity overall. Most of it being driven by pre fills. We have converted just one large market, and why this opportunity is such a big lift for KORU is that the standard of care in Europe has been electronic pumps. Our studies in head-to-head show a 50% reduction in the number of steps required for patients to use our system versus electronic pumps, and also, it's easier for healthcare professionals to train. So I'm not going to give details of what the next countries are. But suffice to say that we've only got one down, and we think we have a lot of headroom in front of us. With a lot of work to do. But it is a major growth opportunity, and we're putting a lot of effort into that today.

That's great. And then, obviously, you know, pay share gains have been a big piece of, you know, the SCIG growth for you. But you know, any color on the just market growth dynamics at this point in the year, maybe with early flu season starting and how you feel about you know, that going into the end of the year and into 2026?

Yeah. So just overall, what we've seen is the underlying rate of patient diagnosis is going up. I would say we've seen definite acceleration quarter to quarter. It's a little early yet. Usually, the diagnosis lags a couple of months by the infection. So while flu season starts, usually these patients require four, five, six infections before their PID may be diagnosed. So we'll wait and see. But fingers crossed on that one. We've had a strong year thus far. I would say the second dynamic, which I introduced in the call today, was we're seeing a lot more SID, secondary immunodeficiency, with general underlying dynamics like aging populations, etcetera, driving it. But the big one is the cancer treatments. The chemotherapy drugs, the CAR T cell therapies that reduce the immune system by design. So that those drugs can work. Then the patient needs immunotherapy. So we see a lot of the IgM manufacturers now starting trials for SID. Because currently that is not reimbursed in the US. So we see this as being a potential today that's not built into our numbers. That's probably a story that plays more into 2027. By the time they complete those trials. But we're certainly seeing a lot of off-label use of SID today.

Great. Thanks for taking the questions.

Our next question comes from Joseph Dowling with Piper Sandler. You may proceed with your question.

Hey, guys. Thanks for taking the question. I'm for Jason today. Just a quick question on gross margin, looking at the four Q and then and then the 26 as well. I know you're probably not too keen on divulging any specifics here. But just directionally, can you provide any commentary on how we should expect gross margin to develop here over the next, call it, twelve to eighteen months? I know there's, you know, international mix dynamics, some manufacturing efficiencies, tariffs, some pricing, new launches, things like that. But any color there would be really helpful.

Yes. Hi, Joseph. Thanks for the question. Yes. So as we mentioned, just starting with this year, we have seen that geographic mix change. And, obviously, the geographic mix change where you think about the ASPs in the different markets as you grow more internationally, you have a lower ASP, you know, driven by emerging markets or established markets. When you think about that dynamic and you accelerate that into the next twelve to eighteen months, you know, we are doing our best to hold our margins. You know, we are always working on our cost and manufacturing with our operational excellence programs to identify opportunities, you know, driven by volumes. Right? Because we're a growing business. So we will continue to work on our margin profile. You know, we have long-range plans to get our margins, you know, 65 plus. So that is our strategy and that we will continue to focus on as we grow international.

And maybe just to add on to what Tom said, obviously, we started the year with a 61% to 63% margin range. With a couple of manufacturing issues, the growth in international, which we did not anticipate. We knew it was gonna be good, but as good as it is, you know, growing, you know, through the year. I think Tom will probably double that business through the third quarter already. So the fact that we're able to maintain that original margin gain. Also, I forgot tariffs as well. Know, just a huge credit to our operations team who have really done a great job of bringing back some efficiencies, which is why we're still confident despite those things holding on to that 61 to 63. And, you know, continued march towards that 65% range that we're headed for over the next three to four years.

Great. Appreciate that, guys. And then one quick one on Japan. Can you just give us any color on maybe like the cadence of the ramp into next year? That'll just be helpful for as we look at our models here.

Sure. So, on Japan, I would say the great news is we're in the market. We've got sales. I think I said, this year, the sales would be somewhere just 3 to 500,000. I think we're feeling pretty good about that range. Japan is primarily today an in-system. And so we think it'll take a little bit longer for Japan to evolve. But I would say the overarching comment on international that is more than made up for that is the strength of the pre fills. So we're excited still about Japan. And now I would say it's come it's still a growth driver, but it's probably now number three or four on our list versus, you know, the broader presale opportunity is number one by and large.

Great. Thanks, Linda. Appreciate it. Our next question comes from Chase Knickerbocker with Craig Hallum. You may proceed with your question.

Good afternoon. Congrats on the nice quarter here. Thanks for taking the questions. Maybe, maybe just to start on US core. So just to clarify, I guess, a couple of things. So that $1,200,000 was basically adjusting for those ordering dynamics from OUS distributor to US distributor. And then that would make US growth, call it, you know, 14% kinda year over year if we add that 1.2 there. And then maybe just give us an update on what SCIG growth was from a market perspective in the third quarter.

So thank you, Chase. Yes, excited about the quarter. And appreciate the well wishes. The order dynamics, I think, Tom laid them out well. And you got it perfectly. It's a combination. The only thing I would correct, yes, it's the $1,200,000. That should have been in the US. That was a combination of three things. It was the stocking deceleration from one of our major US distributors and then the order dynamic between the US and OUS. Regarding the broader SCIG market growth, we don't have the numbers yet for Q3. Those usually lag a couple of months behind for us. But we know that from quarter one and quarter two, that that number was in that 8% to 9% range overall. With acceleration between quarters in the growth levels. Being driven by PID, just really strong demand and patient growth. And PID and then also the SID piece that I mentioned earlier.

Got it. Maybe just you know, you noted some stocking related to the presold conversion. In Europe as well. Can you just maybe speak to whether or not this is a new geography or the same one that we were talking about last quarter? And then I know you don't wanna give specifics as far as the geographies that you expect kind of these rollouts prefilled conversions to take in. But can you maybe just give us your overall thoughts as far as how you see the cadence? Is this gonna be something that's a phase in kinda country by country? And it, you know, happens over the course of the next eighteen to twenty-four months, or just give us your overall thoughts there on the cadence?

Yeah. So, one thing I should have mentioned on the last call, you said the 14% growth, and I think yes, that that's about right, the number for the US market. So regarding prefilled syringes and the first country, that country was a country that was dominated by pumps. We had very low share positions in that market with our consumables. And they converted very quickly. They delisted their vials completely in that market and went 100% to prefilled. And we were very fortunate to they did that, you know, pretty rapidly. We still see some upside in that market because the pharma company continues to win new tenders based on their pre fills. So that's great news. Regarding the cadence for pre fills, we believe that the manufacturer that we're working with will complete most of the work in the major markets by 2026. They are being, you know, quite aggressive as they see it to be a competitive advantage for them today. And what I would say is that the decision making, though, is done on a country by country basis. So reimbursement is different. How the patient receives the product is different. So we've got a lot of work to do with each of those country leaders to ensure that, you know, we work with them on very specific go-to-market plans to make sure that the patient experience and the healthcare professional experience is what we all want it to be. So we think most of the opportunity will be over the next twenty-four months in total for that opportunity.

Got it. Makes sense. Maybe just sneak one last one in. Just kinda check the box. I mean, this dynamic with the OUS distributor to the US distributor that kinda cross geography ordering, how are you able to confirm I mean, how are you able to, you know, make sure it doesn't happen again?

Thanks. So I'll start and then maybe see if Tom wants to add anything. So we and and by the way, right in my career, in this space, it's not the first time I've seen something like this happen. Typically, what we do in all of our contracts is we protect any pricing we provide per the market. And we require tracings to say, where is that product going to? That's why we were able to catch it pretty quickly. And so we've since worked with both distributors to ensure that, you know, we're now ensuring that product goes to the right markets for which the contracts have been written. So we're confident that it will not happen again. And, we were we had it corrected within the quarter. Thanks for the questions.

This now concludes our question and answer session. I would like to turn the floor back over to Linda for closing comments.

So thank you all for joining us this afternoon. We'll look forward to providing updates on our strategic progress. We've got several upcoming investor events ahead of our fourth-quarter call in March. Have a great rest of your evening.

Ladies and gentlemen, thank you for your participation. This does conclude today's teleconference. Please disconnect your lines and have a wonderful day.