Financial Data and Key Metrics Changes - Revenue for Q4 2025 was $10.9 million, marking a 23% year-over-year growth, and full-year revenue reached $41.1 million, a 22% increase from $33.6 million in 2024 [9][22][23] - The company achieved positive cash flow from operations for both Q3 and Q4, and for the full year, with cash ending at $8.9 million [11][25] - Gross margin for the full year was 62.3%, with a slight reduction of 30 basis points year-over-year due to higher material costs [24][25] Business Line Data and Key Metrics Changes - Domestic core business grew 18% year-over-year in Q4, while international core business saw a significant growth of 71% [9][22] - The PST business decreased by 30% year-over-year, attributed to the timing of contract milestones [22][23] - The recurring global patient base increased by approximately 20% to 59,000 chronic SCIG patients [14] Market Data and Key Metrics Changes - The SCIG market grew approximately 10% in 2025, with KORU's domestic and international core businesses outperforming this growth [9][12] - In Europe, KORU's market share increased from 10% to 20%, with a total addressable market of approximately $50 million [16][35] - The company anticipates significant growth opportunities in the oncology market with the entry of new drugs [29][68] Company Strategy and Development Direction - KORU is focused on three strategic pillars: protecting and growing the core domestic business, expanding internationally, and enabling more drugs to reach more patients [12][62] - The company is diversifying its business with new drug collaborations and entering new therapeutic areas, including oncology [10][15] - The shift from hospital to home care is seen as a significant opportunity for large volume subcutaneous infusion [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, projecting 2026 revenue guidance of $47.5 million to $50 million, representing a growth of 15%-22% [11][26] - The company is prepared for geopolitical risks and anticipates a ramp-up in revenue in the second half of 2026 [27] - Management highlighted the importance of operational excellence programs to maintain margins and manage costs effectively [28] Other Important Information - Linda Tharby announced her retirement effective June 30, 2026, with Adam Kalbermatten set to succeed her as CEO [4][5] - The company received EU MDR certification for the Freedom60 system, enabling the conversion from vials to prefilled syringes [10][16] Q&A Session Summary Question: What does the Freedom60 product do for the market? - The Freedom60 product opens up a $50 million total addressable market in Europe, with significant share gain potential [35][36] Question: Can you provide more detail on the guidance composition? - The guidance range is influenced by the speed of prefill conversions and new drug approvals, with potential impacts from geopolitical factors [64][66] Question: How is the company positioned in Japan? - Japan is seen as a significant market opportunity, with both pumps and consumables approved, and potential growth driven by prefilled syringes [68][70]

Financial Data and Key Metrics Changes - Revenue for Q4 2025 was $10.9 million, marking a 23% year-over-year growth, and full-year revenue reached $41.1 million, a 22% increase from $33.6 million in 2024 [9][22][23] - The company achieved positive cash flow from operations for the full year, with cash ending at $8.9 million, reflecting a cash usage of $700,000 [11][25] - Gross margin for the full year was 62.3%, with a slight reduction of 30 basis points year-over-year due to higher material costs [24][25] Business Line Data and Key Metrics Changes - Domestic core business grew 18% year-over-year in Q4, while international core business saw a significant growth of 71% [9][22] - The PST business experienced a 30% decline year-over-year, attributed to the timing of contract milestones [22][23] Market Data and Key Metrics Changes - The domestic SCIG market grew approximately 10% in 2025, while KORU's domestic core business outperformed this with an 18% growth [9][22] - Internationally, KORU's market share in Europe increased from 10% to 20%, with an overall European SCIG pump and consumables market valued at approximately $50 million [16][36] Company Strategy and Development Direction - KORU is focused on expanding its core domestic business, increasing international presence, and enabling more drugs to reach patients [11][12] - The company aims to capture additional market share in the SCIG market, which is projected to grow at 8%-10% over the next five years [12][31] - New collaborations and drug approvals are expected to drive future growth, including entry into oncology markets [15][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, with 2026 revenue guidance set at $47.5 million to $50 million, representing a growth of 15%-22% [11][26] - The company is prepared for geopolitical risks and anticipates a ramp-up in revenue in the latter half of 2026 due to new product introductions and market expansions [27][66] Other Important Information - Linda Tharby announced her retirement effective June 13, 2026, with Adam Kalbermatten set to succeed her as CEO [4][5] - The company received EU MDR certification for the Freedom60 system, enabling further market penetration in Europe [10][30] Q&A Session Summary Question: What does the Freedom60 product do for the market? - The Freedom60 product opens up a $50 million total addressable market in Europe, with significant share gain potential [35] Question: Can you provide more detail on the guidance range? - The guidance range reflects potential faster prefill conversions and new drug approvals, with geopolitical factors also considered [65] Question: How is the company positioned in Japan? - Japan is seen as a significant market opportunity, with both pumps and consumables approved, and growth expected as prefilled syringes gain traction [70]

Financial Data and Key Metrics Changes - Revenue for Q4 2025 was $10.9 million, marking a 23% year-over-year growth, and full-year revenue reached $41.1 million, a 22% increase from $33.6 million in 2024 [20][22] - The company achieved positive cash flow from operations for both Q3 and Q4, and for the full year, with cash ending at $8.9 million [10][24] - Gross margin for the full year was 62.3%, with a slight reduction due to higher material costs and tariffs [23] Business Line Data and Key Metrics Changes - Domestic core business grew 18% year-over-year in Q4, while international core business saw an impressive growth of 71% [20][22] - The PST business decreased by 30% year-over-year due to milestone-based revenue recognition timing [21] - The recurring global patient base increased by approximately 20% to 59,000 patients [12] Market Data and Key Metrics Changes - The SCIG market grew approximately 10% in 2025, with KORU's domestic and international core businesses outperforming this growth [8][20] - In Europe, KORU's market share in the SCIG pump and consumables market increased from 10% in 2024 to 20% in 2025 [15] - The overall European SCIG market is valued at approximately $50 million, with significant growth potential as the market shifts from vial-based delivery to prefilled syringes [15][16] Company Strategy and Development Direction - KORU is focused on three strategic pillars: protecting and growing the core domestic business, expanding internationally, and enabling more drugs to reach more patients [10][31] - The company aims to diversify its business with new product developments and collaborations, including entry into oncology and nephrology markets [12][13] - KORU plans to leverage its strong position in the SCIG market, which is projected to grow at 8%-10% over the next five years [11][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, with 2026 revenue guidance set at $47.5 million to $50 million, representing a growth of 15%-22% [10][25] - The company is prepared for geopolitical risks and anticipates a ramp-up in revenue in the second half of 2026 as new products are introduced [26] - Management highlighted the importance of operational excellence programs to offset external cost pressures [27] Other Important Information - The CEO announced retirement effective June 30, 2026, with the Chief Commercial Officer set to succeed [4][5] - KORU received EU MDR certification for the Freedom60 system, enabling prefilled syringe compatibility, which is expected to enhance market penetration [9][29] Q&A Session Summary Question: What does the Freedom60 product do for the market? - The Freedom60 opens up a $50 million total addressable market in Europe, with significant share gain potential as the company moves from 10% to 20% market share [35] Question: Can you provide more detail on the guidance range? - The guidance range is influenced by the speed of prefill conversions and new drug approvals, with potential impacts from geopolitical factors [66] Question: What is the growth opportunity in Japan? - Japan is seen as a significant market with potential for half a million to a million-dollar opportunity as the market shifts towards home care [70]

Financial Data and Key Metrics Changes - KORU Medical Systems achieved revenue of over $10 million for the second consecutive quarter, representing a 27% year-over-year growth, driven by a 30% increase in the core subcutaneous immunoglobulin (SCIG) business [4][16] - Gross profit grew by 21% year-over-year, with a gross margin of 60.2%, a decrease of 320 basis points from the prior year due to higher manufacturing costs and geographical customer mix [5][18] - The company raised its full-year revenue guidance to $40.5-$41 million, indicating a growth of approximately 20%-22% [5][21] Business Line Data and Key Metrics Changes - The SCIG business grew by 30%, supported by international expansion and strong patient growth, while the U.S. SCIG business represented the largest recurring revenue base [4][6] - International revenue grew by 230%, with the company increasing its international market share from approximately 10% to 15%-20% in the underlying $60 million OUS SCIG market [16][8] - The company has nine active collaborations with potential new drugs expected to be added to its system by the end of 2026, with a commercial potential of up to $10 million by the end of 2028 [11][12] Market Data and Key Metrics Changes - The SCIG market is projected to grow approximately 9% annually over the next five years, outpacing the IVIG segment, with significant headroom for expansion due to increasing diagnoses of secondary immunodeficiency [6][7] - The oncology infusion consumables market is projected to grow from approximately $60 million in 2025 to $138 million by 2030, indicating a significant opportunity for KORU [15] Company Strategy and Development Direction - KORU is focused on expanding its pipeline and broadening its label through new collaborations, including two new PFT collaborations announced during the quarter [5][10] - The company aims to penetrate oncology infusion centers, with a successful U.S.-based oncology study validating its value proposition in this market [5][14] - KORU's strategy includes partnering with pharmaceutical companies to accelerate adoption and growth in the subcutaneous market [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business's momentum, highlighting robust growth in both U.S. and international markets, and reaffirmed guidance for gross margins and cash flow from operations [5][22] - The company anticipates continued growth driven by international opportunities and a strong SCIG market, with expectations to end the year with at least $8.2 million in cash [21][22] Other Important Information - The company reported a positive adjusted EBITDA and generated positive cash flow, reflecting disciplined operating expense management [5][19] - KORU's cash usage has decreased to $1.1 million year-to-date, representing a 60% decrease from the previous year [20] Q&A Session Summary Question: Feedback on oncology pilot study and reimbursement model - Management reported high satisfaction rates among nurses and patients, with 70% of nurses able to multitask during administration, and confirmed that existing reimbursement codes cover the administration of drugs using a pump [26][28] Question: Guidance for Q4 and 2026 outlook - Management indicated a strong acceleration in revenues expected for the second half of the year, with a split of approximately 70% U.S. business and 23-24% international business for Q4 [29][30] - For 2026, management is optimistic about growth opportunities, indicating a number starting with a two for revenue guidance [31] Question: Opportunities in the EU and market dynamics - Management highlighted significant growth potential in the EU driven by prefilled conversions, estimating a $10 million-$20 million opportunity overall [32][33] Question: Gross margin expectations - Management aims to maintain gross margins in the range of 61-63% while working towards a long-term goal of 65% [36][37] Question: Japan market entry and growth cadence - Management reported initial sales in Japan and indicated that while it remains a growth driver, the broader prefill opportunity is prioritized [39][43]

Q2 2025 Earnings Call August 6, 2025 1 Forward Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. All statements that are not historical fact are forward-looking statements. Forward-looking statements discuss the Company's current expectations and projections relating to its financial position, results of operations, plans, objectives, future performance, and business. Forwa ...

Financial Data and Key Metrics Changes - Revenue for the first quarter reached $9,600,000, representing an 18% increase year-over-year [7] - Gross margin improved to 62.8%, a 50 basis point increase compared to the same period last year [8][26] - The company raised its 2025 revenue guidance to a range of $38,500,000 to $39,500,000, indicating a 15% to 17% year-over-year growth [9][29] Business Line Data and Key Metrics Changes - Domestic core revenues were $6,900,000, reflecting a 16% increase year-over-year, driven by new patient starts and market share gains [23] - International core business revenues reached $2,400,000, representing a 36% growth over the prior year [24] - Pharma services and clinical trials revenues declined by 39% to $300,000 due to lower clinical trial orders [25] Market Data and Key Metrics Changes - The overall SCIG market grew approximately 10% in Q1, while the company's domestic core business grew 16% [12] - Internationally, the company achieved 36% growth, driven by patient growth and new distributor relationships [12] - The total international SCIG total addressable market (TAM) is estimated at $60,000,000, with the company currently holding approximately a 10% share [16] Company Strategy and Development Direction - The company aims to expand its platform to support subcutaneous delivery of additional large volume drugs, capitalizing on the shift from IV to subcutaneous formulations [11] - The strategic vision includes strengthening the core business while pursuing new drug opportunities, with a focus on operational efficiencies and market expansion [10][11] - The company plans to submit two additional commercialized drugs for FDA clearance by the end of 2025, increasing its pipeline to five planned submissions [8][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for its core business, citing a resilient market growth even amid macroeconomic uncertainties [15] - The company is optimistic about its international expansion plans, targeting a market share increase to 30% to 40% over the next several years [16] - Management reiterated expectations for positive cash flow from operations in 2025, with a focus on improving operating leverage [30] Other Important Information - The company has nine active collaborations with pharmaceutical partners and plans to expand its addressable market through these partnerships [11][17] - The company is actively monitoring the changing policy environment regarding tariffs and has low exposures to tariffs due to the majority of raw materials being of US origin [27] Q&A Session Summary Question: Thoughts on adding new drugs without current partnerships - Management is excited about pursuing drugs independently, leveraging strong relationships with specialty pharmacies, and sees significant upside potential [41][43] Question: Revenue cadence throughout the year - Management expects international growth to be around 30%, with some impact from distributor stocking orders in Q2 [45][47] Question: Prefilled syringe opportunity and tender updates - Prefilled syringe penetration in the US is over 65%, with plans for further penetration outside the US [52][54] Question: Tariff impact on guidance - Tariff impacts are included in the gross margin guidance, with an estimated impact of under 100 basis points [57][84] Question: Market opportunity for new drugs - The iron chelation drug has an estimated patient base of 30,000, while the antibiotic drug has over 300,000 patients, with significant market potential [90][91]

Financial Performance & Guidance - KORU Medical achieved Q1 2025 revenues of $9.6 million, representing an 18% increase year-over-year[8] - The company's core business experienced 21% growth, driven by recurring revenues, new patient starts, share expansion, and geographic expansion[8] - Gross margin improved to 62.8%, a 50 basis points increase[7] - KORU Medical raised its 2025 revenue guidance to $38.5-$39.5 million, projecting 15%-17% growth, and reaffirmed 61%-63% gross margins, with positive cash flow from operations expected for the full year[7] Strategic Growth & Market Expansion - Domestic core business revenue grew by 16% year-over-year[12] - International core business experienced 36% year-over-year growth[12] - Approximately 75% of KORU's revenue is recurring, excluding initial pump sales and Novel Therapies service revenue[15] Pipeline & Future Catalysts - KORU Medical plans to submit for FDA 510(k) clearance with 2 commercialized drugs on the Freedom Infusion System in 2025[8] - The company has 15 pharma collaborations in total, with 2 added year-to-date in 2025[13] - KORU Medical estimates its international market share at 10% with a goal of 30-40%[19]