KORU Medical Systems(US:KRMD)2025-05-07 21:30Financial Data and Key Metrics Changes - Revenue for Q1 2025 reached $9.6 million, an 18% increase year-over-year, marking a record for the company [7][23] - Gross margin improved to 62.8%, a 50 basis point increase compared to the same period last year [9][26] - The company raised its 2025 revenue guidance to a range of $38.5 million to $39.5 million, representing a 15% to 17% year-over-year growth [9][29] Business Line Data and Key Metrics Changes - Domestic core revenues were $6.9 million, a 16% increase year-over-year, driven by new patient starts and market share gains [23] - International core business revenues reached $2.4 million, representing a 36% growth over the prior year, driven by expansion into new geographies and a key tender win [24][12] - Pharma services and clinical trials revenues declined by 39% to $300,000 due to lower clinical trial orders [24] 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 in the Middle East and North Africa [12] - The total international SCIG total addressable market (TAM) is estimated at $60 million, 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, bringing the total pipeline to five planned submissions [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for the core business, citing a resilient market growth even amid macroeconomic uncertainties [15] - The company is optimistic about its international expansion plans, targeting a growth in market share from 10% to 30%-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, with a robust pipeline of 17 total opportunities [17] - The company is actively monitoring the changing policy environment regarding tariffs and supply chain impacts [27] Q&A Session Summary Question: Thoughts on adding new drugs without current partnerships - Management is excited about pursuing drugs independently, driven by strong relationships with specialty pharmacies and the potential for revenue growth with minimal investment [41][43] Question: Revenue cadence throughout the year - Management expects international revenue growth to be around 30%, with some impact from distributor stocking orders in Q2 [46][48] Question: Prefilled syringe opportunity and tender details - Prefilled syringe penetration in the US is now over 65%, with plans for further penetration outside the US [50][51] Question: Update on ePump opportunity and distributor dynamics - The company sees potential for increased volumes of consumables with e pumps, driven by new market openings and share gains [60] 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 potential for home administration [88][90]