KRMD

Image source: The Motley Fool. Wednesday, Aug. 5, 2026 at 4:30 p.m. ET President and Chief Executive Officer - Adam Kalbermatten Chief Financial Officer - Thomas Adams Investor Relations - Louisa Smith Operator: Greetings, and welcome to KORU Medical Systems Second Quarter 26 Earnings Conference Call. At this time, all participants are in a listen-only mode. A Q&A session will follow the formal presentation. If anyone should require operator assistance during the conference, As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Louisa Smith. Thank you. You may begin. Louisa Smith: Thank you, operator, and good afternoon, everyone. Joining me on the call today are Adam Kalbermatten, President and CEO and Tom Adams, CFO. Earlier today, KORU released financial results for the second quarter ended 06/30/2026. 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 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 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, 08/05/2026 at approximately 04:30 eastern time. Since then, the company may have made additional comments related to the topics discussed. I would now like to turn the call over to Adam. Please go ahead. Adam Kalbermatten: Thank you, Louisa, and good afternoon, everyone. I will begin with commentary on this quarter's highlights and strategic progress. Tom will then speak to our financial performance and the current assumptions around guidance, before we open the line for questions. This is my first quarter reporting as CEO, and I want to start by saying how excited I am about the company's position and the opportunities that lie ahead for KORU. Today, we are the global leader in large volume subcutaneous infusion devices for drug delivery serving the at-home infusion needs of roughly 60 thousand chronic and recurring IG patients through our Freedom Infusion System. The broad market opportunity for subcutaneous Ig administration continues to shift from hospitals to infusion centers and increasingly into the home. KORU continues to be positioned as a direct beneficiary of that shift by providing an easy-to-use and differentiated way for patients to deliver their therapies outside the clinical setting. My focus as CEO is on extending our leadership position as the broader drug landscape follows this shift towards alternate sites of care focused on subcutaneous infusion versions versus IV. We are constantly assessing opportunities to bring more drugs onto our label and improve our technology. To achieve this, our fundamental strategy remains focused on scaling our industry leading mechanical platforms while selectively integrating smart capabilities that complement our core devices. By adding data-driven smart connectivity into our existing infusion as is our intention with this quarter's technology asset acquisition. We aim to provide an enhanced level of support for the patients who want it. While offering valuable data-driven insights to our pharmaceutical and special pharmacy partners. This approach allows us to preserve the simple, trusted mechanical experience that patients rely on while building the foundational capabilities to lead the drug delivery market as it gradually adopts connected health solutions. I am pleased with our performance in Q2, delivering $12 million in revenue, representing 18% growth for the quarter, 20% for the first half of the year. This momentum is built on the strong predictable foundation of our recurring IG patient base, coupled with our proven ability to capture new patient starts and actively expand our market share both in The US and internationally across both home and alternate site clinical environments. Financially, we executed well We improved gross margin by nearly 200 basis points above our 2026 range, and notably, we delivered positive net income for the first time since 2019. A major milestone in KORU's strategic evolution and further evidence of our ability to drive profitable growth. As I step into the CEO role, we are actively building upon this momentum. Our foundational 3 pillar strategy remains our central focus and we are executing against it with a heightened sense of urgency, scale, and vision. Looking at our growth pillars, on the domestic side, we grew our core business more than 12% year-over-year. Which is heavily supported by patient retention and continued market share gains with new patient starts in a growing population. Our domestic business continues to remain strong and has been growing at or above expectations in the market quarter after quarter. On Restigo, we continue to see adoption with new patient starts and are receiving strong feedback from both clinicians and patients. We view RYSTIGGO as a contributor to our domestic business, but more importantly, as a strategic validation of our platform's capability to deliver innovative non IG chronic therapies. We are highly encouraged by this ongoing expansion which further reinforces our ability to successfully diversify our clinical indications and expand our addressable patient footprint. Internationally, we grew the business by 59% year-over-year. This strong performance was driven by high volumes of both pumps and consumables, which was fueled by sales to distributors who are supporting the conversion of patients into prefilled syringe formats. Along with strong momentum from new patient starts within our established international markets. Looking ahead to the back half of this year, we remain highly focused on executing our international expansion, though we expect our near term international core growth to moderate as we navigate some specific regional launch dynamics. As we continue to build out our presence in newer prefilled syringe markets, some markets may take longer to ramp than we initially anticipated. In tender markets, we win the pharma practically overnight. In other markets like The US, where we win every new patient start as our distributors methodically convert from vial to PFS 1-by-1, it may take a little bit more time. In our Q1 call, we noted that our growth rates in these newer regions can be lumpy as we deepen our local market knowledge expand our capabilities. It is crucial for the long term health of the business that we establish the right distribution and reimbursement pathways. Unlocking this opportunity is simply taking us a little longer than forecasted in our assumptions. While this pacing may impact the international core growth rate in the short-term, remain encouraged by the progress in these markets as the foundational pieces fall into place. We also remain confident in the size of the overall international prefilled syringe market opportunity and are bullish in our long term ability to capture significant market share internationally. Building the right commercial and regulatory foundation in these new conversion markets takes time, but we are highly disciplined and diligent at the outset so that we are positioned to maintain permanent market leadership. in the future. In our pharma services business, we continue to systematically advance our established program while initiating early stage discussions with new potential pharmaceutical partners. Because many of these collaborations are designed to navigate the multiyear pharmaceutical development pathway. They serve as the engine for fueling our long-term growth pipeline. Biogen's recent acquisition of Apellis is an example of this. There may be some challenges to the timing and magnitude of near term clinical trial activity as they work through standard post acquisition integration activities. But we remain focused on a long-term partnership supporting their clinical development pipeline as their subcutaneous infusion programs advance. Turning to some strategic updates. We are pleased to announce our acquisition of a connected monitoring technology asset we believe will enhance the patient experience, deepen our value proposition, give us a meaningful new capability in generating real time data insights, and assist us in entering new clinical trials with pharmaceutical partners. Ultimately, the technology will support a better day-to-day experience for patients in addition to providing specialty pharmacies and pharmaceutical companies real world evidence across the patient base. Additionally, we believe this will be a key differentiator of the best in class KORU mechanical platform in our pharma services business where partners will have real time insights into dosing data during clinical trials. This capability will be valuable because precise adherence tracking and real world data capture are vital for ensuring trial integrity, accelerating regulatory approval timelines, and ultimately, generating the robust evidence required to secure favorable payer reimbursement upon commercialization. This is a multiyear build for us, but we are very excited to have the technology see it as an important building block for how we position our platform going forward. It reflects the broader approach we intend to take as we keep expanding the KORU platform and remain thoughtful about the right opportunities that have potential to strengthen our market position. Turning to an important emerging catalyst for our core SCIG business, I want to highlight the continued industry advancements we are seeing within secondary immunodeficiency, or SID. Today's SID market growth is expanding beyond the broader SCID market, largely driven by patients who develop immunodeficiencies following treatments with immunosuppressive drugs such as chemotherapy or cell therapies for various cancers and autoimmune conditions. To address this growing unmet need, major pharmaceutical players have made SID a clinical priority. With several ongoing pivotal clinical trials expected to reach their endpoints over the next 12 to 18 months. As these trials conclude, SCIg manufacturers to expand their active marketing efforts to hematologists and oncologists, we anticipate a significant expansion in reimbursement coverage domestically for secondary immunodeficiencies. For KORU, this represents a new incremental high growth patient population. Because our platform is already a trusted standard of care for subcutaneous IG delivery, we are perfectly positioned to capture this volume and meaningfully broaden our total addressable market. with these new indications as they come online. Turning to our regulatory pipeline, I would like to provide an update on our 2 recent 510(k) submissions. Phesgo and deferoxamine. First, regarding our broader oncology strategy, and our submission for use of the Freedom system with Phesgo. We have made a strategic decision to pivot our focus towards alternative molecules for our initial entry into The US and withdraw our application from the FDA for Phesgo in The US. Following productive conversations with the agency, there are specific considerations with the Phesgo label that are making pursuing other high volume oncology biologics more favorable to our oncology strategy in The US. Our conviction in the oncology market remains unchanged, it is a core strategic priority where we see a large opportunity for KORU. Simultaneously, we continue to advance our international oncology including with Phesgo. Which we view as a highly compelling long-term growth driver. Bolstered by the strong insights and positive nursing studies we have already generated in Europe. Such as our work in Denmark last year. While we refine our US oncology pathway, our regulatory momentum in other non Ig therapies remain strong. As a reminder, Koru officially submitted a 510(k) application for the clearance of the Freedom Infusion System with deferoxamine at the end of the first quarter. That application remains active, and our team is engaged in productive collaborative discussions with the FDA as we navigate the standard review process. We are committed to getting deferoxamine on label and believe it will unlock an estimated 200 thousand annual US infusions and further solidify our platform's expansion into non IG therapies. Regarding our new product pipeline, remain on track with our target for a 510(k) submission by the end of next year for our next generation pump. Which we are calling Freedom360. In the second quarter, we completed the final stages of the development process for Freedom360, which were steps that had represented the greatest area of risk in the development timeline. With that critical milestone now behind us, we are confident in our US submission timing. I am proud of the team's execution and the robust growth we demonstrated across the business this quarter. Stepping back, our fundamental strategy remains rooted in our 3 growth pillars, But as CEO, my mandate is to actively accelerate our execution against them. I am more energized by the magnitude of the opportunities ahead of us today than I was on day 1. We are successfully transforming KORU from a highly reliable mechanical device manufacturer into a dominant digitally enabled drug delivery platform. Whether it is preparing for our upcoming Freedom360 launch, advancing our international and oncology road maps, or integrating digital connected health capabilities, we are deliberately widening our competitive moat. We have a clear, disciplined strategy to drive sustainable, profitable growth and deliver significant long-term value to our shareholders. and the patients we serve. With that, I will turn it over to Tom to walk through the financials. Thomas Adams: Thanks, Adam. During the second quarter, we delivered record quarterly revenues. $12 million representing 18% growth year over year. Our domestic core revenue was $8 million for the quarter, up 12% year-over-year. Growth was driven primarily by momentum from new patient starts and continued market share gains as we once again outpaced the underlying SCIG market. International core revenue $3.5 million for the quarter, up 59% year-over-year over year and driven by growth in our established markets and additional volumes driven by supporting the prefilled syringe conversion strategy in Europe through distribution channels. pharma services revenue was $600 thousand for the quarter, down 35% year-over-year. Driven primarily by lower orders for clinical trial use due to customer order timing. Once again, I will remind our audience that the pharma services business will continue to have inherent variability from quarter to quarter based on customer time lines. On gross margin, we delivered 65.1% for the quarter versus 63.5% in the prior year period. A 160 basis point increase over the prior year. The primary drivers of the improvement included productivity and efficiency led reductions in manufacturing costs. Along with higher average selling prices and a more favorable customer mix. Also of importance during the quarter, we extended a key supplier contract And with the signing of this new multiyear agreement, we were able to secure improved pricing which will continue to improve as our business grows resulting in continued margin expansion. Turning to cash. We ended the quarter with $8.3 million reflecting minimal cash usage of $500 thousand in the quarter. We were expecting Q2 to be our heaviest usage quarter but with lower net losses from strong revenues, and improved gross margins along with tighter management of spending, we were able to generate positive cash flow from operations. Additionally, we closed the technology asset acquisition in the second quarter while maintaining minimal cash usage. Based on our current run rate, we believe our current cash is sufficient to support operations for the foreseeable future. As we achieve cash flow positivity in the coming quarters. As a reminder, we also have access to our unused $10 million debt facility which provides additional financial flexibility or incremental opportunities as we execute against our growth plans. I would also like to note that we did not draw down on our credit facility to fund the technology acquisition. During the quarter. As we review the first half of the year, we see strength across the P&L and balance sheet. We grew 20% revenue, gross margin trended higher, and it improved by 20 basis points to 60.3%. We continue to deliver improved operating leverage against our revenue growth with operating expenses increasing only 9%. We improved net losses by 60% and losses and delivered positive adjusted EBITDA of $900 thousand Finally, we have demonstrated improvement in cash usage by 62% versus a year ago. Having said this, we will continue to invest strategically in areas that improve and grow our business in sales and marketing, and research and development, and we will do so while maintaining spending discipline across the business to drive operational leverage. Turning to guidance. In prior commentary, we noted the back half revenue would be weighted more heavily largely driven by new prefilled geographies ramping up. However, as Adam described, we are navigating complexities associated with specific regional launches in nontender offer markets in order to ensure we have the proper market foundations in place. This deliberate setup in select geographies positions us for a more effective launch. but it is also resulting in a more moderate ramp in the third and fourth quarters. As a result, we are narrowing our full year revenue guidance to $47.5 million to $48.5 million We view this as primarily timing related as the broader prefilled conversion story across the rest of Europe continues to move in the right direction. We have updated our internal forecast to assume recognition of the opportunity in certain markets more meaningfully in 2027 versus the second half of 26. We remain encouraged by the overall market opportunity. it is just that unlocking it is taking a little longer than our guidance assumptions accounted for. Also, I will note that while our initial guidance assumes some modest incremental revenue, from pending 510(k)s clearances, the update on Phesgo that Adam detailed is not a contributing factor to our updated outlook. Following the signing of an extended supplier contract, we believe that the bottom end of our gross margin guidance has been sufficiently derisked and there is room for additional upside in the back half of the year. As a result, we are raising gross margin guidance from 61% to 63%, to 62% to 64%. We are also adjusting our cash guidance to account for the technology acquisition and associated operating costs. With a small team of R&D headcount. We now expect that our year end cash balance will be greater than $7.5 million We also want to reiterate that we still expect to have positive adjusted EBITDA for the full year. I will now turn the call back over to Adam for additional comments on our forward momentum. Adam? Adam Kalbermatten: Thank you, Tom. Before we open the call to questions, I want to reiterate why I am so energized by the road ahead for KORU. Over the past few years, we have systematically transformed KORU, a single therapy device provider into a true multifaceted technology platform. We have successfully expanded our label with novel therapies like RYSTIGGO, more than doubled our international footprint, engineered next generation capabilities to capture the market shift to prefilled syringes, and built a robust pharma services pipeline that embeds us directly into the clinical trials of innovative new drugs. We are operating from a position of strength in a large and rapidly expanding market for subcutaneous drug delivery. Our core business commands a leading share consistently outpaces underlying market growth, and generates highly durable recurring revenue driven by the 60 thousand patients who rely on our system every single day. Building on this incredibly solid foundation, we have several powerful strategic catalysts on the horizon. Expansion across our core IG business in the secondary immunodeficiency market, oncology initiatives, our pharma services expansion, and the integration of our newly acquired Connected Health technology. all of which we believe will meaningfully accelerate our growth trajectory, expand our competitive moat, and elevate our platform's value. Each of these initiatives represents a deliberate step in our evolution reinforcing KORU's position as the definitive standard of care in home and alternate site drug delivery. Our long term targets remain resolute. $100 million in revenue, gross margins above 65%, and EBITDA margins of 20% or greater. This quarter's milestone of returning to positive net income proves our model works. We intend to keep executing with that same rigorous discipline as we build the definitive standard of care in home infusion. With that, I would now like to open the call for questions. Operator: Thank you. At this time, we will be conducting a Q&A session. If you would like to ask a question, please press 1 on your telephone keypad. You may press 2 if you like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset. 1 moment please while we poll for questions. Our first question comes from Frank Takkinen with Lake Street Capital. Your line is now live. Frank Takkinen: Great. Thank you for taking the questions and congrats on the solid Q2. I was hoping to start with asking for a little bit more color on the OUS dynamics What needs to happen in order to unlock some of the nontender markets? To capture some of the some of the growth you were counting on in 2026 and with any of these initiatives, could they potentially be pulled forward still into 2026 and you are exercising some conservatism, or is this mostly all really going to hit in 2027? Adam Kalbermatten: Hi, Frank. it is Adam. Thanks for the question. Appreciate the congrats on the solid quarter. On international, we are still really excited about the opportunity overall. We see this as a as a major growth driver for Karoo moving forward. I think as we look at the back half of the year, it is really about how do we get all of the different elements in place in each of the different regional dynamics there. We are working really hard on that. We see it as something that we continue to make very good progress. A lot of the patient starts are kinda warming up here. And over the next, call it 12 to 18 months, we still see a pretty big opportunity here. it is really about a delay in the timing, but really, really excited about the overall opportunity. And, you know, I think you were asking if there is some potential upside here. You know, we are going as quick as we can it is really about getting all of these different dynamics in place and all the different, you know, the countries there. Tom, anything else you can add to that? Thomas Adams: No. I think you covered that, Adam. Frank Takkinen: Okay. And then maybe a follow-up on the connected monitoring technology acquisition. Let me just go a little bit deeper into the use case for this. When you might if the where in development stage this might be, if there is still things that need to happen before it is deployed into the field, and any other relevant color you would be welcoming to provide. Adam Kalbermatten: Yeah. We are we are super excited about this. This was an acquisition that came up for us It was something that was opportunistic as we were looking at our mechanical system. We really love the simplicity that the mechanical system provides to patients. it is something that as we looked at where that platform was going to continue to go, we wanted to look at how could we bring additional value to those patients. And this was something that as we were looking at those different options, we came across this technology asset and are very, very hopeful for what that could bring down the line. I wanna stress that it is a it is a multiyear build here. So it is gonna take some time, but it is something that we look at the ability to communicate with patients, collect additional data from the infusion, But we are still in the early stages of looking at that. We just wanted to signal that we did make that acquisition this quarter. Frank Takkinen: Okay. Fair enough. I will hop back in queue. Thank you. Operator: Our next question comes from Chase Knickerbocker with Craig Hallum Capital Group. Your line is now live. Chase Knickerbocker: Good afternoon. Thanks for taking the questions. If I just start on kind of a little bit more detail around kind of the Phesgo dynamics, So can you just kind of give a little bit more detail as far as kind of what the FDA feedback was? And then you kind of mentioned you know, focusing on other molecules that would potentially be more attractive. to get on label. Can you just kind of define what that the kind of characteristics of an attractive molecule for you in oncology would be? Thanks. Adam Kalbermatten: Hi, Chase. Good to hear from you. I want to start by saying we are still really, really excited about the oncology market opportunity we have here. We see it across a number of different molecules. Being about $60 million as we look at that total TAM today. Continuing to grow over the next 4-5 years to upwards of $140 million. As it impact as it impacts Phesgo here in the recent news in our pivot, you know, we applied to bring Phesgo on label at the end of last year last year. We have had a number of ongoing discussions with the FDA Through those discussions, we identified a consideration with the Phesgo label, so with the actual drug label, that made pursuing other high volume oncology biologics as a more attractive opportunity for us. So that is what resulted in us making that decision here to pivot. In terms of Phesgo, you know, internationally, we still see that as an avenue that we continue to go forward. But it is really about focusing on those molecules where we see a more attractive volume and return on our investment for what we are trying to do here. So still really, really excited about oncology. And still excited about Phesgo internationally. But in our US entry, looking to make a pivot here. Chase Knickerbocker: Got it. I guess just maybe to follow-up on that, any sort of kind of changes in timelines as far as U. S. Oncology market entry or kind of changes in go to market there? And then just second, as a follow-up, could you just maybe give us an update as it relates to kind of your outlook if anything's changed as far as how you are thinking about the domestic core business? Maybe just an update on, you know, you still thinking about kinda 8% to 10% kind of core SCIG market growth in The US and then, you know, call it several 100 basis points of outperformance for your business? Thanks. Adam Kalbermatten: Absolutely. That was a good 1, Chase. Let me start with the first part of the question, and I will pass the other 1 to Tom on the domestic side. I think as we are looking at oncology kind of going forward here, we had been planning our entry for later this year as we had approval with Phesgo. We were expecting second half I think it is fair to say that is gonna shift a bit now. You know, we are still working through exactly what that timing's gonna look like and announce that. But, I can say we are actively in that process. So we are gonna be a little bit delayed and I hope we are going to be able to continue that going at a at a pretty rapid pace here. That said, on the on the domestic SCIG market, we see some healthy growth continuing there. We are continuing to grow above market In terms of the details, Tom, if you wanna jump in with anything. Thomas Adams: Yeah. Thanks and hi, Chase. Yeah. On The US side, our US business is still very strong. We continue to outperform the SCIG market. And when we think about our guide, our guide basically continues to have U.S. as a strong market. Pharma services, our clinical trial business continues to do well. And as we mentioned, this guide is fairly isolated to our international business. Understood. Chase Knickerbocker: Thanks. Operator: Our next question comes from Caitlin Roberts with Canaccord Genuity. Your line is now live. Caitlin Roberts: Great. Thanks for taking the questions. I would love a bit more color on just the OUS dynamics. If you could provide any insight into what percent of the markets you would say are tender versus kind of the 1-by-1 work like in the U.S.? And, you know, just given those dynamics and maybe pursuing those more gradual markets. Will this maybe smooth out the revenue expectations for OUS here? Adam Kalbermatten: Hi, Caitlin. Great question. When we think about the overall market, internationally, specifically Europe, you know, it is primarily a market today that is dominated by electronic pumps. that is the standard of care there. So we are going in, and we are following where pre filled syringes are entering the market. And we are kind of seeing that as fertile ground for us to work on bringing additional value to the patients. It starts with those prefilled syringes that the patients have a more patient friendly experience, a simplified experience And we like to introduce the KOROUP pump as a way to continue to amplify that simplicity that we can bring. In terms of the markets themselves, what happened over the last call it, 3, 4 quarters is we were we were converting 1 of those markets that was pharmaceutical tender market that we fast followed really quickly with that pharmaceutical company. As we continue to look at these other countries, they are more what we would refer to as kind of competitive markets where they are not tender driven markets and that means we need to look at how we are managing that channel, through the distributors, through the relationships that we have with different home care companies that are training the patients, and how do we make sure that we have those right relationships. So the good news is we do have a lot of those relationships. Now we are in the process of kind of going through new patient starts. The process is that the whole market does not convert all at 1 time. It converts through those new patient starts, very similar to how The U. S. Domestic market works in that you kind of get those new patient starts and then as you continue to convert those patients, the consumables flow through to support them as well once they start on the pumps. Tom, anything you wanna add on that? Thomas Adams: No. I think we are good, Adam. Thanks. Caitlin Roberts: Great. And then maybe just a question on secondary immunodeficiency. what is the go to market strategy here, and does that differ from, you know, the core SCID market in The U. S? Adam Kalbermatten: Absolutely. Yeah. So as we think about secondary immunodeficiency we look at it as work that many of the major pharmaceutical companies are already engaged in. there is a number of clinical trials ongoing. Those clinical trial endpoints are coming up towards the end of 27. A lot of those clinical trials are being done with existing SCIG drugs that Koru already has on label. So as we think about it, we are trying to stay on top of exactly what those clinical trials are, who are the manufacturers, what is the pathway towards getting approval, for different indications in SID, and then what is the channel that we would need to set up to make sure that we can get our products in the hand of those patients. But the good news about all of that is that we have those drugs already on label for many of those that are in those clinical trials today. And as soon as the pharmaceutical companies wrap up those clinical trial endpoints, we are really excited about the opportunity to serve more patients and bring them on our system. Caitlin Roberts: Great. Thank you. Operator: Our next question comes from Joseph Downing with Piper Sandler. Your line is now live. Joseph Downing: Hey, Adam and Tom. Thanks for taking the question. Congrats on the quarter. Just another question on the Phesgo withdrawal here. So obviously, it sounds like you are keeping Phesgo alive internationally. and just looking at the deck, it now looks like it sized the opportunity around 600 thousand annual infusion versus the 1.1 or 1.2 million call out previously. I am just curious, is that delta simply the U.S. coming out? And can you frame the international and how the economics compare here from whether it is a pricing channel geographies, anything you want to divulge there? Thanks. Adam Kalbermatten: Hey, Joe. Thanks for the question. Yes, you caught the correct drawdown that we had when we pulled out The US market for Phesgo since we are focused now on the international. I would highlight that as we look at our entry, we are still very focused on The US. International is 1 that we are also planning to move forward to. there is some additional work we have to do in terms of real world evidence. Order to bring drugs on label in Europe. Through the MDR process. So that is going to continue to take some time. In terms of the economics, you know, everything that we see continue to be very favorable for us in the international markets in Europe as well when it comes to these oncology drugs. Obviously, reimbursement's a little bit different than what we had studied in The US, but we are still seeing very, very positive contributions that we could make there. And we continue to see, a lot of a lot of very strong interest there. Yeah. And I will add on to this 1, Adam. Thomas Adams: When we think about Phesgo, the volume of infusions internationally is much more prevalent than what we see in The US. So it is it is it is a it is a higher volume in terms of annual infusions all across international markets versus and European markets, I should say, specifically. Versus The United States. Adam Kalbermatten: Good point, Tom. Joseph Downing: Right. I appreciate all the color there. And then, Adam, I just have kind of a bigger picture question for you now that you have been in the seat for a little bit. So given the long range framework that you inherited, I am just curious how you are thinking about what it takes to get this business to be kind of a sustainable 20% grower here. And how you plan maybe holding it there for multiple years rather than you know, a 1-off year. And I am curious specifically if this can be a sustainable 20% grower if The US is kind of in that low double digit, mid-teens, you know, range? Thanks. Adam Kalbermatten: Yeah, absolutely. Great question. So on our long term strategy, right, there is really the 3 growth pillars. it is continuing to grow domestically, defending our share. second, growing internationally. And then third, it is really about working with pharma companies and bringing more drugs on label. As we as we continue to grow within the IG market, we continue to intend to grow and take more than our fair share there as we have been doing. We have got a pretty good track record there. To get our growth rates up higher, it is really about bringing new drugs on label, and continuing to expand internationally. So when we talk about Phesgo, when we talk about on oncology and the broader opportunities, it is really about how can we increase our TAM and get those additional drugs on label so that we can bump up the markets that we serve, get more patients on our products. And then continue to serve those patients over the long term. Great. that is thorough. Thanks, Adam. Thomas Adams: Thanks, Tom. Operator: We have reached the end of the question-and-answer session. I would now like to turn the call back over to management for any closing comments. Adam Kalbermatten: Thank you all for joining us this afternoon. Really enjoyed the call here and looking forward to updating you further on our progress in our third quarter call. Have a great evening and rest of your day. Operator: This concludes today's conference. You may disconnect your lines at this time. And we thank you for your participation. 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This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has positions in and recommends Koru Medical Systems. The Motley Fool has a disclosure policy. KORU (KRMD) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Delivered 18% revenue growth in Q2, reaching positive net income for the first time since 2019, validating the company's path toward profitable scale. Domestic core business grew 12% by outpacing the subcutaneous immunoglobulin (SCIG) market through high patient retention and capturing new patient starts. International revenue surged 59% driven by established market momentum and distributor-led conversions to prefilled syringe (PFS) formats in Europe. Withdrew the US FDA 510(k) application for Phesgo following label-specific considerations, pivoting the domestic oncology strategy toward other high-volume biologics. Acquired a connected monitoring technology asset to integrate data-driven insights into the mechanical platform, aimed at enhancing patient adherence and pharma clinical trial integrity. Positioned the Freedom system to capture incremental growth from the emerging secondary immunodeficiency (SID) market as major clinical trials conclude over the next 12-18 months. Narrowed full-year revenue guidance to $47.5M-$48.5M, reflecting a more moderate ramp in international non-tender markets as foundational distribution and reimbursement pathways take longer to establish. Raised gross margin guidance to 62%-64% following a key multi-year supplier contract extension that secured improved pricing and derisked the bottom end of previous estimates. Maintained the timeline for the Freedom360 next-generation pump, with a US 510(k) submission targeted for the end of 2027 after completing high-risk development stages. Expects near-term international growth to moderate in the second half of 2026, with more meaningful revenue contributions from new geographies shifting into 2027. Anticipates positive adjusted EBITDA for the full year 2026 while continuing strategic investments in R&D and sales and marketing. Pharma Services revenue declined 35% due to customer order timing, highlighting the inherent quarterly variability of clinical trial-related business. The Biogen acquisition of Apellis may create near-term timing challenges for clinical trial activity during standard post-acquisition integration. The shift to focus on international markets for Phesgo resulted in a drawdown of the estimated annual infusion opportunity to 600,000, as the company pulled out of the U.S. market for that drug., though international oncology efforts remain active. Cash guidance adjusted to a year-end balance greater than $7.5M to account for the technology acquisition and associated R&D headcount costs. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management explained that unlike tender markets which convert 'overnight', competitive markets require a methodical 1-by-1 patient conversion process through distributors. The delay in international growth is characterized as a timing issue rather than a loss of opportunity, with patient starts currently 'warming up' for a 12-18 month ramp. The decision was driven by specific drug label considerations identified during FDA discussions that made other oncology molecules more attractive for US entry. Management remains 'bullish' on oncology, noting the international Phesgo opportunity remains intact due to higher infusion volumes in European markets. The acquisition is described as a 'multi-year build' intended to add digital value to the core mechanical system without sacrificing its simplicity. Primary benefits include providing real-world evidence for specialty pharmacies and improving data capture for pharmaceutical partners during clinical trials. KORU is targeting SID as a high-growth patient population resulting from immunosuppressive treatments like chemotherapy. The company is well-positioned because many ongoing SID clinical trials use drugs already on KORU's label, allowing for rapid adoption once trials reach endpoints in late 2027.

Interested in KORU Medical Systems, Inc.? Here are five stocks we like better. Second-quarter revenue rose 18% to $12 million, driven by domestic patient starts, market-share gains and strong international core revenue growth. KORU also reported positive net income for the first time since 2019 and improved gross margin to 65.1%. KORU narrowed its full-year revenue outlook to $47.5 million-$48.5 million because international prefilled-syringe launches are taking longer to develop, with some growth now expected in 2027. It raised full-year gross-margin guidance to 62%-64% and maintained its outlook for positive adjusted EBITDA. The company is expanding its long-term pipeline through a connected-monitoring technology acquisition, oncology applications and potential deferoxamine approval, while its next-generation Freedom 360 pump remains on track for a 510(k) submission by the end of 2027. KORU Medical Systems (NASDAQ:KRMD) reported second-quarter revenue of $12 million, up 18% from a year earlier, as domestic patient starts, market-share gains and international demand supported growth. The company also said it achieved positive net income for the first time since 2019 and raised its full-year gross-margin outlook, while narrowing revenue guidance because certain international prefilled-syringe market launches are taking longer to develop than expected. President and CEO Adam Kalbermatten, reporting his first quarter in the role, said revenue rose 20% during the first half of 2026. He described KORU as serving approximately 60,000 chronic and recurring immunoglobulin, or IG, patients through its Freedom Infusion System and said the company is positioned to benefit as subcutaneous drug delivery shifts from hospitals toward infusion centers and home settings. → SpaceX’s First Earnings Report Could Decide Whether Shorts or Bulls Have Control Chief Financial Officer Tom Adams said domestic core revenue totaled $8 million, an increase of 12% year over year. The growth was driven by new patient starts and market-share gains, with KORU continuing to outpace the underlying subcutaneous immunoglobulin, or SCIg, market, according to management. International core revenue increased 59% to $3.5 million. Adams attributed the increase to growth in established markets, as well as distributor volumes supporting a European conversion to prefilled syringe formats. Kalbermatten said the company has seen both pump and consumables demand from distributors supporting those conversions. → 3 Drone Stocks That Should Soar After the Summer Slump Pharma Services and Technology, or PST, revenue was $600,000, down 35% from the prior-year period. Adams said the decline reflected lower clinical-trial orders because of customer order timing, and reiterated that PST revenue can vary meaningfully between quarters based on pharmaceutical customer timelines. Gross margin was 65.1%, compared with 63.5% a year earlier. Adams cited manufacturing productivity and efficiency gains, higher average selling prices and a favorable customer mix. He also said KORU extended a key supplier contract under a multiyear agreement that provided improved pricing expected to support further margin expansion as the business grows. → The Bitcoin Comeback May Already Be Underway—2 ETFs for Exposure The company ended the quarter with $8.3 million in cash, reflecting approximately $500,000 in cash usage during the period. Adams said KORU generated positive cash flow from operations during what management had expected to be its highest cash-use quarter, while also completing its technology asset acquisition. The company also has an unused $10 million debt facility, though it did not draw on that facility to fund the acquisition. KORU narrowed its full-year revenue outlook to a range of $47.5 million to $48.5 million. Management previously expected the second half to carry more of the year’s growth, largely due to new prefilled-syringe geographies ramping up. Kalbermatten said some non-tender international markets require the company to establish distribution, reimbursement and home-care relationships before volumes can build. In tender markets, pharmaceutical wins can convert volume quickly, he said, while competitive markets require more gradual patient-by-patient conversions similar to the U.S. market. “Unlocking this opportunity is simply taking us a little longer than forecasted in our assumptions,” Kalbermatten said. Adams said KORU now expects to recognize the opportunity in certain markets more meaningfully in 2027 rather than in the second half of 2026. Management characterized the revision as primarily related to timing and said the broader European prefilled-syringe conversion trend remains favorable. At the same time, KORU raised full-year gross-margin guidance to 62% to 64%, from 61% to 63%, following the supplier agreement. The company now expects year-end cash to exceed $7.5 million, reflecting the connected-technology acquisition and related research-and-development staffing costs. It reaffirmed expectations for positive adjusted EBITDA for the full year. During the quarter, KORU acquired a connected monitoring technology asset intended to add data and connectivity capabilities to its mechanical infusion systems. Kalbermatten said the technology could eventually support patient communication, infusion data collection, adherence tracking and real-world evidence for specialty pharmacies and pharmaceutical partners. He emphasized that the initiative remains a multiyear build and is still in early stages. Management said connected capabilities could be especially valuable in clinical trials by providing real-time dosing data and supporting trial integrity and reimbursement evidence. KORU also withdrew its U.S. Food and Drug Administration 510(k) submission seeking use of the Freedom system with PHESGO. Kalbermatten said discussions with the FDA identified considerations related to the PHESGO drug label that made other high-volume oncology biologics more attractive for the company’s initial U.S. oncology entry. The company said its conviction in the oncology opportunity remains unchanged, but its U.S. entry is likely to shift from the previously anticipated second-half timing as it evaluates alternative molecules. KORU continues to pursue PHESGO internationally, where management said it sees a compelling long-term opportunity and where annual infusion volumes are higher than in the U.S. KORU’s active 510(k) submission for deferoxamine remains under FDA review. Management said clearance could support an estimated 200,000 annual U.S. infusions. The company also said development of its next-generation Freedom 360 pump has completed its final higher-risk stages and remains on track for a 510(k) submission by the end of 2027. Management highlighted secondary immunodeficiencies as a potential future catalyst for its SCIg business. Kalbermatten said several pharmaceutical companies are conducting pivotal trials involving patients who develop immunodeficiencies after treatments such as chemotherapy, cell therapies and immunosuppressive drugs. He said trial endpoints are expected over the next 12 to 18 months, while an analyst discussion referenced some trial endpoints toward the end of 2027. KORU said many of the SCIg drugs used in those trials are already on its label, potentially allowing the company to serve additional patients if new indications receive approval and reimbursement coverage expands. Kalbermatten reiterated KORU’s long-term targets of $100 million in revenue, gross margin above 65% and EBITDA margin of 20% or greater. He said the company’s strategy remains centered on domestic IG growth, international expansion and adding new therapies through pharmaceutical partnerships. KORU Medical Systems, Inc develops and manufactures medical devices and supplies in the United States and internationally. It offers the freedom infusion systems to deliver life-saving therapies to patients with chronic illnesses, such as primary immunodeficiency diseases, chronic inflammatory demyelinating polyneuropathy, and paroxysmal nocturnal hemoglobinuria. Its products include the FREEDOM60 syringe infusion system, the FreedomEdge syringe driver, HIgH-Flo subcutaneous safety needle sets, and precision flow rate tubing products. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "KORU Medical Systems Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

This article first appeared on GuruFocus. Release Date: August 05, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Record quarterly revenue of $12 million, up 18% year-over-year, with 20% growth in the first half of 2026. Achieved positive net income for the first time since 2019, a major milestone. Gross margin improved to 65.1%, up 160 basis points year-over-year, and raised full-year guidance to 62%-64%. International revenue grew 59% year-over-year, driven by strong demand in established markets and pre-filled syringe conversions. Acquired a connected monitoring technology asset to enhance patient experience and provide real-time data insights, strengthening the platform's value proposition. Domestic core business grew 12% year-over-year, outpacing the underlying SCIG market with continued market share gains. Completed final development stages for Freedom 360, the next-generation pump, on track for 510 submission by end of next year. Generated positive cash flow from operations in Q2, with minimal cash usage of $500,000 and year-end cash expected above $7.5 million. Extended a key supplier contract with improved pricing, supporting continued margin expansion. Positioned to benefit from the growing secondary immunodeficiency (SID) market, with several pivotal trials expected to conclude in the next 12-18 months. Narrowed full-year revenue guidance to $47.5-$48.5 million due to slower-than-expected ramp in international pre-filled syringe markets. International growth is expected to moderate in the near term as certain regional launches take longer to materialize. PST revenue declined 35% year-over-year due to lower clinical trial orders, highlighting inherent variability in this segment. Withdrew the U.S. FDA application for FESGO, delaying U.S. oncology market entry and shifting focus to alternative molecules. The connected monitoring technology acquisition is a multi-year build, with no immediate revenue contribution. Biogen's acquisition of Apellis may cause near-term delays in clinical trial activity, impacting PST timelines. Cash balance remains modest at $8.3 million, though sufficient for foreseeable operations. International expansion requires establishing proper distribution and reimbursement pathways, which is taking longer than initially anticipated. The company's long-term growth targets depend on successful execution of multiple strategic initiatives, which carry execution risks. The FESGO withdrawal reduces the U.S. oncology opportunity, with the total addressable market now estimated at $600K versus previous higher figures. Warning! GuruFocus has detected 4 Warning Signs with IONQ. Is KRMD fairly valued? Test your thesis with our free DCF calculator. Q: Can you provide more color on the OUS dynamics and what needs to happen to unlock growth in the non-tender markets that was previously expected in 2026? Could any of these initiatives be pulled forward into 2026, or will they mostly hit in 2027?A: Adam Kalbermatten (President and CEO): We remain excited about the international opportunity as a major growth driver. The back-half focus is on getting all the different elements in place across various regional dynamics. We are making good progress, and patient starts are warming up. Over the next 12 to 18 months, we still see a big opportunity, but it's a delay in timing. We are moving as quickly as possible to establish the right distribution and reimbursement pathways, which is crucial for long-term health. Q: Can you provide more detail on the FDA feedback regarding the FESGO withdrawal and define the characteristics of an attractive oncology molecule for KORU in the U.S.?A: Adam Kalbermatten (President and CEO): We are still very excited about the oncology market opportunity, which we see as a $60 million TAM today, growing to upwards of $140 million over the next four to five years. Through ongoing discussions with the FDA, we identified specific considerations with the FESGO label that made pursuing other high-volume oncology biologics a more attractive opportunity for our U.S. entry. We are pivoting to focus on molecules with more attractive volume and return on investment. Internationally, we still see FESGO as a compelling long-term growth driver. Q: What is the go-to-market strategy for secondary immunodeficiency (SID), and does it differ from the core SCIG market in the U.S.?A: Adam Kalbermatten (President and CEO): Many major pharmaceutical companies are already engaged in SID clinical trials, with endpoints expected towards the end of 2027. Many of these trials use existing SCIG drugs that KORU already has on label. We are tracking these trials and preparing the channels needed to get our products to patients. The advantage is that since the drugs are already on label, we are well-positioned to capture this new incremental high-growth patient population as approvals come online. Q: Regarding the FESGO withdrawal, the deck now sizes the opportunity around $600K versus the previously called out $1.1 or $1.2 million. Is that delta simply the U.S. coming out, and how do the international economics compare?A: Adam Kalbermatten (President and CEO) and Tom Adams (CFO): Yes, the drawdown reflects pulling the U.S. market out of the FESGO opportunity. We are still focused on the U.S. for other molecules, but internationally, we need to do additional work on real-world evidence for the MDR process in Europe. The economics remain favorable internationally, though reimbursement differs from the U.S. Tom Adams added that the volume of infusions internationally is much more prevalent than in the U.S., making it a higher-volume opportunity. Q: Now that you've been in the CEO seat, what does it take to make this a sustainable 20% grower, especially if the U.S. is growing in the low double-digit to mid-teens range?A: Adam Kalbermatten (President and CEO): Our long-term strategy is built on three growth pillars: growing domestically and defending share, growing internationally, and working with pharma to bring more drugs on label. We have a strong track record of taking more than our fair share in the IG market. To increase growth rates, we need to bring new drugs on label and expand internationally. Expanding our TAM through new indications like oncology is key to serving more patients and driving long-term growth. Q: Can you provide more detail on the connected monitoring technology acquisition, its use case, and the development stage?A: Adam Kalbermatten (President and CEO): We are very excited about this opportunistic acquisition. We love the simplicity of our mechanical system, and this technology will allow us to bring additional value to patients by enabling communication and data collection during infusions. It's a multi-year build, and we are in the early stages. The technology will provide real-time insights for patients, specialty pharmacies, and pharma partners, and will be a key differentiator in our PST business for clinical trial data capture. Q: Can you provide insight into what percent of international markets are tender versus gradual one-by-one conversion markets, and will pursuing the gradual markets smooth out OUS revenue expectations?A: Adam Kalbermatten (President and CEO): The European market is primarily dominated by electronic pumps today. We are following where prefilled syringes are entering the market. Previously, we converted a pharmaceutical tender market quickly. The other countries are more competitive, non-tender-driven markets, requiring us to manage channels through distributors and home care companies. We have many of those relationships in place and are working through new patient starts. The market doesn't convert all at once; it converts through new patient starts, similar to the U.S. domestic market. Q: Can you provide an update on the outlook for the domestic core business and whether you still expect 8% to 10% core SCIG market growth with several hundred basis points of outperformance?A: Tom Adams (CFO): Our U.S. business remains very strong, and we continue to outperform the SCIG market. Our guidance continues to assume a strong U.S. market and a solid PST clinical trial business. The guidance adjustment is fairly isolated to our international business. Q: Regarding the FESGO pivot, are there any changes to the timeline for U.S. oncology market entry?A: Adam Kalbermatten (President and CEO): We had been planning our U.S. oncology entry for later this year, expecting approval with FESGO in the second half. That timing will now shift as we work through the pivot to alternative molecules. We are actively in the process and will announce the new timing, but we will be a bit delayed. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

KORU Medical Systems, Inc. (KRMD) came out with quarterly earnings of $0.01 per share, beating the Zacks Consensus Estimate of a loss of $0.02 per share. This compares to break-even earnings per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +150.00%. A quarter ago, it was expected that this company would post a loss of $0.02 per share when it actually produced a loss of $0.02, delivering no surprise. Over the last four quarters, the company has surpassed consensus EPS estimates three times. KORU Medical Systems, Inc., which belongs to the Zacks Medical Info Systems industry, posted revenues of $12.05 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 2.78%. This compares to year-ago revenues of $10.19 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. KORU Medical Systems, Inc. shares have lost about 27% since the beginning of the year versus the S&P 500's gain of 13%. While KORU Medical Systems, Inc. has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for KORU Medical Systems, Inc. was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.01 on $12.23 million in revenues for the coming quarter and -$0.04 on $48.85 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical Info Systems is currently in the top 30% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Senseonics Holdings (SENS), is yet to report results for the quarter ended June 2026. The results are expected to be released on August 6. This medical technology company is expected to post quarterly loss of $0.55 per share in its upcoming report, which represents a year-over-year change of -37.5%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Senseonics Holdings' revenues are expected to be $13.08 million, up 96.7% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report KORU Medical Systems, Inc. (KRMD) : Free Stock Analysis Report Senseonics Holdings, Inc. (SENS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

MAHWAH, N.J., August 05, 2026--(BUSINESS WIRE)--KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today reported financial results for the second quarter ended June 30, 2026. The Company also updated guidance for the full year 2026. Second Quarter 2026 and Recent Highlights Net revenues grew 18% over the prior year period to $12.0 million Gross profit grew 20% over the prior year period to $7.8 million, with gross margin of 65.1% Net income improved 222% over the prior year period to $0.25 million Acquired a connected monitoring technology asset, representing strategic investment to potentially enhance and differentiate the KORU platform through valuable real-time data insights into patient usage Strategically shifting U.S. oncology market entry to focus on alternative higher volume molecules and withdrawing 510(k) application for the FreedomEDGE® with Phesgo® in the U.S. Entered into a multi-year supply agreement to support operational strategy, product assurance, and long-term gross margin expansion Refining full year 2026 guidance to include: Revenue of $47.5 - $48.5 million, gross margin of 62% - 64%, positive adjusted EBITDA, and year end cash balance of greater than $7.5 million "We delivered record revenue, improved gross margins and generated positive net income for the quarter, all of which demonstrate our ability to drive durable and profitable growth in the subcutaneous drug delivery market," said Adam Kalbermatten, President and CEO of KORU Medical. "We also acquired a technology asset, representing a strategic investment in connected monitoring potential to further enhance the patient experience and differentiate KORU’s value proposition to our partners. "Looking ahead for the remainder of 2026, we expect our international core growth to moderate as we navigate regional launch dynamics in specific European markets converting to pre-filled syringes. We remain confident in the size of our international opportunity and view capturing this business only as a matter of timing. Additionally, we have withdrawn our Phesgo® 510(k) application and shifted our U.S. oncology strategy to focus on alternative molecules with higher infusion volumes. Overall, we are pleased with our performance in the quarter and are focused on executing our growth strategy with operational discipline to drive durable value creation." 2026 Second Quarter Financial Results Total net revenues increased $1.9 million, or 18.2%, to $12.0 million for the three months ended June 30, 2026, as compared to $10.2 million in the prior year period. Domestic core revenues were $8.0 million, an increase of 12.4% over the prior year period, primarily due to higher pump and consumable volumes, driven by new patient starts and market share gains within new and existing accounts, supported by a strong underlying SCIg market. International core revenues were $3.5 million, an increase of 59.1% over the prior year period, due to higher pump and consumable volumes, driven by distributor purchases supporting pre-filled syringe (PFS) conversions, and new patient starts in established EU markets. Pharma services and clinical trials net revenues were $0.6 million, a decrease of 35% over the prior year period, primarily due to lower clinical trial product revenues related to customer order timing. Gross profit increased $1.4 million, or 21.2%, to $7.8 million in the three months ended June 30, 2026, as compared to $6.5 million in the prior year period, primarily driven by volume growth. Gross margin increased to 65.1% in the three months ended June 30, 2026, as compared to 63.5% in the prior year period. The increase in gross margin was primarily driven by lower manufacturing costs, and higher average selling prices. Total operating expenses increased $0.4 million, or 6.3%, to $7.2 million for the second quarter of 2026 primarily driven by an increase of $0.6 million in selling, general, and administrative expenses, and a decrease of $0.1 million in research and development expenses. The increase in selling, general and administrative expenses was primarily driven by increases in compensation and benefits from new hires, and legal fees, partially offset by lower stock compensation, recruiting, and consulting expenses. Net income increased $0.5 million to $0.3 million or $0.01 per diluted share for the second quarter of 2026, compared to a net loss of ($0.2) million, or ($0.01) per diluted share, for the prior year period. Adjusted EBITDA for the quarter was $0.9 million, or $0.02 per adjusted diluted share versus $0.3 million or $0.01 per adjusted diluted share in the prior year period. A reconciliation of adjusted EBITDA and adjusted diluted EPS to the most directly comparable GAAP measures is provided at the end of this press release. Cash and cash equivalents were $8.3 million as of June 30, 2026, reflecting cash usage of $0.5 million in the second quarter of 2026. Updated 2026 Guidance Narrowing full year 2026 net revenues to be between $47.5 - $48.5 million, representing growth of 15% - 18% Raising full year 2026 gross margin to be between 62 - 64% Reiterating positive adjusted EBITDA for the full year Updating year end cash balance to be greater than $7.5 million to account for the technology acquisition Conference Call and Webcast Details The Company will host a live conference call and webcast to discuss these results and provide a corporate update on Wednesday August 5, 2026, at 4:30 PM ET. To participate in the call, please dial (877) 407-0784 (domestic) or (201) 689-8560 (international). The live webcast will be available on the IR Calendar on the News/Events page of the Investors section of KORU Medical’s website. Non-GAAP Measures This press release includes the non-GAAP financial measures "adjusted diluted EPS" and "adjusted EBITDA" that are not in accordance with, nor an alternate to, generally accepted accounting principles and may be different from non-GAAP measures used by other companies. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Non-GAAP financial measures should not be considered a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. They are limited in value because they exclude charges that have a material effect on KORU Medical’s reported results and, therefore, should not be relied upon as the sole financial measures to evaluate the Company’s financial results. Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with GAAP financial results. Reconciliations of the Company’s non-GAAP measures are included at the end of this press release. About KORU Medical Systems KORU Medical Systems develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world. The Freedom Syringe Infusion System (the "Freedom System") currently includes the Freedom60® and FreedomEDGE® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HigH-Flo Subcutaneous Safety Needle Sets™. The Freedom System, which received its first FDA clearance in 1994, is used for self-administration in the home by the patient and/or delivery in an ambulatory infusion center by a healthcare professional. Through its Pharma Service and Clinical Trials business, KORU Medical provides products for use by biopharmaceutical companies in feasibility/clinical trials during the drug development process and, as needed, is capable of customizing the Freedom System for clinical and commercial use across multiple drug categories. For more information, please visit www.korumedical.com. Forward-looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. All statements that are not historical fact are forward-looking statements, including, but not limited to, financial guidance and expected operating performance for fiscal 2026. Forward-looking statements discuss the Company’s current expectations and projections relating to its financial position, results of operations, plans, objectives, future performance, and business. Forward-looking statements can be identified by words such as "potential", "guidance", and "expect". Actual results may differ materially from the results predicted and reported results should not be considered as an indication of future performance. The potential risks and uncertainties that could cause actual results to differ from the results predicted include, among others, ability to adapt new technology, uncertainties associated with inflation, tariffs, war and other geopolitical conflicts, customer ordering patterns, availability and costs of raw materials and labor and our ability to recover such costs, future operating results, growth of new patient starts and the Ig market, our compliance with Food and Drug Administration and foreign authority regulations and the outcome of regulatory audits, introduction and adoption of competitive products, acceptance of and demand for new and existing products, ability to penetrate new markets, success in enforcing and obtaining patents, reimbursement related risks, government regulation of the home health care industry, success of our research and development effort, expanding the market of the Freedom System, demand in the SCIg market, availability of sufficient capital if or when needed, dependence on key personnel, the impact of recent accounting pronouncements, and those risks and uncertainties included under the captions "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2025, which is on file with the SEC and available on our website at www.korumedical.com/investors and on the SEC website at www.sec.gov. All information provided in this release and in the attachments is as of August 5, 2026. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. We undertake no duty to update this information unless required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260805069380/en/ Contacts Investor Contact: Louisa [email protected]

Q1 revenue was $11.8 million, up 22% YoY, driven by domestic SCIg share gains and 35% international core growth; adjusted EBITDA was essentially break-even and net loss narrowed to $800,000 while cash usage was minimal ($0.1M, $8.8M cash on hand). Leadership transition: CEO Linda Tharby will step down and be succeeded by President/CCO Adam Kalbermatten on July 1, with management expressing strong confidence in a smooth handover and continuity of strategy. Company reiterated full-year 2026 guidance ($47.5–50M revenue, 61–63% gross margin, positive adjusted EBITDA and cash flow) while expanding beyond immunoglobulins with eight active non-IG opportunities, oncology engagement (PHESGO), and multiple 510(k) submissions for new indications and next‑gen pumps. Interested in KORU Medical Systems, Inc.? Here are five stocks we like better. KORU Medical Systems (NASDAQ:KRMD) reported a “record start to the year” in the first quarter of 2026, posting revenue of $11.8 million, up 22% from the prior-year period, as the company pointed to domestic share gains in subcutaneous immunoglobulin (SCIg), accelerating international growth tied to prefilled syringe conversions, and continued progress expanding its infusion platform to additional drugs. Chief Executive Officer Linda Tharby opened the call by noting it would be her final earnings call as CEO. As previously announced, President and Chief Commercial Officer Adam Kalbermatten is slated to succeed her on July 1. Tharby said the transition “is well underway and is progressing extremely well,” adding that she has “great confidence in Adam’s leadership.” → The Real SpaceX Play: 5 Chip Stocks Powering the IPO Before It Launches Tharby said the quarter’s results reflected “the strength and consistency of a recurring revenue model business built on the foundation of approximately 60,000 patients on the KORU platform.” She highlighted 12% year-over-year growth in the Domestic Core business and 35% growth in International Core. Chief Financial Officer Tom Adams attributed U.S. growth to “higher consumable volumes from new patient starts and market share gains within new and existing accounts against a healthy SCIg market backdrop.” International growth was driven by “higher pumps and consumable volumes in support of pre-filled syringe conversions in the EU market,” with Adams noting strong first-quarter distributor orders in a new 50 mL prefill market and an expectation that “end user pull-through of our consumables” would follow. → Tyson Foods' Total Returns: Tasty Treats for Income Investors? Adams also said PST revenues rose 166% from the prior-year period due to higher clinical trial product revenue from pharmaceutical collaborations. He cautioned that the PST business remains “variable based on milestone and clinical trial timing,” though he described underlying activity with pharmaceutical companies as high. Gross margin was 61.5% for the quarter versus 62.8% a year earlier. Adams said the decline primarily reflected higher production costs related to the timing of production runs late in 2025 that were amortized in Q1, as well as “tariff-related charges that did not occur in the prior period.” He added that favorable geographic sales mix partially offset those impacts, and that excluding an 87-basis-point tariff effect, gross margin would have been 62.4%. → Berkshire Hathaway’s Record Cash Hoard: Why and What's Next? Despite the quarter’s tariff headwinds, Adams reiterated confidence in full-year gross margin guidance of 61% to 63%. On profitability, Adams said net loss improved 33% to $800,000, while adjusted EBITDA was essentially break-even at negative $10,000, a 95% improvement year over year. Operating expenses increased 11% as the company continued to invest in sales and marketing and R&D “while maintaining spending discipline.” Cash usage was minimal. Tharby said the company used only $100,000 in cash in the quarter, ending with $8.8 million in cash. Adams characterized cash flow from operations as “essentially break even,” and said Q2 is expected to be the heaviest cash usage quarter due to annual bonus payouts made in April. He reiterated expectations for positive cash flow in the back half of the year and noted the company has access to an unused $10 million debt facility for additional flexibility. Kalbermatten framed company priorities around three pillars: protecting and growing the domestic core business, expanding internationally, and adding more drugs to the Freedom Infusion System platform. On the domestic side, Kalbermatten said the U.S. business continues to outperform the underlying SCIg market, supported by new patient diagnosis starts in legacy accounts and competitive conversions. In response to an analyst question, Adams cited third-party market data suggesting the U.S. SCIg market grew “right around 8%” in Q1, while KORU outpaced that rate. Kalbermatten also discussed the company’s rollout tied to recent clearance for RYSTIGGO on KORU’s label, noting clinical evaluations are underway with specialty pharma companies. He said incremental revenue contribution from RYSTIGGO this year is expected to be “modest,” but described the launch as an entry point into the ambulatory infusion clinic channel because RYSTIGGO is administered in both home and clinic settings. Kalbermatten highlighted secondary immunodeficiency (SID) as an emerging opportunity, noting that outside the U.S., SID is already a priority for major pharma players and that several pivotal trials are expected to reach endpoints in 2027. He said expanded reimbursement could broaden the U.S. SCIg opportunity and that SID growth has been tracking ahead of the broader SCIg market, currently driven primarily by immunologists. Internationally, Kalbermatten said the company’s growth has been led by SCIg and that KORU is establishing a footprint intended to support expansion into non-IG drugs over time. He said key EU markets are coming online in 2026 through manufacturer-driven vial-to-prefilled syringe conversions, but warned growth rates could be variable as the company deepens its capabilities across reimbursement, pharmaceutical, and home care partnerships. In Q&A, he said KORU is tracking conversion activity across five countries the company has previously identified as large-volume prefilled syringe markets. Management also detailed progress on expanding beyond immunoglobulin (IG). Tharby said two existing pharma collaborations advanced assets within phase III clinical trials, including one for an expanded indication and another that restarted trials for a new drug application. Kalbermatten said KORU now has eight active non-IG opportunities in development, which together represent “more than 6 million annual infusions worldwide.” Kalbermatten said Apellis advanced EMPAVELI into phase III trials for its fourth indication (delayed graft function), which he estimated represents an additional 25,000 annual infusions across a pediatric patient base. He said an undisclosed partner reinitiated phase III clinical trials on another asset that KORU believes represents 500,000 annual infusions annually. Tharby and Kalbermatten said KORU submitted a 510(k) application in Q1 for use of the Freedom Infusion System with deferoxamine, which Kalbermatten estimated at approximately 200,000 annual infusions. Kalbermatten said the company removed vancomycin from its active development pipeline after assessing market opportunity, current usage, and the “risk of an infusion to the central artery,” adding the incremental 2026 revenue previously expected from vancomycin had been modest. On oncology, Kalbermatten said the company is in “active communication with the FDA” regarding its PHESGO submission and is also in early discussions around an additional high-volume oncology asset. In Q&A, he described oncology as “almost a $40 million market opportunity” today that could grow over the next five years to “over $120 million,” and estimated PHESGO alone at approximately 1.1 million to 1.2 million units per year. He said the company hopes to provide an update on PHESGO “towards the end of this year, hopefully in the next quarter.” Kalbermatten also said KORU plans to submit a 510(k) and MDR applications in 2026 for the next generation Freedom60 pump and is targeting submission of a flow controller in late 2026 or early 2027. In response to a question, he said the next-generation device—referred to as the Freedom 360 pump—is nearing the end of development and is undergoing design verification testing, with regulatory submissions in the U.S. and Europe expected in the second half of 2026. Adams reiterated full-year 2026 guidance for revenue of $47.5 million to $50 million (15% to 22% growth), gross margin of 61% to 63%, and positive adjusted EBITDA and positive cash flow. Management said Q1 revenue benefited from strong clinical trial-related PST revenue and strong distributor orders in international prefill markets, and executives said they want to monitor end-user adoption following those distributor orders. Asked why guidance was unchanged despite the strong quarter, Kalbermatten said variability remains around the pace of vial-to-prefilled syringe conversions in Europe and market-by-market entry dynamics. Adams added that international phasing often includes initial pump orders for launches, followed by adoption and then stronger pull-through later, similar to prior-year patterns. Adams also said the company incorporated geopolitical risk related to the Middle East into its guidance. In Q&A, he said KORU is cautious due to regional risk and has not seen strength in orders so far this year from its primary distributor there, though he described it as “not a meaningful part of our business.” Tharby closed by thanking employees, partners, and shareholders, saying she was “extremely proud” of the company’s performance and expressed confidence in the strategy and leadership transition. KORU Medical Systems, Inc develops and manufactures medical devices and supplies in the United States and internationally. It offers the freedom infusion systems to deliver life-saving therapies to patients with chronic illnesses, such as primary immunodeficiency diseases, chronic inflammatory demyelinating polyneuropathy, and paroxysmal nocturnal hemoglobinuria. Its products include the FREEDOM60 syringe infusion system, the FreedomEdge syringe driver, HIgH-Flo subcutaneous safety needle sets, and precision flow rate tubing products. The article "KORU Medical Systems Q1 Earnings Call Highlights" was originally published by MarketBeat.

Domestic core growth of 12% was driven by new patient diagnosis starts and competitive conversions, outpacing the underlying 8% SCIg market growth. International core revenue surged 35% as the company capitalized on pharmaceutical manufacturer-driven conversions from vials to prefilled syringes in European markets. Management attributed the record start to the year to the stability of a recurring revenue model supported by approximately 60,000 patients on the KORU platform. The non-Ig pipeline reached a milestone with eight active drug opportunities representing over 6 million annual infusions, double the current SCIg business volume. Operational discipline resulted in a near-breakeven adjusted EBITDA and minimal cash usage of $100,000, signaling a path toward sustainable profitability. Strategic focus is shifting toward the ambulatory infusion clinic channel following the label clearance for RYSTIGGO, marking an expansion beyond home-based care. Full-year 2026 guidance is reiterated, including revenue growth of 15% to 22%, gross margins of 61% to 63%, positive adjusted EBITDA, and a transition to positive cash flow in the second half of the year. Revenue is expected to be back-half weighted as new prefilled syringe geographies ramp up and pending 510(k) clearances for oncology assets begin to contribute. Management plans to submit regulatory filings for the next-generation Freedom60 pump in late 2026, designed to accommodate all prefilled syringe sizes in a single device. The company is monitoring secondary immunodeficiency (SID) as a major growth catalyst, with pivotal trials expected to conclude in 2027 potentially expanding the addressable market. Guidance incorporates caution regarding geopolitical risks in the Middle East, which may impact distributor order patterns in that specific region. KORU removed vancomycin from its development pipeline to reallocate resources toward higher-volume commercial opportunities and mitigate clinical risks. Gross margins were 61.5% in the quarter, with the company monitoring potential supply chain impacts and using cost improvement initiatives to maintain their full-year range of 61% to 63%. CEO Linda Tharby will step down on July 1, 2026, with current President and CCO Adam Kalbermatten confirmed as her successor. Q2 2026 is projected to be the heaviest cash usage period of the year due to one-time annual performance bonus payouts. Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management cited variability in the timing of international 'vial to prefilled' conversions and the need to see patient pull-through follow initial distributor stocking. The company prefers to see how the second quarter plays out before adjusting the full-year outlook. KORU is in active discussions with the FDA regarding the Phesgo 510(k) and expects a status update by the next quarter. The oncology market is viewed as a $40 million opportunity today, potentially growing to $120 million over the next five years. Growth in Europe is currently driven by five key countries where pharmaceutical partners are introducing prefilled syringes. Unlike previous tender-driven markets, current expansion relies on 'blocking and tackling' to convert markets through reimbursement and home care partnerships. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here.

MAHWAH, N.J., May 06, 2026--(BUSINESS WIRE)--KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today reported financial results for the first quarter ended March 31, 2026. The Company also reiterated guidance for the full year 2026. Recent Highlights First quarter 2026 net revenues of $11.8 million grew 22% over the prior year period First quarter 2026 gross profit grew 20% over the prior year period to $7.2 million, with gross margin of 61.5% First quarter 2026 net loss improved 31% to ($0.8) million Ending cash balance of $8.8 million reflects cash usage of approximately $0.1 million in the first quarter of 2026 Submitted 510(k) application for use of the Freedom Infusion System with Deferoxamine Two existing non-Ig pharma collaborations advanced to Phase III clinical trials "We are proud to deliver a record start to 2026, with $11.8 million in revenue, representing 22% growth," said Linda Tharby, CEO of KORU Medical. "Our Core business continues to outperform the underlying SCIg market, driven by increased share gains in current and new accounts. Internationally, momentum remains robust as we expand into prefilled syringe markets with our patient-preferred Freedom Infusion System. With a growing recurring patient base and scalable commercial model, KORU is well positioned for further success." Adam Kalbermatten, President and Chief Commercial Officer, added, "Equally exciting to our strength in core markets is the momentum we are building in new drug categories with our support of late-stage molecules through their regulatory pathways, including compelling oncology opportunities ahead. A strong team, a clear strategic roadmap, and an expanding platform to access new therapies and new geographies, makes me confident in our long-term strategy and the strong foundation we have built to execute." Total net revenues increased $2.1 million, or 22.1%, to $11.8 million for the three months ending March 31, 2026, as compared to $9.6 million in the prior year period. Domestic core revenues were $7.7 million, an increase of 11.7% over the prior year period, primarily due to higher consumable volumes, driven by new patient starts and market share gains within new and existing accounts, supported by a strong underlying SCIg market. International core revenues were $3.3 million, an increase of 35.2% over the prior year period, primarily due to higher pump and consumable volumes, driven by distributor purchases supporting pre-filled syringe (PFS) conversions for a key EU market. Pharma services and clinical trials net revenues were $0.7 million, an increase of 166.0% over the prior year period, primarily due to higher clinical trial product revenues for advancing existing collaborations. Gross profit increased $1.2 million, or 19.6%, to $7.2 million in the three months ending March 31, 2026, as compared to $6.0 million in the prior year period. Gross margin decreased to 61.5% in the three months ending March 31, 2026, as compared to 62.8% in the prior year period. The decrease in gross margin was primarily driven by higher production costs based on timing of production runs in the prior quarter that were amortized in the three months ended March 31, 2026, and tariff-related charges that did not occur in the prior year period, partially offset by a favorable geographic sales mix. Total operating expenses increased $0.8 million, or 11.0%, to $8.1 million for the first quarter of 2026 primarily driven by an increase of $0.6 million in selling, general, and administrative expenses, and an increase of $0.2 million in research and development expenses. The increase in selling, general and administrative expenses was primarily driven by increases in legal fees and compensation expenses related to salary and stock compensation, partially offset by lower temporary labor expenses. Net loss decreased $0.4 million to $0.8 million or ($0.02) per diluted share for the first quarter of 2026, compared to a net loss of $1.2 million, or ($0.03) per diluted share, for the prior year period. Adjusted EBITDA for the quarter was ($0.01) million, or $0.00 per diluted share versus ($0.2) million or ($0.00) per diluted share in the prior year period. A reconciliation of adjusted EBITDA and adjusted diluted EPS to the most directly comparable GAAP measures is provided at the end of this press release. Cash and cash equivalents were $8.8 million as of March 31, 2026, reflecting cash usage of $0.1 million in the first quarter of 2026. Reiterating 2026 Guidance KORU Medical expects: Reiterating full year 2026 net revenues between $47.5 - $50.0 million, representing growth of 15% - 22% Reiterating full year 2026 gross margin between 61 - 63% Reiterating positive adjusted EBITDA and positive cash flow for the full year 2026 Conference Call and Webcast Details The Company will host a live conference call and webcast to discuss these results and provide a corporate update on Wednesday, May 6, 2026, at 4:30 PM ET. To participate in the call, please dial (877) 407-0784 (domestic) or (201) 689-8560 (international). The live webcast will be available on the IR Calendar on the News/Events page of the Investors section of KORU Medical’s website. Non-GAAP Measures This press release includes the non-GAAP financial measures "adjusted diluted EPS" and "adjusted EBITDA" that are not in accordance with, nor an alternate to, generally accepted accounting principles and may be different from non-GAAP measures used by other companies. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Non-GAAP financial measures should not be considered a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. They are limited in value because they exclude charges that have a material effect on KORU Medical’s reported results and, therefore, should not be relied upon as the sole financial measures to evaluate the Company’s financial results. Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with GAAP financial results. Reconciliations of the Company’s non-GAAP measures are included at the end of this press release. About KORU Medical Systems KORU Medical Systems develops, manufactures, and commercializes innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world. The Freedom Syringe Infusion System (the "Freedom System") currently includes the Freedom60® and FreedomEDGE® Syringe Infusion Drivers, Precision Flow Rate Tubing™ and HigH-Flo Subcutaneous Safety Needle Sets™. The Freedom System, which received its first FDA clearance in 1994, is used for self-administration in the home by the patient and/or delivery in an ambulatory infusion center by a healthcare professional. Through its Pharma Service and Clinical Trials business, KORU Medical provides products for use by biopharmaceutical companies in feasibility/clinical trials during the drug development process and, as needed, is capable of customizing the Freedom System for clinical and commercial use across multiple drug categories. For more information, please visit www.korumedical.com. Forward-looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. All statements that are not historical fact are forward-looking statements, including, but not limited to, financial guidance and expected operating performance for fiscal 2026. Forward-looking statements discuss the Company’s current expectations and projections relating to its financial position, results of operations, plans, objectives, future performance, and business. Forward-looking statements can be identified by words such as "guidance", "expect" and "will". Actual results may differ materially from the results predicted and reported results should not be considered as an indication of future performance. The potential risks and uncertainties that could cause actual results to differ from the results predicted include, among others, uncertainties associated with inflation, tariffs, war and other geopolitical conflicts, customer ordering patterns, availability and costs of raw materials and labor and our ability to recover such costs, future operating results, growth of new patient starts and the Ig market, our compliance with Food and Drug Administration and foreign authority regulations and the outcome of regulatory audits, introduction and adoption of competitive products, acceptance of and demand for new and existing products, ability to penetrate new markets, success in enforcing and obtaining patents, reimbursement related risks, government regulation of the home health care industry, success of our research and development effort, expanding the market of the Freedom System, demand in the SCIg market, availability of sufficient capital if or when needed, dependence on key personnel, the impact of recent accounting pronouncements, and those risks and uncertainties included under the captions "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2025, which is on file with the SEC and available on our website at www.korumedical.com/investors and on the SEC website at www.sec.gov. All information provided in this release and in the attachments is as of May 6, 2026. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. We undertake no duty to update this information unless required by law. Stock-based Compensation Expense. We have excluded the effect of stock-based compensation expense in calculating our non-GAAP measures. We record non-cash compensation expenses related to grants of options and restricted shares for executives, employees and consultants, and grants of shares to our board of directors. Depending upon the size, timing and the terms of the grants, the non-cash compensation expense may vary significantly but will recur in future periods. Litigation Expense. We have excluded the effect of start-up litigation expense in calculating our non-GAAP measures. In the first quarter 2025 we incurred legal fees with respect to a claim filed by the Company alleging patent infringement, which we would not have otherwise incurred in the period presented as part of continuing operations. View source version on businesswire.com: https://www.businesswire.com/news/home/20260506348238/en/ Contacts Investor Contact: Louisa Smith [email protected]