KORU Medical (KRMD) Q4 2025 Earnings Transcript

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DATE

Thursday, March 12, 2026 at 4:30 p.m. ET

CALL PARTICIPANTS

• President and Chief Executive Officer — Linda Tharby
• Chief Financial Officer — Tom Adams
• Chief Commercial Officer (CEO-Designate) — Adam Kalbermatten
• Investor Relations — Louisa Smith

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TAKEAWAYS

• Total Revenue -- $10.9 million, growing 23% year over year, marking the third consecutive quarter of greater than 20% revenue growth.
• Full-Year Revenue -- $41.1 million, up 22%, driven by gains in both Domestic and International Core businesses.
• Domestic Core Revenue Growth -- 18% year over year for the quarter and 11% for the year, reflecting new patient starts and share gains.
• International Core Revenue Growth -- 71% year over year for the quarter and 80% for the year; underlying growth for the year was 73% excluding distributor realignment effects.
• PST Revenue -- Decreased 30% year over year in the quarter, attributed to milestone timing, not activity levels.
• Gross Margin -- 62.3% full-year, a slight decline due to increased material costs, tariffs, and geographic sales mix.
• Operating Expenses -- Increased just 3% for the year alongside 22% revenue growth, demonstrating operating leverage.
• Adjusted EBITDA -- $600,000 positive for the full year, improving 124% and marking three consecutive quarters of positive adjusted EBITDA.
• Cash Position -- Ended the year with $8.9 million in cash; achieved positive operating cash flow in the third and fourth quarters and for the year.
• Guidance for 2026 Revenue -- $47.5 million to $50 million, reflecting targeted 15%-22% growth.
• 2026 Gross Margin Guidance -- 61%-63%, supported by pricing and manufacturing efficiencies.
• Patient Base -- Approximately 59,000 global chronic subcutaneous immunoglobulin (SCIg) patients, up 20% year over year.
• Market Share in Europe -- Increased to 20% from approximately 10% in the $50 million European SCIg pump and consumables market.
• Regulatory Milestones -- Received EU MDR certification for the FREEDOM60 with prefilled syringe compatibility, and FDA 510(k) clearance for RYSTIGGO on the Freedom Infusion System.
• Pipeline Developments -- Nine subcutaneous drugs cleared for use and nine new drug pipeline opportunities, including two new pharma collaborations in nephrology (Phase III) and a multi-indication molecule (Phase I).
• Oncology Entry -- 510(k) filed for Phesgo in Q4 2025, with anticipated market entry in the second half of 2026.
• Product Innovation -- MDR-cleared FREEDOM60 and FreedomEdge pumps now available for prefilled administration in Europe; next-generation pumps and flow controller regulatory submissions planned for 2026 and early 2027.
• RYSTIGGO U.S. Opportunity -- Estimated 20,000 annual U.S. infusions, potentially growing to over 100,000 by 2030, with initial channel expansion into infusion clinics.
• Recurring Revenue Model -- Maintained across nearly 60,000 global patients, creating stable baseline growth.

SUMMARY

KORU Medical Systems (NASDAQ:KRMD) announced a planned CEO succession, with Adam Kalbermatten slated to become CEO on July 1 and Linda Tharby remaining as Board member and advisor through 2026. The company highlighted continued outperformance versus growth in the core SCIg market, particularly its European expansion and rising global penetration. Management explicitly guided to ongoing operating leverage, projecting positive adjusted EBITDA and cash flow for 2026, and outlined further diversification into non-IG indications, especially oncology and nephrology. Regulatory milestones such as EU MDR and FDA 510(k) clearances were emphasized as positioning the company for expanded pharma partnerships and channel entry. Forward-looking statements signal investment in new production lines and a significant addressable opportunity in both the U.S. and ex-U.S. markets as additional drugs and markets activate.

• Kalbermatten said, "We have a proven strategy really built around 3 pillars: protecting and growing the Core Domestic business, expanding internationally and enabling more drugs to reach more patients."
• Management noted up to 80% reduction in drug preparation tasks resulting from the shift to prefilled syringes in Europe, which may influence ongoing adoption rates.
• Pharma partnerships in development span 9 active drug opportunities, with estimated combined potential of over 7 million annual infusions globally.
• 2026 revenue cadence is anticipated to be weighted toward the second half due to timing of inventory builds and product clearances.
• The company expects a new market addition for prefilled products in Europe every quarter during 2026, supported by expanded regulatory clearances.
• Potential geographic expansion in Japan is anticipated as both pump and consumable approvals are in place and prefilled syringe adoption grows.

INDUSTRY GLOSSARY

• SCIg (Subcutaneous Immunoglobulin): Immunoglobulin therapy administered via the subcutaneous route, commonly used for treating primary and secondary immunodeficiency disorders; KORU's core indication and revenue driver.
• EU MDR (European Union Medical Device Regulation): European regulatory framework required for medical device commercialization, critical for market access and prefilled syringe initiatives in Europe.
• 510(k) Clearance: U.S. FDA premarket notification required to demonstrate a medical device is safe and effective for its intended use; enables KORU's product and channel expansion.
• Prefilled Syringe Conversion: The market trend and operational process of transitioning from drug vials to fully prepared, prefilled syringes for infusion, reducing preparation time and improving patient convenience.

Full Conference Call Transcript

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

Louisa Smith: Thank you, operator, and good afternoon, everyone. Joining me on the call today are Linda Tharby, President and CEO of KORU Medical Systems; Tom Adams, Chief Financial Officer; and Adam Kalbermatten, Chief Commercial Officer. Earlier today, KORU released financial results for the fourth quarter and full year ended December 31, 2025. A copy of the press release is available on the company's website. I encourage listeners to have our press release in front of them, which includes our financial results and commentary on the quarter. Additionally, we will use slides to support further commentary in today's call, which are also available on the Investor Relations section of our website.

During this call, we will make certain forward-looking statements regarding our business plans and other matters. These comments are based on our predictions and expectations as of today. Actual events or results could differ materially due to risks and uncertainties, including those mentioned in the associated press release and our most recent filings with the SEC. We assume no obligation to update any forward-looking statements. During the call, management will also discuss certain non-GAAP financial measures. You will find additional disclosures, including reconciliations of these non-GAAP measures with comparable GAAP measures in our press release, the accompanying investor presentation and SEC filings.

For the benefit of those listening to the replay, this call was held and recorded on Thursday, March 12, 2026, at approximately 4:30 p.m. Eastern Time. Since then, the company may have made additional comments related to the topics discussed. I'd now like to turn the call over to Linda Tharby, President and CEO. Linda, please go ahead.

Linda Tharby: Good afternoon, everyone, and thanks for joining us today. Before I provide further detail on our fourth quarter and full year performance, I want to take the opportunity to comment on the announcement of my retirement as was press released earlier today. After 5 fulfilling years, I have made the decision to retire and will resign as CEO of KORU Medical effective June 30. This has been one of the most meaningful chapters in my career, and I am proud of what we have built together, including the strength of the business, our growing leadership position in large-volume drug delivery and an exceptional team that will continue to maximize KORU's potential and move the growth strategy forward.

My family and I are ready to embrace the next chapter of my life, and I will turn my focus to Board and advisory activity. This transition has been thoughtfully planned by the Board, and I'm very pleased to announce that Adam Kalbermatten, our Chief Commercial Officer, has been selected as my successor. When Adam joined KORU in 2025, it was immediately clear he was a natural fit, not just for the CCO role, but for the potential to lead the company as a whole. Adam brings strategic discipline, commercial leadership and a proven track record of creating shareholder value.

He has spent his entire 20-plus year career in drug delivery, spanning large and small med tech companies and including a CEO role, where he led an effective turnaround and growth strategy that resulted in a successful acquisition by Becton, Dickinson. The Board's confidence in Adam is grounded both in him personally and in the strength of the broader team beside him. With over 115 years of combined med tech and pharma experience across the executive leadership team. KORU has the strategic depth needed to continue to drive our growth potential. As we look ahead, we are committed to a smooth and seamless transition.

I will remain on the Board and continue to serve in an advisory capacity through the end of 2026. Adam will be appointed President effective March 15 and will assume the role of CEO on July 1. Many of you have had the opportunity to meet Adam at investor conferences and industry events over the past year, and I look forward to partnering with him through this transition period. I want to thank my family for their support throughout my career.

The Board for their partnership and guidance; our shareholders for the trust you have placed in us; our customers for your passion and knowledge; and above all, our KORU team for the enthusiasm and dedication they have demonstrated throughout my tenure. It has been an honor to be part of the KORU team, and I'm confident the best chapters of this company are ahead. And now with that out of the way, let's turn to our fourth quarter and full year results. I'll begin with some commentary on our fourth quarter and full year highlights and strategic progress. Then I will hand the call over to Tom to review our financial results before we open the call for questions.

2025 was a very good year for the organization. We accelerated our revenue growth and made progress in all of our strategic growth pillars, protecting and growing our Core Domestic business, expanding internationally and enabling more drugs to reach more patients. Revenue of $10.9 million in the fourth quarter marked our third consecutive quarter of greater than 20% revenue growth and we delivered full year revenue of $41.1 million, a 22% increase over the prior year. This consistent performance reflects the fundamental strength of our business. A few highlights I want to call out. First, both our Domestic and International Core businesses continued to outperform the underlying SCIg market, which grew approximately 10% in 2025.

In the fourth quarter, Domestic and International Core grew 18% and 71%, respectively, driven by a recurring base of approximately 59,000 patients. We received EU MDR certification for the FREEDOM60 with prefilled syringe compatibility, marking a critical regulatory milestone that positions us to pursue the ongoing valve-to-prefilled syringe conversion across Europe. We also received 510(k) clearance for RYSTIGGO in January, which marks the ninth drug cleared on the Freedom Infusion System and our second non-IG clearance. This is a step in our strategy to expand our platform beyond IG, and it opens a meaningful new channel for us in the infusion clinic setting. I'll speak to further details on the RYSTIGGO opportunity in a subsequent slide.

We are also announcing two new pharma collaborations as we continue to expand our development pipeline into two new therapeutic areas, a Phase III nephrology molecule and a Phase I multi-indication drug. We ended the year with $8.9 million in cash and achieved positive cash flow from operations, continuing the progress we've made towards sustained profitability. Building on that momentum, we are initiating 2026 revenue guidance of $47.5 million to $50 million, representing growth of 15% to 22%, and positive adjusted EBITDA and cash flow positive for the full year. Tom will provide additional color on our guidance and underlying assumptions. Now moving to a few comments on our strategy.

Health care continues to move from the hospitals to infusion centers to the home and large volume subcutaneous infusion is a direct beneficiary of that shift. In our Core SCIg business, we operate in a greater than $450 million global market, where penetration versus IVIG remains below 20% in the U.S. and external forecast project continued 8% to 10% growth over the next 5 years. We have 7 launched SCIg drugs from the major IG pharma manufacturers on our label and drug manufacturers are actively innovating their IG portfolios, all of which create opportunities for increased subcutaneous penetration and for KORU to capture additional global share.

Outside of SCIg, there are more than 95 new drugs in development with volumes greater than 10 ml across multiple indications. IG was the first mover in large volume subcutaneous delivery, and there is significant investment going into subcu formulations across broader therapeutic areas. A large part of our strategy is enabling the administration of those drugs on our system. Turning to our Domestic business. I want to highlight a few key areas, our growing recurring revenue base and the expansion into new therapeutic areas. We have grown our recurring global patient base by approximately 20% to 59,000 global chronic SCIg patients on the KORU Freedom System.

The global SCIg market saw healthy growth of approximately 10% this year and industry projections are for 8% to 10% growth in the coming 5 years. With our growth of over 20% this year, we are growing our global SCIg leadership position and will continue to expand through our new product development efforts and key accounts and pharma collaborations. We are also beginning to diversify our business. The clearance of RYSTIGGO, a non-IG drug enables our entry into the infusion clinic channel. With our filing of the 510(k) for Phesgo in the fourth quarter of 2025, we are also anticipating entry into the oncology market in the second half of 2026.

We are also closely watching the evolving clinical activity around secondary immunodeficiency or SID. Outside the U.S., SID has been a key focus in many of the large pharma players and there are several ongoing pharma trials that are expected to complete in 2027. Increases in SID are being driven by an aging population, higher prevalence of chronic illnesses and increased use of immunosuppressive treatments, such as CAR T cell therapy. As reimbursement coverage expands in this area, it could meaningfully broaden our U.S. opportunity. Moving to International. This business was one of our largest growth drivers in 2025 with growth of 80%, and we see even greater potential ahead.

The overall European SCIg pump and consumables market is valued at approximately $50 million, and we grew our share from approximately 10% in 2024 to 20% in 2025. We remain well positioned to continue expanding our presence in the market and capturing additional growth opportunities. We expect most of our growth to come from the continued shift across large pharma from vial-based delivery to prefilled syringes. The shift from vials to prefilled syringes simplifies the administration process significantly with up to 80% reduction in drug preparation tasks. This last quarter, we received our MDR certification in the EU for our KORU FREEDOM60 system. Combined with the earlier FreedomEdge MDR clearance, we now have two clear pumps for prefill administration.

Our system was preferred by over 75% of patients due to its ease of use. That's a meaningful improvement in the day-to-day experience for patients managing a chronic condition at home. Overall, the European opportunity is significant, and we believe we are only beginning to capture it. With 2 MDR cleared pumps, a system that is patient-preferred and pharma driving a broad shift to prefilled syringes, we are well positioned to continue taking share. With a roughly $50 million addressable market in Europe alone, we see a significant opportunity ahead. And now let me turn to our pipeline. Beyond IG, the new drug pipeline now has 9 active opportunities. That combined represent more than 7 million annual infusions worldwide.

Within the next year, we anticipate having 3 commercial stage assets on our label, vancomycin, deferoxamine and the Phesgo oncology opportunity. Together, these represent approximately 2.2 million estimated annual global infusions. Two of those 9 opportunities are new this last quarter, a Phase III nephrology drug, and a Phase I multi-indication drug. We are working with our pharmaceutical partners to help advance the delivery of these molecules. Once launched, they are expected to represent combined commercial opportunity of approximately 3 million annual infusions. We now have 9 subcutaneous drugs cleared for use with the FREEDOM Infusion System. IG representing approximately 5.4 million annual infusions and non-IG representing approximately 250,000 infusions.

On the IG side, our 6 active collaborations with the major IG manufacturers span new device formats and expanded indications. Work that directly supports continued share gains and geographic expansion as those programs move towards launch. When you step back and look at the full picture, 9 subcutaneous drugs on label with low penetration, 9 drugs in active development with KORU and more than 95 large-volume subcutaneous drugs still in development across the pharma landscape. The runway here is substantial. And now let me spend a moment on RYSTIGGO, for which we received 510(k) clearance on our Freedom Infusion system in January.

RYSTIGGO is indicated for generalized myasthenia gravis, a chronic autoimmune disease that causes muscle weakness affecting a patient's ability to control voluntary movements, including swallowing and breathing. In the U.S., this represents a patient population of approximately 60,000 patients. UCB launched the drug in July 2023 and currently publicly reports having reached more than 2,400 GMG patients globally at the end of 2025. We project our total U.S. market opportunity to be about 20,000 infusions in '25, growing to over 100,000 infusions in 2030. It's worth noting that RYSTIGGO has already been used off-label with the Freedom Infusion system. So this clearance enables us to go after further share.

Additionally, this clearance marks our first collaboration with UCB and enables our entry into the infusion clinic channel, which opens a new commercial pathway for KORU beyond the home. I'm extremely proud of the team's execution and the strong momentum we built. The strong patient growth in our U.S. and international markets and meaningful pharma pipeline progress across both IG and non-IG opportunities, we're well positioned heading into 2026. I'll now turn the call over to Tom to review our financial results and guidance for 2026.

Tom Adams: Thanks, Linda, and good afternoon, everyone. We are pleased with another strong quarter of revenue where we delivered $10.9 million, representing 23% year-over-year growth. This marks 3 consecutive quarters of greater than 20% revenue growth, a reflection of the momentum we've built across the business. Breaking down the performance by business. Domestic Core grew 18% year-over-year, driven by the SCIg market, which grew between 8% to 10% in the quarter. New KORU patient starts and market share gains, resulting in higher pump and consumable volumes. International Core grew 71% year-over-year, fueled by new patient starts and increased penetration into established European markets.

Prefilled syringe conversions were a significant driver and we expect this to remain a tailwind as additional markets convert. Our PST business decreased 30% year-over-year. This business is inherently variable given the milestone-based nature of revenue recognition. The decrease reflects timing of contract milestones, for work completed and does not reflect the change in the activity level of our collaboration portfolio, which as Linda just described, continues to grow. For the full year, we delivered revenue of $41.1 million, representing 22% growth over the $33.6 million we reported in 2024. Domestic Core grew 11% for the full year driven by SCIg market growth and new account share gains that increased consumables and pump volumes.

Accounting for the dynamic that occurred with our international distributors going back to the U.S. which we discussed in the third quarter call, underlying growth would have been 14% for the full year. International Core grew 80% for the full year, driven by strong SCIg market growth our growing footprint in European markets and entry into several new geographies. Accounting for the international distributor sales dynamic, underlying growth would have been 73% for the full year. Finally, PST declined modestly. Again, due to the project milestone timing, partially offset by higher clinical trial orders versus the prior year. Moving to gross margin.

We had a 30 basis point reduction over the last year's Q4, driven by higher material costs and tariffs that were mostly offset by a stronger customer mix in the U.S. where we have higher average selling prices. We delivered a full year gross margin of 62.3% in line with our expectations at the start of 2025. The year-over-year decrease was driven by higher packaging material costs, tariff-related charges and geographic sales mix from our growing international business. Despite these headwinds, we remain resilient in keeping margins above 50% every quarter and on a full year basis. Turning to cash. We ended the year with $8.9 million in cash, representing full year cash usage of $700,000.

Importantly, we achieved positive cash flow from operations in both the third and fourth quarters and also for the full year. The key drivers were revenue growth and disciplined spending that enabled a further reduction in net losses. We largely maintained our working capital balance while managing the growth needs of the business, and we continue to invest in capital expenditures to support future new product launches. Turning to our full year financial highlights. I want to call out two things in particular. First, with 22% revenue growth, operating expenses increased by just 3%, demonstrating the discipline we've maintained and the continued operating leverage we have generated.

And second, we delivered positive adjusted EBITDA of $600,000, a 124% improvement versus the prior year, marking 3 consecutive quarters of positive adjusted EBITDA. Together, this reflects significant P&L improvement as we march towards profitability. Looking ahead to 2026, we are initiating guidance of $47.5 million to $50 million in revenue, representing growth of 15% to 22% and gross margins for the full year of 61% to 63%. We are also targeting positive adjusted EBITDA and positive cash flow for the full year.

On revenue, the primary drivers will be continued U.S. and international share gains in SCIg, NRE revenue from at least 4 new collaborations, 2 already signed and modest incremental revenue from recent or soon to be cleared 510(k) filings. We have also incorporated some geopolitical risk into our guidance given recent events in the Middle East. As you think about our 2026 revenue cadence, I'd note that first half of 2025 benefited from a meaningful prefill inventory build in a key EU market, which we do not expect to repeat at the same level in 2026.

Additionally, we would expect revenue to ramp in the back half as we see revenue recognition from recent and pending 510(k) clearances and the introduction of prefilled syringes into new geographies. On gross margin, we expect pricing and manufacturing efficiencies to support the 61% to 63% range as we enter new markets and channels. The associated revenue mix may move margins slightly in either direction, but we feel confident holding that range overall. We also have planned for start-up costs for the new production line for the next-generation pumps. We are confident that we will continue to offset incremental external pressure on costs with our operational excellence programs.

On profitability, we are guiding to cash flow positive and positive adjusted EBITDA for the full year. Cash usage is expected to mirror the 2025 cadence with operating leverage building throughout the year and positive cash flow anticipated in the second half. I'll now turn the call back to Linda for closing remarks.

Linda Tharby: Thank you, Tom. I want to close with a few thoughts on key milestones in 2026 and our broader market opportunity. . We started the year off strong. In our Domestic Core, we have gained the UCB RYSTIGGO 510(k) clearance and our Roche Phesgo 510(k) application submitted on time in December, giving us two new non-IG drugs currently moving to commercial potential in 2026. We also have our next-generation pump, the FREEDOM60 expected to have 510(k) and MDR submissions this year. The Phase II Flow Controller 510(k) submission is projected for a global submission either in late 2026 or early 2027.

Internationally, we have achieved MDR clearance of our FREEDOM60 with prefilled syringe compatibility, and we have now begun to ship that product into the EU market, anticipating prefilled conversions in several EU markets. On our efforts to add new drugs to our label, we have signed 2 of our 4 new collaborations and anticipate 2 additional 510(k) submissions this year for deferoxamine and vancomycin. In closing, I want to step back and frame why we believe KORU is well positioned, not just for 2026, but for the years ahead. This slide references the strong foundation that we have built for our business, some of our recent accomplishments and finally, where we believe we are headed.

On the left, you'll note some of the foundational aspects that make KORU an attractive opportunity. We operate in a large and growing market for subcutaneous drug delivery with approximately 95 large volume drugs in development by major pharmaceutical companies. We have a leading position in the U.S. market that is growing 8% to 10%, where we consistently outperform market growth rates. We have significant momentum with international expansion with much more runway to grow and gain share. Underpinning this is a recurring revenue model across a global base of nearly 60,000 patients. And looking ahead, we have 9 pipeline drug opportunities outside of IG, with RYSTIGGO and our oncology market entry, representing near-term commercial opportunity in 2026.

Moving to the right, the middle box is a reference to our recent accomplishments and performance, where we have demonstrated the ability to consistently grow revenues more than 20%, where we have attractive gross margins, and where we have proven the operating efficiency of our business model, delivering a 63% in improvement in cash burn and 124% improvement in adjusted EBITDA for 2025. On the right are our long-term targets and some of our strategic goals that Adam and team will continue to work towards, $100 million in revenue, accelerated growth rates, gross margins above 65% and an EBITDA margin of 20% or greater. 2025 performance shows that the model is working. 2026 is about continuing to execute against it.

Before opening the line for Q&A, I want to again thank the entire KORU team for their continued commitment to our mission. Looking back on my tenure with the organization, the progress we have made together is something I'm immensely proud of. The business is stronger. The strategy is clear. And with Adam stepping into the CEO role, I have every confidence in what lies ahead. It has been an honor being part of the KORU team, and I look forward to seeing the next chapter unfold. Operator, please open the line for questions.

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

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

Linda Tharby: Frank, and thank you. It has been an extreme pleasure working with you and the broader Lake Street team. Clearly, very confident as we think about Adam stepping into role and the broader team that surrounds him. So on your questions on the FREEDOM60 and the opportunity that lies ahead of us. Maybe I'll just start with the broader opportunity we're going after here is a $50 million total addressable market in Europe. We were very successful in 2025 in moving our share position from a 10% to a 20% share, but obviously, if you position that share closer to our 60% U.S. share, you see the magnitude of the opportunity we have in front of us in Europe. .

So most of that opportunity and share gain in 2025 was driven by a successful prefill conversion in a major market in Europe, and the pharma partner that we're working with has plans to roll this out in several new markets over the course of the coming year. And the 5 geographies you referred to are not new markets for us, but there are markets we're in today, but with fairly low penetration, and we see the opportunity in prebills to really grow that market significantly. So what we see today is that we have our second market.

We've started our year off strong in '26 with our second market that's really going live now with this prefill launch, and we expect to see likely a new market being added 1 to 2 every quarter as we move through the year. I think the last part of the question was just the FREEDOM60 and the new approval. Very excited about that because now we have 2 pumps, both our 60 and our Edge that are both approved. We required some slight modifications to our FREEDOM60 and an update to our IFU, we just received approval on that in the fourth quarter of '26. So great news for us.

We've now just started distributing that new product into the market today. And of course, what comes at the back end of the year is our FREEDOM360, which is our pump that will work for all prefills. So hopefully, that got all of those questions.

Frank Takkinen: Perfect. Maybe just for my second one, Tom, a little more composition of the guide would be good color. I heard ramping revenue throughout the year as some of these initiatives progress, but maybe how much contribution from U.S.? How should we think about that growth rate, OUS? And then any cadencing color you'd like to provide would be great, too.

Tom Adams: Frank, thanks for the question. Yes. Great. So we're continuing to see momentum coming into Q1 after a record Q4. So that's very strong for us, particularly on the international side. So as mentioned earlier, prefill still is a driver of that market. So we continue to see that progress. I would say from -- on the international side, you will see a step up in the back half of the year, based on what Linda just mentioned in some of those countries going online for prefills. And then on the U.S. side, I think that's slow and steady. I mean you've seen the last couple of years, a pretty steady growth rate on the U.S. side.

And then, of course, as we get further along into the year, you will see more growth from some of those 5 tenant approvals that are upcoming. And then yes, then we'll just continue to grow up there. And then on the PST side, you'll see consistent revenue trajectory like you've seen in the last couple of years.

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

Chase Knickerbocker: I just want to echo Frank's comments. Obviously, we wish you the best, Linda and all your future endeavors. I appreciate everything you've done there, which is quite a bit. So -- and obviously, congrats Adam on the new role as well. Maybe just first for me on the Domestic side. 18% growth is obviously substantially above the market. Can you give us some sense for what's happening in the market is allowing you to take so much share? And maybe 1 and then 2 on that front, how should we think about the opportunity for further share gains in 2026 after a pretty strong year in '25?

Linda Tharby: So thanks, Chase, for the well wishes. I appreciate it, and you and the Craig-Hallum team have been great. So first, yes, very proud of the U.S. growth in the fourth quarter. We continue to see new account gains overall on that business. And of course, we had the return happen of the distributor in international that move back to the U.S. So as we projected, all that business is now back, which is great news. I'll give it to Tom, maybe to add some specifics on the U.S. and what we might see in '26.

Tom Adams: Yes. So in '26, as I mentioned, we continue to see a strong SCIg market, and we expect that to continue to grow throughout the course of the year. And then, as I just mentioned to Frank, as we continue to receive approvals for new drugs on label throughout the year, we expect some growth off of that as well. So we will continue to see that revenue grow sequentially in the U.S. market. .

Chase Knickerbocker: Maybe on that front, on the novel therapies that we're adding, particularly in the second half. Can you give us a sense for kind of the magnitude of impact there? And then just second for you, Tom. If we think about EBITDA in the year, obviously, a little bit kind of open-ended on guidance. Can you give us a sense for how much operating leverage we should kind of expect from you guys in '26? Obviously, low single-digit OpEx growth in '25 was quite a bit of operating leverage. Can you just give us some goalposts as far as what we should be expecting for OpEx growth in '26?

Linda Tharby: So maybe I'll just start with novel therapies and the overall impact that we're thinking about. And what I would say is we have changed its name to pharmaceutical services and clinical trials. So we're still figuring that out here, but now we're calling that our PSD business. So obviously, in terms of overall revenues, these revenues are milestone-based upon the overall innovations and clinical trials that we're servicing. So that number I would suggest has always been around where it's been historically.

So not to expect anything new there, but obviously, very excited about the two new deals that we signed this past quarter, and maybe I'll turn it over to Adam just to talk a little bit more about that.

Adam Kalbermatten: Yes. Thanks, Linda. So over the last quarter, we signed two new deals with pharmaceutical companies. One of them is a nephrology drug that's in Phase III. We're really excited about that. The other one is molecule in early Phase I. It's a multi-indication drug. In total, this represents approximately 3 million annual infusions between the two of them. So really excited to add those into our pipeline and get the work going on the feasibility side to keep these moving through the pharmaceutical pipeline and into our future prospects.

Linda Tharby: Thanks, Adam. And I think before I just turn it over, I think what you were looking for as well here, Chase was the new drugs on label, and what we see in the near term with RYSTIGGO, and then the other two drugs vancomycin and deferoxamine. Overall, I think a couple of things. First of all, that many of these drugs are administered in infusion clinics. So that is a new entry point for us, and we've already started to hear some of our customers say, "Hey, can we try these other drugs." So we see that as a broader opportunity, one which I'm not going to put a number on today.

But I think the numbers that we've mentioned in the past for these 3 drugs in total, somewhere between $0.5 million upwards of $0.5 million of opportunities. We've got a modest number today knowing that two of those drugs are not approved yet. And so we'll refresh the models as time goes on, and we learn more and see how many new accounts we can gain. I would also say on RYSTIGGO, we already had a large portion of that business off label. So excited for the entry. We're already hard at work there, and we'll have more to report as quarters go on. And Tom, a question on the operating leverage.

Tom Adams: Yes. Just on the EBITDA, Chase, we continue -- last year was a great year for us. We had adjusted EBITDA positive. We're excited about that. We're excited to hit cash flow positivity. And as I mentioned in the guidance, we will be positive adjusted EBITDA once again and continuing to grow from there as well as cash flow positive for the full year, not just in operations, but for the full year. So we're excited about that again. We will continue to see leverage because our business model allows it with the way our SG&A is set up in our business.

So we'll get more specific on that as the year funds through, but we expect to continue to progress on those fronts.

Operator: Our next question is from Caitlin Roberts with Canaccord Genuity.

Caitlin Cronin: Linda, I'm so sad to see you go, but you're truly an inspiration to women and meta-like in the industry. So thank you so much. I guess just starting with RYSTIGGO, how are you thinking about the go-to-market model here in infusion clinics? And how does this really position you to penetrate the oncology opportunity more quickly when cleared?

Linda Tharby: Right. So first, Caitlin, thank you so much. The Canaccord team has been great. And you personally, right back at you in terms of women in leadership, and thank you to all the men who support us in doing what we do. So getting to the overall RYSTIGGO opportunity and how that entry into infusion clinics, I would say, broadly, what we discussed in the earnings was that RYSTIGGO, we see is about 20,000 infusions in the U.S. here today, going to about 100,000 infusions over the course of the next 5 years and even a bigger opportunity globally, which we're at early stages of looking at today. .

In terms of infusion clinics and our entry strategy, fortunately for us, this channel today is many of the same specialty pharmacies we deal with are dealing with this channel. I'm going to let Adam say a few words in a moment relative to he's thinking about anything broader relative to our infusion clinic entry, but I would certainly say that oncology infusion center, which I understand can be a little confusing, but oncology infusion centers are different than ambulatory infusion centers and sometimes there's an overlap. So we see this as good for our pending oncology opportunity. It gives us a leap and head start, and then a broader opportunity once we get approval in oncology.

Adam, I don't know if you want to add anything.

Adam Kalbermatten: Thanks, Linda. Caitlin, I'll start by saying this is our first collaboration with UCB, and it diversifies our revenue beyond just CIG in a meaningful way. On the strategic side, it's significant because as you mentioned, it opens up a new commercial channel for us beyond the home and that's into the infusion clinics. And we see there's a lot more opportunity there in the future beyond RYSTIGGO. As Linda mentioned, we do have off-label sales there today. We look forward to continuing to grow that now that we have the product on label and we could be promoting it. So I want to highlight UCB's reported just over 65% year-on-year growth in global RYSTIGGO sales.

So we see this drug has a lot of momentum, and we're really looking forward to continue helping to bring value there. So acknowledging, we've had some really great success over the last few years here under Linda's leadership. The strategic priorities don't change. We have a proven strategy really built around 3 pillars: protecting and growing the Core Domestic business, expanding internationally and enabling more drugs to reach more patients. So I focus really on accelerating the execution against those pillars. I see it as we have a lot of runway in front of us and my job is to make sure we're running as fast and as efficiently as possible towards those opportunities.

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

Joseph Downing: Linda and Tom. First and foremost, Linda, I wanted to congratulate you on your retirement. It's been a pleasure working with you and wishing you all the best in the future. Yes, I just wanted to touch on the guidance range here. So it was pretty much in line with where we expected. Just looking at kind of the high end and low end, how you get to each. Curious if you can walk through that. I'm curious if on the low end is a scenario kind of where the new drug clearances and OUS prefill conversions slip into 2027 a little bit. And then the high end is more of you execute everything on schedule in '26.

Just curious if you could walk through a little bit more detail there?

Linda Tharby: Great. Joe, thank you, and you and your Piper colleagues have been great, and congratulations to you on your recent promotion as well. So referring to the guidance range, I think you had it right. Prefills and the new drugs on label would be -- those are the things that vary. If we get prefill conversions faster, the markets get going faster. That's a great thing. And also new drugs, we get further traction or we get them on our label sooner, there's another big opportunity. The other third piece would be a little bit about the Middle East, which we've got a little bit of a factor in here and depending on the timing of that.

And then finally, I would just say, oncology is something we do not have today, a big number in here at all, a very small number. So if we get a bigger head start on oncology or we're looking at new drugs now, I think that could be a meaningful area for us as well.

Joseph Downing: I appreciate that and for your comments. One more just on Japan. I know it's been kind of a deemphasized piece of the business with all the great stuff going on in some of the other U.S. markets, but just curious like where you're looking at that for 2026 guidance or expectations there just at a higher level. And is there a point there where the pharma-driven prefill opportunity kind of opens up and makes Japan kind of move back up the list? Yes. Just any color there would be helpful.

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

Adam Kalbermatten: Yes. Thanks, Linda. In Japan, I'll start with good news, right? So both pumps are approved. Consumables are approved as well. So we're pretty well positioned to continue to grow in that market. At the time we're seeing prefilled syringes there as being important, just as we kind of see in these other international markets. So as those prefills continue to grow, we expect that we're going to be growing with them. So it's a pretty exciting opportunity for us.

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

Linda Tharby: Right. Thank you, operator. I would just want to say thank you to all of you again. I have so appreciated all of your support your guidance, and most of all, your partnership in working with everyone on the call. Thank you all for taking some time with us this afternoon. Incredibly proud I want to say my last thanks to this entire KORU team, to my daughters who actually listened into an earnings call for a change. I told them there were some big news today. So I think they listened in. So thank you to my daughters. Thank you to our Board. Thank you to our investors I'm not gone yet.

I am a big investor and will remain so and I look forward to working with all of you as this retirement goes on. But I'm here, as I said, to the end of June, looking forward to supporting Adam and the team and through the end of the year. Have a great rest of your day, and thank you so much.

Operator: This concludes today's conference. You may disconnect your lines at this time. Thank you again for your participation.

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