KORU Medical Systems, Inc.

What they do

KORU Medical develops, manufactures, and sells the FREEDOM Infusion Systems, including the FREEDOM60 and FreedomEdge syringe drivers, HIgH-Flo needles, and Precision Flow Rate Tubing. Revenue comes from three sources: domestic core (US and Canada), international core, and pharma services and clinical trials. The products are used for self-administered subcutaneous drug delivery, mainly immunoglobulin for Primary Immunodeficiency Diseases (PIDD) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Pharma services include product sales for clinical trials and non-recurring engineering services for biopharmaceutical partners.

Revenue drivers

• Domestic Core (US and Canada) — Largest segment at 66.2% of Q2 2026 revenue ($8.0M), grew 12.4% year-over-year on higher pump and consumable volumes from new patient starts and market share gains.
• International Core — 28.8% of Q2 2026 revenue ($3.5M), grew 59.1% year-over-year, driven by distributor purchases supporting pre-filled syringe conversions and new patient starts in established EU markets.
• Pharma Services and Clinical Trials — 5.0% of Q2 2026 revenue ($0.6M), down 35% year-over-year due to lower clinical trial product revenues related to customer order timing.
• Overall Revenue Mix — Core business (domestic + international) accounts for 95% of revenue; pharma services is a smaller, variable stream tied to drug development milestones.

Recent performance

For Q2 2026, revenue was $12.0 million, up 18.2% from $10.2 million in the prior year. Gross profit rose 21.2% to $7.8 million, with gross margin expanding to 65.1% from 63.5%. The company reported net income of $0.25 million, an improvement of 222% over the prior year. For full year 2025, revenue was $41.1 million (up 22.2% from 2024), with a gross margin of 62.3%. Operating cash flow turned positive in 2025 at $0.46 million.

Strategy

Management aims to strengthen leadership in the subcutaneous immunoglobulin (SCIg) market and expand into emerging subcutaneous drug therapies. They are investing in a connected monitoring technology asset to provide real-time patient usage data and differentiate the platform. The company is shifting its U.S. oncology market entry strategy away from the FreedomEDGE with Phesgo to focus on alternative molecules with higher infusion volumes. A multi-year supply agreement was signed to support operational strategy and long-term gross margin expansion. They are also focused on driving international growth, including pre-filled syringe conversions in European markets.

Risks

• Dependence on immunoglobulin drug supply — Demand for their products depends on an adequate supply of immunoglobulin drugs to be administered by the FREEDOM System.
• Tariff exposure — The company imports materials subject to U.S. tariffs; although a court ordered refunds, the amount and timing are uncertain and not expected to be material.
• Product development and regulatory challenges — Failure to introduce new products or obtain regulatory concurrence on a timely basis could make products obsolete and hurt revenue.
• Oncology strategy shift — Withdrawal of the Phesgo 510(k) application may slow entry into the U.S. oncology market and depends on success in alternative molecules.

Outlook

Management updated full-year 2026 guidance to revenue of $47.5–$48.5 million, gross margin of 62%–64%, positive adjusted EBITDA, and year-end cash balance greater than $7.5 million. They expect international core growth to moderate due to regional launch dynamics in certain European markets converting to pre-filled syringes. They remain confident in the international opportunity, viewing it as a timing issue, and are focused on executing the growth strategy with operational discipline.