What KORU Medical Systems (KRMD) Said on Its Q3 Earnings Call

Key Points

• Q3 revenue rose 11% to $11.6 million, gross margin expanded to 65.2% from 60.2%, and KORU posted its second consecutive quarter of positive net income at $200,000.
• KORU raised the low end of its 2026 revenue forecast to $48 million and gross margin forecast to 63%, and increased its year-end cash target to more than $8 million.
• Domestic core revenue grew 32% as reported, while new distribution agreements in Europe and Africa broaden KORU’s reach. Its pipeline includes a next-generation pump submission planned by year-end 2026 and potential deferoxamine-related revenue from 2027 onward.

KORU Medical Systems NASDAQ: KRMD raised the lower end of its 2026 revenue and gross margin guidance after reporting third-quarter revenue growth of 11%, a second consecutive quarter of positive net income and new distribution agreements in Europe and Africa.

The infusion device company reported revenue of $11.6 million for the quarter ended September 30, while gross margin expanded to 65.2% from 60.2% a year earlier. Net income was $200,000.

President and CEO Adam Kalbermatten said the quarter’s revenue growth was below where the company wanted it to be, but was consistent with the slowdown management had outlined on its previous earnings call. KORU expects growth to accelerate to the high teens in the fourth quarter.

Core Growth and International Expansion

Domestic core revenue was $8.1 million, up 32% on a reported basis. Chief Financial Officer Tom Adams said normalized domestic growth was 10%, supported by higher pump consumable volumes, new patient starts and market share gains. The prior-year quarter was affected by approximately $1.2 million in one-time distributor impacts, he said.

International core revenue fell 17% on a reported basis but rose 23% when normalized for those distributor impacts. Revenue from Pharma Services and Clinical Trials declined 27%, reflecting lower orders for a customer’s clinical trial program.

Kalbermatten said KORU signed a sales and distribution agreement with a partner in one of Europe’s largest markets that will support patient starts across multiple countries. The company received an initial order and expects to begin seeing benefits in the fourth quarter. KORU also signed a distribution agreement with a partner in Africa and shipped an initial order during the quarter.

In response to an analyst’s question about 2027, Kalbermatten said the company was still working through its budget and would provide guidance when it reports fourth-quarter results. He said domestic growth of 10% to 15% was consistent with how management viewed the opportunity, while declining to give a specific international growth range.

Kalbermatten estimated KORU’s international market share at roughly 20%, describing the figure as an approximation. He said the company sees room to grow by adding patients in existing and new markets.

Higher Guidance and Cash Target

KORU raised the lower end of its full-year revenue forecast to $48 million to $48.5 million, from $47.5 million to $48.5 million. The updated range represents growth of 17% to 18%, according to management. The company also raised the lower end of its gross margin forecast to 63%, from 62%, while retaining the 64% upper end.

Adams attributed the third-quarter margin improvement to lower manufacturing costs, including improved production efficiency and lower tariffs, as well as a geographic customer mix weighted toward higher-priced markets. He said an extended supply agreement with KORU’s contract manufacturer also secures pricing and volume efficiencies as the business grows.

The company continues to expect positive adjusted EBITDA for the full year and raised its year-end cash target to more than $8 million, from $7.5 million. KORU ended the third quarter with $7.4 million in cash and had an unused $10 million debt facility. Adams said the company expects at least $600,000 of positive cash flow in the fourth quarter.

For the first nine months of 2026, revenue increased 17% to $35.4 million, while the net loss narrowed to $300,000 from $2.2 million a year earlier. Adjusted EBITDA rose to $2.2 million from $100,000.

Drug and Device Pipeline

Three U.S. specialty pharmacies began dispensing KORU products during the quarter to support home administration of RYSTIGGO, Kalbermatten said. Two use the complete KORU system, while one uses its needle set. He said the company expects the channel to grow as new patient starts increase.

KORU is also pursuing regulatory clearance to add deferoxamine, an iron-chelating treatment, to its device label. Kalbermatten said the 510(k) application remains under review by the Food and Drug Administration. He said clearance could come in the near term but that timing rests with the agency, and the company anticipates a contribution from the drug in 2027 and beyond.

Patients are being dosed with KORU’s Freedom Infusion System in a pharmaceutical partner’s phase III trial of an investigational enzyme replacement therapy, while another partner is approaching a phase III trial of a nephrology drug, Kalbermatten said. He added that KORU plans to provide more details on its oncology work in the first half of 2027.

The company expects to submit its next-generation Freedom360 pump for regulatory review by the end of 2026. Kalbermatten said KORU is seeking its first approval in the U.S. and expects the product to provide additional value in the second half of 2027, following regulatory review and specialty pharmacy evaluations.

KORU’s long-term targets remain $100 million in revenue, gross margins above 65% and EBITDA margins of at least 20%, Kalbermatten said. He did not give a deadline for reaching those goals.

About KORU Medical Systems (NASDAQ:KRMD)

KORU Medical Systems, Inc. develops, manufactures and markets portable infusion systems and related accessories for the home and alternate-site infusion markets. The company's products are designed to support the controlled delivery of specialty drugs, including subcutaneous immunoglobulin (SCIG) therapies, through ambulatory infusion systems. KORU's principal product platform is the Freedom Syringe Infusion System, which includes ambulatory syringe pumps such as the Freedom60, FreedomEdge and FreedomIQ, along with flow-control tubing sets and other disposable components.

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