KORU Medical Systems, Inc.
For the period ended Dec 31, 2025. Filed Mar 12, 2026.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 12, 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-K
Period ended 2024-12-31; filed 2025-03-12.
0001161697-25-000103
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-12.
0001161697-26-000052
Item 7. 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 59 previous paragraphs and 59 current paragraphs.
39 unchanged; 16 reworded; 3 added; 4 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 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 (3)
Current report
Research and development expenses decreased $0.9 million, or 16.6%, to $4.4 million, during the year ended December 31, 2025 compared with the same period last year, primarily due to lower compensation and benefit expense and CTO severance expenses from the prior year, partially offset by higher temporary labor expenses for product development.
Current report
Depreciation and amortization expense decreased $0.1 million, or 8.8%, to $0.8 million, during the year ended December 31, 2025, as compared with the same period last year, primarily driven by asset retirement and decreased capital spending.
Current report
Our net loss decreased $3.4 million or 56.5% in the year ended December 31, 2025 compared with the same period last year, driven by higher gross profit of $4.3 million, partially offset by an increase in operating expense of $0.8 million.
Removed paragraphs (4)
Previous report
Research and development expenses decreased $0.5 million, or 8.4%, to $5.3 million, during the year ended December 31, 2024 compared with the same period last year, primarily due to lower overall project spend driven by timing, partially offset by CTO severance costs and an increase in compensation and benefits-related bonus accrual related to year over year company performance.
Previous report
Depreciation and amortization expense remained flat at $0.9 million during the year ended December 31, 2024, as compared to $0.9 million during the same period in 2023, primarily driven by capital spending related to projects.
Previous report
Our net loss decreased $7.7 million in the year ended December 31, 2024 compared with the same period last year, mostly driven by lower net operating losses of $3.8 million as a result of our gross profit improvement of 27.7%, and an operating expense increase of 3%. In the prior year we established an allowance for the non-realization of deferred tax assets which reversed a tax benefit of $4.0 million, partially offsetting in the current year was lower interest income of $0.1 million driven by a lower cash balance coupled with lower yields.
Previous report
Further contributing to this change were the establishment of an allowance for non-realization of deferred tax assets of $4.0 million, stock-based compensation of $2.8 million, depreciation and amortization of $0.9 million, and a loss on disposal of fixed assets of $0.1 million.
Reworded paragraphs (16)
Previous wording
Our revenues derive from three business sources: (i) domestic core (which consists of US and Canada), (ii) international core, and (iii) novel therapies. Our domestic core and international core revenues consist of sales of our products for the delivery of subcutaneous drugs that are FDA cleared for use with the FREEDOM Infusion System, with the primary delivery for immunoglobulin to treat Primary Immunodeficiency Diseases (“PIDD”) and Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”). Novel therapies revenues consist of product revenues from our infusion system (syringe drivers, tubing and needles) for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in the drug development process as well as non-recurring engineering services revenues (“NRE”) received from biopharmaceutical companies to ready or customize the FREEDOM System for clinical and commercial use.
Current wording
Our revenues derive from three business sources: (i) domestic core (which consists of US and Canada), (ii) international core, and (iii) pharma services and clinical trials. Our domestic core and international core revenues consist of sales of our products for the delivery of subcutaneous drugs that are FDA cleared for use with the FREEDOM Infusion System, with the primary delivery for immunoglobulin to treat Primary Immunodeficiency Diseases (“PIDD”) and Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”). Pharma services and clinical trials revenues consist of product revenues from our infusion system (syringe drivers, tubing and needles) for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in the drug development process as well as non-recurring engineering services revenues (“NRE”) received from biopharmaceutical companies to ready or customize the FREEDOM Infusion System for clinical and commercial use.
Previous wording
The Company ended the 2024 fiscal year with $33.6 million in net revenues, an 18.0% increase compared with $28.5 million in the same period last year driven by growth in our core domestic and international business of 12.3% and 31.5% respectively, and further driven by a 61.9% increase in our novel therapies business.
Current wording
The Company ended the 2025 fiscal year with $41.1 million in net revenues, a 22.2% increase compared with $33.6 million in the same period last year driven by growth in our domestic core and international core businesses of 11.0% and 80.0% respectively, partially offset by a 5.6% decrease in our pharma services and clinical trials business net revenues.
Previous wording
Gross profit, for the year ended December 31, 2024, was $21.3 million, an increase of 27.7% or $4.6 million from the same period last year. Gross margin was 63.4% for the year ended December 31, 2024, an increase from 58.6% from the prior year. We define gross margin as gross profit stated as a percentage of net revenues.
Current wording
Gross profit for the year ended December 31, 2025, was $25.6 million, an increase of 20.0% or $4.3 million from the same period last year. Gross margin was 62.3% for the year ended December 31, 2025, a decrease from 63.4% from the prior year. We define gross margin as gross profit stated as a percentage of net revenues.
Previous wording
Operating expenses for the year ended December 31, 2024, were $27.8 million, up from $27.0 million for the same period last year.
Current wording
Operating expenses for the year ended December 31, 2025, were $28.6 million, up from $27.8 million from the same period last year.
Previous wording
Total net revenues increased $5.1 million, or 18.0%, to $33.6 million, for the year ended December 31, 2024, as compared with the same period last year. Domestic core growth of 12.3% was primarily driven by volume growth in pumps and consumables attributed to overall SCIg market growth and new account share gains. International core growth of 31.5% was driven by overall SCIg market growth, increased penetration in several established EU markets, and the entry into multiple new geographic markets. Novel therapies net revenues increased $0.9 million, or 61.9%, driven primarily by an increase in NRE collaborations and an increase in clinical trial supply shipments when compared to the prior year.
Current wording
Total net revenues increased $7.5 million, or 22.2%, to $41.1 million, for the year ended December 31, 2025, as compared with the same period last year. Domestic core growth of 11.0% was primarily driven by volume in consumables and pumps attributed to subcutaneous immunoglobulin (SCIg) market growth and new account share gains. International core growth of 80.0% was primarily driven by SCIg market growth, increased penetration in several established EU markets, and entry into multiple new geographic markets. Pharma services and clinical trials net revenues decreased $0.1 million, or 5.6%, driven by lower NRE collaborations revenues resulting from the timing of project milestones partially offset by higher clinical trial orders when compared to the prior year.
Previous wording
Gross profit increased $4.6 million, or 27.7%, to $21.3 million, in the year ended December 31, 2024, compared to the same period in 2023 driven by the increase in net revenues of $5.1 million coupled with significant gross margin improvement. Gross margin increased to 63.4% in the year ended 2024 compared to 58.6% for the year ended 2023, primarily driven by increased manufacturing productivity, improved margin on product revenue mix, and increases in average selling prices versus the prior year.
Current wording
Gross profit increased $4.3 million, or 20.0%, to $25.6 million, in the year ended December 31, 2025, compared to the same period in 2024 driven by the increase in net revenues of $7.5 million partially offset by an increase in manufacturing costs. Gross margin decreased to 62.3% in the year ended 2025 compared to 63.4% for the year ended 2024, primarily driven by higher materials costs, tariff-related charges, and geographic sales mix from outside the United States, partially offset by higher average selling prices in the US market.
Previous wording
Selling, general and administrative expenses increased $1.3 million, or 6.2%, to $21.6 million, during the year ended December 31, 2024 compared with the same period last year, primarily due to a $1.7 million increase in compensation and benefits-related bonus accrual and sales commission related to year over year company performance, partially offset by lower recruiting expenses and liability insurance costs.
Current wording
Selling, general and administrative expenses increased $1.7 million, or 8.1%, to $23.4 million, during the year ended December 31, 2025 compared with the same period last year, primarily due to an increase in compensation and benefits-related bonus accrual, sales commission related to year over year company performance, and legal fees, partially offset by lower consulting expenses.
Previous wording
Our principal source of liquidity is our cash on hand of $9.6 million as of December 31, 2024. Our principal source of operating cash inflows is from sales of our products in our core business, NRE services, and clinical trial products to our customers. 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, innovation, and equipment. Operating expenses for the 2024 fiscal year were $27.8 million.
Current wording
Our principal source of liquidity is our cash on hand of $8.9 million as of December 31, 2025. Our principal source of operating cash inflows is from sales of our products in our core business, clinical trial products, and NRE services to our customers. Our principal cash outflows relate to the purchase and production of inventory, selling, general and administrative expenses, and funding of research and development, to develop new products, support future growth, achieve operating efficiencies, and maintain product quality, we are continuing to invest in research and development, innovation, and equipment. Operating expenses for the 2025 fiscal year were $28.6 million.
Previous wording
Our inventory position was $2.8 million at December 31, 2024, which reflects a decrease of $0.7 million from December 31, 2023.
Current wording
Our inventory position was $3.7 million at December 31, 2025, which reflects an increase of $0.9 million from December 31, 2024.
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 a combination. 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 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, tariffs, 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 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 growth opportunities.
Previous wording
Net cash used in operating activities of $4.9 million for the year ended December 31, 2023 was primarily due to the net loss of $13.7 million, plus cash flows used to reduce accrued expenses of $1.2 million primarily from the payment of 2023 employee bonuses, and a decrease in accounts payable of $1.4 million. Partially offsetting these increases were cash flows generated from a decrease in inventory of $2.9 million, a decrease in accounts receivable of $0.5 million, and other changes in working capital of $0.4 million.
Current wording
Net cash produced from operating activities was $0.5 million for the year ended December 31, 2025. This net cash produced was primarily due to the net loss of $2.6 million, an increase in inventory of $0.9 million, an increase in accounts receivable of $0.5 million, and an increase in prepaids and other assets of $0.2 million, offset by an increase in accrued expenses for 2025 bonuses and payroll of $0.6 million, and an increase in accounts payable of $0.6 million.
Previous wording
Net cash used in investing activities of $0.8 million for the year ended December 31, 2023, was for capital expenditures for research and development and manufacturing equipment
Current wording
Net cash used in investing activities of $0.9 million for the year ended December 31, 2025, was driven by capital expenditures for manufacturing equipment related to our production line for our next generation consumables and infusion pumps.
Previous wording
Net cash used in financings activities of $0.2 million for the year ended December 31, 2023, due to payments on our note payable for insurance premium financings, partially offset by the borrowings for the insurance premium financing, and $0.1 million for payments on our finance leases.
Current wording
Net cash used in financing activities of $0.2 million for the year ended December 31, 2025 was primarily due to payments on our note payable for insurance premium financing, partially offset by new borrowings for a subsequent insurance premium financing agreement. The insurance premium financing note was also paid off early, without penalty, during the period.
Previous wording
We have finance and operating leases for our corporate office and certain office and computer equipment. Our three operating leases have remaining lease terms of 7.7 years, 4.1 years, and 3.4 years, respectively. Our three finance leases have remaining lease terms of 2.4 years, 2.0 years, and 3.8 years, respectively.
Current wording
We have finance and operating leases for our corporate office and certain office and computer equipment. Our three operating leases have remaining lease terms of 6.7 years, 3.1 years, and 2.4 years, respectively. Our three finance leases have remaining lease terms of 1.4 years, 1.0 years, and 2.8 years, respectively.
Previous wording
Our revenues are derived from three business sources: (i) domestic core (which consists of US and Canada), (ii) international core, and (iii) novel therapies. Our core domestic and international revenues consist of sales of our syringe drivers, tubing and needles (“Product Revenue”) for the delivery of subcutaneous drugs that are FDA cleared for use with the KORU Medical infusion system, with the primary delivery for immunoglobulin to treat Primary Immunodeficiency Diseases (“PIDD”) and Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”). Novel therapies consist of Product Revenue for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in the drug development process as well as non-recurring engineering services (“NRE”) revenues (including testing and registration services) received from biopharmaceutical companies to ready or customize the FREEDOM System for clinical and commercial use across multiple drug categories.
Current wording
Our revenues are derived from three business sources: (i) domestic core (which consists of US and Canada), (ii) international core, and (iii) pharma services and clinical trials. Our core domestic and international revenues consist of sales of our syringe drivers, tubing and needles (“Product Revenue”) for the delivery of subcutaneous drugs that are FDA cleared for use with the KORU Medical infusion system, with the primary delivery for immunoglobulin to treat Primary Immunodeficiency Diseases (“PIDD”) and Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”). Pharma services and clinical trials consist of Product Revenue for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in the drug development process as well as non-recurring engineering services (“NRE”) revenues (including testing and registration services) received from biopharmaceutical companies to ready or customize the FREEDOM System for clinical and commercial use across multiple drug categories.
Previous wording
Contracts are often modified to account for changes in contract specifications and requirements. Contract modifications exist when the modification either creates new, or changes existing, enforceable rights and obligations. Generally, when contract modifications create new performance obligations, the modification is considered to be a separate contract and revenue is recognized prospectively. When contract modifications change existing performance obligations, the impact on the existing transaction price and measure of progress for the performance obligation to which it relates is generally recognized as an adjustment to revenue (either as an increase in or a reduction of revenue) on a cumulative catch-up basis. Contract assets primarily represent revenue earnings over time that are not yet billable based on the terms of the contracts. Contract liabilities (i.e., deferred revenue) consist of fees invoiced or paid by the Company’s customers for which the associated performance obligations have not been satisfied and revenue has not been recognized based on the Company’s revenue recognition criteria described above. As of December 31, 2023, the Company has recognized a contract asset of zero which is included in other accounts receivable in the accompanying balance sheet.
Current wording
Contracts are often modified to account for changes in contract specifications and requirements. Contract modifications exist when the modification either creates new, or changes existing, enforceable rights and obligations. Generally, when contract modifications create new performance obligations, the modification is considered to be a separate contract and revenue is recognized prospectively. When contract modifications change existing performance obligations, the impact on the existing transaction price and measure of progress for the performance obligation to which it relates is generally recognized as an adjustment to revenue (either as an increase in or a reduction of revenue) on a cumulative catch-up basis. Contract assets primarily represent revenue earnings over time that are not yet billable based on the terms of the contracts. Contract liabilities (i.e., deferred revenue) consist of fees invoiced or paid by the Company’s customers for which the associated performance obligations have not been satisfied and revenue has not been recognized based on the Company’s revenue recognition criteria described above. As of December 31, 2025, the Company has recognized a contract asset of $319,955 which is included in other accounts receivable in the accompanying balance sheet.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Further contributing to this change were non-cash items of $3.4 million including stock-based compensation expense of $2.7 million, depreciation and amortization expense of $0.8 million, and partially offset by a $0.1 million decrease in non-cash leasing liabilities.