KORU Medical Systems Q2 2025 Earnings Call Transcript

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Provided by Quartr
August 6, 2025

Key Takeaways

  • Positive Sentiment: Coru delivered record Q2 revenue of $10.2 million, up 21% year-over-year, driven by outperformance across its domestic IG business, international expansion, and pharma services.
  • Positive Sentiment: International revenue surged 34% in Q2 as prefilled syringe conversions in Europe gained traction and Japan registrations wrapped up, supporting a $1 million raise to 2025 guidance.
  • Positive Sentiment: Coru expects to achieve positive cash flow from operations in 2025, with Q2 cash usage of $0.6 million and year-end cash projected at no less than $8.1 million following disciplined spending.
  • Positive Sentiment: The company’s pipeline now includes 10 new drugs targeted for 2026 commercialization, alongside next-generation pump and flow controller submissions to broaden its large-volume SC delivery platform.
  • Negative Sentiment: Gross margins contracted by 150 bps year-over-year to 63.5%, with ongoing tariff impacts and lower average selling prices in international markets forecast to keep full-year margins in the 61–63% range.
AI Generated. May Contain Errors.
Earnings Conference Call
KORU Medical Systems Q2 2025
00:00 / 00:00

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Operator

Hello and welcome to the Kuru Medical Systems Second Quarter twenty twenty five Financial Results Conference Call and Webcast. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to Louisa Smith of the Gilmartin Group. Please go ahead.

Louisa Smith
Principal at Gilmartin Group

Thank you, Judith, and good afternoon, everyone. Joining me on the call today are Linda Sarby, President and CEO of Coru Medical Systems, and Tom Adams, Chief Financial Officer. Earlier today, Coru released financial results for the second quarter ended 06/30/2025. A copy of the press release is available on the company's website. I encourage listeners to have our press release in front of you, which includes our financial results as well as commentary on the quarter.

Louisa Smith
Principal at Gilmartin Group

Additionally, we will use slides to support further commentary in today's call, which are also available on the Investor Relations section of our website. During this call, we will make certain forward looking statements regarding our business plans and other matters. These comments are based on our predictions and expectations as of today. Actual events or results could differ materially due to risks and uncertainties, including those mentioned in the associated press release and our most recent filings with the SEC. We assume no obligation to update any forward looking statements.

Louisa Smith
Principal at Gilmartin Group

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, 08/06/2025, at approximately 04:30PM Eastern Time. Since then, the company may have made additional comments related to the topics discussed. I'd now like to turn the call over to Linda Tharby, President and CEO. Linda, please go ahead.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Thank you, Louisa. Good afternoon, everyone, and thank you for joining today's earnings call. I'll begin with some commentary on our strategic vision and the opportunity ahead in the large volume subcutaneous drug delivery market, followed by highlights from the second quarter. Tom will then review our financial results before we open the call for your questions. Let me start with the big picture.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Coru is a leader in the large volume subcutaneous drug delivery market, with the Freedom system being cleared for use with the first drug in 2017. We are well positioned to capitalize on the accelerating shift from hospital IV based treatments to more convenient subcutaneous therapies delivered at home and in infusion clinics. Today, our Freedom system serves approximately 45,000 patients, primarily on IG therapy for chronic conditions, providing a strong, stable base of recurring revenue. We are also focused on expanding beyond SEIG, where we currently have 10 active opportunities and many more we are pursuing to bring new drugs onto our Freedom Infusion platform. Over the past decade, healthcare has begun to shift from the hospital to infusion clinics to the home, and Quora is uniquely positioned to capitalize.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

We are cleared for use with all SCIG drugs on the market. Between subcutaneous and IV formulations, we estimate that the opportunity for drug delivery devices for IG therapy is approximately $450,000,000 with only 20% penetrated by subcutaneous formulations. Beyond IG, there are currently more than 50 drugs in development that are formulated at volumes of greater than 10 mL, requiring a specialized drug delivery solution, a significant opportunity that aligns with Coru's core competencies in large volume drug delivery. Our strategy is based on three growth pillars. Depending on growing our core domestic business, where we are the market leader and have the opportunity to increase penetration expanding internationally, where subQ penetration is higher and we have share growth opportunity and enabling the delivery of additional drug therapies to reach more patients.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Now turning to our results for the second quarter. We reached a historic milestone in Q2 with over $10,000,000 in revenue. Revenue grew over 20% with continued momentum across all three strategic growth pillars. Our domestic core business continues to outperform a growing SCIG market, and we are seeing significant acceleration in international expansion with over 30% growth. Our pharma services and clinical trials segment also saw strong growth, by clinical supply agreements.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

We continue to expand our patient base through market share gains with recurring revenues from chronic SCIG patients. Further, the FDA recently approved an expanded indication for Empivalli, a non SCIG drug already on our label for C3G and primary IC MPGN, creating further opportunity. We also submitted a five ten ahead of schedule for rare disease biologic, another milestone in our strategy to bring more non IG drugs onto the Freedom platform. Following our success in The EU, we have also initiated a US based oncology pilot program with over 50 patients enrolled at six infusion centers across four different subcutaneous oncology drugs. Insights from this pilot will help with data generation to inform our strategic decisions around pursuit of the oncology opportunity, which we look forward to updating you on in the coming quarters.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

We also advanced our goals towards profitability this quarter, with Q2 cash usage of $600,000 This was driven by the trifecta of strong revenue growth, sustained gross margin performance, and disciplined capital allocation that is delivering meaningful operating leverage. And finally, I'm excited to announce that Adam Kalbermattin has joined Coru as Chief Commercial Officer, bringing twenty years of success in leading drug delivery partnerships across pharma and biotech in both large and small cap companies. Adam will be instrumental in further acceleration of our global commercial and PSD strategies. Two weeks in, he has hit the ground running. Let's take a closer look at performance across our three strategic pillars, starting with our core business results.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Our domestic core business continued to outperform strong SCIG market growth, fueled by market share gains in key accounts. The addition of the new label expansion for Empivalli will provide an opportunity to further grow our patient base. Internationally, we continue to deliver significant growth fueled by expansion into new geographies and our first prefilled syringe market conversion in Europe, an early step in what we believe is a much larger long term strategy. We expect even further contribution from our prefilled efforts in the back half. You'll notice we've updated our pipeline slide distinguishing between core IG opportunities and new drugs added to our label.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

I'll cover the latter on the next slide. We believe this view more clearly illustrates how device innovation, label expansion, and strategic collaborations are driving share gains and targeted geographic expansion for our core IG business. Within our IG partnerships, we made two key advances this quarter. First, we completed all pump and consumable registrations in Japan, paving the way for sales alongside two leading IG therapies. We expect to realize sales in the back half of this year.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

The final step, clearance of our flow controller with the third IG drug, is expected in 2026. In addition, one of our IG drug collaborations progressed to a combined Phase three trial. More broadly, we continue to make strong progress across our IG device and drug partnerships with a major milestone on the horizon, multiple anticipated clearance for our next generation pump in 2026, which will unlock new market share and geographic expansion opportunities. Moving to our third growth pillar, we continue to see good progress in our opportunity to enable the delivery of more drugs and ultimately bring more patients to our platform. Our pipeline includes five new drugs that we expect to be commercialized on our Freedom Infusion platform by the 2026 and ten total pipeline drugs, a mix of independent five ten submissions and formal pharmaceutical collaborations.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Notably, we named two drugs we are pursuing independently: deferoxamine for ion chalation and vancomycin, an antibiotic, with both now expected to receive clearance by 2026. In total, these two drugs represent approximately 1,000,000 total infusions, of which we expect to realize about $500,000 in incremental revenue next year. Through our relationships with specialty pharmacies, we're in the process of identifying and potentially pursuing additional drugs that fit into this category to drive additional annual infusions into our core business. As noted in my opening remarks, the FDA recently approved an expanded indication for Empivale, representing approximately 100,000 annual infusions. We estimate Cora's opportunity to be around 20,000 of those infusions.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

We've also submitted ahead of schedule a five ten for a rare disease biologic representing 40,000 annual infusions. We hope to receive clearance on this by the end of this year. Our revised total addressable market for new drugs now stands at approximately 1,800,000,000, based on estimated patient populations and dosing schedules and ASPs from our prior 2,200,000,000. As our new drug pipeline continues to evolve, we will assess each therapy's infusion volume to determine Koru's serviceable opportunity. We are encouraged by our robust and growing pipeline with some near term commercial opportunities.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Moving to product development. Our initiatives are progressing well and will be drivers of near term growth. I'm pleased to report that we launched our Phase I flow controller in Q2 ahead of schedule. Phase II flow controller submission is expected by the 2026 and will provide enhanced performance and expanded label indications that will expand our access to new patients in new markets. Our next gen pump development is on track with a five ten submission expected by 2025 to 2026.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

This pump will accommodate all available prefilled syringes, will be vial and syringe compatible, and offer patients improved mobility and usability. We now expect to file a five ten for our new consumable sets in the 2026, allowing us the time and opportunity to incorporate further market feedback. We do not expect this to have any negative impact on revenue figures in 2025 or 2026. We are prioritizing the pump development, a decision that has the potential to accelerate our international growth. Overall, I'm very pleased with the momentum we built in the first half of the year and remain confident in our ability to carry this trajectory through the remainder of 2025.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

We've established a strong foundation to execute across all of our growth pillars and our teams continue to deliver steady, focused progress every day. With that, I'll turn the call over to Tom to walk through our financial results and share our updated 2025 guidance.

Tom Adams
Tom Adams
CFO at KORU Medical Systems

Thank you, Linda. Starting with revenue, we were pleased to deliver record revenues of $10,200,000 in the second quarter representing 21% growth over the prior year period. Our domestic core revenues were $7,100,000 a 15% increase over the prior year. This performance continues to demonstrate our ability to outpace the overall FCIG market growth driven by new patient starts and market share gains leading to continued strength in consumable volumes. In our international core business we delivered revenues of 2,200,000.0 representing growth of 34% over the prior year.

Tom Adams
Tom Adams
CFO at KORU Medical Systems

This growth was driven by expansion into new geographies and the continued success of our prefilled syringe strategy in Europe. Our pharma services and clinical trials revenues were $900,000 representing 42% growth over the prior year, driven by strength in clinical trial orders from a non IG partner, demonstrating the diversification of our PSP business beyond SCIG. Moving over to our gross margin performance, starting with the chart on the left side, our second quarter margins were 63.5% representing a 150 basis point decline year over year. This decline was primarily driven by two specific factors, tariff impacts this year of 90 basis points and a prior year favorable inventory revaluation adjustments of 90 basis points. These headwinds were partially offset by volume efficiencies and improved PST margins.

Tom Adams
Tom Adams
CFO at KORU Medical Systems

For the second half of the year we expect gross margins in the 61% to 63% range impacted by increased revenue in lower average selling price markets and ongoing tariff impacts. We are reiterating our guidance range of 61% to 63% for the full year 2025. Turning to cash, we finished the quarter with an $8,100,000 cash balance representing cash usage of $600,000 during the second quarter driven by lower net losses resulting from higher revenues, sustained gross margins, and disciplined operating expense spending. From the net loss, we removed non cash related items of $600,000 driven primarily by stock compensation expenses and depreciation. Our working capital was higher in the quarter driven by inventory replenishment and timing of accounts receivable collections.

Tom Adams
Tom Adams
CFO at KORU Medical Systems

We also had an investment in the quarter for manufacturing equipment related to our new products. Looking at our cash usage strategy trajectory over the past three years, we've made significant progress in reducing our cash consumption. We improved from $5,900,000 in cash usage in 2023 to 1,900,000.0 in 2024. With the majority of our significant infrastructure investments behind us we continue to trend favorably. Cash usage for the first half was 1,500,000.0 and for the 2025 we expect our usage to be neutral to positive, putting us on track to achieve our goal of positive cash flow from operations for the full year 2025 and ending the year with at least $8,100,000 in cash.

Tom Adams
Tom Adams
CFO at KORU Medical Systems

Our first half financial highlights demonstrate strength across our P and L. Revenue grew 19% to $19,800,000 compared to $16,600,000 in the 2024 with a corresponding operating expense increase of 3%. This demonstrates our ability to run a disciplined capital allocation process and edge closer towards profitability. Gross margin remained strong at 63.1%, down 50 basis points year over year. Our adjusted EBITDA improved 101% to be slightly positive compared to a negative 1,300,000 in the '24 And adjusted earnings per share of 0¢ per share versus a loss of 2¢ per share in the same period last year.

Tom Adams
Tom Adams
CFO at KORU Medical Systems

Looking ahead we are raising our revenue guidance to 39,500,000.0 to 40,500,000.0 representing 18% to 20% growth, an increase from our prior range of 38,500,000.0 to $39,500,000 driven by significant opportunities for further growth from prefilled conversions internationally, partially offset by an expected inventory reduction from a large distributor in The US in Q3. We are reiterating our gross margins in the range of 61% to 63%. We anticipate gross margin pressures from the first half to second half, driven by a stronger mix of growth in international markets with lower average selling prices. In addition to supply chain inflationary and tire pressures, we expect pricing and manufacturing efficiencies to mitigate some of these unfavorable impacts. For cash flow generation, we are reiterating our expectation of positive cash flow from operations for the full year 2025.

Tom Adams
Tom Adams
CFO at KORU Medical Systems

We anticipate operating expenses exclusive of stock compensation in the range of $26,000,000 to $27,000,000 with higher operating expenses spend occurring in the 2025, driven largely by R and D project work. Additionally, we still expect less than $2,000,000 of investing activities and capital expenditures for new production lines. I'll now turn the call back over to Linda for some closing commentary on future milestones and our vision for continued growth.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Thank you, Tom. We're very pleased with our second quarter performance and the momentum across all of our strategic growth pillars. Our strong results, expanding pipeline, and profitability trajectory demonstrate the strength of our business model and the significant opportunities ahead. Key milestones ahead include advancing our Phase II flow controller submissions, continuing our international expansion with focus on the pre fill opportunity, and pipeline progression with expected filing of three new drugs by 2026. As for the longer term vision for the company, our goal is to sustain plus 20% growth through investments in core international and new product and new drug pipeline initiatives.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

2025 has been a pivotal year in setting that foundation. To close a few key takeaways that we believe make KORU a compelling growth story. We delivered another strong quarter, with revenue growing over 20%, fueled by recurring core revenue and continued patient growth in our core IG business, further strengthened by international expansion. We are starting to see the tailwinds of macro trends favoring subcutaneous delivery. Our pipeline of 10 new drugs with more on the horizon meaningfully expands our long term opportunity.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Our raised guidance reflects the confidence we have in our strategy and execution. And finally, a sincere thank you to the entire Cora team for showing up with purpose and passion every day to help patients around the world. Operator, please open the line for questions.

Operator

Thank you. We will now be conducting the question and answer session. You may key in star and then two to leave the question queue. For participants making use of speaker equipment, it may be necessary to pick up your handset before selecting the star key. Our first question comes from Frank Tekkenun of Lake Street Capital Markets. Please go ahead.

Frank Takkinen
Senior Research Analyst - Medical Device at Lake Street Capital Markets

Great. Thanks for taking the questions. Congrats on a solid quarter and guide up. I was hoping to start with the guide. Looks like you flowed through the beat.

Frank Takkinen
Senior Research Analyst - Medical Device at Lake Street Capital Markets

Looks like you've got good momentum in the core business. OUS is clearly trending favorably as well. I'm just curious if you could kind of parse out expectations domestic versus OUS and then maybe cadence in Q3 versus Q4 expectations.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Yes. Hi, Frank. Thank you. We're very pleased with the quarter and obviously in the momentum we expect with the million dollar raise in the overall guidance range. What I would say on the guidance range is obviously the international is driving tremendous growth for us and we expect that to continue at an even accelerated pace in the back half, offset by what Tom talked about on The US side.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

I'll turn it over to Tom for further comments on Q3 versus Q4.

Tom Adams
Tom Adams
CFO at KORU Medical Systems

Yeah, hi Frank. Yeah, so Frank, the way we're looking at our business is with the million dollar raise, as Linda mentioned correctly, most of that raise we will see in international markets. We're seeing some really nice revenue growth with the prefilled opportunity that we both recognized in our prepared remarks. And so you can expect really steady and strong growth outpacing what you'd seen in the first two quarters. And then as Linda mentioned domestically, we did receive some word from a large US distributor that they're going through an inventory reduction program here in Q3.

Tom Adams
Tom Adams
CFO at KORU Medical Systems

So we see a little bit drop off in Q3 from that but then we should see it bounce back up in Q4. And on the PST side, we continue to see stable growth on our PST which is our clinical trials services business. So you can expect more of what you saw the first half of the year in the back half.

Frank Takkinen
Senior Research Analyst - Medical Device at Lake Street Capital Markets

Got it, that's helpful. And then maybe just to follow-up on kind of something you guys both referenced pre filters in Europe. I know that's just getting started and that's a large growth opportunity. So any incremental color you can provide on what's driving that success and then kind of how we should think about the durability of that growth and how large of an opportunity that can be for you guys?

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Yeah, so on prefilled, quite excited to see that really taking shape this quarter. But just to describe the broad opportunity, pharma is converting their drugs, specifically our IG partners, from presentation in a vial to a pre filled syringe. Our Freedom system works perfectly with a pre filled syringe in that the patient puts that syringe in the pump, closes the device, and you're ready to perform your infusion. So it cuts out a number of the steps, more than a 40% reduction and plus 75% patient preference for pre fills. So what's driving the international opportunity is our share position has historically been in the 10% to 15% range in Europe.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

And what we see is, as the pre fill market converts to pre fills, that we are the preferred device. And so that conversion you're seeing now is country that we've converted and that's reflected partially in our Q2 results. We expect to see more in the back half and we're working now with all of our pharma partners, but one in particular on their prefilled syringe conversion program. We believe there are several more markets that we can convert into 'twenty six. And then with our new pump opportunity in, we expect to be launching with them by the '6 in several new markets around the world.

Frank Takkinen
Senior Research Analyst - Medical Device at Lake Street Capital Markets

Got it. That's helpful color. I'll stop there. Thank you. Congrats again.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Thank you.

Operator

The next question comes from Chase Knickerbocker of Craig Hallum. Please go ahead.

Chase Knickerbocker
Senior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC

Good afternoon. Congrats on the nice quarter here and thanks for taking the questions. Maybe just a follow-up on something Frank asked there. In that one market I might have missed this, Linda, sorry. In that one market that has converted internationally, what is or what do you expect your market share to be there kind of compared to that market share rate that you just kind of shared in Europe?

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Yeah, so we know that our share position coming into the year was probably somewhere between 1015%. We think now it's in the low 20%. Market is a top five market in Europe, and we believe that there are four or five other markets that we can go to for further conversions. So we're just getting started. We don't think the conversion is fully complete.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

You'll see more on that, which is giving us the confidence to raise our guidance by the $1,000,000 range due to what we anticipate will be further conversions in the back half.

Chase Knickerbocker
Senior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC

Got it. And so that is low 20s numbers, are you saying in Europe? You're saying in that market specifically, right? And so I'm saying Share?

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Yeah, I'm saying overall in Europe, we don't have yet all of the details on exactly how much we have in that particular market, whether that has brought us to we just don't have that range for that particular market yet. The team will be in Europe and working more closely with the pharma partner to figure that out over the course of the next couple of months. We do know that there's a lot of obviously untapped opportunity. We know that that market in particular was one where our share position was probably lower than most. It's where we faced our biggest competitor in electronic pumps, so we feel good about that first market. And more to come.

Chase Knickerbocker
Senior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC

Got it, thanks. Just on domestic SEIG market in the quarter, can you share what the growth rate was and kind of any commentary you're hearing about how your pharma partners are thinking about the remainder of the year for the SCIG market in The US?

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

I would say we've seen the growth rates continue in that high single digit, low double digit through the first half of the year. We look at who has reported thus far in IG, they're all reporting strong double digit growth in their SCIG franchises, so we're encouraged by that. And that is really just we continue to see further new patient starts on SCIG, which is really driving a lot of growth. We continue to see new patients being diagnosed, and then finally we know that there is a trial occurring now for secondary immunodeficiency, which has prior been a very strong driver in Europe for SCIG. And when that trial is concluded, we believe will be another growth driver for the SCIG market in The US.

Chase Knickerbocker
Senior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC

Got it. And maybe last couple from me. Maybe just on the consumable delay. Can you just speak to specifically what kind of product design you're looking to add to that that kind of caused that delay? And then kind of along the same lines on the next gen pump, what's left to do before the submission there?

Chase Knickerbocker
Senior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC

How kind of competent are you in that timeline, call it late twenty five or late twenty six? Thanks.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

So on the consumable delay, I think this was a major shift in our consumables line. It was both looking at two things. Number one was a dramatic improvement in comfort, which related to the needle technology, and the second was a big improvement in convenience. So reducing the number of steps required by the patient to perform the infusion quite dramatically. Just in showing this in regular research with our customers, with patients, and with our pharma partners, we just want to make a few tweaks to it that we think will appeal better to the overall requirements in the market.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

So chose to take a bit of a delay in that program. And again, I don't see that impacting our 25 or 26 revenues. So excited for what we learned and we'll make those changes and progress forward. On the NextGen pump, we feel very confident. We've had it out patients, with specialty pharmacies, with pharma companies, everybody's super excited about that launch.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

We don't see any major delays at this point. We're through all of the major technical hurdles. We believe, touch wood, that by the end of Q1 at the latest, we'll be submitting for 05/10 approval.

Chase Knickerbocker
Senior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC

Thanks, Linda. Congrats again.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Thank you.

Operator

The next question comes from Caitlin Cronin of Canaccord. Please go ahead.

Caitlin Cronin
Director - MedTech Equity Research at Canaccord Genuity Inc

Hi, thanks so much for taking the questions and congrats on a great quarter. You know, just going off of the NextGen pump, just a reminder of why that is important, particularly for OUS and then with the prioritizing of that now, what is the timing of that clearance and launch OUS?

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

So the next gen pump, the importance of it is that with the launch of pre fills, patients take multiple pre fills with their weekly dosing regimen. And in order to use those multiple pre fills, they're all in different sizes. And in order for patients to do that today, what they're doing is sometimes using a pre fill and then they have to take a pre fill and go in to pull it into a different sized syringe. Or they could use two different pumps. So just in explaining it, it sounds complex.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

So our new pump will work with any prefill available on the marketplace. They go from five mls to 50 mls, and it will also work with any vial or prefill. It also has expanded mobility, dosing window, ease of use. So very excited about that, and the value prop is very strong. Regarding timing, we expect to submit for US $5.10, as I've said.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

And then EU, we would follow one quarter beyond that. So we're anticipating filing in the EU by 2026.

Caitlin Cronin
Director - MedTech Equity Research at Canaccord Genuity Inc

That's great. And then with the tariff impact sitting, just any updates on the expectations of that and the cadence and how you're mitigating?

Tom Adams
Tom Adams
CFO at KORU Medical Systems

Yeah, hi Caitlin. I'll take that one. Sure. With respect to the tariffs, our largest supplier that has the highest impact on tariffs is our third party contract manufacturer. We've looked at their bills and materials and we've worked with them to really understand the impacts from a materials perspective, where materials came from, and what the actual tariff impact was from the value add from that contractor.

Tom Adams
Tom Adams
CFO at KORU Medical Systems

And when we look at our business over the full year, it's about a 90 bps impact, which is roughly 2% on every order. That's how detailed we were at looking at that. So we feel pretty strong that we have that under control. In terms of just mitigation, we're constantly doing operational excellence programs in our own facilities, looking at ways to create efficiencies through our volumes, and also certain programs for rebates from vendors, etc. As we grow our company and we continue to see increases in volumes, we're able to take advantage of some of those volumes and some of those efficiencies through that process.

Tom Adams
Tom Adams
CFO at KORU Medical Systems

We feel pretty good that we have everything under control from a tariff related standpoint.

Caitlin Cronin
Director - MedTech Equity Research at Canaccord Genuity Inc

Great. And maybe just one more. Confidence on that distributor impact in The US is really going to be just a Q3 event.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Yeah, maybe I'll start and then turn it to Tom. We look most importantly at our volumes relative to what we call our end user demand. So, we have data on what those distributors sell to our end user specialty pharmacies. That demand is very, very strong. So then we can deduce how much inventory they're carrying, and we know that based upon our demand and the overall market growth, that we feel quite good about the end user demand being sustained.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

So a one time their overall company goal to reduce a week of inventory, will take a small hit in the third quarter, but won't impact us that much relative to some of the other growth drivers, I. E. International that we talked through.

Tom Adams
Tom Adams
CFO at KORU Medical Systems

Yeah, just to add on to what Linda's saying Caitlin, our distributors they keep their own safety stocks and they keep their own inventory levels and sometimes they reduce them. They have initiatives to reduce them. They still service our customers but if they're carrying let's say they're carrying four weeks they might choose to carry three weeks during a particular period. So we just react to that because at the end of the day we sell to distributors and that's the sales that we report. So that's the reason for the Q3 debt that I mentioned earlier.

Caitlin Cronin
Director - MedTech Equity Research at Canaccord Genuity Inc

Got it. Makes sense. Thanks for taking the questions.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Thanks, Caitlin.

Louisa Smith
Principal at Gilmartin Group

Operator? Operator, we can move to the next in queue.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Hello?

Louisa Smith
Principal at Gilmartin Group

Operator, are you there? Sorry to our audience. Operator says she's reconnecting. Just a moment.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Okay, folks, we will definitely be asking for a refund on this call. I think we're just holding patient while we're waiting for the operator.

Operator

Apologies. We'll take the next question. It's from Jason Bednar of Piper Sandler. Congrats

Jason Bednar
Jason Bednar
MD & Senior Research Analyst at Piper Sandler Companies

on a nice quarter, everyone. Looks like you're expecting positive cash generation in the back half of the year here, Linda and Tom. That's good to see. I guess, how are you thinking strategically about cash from here now that we're kind of in that cash generation mode? Are you going to build a cushion first?

Jason Bednar
Jason Bednar
MD & Senior Research Analyst at Piper Sandler Companies

Are you thinking about reinvesting in the business to sustain that strong top line or maybe even accelerate it? And if it's the latter, do you see this more as an R and D push or an SG and A type investment? Any color there would be great.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Thanks Jason on the congrats on the quarter. So regarding capital first, we're obviously thrilled that we hit the cash flow positive in this quarter and the outlook for the remainder of the year, which as we mentioned is kind of the combination of both the top line revenue growth and the gross margin, but we started I would say about a year and a half ago to really tighten in our capital allocation and look at the balance of our portfolio on both short and long term opportunities. What we see behind us are the big investments in infrastructure and people and teams, which is why you saw the cash burn come down. And now moving forward, we have a very good operating model where our partnerships with pharmaceutical companies and our agreements with key accounts allow us to have a fairly low SG and A. So as we move forward, we will absolutely look at every opportunity for growth.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

We obviously feel that most of those investments will be in SSG and A, and we're fortunate and that most of them are one year payback, which allows us to maintain that $8,000,000 cash balance is how we're thinking about it. But if we see big opportunities, you know, outsized growth or international opportunities, you know, those ones pay back quickly. You know, the oncology pilot, let's see where that one goes, but that could be another opportunity. Those would be opportunities where, we would look to say, what can we do either with what's in debt or otherwise to pursue those. But we feel good about our cash position and ability to maintain that growth above 20% with what we have today.

Jason Bednar
Jason Bednar
MD & Senior Research Analyst at Piper Sandler Companies

All right, that's helpful and a nice segue into my follow-up question, Linda. We are getting closer and almost real time tapping into this new pipeline with new drugs, expanded indications. What's the right way to think about the commercial uptake of that pipeline? Is it more of like a linear adoption curve? Is it taking more of a hockey stick type approach?

Jason Bednar
Jason Bednar
MD & Senior Research Analyst at Piper Sandler Companies

I think we're all going to try and figure out how model these as they get become more real and move further down the path. But how would you have us think about those collectively?

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Yeah, I would say that we tried hard to give now a number of potential total infusions. Of course, that doesn't represent our opportunity. We'll try and give an indication. I think I said on the last call that the two we're pursuing on our own, the vancomycin and dexteroxamine will be about a half a million next year. Similar numbers for the two, Empiveli and the rare disease indication next year.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

So probably next year between those two just shy of a million dollars in upside. And then you'll see kind of a similar linear progression over the course of the years. I would say the big pops that we see would obviously be oncology if that one occurs, given the overall size of that market. We're excited that we're in clinics, but obviously the value prop is proving strong here, but more work to do in terms of reimbursement and economics around that one.

Jason Bednar
Jason Bednar
MD & Senior Research Analyst at Piper Sandler Companies

Okay, very helpful. Thanks so much.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Thank you, Jason.

Louisa Smith
Principal at Gilmartin Group

Operator, we can take the next question.

Operator

The next question is from Anderson Shock of B. Riley Securities. Please proceed with your question.

Anderson Schock
Medtech Equity Research Analyst at B Riley Financial

Hi, thank you for taking the questions and congrats on the really strong quarter and positive adjusted EBITDA. So with the Japan launch expected to generate revenue in the back half of the year, I guess, should we think about the back half for international growth? Is 30% still the target for 2025? It looks like if you remain flat sequentially on international revenue, you'd be closer to 50% growth year over year. Is there any seasonality we should be thinking about in the back half?

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Yeah, maybe I'll just touch on Japan and then I'll turn it to Tom for some of the more detailed questions on international. So overall in Japan, we still believe that it is a top 10 IG market. We're excited, SCIG is just getting started there. We just recorded our first sales. It is included in the guidance that we see, but we see a bigger impact in Japan for 2026 than 2025.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Tom, maybe I'll hand it to you for the specifics around growth on international.

Tom Adams
Tom Adams
CFO at KORU Medical Systems

Yeah, Anderson, so if you think about the back half, as we mentioned, we've had a very strong front half of about 35 or so percent growth. You can expect that to increase significantly over that number. As we mentioned, when we think about the million dollar increase, I'd say that's primarily all into international business. So as you think about your model and where that goes, would say you'd want to layer that into Q3, Q4 almost evenly across the international business.

Anderson Schock
Medtech Equity Research Analyst at B Riley Financial

Okay, got it. And then on the last call you mentioned you anticipate another order from the first quarter's tender win in the back half of the year. Do you have any updates on the timing or size of this?

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

I would say it is included in the guidance that we provided. We do have visibility to it. I'm not going to give the exact numbers. But I would say what we saw start to be fulfilled in quarter two, we'll see equally strong orders the back half of the year.

Anderson Schock
Medtech Equity Research Analyst at B Riley Financial

Okay, got it. And then on the pharma services and clinical trial side, I guess what drove this increase? Is this just one time NREs? Or should we expect to see this quarter's revenue of as the new norm?

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Yeah, I would say I would not expect this quarter revenues to be the norm. It was driven by what we mentioned in the remarks, which is clinical trial orders for a non IG drug, which is encouraging for us. Those clinical trials generally mean the drug is in a clinical trial and that one in particular is in a phase three, so we'll get a clearance soon. I think what we said about pharma services that Tom had mentioned in a prior question is, you can anticipate front half and back half revenues for PST to be about the same. Possibly a little bit of upside if we get more opportunities than we're currently anticipating.

Anderson Schock
Medtech Equity Research Analyst at B Riley Financial

Okay, got it. Thank you for taking our questions and good luck on the refund.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Thank you so much.

Operator

We have reached the end of the question and answer session, and I'll hand the call over to the CEO, Linda Tharby, for closing remarks.

Linda Tharby
Linda Tharby
President, Director & CEO at KORU Medical Systems

Thank you all for joining us this afternoon. We look forward to providing you with further updates on additional opportunities as we make progress against our twenty twenty five milestones. Have a great rest of your day.

Operator

This concludes today's conference. You may now disconnect your lines and enjoy the rest of your

Executives
    • Linda Tharby
      Linda Tharby
      President, Director & CEO
    • Tom Adams
      Tom Adams
      CFO
Analysts
    • Louisa Smith
      Principal at Gilmartin Group
    • Frank Takkinen
      Senior Research Analyst - Medical Device at Lake Street Capital Markets
    • Chase Knickerbocker
      Senior Equity Research Analyst - Healthcare at Craig-Hallum Capital Group LLC
    • Caitlin Cronin
      Director - MedTech Equity Research at Canaccord Genuity Inc
    • Jason Bednar
      MD & Senior Research Analyst at Piper Sandler Companies
    • Anderson Schock
      Medtech Equity Research Analyst at B Riley Financial
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