KORU Medical Systems(US:KRMD)2025-05-07 21:32Financial 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]