KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today reported financial results for the second quarter ended June 30, 2025.
Financial Highlights
Second quarter 2025 net revenues of $10.2 million, a 21% increase over the prior year period
•Second quarter 2025 net revenues of $10.2 million, a 21% increase over the prior year period
•Core business (Domestic and International) net revenues of $9.3 million, a 19% increase over the prior year period
•Pharma Services and Clinical Trials (PST) net revenues of $0.9 million, a 42% increase over the prior year period
•Gross profit of $6.5 million, an 18% increase over the prior year period, and gross margin of 63.5%
•Ending cash balance of $8.1 million reflective of a quarterly cash usage of $0.6 million driven by improved gross profit and increased operating leverage
•Raising full year 2025 revenue guidance to $39.5 – $40.5 million, representing growth of 18% – 20%, from prior range of $38.5 – $39.5 million; reiterating full year gross margin guidance of 61% – 63%, and positive cash flow from operations for full year 2025 with ending cash balance greater than $8.1 million
Business Highlights
•Adam Kalbermatten joins as Chief Commercial Officer, bringing 20 years of success leading drug delivery partnerships across pharma and biotech.
•Freedom Infusion System™ indicated for use with recently expanded indication of Empaveli® for C3G and Primary IC-MPGN treatment.
•Submitted for FDA 510(k) clearance for a commercialized rare disease biologic drug with the Freedom Infusion System™
“We achieved a milestone this quarter, surpassing $10 million in revenue for the first time and delivering our sixth consecutive quarter of double-digit growth,” said Linda Tharby, President and CEO of KORU Medical. “Strategically, we continued to outperform the strong SCIg market through global share gains, advanced our international expansion, and submitted a 510(k) filing to add a new drug to our Freedom Infusion System. Operationally, we delivered positive adjusted EBITDA, reflecting our disciplined execution and focused capital allocation, while continuing to invest in strategic growth areas. We believe this performance positions us well to drive continued shareholder value as we scale.”
Total net revenues increased $1.8 million, or 20.9%, to $10.2 million for the three months ended June 30, 2025, as compared to $8.4 million in the prior year period. Domestic core revenues were $7.1 million, an increase of 15.3% over the prior year period, primarily due to higher consumable volumes, driven by new patient starts and market share gains from new and existing accounts, supported by a strong underlying SCIg market. International core revenues were $2.2 million, an increase of 33.9% over the prior year period, primarily due to higher consumable and pump volumes, driven by prefill patient conversions, new patient starts, market share gains within existing markets, and entry into new geographic markets. Pharma services and clinical trials net revenues were $0.9 million, an increase of 42.1% over the prior year period, primarily driven by higher revenues from product sales for clinical trials.
Gross profit increased $1.0 million, or 18.2%, to $6.5 million in the three months ended June 30, 2025, as compared to $5.5 million in the prior year period. Gross margin decreased to 63.5% in the three months ended June 30, 2025, as compared to 65.0% in the prior year period. The decrease in gross margin was primarily driven by a favorable inventory valuation adjustment that occurred in the prior year period and tariff related charges in the current year, partially offset by volume efficiencies, and stronger margins in our pharma services and clinical trial business.
Total operating expenses for the second quarter of 2025 were $6.8 million, an increase of $0.1 million, or 1.7%, over the prior year period primarily driven by increases in recruiting expenses related to the Chief Commercial Officer search and higher temporary headcount spend related to our new product development, partially offset by lower compensation-related expenses related to timing of hiring that role.
Our net loss decreased to $0.2 million in the three months ended June 30, 2025, as compared to the prior year period, primarily driven by an increase in gross profit of $1.0 million due to increased revenues, partially offset by an operating expense increase of $0.1 million.
Adjusted EBITDA for the second quarter of 2025 was $0.3 million, or $0.01 per diluted share, compared to adjusted EBITDA of ($0.4) million, or ($0.01) per diluted share, for the prior year period. A reconciliation of adjusted EBITDA and adjusted diluted EPS is provided at the end of this press release.
Cash and cash equivalents were $8.1 million as of June 30, 2025, reflecting cash usage of $0.6 million in the second quarter of 2025.
2025 Guidance
•Raising full year 2025 net revenues guidance to $39.5 – $40.5 million, representing growth of 18% – 20%, from prior range of $38.5 – $39.5 million
•Reiterating full year 2025 gross margin guidance of 61% – 63%
•Reiterating positive cash flow from operations for full year 2025 and ending cash balance greater than $8.1 million
Conference Call and Webcast Details
The Company will host a live conference call and webcast to discuss these results and provide a corporate update on Wednesday, August 6, 2025, at 4:30 PM ET.
To participate in the call, please dial (877) 407-0784 (domestic) or (201) 689-8560 (international). The live webcast will be available on the IR Calendar on the News/Events page of the Investors section of KORU Medical’s website.
Non-GAAP Measures
This press release includes the non-GAAP financial measures “adjusted diluted EPS” and “adjusted EBITDA” that are not in accordance with, nor an alternate to, generally accepted accounting principles and may be different from non-GAAP measures used by other companies. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Non-GAAP financial measures should not be considered a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. They are limited in value because they exclude charges that have a material effect on KORU Medical’s reported results and, therefore, should not be relied upon as the sole financial measures to evaluate the Company’s financial results. Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results. Reconciliations of the Company’s non-GAAP measures are included at the end of this press release.
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