KORU Medical Systems — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net revenues for the quarter ended September 30, 2026, increased 11.2% year-over-year to $11.6 million ($11,566,555), compared to $10.4 million in the prior year period; year-to-date net revenues grew 17% to $35.4 million.
• Gross profit increased 20.5% to $7.5 million ($7,546,084) from $6.3 million in the prior year period, driven by a gross margin improvement from 60.2% to 65.2%.
• Net income turned positive, improving by $1.0 million to $0.2 million ($218,103) compared to a net loss of $0.8 million ($777,966) in the prior year period.
• Adjusted EBITDA increased to $1.3 million ($1,313,257) from $0.1 million ($89,197) in the prior year period.
• Cash and cash equivalents were $7.4 million ($7,364,200) as of September 30, 2026, reflecting a cash usage of $0.9 million in the quarter.
• Total operating expenses increased 3.2% to $7.4 million ($7,358,966), primarily driven by a $0.3 million increase in research and development expenses.
• Inventory increased to $4.7 million from $3.7 million year-end 2025; accounts receivable increased to $6.4 million from $6.0 million year-end 2025.
• A new note payable of $332,479 was recorded as of September 30, 2026, compared to zero in the prior period.

Guidance and Future Outlook:

• Full-year 2026 revenue guidance revised upward to $48.0 - $48.5 million, representing 17% - 18% year-over-year growth, compared to the previous range of $47.5 - $48.5 million.
• Full-year 2026 gross margin guidance revised to 63% - 64%, up from the previous range of 62% - 64%.
• Full-year 2026 adjusted EBITDA guidance reiterated as positive.
• Year-end cash balance guidance raised to greater than $8.0 million, from the previous guidance of greater than $7.5 million.
• Management anticipates revenue growth to reaccelerate in the fourth quarter following the completion of a competitive non-tender market entry in Europe.

Business Segments and Product Lines:

• Domestic Core revenues grew 31.6% to $8.1 million ($8,058,131), driven by higher pump and consumable volumes, new patient starts, and market share gains.
• International Core revenues decreased 16.5% to $3.1 million ($3,084,050), primarily due to a higher prior-year comparison base involving distributor inventory purchases.
• Pharma Services and Clinical Trials revenues decreased 27.4% to $0.4 million ($424,374), reflecting lower purchases for a customer's clinical trial program.
• Signed two new sales and distribution agreements with partners in Europe and Africa to expand geographic footprint.
• Acquired a technology asset, resulting in headcount additions and increased R&D expenses related to salary and stock compensation.
• Capitalized software development costs of $206,863 were recorded in the quarter.

Market and Competitive Landscape:

• Revenue growth moderated in the third quarter compared to the first half of 2026 due to timing of entry into a competitive non-tender market in Europe.
• Domestic growth was partially impacted by lower orders from a U.S. distributor in Q3 2025, which had purchased products through an international distributor to reduce inventory levels.
• International revenue comparisons were affected by a strategic market distributor purchasing in anticipation of conversions from vials to prefilled products and for resale in the U.S.

Risks and Challenges:

• Forward-looking statements highlight risks including inflation, tariffs, geopolitical conflicts, and raw material availability.
• Risks include regulatory compliance, FDA and foreign authority audits, and the outcome of regulatory audits.
• Potential risks involve the introduction of competitive products, reimbursement risks, and dependence on key personnel.
• The company faces risks related to the adoption of new technology and the ability to recover costs for raw materials and labor.

Management Commentary and Tone:

• Adam Kalbermatten, President and CEO, stated that total revenue represents "another quarter of consistent above-market growth" driven by a recurring patient base.
• Management expressed confidence in the scalability of the business model following the second consecutive quarter of positive net income and adjusted EBITDA.
• The tone is optimistic regarding geographic expansion, specialty pharmacy partnerships, and pipeline advancements, with plans to continue investing resources in long-term growth.

Other Key Points:

• The company acquired an intangible asset for $961,035, of which $500,000 was settled through the issuance of 125,628 shares of common stock during the nine months ended September 30, 2026.
• Stock-based compensation expense was $927,869 for the quarter and $2.1 million for the nine months ended September 30, 2026.
• A loss on disposal of fixed assets of $406,269 was recorded for the nine-month period.
• The company hosts a conference call and webcast on November 10, 2026, at 4:30 PM ET to discuss results.
• The Freedom Syringe Infusion System received its first FDA clearance in 1994 and includes the Freedom60® and FreedomEDGE® Syringe Infusion Drivers.