KORU Medical Systems, Inc.
For the period ended Mar 31, 2026. Filed May 6, 2026.
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.
Mar 31, 2026 · Filed May 6, 2026
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 2025-09-30; filed 2025-11-12.
0001161697-25-000372
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-06.
0001161697-26-000108
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 45 current paragraphs.
23 unchanged; 14 reworded; 6 added; 16 removed; 4 previous and 2 current paragraphs rearranged.
Tables are not compared: 9 previous and 5 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 (6)
Current report
The Company ended the first quarter of 2026 with $11.8 million in net revenues, a 22.1% increase compared to $9.6 million in the same period last year. Revenues were driven by growth in our core domestic and international business of 11.7% and 35.2%, respectively, along with an increase of 166.0% in our pharma services and clinical trials business.
Current report
The Company imports certain materials and products that are subject to U.S. government tariffs and import duties. On February 20, 2026, a US federal court ordered the U.S. government to begin refunding certain tariffs. The Company believes that some of the tariffs it has paid may be eligible for refund; however, the amount and timing of any potential refunds are uncertain. Accordingly, the Company has not recorded, nor plans to record, any benefit related to possible tariff refunds at this time.
Current report
Total net revenues increased $2.1 million, or 22.1%, to $11.8 million for the three months ended March 31, 2026, as compared to $9.6 million in the prior year period. Domestic core revenues were $7.7 million, an increase of 11.7% over the prior year period, primarily due to higher consumable volumes, driven by new patient starts and market share gains within new and existing accounts, supported by a strong underlying SCIg market. International core revenues were $3.3 million, an increase of 35.2% over the prior year period, primarily due to higher pump and consumable volumes, driven by distributor purchases supporting pre-filled syringe (PFS) conversions for a key EU market. Pharma services and clinical trials net revenues were $0.7 million, an increase of 166.0% over the prior year period, primarily due to higher clinical trial product revenues for advancing existing collaborations.
Current report
Research and development expenses increased $0.2 million, or 18.1%, to $1.3 million during the three months ended March 31, 2026, as compared to $1.1 million in the prior year period, primarily due to higher compensation expenses for salary and stock compensation related to headcount additions, partially offset by lower temporary labor expenses.
Current report
Credit Facility
Current report
On March 8, 2024, the Company entered into a loan and security agreement with a large domestic banking institution, as lender, providing for a credit facility consisting of a $5,000,000 revolving credit facility and a $5,000,000 term loan facility. On March 30, 2026, the Company entered into an amendment to the agreement extending the revolver maturity to March 30, 2028 and the term loan maturity to December 1, 2029, extending the interest-only period on the term loan through at least June 30, 2027, and lowering the interest rate floor on both facilities from 6.50% to 5.50%. The Company has not drawn on the credit facility, and there is no obligation to do so at any time. Borrowings are secured by a first-priority lien on substantially all of the assets of the Company, subject to customary exceptions. The credit facility contains customary affirmative and negative covenants and events of default. For a complete description of the terms of the credit facility, see Note 4 to the condensed financial statements included herein.
Removed paragraphs (16)
Previous report
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 report
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 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.
Previous 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.
Previous report
Net Revenues
Previous report
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 report
Gross Profit
Previous report
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 report
Operating Expenses
Previous report
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 report
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 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.
Previous report
Net Loss
Previous report
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 report
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 report
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.
Reworded paragraphs (14)
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 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.
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 and adoption 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, 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. 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,” “KORU,” “we,” “us” or “our” refers to KORU Medical Systems, Inc.
Current wording
Throughout this report, the “Company,” “KORU Medical,” “we,” “us” or “our” refers to KORU Medical Systems, Inc.
Previous 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.
Current wording
Gross profit for the first quarter of 2026 was $7.2 million, a 19.6% increase compared to $6.0 million in the same period last year, primarily driven by volume growth. Gross margin was 61.5% for the three months ended March 31, 2026, a decrease from 62.8% in the prior year period. We define gross margin as gross profit stated as a percentage of net revenues.
Previous 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.
Current wording
Operating expenses for the first quarter of 2026 were $8.1 million, compared to $7.3 million for the same period last year, driven by an increase of $0.6 million in selling, general, and administrative expenses, and an increase of $0.2 million in research and development expenses.
Previous 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.
Current wording
Gross profit increased $1.2 million, or 19.6%, to $7.2 million in the three months ended March 31, 2026, as compared to $6.0 million in the prior year period, primarily driven by volume growth. Gross margin decreased to 61.5% in the three months ended March 31, 2026, as compared to 62.8% in the prior year period. The decrease in gross margin was primarily driven by higher production costs based on timing of production runs in the prior quarter that were amortized in the three months ended March 31, 2026, and tariff-related charges that did not occur in the prior year period, partially offset by a favorable geographic sales mix.
Previous 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.
Current wording
Selling, general and administrative expenses increased $0.6 million, or 10.5%, to $6.6 million during the three months ended March 31, 2026, as compared to $6.0 million in the prior year period. The increase in selling, general and administrative expenses was primarily driven by increases in legal fees and compensation expenses related to salary and stock compensation, partially offset by lower temporary labor expenses.
Previous 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.
Current wording
Our net loss decreased $0.4 million in the three months ended March 31, 2026, as compared to the prior year period, primarily driven by an increase in gross profit of $1.2 million, driven by increased revenues, partially offset by operating expense increases of $0.8 million.
Previous 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.
Current wording
Our principal source of liquidity is our cash on hand of $8.8 million as of March 31, 2026. Our principal source of operating cash inflows is from sales of our products and NRE. 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.
Previous wording
Our inventory position was $4.4 million at September 30, 2025, which reflects an increase of $1.6 million from December 31, 2024.
Current wording
Our inventory position was $4.5 million at March 31, 2026, which reflects an increase of $0.8 million from December 31, 2025, due to expected future demand from our customers.
Previous wording
We expect that our cash on hand and cash flows from operations will be sufficient to meet our requirements at least through the next twelve months. Continued execution on our longer-term strategic plan may require the Company to draw on our credit facility, take on additional debt, raise capital through issuance of equity, or utilize a combination of the above. Our future capital requirements may vary from those currently planned and will depend on many factors, including our rate of sales growth, the timing and extent of spending on various strategic initiatives including research and development, our international expansion, the timing of new product introductions, market acceptance of our solutions, and overall economic conditions including inflation and the potential impact of global supply imbalances on the global financial markets. To the extent that current and anticipated future sources of liquidity are or are expected to be insufficient to fund our future business activities and requirements, we may be required to draw on our new credit facility or seek additional equity or debt financing sooner. There can be no assurance the Company will be able to obtain the financing or raise the capital required to fund its operations or planned expansion.
Current wording
We expect that our cash on hand, cash flows from operations, and as needed, cash available under our credit facility, will be sufficient to meet our requirements at least through the next twelve months. Continued execution on our longer-term strategic plan may require the Company to draw on our credit facility, take on additional debt, raise capital through issuance of equity, or utilize a combination of the above. Our future capital requirements may vary from those currently planned and will depend on many factors, including our rate of sales growth, the timing and extent of spending on various strategic initiatives including research and development, our international expansion, the timing of new product introductions, market acceptance of our solutions, and overall economic conditions including inflation and the potential impact of global supply imbalances on the global financial markets. To the extent that current and anticipated future sources of liquidity are or are expected to be insufficient to fund our future business activities and requirements, we may be required to draw on our new credit facility or seek additional equity or debt financing sooner. There can be no assurance the Company will be able to obtain the financing or raise the capital required to fund operations or planned expansion.
Previous 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.
Current wording
Net cash from operating activities was $0.01 million for the three months ended March 31, 2026, as compared to $(0.2) million in the prior year period. This net cash inflow of $0.01 million was primarily due to the net loss of $0.8 million, an increase in inventory of $0.8 million, offset by higher accounts payable of $0.4 million, higher accrued expenses of $0.2 million, and lower accounts receivable of $0.2 million. Additional offsets to the net loss were non-cash items including stock-based compensation expense of $0.7 million, and depreciation and amortization expense of $0.2 million.
Previous 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.
Current wording
Net cash used in operating activities was $0.2 million for the three months ended March 31, 2025, as compared to $0.3 million in the prior year period. This net cash usage of $0.2 million was primarily due to the net loss of $1.2 million, an increase in accounts receivable of $0.2 million, and increases in inventory of $0.5 million, partially offset by increases in accounts payable of $0.4 million, expense and payroll related accruals of $0.3 million, and other liabilities of $0.1 million. Additional offsets to the net loss were non-cash items including stock-based compensation expense of $0.7 million, and depreciation and amortization expense of $0.2 million.
Previous 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.
Current wording
Net cash used in investing activities of $0.4 million for the three months ended March 31, 2025, was for capital expenditures for manufacturing equipment related to our new consumables production lines.
Previous 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.
Current wording
Net cash used in financing activities of $0.2 million for the three months ended March 31, 2025 was due primarily to payments on our note payable for insurance premium financing.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Net cash used in investing activities of $0.1 million for the three months ended March 31, 2026, was for capital expenditures for manufacturing equipment related to our new infusion pump production line.
Current report — wording carried from elsewhere
Net cash used in financing activities of $0.03 million for the three months ended March 31, 2026 was due to payments for our finance leases.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
Nine months ended September 30, 2025, compared to September 30, 2024
Previous report — wording carried elsewhere
The following table summarizes our net revenues for the nine months ended September 30, 2025, and 2024:
Previous report — wording carried elsewhere
Our gross profit for the nine months ended September 30, 2025 and 2024 is as follows:
Previous report — wording carried elsewhere
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: