KRMD

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, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Louisa Smith with Investor Relations. Please go ahead.

Thank you, operator, and good afternoon, everyone. Joining me on the call today are Linda Tharby, Chief Executive Officer of KORU Medical Systems, Adam Kalbermatten, President and Chief Commercial Officer, and Tom Adams, Chief Financial Officer. Earlier today, KORU released financial results for the 1st quarter ended March 31, 2026. 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 may 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 and the accompanying investor presentation and SEC filings.

For the benefit of those listening to the replay, this call was held and recorded on Wednesday, May 6, 2026, at approximately 4:30 P.M. 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, Chief Executive Officer. Linda, please go ahead.

Thank you, Louisa, and good afternoon, everyone. Before we get into the quarter, I want to briefly acknowledge that this will be my final earnings call as CEO. As we shared last quarter, Adam has been appointed as my successor and will step into the role on July 1st. The transition is well underway and is progressing extremely well. I have great confidence in Adam's leadership and in the continued momentum of the business under his direction.

I'll begin today with some commentary on our performance highlights in the quarter, and then Adam will step in to speak about our broader strategy. Tom will then walk through our financial results before we open the call for questions. Q1 2026 was a record start to the year. We delivered $11.8 million in revenue, representing 22% growth over the prior year period.

This reflects the strength and consistency of a recurring revenue model business built on the foundation of approximately 60,000 patients on the KORU platform. A few highlights. Domestic core grew 12% year-over-year, driven by new patient diagnosis starts in both legacy KORU accounts as well as competitive conversions, driving outperformance within a strong underlying SCIg market.

International core grew 35%, driven by prefilled syringe conversions in Europe and strong distributor orders in a new market to support this growth. Within our non-IG pipeline, two of our existing pharma collaborations advanced assets within their phase III clinical trials, including one for an expanded indication and the other restarting their trials for a new drug application.

We executed to plan in submitting our 510(k) application for the use of the Freedom Infusion System with deferoxamine, reflecting further tangible progress in our growing commitment to expand beyond IG. From a balance sheet perspective, we used only $100,000 in cash this quarter, ending the period with $8.8 million in cash, reflecting our continued progress towards sustainable profitability.

We are reiterating our full year 2026 guidance for revenue, growth margins, adjusted EBITDA, and cash flow. Overall, this was a very good quarter, delivering strong revenue growth and continued execution against our strategic priorities. Now, I am pleased to turn it over to Adam.

Thank you, Linda. I'm encouraged by what lies ahead for KORU. Before I discuss our strategy more broadly, I'd like to take a moment to reflect on how our recent performance fits into the 3 pillar strategy, protecting and growing our domestic core business, international expansion, and enabling more patients by adding more drugs to our Freedom Infusion System. The 3 strategic pillars we've been executing against are all moving in the right direction, and they remain central to our focus as I step into my role as CEO.

The first pillar is protecting and growing our domestic core business. Our U.S. business continues to outperform the underlying SCIg market, driven by capture of new patient diagnosis starts in both legacy KORU accounts as well as competitive account conversion and further supported by a strong recurring revenue base serving chronic immunodeficient patients.

Regarding the recent clearance for RYSTIGGO on KORU's label, our commercial rollout with this asset is advancing as planned. We are working through clinical evaluations with specialty pharma companies, and we expect the incremental revenue contribution from RYSTIGGO this year to be modest.

Most importantly, however, this rollout represents meaningful progress as an entry point into the ambulatory infusion clinic channel and marks an important expansion of our platform beyond the home setting as RYSTIGGO is administered across both home and ambulatory infusion clinic environments. We believe this positions us well for increasingly meaningful contributions in this channel in the years ahead. We also want to highlight secondary immunodeficiency, or SID, as an important emerging opportunity for KORU.

Outside the U.S., SID has already become a key priority for major pharma players, and there has been increasing focus on IG manufacturers translating that success in the U.S. market, with several ongoing pivotal trials expected to reach their endpoints in 2027. Should reimbursement coverage expand in this area domestically, it could meaningfully broaden our addressable opportunity in SCIg with another indication.

In terms of current market dynamics, SID market growth has been tracking ahead of the broader SCIg market, with growth currently being driven primarily by immunologists. However, we anticipate as the clinical trials conclude, SCIg manufacturers will begin actively marketing to hematologists, oncologists who recognize the unmet need for patients following courses of treatment with immunosuppressive drugs like chemotherapy, and ultimately opening up an entirely new and incremental patient population that we believe KORU is well-positioned to serve.

The second pillar is international expansion, and this remains 1 of the most exciting areas of our business. Today, our international growth has been led by SCIg. Consistent with our domestic strategy, we are establishing a footprint designed to support an extension into non-IG drugs over time. In the first quarter, we delivered 35% international growth, and we believe we are still in the early stages of a much larger long-term opportunity.

With key EU markets coming online in 2026 through the pharmaceutical manufacturer-driven vial to prefilled syringe conversions, there is significant runway for continued market penetration. Our growth rates in these markets will continue to be variable as we continue to deepen our knowledge and expand our capabilities across reimbursement, pharmaceutical, and home care partnerships.

Beyond this core SCIg opportunity, we are also actively exploring the expansion of our oncology initiative into international markets, an area we view as a longer-term growth driver for the company and one for which we already have compelling market insight, given some of our early hospital work on the KORU value proposition, including last year's Denmark nursing study.

The third pillar is enabling more drugs to reach more patients. Our pipeline continues to advance meaningfully with new drug submissions, phase III trials with the KORU Freedom infusion system, and multiple new feasibility agreements. We are engaged in active conversations with partners across multiple therapeutic areas, conversations that we believe will translate into tangible opportunities for KORU in the years ahead.

Turning to the pipeline, we now have 8 active non-IG drug opportunities in development, which together represent more than 6 million annual infusions worldwide, a meaningful reflection of the breadth and scale of what we are building. To put that in context, 6 million incremental annual infusions would represent approximately double our current SCIg business revenue, where we estimate we're enabling the delivery of nearly 3 million infusions a year, underscoring the significant long-term growth potential embedded in our pipeline.

I wanna highlight 2 important updates this quarter. As Linda noted earlier, 2 of our existing non-IG pharmaceutical collaborations have advanced to phase III clinical trials, and we remain an infusion device supplier for those trials. Apellis continues to invest resources in adding new clinical indications for EMPAVELI, having progressed into phase III trials for the drug's fourth indication. This one in DGF, or delayed graft function.

We estimate this unmet need within nephrology represents an additional 25,000 annual infusions across the pediatric patient base. Second, one of our undisclosed pharmaceutical partners has reinitiated phase III clinical trials on one of its assets, for which we believe the opportunity to be 500,000 annual infusions.

The progression of both of these drugs in their clinical pipelines represents meaningful signals of forward momentum across our development portfolio and another step forward in potentially recognizing commercial revenue opportunity upon these drugs' commercial launches.

Additionally, we submitted our 510(k) application this quarter for use of the Freedom Infusion System with deferoxamine, for which we estimate that there are approximately 200,000 annual infusions of this drug, another base hit for our non-IG strategy. We also made the decision this quarter to remove vancomycin from our active development pipeline.

As we reviewed the market opportunity, the current usage we are already seeing, and the risk of an infusion to the central artery, we chose to commit our resources to align to our greatest commercial opportunities. The incremental 2026 revenue associated with vancomycin was expected to be modest. We remain confident that our current guidance still accurately reflects the strength and trajectory of the business going forward.

Turning to oncology specifically, we continue to have highly constructive discussions with pharmaceutical partners on a range of oncology assets. The opportunity ahead remains strong. We are in active communication with the FDA regarding our PHESGO submission. We are also in early discussions around an additional high-volume oncology asset that we believe could be significant for us. We look forward to providing further updates as these discussions progress.

The momentum building across our domestic business, international expansion, and pipeline reflects progress on our three-pillar strategy. Each pillar is advancing, and the compounding effect of that execution is what drives durable long-term value creation. We remain focused on maintaining that discipline as we move into the next phase of KORU's growth. I'll now turn things over to Tom for a review of our quarterly financial results and 2026 outlook.

Hey, thanks, Adam. Good afternoon, everyone. We are very pleased with another strong quarter with revenue of $11.8 million, which represents 22% year-over-year growth and speaks to the underlying strength of the business. Breaking down by segment, domestic core grew 12% year-over-year. Growth was driven by higher consumable volumes from new patient starts and market share gains within new and existing accounts against a healthy SCIg market backdrop.

International core grew 35% year-over-year, driven by higher pumps and consumable volumes in support of pre-filled syringe conversions in the EU market. We saw strong first quarter distributor orders from one of our new 50 mL pre-fill markets, where we saw a bolus of pump orders for new patient starts. Moving forward, we'll expect to see end user pull-through of our consumables.

We remain highly encouraged by the opportunity ahead of us in the EU. PST revenues grew 166% over the prior year period, driven by higher clinical trial product revenues from our pharma collaborations who are advancing in their clinical trials. As always, this business will remain variable based on milestone and clinical trial timing. The underlying activity level with pharmaceutical companies remains high.

On gross margin, we delivered 61.5% for the quarter to 62.8% in the prior year period, a 130 basis points reduction year-over-year. The primary drivers of the decrease were higher production costs based on timing of production runs at the end of 2025 that were amortized in Q1, as well as tariff-related charges that did not occur in the prior period.

These were partially offset by favorable geographic sales mix. Adjusting for the 87 basis point tariff impact, gross margins for the quarter would have been 62.4%. Despite the tariff headwinds in the quarter, we remain confident in our full year guidance range of 61%-63%. Turning to cash, we entered the quarter with $8.8 million, reflecting minimal cash usage of $100,000 in the quarter.

This was driven by 22% revenue growth and continued operating leverage. On a cash flow from operations basis, Q1 was essentially break even. A strong result given the normal seasonality patterns of the business. As we've noted before, Q2 is expected to be our heaviest cash usage quarter for the year, driven by the annual one-time cash outlay for last year's performance bonuses paid in April.

We expect positive cash flow in the back half of the year as revenue ramps and planned operating leverage builds. Based on these dynamics, our full year guidance of positive cash flow remains intact. As a reminder, we also have access to our unused $10 million debt facility, which provides additional financial flexibility for incremental opportunities as we execute against our growth plan.

Looking at the full picture for Q1, revenue grew 22%, gross margin was 61.5%, and net losses improved 33% to $800,000. Adjusted EBITDA was -$10,000, essentially break even, and a 95% improvement versus the prior year period. Operating expenses increased 11% versus the prior year. We continue to invest strategically in sales and marketing and R&D to support growth while maintaining spending discipline across the business to drive operational leverage.

On guidance, we are reiterating our full year 2026 outlook with revenue of $47.5 million-$50 million, representing growth of 15%-22%, gross margin of 61%-63%, and positive adjusted EBITDA and positive cash flow for the whole year. Growth momentum in the business continued to advance in the quarter.

We are maintaining the current range with the guidance we provided in March. Our Q1 results were benefited from strong PST revenues associated with clinical trial orders. We are also watching how dynamics related to how end user adoption develops behind the strong distributor orders we saw in Q1 in our pre-fill markets. Let me walk through each component in further detail.

On revenue, the primary growth drivers are continued U.S. and international share gains in SCIg, NRE, and clinical trial revenue from ongoing and new collaborations, and modest incremental revenue from pending five ten clearances. We continue to expect these drivers to build through the year, taking into account some upticks in initial orders.

We expect the back half to be weighted more heavily as recent clearances and new pre-filled geographies ramp up and patients are added. We have also incorporated geopolitical risk associated with the Middle East in our guidance. We continue to expect revenue to ramp in the second half. On gross margin, we are maintaining our full year range of 61%-63%.

We expect pricing and manufacturing efficiencies to support our range through revenue mix variability in new markets and channels could move margin modestly in either direction quarter to quarter. We continue to be active and are making progress with cost improvement initiatives through our Operational Excellence programs to drive margins higher.

On cash, we were disciplined in our usage this quarter. Q2 is expected to be our heaviest usage quarter from our annual one-time prior year bonus payouts. Moving into the second half, we see operating leverage building through the year with positive cash flow anticipated in the second half. I'll now turn the call back over to Adam for additional comments on our forward momentum. Adam?

Thanks, Tom. I want to take a few minutes to talk about what lies ahead. On the domestic side, we now have 2 new non-IG drugs on label. RYSTIGGO was cleared earlier this year in January, in addition to the earlier EMPAVELI in the U.S., Aspaveli in the EU approvals starting in 2022, which are now generating broader patient indications. Our oncology opportunity continues to advance.

Our PHESGO 510(k) is currently under active FDA review. We are also in productive discussions related to another high-volume oncology asset. On the international side, we achieved EU MDR clearance of our Freedom60 with prefilled syringe compatibility earlier this year and are supporting the EU conversion. We are also actively exploring the expansion of our oncology opportunity into international markets.

Alongside our pipeline and market expansion work, we continue to invest in the next generation of the Freedom platform. We plan to submit a 510(k) and MDR applications for the next generation Freedom60 pump in 2026, and we are targeting a submission for the flow controller in late 2026 or early 2027. The pharmaceutical pipeline remains strong. We have four new collaborations targeted for this year, two of which have already been signed. Two existing collaborations have advanced to phase III clinical trials.

With the deferoxamine 510(k) submitted this quarter, we are steadily building towards a diversified platform spanning multiple therapeutic areas, one that we believe will define the next chapter of recurring revenue growth for KORU. I want to close with a broader framing of where we are going because I believe the best is genuinely ahead of us.

The foundation we have built is differentiated and durable. A growing recurring patient base, a patient-preferred delivery system, deep and expanding pharma partnerships, and a platform purpose built to support multiple drug categories across multiple therapeutic areas. That foundation positions KORU for something meaningfully larger than where we are today. Our long-term targets are clear, and we are executing toward them with discipline.

$100 million in revenue, accelerated double-digit revenue growth, gross margins above 65%, and EBITDA margins of 20% or greater. Achieving those targets requires continued focus on three things: growing our domestic market share, expanding internationally as we help to enable the pharmaceutical manufacturer vial to pre-filled syringe market conversion, and adding more drugs on our label. We know what we need to do, and we are doing it. The first quarter results are a tangible demonstration that we are on the right path.

The pipeline is advancing, the platform is expanding, and the team is executing against the strategy in an exceptional way. As I step into the role of CEO, I do so with a deep sense of responsibility and an equally deep sense of confidence in what this capable company is able to achieve. KORU's most significant chapter of growth is ahead of us, and it cannot be more energized about what that means coming next. With that, I'll turn it back to Linda for closing remarks.

Thank you, Adam. Q1 set the tone for 2026, underscoring the results we've been working hard to deliver. As a reflection of how far this organization has come, as I step back from my role at KORU, I leave with real confidence in Adam's leadership, in the strategy, and in this team's ability to execute it against it. The strategic pillars are in place, the pipeline is advancing.

The commercial momentum is there. I have no doubt that the path to $100 million in revenue, margins above 65%, EBITDA of 20% or greater is within reach. It has been a privilege to lead this company and to work alongside such a talented and dedicated group of people. I want to express my sincere gratitude to our employees, our customers, our partners, and our shareholders.

To the entire KORU team, thank you. What we have built together and what you will continue to build is something I am incredibly proud of. I'll remain fully supportive during the transition, and I'm confident the company's best days are ahead. Operator, please open the line for questions.

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star key. Thank you. Our first question, we will hear from Caitlin Roberts with Canaccord Genuity.

Great. Thank you so much for taking the questions. Linda, again, congratulations on the next chapter of your journey. Just to start off, maybe just the rationale for keeping top-line guidance the same despite the beat this quarter, and if you can give us some insight into the maybe updated cadence for the year?

Thank you, Caitlin, for your wishes. Yes, we are very excited that we have a strong quarter behind us and, good momentum heading into the year. I will let Adam comment on the guidance for the year.

Hi, Caitlin. Thanks for the question. As Linda was mentioning, we're really happy with the strong start to the year in Q1. We have a lot of momentum. We're continuing to outperform the market. International growth remains strong. In addition, we're finding a lot of new opportunities.

One of the things as we're going after bigger opportunities, we are seeing that there's some more variability there, really around the filed pre-fill syringe conversions in Europe and how we're going about entering each of those markets. It's coming down to we continue to see a lot of really good momentum there. At the moment, we're pretty confident in our guidance, and we're just not looking to make any changes on that at the moment until the year plays out a little bit further.

Understood.

Tom.

Oh, sorry.

I was just gonna hand it to Tom for the cadence question, Caitlin.

Hi, Caitlin. Caitlin, you can think of our In terms of our guidance, you can think of the pattern, specifically in Europe, similar to last year, where we have initial markets that are ordering pumps, if you will, to start their initial adoption. We expect to see that adoption play through in Q2. After that happens, we expect to see strength in the back half of the year. Very similar to what we saw last year in the case of the European and the international markets.

Understood. Then just thinking about adding new drugs to the core revenues, you know, how much of your core mix is EMPAVELI and Aspaveli today? Do you have any expectations for non-IG mix this year over the next few years?

Maybe, just I'll start and then hand it to Adam for more specifics. Broadly, we don't comment on any specific drug's contribution, but what we have said is that all of the new drugs we're adding, we expect to add between a half a million and $1 million in 2026 via those new label additions. With that, I'll turn it to Adam.

Yeah. As we're thinking about non-IG drugs, I mean, one of the recent ones we had approval on is with RYSTIGGO, and we're seeing some really good traction on that so far. Between RYSTIGGO and some of the other drugs outside IG, we're continuing to look at anywhere between $0.5 million and $1 million overall is what we're targeting to plan. We're tracking really well against that overall through the first quarter and looking forward to continuing to execute that plan as we get to the rest of the year. Tom, anything else you want to add to that?

No, I think you guys hit it pretty well.

Great. Thank you.

I'll move to Frank Takkinen with Lake Street Capital Markets.

Great. Thank you for taking the questions and wishing you the best in retirement, Linda Tharby. I look forward to keeping in touch. Was hoping to start with some additional color on oncology conversations. I think, Adam Kalbermatten, twice in the prepared remarks, you referenced kind of the what's up, what's up beyond PHESGO, in large volume oncology infusions.

Can you just maybe speak a little bit more about that? When could we see the second oncology? I know we're still waiting for the first, when could we see the second oncology? Maybe magnitude of size would be helpful color as well. Thanks.

Yeah. Hi, Frank Takkinen. Great question. You picked up on that earlier. We're really excited about the oncology opportunity, right? Just to kind of frame that out at a higher level. We're seeing it today as almost a $40 million market opportunity growing over the next 5 years to over $120 million.

Putting that in perspective, that's roughly 4 million units today, growing to over 10 million units. We did file for PHESGO at the end of last year. We are in active discussions with the FDA, we still continue to be really excited about that. We continue to expand into other areas, where we have some other potential drugs that we're looking to bring on label. We do have some active discussions ongoing now.

As we see it continuing to go forward, we're hoping that towards the end of this year, hopefully in the next quarter, we have an update on where we are with PHESGO moving forward. At a high level still, really excited about where this is going and what it can do for us. PHESGO alone is approximately 1.1.2 million units a year. We see that as being something that would be great entering into these infusion clinics.

Got it. That's helpful color. Then I was hoping to follow up on the distributor. I think last year we saw this play out, and obviously there was an extreme growth from the geography launch with pre-fills last year. We had a distributor order come in, and I think there was a concern that that was gonna be the big order of the year. Then what we actually saw was orders increasing in magnitude of size throughout the year. Is there a chance that that dynamic could actually happen again as this geography is just getting up and running on pre-fills?

Yep. Frank, it's-Thanks for the question. Similar to last year, you're correct. We did see some nice orders in the first quarter of 2025. We saw a little bit of a lag after that in this particular market. As I mentioned, as adoption and rollout happens, that took about a quarter. You're right, we saw the ramp-up really start to pick up in the second half of the year, particularly in our international business. We do expect a similar pattern, but we entered the next phase of a launch in a particular market. We see a similar pattern rolling out here in 2026.

Perfect. Helpful. Thank you.

Next, I'll move to Jason.

Hey, you guys, can you hear me okay?

Yeah, we can hear you, Jason.

Great. Great. Linda, I will add to the well wishes here. It's been great working with you and wish you all the best. You know, Adam, I want to follow up on I think Caitlin's question earlier on the revenue side.

I think the midpoint of the guide, and I appreciate it's early in the year, so you'd like them unchanged, but it does imply a little bit of a decel from the revenue growth rate we saw in first quarter. I think in midpoint, something like mid-teens implied over the balance of the year. What decels from here?

Is it the U.S. that decels in the growth? Is it the international that decels in the growth? Also within the whole answer, if you could, you know, I think I heard you're building in a little bit of, you know, cushion or uncertainty around the Middle East. If you could maybe quantify or size that for us, it'd be helpful.

Yeah. Absolutely. I heard a few things in there. Let me start, and then I'll maybe I'll pass it to Tom. In terms of where we've started the year, we're feeling really good about everything ongoing, both domestically and internationally.

As we look at international and where we see some of the high growth coming, you know, it's really country by country and figuring out the pieces of the puzzle in each of these countries, how the healthcare systems work. As we're going forward, we're planning to do a lot of blocking and tackling. Depending on how that uptake continues to go, it's gonna go at different speeds in different markets.

Compared to last year when we converted the large international market, it's a little bit of a different approach where it wasn't a pharma-driven tender. It's more of a how do we go out and actively convert those markets on our own. We're working with partners to do that, but it's a little bit of a different approach to last year.

We wanna continue to see how that plays out over the 2nd quarter with the balance of the year. Overall, we're still seeing very positive momentum, very happy with how we started the year, and we're encouraged, you know, that we're on track and continuing to move forward in a very positive fashion. Tom, maybe you wanna take that 2nd part of the question.

Yeah. I'll just reiterate some of what Adam said. The fact of the matter is that we are still largely a distributor market in our international business. With that, you know, you do get distributor orders that are ramping up for launches. We did see some of that in Q1. We know that some of that has to play out. We know that we need to see that patient conversion happen. We typically see it backed up by orders after that conversion starts to pull through. We did see some of that in Q1. Again, the type of market is different.

Tender markets are generally faster, because the pharmaceutical is the financial backer of the tender markets, and the reimbursement markets are generally a little slower. We're taking all those dynamics into effect with our phasing in our quarters. I will say we started off pretty strong, with our Q1 results.

He also asked about the timing and the phasing for the Middle East and the commentary there, Tom, if you can comment on that.

Yeah. In terms of the Middle East, if you all remember last year, we started up a distributor in the Middle East. We have one large one that dominates it for us. We saw some strength. We are just cautious this year, just due to the geopolitical risk. We don't see the strength in the orders so far this year, we're just putting some caution around that Middle East distributor. Not a meaningful part of our business, but one that we're just making sure that we're cautious with given the risk in the region.

Okay. All right. That's helpful. Then just as a follow-up, I mean, actually kind of dovetailing off of that, the Mid East, you know, point. You know, a lot of companies are dealing with, you know, fuel surcharges, freight increases as they source product, just given where oil is. I don't know if you're seeing that.

Maybe you can, you can speak to that a little bit, just how you're handling that and, in terms of, you know, are there mitigation actions underway if you are seeing that in your sourcing? Then also, are you passing along any fuel surcharges or price increases, to your customers? Thank you.

Yeah. Thanks, Jason. We, you know, we're watching that situation closely, specifically with oil prices with respect to our supply chain. We do procure plastics from different parts of Asia, et cetera. We are watching it. So far, we haven't seen any impacts that were material to our business. We will continue to monitor the situation. We know this conflict started in Q1, we think there'll be some time before it really hits. For now, we don't see any meaningful impacts.

All right. Perfect. Thanks so much. Congrats, Linda.

Thank you, Jason. Pleasure to work with you as well.

Next, we'll move to Chase Knickerbocker with Craig-Hallum Capital Group.

Good afternoon. Thanks for taking the questions, guys. Just first for me, if you could give us a quick update on, kinda what you saw from a SCIg volume growth in the market in Q1. Then just secondly, you know, another one on international.

If we kinda look at where the strength came from in Q1, maybe talk us through kinda how many geographies this reflects as far as pre-filled conversions. You know, how many has it occurred in now? Is it 1 or 2 geographies that we may be sold into ahead of those conversions that kinda led to a little bit of a stocking benefit in Q1? Maybe just kinda some additional thoughts on those fronts.

Hi, Chase. I'll start with your question. You had a few in there. On the international market side, we are seeing strong growth across a few different specific markets there. You know, in the past, we've mentioned 5 specific countries where we saw the large volume pre-filled syringes entering the market. We are working in all of those markets.

They continue to go through what I would describe as the initial conversions and continuing to progress with those new patient starts and conversions. Each of them is a little bit different depending on how the pharmaceutical partners are introducing them. We're following closely behind in all of them.

We're making progress across the board. I think you were specifically asking if we're in 1 or 2. You know, we are tracking in all five of those that we've previously mentioned. In terms of volume growth, Tom, I don't know if you wanna take that one on the numbers side of things of what we're seeing so far.

I think it was for SCIg growth.

On the SCIg side, in the U.S. market, we saw strong growth. In terms of the market, we did outpace the market. We, you know, our third-party marketing source had a number of right around 8%, and we outpaced that with our performance. We see strength in the U.S. business. We expect that strength to continue, and we expect to continue to grow sequentially in our U.S. business. We left the quarter feeling very good with, you know, future strength in that business.

Got it. Maybe just on the 510(k) submission for the next gen pump. Can you just give us an idea kinda what's left to do to enable that submission? If we should think about kinda timing on MDRs kinda similar to 510(k), if those will happen pretty concurrently.

Yeah. We're really excited about our Freedom 360 pump. That's our new pump that we have under development right now that's looking to accommodate all sizes of pre-filled syringes in one device. This is super exciting as the market continues to progress from vials to pre-filled syringes across the different geographies.

In terms of where are we right now, we are at the end of our development process. We're actually in the middle of going through some final checks on that development side, called design verification testing. As we get to the second half of this year, we are looking to submit our regulatory filings in both the U.S. and Europe. We're super excited about how this is continuing to progress.

We've had a number of different industry meetings and specific pharmaceutical partner meetings where we've been discussing the pump. Across the board, we're getting very positive feedback. A lot of excitement building here, and we're kinda at the 10-yard line looking to drive this one across the goal line pretty soon here towards the end of the year.

Got it. Thanks for taking the questions, and congrats again, Linda.

There are no further questions at this time. I would like to turn the floor back to Linda Tharby for any additional or closing remarks.

Great. Thank you for your questions. I'm extremely proud of the strong track record of the company over the last five years, which reflects the strong team that I am leaving behind here at KORU. I want to thank Adam, who is knee-deep in this transition and going extremely well. With the strategic momentum that we have ahead of us, I really think the company is well-positioned as we move forward. Thanks to everyone for all the support. Operator, you can close the call.

Thank you. This does conclude today's teleconference. We thank you for your participation. You may disconnect your lines at this time.

Greetings, and welcome to the KORU Medical Systems Fourth Quarter 2025 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce Louisa Smith, Investor Relations. Please go ahead.

Thank you, operator, and good afternoon, everyone. Joining me on the call today are Linda Tharby, President and CEO of KORU Medical Systems; Tom Adams, Chief Financial Officer; and Adam Kalbermatten, Chief Commercial Officer. Earlier today, KORU released financial results for the fourth quarter and full year ended December 31, 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 Thursday, March 12, 2026, at approximately 4:30 p.m. 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.

Good afternoon, everyone, and thanks for joining us today. Before I provide further detail on our fourth quarter and full year performance, I want to take the opportunity to comment on the announcement of my retirement as was press released earlier today. After 5 fulfilling years, I have made the decision to retire and will resign as CEO of KORU Medical effective June 30. This has been one of the most meaningful chapters in my career, and I am proud of what we have built together, including the strength of the business, our growing leadership position in large-volume drug delivery and an exceptional team that will continue to maximize KORU's potential and move the growth strategy forward. My family and I are ready to embrace the next chapter of my life, and I will turn my focus to Board and advisory activity. This transition has been thoughtfully planned by the Board, and I'm very pleased to announce that Adam Kalbermatten, our Chief Commercial Officer, has been selected as my successor. When Adam joined KORU in 2025, it was immediately clear he was a natural fit, not just for the CCO role, but for the potential to lead the company as a whole. Adam brings strategic discipline, commercial leadership and a proven track record of creating shareholder value. He has spent his entire 20-plus year career in drug delivery, spanning large and small med tech companies and including a CEO role, where he led an effective turnaround and growth strategy that resulted in a successful acquisition by Becton, Dickinson. The Board's confidence in Adam is grounded both in him personally and in the strength of the broader team beside him. With over 115 years of combined med tech and pharma experience across the executive leadership team. KORU has the strategic depth needed to continue to drive our growth potential. As we look ahead, we are committed to a smooth and seamless transition. I will remain on the Board and continue to serve in an advisory capacity through the end of 2026. Adam will be appointed President effective March 15 and will assume the role of CEO on July 1. Many of you have had the opportunity to meet Adam at investor conferences and industry events over the past year, and I look forward to partnering with him through this transition period. I want to thank my family for their support throughout my career. The Board for their partnership and guidance; our shareholders for the trust you have placed in us; our customers for your passion and knowledge; and above all, our KORU team for the enthusiasm and dedication they have demonstrated throughout my tenure. It has been an honor to be part of the KORU team, and I'm confident the best chapters of this company are ahead. And now with that out of the way, let's turn to our fourth quarter and full year results. I'll begin with some commentary on our fourth quarter and full year highlights and strategic progress. Then I will hand the call over to Tom to review our financial results before we open the call for questions. 2025 was a very good year for the organization. We accelerated our revenue growth and made progress in all of our strategic growth pillars, protecting and growing our Core Domestic business, expanding internationally and enabling more drugs to reach more patients. Revenue of $10.9 million in the fourth quarter marked our third consecutive quarter of greater than 20% revenue growth and we delivered full year revenue of $41.1 million, a 22% increase over the prior year. This consistent performance reflects the fundamental strength of our business. A few highlights I want to call out. First, both our Domestic and International Core businesses continued to outperform the underlying SCIg market, which grew approximately 10% in 2025. In the fourth quarter, Domestic and International Core grew 18% and 71%, respectively, driven by a recurring base of approximately 59,000 patients. We received EU MDR certification for the FREEDOM60 with prefilled syringe compatibility, marking a critical regulatory milestone that positions us to pursue the ongoing valve-to-prefilled syringe conversion across Europe. We also received 510(k) clearance for RYSTIGGO in January, which marks the ninth drug cleared on the Freedom Infusion System and our second non-IG clearance. This is a step in our strategy to expand our platform beyond IG, and it opens a meaningful new channel for us in the infusion clinic setting. I'll speak to further details on the RYSTIGGO opportunity in a subsequent slide. We are also announcing two new pharma collaborations as we continue to expand our development pipeline into two new therapeutic areas, a Phase III nephrology molecule and a Phase I multi-indication drug. We ended the year with $8.9 million in cash and achieved positive cash flow from operations, continuing the progress we've made towards sustained profitability. Building on that momentum, we are initiating 2026 revenue guidance of $47.5 million to $50 million, representing growth of 15% to 22%, and positive adjusted EBITDA and cash flow positive for the full year. Tom will provide additional color on our guidance and underlying assumptions. Now moving to a few comments on our strategy. Health care continues to move from the hospitals to infusion centers to the home and large volume subcutaneous infusion is a direct beneficiary of that shift. In our Core SCIg business, we operate in a greater than $450 million global market, where penetration versus IVIG remains below 20% in the U.S. and external forecast project continued 8% to 10% growth over the next 5 years. We have 7 launched SCIg drugs from the major IG pharma manufacturers on our label and drug manufacturers are actively innovating their IG portfolios, all of which create opportunities for increased subcutaneous penetration and for KORU to capture additional global share. Outside of SCIg, there are more than 95 new drugs in development with volumes greater than 10 ml across multiple indications. IG was the first mover in large volume subcutaneous delivery, and there is significant investment going into subcu formulations across broader therapeutic areas. A large part of our strategy is enabling the administration of those drugs on our system. Turning to our Domestic business. I want to highlight a few key areas, our growing recurring revenue base and the expansion into new therapeutic areas. We have grown our recurring global patient base by approximately 20% to 59,000 global chronic SCIg patients on the KORU Freedom System. The global SCIg market saw healthy growth of approximately 10% this year and industry projections are for 8% to 10% growth in the coming 5 years. With our growth of over 20% this year, we are growing our global SCIg leadership position and will continue to expand through our new product development efforts and key accounts and pharma collaborations. We are also beginning to diversify our business. The clearance of RYSTIGGO, a non-IG drug enables our entry into the infusion clinic channel. With our filing of the 510(k) for Phesgo in the fourth quarter of 2025, we are also anticipating entry into the oncology market in the second half of 2026. We are also closely watching the evolving clinical activity around secondary immunodeficiency or SID. Outside the U.S., SID has been a key focus in many of the large pharma players and there are several ongoing pharma trials that are expected to complete in 2027. Increases in SID are being driven by an aging population, higher prevalence of chronic illnesses and increased use of immunosuppressive treatments, such as CAR T cell therapy. As reimbursement coverage expands in this area, it could meaningfully broaden our U.S. opportunity. Moving to International. This business was one of our largest growth drivers in 2025 with growth of 80%, and we see even greater potential ahead. The overall European SCIg pump and consumables market is valued at approximately $50 million, and we grew our share from approximately 10% in 2024 to 20% in 2025. We remain well positioned to continue expanding our presence in the market and capturing additional growth opportunities. We expect most of our growth to come from the continued shift across large pharma from vial-based delivery to prefilled syringes. The shift from vials to prefilled syringes simplifies the administration process significantly with up to 80% reduction in drug preparation tasks. This last quarter, we received our MDR certification in the EU for our KORU FREEDOM60 system. Combined with the earlier FreedomEdge MDR clearance, we now have two clear pumps for prefill administration. Our system was preferred by over 75% of patients due to its ease of use. That's a meaningful improvement in the day-to-day experience for patients managing a chronic condition at home. Overall, the European opportunity is significant, and we believe we are only beginning to capture it. With 2 MDR cleared pumps, a system that is patient-preferred and pharma driving a broad shift to prefilled syringes, we are well positioned to continue taking share. With a roughly $50 million addressable market in Europe alone, we see a significant opportunity ahead. And now let me turn to our pipeline. Beyond IG, the new drug pipeline now has 9 active opportunities. That combined represent more than 7 million annual infusions worldwide. Within the next year, we anticipate having 3 commercial stage assets on our label, vancomycin, deferoxamine and the Phesgo oncology opportunity. Together, these represent approximately 2.2 million estimated annual global infusions. Two of those 9 opportunities are new this last quarter, a Phase III nephrology drug, and a Phase I multi-indication drug. We are working with our pharmaceutical partners to help advance the delivery of these molecules. Once launched, they are expected to represent combined commercial opportunity of approximately 3 million annual infusions. We now have 9 subcutaneous drugs cleared for use with the FREEDOM Infusion System. IG representing approximately 5.4 million annual infusions and non-IG representing approximately 250,000 infusions. On the IG side, our 6 active collaborations with the major IG manufacturers span new device formats and expanded indications. Work that directly supports continued share gains and geographic expansion as those programs move towards launch. When you step back and look at the full picture, 9 subcutaneous drugs on label with low penetration, 9 drugs in active development with KORU and more than 95 large-volume subcutaneous drugs still in development across the pharma landscape. The runway here is substantial. And now let me spend a moment on RYSTIGGO, for which we received 510(k) clearance on our Freedom Infusion system in January. RYSTIGGO is indicated for generalized myasthenia gravis, a chronic autoimmune disease that causes muscle weakness affecting a patient's ability to control voluntary movements, including swallowing and breathing. In the U.S., this represents a patient population of approximately 60,000 patients. UCB launched the drug in July 2023 and currently publicly reports having reached more than 2,400 GMG patients globally at the end of 2025. We project our total U.S. market opportunity to be about 20,000 infusions in '25, growing to over 100,000 infusions in 2030. It's worth noting that RYSTIGGO has already been used off-label with the Freedom Infusion system. So this clearance enables us to go after further share. Additionally, this clearance marks our first collaboration with UCB and enables our entry into the infusion clinic channel, which opens a new commercial pathway for KORU beyond the home. I'm extremely proud of the team's execution and the strong momentum we built. The strong patient growth in our U.S. and international markets and meaningful pharma pipeline progress across both IG and non-IG opportunities, we're well positioned heading into 2026. I'll now turn the call over to Tom to review our financial results and guidance for 2026.

Thanks, Linda, and good afternoon, everyone. We are pleased with another strong quarter of revenue where we delivered $10.9 million, representing 23% year-over-year growth. This marks 3 consecutive quarters of greater than 20% revenue growth, a reflection of the momentum we've built across the business. Breaking down the performance by business. Domestic Core grew 18% year-over-year, driven by the SCIg market, which grew between 8% to 10% in the quarter. New KORU patient starts and market share gains, resulting in higher pump and consumable volumes. International Core grew 71% year-over-year, fueled by new patient starts and increased penetration into established European markets. Prefilled syringe conversions were a significant driver and we expect this to remain a tailwind as additional markets convert. Our PST business decreased 30% year-over-year. This business is inherently variable given the milestone-based nature of revenue recognition. The decrease reflects timing of contract milestones, for work completed and does not reflect the change in the activity level of our collaboration portfolio, which as Linda just described, continues to grow. For the full year, we delivered revenue of $41.1 million, representing 22% growth over the $33.6 million we reported in 2024. Domestic Core grew 11% for the full year driven by SCIg market growth and new account share gains that increased consumables and pump volumes. Accounting for the dynamic that occurred with our international distributors going back to the U.S. which we discussed in the third quarter call, underlying growth would have been 14% for the full year. International Core grew 80% for the full year, driven by strong SCIg market growth our growing footprint in European markets and entry into several new geographies. Accounting for the international distributor sales dynamic, underlying growth would have been 73% for the full year. Finally, PST declined modestly. Again, due to the project milestone timing, partially offset by higher clinical trial orders versus the prior year. Moving to gross margin. We had a 30 basis point reduction over the last year's Q4, driven by higher material costs and tariffs that were mostly offset by a stronger customer mix in the U.S. where we have higher average selling prices. We delivered a full year gross margin of 62.3% in line with our expectations at the start of 2025. The year-over-year decrease was driven by higher packaging material costs, tariff-related charges and geographic sales mix from our growing international business. Despite these headwinds, we remain resilient in keeping margins above 50% every quarter and on a full year basis. Turning to cash. We ended the year with $8.9 million in cash, representing full year cash usage of $700,000. Importantly, we achieved positive cash flow from operations in both the third and fourth quarters and also for the full year. The key drivers were revenue growth and disciplined spending that enabled a further reduction in net losses. We largely maintained our working capital balance while managing the growth needs of the business, and we continue to invest in capital expenditures to support future new product launches. Turning to our full year financial highlights. I want to call out two things in particular. First, with 22% revenue growth, operating expenses increased by just 3%, demonstrating the discipline we've maintained and the continued operating leverage we have generated. And second, we delivered positive adjusted EBITDA of $600,000, a 124% improvement versus the prior year, marking 3 consecutive quarters of positive adjusted EBITDA. Together, this reflects significant P&L improvement as we march towards profitability. Looking ahead to 2026, we are initiating guidance of $47.5 million to $50 million in revenue, representing growth of 15% to 22% and gross margins for the full year of 61% to 63%. We are also targeting positive adjusted EBITDA and positive cash flow for the full year. On revenue, the primary drivers will be continued U.S. and international share gains in SCIg, NRE revenue from at least 4 new collaborations, 2 already signed and modest incremental revenue from recent or soon to be cleared 510(k) filings. We have also incorporated some geopolitical risk into our guidance given recent events in the Middle East. As you think about our 2026 revenue cadence, I'd note that first half of 2025 benefited from a meaningful prefill inventory build in a key EU market, which we do not expect to repeat at the same level in 2026. Additionally, we would expect revenue to ramp in the back half as we see revenue recognition from recent and pending 510(k) clearances and the introduction of prefilled syringes into new geographies. On gross margin, we expect pricing and manufacturing efficiencies to support the 61% to 63% range as we enter new markets and channels. The associated revenue mix may move margins slightly in either direction, but we feel confident holding that range overall. We also have planned for start-up costs for the new production line for the next-generation pumps. We are confident that we will continue to offset incremental external pressure on costs with our operational excellence programs. On profitability, we are guiding to cash flow positive and positive adjusted EBITDA for the full year. Cash usage is expected to mirror the 2025 cadence with operating leverage building throughout the year and positive cash flow anticipated in the second half. I'll now turn the call back to Linda for closing remarks.

Thank you, Tom. I want to close with a few thoughts on key milestones in 2026 and our broader market opportunity. . We started the year off strong. In our Domestic Core, we have gained the UCB RYSTIGGO 510(k) clearance and our Roche Phesgo 510(k) application submitted on time in December, giving us two new non-IG drugs currently moving to commercial potential in 2026. We also have our next-generation pump, the FREEDOM60 expected to have 510(k) and MDR submissions this year. The Phase II Flow Controller 510(k) submission is projected for a global submission either in late 2026 or early 2027. Internationally, we have achieved MDR clearance of our FREEDOM60 with prefilled syringe compatibility, and we have now begun to ship that product into the EU market, anticipating prefilled conversions in several EU markets. On our efforts to add new drugs to our label, we have signed 2 of our 4 new collaborations and anticipate 2 additional 510(k) submissions this year for deferoxamine and vancomycin. In closing, I want to step back and frame why we believe KORU is well positioned, not just for 2026, but for the years ahead. This slide references the strong foundation that we have built for our business, some of our recent accomplishments and finally, where we believe we are headed. On the left, you'll note some of the foundational aspects that make KORU an attractive opportunity. We operate in a large and growing market for subcutaneous drug delivery with approximately 95 large volume drugs in development by major pharmaceutical companies. We have a leading position in the U.S. market that is growing 8% to 10%, where we consistently outperform market growth rates. We have significant momentum with international expansion with much more runway to grow and gain share. Underpinning this is a recurring revenue model across a global base of nearly 60,000 patients. And looking ahead, we have 9 pipeline drug opportunities outside of IG, with RYSTIGGO and our oncology market entry, representing near-term commercial opportunity in 2026. Moving to the right, the middle box is a reference to our recent accomplishments and performance, where we have demonstrated the ability to consistently grow revenues more than 20%, where we have attractive gross margins, and where we have proven the operating efficiency of our business model, delivering a 63% in improvement in cash burn and 124% improvement in adjusted EBITDA for 2025. On the right are our long-term targets and some of our strategic goals that Adam and team will continue to work towards, $100 million in revenue, accelerated growth rates, gross margins above 65% and an EBITDA margin of 20% or greater. 2025 performance shows that the model is working. 2026 is about continuing to execute against it. Before opening the line for Q&A, I want to again thank the entire KORU team for their continued commitment to our mission. Looking back on my tenure with the organization, the progress we have made together is something I'm immensely proud of. The business is stronger. The strategy is clear. And with Adam stepping into the CEO role, I have every confidence in what lies ahead. It has been an honor being part of the KORU team, and I look forward to seeing the next chapter unfold. Operator, please open the line for questions.

[Operator Instructions] Our first question is from Frank Takkinen with Lake Street Capital Markets.

Great. First off, Linda, congratulations on all you have achieved. We're certainly sad to see you go, but look forward to working closer with Adam and the rest of the KORU team, I wish you the absolute best in your next chapter. I was hoping to start with some questions on OUS, maybe two questions. . First, on FREEDOM60, maybe talk about what this product does for you in that market? How much of the market might this open up? And then two, you've spoken about, I want to say it's the 5 geographies that you plan to enter, how should we think about the cadence of those geographies and the progress so far.

Frank, and thank you. It has been an extreme pleasure working with you and the broader Lake Street team. Clearly, very confident as we think about Adam stepping into role and the broader team that surrounds him. So on your questions on the FREEDOM60 and the opportunity that lies ahead of us. Maybe I'll just start with the broader opportunity we're going after here is a $50 million total addressable market in Europe. We were very successful in 2025 in moving our share position from a 10% to a 20% share, but obviously, if you position that share closer to our 60% U.S. share, you see the magnitude of the opportunity we have in front of us in Europe. . So most of that opportunity and share gain in 2025 was driven by a successful prefill conversion in a major market in Europe, and the pharma partner that we're working with has plans to roll this out in several new markets over the course of the coming year. And the 5 geographies you referred to are not new markets for us, but there are markets we're in today, but with fairly low penetration, and we see the opportunity in prebills to really grow that market significantly. So what we see today is that we have our second market. We've started our year off strong in '26 with our second market that's really going live now with this prefill launch, and we expect to see likely a new market being added 1 to 2 every quarter as we move through the year. I think the last part of the question was just the FREEDOM60 and the new approval. Very excited about that because now we have 2 pumps, both our 60 and our Edge that are both approved. We required some slight modifications to our FREEDOM60 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 FREEDOM360, which is our pump that will work for all prefills. So hopefully, that got all of those questions.

Perfect. 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 cadencing color you'd like to provide would be great, too.

Frank, thanks for the question. Yes. 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, prefill still is a driver of that market. So we continue to see that progress. I would say from -- on 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 prefills. And then on the U.S. side, I think that's slow and steady. I mean you've seen the last couple of 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 5 tenant approvals that are upcoming. And then yes, then we'll just continue to grow up there. And then on the PST side, you'll see consistent revenue trajectory like you've seen in the last couple of years.

Our next question is from Chase Knickerbocker with Craig Hallum Capital Group.

I just want to echo Frank's comments. Obviously, we wish you the best, Linda and all your future endeavors. I appreciate everything you've done there, which is quite a bit. So -- and obviously, congrats Adam on the new role as well. Maybe just first for me on the Domestic side. 18% growth is obviously substantially above the market. Can you give us some sense for what's happening in the market is allowing you to take so much share? And maybe 1 and then 2 on that front, 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. I appreciate it, and you and the Craig-Hallum 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 move 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.

Yes. 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. If we think about EBITDA in the year, obviously, a little bit kind of open-ended on guidance. Can you give us a sense for how much operating leverage we should kind of expect from you guys in '26? Obviously, 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 its 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.

Yes. Thanks, Linda. So over the last quarter, we signed two new deals with pharmaceutical companies. One of them is a nephrology drug that's in Phase III. We're really excited about that. The other one is molecule in early Phase I. 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 RYSTIGGO, and then the other two drugs vancomycin and deferoxamine. 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 3 drugs in total, somewhere between $0.5 million upwards of $0.5 million of opportunities. We've got a modest number today knowing that two of those drugs are not approved yet. And so 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 RYSTIGGO, 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, a question on the operating leverage.

Yes. Just on the EBITDA, Chase, we continue -- last year was a great year for us. We had adjusted EBITDA positive. We're excited about that. We're excited to hit cash flow positivity. And as I mentioned in the guidance, we will be positive adjusted EBITDA once again and continuing to grow from there as well as 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 funds through, but we expect to continue to progress on those fronts.

Our next question is from Caitlin Roberts with Canaccord Genuity.

Linda, I'm so sad to see you go, but you're truly an inspiration to women and meta-like in the industry. So thank you so much. I guess just starting with RYSTIGGO, 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, 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 RYSTIGGO opportunity and how that entry into infusion clinics, I would say, broadly, what we discussed in the earnings was that RYSTIGGO, 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 5 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 he's thinking about anything broader relative to our infusion clinic entry, but I would certainly say that oncology infusion center, 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. Caitlin, I'll start by saying this is our first collaboration with UCB, and it diversifies our revenue beyond just CIG 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. And we see there's a lot more opportunity there in the future beyond RYSTIGGO. 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 could be promoting it. So I want to highlight UCB's reported just over 65% year-on-year growth in global RYSTIGGO sales. So we see this drug has a lot of momentum, and we're really looking forward to continue helping to bring value there. So acknowledging, we've had some really great success over the last few years here under Linda's leadership. The strategic priorities don't change. We have a proven strategy really built around 3 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 as efficiently as possible towards those opportunities.

[Operator Instructions] Our next question is from Joseph Downing with Piper Sandler.

Linda and Tom. First and foremost, Linda, 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. Yes, I just wanted to touch on the guidance range here. So it was pretty much in line with where we expected. Just looking at kind of the high end and low end, how you get to each. Curious if you can walk through that. I'm curious if on the low end is a scenario kind of where the new drug clearances and OUS prefill conversions slip into 2027 a little bit. And then the high end is more of you execute everything on schedule in '26. Just curious if you could walk through a little bit more detail there?

Great. 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 had 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, 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 on oncology or we're looking at new drugs now, I think that could be a meaningful area for us as well.

I appreciate that and for your comments. One more just on Japan. I know it's been kind of a deemphasized 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 prefill opportunity kind of opens up and makes Japan kind of move back up the list? Yes. Just any color there would be helpful.

Yes, I'll start, and then turn it over to Adam. So Japan, we see, again, being 1 of the larger IG markets overall, we see that this could be $0.5 million to $1 million total opportunity. We know that today, that's very much a hospital, but moving to the home opportunity and lots of exciting stuff that I'm going to let Adam talk through.

Yes. Thanks, Linda. 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. At the time we're seeing prefilled syringes there as being important, just as we kind of see in these other international markets. So as those prefills continue to grow, we expect that we're going to be growing with them. So it's a pretty exciting opportunity for us.

No further questions at this time. I would like to hand the floor back over to Linda Tharby for any closing remarks.

Right. Thank you, operator. I would 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 KORU team, to my daughters who actually listened into an earnings call for a change. I told them there were 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.