KORU Medical Systems Q2 2026 Earnings Report

KORU Medical Systems EPS Results

• Actual EPS: $0.01
• Consensus EPS: -$0.02
• Beat/Miss: Beat by +$0.03
• One Year Ago EPS: N/A

KORU Medical Systems Revenue Results

• Actual Revenue: $12.05 million
• Expected Revenue: $11.62 million
• Beat/Miss: Beat by +$427.42 thousand
• YoY Revenue Growth: N/A

KORU Medical Systems Announcement Details

• Quarter: Q2 2026
• Date: 8/5/2026
• Time: After Market Closes
• Conference Call Date: Wednesday, August 5, 2026
• Conference Call Time: 4:30PM ET

KORU Medical Systems (NASDAQ:KRMD) 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 company was incorporated in 1980 and is based in Mahwah, New Jersey.

KORU Medical Systems Q2 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: Q2 revenue reached a record $12 million, up 18% year over year, driven by 12% growth in domestic core revenue and 59% international growth. Management said domestic demand, patient retention, new starts, and market-share gains remain strong.
• Positive Sentiment: Gross margin improved to 65.1% from 63.5% a year ago, supported by manufacturing efficiencies, pricing, mix, and improved supplier terms. KORU also reported positive net income for the first time since 2019, positive operating cash flow in the quarter, and reiterated expectations for positive adjusted EBITDA for the full year.
• Negative Sentiment: The company narrowed 2026 revenue guidance to $47.5 million-$48.5 million from its prior outlook, citing slower-than-expected launches in certain international, non-tender markets. Management now expects some of that prefilled-syringe opportunity to contribute more meaningfully in 2027.
• Negative Sentiment: KORU withdrew its U.S. PHESGO 510(k) application after discussions with the FDA and will pursue other oncology biologics instead, delaying its planned U.S. oncology entry. PHESGO remains part of the international strategy, but additional real-world evidence and regulatory work are required.
• Neutral Sentiment: The company acquired connected-monitoring technology intended to add adherence tracking, real-world evidence, and patient support to its infusion platform, though management characterized it as a multi-year development effort. KORU also said Freedom 360 development has cleared its highest-risk stages and remains on track for a U.S. 510(k) submission by the end of 2027.

Presentation

[Operator]

Greetings, welcome to KORU Medical Systems' second quarter 2026 earnings conference call. At this time, all participants are on a listen-only mode. A question-and-answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. 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, Principal at Gilmartin Group]

Thank you, operator, 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 June 30th, 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.

[Louisa Smith, Principal at Gilmartin Group]

Actual events or results could differ materially due to risks and uncertainties, including those mentioned in the associated press release and our most recent filings with the SEC. We assume no obligation to update any forward-looking statements. During the call, management will also discuss certain non-GAAP financial measures. You will find additional disclosures, including reconciliations of these non-GAAP measures with comparable GAAP measures in our press release, the accompanying investor presentation, and SEC filings. For the benefit of those listening to the replay, this call was held and recorded on Wednesday, August 5th, 2026, at approximately 4:30 P.M. Eastern Time. Since then, the company may have made additional comments related to the topics discussed. I'd now like to turn the call over to Adam. Please go ahead.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

Thank you, Louisa, good afternoon, everyone. I'll 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, 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 60,000 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.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

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 systems, 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 specialty pharmacy partners.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

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'm pleased with our performance in Q2, delivering $12 million in revenue, representing growth of 18% for the quarter and 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 U.S. 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.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

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 three-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 RYSTIGGO, we continue to see adoption with new patient starts and are receiving strong feedback from both clinicians and patients.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

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 pre-filled 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.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

As we continue to build out our presence in newer pre-filled 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 U.S., where we win every new patient start as our distributors methodically convert from vial to PFS one by one, it may take a little bit more time. In our Q1 call, we noted that our growth rates in these newer regions can be variable as we deepen our local market knowledge and 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.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

While this pacing may impact the international core growth rate in the short term, we 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 pre-filled 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 PST business, we continue to systematically advance our established programs while initiating early-stage discussions with new potential pharmaceutical partners. Because many of these collaborations are designed to navigate the multi-year pharmaceutical development pathway, they serve as the engine for fueling our long-term growth pipeline.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

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 remain focused on a long-term partnership and 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, which 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.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

Additionally, we believe this will be a key differentiator of the best-in-class KORU mechanical platform in our PST 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 multi-year build for us, but we are very excited to have the technology and 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.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

Turning to an important emerging catalyst for our core SCIg business, I want to highlight the continued industry advancements we are seeing within secondary immunodeficiencies, or SID. Today, SID market growth is expanding beyond the broader SCIg 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 12-18 months. As these trials conclude and SCIg manufacturers 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.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

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 two recent 510 submissions, PHESGO and deferoxamine. First, regarding our broader oncology strategy and our submission for use of the Freedom system with PHESGO. We've made a strategic decision to pivot our focus towards alternative molecules for our initial entry into the U.S. and withdraw our application from the FDA for PHESGO in the U.S. 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 U.S. Our conviction in the oncology market remains unchanged.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

It's a core strategic priority where we see a large opportunity for KORU. Simultaneously, we continue to advance our international oncology initiatives, including with PHESGO, which we view as a highly compelling long-term growth driver, bolstered by the strong insights and positive nursing studies we've already generated in Europe, such as our work in Denmark last year. While we refine our U.S. oncology pathway, our regulatory momentum in other non-IG therapies remains strong. As a reminder, KORU officially submitted a 510 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're committed to getting deferoxamine on label and believe it will unlock an estimated 200,000 annual U.S. infusions and further solidify our platform's expansion into non-IG therapies.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

Regarding our new product pipeline, we remain on track with our target for a 510 submission by the end of next year for our next generation pump, which we're calling Freedom 360. In the second quarter, we completed the final stages of the development process for Freedom 360, 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 U.S. 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 three growth pillars. 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 one.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

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 Freedom 360 launch, advancing our international and oncology roadmaps, 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'll turn it over to Tom to walk through financials.

[Tom Adams, CFO at KORU Medical Systems]

Thanks, Adam. During the second quarter, we delivered record quarterly revenues of $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 was $3.5 million for the quarter, up 59% 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. PST revenue was $600,000 for the quarter, down 35% year-over-year, driven primarily by lower orders for clinical trials use due to customer order timing. Once again, I'll remind our audience that the PST business will continue to have inherent variability from quarter to quarter based on customer timelines.

[Tom Adams, CFO at KORU Medical Systems]

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 multi-year 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 $500,000 in the quarter. We were expecting Q2 to be our heaviest usage quarter. 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.

[Tom Adams, CFO at KORU Medical Systems]

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 for incremental opportunities as we execute against our growth plans. I'd 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 revenue by 20%, gross margin tended higher, and we improved by 20 basis points to 63.3%.

[Tom Adams, CFO at KORU Medical Systems]

We continued to deliver improved operating leverage against our revenue growth, with operating expenses increasing only 9%. We improved net losses by 60% and delivered positive adjusted EBITDA of $900,000. 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 non-tender offer markets in order to ensure we have the proper market foundations in place.

[Tom Adams, CFO at KORU Medical Systems]

This deliberate setup in select geographies positions us for a more effective launch, but 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-$48.5 million. We view this as primarily timing related as the broader pre-fill 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 2026. We remain encouraged by the overall market opportunity. It's just that unlocking it is taking a little longer than our guidance assumptions accounted for.

[Tom Adams, CFO at KORU Medical Systems]

I will note that while our initial guidance assumes some modest incremental revenue from pending 510(k) clearances, the update on PHESGO 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 de-risked, 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%-63% to 62%-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 seven and a half million. We also want to reiterate that we still expect to have positive adjusted EBITDA for the full year.

[Tom Adams, CFO at KORU Medical Systems]

I'll now turn the call back over to Adam for additional comments on our forward momentum. Adam?

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

Thank you, Tom. Before we open the call to questions, I want to reiterate why I'm so energized by the road ahead for KORU. Over the past few years, we have systematically transformed KORU from 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's shift to pre-filled 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 60,000 patients who rely on our system every single day.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

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 that 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.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

I'd now like to open the call for questions.

[Operator]

Thank you. At this time, we'll be conducting a question-and-answer session. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One 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, Analyst at Lake Street Capital]

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 non-tender markets to capture some of the growth you were counting on in 2026? With any of these initiatives, could they potentially be pulled forward still into 2026 and you're exercising some conservatism, or is this mostly all really going to hit 2027?

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

Hi, Frank. It's Adam. Thanks for the question. Appreciate the congrats on the solid quarter. On international, we're still really excited about the opportunity overall. We see this as a major growth driver for KORU moving forward. I think as we look at the back half of the year, it's 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 kind of warming up here. Over the next, call it 12-18 months, we still see a pretty big opportunity here. It's really about a delay in the timing, but really excited about the overall opportunity. I think you were asking if there's some potential upside here.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

We're going as quick as we can. It's really about getting all of these different dynamics in place in all the different countries there. Tom, anything else you want to add to that?

[Tom Adams, CFO at KORU Medical Systems]

No, I think you covered that, Adam.

[Frank Takkinen, Analyst at Lake Street Capital]

Okay. Then maybe a follow-up on the connected monitoring technology acquisition. I'm going to just go a little bit deeper into the use case for this. Where in the development stage this might be, if there's still things that need to happen before it's deployed into the field and any other relevant color you would be welcoming to provide.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

Yeah, we're 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's 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. This was something that as we were looking at those different options, we came across this technology asset and are very hopeful for what that could bring down the line. Want to stress that it's a multi-year build here, it's going to take some time, it's something that we look at the ability to communicate with patients, collect additional data from the infusion. We're still in the early stages of looking at that.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

We just wanted to signal that we did make that acquisition this quarter.

[Frank Takkinen, Analyst at Lake Street Capital]

Okay, fair enough. I'll 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, Analyst at Craig-Hallum Capital Group]

Good afternoon. Thanks for taking the questions. If I just would start on a little bit more detail around the PHESGO dynamics. Can you just give a little bit more detail as far as what the FDA feedback was? Then you mentioned focusing on other molecules that would potentially be more attractive to get on label. Can you just define what the characteristics of attractive molecule for you in oncology would be? Thanks.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

Hi, Chase. Good to hear from you. Want to start by saying we're still 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 four or five years to upwards of $140 million. As it impacts PHESGO here in the recent news in our pivot, we applied to bring PHESGO on label at the end of the year last year. We've 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 higher attractive opportunity for us. That's what resulted in us making that decision here to pivot.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

In terms of PHESGO, internationally, we still see that as an opportunity that we continue to go forward. It's really about focusing on those molecules where we see a more attractive volume and return on our investment for what we're trying to do here. Still really excited about oncology and still excited about PHESGO internationally. In our U.S. entry, just looking to make a pivot here.

[Chase Knickerbocker, Analyst at Craig-Hallum Capital Group]

Got it. I guess just maybe to follow up on that, any sort of changes in timelines as far as U.S. oncology market entry or changes in go to market there? Just second, as a follow-up, could you just maybe give us an update as it relates to your outlook, if anything's changed as far as how you're thinking about the domestic core business? Maybe just an update on, you still thinking about 8%-10% core SCIg market growth in the U.S. and then call it several hundred basis points of outperformance for your business? Thanks.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

Absolutely. That was a good one, Chase. Let me start with the first part of the question, then I'll pass the other one to Tom on the domestic side. I think as we're looking at oncology going forward here, we had been planning our entry for later this year as we had approval with PHESGO. We're expecting second half. I think it's fair to say that's going to shift a bit now. We're still working through exactly what that timing's going to look like and announce that, but I can say we are actively in that process. While we're going to be a little bit delayed, I hope we're going to be able to continue that going at a pretty rapid pace here. That said, on the domestic SCIg market, we see some healthy growth continuing there. We're continuing to grow above market.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

In terms of the details, Tom, if you want to jump in with anything.

[Tom Adams, CFO at KORU Medical Systems]

Thanks, and hi, Chase. On the U.S. side, our U.S. business is still very strong. We continue to outperform the SCIg market. When we think about our guide, our guide basically continues to have U.S. as a strong market. PST, our Clinical Trial business, continues to do well. As we mentioned, this guide is fairly isolated to our international business.

[Chase Knickerbocker, Analyst at Craig-Hallum Capital Group]

Understood. Thanks.

[Operator]

Our next question comes from Caitlin Roberts with Canaccord Genuity. Your line is now live.

[Caitlin Roberts, Analyst at Canaccord Genuity]

Great. Thanks for taking the questions. 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 the one by one work like in the U.S. and just given those dynamics and maybe pursuing those more gradual markets, will this maybe smooth out the revenue expectations for OUS here?

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

Hi, Caitlin. Great question. When we think about the overall market internationally, specifically Europe, it's primarily a market today that's dominated by electronic pumps. That's the standard of care there. We're going in, and we are following where prefilled syringes are entering the market, and we're 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. We like to introduce the KORU 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, three, four quarters, is we were converting one of those markets that was a pharmaceutical tender market that we fast-followed really quickly with that pharmaceutical company.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

As we continue to look at these other countries, they're more what we would refer to as competitive markets, where they're not tender-driven markets. That means we need to look at how we're 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. The good news is we do have a lot of those relationships. Now we're in the process of going through new patient starts. The process is that the whole market doesn't convert all at one time.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

It converts through those new patient starts, very similar to how the U.S. domestic market works in that you 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 want to add on that?

[Tom Adams, CFO at KORU Medical Systems]

No, I think we're good, Adam. Thanks.

[Caitlin Roberts, Analyst at Canaccord Genuity]

Great. Then maybe just a question on secondary immunodeficiency. What's the go-to market strategy here, and does that differ from just the core SCIg market in the U.S.?

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

Absolutely, yeah. As we think about secondary immunodeficiency, we look at it as work that many of the major pharmaceutical companies are already engaged in. There's a number of clinical trials ongoing. Those clinical trial endpoints are coming up towards the end of 2027. A lot of those clinical trials are being done with existing SCIg drugs that KORU already has on label. As we think about it, we're 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.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

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. 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, Analyst at Canaccord Genuity]

Great. Thank you.

[Operator]

Our next question comes from Joseph Downing with Piper Sandler. Your line is now live.

[Joseph Downing, Analyst at Piper Sandler]

Hey, Adam and Tom. Thanks for taking the question. Congrats on the quarter. Just still another question on the PHESGO withdrawal here. Obviously, it sounds like you're keeping PHESGO alive internationally. Looking at the deck, now it looks like it sizes the opportunity around 600,000 annual infusions versus the 1.1 million or 1.2 million call-out previously. I'm just curious, is that delta simply the U.S. coming out? Can you frame how the international and the economics compare here from whether it's pricing, channel, geographies, anything you want to divulge there? Thanks.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

Hey, Joe. Thanks for the question. You caught the correct drawdown that we had when we pulled out the U.S. 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 U.S. International is one that we are also planning to move forward to. There's some additional work we have to do in terms of real-world evidence in order to bring drugs on label in Europe through the MDR process. That is going to continue to take some time. In terms of the economics, 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.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

Obviously, reimbursement's a little bit different than what we had studied in the U.S., we're still seeing very positive contributions that we can make there, and we continue to see a lot of very strong interest there.

[Tom Adams, CFO at KORU Medical Systems]

I will add on to this one, Adam. When we think about PHESGO, the volume of infusions internationally is much more prevalent than what we see in the U.S. It's a higher volume in terms of annual infusions all across international markets and European markets, I should say, specifically, versus the United States.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

Good point, Tom.

[Joseph Downing, Analyst at Piper Sandler]

Adam, I just have a bigger picture question for you now that you've been in the seat for a little bit. Given the long-range framework that you inherited, I'm just curious how you're thinking about what it takes to get this business to be a sustainable 20% grower here, and how you plan on maybe holding it there for multiple years rather than just a one-off year. And I'm curious specifically if this can be a sustainable 20% grower if the U.S. is in that low double digit, mid-teens range. Thanks.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

Yeah, absolutely. Great question. On our long-term strategy, there's really the three growth pillars. It's continuing to grow domestically, defending our share. It's second, growing internationally. And then third, it's really about working with pharma companies and bringing more drugs on label. 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've got a pretty good track record there. To get our growth rates up higher, it's really about bringing new drugs on label and continuing to expand internationally.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

When we talk about PHESGO, when we talk about oncology and the broader opportunities, it's 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.

[Joseph Downing, Analyst at Piper Sandler]

Great. That's thorough. Thanks, Adam. Thanks, Tom.

[Operator]

We have reached the end of the question and answer session. I'd now like to turn the call back over to management for any closing comments.

[Adam Kalbermatten, President and CEO at KORU Medical Systems]

Thank you all for joining us this afternoon. Really enjoyed the call here and looking forward to updating you further on 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.

Participants

Executives

• Adam Kalbermatten, President and CEO
• Tom Adams, CFO

Analysts

• Louisa Smith, Principal at Gilmartin Group
• Frank Takkinen, Analyst at Lake Street Capital
• Chase Knickerbocker, Analyst at Craig-Hallum Capital Group
• Caitlin Roberts, Analyst at Canaccord Genuity
• Joseph Downing, Analyst at Piper Sandler