Q4 2025 KORU Medical Systems Inc Earnings Call

March 12, 2026

Operator: Greetings, and welcome to the KORU Medical Systems Q4 2025 Earnings Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Louisa Smith, Investor Relations. Please go ahead.

Speaker #1: Greetings, and welcome to the KORU Medical Systems fourth quarter 2025 earnings call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation.

Speaker #1: If anyone should require operator assistance, please press *0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Louisa Smith, Investor Relations.

Speaker #1: Please go ahead.

Speaker #2: 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 Kalbermaten, Chief Commercial Officer.

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 Q4 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: Actual events and 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.

Louisa Smith: 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 reconciliation 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, 12 March 2026, at approximately 4:30 PM 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.

Speaker #2: 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 the reconciliation of these non-GAAP measures with comparable GAAP measures, in our press release, the accompanying investor presentation, and SEC filings.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: Linda, please go ahead.

Speaker #3: 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.

Linda Tharby: Good afternoon, everyone, and thanks for joining us today. Before I provide further detail on our Q4 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 five fulfilling years, I have made the decision to retire and will resign as CEO of KORU Medical Systems effective 30 June. This has been one of the most meaningful chapters of 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.

Speaker #3: After five 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 of my career, and I am proud of what we have built together.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: This transition has been thoughtfully planned by the board, and I am very pleased to announce that Adam Kalbermaten, our Chief Commercial Officer, has been selected as my successor.

Linda Tharby: 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+-year career in drug delivery, spanning large and small med tech companies and including a CEO role where he led an effective turnaround in growth strategies 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.

Speaker #3: 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.

Speaker #3: 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 medtech companies, and including a CEO role where he led an effective turnaround and growth strategy that resulted in a successful acquisition by Becton Dickinson.

Speaker #3: 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 medtech and pharma experience across the executive leadership team, KORU has the strategic depth needed to continue to drive our growth potential.

Linda Tharby: 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 15 March and will assume the role of CEO on 1 July. 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Linda Tharby: 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. Now with that out of the way, let's turn to our Q4 and full year results. I'll begin with some commentary on our Q4 and full year highlights and strategic progress. 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Linda Tharby: 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 Q4 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 Q4, domestic and international core grew 18% and 71% respectively, driven by a recurring base of approximately 59,000 patients.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: 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.

Speaker #3: Driven by a recurring base of approximately 59,000 patients. We received EU MDR certification for the Freedom 60 with pre-filled syringe compatibility, marking a critical regulatory milestone that positions us to pursue the ongoing vow to pre-filled syringe conversion across Europe.

Linda Tharby: We received EU MDR certification for the Freedom60 with prefilled syringe compatibility, marking a critical regulatory milestone that positions us to pursue the ongoing vial 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.

Speaker #3: We also received 510(k) clearance for Ristigo in January, which marks the ninth drug cleared on the Freedom Infusion System, and our second non-IG clearance.

Speaker #3: This is a step in our strategy to expand our platform beyond IG in an opens a meaningful new channel for us in the infusion clinic setting.

Speaker #3: I'll speak to further details on the Ristigo 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.

Speaker #3: A phase three nephrology molecule and a phase one multi-indication drug. We ended the year with $8.9 million in cash and achieved positive cash flow from operations.

Linda Tharby: 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 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. Healthcare continues to move from the hospital to infusion centers to the home, and large volume subcutaneous infusion is a direct beneficiary of that shift.

Speaker #3: Continuing the progress we've made towards sustained profitability, we are building on that momentum and initiating 2026 revenue guidance of $47.5 to $50 million, representing growth of 15% to 22%, and positive adjusted EBITDA and cash flow positive for the full year.

Speaker #3: Tom will provide additional color on our guidance and underlying assumptions. Now, moving to a few comments on our strategy. Healthcare continues to move from the hospital to infusion centers to the home.

Speaker #3: 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 US and external forecasts project continued 8% to 10% growth over the next five years.

Linda Tharby: In our core SCIg business, we operate in a greater than $450 million global market where penetration versus IVIG remains below 20% in the US, and external forecasts project continued 8% to 10% growth over the next five years. We have seven 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 Sub-Q formulations across broader therapeutic areas.

Speaker #3: We have seven 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.

Speaker #3: 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.

Speaker #3: And there are significant investments going into subQ formulations across broader therapeutic areas. A large part of our strategy is enabling the administration of those drugs on our system.

Linda Tharby: 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 account 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.

Speaker #3: 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.

Speaker #3: 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 five years.

Speaker #3: 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 account and pharma collaborations.

Speaker #3: We are also beginning to diversify our business. The clearance of Ristigo, a non-IG drug, enables our entry into the infusion clinic channel. With our filing of 510(k) for FESCO in the fourth quarter of 2025, we are also anticipating entry into the oncology market in the second half of 2026.

Linda Tharby: With our filing of the 510(k) for Phesgo in Q4 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 US, 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 US 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.

Speaker #3: We are also closely watching the evolving clinical activity around secondary immunodeficiency or SID. Outside the US, 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.

Speaker #3: 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.

Speaker #3: As reimbursement coverage expands in this area, it could meaningfully broaden our US 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.

Speaker #3: 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.

Linda Tharby: 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 systems. Combined with the earlier FreedomEdge MDR clearance, we now have two cleared pumps for prefilled administration. Our system was preferred by over 75% of patients due to its ease of use.

Speaker #3: 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 pre-filled syringes.

Speaker #3: The shift from vials to pre-filled syringes simplifies the administration process significantly. With up to 80% reduction in drug preparation tasks, this last quarter received our MDR certification in the EU for our KORU Freedom 60 system.

Speaker #3: Combined with the earlier Freedom Edge MDR clearance, we now have two clear pumps for pre-fill administration. Our system was preferred by over 75% of patients due to its ease of use.

Speaker #3: 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.

Linda Tharby: 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 two 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. 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.

Speaker #3: With two MDR-cleared pumps, a system that is patient-preferred, and pharma driving a broad shift to pre-filled syringes, we are well positioned to continue taking share.

Speaker #3: 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 nine active opportunities.

Speaker #3: That combined represents more than 7 million annual infusions worldwide. Within the next year, we anticipate having three commercial-stage assets on our label: vancomycin, cefuroximin, and the FESCO oncology opportunity.

Speaker #3: Together, these represent approximately 2.2 million estimated annual global infusions. Two of those nine opportunities are new this last quarter. A phase three nephrology drug and a phase one multi-indication drug.

Linda Tharby: 2 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 a 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 are 6 active collaborations with the major IG manufacturers, spanning new device formats and expanded indications. Work that directly supports continued share gains and geographic expansion as those programs move towards launch.

Speaker #3: We are working with our pharmaceutical partners to help advance the delivery of these molecules. Once launched, they are expected to represent a combined commercial opportunity of approximately 3 million annual have nine subcutaneous drugs cleared for use with the Freedom infusion system.

Speaker #3: IG representing approximately 5.4 million annual infusions and non-IG representing approximately 250,000 infusions. On the IG side are six active collaborations with the major IG manufacturers spanning new device formats and expanded indications, work that directly supports continued share gains and geographic expansion as those programs move towards launch.

Speaker #3: When you step back and look at the full picture, nine subcutaneous drugs on-label with low penetration, nine 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.

Linda Tharby: 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. 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 US, this represents a patient population of approximately 60,000 patients.

Speaker #3: And now let me spend a moment on Ristigo, for which we received 510(k) clearance on our Freedom Infusion System in January. Ristigo 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.

Speaker #3: In the US, 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.

Linda Tharby: 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 US market opportunity to be about 20,000 infusions in 2025, growing to over 100,000 infusions in 2030. It's worth noting that RYSTIGGO has already been used off-label with their 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've built. With strong patient growth in our US and international markets and meaningful pharma pipeline progress across both IG and non-IG opportunities, we're well-positioned heading into 2026.

Speaker #3: 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 Ristigo has already been used off-label with the Freedom infusion system.

Speaker #3: 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.

Speaker #3: I'm extremely proud of the team's execution and the strong momentum we've built. With strong patient growth in our US and international markets and meaningful pharma pipeline progress across both IG and non-IG opportunities, we're well positioned heading into 2026.

Speaker #3: I'll now turn the call over to Tom to review our financial results and guidance for 2026.

Linda Tharby: I'll now turn the call over to Tom to review our financial results and guidance for 2026.

Speaker #2: 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 three consecutive quarters of greater than 20% revenue growth.

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. Pre-filled 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.

Speaker #2: A reflection of the momentum we've built across the business. Breaking down the performance by business, domestic KORU grew 18% year-over-year, driven by the SCIG market, which grew between 8% to 10% in the quarter.

Speaker #2: New KORU patient starts and market share gains, resulting in higher pump and consumable volumes. International KORU grew 71% year-over-year, fueled by new patient starts and increased penetration into established European markets.

Speaker #2: Pre-filled 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.

Speaker #2: This business is inherently variable, given the milestone-based nature of revenue recognition. The decrease reflects timing of contract milestones where work was completed and does not reflect a change in the activity level of our collaboration portfolio.

Tom Adams: The decrease reflects timing of contract milestones for work completed and does not reflect a 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 US, which we discussed in the Q3 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.

Speaker #2: 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.

Speaker #2: Domestic KORU 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 distributor selling back to the US, which we discussed in the third quarter call, underlying growth would have been 14% for the full year.

Speaker #2: International KORU grew 80% for the full year, driven by strong SCIG market growth. Our growing footprint in European markets and entry into several new geographies.

Speaker #2: Accounting for the international 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.

Tom Adams: 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 last year's Q4, driven by higher material costs and tariffs that were mostly offset by a stronger customer mix in the US, 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 60% every quarter and on a full year basis.

Speaker #2: Moving to gross margin, we had a 30 basis point reduction over last year's Q4, driven by higher material costs and tariffs. That was mostly offset by a stronger customer mix in the US, where we have higher average selling prices.

Speaker #2: 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.

Speaker #2: Despite these headwinds, we remain resilient in keeping margins above 60% every quarter and on a full-year basis. Regarding cash, we ended the year with $8.9 million in cash, representing full-year cash usage of $700,000.

Tom Adams: 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 Q3 and Q4 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 maintain 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.

Speaker #2: 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 discipline spending that enabled a further reduction in net losses.

Speaker #2: 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.

Speaker #2: 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.

Speaker #2: 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 three consecutive quarters of positive adjusted EBITDA.

Tom Adams: Second, we delivered positive adjusted EBITDA of $600,000, a 124% improvement versus the prior year, marking three 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 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 US and international share gains in SCIg, NRE revenue from at least four new collaborations, two already signed, and modest incremental revenue from recent or soon-to-be-cleared 510(k) filings.

Speaker #2: Together, this reflects significant P&L improvement as we march towards profitability. Looking ahead to 2026, we are initiating guidance of $47.5 to $50 million in revenue, representing growth of 15% to 22%, and gross margins for the full year of 61% to 63%.

Speaker #2: 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, and SCIG, NRE revenue from at least four new collaborations—two already signed—and modest incremental revenue from recent or soon-to-be-cleared 510(k) filings.

Speaker #2: 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 pre-fill inventory build and a key EU market.

Tom Adams: 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 pre-fill 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 pre-filled 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.

Speaker #2: 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 pre-filled syringes into new geographies.

Speaker #2: 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.

Speaker #2: We also have planned for startup costs for the new production line for the next generation pumps. We are confident that we will continue to offset incremental external pressure and costs with our operational excellence programs.

Tom Adams: 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.

Speaker #2: On profitability, we are guiding to 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.

Speaker #2: I'll now turn the call back to Linda for closing remarks.

Speaker #1: 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, and our domestic KORU, we have gained the UCB risk-to-go 510(k) clearance, and our Roche FESCO 510(k) application submitted on time in December, giving us two new non-Ig drugs currently moving to commercial potential in 2026.

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 pre-filled syringe compatibility, and we have now begun to ship that product into the EU market, anticipating pre-filled conversions in several EU markets.

Speaker #1: We also have our next-generation pump, the Freedom 360, expected to have 510(k) and MDR submissions this year. The Phase Two flow controller 510(k) submission is projected for a global submission either in late 2026 or early 2027.

Speaker #1: Internationally, we have achieved MDR clearance of our Freedom 60 with pre-filled syringe compatibility and we have now begun to ship that product into the EU market, anticipating pre-fill conversions in several EU markets.

Speaker #1: On our efforts to add new drugs to our label, we have signed two of our four new collaborations, and anticipate two additional 510(k) submissions this year for Deferoxamine and Vancomycin.

Linda Tharby: 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 US market that is growing 8% to 10%, where we consistently outperform market growth rates.

Speaker #1: 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 foundations that we have built for our business, some of our recent accomplishments, and finally, where we believe we are headed.

Speaker #1: 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.

Speaker #1: With approximately 95 large-volume drugs in development by major pharmaceutical companies, we have a leading position in a U.S. market that is growing 8 to 10 percent, where we consistently outperform market growth rates.

Speaker #1: 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.

Linda Tharby: 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. 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% improvement in cash burn and a 124% improvement in adjusted EBITDA for 2025.

Speaker #1: And looking ahead, we have nine pipeline drug opportunities outside of IG, with risk-to-go and our oncology market entry representing near-term commercial opportunity in 2026.

Speaker #1: 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 percent, where we have attractive gross margins, and where we have proven the operating efficiency of our business model.

Speaker #1: Delivering a 63% improvement in cash burn and a 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.

Linda Tharby: 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.

Speaker #1: $100 million in revenue, accelerated growth rates, gross margins above 65 percent, and an EBITDA margin of 20 percent or greater. 2025 performance shows that the model is working.

Linda Tharby: $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.

Speaker #1: 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.

Speaker #1: 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.

Speaker #1: 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.

Linda Tharby: Operator, please open the line for questions.

Speaker #2: Thank you. Now, 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.

Operator: Thank you. We're now conducting a question and answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys. One moment please while we poll for questions. Thank you. Our first question is from Frank Takkinen with Lake Street Capital Markets.

Speaker #2: You may press star two to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up the handset before pressing the star keys.

Speaker #2: One moment, please, while we pull for questions. Thank you. Our first question is from Frank Takkanen with Lake Street Capital Markets.

Speaker #3: Great. Thank you for taking the questions. 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.

Frank Takkinen: Great. Thank you for taking the questions. 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. 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? Then two, you've spoken about, I wanna say it's five geographies that you plan to enter. How should we think about the cadence of those geographies and the progress so far?

Speaker #3: 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 Freedom 60. 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 five geographies—that you plan to enter.

Speaker #3: How should we think about the cadence of those geographies, and the progress so far?

Speaker #4: Good afternoon, Frank. And thank you. It has been an extreme pleasure working with you and the broader Lakestreet team. Clearly, very confident as we think about Adam stepping into role, and the broader team that surrounds him.

Linda Tharby: Good afternoon, 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. 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. Obviously, if you position that share closer to our 60% US share, you see the magnitude of the opportunity we have in front of us in Europe.

Speaker #4: So, on your questions on the Freedom 60 and the opportunity that lies ahead of us, maybe I'll just start with the broader opportunity. We're going after a $50 million total addressable market in Europe.

Speaker #4: We are very successful in 2025 in moving our share position from a 10 to a 20 percent share. But obviously, if you position that share closer to our 60 percent U.S. share, you see the magnitude of the opportunity we have in front of us in Europe.

Speaker #4: So most of that opportunity and share gain in 2025 was driven by a successful pre-fill 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.

Linda Tharby: Most of that opportunity and share gain in 2025 was driven by a successful prefill conversion in a major market in Europe. 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. The five geographies you refer to are not new markets for us, but they are markets we're in today, but with fairly low penetration, and we see the opportunity in prefills to really grow that market significantly. What we see today is that we have our second market. We've started our year off strong in 2026 with our second market that's really going live now with this prefill launch.

Speaker #4: And the five geographies you referred to are not new markets for us, but they're markets we're in today. But with fairly low penetration and we see the opportunity in pre-fills to really grow that market significantly.

Speaker #4: 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 pre-fill launch.

Speaker #4: And we expect to see, likely, a new market being added—one to two every quarter—as we move through the year. I think the last part of the question was just the FREEDOM60 and the new approval.

Linda Tharby: 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 two 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 Q4 of 2026. Great news for us. We've now just started distributing that new product into the market today. Of course, what comes at the back end of the year is our Freedom360, which is our pump that will work for all prefills.

Speaker #4: Very excited about that because now we have two pumps both our 60 and our edge that are both approved. We required some slight modifications to our Freedom 60 and an update to our IFU.

Speaker #4: 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.

Speaker #4: And of course, what comes at the back end of the year is our Freedom 360, which is our pump that will work for all pre-fills.

Speaker #4: So hopefully that got all of those questions.

Linda Tharby: Hopefully that got all of those questions.

Speaker #3: Perfect. Thank you. 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.

Frank Takkinen: Perfect. Thank you. 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 US. How should we think about that growth rate, OUS. And then any cadence in color you'd like to provide would be great too. Thanks.

Speaker #3: But maybe how much contribution from US? How should we think about that growth rate? OUS? And then any cadence in color you'd like to provide would be great too.

Speaker #3: Thanks.

Speaker #5: Yeah. Hi, Frank. Thanks for the question. Yeah, 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.

Tom Adams: Hi, Frank. Thanks for the question. Great. We're continuing to see momentum coming into Q1 after a record Q4. That's very strong for us, particularly on the international side. As mentioned earlier, prefill still is a driver of that market. We continue to see that progress. I would say 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. On the US side, I think that's slow and steady. I mean, we've, you've seen the last couple years a pretty steady growth rate on the US side.

Speaker #5: So as mentioned earlier, pre-fill 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.

Speaker #5: Based on what Linda just mentioned and some of those countries, going online for pre-fills. And then on the US side, I think that's slow and steady.

Speaker #5: I mean, you've seen the last couple of years a pretty steady growth rate. On the US side. And then, of course, as we get further along into the year, you will see more growth from some of those 510 approvals that are upcoming.

Tom Adams: Of course, as we get further along into the year, you will see more growth from some of those 510(k) approvals that are upcoming. We'll just continue to grow off of there. On the PST side, you'll see consistent revenue trajectory like you've seen the last couple of years.

Speaker #5: And then, yeah, then we'll just continue to grow off of there. And then on the PST side, you'll see consistent revenue trajectory like you've seen the last couple of years.

Speaker #3: Okay. That's helpful. Thanks for taking the questions. Our next question is from Chase Knickerbocker with Craig Hallam Capital Group.

Frank Takkinen: Okay. That's helpful. Thanks for taking the questions.

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

Speaker #6: Good afternoon. Just want to echo Frank's comments. Obviously, we wish you the best, Linda, and all your future endeavors. Appreciate everything you've done here, which is quite a bit.

Chase Knickerbocker: Good afternoon. Just wanna echo Frank's comments. Obviously, we wish you the best, Linda, in all your future endeavors. Appreciate everything you've done here, which is quite a bit. Obviously congrats, Adam, on the new role as well. Maybe just first for me on the domestic side. You know, 18% growth is obviously substantially above the market. Can you give us some sense for what's happening in the markets allowing you to take so much share? Maybe one, and then two on that front, you know, how should we think about the opportunity for further share gains in 2026 after a pretty strong year in 2025?

Speaker #6: 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.

Speaker #6: Can you give us some sense for what's happening in the markets allowing you to take so much share? And maybe one, and then two on that front, how should we think about the opportunity for further share gains in 2026 after a pretty strong year in '25?

Speaker #4: So, thanks, Chase, for the well wishes. 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.

Linda Tharby: Thanks Chase for the well wishes. Appreciate it. You and the Craig-Hallum team have been great. First, yes, very proud of the US growth in Q4. We continue to see new account gains overall on that business. Of course, we had the return happen of the distributor in international that moved back to the US. 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 US and what we might see in 2026.

Speaker #4: 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 moved back to the US.

Speaker #4: 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 US and what we might see in '26.

Speaker #5: Yeah. So in '26, as I mentioned, we continue to see a strong SEIG market. And we expect that to continue to grow throughout the course of the year.

Tom Adams: Yeah. In 2026, as I mentioned, you know, we continue to see a strong SCIg market, and we expect that to continue to grow throughout the course of the year. 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. We will continue to see that revenue grow sequentially in the US market.

Speaker #5: 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.

Speaker #5: So, we will continue to see that revenue grow sequentially in the US market.

Speaker #6: 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?

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? Then just second for you, Tom, you know, if we think about EBITDA in the year, obviously a little bit of kind of open-ended on guidance. Can you give us a sense for, you know, how much operating leverage we should kind of expect from you guys in 2026? Obviously, you know, low single digit OpEx growth in 2025 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 2026?

Speaker #6: And then just second for you, Tom, if we think about EBITDA on the year, obviously a little bit of kind of open-ended on guidance.

Speaker #6: 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.

Speaker #6: Can you just give us some goalposts as far as what we should be expecting for OPEX growth in '26?

Speaker #4: 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 this name to pharmaceutical services and clinical trials.

Linda Tharby: Maybe I'll just start with novel therapies and the overall impact that we're thinking about. What I would say is, we have changed this name to pharmaceutical services and clinical trials. We're still figuring that out here, but now we're calling that our PST business. Obviously, in terms of overall revenues, these revenues are milestone-based, based upon the overall innovations and clinical trials that we're servicing. That number, I would suggest, has always been around where it's been historically. Not to expect anything new there, but obviously very excited about the two new deals that we signed this past quarter. Maybe I'll turn it over to Adam just to talk a little bit more about that.

Speaker #4: So we're still figuring that out here. But now we're calling that our PST business. So obviously, in terms of overall revenues, these revenues are milestone-based, based upon the overall innovations and clinical trials that we're servicing.

Speaker #4: So that number, I would suggest is 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.

Speaker #4: And maybe I'll turn it over to Adam just to talk a little bit more about that.

Speaker #3: Yeah. Thanks, Linda. So over the last quarter, we signed two new deals with pharmaceutical companies. One of them is in nephrology drug that's in phase three.

Adam Kalbermatten: Yeah. Thanks, Linda. Over the last quarter, we signed 2 new deals with pharmaceutical companies. One of them is a nephrology drug that's in phase 3. We're really excited about that. The other one's a molecule in early phase 1. It's a multi-indication drug. In total, this represents approximately 3 million annual infusions between the two of them. 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.

Speaker #3: We're really excited about that. The other one's a molecule in early phase one. It's a multi-indication drug. In total, this represents approximately 3 million annual infusions between the two of them.

Speaker #3: 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.

Speaker #4: 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.

Linda Tharby: Thanks, Adam.

Adam Kalbermatten: Yeah.

Adam Kalbermatten: 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 nearer term with risdiplam 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. 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?" We see that as a broader opportunity, one which I'm not gonna put a number on today.

Linda Tharby: 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 nearer term with risdiplam 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. 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?" We see that as a broader opportunity, one which I'm not gonna put a number on today.

Speaker #4: And what we see in the near term, with Ristigo and then the other two drugs, vancomycin and deparoxetine, overall, I think a couple of things.

Speaker #4: First of all, many of these drugs are administered in infusion clinics, so that is a new entry point for us. 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.

Speaker #4: 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 three drugs in total, somewhere between half a million, upwards of a half a million dollars of opportunities.

Linda Tharby: I think the numbers that we've mentioned in the past for these three drugs in total, somewhere between half a million upwards of half a million dollars of opportunity. We've got a modest number today knowing that two of those drugs are not approved yet. You know, 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 risdiplam, we already had a large portion of that business off label. Excited for the entry. We're already hard at work there, and we'll have more to report as quarters go on. Tom, question on the operating leverage.

Speaker #4: 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.

Speaker #4: I would also say, on Ristigo, we already had a large portion of that business off-label. So, excited for the entry. We're already hard at work there.

Speaker #4: And we'll have more to report as the quarters go on. And Tom, question on the operating leverage.

Speaker #5: Yeah. Just on the EBITDA, Chase. We continue last year was a great year for us. We hit adjusted EBITDA positive. We're excited about that.

Tom Adams: Yeah, just on the EBITDA, Chase. Last year was a great year for us. You know, we hit adjusted EBITDA positive. We're excited about that. We're excited to hit cash flow positivity. As I mentioned in the guidance, you know, we will be positive adjusted EBITDA once again and continuing to grow from there, as well as, you know, cash flow positive for the full year, not just in operations, but for the full year. 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. We'll get more specific on that as the year runs through, but we expect to continue to progress on those fronts.

Speaker #5: 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 the growth from there, as well as cash flow positive for the full year, not just an operations, but for the full year.

Speaker #5: 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.

Speaker #5: So, we'll get more specific on that as the year runs through, but we expect to continue to progress on those fronts.

Speaker #6: Understood. Thanks, guys.

Chase Knickerbocker: Understood. Thank you.

Speaker #3: Now our next question is from Caitlin Roberts with Canacor Genuity.

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

Speaker #7: Great. Thanks so much for taking the questions and, Linda, I'm so sad to see you go. But you're truly an inspiration to women and men alike in the industry.

Caitlin Cronin: Great. Thanks so much for taking the questions. Linda, I'm so sad to see you go, but you're truly an inspiration to women and men alike in the industry. Thank you so much. I guess just starting with Risdiplam, how are you thinking about the go-to-market model here in infusion clinics? How does this really position you to penetrate the oncology opportunity more quickly when cleared?

Caitlin Roberts: Great. Thanks so much for taking the questions. Linda, I'm so sad to see you go, but you're truly an inspiration to women and men alike in the industry. Thank you so much. I guess just starting with Risdiplam, how are you thinking about the go-to-market model here in infusion clinics? How does this really position you to penetrate the oncology opportunity more quickly when cleared?

Speaker #7: So thank you so much. I guess just starting with Ristigo, 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?

Speaker #4: Right. So first, Caitlin, thank you so much. The Canacor team has been great. And you personally right back at you in terms of women in leadership.

Linda Tharby: Right. First, Caitlin, thank you so much. The Canaccord team has been great, and you personally, you know, 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. Getting to the overall RYSTIGGO opportunity and how that entry into infusion clinics, I would say broadly what we discussed in this earnings was that, RYSTIGGO we see as about 20,000 infusions in the US here today, going to about 100,000 infusions over the course of the next five years. Even a bigger opportunity globally, which we're at early stages of looking at today.

Speaker #4: And thank you to all the men who support us in doing what we do. So getting to the overall Ristigo opportunity, and how that entry into infusion clinics, I would say broadly what we discussed in the earnings was that Ristigo, we see as about 20,000 infusions in the US here today going to about 100,000 infusions over the course of the next five years.

Speaker #4: 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.

Linda Tharby: 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 gonna let Adam say a few words in a moment relative to if he's thinking about anything broader relative to our infusion clinic entry. I would certainly say that oncology infusion centers, which I understand can be a little confusing, but oncology infusion centers are different than ambulatory infusion centers, and sometimes there's an overlap. 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 wanna add anything.

Speaker #4: I'm going to let Adam say a few words in a moment, relative to his thinking about anything broader relative to our infusion clinic entry.

Speaker #4: But I would certainly say that oncology infusion centers which I understand can be a little confusing, but oncology infusion centers are different than ambulatory infusion centers.

Speaker #4: 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.

Speaker #4: Adam, I don't know if you want to add anything.

Speaker #3: Thanks, Linda. Hi, Caitlin. I'll start by saying this is our first collaboration with UCB, and it diversifies our revenue beyond just SCIG in a meaningful way.

Adam Kalbermatten: Thanks, Linda. Hi, Caitlin. You know, I'll start by saying, you know, this is our first collaboration with UCB, and it diversifies our revenue beyond just SCIg 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. You know, 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 can be promoting it. You know, wanna highlight UCB's reported over 65% year-on-year growth in global RYSTIGGO sales.

Speaker #3: 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.

Speaker #3: And we see there's a lot more opportunity there in the future beyond Ristigo. 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 can be promoting it.

Speaker #3: So I want to highlight UCB's reported over 65% year-on-year growth in global Ristigo sales. So we see this drug has a lot of momentum.

Adam Kalbermatten: We see this drug has a lot of momentum, and we're really looking forward to continuing helping to bring value there.

Speaker #3: And we're really looking forward to continuing helping to bring value there.

Speaker #7: Awesome. And Adam, while I have you, just curious: what is your vision for the company as you take the helm, coming from the seat that you're currently in?

Caitlin Cronin: Awesome. Adam, while I have you, just curious what your vision for the company is as you take the helm, you know, coming from the seat that you're currently in?

Caitlin Roberts: Awesome. Adam, while I have you, just curious what your vision for the company is as you take the helm, you know, coming from the seat that you're currently in?

Speaker #4: Yeah. 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 three pillars: protecting and growing the core domestic business, expanding internationally, and enabling more drugs to reach more patients.

Adam Kalbermatten: Acknowledging we've had some really great success over the last two years here under Linda's leadership, you know, the strategic priorities don't change. We have a proven strategy really built around three pillars, protecting and growing the core domestic business, expanding internationally, and enabling more drugs to reach more patients. My focus is 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.

Speaker #4: So my focus is really on accelerating the execution against those pillars. I see it as we have a lot of runway in front of us.

Speaker #4: And my job is to make sure we're running as fast and as efficiently as possible towards those opportunities.

Speaker #7: Awesome. Thanks so much.

Caitlin Cronin: Awesome. Thanks so much.

Caitlin Roberts: Awesome. Thanks so much.

Speaker #3: And a reminder, if you'd like to ask a question, please press star one. Now our next question is from Joseph Dowing with Piper Sandler.

Operator: As a reminder, if you'd like to ask a question, please press star one. Our next question is from Joseph Dowling with Piper Sandler.

Speaker #5: Hey, Linda and Tom. First and foremost, Linda, I wanted to congratulate you on your retirement. It's been a pleasure working with you, and I wish you all the best in the future.

Joseph Dowling: Hey, 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. Yeah, I just wanted to touch on the guidance range here. It was pretty much in line with what we expected. Just looking at, you know, 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, it's a scenario kinda where the new drug clearances and OUS prefill conversions slip into 2027 a little bit, and then the high end is more of, you know, you execute everything on schedule in 2026. Just curious if you could walk through a little bit more detail there.

Joseph Downing: Hey, 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. Yeah, I just wanted to touch on the guidance range here. It was pretty much in line with what we expected. Just looking at, you know, 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, it's a scenario kinda where the new drug clearances and OUS prefill conversions slip into 2027 a little bit, and then the high end is more of, you know, you execute everything on schedule in 2026. Just curious if you could walk through a little bit more detail there.

Speaker #5: Yeah, I just wanted to touch on the guidance range here. So, it was pretty much in line with what we expected. Just looking at the high end and low end, how you get to each.

Speaker #5: Curious if you could walk through that. I'm curious if on the low end, is the scenario kind of where the new drug clearances and OUS prefill conversions slip into 2027 a little bit?

Speaker #5: 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.

Speaker #4: Right. Hi, 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 have it right.

Linda Tharby: Right. Hi, Joe. Thank you, and you and your Piper colleagues have been great. Congratulations to you on your recent promotion as well. Referring to the guidance range, I think you have 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. Also if 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.

Speaker #4: 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.

Speaker #4: That's a great thing. And also, if new drugs get further traction or we get them on our label sooner, there's another big opportunity.

Speaker #4: 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.

Speaker #4: And then finally, I would just say oncology is something we do not have today—a big number in here at all, just a very small number.

Linda Tharby: Finally, I would just say, you know, oncology is something we do not have today, a big number in here at all, a very small number. 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.

Speaker #4: 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.

Speaker #3: Thanks, Linda. I appreciate that, and your comments. One more, just on Japan. I know it's been kind of a de-emphasized piece of the business, with all the great stuff going on in some of the other US markets.

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

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

Speaker #3: But just curious 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?

Speaker #3: Yeah. Just any color there would be helpful.

Speaker #4: Yeah, I'll start and then turn it over to Adam. So Japan, we see again being one of the larger IG markets overall. We see that this could be a $500,000 to $1 million total opportunity.

Linda Tharby: Yeah, I'll start and then turn it over to Adam. Japan, we see, again, being one of the larger IG markets. Overall, we see that this could be a half a million to a million-dollar 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 gonna let Adam talk through.

Speaker #4: 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.

Speaker #3: Yeah. 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.

Adam Kalbermatten: Yeah. Thanks, Linda. You know, in Japan, I'll start with good news, right? Both pumps are approved. Consumables are approved as well. We're pretty well positioned to continue to grow in that market. You know, at the time, we're seeing prefilled syringes there as being important, just as we kinda see in these other international markets. As those prefills continue to grow, we expect that we're gonna be growing with them. It's a pretty exciting opportunity for us.

Speaker #3: 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.

Speaker #3: So it's a pretty exciting opportunity for us.

Speaker #5: Great. Thank you all. And Adam, looking forward to working with you a little closer moving forward.

Joseph Dowling: Great. Thank you all. Adam, looking forward to working with you a little closer moving forward.

Joseph Downing: Great. Thank you all. Adam, looking forward to working with you a little closer moving forward.

Speaker #4: Yeah. Likewise. Thanks, Joe.

Adam Kalbermatten: Yeah. Likewise. Thanks, Joe.

Speaker #3: Thank you. There are no further questions at this time. I would like to hand the floor back over to Linda Tharby for any closing remarks.

Operator: Thank you. There are no further questions at this time. I would like to hand the floor back over to Linda Tharby for any closing remarks.

Speaker #4: All right. Thank you, operator. I 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.

Linda Tharby: Great. Thank you, operator. I just wanna 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 wanna say my last thanks to this entire KORU team, to my daughters who actually listened in to an earnings call for a change. I told them there was some big news today, so I think they listened in. 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. Look forward to working with all of you as this retirement goes on.

Speaker #4: 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 in to an earnings call for a change.

Speaker #4: I told them there was some big news today. So I think they listened in. So thank you to my daughters. Thank you to our board.

Speaker #4: Thank you to our investors. I'm not gone yet. I am a big investor, and will remain so. I look forward to working with all of you as this retirement goes on.

Speaker #4: 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.

Linda Tharby: 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.

Speaker #4: 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.

Q4 2025 KORU Medical Systems Inc Earnings Call

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