KORU Medical Systems, Inc. Q1 FY2025 earnings call

• Strong first quarter performance with revenue of $9.6 million, an 18% increase over the prior year. - Plan to submit two additional commercialized drugs for 510(k) clearance by end of 2025, bringing total pipeline submissions to five in 2025. - Gross margin of 62.8% achieved, an improvement of 50 basis points compared to the same period last year. - Raised 2025 revenue guidance to $38.5 million to $39.5 million, representing 15% to 17% year-over-year growth. - Reaffirmed full year gross margin target of 61% to 63% and expectation to generate positive cash flow from operations in 2025. - Domestic core business grew 16% year-on-year with sixth quarter of sequential growth and share gains. - International business achieved 36% growth driven by patient growth and new distributor relationships, with plans to expand into key markets. - Pipeline has 17 total opportunities, including 15 active collaborations, and key pipeline developments such as FREEDOM 60 system clearance in Japan, successful Phase 3 trial in nephrology collaboration, progress in oncology infusion clinic market, and addition of iron chelation and antibiotic drug programs.

Revenue for the first quarter reached $9.6 million, a record. Domestic core revenues were $6.9 million, a 16% increase over the prior year, representing a significant portion of the total revenue. International core revenues were $2.4 million, a 36% increase over the prior year. Pharma Services and Clinical Trials revenues were $300,000, a 39% decline over the prior year. Domestic core contributed approximately 71.9% of total revenue ($6.9M / $9.6M), international core contributed approximately 25% ($2.4M / $9.6M), and Pharma Services and Clinical Trials contributed approximately 3.1% ($300,000 / $9.6M).

• Raised 2025 revenue guidance to a range of $38.5 million to $39.5 million, representing a 15% to 17% year-over-year growth. - Reaffirmed full year gross margin target of 61% to 63%, inclusive of global tariff situation impact. - Expect to generate positive cash flow from operations in 2025. - Key drivers include sustained global SCIg market growth, domestic and international share gains, flow controller product line expansion, Japanese market entry, and addition of new collaborations to Novel Therapies pipeline.

• Impact of global tariff situation on supply chain and cost of goods sold, which is included in the reaffirmed gross margin target.

Q: Can you give an update on the e-Pump opportunity and collaborations?

A: We work with several e-Pump companies (primarily three), and anticipate they cover over 80% of the global market. We're pursuing the remaining 20% and plan to expand in new geographies with similar collaborations.

Q: What's the market opportunity for the two commercialized drugs being submitted for 510(k) clearance?

A: The iron chelation drug has an estimated patient base of about 30,000, and the antibiotic drug has over 300,000 patients (though majority in hospital). Current estimate is a $0.5 million impact on 2026 revenue, with payback in far less than one year.