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]