KORU Medical Systems, Inc.
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 12, 2025
KRMD$3.09+2.0%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-06.
0001161697-25-000217
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001161697-25-000372
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 57 previous paragraphs and 57 current paragraphs.
28 unchanged; 26 reworded; 3 added; 3 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 9 previous and 9 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (3)
Current report
Total net revenues increased $2.2 million, or 27.2%, to $10.4 million for the three months ended September 30, 2025, as compared to $8.2 million in the prior year period. Domestic core revenues were $6.1 million, a decrease of 5.0% over the prior year period, primarily due to lower orders from a US distributor who purchased a portion of its KORU product from one of our international distributors, as well as an inventory reduction by such US distributor, partially offset by market growth from new patient starts and share gains in key accounts. International core revenues were $3.7 million, an increase of 229.6% over the prior year period, primarily due to supplying a distributor in a strategic market to meet anticipated demands of prefilled conversion from vials, new patient starts within existing markets, and product purchases by an international distributor who subsequently sold into the US market, as mentioned above. Pharma services and clinical trials net revenues were $0.6 million, a decrease of 4.4% over the prior year period, primarily driven by staging of NRE work versus the prior year period, reflecting the inherent variability of this business.
Current report
Research and development expenses decreased $0.6 million, or 39.2%, to $0.9 million during the three months ended September 30, 2025, as compared to $1.5 million in the prior year period, primarily due to severance occurring in the prior year, and lower project spend in the current period.
Current report
Depreciation and amortization expense decreased $0.05 million, or 6.7%, during the nine months ended September 30, 2025, as compared with $0.7 million in the same prior year period, primarily due to a prior year fixed asset reclass.
Removed paragraphs (3)
Previous report
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, and 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.
Previous report
Research and development expenses increased $0.06 million, or 5.3%, to $1.2 million during the three months ended June 30, 2025, as compared to $1.1 million in the prior year period, primarily due to higher temporary headcount spend related to our new product development.
Previous report
Depreciation and amortization expense remained flat at $0.4 million in the six months ended June 30, 2025, as compared with $0.4 million in the same prior year period.
Reworded paragraphs (26)
Previous wording
Our actual results may vary materially from the forward-looking statements made in this report due to important factors such as uncertainties associated with inflation, tariffs, war and other geopolitical conflicts, customer ordering patterns, availability and costs of raw materials and labor and our ability to recover such costs, future operating results, growth of new patient starts and the Ig market, our compliance with Food and Drug Administration and foreign authority regulations and the outcome of regulatory audits, introduction of competitive products, acceptance of and demand for new and existing products, ability to penetrate new markets, success in enforcing and obtaining patents, reimbursement related risks, government regulation of the home health care industry, success of our research and development effort, expanding the market of FREEDOMTM System, demand in the SCIg market, availability of sufficient capital if or when needed, dependence on key personnel, and the impact of recent accounting pronouncements, as well as those risks and uncertainties described in our Annual Report on Form 10-K for the year ended December 31, 2024. When used in this report, the words “estimate,” “project,” “believe,” “may,” “will,” “anticipate,” “intend,” “expect” and similar expressions are intended to identify forward-looking statements, which include, without limitation, statements regarding need for additional financing and impact of tariff-related charges. Such statements reflect current views with respect to future events based on currently available information and are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to release publicly any revision to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Current wording
Our actual results may vary materially from the forward-looking statements made in this report due to important factors such as uncertainties associated with inflation, tariffs, war and other geopolitical conflicts, customer ordering patterns, availability and costs of raw materials and labor and our ability to recover such costs, future operating results, growth of new patient starts and the Ig market, our compliance with Food and Drug Administration and foreign authority regulations and the outcome of regulatory audits, introduction of competitive products, acceptance of and demand for new and existing products, ability to penetrate new markets, success in enforcing and obtaining patents, reimbursement related risks, government regulation of the home health care industry, success of our research and development effort, expanding the market of FREEDOMTM System, demand in the SCIg market, availability of sufficient capital if or when needed, dependence on key personnel, and the impact of recent accounting pronouncements, as well as those risks and uncertainties described in our Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report for the quarter ended March 31, 2025. When used in this report, the words “estimate,” “project,” “believe,” “may,” “will,” “anticipate,” “intend,” “expect” and similar expressions are intended to identify forward-looking statements, which include, without limitation, statements regarding need for additional financing and impact of tariff-related charges. Such statements reflect current views with respect to future events based on currently available information and are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to release publicly any revision to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
Previous wording
Throughout this report, the “Company,” “KORU Medical,” “we,” “us” or “our” refers to KORU Medical Systems, Inc.
Current wording
Throughout this report, the “Company,” “KORU Medical,” “KORU,” “we,” “us” or “our” refers to KORU Medical Systems, Inc.
Previous wording
The Company ended the second quarter of 2025 with $10.2 million in net revenues, a 20.9% increase compared to $8.4 million in the same period last year. Revenues were driven by growth in our core domestic and international business of 15.3% and 33.9%, respectively, as well as with an increase of 42.1% in our pharma services and clinical trials business.
Current wording
The Company ended the third quarter of 2025 with $10.4 million in net revenues, a 27.2% increase compared to $8.2 million in the same period last year. Revenues in our core business were $9.8 million, a 29.7% increase over the prior year period. Growth in our international core business of 229.6% was offset by a decline in our domestic core business of 5.0%, as well as a decline in our pharma services and clinical trials business of 4.4%. Our geographic mix within core revenues was impacted by a US distributor’s purchase of KORU products from an international distributor.
Previous wording
Gross profit for the second quarter of 2025 was $6.5 million, an 18.2% increase compared to $5.5 million in the same period last year, primarily driven by additional revenue from volume growth in our core domestic and international businesses. Gross margin was 63.5% for the three months ended June 30, 2025, a decrease from 65.0% in the prior year period due to a one-time inventory valuation adjustment in the prior year. We define gross margin as gross profit stated as a percentage of net revenues.
Current wording
Gross profit for the third quarter of 2025 was $6.3 million, a 20.8% increase compared to $5.2 million in the same period last year, primarily driven by additional revenue from volume growth in the international core business. Gross margin was 60.2% for the three months ended September 30, 2025, a decrease from 63.4% in the prior year period due to higher manufacturing costs, geographic mix, and tariff charges. We define gross margin as gross profit stated as a percentage of net revenues.
Previous wording
Operating expenses for the second quarter of 2025 were $6.8 million, compared to $6.7 million for the same period last year, driven by an increase in selling, general, and administrative expenses, and research and development expenses.
Current wording
Operating expenses for the third quarter of 2025 were $7.1 million, compared to $6.9 million for the same period last year, driven by an increase in selling, general, and administrative expenses, partially offset by decreases in research and development expenses.
Previous wording
During the second quarter of 2025, we incurred tariff-related charges of $0.1 million. At this time, we expect tariff-related charges to have a gross margin impact of less than 100 bps on an annualized basis.
Current wording
During the third quarter of 2025, we incurred tariff-related charges of $0.1 million. At this time, we expect tariff-related charges to have a gross margin impact of less than 100 basis points on an annualized basis.
Previous wording
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 due to revenue mix.
Current wording
Gross profit increased $1.1 million, or 20.8%, to $6.3 million in the three months ended September 30, 2025, as compared to $5.2 million in the prior year period. Gross margin decreased to 60.2% in the three months ended September 30, 2025, as compared to 63.4% in the prior year period. The decrease in gross margin was primarily driven by higher manufacturing costs, geographic sales mix from outside the United States, and tariff-related charges.
Previous wording
Selling, general and administrative expenses increased $0.06 million, or 1.2%, to $5.4 million during the three months ended June 30, 2025, as compared to $5.3 million in the prior year period. The increase in selling, general and administrative expenses was primarily driven by increases in recruiting expenses related to the Chief Commercial Officer search, partially offset by lower compensation-related expenses related to timing of hiring that role.
Current wording
Selling, general and administrative expenses increased $0.9 million, or 16.9%, to $6.0 million during the three months ended September 30, 2025, as compared to $5.1 million in the prior year period. The increase in selling, general and administrative expenses was primarily driven by increases in compensation and benefits, mostly due to higher bonus accruals and commissions due to higher revenues, legal fees, and facility expense.
Previous wording
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.
Current wording
Our net loss decreased to $0.8 million in the three months ended September 30, 2025, as compared to the prior year period, primarily driven by an increase in gross profit of $1.1 million due to increased revenues, partially offset by an increase in operating expense $0.2 million.
Previous wording
Six months ended June 30, 2025, compared to June 30, 2024
Current wording
Nine months ended September 30, 2025, compared to September 30, 2024
Previous wording
The following table summarizes our net revenues for the six months ended June 30, 2025, and 2024:
Current wording
The following table summarizes our net revenues for the nine months ended September 30, 2025, and 2024:
Previous wording
Total net revenues increased $3.2 million, or 19.3% to $19.8 million, for the six months ended June 30, 2025, as compared with the same prior year period. Domestic core revenues increased by 15.8% to $14.0 million, primarily due to volume growth in pumps and consumables, driven by new patients starts and market share gains. International core revenues increased by 34.8% to $4.6 million, primarily due to higher consumable and pump volumes, driven by prefill patient conversions, new patient starts, and market share gains within existing markets, and entry into new geographic markets. Pharma services and clinical trials net revenues increased by $0.1 million, or 8.8% to $1.2 million in the six months ended June 30, 2025, as compared to the prior year period, driven by Phase 3 clinical trial orders.
Current wording
Total net revenues increased $5.4 million, or 21.9% to $30.2 million, for the nine months ended September 30, 2025, as compared with the same prior year period. Domestic core revenues increased by 8.6% to $20.1 million, primarily due to market growth from new patient starts and share gains in key accounts, partially offset by lower orders from a US distributor who purchased a portion of its quarterly KORU product from one of our international distributors, as well as an inventory reduction by such US distributor. International core revenues increased by 82.9% to $8.3 million, primarily due to supplying a distributor in a strategic market to meet anticipated demands of prefilled conversion from vials, new patient starts within existing markets, and product purchases by an international distributor who subsequently sold into the US market, as mentioned above. Pharma services and clinical trials net revenues increased by $0.1 million, or 4.1% to $1.8 million in the nine months ended September 30, 2025, driven by Phase 3 clinical trial orders.
Previous wording
Our gross profit for the six months ended June 30, 2025 and 2024 is as follows:
Current wording
Our gross profit for the nine months ended September 30, 2025 and 2024 is as follows:
Previous wording
Gross profit increased by $1.9 million or 18.3% in the six months ended June 30, 2025, as compared with the same prior year period. The increase in the first half of 2025 was driven by an increase in net revenues of $3.2 million as described above. Gross margin decreased to 63.1% in the six months ended June 30, 2025, as compared with 63.6% 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.
Current wording
Gross profit increased by $3.0 million or 19.1% in the nine months ended September 30, 2025, as compared with the same prior year period. Gross margin decreased to 62.1% in the nine months ended September 30, 2025, as compared with 63.6% in the prior year period. The decrease in gross margin was primarily driven by geographic sales mix from outside the United States, product sales mix, and tariff-related charges.
Previous wording
Our selling, general and administrative, research and development and depreciation and amortization expenses for the six months ended June 30, 2025 and 2024 are as follows:
Current wording
Our selling, general and administrative, research and development and depreciation and amortization expenses for the nine months ended September 30, 2025 and 2024 are as follows:
Previous wording
Selling, general and administrative expenses increased $0.7 million, or 6.2%, during the six months ended June 30, 2025, as compared with the prior year period, primarily due to increases in compensation and benefits expense, legal, and audit fees.
Current wording
Selling, general and administrative expenses increased $1.5 million, or 9.7%, during the nine months ended September 30, 2025, as compared with the prior year period, primarily due to increases in compensation and benefits, new hires, and legal fees.
Previous wording
Research and development expenses decreased $0.3 million, or 11.5% during the six months ended June 30, 2025, as compared with the same prior year period, primarily due to lower project spend for outsourced activities.
Current wording
Research and development expenses decreased $0.9 million, or 21.7%, during the nine months ended September 30, 2025, as compared with the same prior year period, primarily due to lower severance related expenses and project spend due to shifting timelines related to new product development projects.
Previous wording
Our net loss decreased $1.6 million in the six months ended June 30, 2025, as compared with the same prior year period, mostly driven by an increase in gross profit of $1.9 million or 18.3%, partially offset by an increase in operating expenses of $0.3 million or 2.5%.
Current wording
Our net loss decreased $2.4 million in the nine months ended September 30, 2025, as compared with the same prior year period, mostly driven by an increase in gross profit of $3.0 million or 19.1%, partially offset by an increase in operating expenses of $0.6 million or 2.8%.
Previous wording
Our principal source of liquidity is our cash on hand of $8.1 million as of June 30, 2025. Our principal source of operating cash inflows is from sales of our products. Our principal cash outflows relate to the purchase and production of inventory, funding of research and development, and selling, general and administrative expenses. To develop new products, support future growth, achieve operating efficiencies, and maintain product quality, we are continuing to invest in research and development and manufacturing equipment.
Current wording
Our principal source of liquidity is our cash on hand of approximately $8.5 million as of September 30, 2025. Our principal source of operating cash inflows is from sales of our products. Our principal cash outflows relate to selling, general and administrative expenses, the purchase and production of inventory, and funding of research and development.
Previous wording
Our inventory position was $3.9 million at June 30, 2025, which reflects an increase of $1.1 million from December 31, 2024.
Current wording
Our inventory position was $4.4 million at September 30, 2025, which reflects an increase of $1.6 million from December 31, 2024.
Previous wording
Net cash used in operating activities was $0.7 million for the six months ended June 30, 2025, as compared to $0.3 million in the prior year period. This net cash usage of $0.7 million was primarily due to the net loss of $1.3 million, a decrease in accounts receivable and contract assets of $0.9 million and an increase in prepaid expenses of $0.4 million, offset by increases in inventory of $1.1 million and decreases in accounts payable of $0.6 million. Additional offsets to the net loss were non-cash items including stock-based compensation expense of $1.1 million, and depreciation and amortization expense of $0.4 million.
Current wording
Net cash used in operating activities was $0.6 million for the nine months ended September 30, 2025, as compared to $1.3 million in the prior year period. This net cash usage of $0.6 million was primarily due to the net loss of $2.2 million, working capital increases of $0.9 million, consisting of increases in inventory of $1.6 million, and an increase in prepaid expenses of $0.2 million partially offset by decrease in accounts receivable and contract assets of $0.3 million, an increase in accounts payable of $0.2 million, and an increase in accrued expenses of $0.4 million . Additional offsets to the net loss were non-cash items including stock-based compensation expense of $1.7 million, and depreciation and amortization expense of $0.6 million.
Previous wording
Net cash used in operating activities was $0.3 million for the six months ended June 30, 2024, as compared to $4.8 million in the prior year. This net cash usage of $0.3 million was primarily due to the net loss of $2.9 million and an increase in accounts receivable of $1.8 million, which was mostly offset by decreases in inventory of $0.9 million, decreases in pre-paid expenses of $0.8 million, and increases in accounts payable and accruals of $1.0 million. Additional offsets to the net loss were non-cash items including stock-based compensation expense of $1.3 million, and depreciation and amortization expense of $0.4 million.
Current wording
Net cash used in operating activities was $1.3 million for the nine months ended September 30, 2024, as compared to $6.0 million in the same period in 2023. This net cash usage of $1.3 million was primarily due to the net loss of $4.5 million, working capital decreases of $0.6 million, consisting of an increase in accounts receivable of $1.2 million, and increases in inventory of $0.4 million, partially offset by increases in accounts payable and payroll bonus accruals of $1.9 million, and decreases in pre-paid expenses of $0.3 million. Additional offsets to the net loss were non-cash items including stock-based compensation expense of $1.9 million, and depreciation and amortization expense of $0.7 million.
Previous wording
Net cash used in investing activities of $0.5 million for the six months ending June 30, 2025, was due to capital expenditures related to purchases of manufacturing equipment for our new consumable and pump production lines.
Current wording
Net cash used in investing activities of $0.5 million for the nine months ending September 30, 2025, was due to capital expenditures related to purchases of manufacturing equipment for our new consumable and pump production lines.
Previous wording
Net cash used in investing activities of $0.3 million for the six months ending June 30, 2024, was for capital expenditures for research and development and manufacturing equipment.
Current wording
Net cash used in investing activities of $1.4 million for the nine months ending September 30, 2024, was for capital expenditures for manufacturing equipment related to our new consumables production lines.
Previous wording
Net cash used in financing activities of $0.4 million for the six months ended June 30, 2025 was primarily due to payments on our note payable for insurance premium financing.
Current wording
Net cash gained from financing activities of $0.04 million for the nine months ended September 30, 2025 was primarily due to cash receipts related to the exercise of employee stock options, mostly offset by payments on our note payable for insurance premium financing.
Previous wording
Net cash used in financing activities of $0.4 million for the six months ended June 30, 2024 was due to payments on our note payable for insurance premium financing.
Current wording
Net cash used in financing activities of $0.03 million for the nine months ended September 30, 2024 was due to payments on our note payable for insurance premium financing, partially offset by new borrowings for a subsequent insurance premium financing agreement.