Full Press Release Details
KORU MEDICAL SYSTEMS ANNOUNCES 27% Q3 REVENUE
GROWTH AND RAISES 2025 REVENUE GUIDANCE
MAHWAH, NJ - November 12, 2025 - 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 third quarter ended September 30, 2025.
| Third quarter 2025 net revenues of $10.4 million, a 27% increase over the prior year period | |
| Core business (Domestic and International) net revenues of $9.8 million, a 30% increase over the prior year period | |
| Announced two new Pharma Services and Clinical Trials (PST) collaborations expanding opportunity to reach new patient populations | |
| Gross profit of $6.3 million, a 21% increase over the prior year period, and gross margin of 60.2% | |
| Reported net loss of ($0.8) million, a 51% improvement over the prior year period, positive adjusted EBITDA of $0.09 million, a 121% improvement over the prior year period, and ending cash balance of $8.5 million reflective of quarterly cash generation of $0.4 million | |
| Raising full year 2025 revenue guidance to $40.5 - $41.0 million, representing year-over-year growth of 20% - 22%, from prior range of $39.5 - $40.5 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 $8.2 million |
"During the third quarter we continued to make
progress on our key strategic goals. We achieved our second consecutive quarter of more than 20% revenue growth, driven by a strong core
SCIg business, while delivering positive adjusted EBITDA and cash flow generation. Additionally, we announced two new pharmaceutical collaborations,
creating opportunities to reach broader patient populations," said Linda Tharby, President and CEO of KORU Medical. "As we
look ahead, we remain focused on accelerating revenue growth, advancing our innovation pipeline, expanding our international footprint,
and forming new pharmaceutical collaborations that utilize the Freedom system to treat more patients on a global scale."
2025 Third Quarter Financial Results
| Three Months Ended September 30, | Change from Prior Year | % of Net Revenues | ||||||||||||||
| 2025 | 2024 | $ | % | 2025 | 2024 | |||||||||||
| Net Revenues | ||||||||||||||||
| Domestic Core | $ | 6,122,365 | $ | 6,447,469 | $ | (325,104 | ) | (5.0% | ) | 58.9% | 78.8% | |||||
| International Core | 3,695,524 | 1,121,196 | 2,574,328 | 229.6% | 35.5% | 13.7% | ||||||||||
| Total Core | 9,817,889 | 7,568,665 | 2,249,224 | 29.7% | 94.4% | 92.5% | ||||||||||
| Pharma Services and Clinical Trials | 584,274 | 611,312 | (27,038 | ) | (4.4% | ) | 5.6% | 7.5% | ||||||||
| Total | $ | 10,402,163 | $ | 8,179,977 | $ | 2,222,186 | 27.2% | 100% | 100% |
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 impacted by a US distributor's purchase of KORU product
from one of our international distributors, and an inventory reduction by such US distributor, which were 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. 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, which is reflective of the inherent variability of this business.
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, and tariff-related charges. Gross margin is expected to improve
in the fourth quarter of 2025.
Total operating expenses for the third quarter of
2025 were $7.1 million, an increase of $0.2 million, or 3.5%, over the prior year period, primarily driven by increases in compensation
and benefits related to higher bonus accruals due to higher revenues, and legal fees, offset by lower research and development expenses
due to severance in the prior year period, and lower project spend in the current period.
Our net loss decreased to $0.8 million in the three
months ended September 30, 2025, as compared to $1.6 million in 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 of $0.2 million.
Adjusted EBITDA for the third quarter of 2025 was
$0.09 million, or $0.00 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 $8.5 million as of
September 30, 2025, reflecting cash generation of $0.4 million in the third quarter of 2025.
| Raising full year 2025 net revenues guidance to $40.5 - $41.0 million, representing year-over-year growth of 20% - 22%, from prior range of $39.5 - $40.5 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 $8.2 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, November 12, 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.
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.
About KORU Medical Systems
KORU Medical develops, manufactures, and commercializes
innovative and patient-centric large volume subcutaneous infusion solutions that improve quality of life for patients around the world.
The Freedom Syringe Infusion System ("the Freedom System") currently includes the Freedom60 and FreedomEdge Syringe
Infusion Drivers, Precision Flow Rate Tubing and HigH-Flo Subcutaneous Safety Needle Sets . The Freedom System, which received
its first FDA clearance in 1994, is used for self-administration in the home by the patient and/or delivery in an ambulatory infusion
center by a healthcare professional. Through its Pharma Services and Clinical Trials business, KORU Medical provides products for use
by biopharmaceutical companies in feasibility/clinical trials during the drug development process and, as needed, is capable of customizing
the Freedom System for clinical and commercial use across multiple drug categories. For more information, please visit www.korumedical.com.
Forward-looking Statements
This press release contains forward-looking statements
within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. All statements that are
not historical fact are forward-looking statements, including, but not limited to, financial guidance for fiscal 2025. Forward-looking
statements discuss the Company's current expectations and projections relating to its financial position, results of operations,
plans, objectives, future performance, and business. Forward-looking statements can be identified by words such as "guidance",
"expect", "plan", "believe" and "will". Actual results may differ materially from the
results predicted and reported results should not be considered as an indication of future performance. The potential risks and uncertainties
that could cause actual results to differ from the results predicted include, among others, uncertainties associated with SCIg market
growth, prefilled syringe penetration, plasma supply, clinical trial activity and success, approval and commercialization of new drug
indications, the shift to increased healthcare delivery in the home, new patient diagnoses, customer ordering patterns, global health
crises, innovation and competition, labor and supply price increases, inflationary impacts, labor supply, tariffs and those risks and
uncertainties included under the captions "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31,
2024 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, which are on file with the SEC and available on our website
at www.korumedical.com/investors and on the SEC website at www.sec.gov. All information provided in this release and in the attachments
is as of November 12, 2025. Undue reliance should not be placed on the forward-looking statements in this press release, which are based
on information available to us on the date hereof. We undertake no duty to update this information unless required by law.
KORU MEDICAL SYSTEMS, INC.
| September 30, | December 31, | ||||||
| 2025 | 2024 | ||||||
| (UNAUDITED) | |||||||
| ASSETS | |||||||
| CURRENT ASSETS | |||||||
| Cash and cash equivalents | $ | 8,464,019 | $ | 9,580,947 | |||
| Accounts receivable less allowance for credit losses of $0 as of September 30, 2025 and December 31, 2024 | 5,412,004 | 5,720,750 | |||||
| Inventory | 4,411,710 | 2,803,669 | |||||
| Other receivables | 103,079 | 277,193 | |||||
| Prepaid expenses | 1,028,484 | 749,851 | |||||
| TOTAL CURRENT ASSETS | 19,419,296 | 19,132,410 | |||||
| Property and equipment, net | 4,235,983 | 4,290,515 | |||||
| Intangible assets, net of accumulated amortization of $510,597 and $458,538 as of September 30, 2025 and December 31, 2024, respectively | 681,621 | 730,279 | |||||
| Operating lease right-of-use assets | 2,667,656 | 2,966,341 | |||||
| Other assets | 98,970 | 98,970 | |||||
| TOTAL ASSETS | $ | 27,103,526 | $ | 27,218,515 | |||
| LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
| CURRENT LIABILITIES | |||||||
| Accounts payable | $ | 1,872,162 | $ | 1,649,969 | |||
| Accrued expenses | 4,634,183 | 3,924,184 | |||||
| Note payable | 334,931 | 271,152 | |||||
| Other liabilities | 2,893 | 29,269 | |||||
| Accrued payroll and related taxes | 456,066 | 811,401 | |||||
| Financing lease liability | 120,211 | 115,587 | |||||
| Operating lease liability | 413,486 | 400,258 | |||||
| TOTAL CURRENT LIABILITIES | 7,833,932 | 7,201,820 | |||||
| Financing lease liability, net of current portion | 116,279 | 202,613 | |||||
| Operating lease liability, net of current portion | 2,688,490 | 3,000,403 | |||||
| TOTAL LIABILITIES | 10,638,701 | 10,404,836 | |||||
| STOCKHOLDERS' EQUITY | |||||||
| Common stock, $0.01 par value, 75,000,000 shares authorized, 49,713,694 and 49,377,617 shares issued 46,293,192 and 45,957,115 shares outstanding as of September 30, 2025, and December 31, 2024, respectively | 497,137 | 493,776 | |||||
| Additional paid-in capital | 51,380,158 | 49,581,303 | |||||
| Treasury stock, 3,438,526 shares as of September 30, 2025 and December 31, 2024, at cost | (3,882,494 | ) | (3,882,494 | ) | |||
| Accumulated deficit | (31,529,976 | ) | (29,378,906 | ) | |||
| TOTAL STOCKHOLDERS' EQUITY | 16,464,825 | 16,813,679 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $ | 27,103,526 | $ | 27,218,515 |
KORU MEDICAL SYSTEMS, INC.
STATEMENTS OF OPERATIONS
| Three Months Ended | Nine Months Ended | ||||||||||||
| September 30, | September 30, | ||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||
| NET REVENUES | $ | 10,402,163 | $ | 8,179,977 | $ | 30,232,038 | $ | 24,807,864 | |||||
| Cost of goods sold | 4,137,592 | 2,993,986 | 11,445,362 | 9,038,825 | |||||||||
| Gross Profit | 6,264,571 | 5,185,991 | 18,786,676 | 15,769,038 | |||||||||
| OPERATING EXPENSES | |||||||||||||
| Selling, general and administrative | 5,994,661 | 5,127,658 | 17,338,183 | 15,804,966 | |||||||||
| Research and development | 933,107 | 1,533,845 | 3,242,505 | 4,143,751 | |||||||||
| Depreciation and amortization | 204,482 | 227,785 | 631,326 | 677,019 | |||||||||
| Total Operating Expenses | 7,132,250 | 6,889,288 | 21,212,014 | 20,625,736 | |||||||||
| Net Operating Loss | (867,679 | ) | (1,703,297 | ) | (2,425,338 | ) | (4,856,698 | ) | |||||
| Non-Operating Income (Expense) | |||||||||||||
| Gain (Loss) on currency exchange | 11,790 | 9,485 | 61,571 | (12,674 | ) | ||||||||
| Other income | 3,206 | - | 3,205 | (300 | ) | ||||||||
| Interest income, net | 74,567 | 112,995 | 226,698 | 364,183 | |||||||||
| TOTAL OTHER INCOME | 89,563 | 122,480 | 291,474 | 351,208 | |||||||||
| LOSS BEFORE INCOME TAXES | (778,116 | ) | (1,580,817 | ) | (2,133,864 | ) | (4,505,490 | ) | |||||
| Income Tax Refund (Expense) | 150 | - | (17,206) | - | |||||||||
| NET LOSS | $ | (777,966 | ) | $ | (1,580,817 | ) | $ | (2,151,070 | ) | $ | (4,505,490 | ) | |
| NET LOSS PER SHARE | |||||||||||||
| Basic & Diluted | $ | (0.02 | ) | $ | (0.03 | ) | $ | (0.05 | ) | $ | (0.10 | ) | |
| WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | |||||||||||||
| Basic & Diluted | 46,238,819 | 45,851,019 | 46,140,347 | 45,791,756 |
KORU MEDICAL SYSTEMS, INC.
STATEMENTS OF CASH FLOWS
| For the Nine Months Ended | |||||||
| September 30, | |||||||
| 2025 | 2024 | ||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | |||||||
| Net Loss | $ | (2,151,070 | ) | $ | (4,505,490 | ) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
| Stock-based compensation expense and warrant expense | 1,740,727 | 1,924,131 | |||||
| Depreciation and amortization | 631,326 | 677,019 | |||||
| Loss on disposal of fixed assets | - | 300 | |||||
| Non-cash lease adjustments | - | 243,762 | |||||
| Changes in operating assets and liabilities: | |||||||
| Accounts receivable | 308,749 | (1,119,490 | ) | ||||
| Inventory | (1,608,041 | ) | (447,017 | ) | |||
| Prepaid expenses and other assets | (104,520 | ) | 217,652 | ||||
| Other liabilities | (26,379 | ) | (330,773 | ) | |||
| Accounts payable | 222,193 | 695,107 | |||||
| Accrued payroll and related taxes | (355,335 | ) | 303,927 | ||||
| Accrued expenses | 709,999 | 1,081,539 | |||||
| NET CASH USED IN OPERATING ACTIVITIES | (632,351 | ) | (1,259,333 | ) | |||
| CASH FLOWS FROM INVESTING ACTIVITIES | |||||||
| Purchases of property and equipment | (524,735 | ) | (1,340,994 | ) | |||
| Purchases of intangible assets | (3,400 | ) | (42,786 | ) | |||
| NET CASH USED IN INVESTING ACTIVITIES | (528,135 | ) | (1,383,780 | ) | |||
| CASH FLOWS FROM FINANCING ACTIVITIES | |||||||
| Proceeds from exercise of employee stock options | 89,025 | - | |||||
| Borrowings from insurance finance indebtedness | 406,751 | 487,516 | |||||
| Payments on insurance finance indebtedness | (342,972 | ) | (399,867 | ) | |||
| Payments on finance lease liability | (81,710 | ) | (81,534 | ) | |||
| Payments for taxes related to net share settlement of equity awards | (27,536 | ) | (38,932 | ) | |||
| NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES | 43,558 | (32,817 | ) | ||||
| NET DECREASE IN CASH AND CASH EQUIVALENTS | (1,116,928 | ) | (2,675,930 | ) | |||
| CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 9,580,947 | 11,482,240 | |||||
| CASH AND CASH EQUIVALENTS, END OF PERIOD | $ | 8,464,019 | $ | 8,806,310 | |||
| Supplemental Information | |||||||
| Cash paid during the periods for: | |||||||
| Interest | $ | 36,690 | $ | 46,014 |
KORU MEDICAL SYSTEMS, INC.
STATEMENTS OF STOCKHOLDERS' EQUITY
Three and Nine Months Ended September 30, 2025
| Additional | Total | |||||||||||||||||
| Common Stock | Paid-in | Accumulated | Treasury | Stockholders' | ||||||||||||||
| Shares | Amount | Capital | Deficit | Stock | Equity | |||||||||||||
| BALANCE, DECEMBER 31, 2024 | 49,377,617 | $ | 493,776 | $ | 49,581,303 | $ | (29,378,906 | ) | $ | (3,882,494 | ) | $ | 16,813,679 | |||||
| Issuance of stock-based compensation | 183,881 | 1,839 | 95,661 | - | - | 97,500 | ||||||||||||
| Compensation expense related to stock options | - | - | 359,197 | - | - | 359,197 | ||||||||||||
| Compensation related to restricted stock | - | - | 227,860 | - | - | 227,860 | ||||||||||||
| Issuance of warrants | - | - | 13,032 | - | - | 13,032 | ||||||||||||
| Net loss | - | - | - | (1,166,237 | ) | - | (1,166,237 | ) | ||||||||||
| BALANCE, MARCH 31, 2025 | 49,561,498 | $ | 495,615 | $ | 50,277,053 | $ | (30,545,143 | ) | $ | (3,882,494 | ) | $ | 16,345,031 | |||||
| Issuance of stock-based compensation | 93,961 | 940 | 96,560 | - | - | 97,500 | ||||||||||||
| Compensation expense related to stock options | - | - | 147,944 | - | - | 147,944 | ||||||||||||
| Compensation related to restricted stock | - | - | 142,766 | - | - | 142,766 | ||||||||||||
| Net loss | - | - | - | (206,867 | ) | - | (206,867 | ) | ||||||||||
| BALANCE, JUNE 30, 2025 | 49,655,459 | $ | 496,555 | $ | 50,664,323 | $ | (30,752,010 | ) | $ | (3,882,494 | ) | $ | 16,526,374 | |||||
| Issuance of stock-based compensation | 25,454 | 254 | 97,246 | - | - | 97,500 | ||||||||||||
| Compensation expense related to stock options | - | - | 254,697 | - | - | 254,697 | ||||||||||||
| Compensation related to restricted stock | - | - | 275,195 | - | - | 275,195 | ||||||||||||
| Proceeds from exercise of employee stock options | 32,781 | 328 | 88,697 | - | - | 89,025 | ||||||||||||
| Net loss | - | - | - | (777,966 | ) | - | (777,966 | ) | ||||||||||
| BALANCE, SEPTEMBER 30, 2025 | 49,713,694 | $ | 497,137 | $ | 51,380,158 | $ | (31,529,976 | ) | $ | (3,882,494 | ) | $ | 16,464,825 |
Three and Nine Months Ended September 30, 2024
| Additional | Total | |||||||||||||||||
| Common Stock | Paid-in | Retained | Treasury | Stockholders' | ||||||||||||||
| Shares | Amount | Capital | Deficit | Stock | Equity | |||||||||||||
| BALANCE, DECEMBER 31, 2023 | 49,089,864 | $ | 490,899 | $ | 47,018,707 | $ | (23,312,273 | ) | $ | (3,843,562 | ) | $ | 20,353,771 | |||||
| Issuance of stock-based compensation | 53,725 | 537 | 123,267 | - | - | 123,804 | ||||||||||||
| Compensation expense related to stock options | - | - | 393,113 | - | - | 393,113 | ||||||||||||
| Compensation related to restricted stock | - | - | 130,676 | - | - | 130,676 | ||||||||||||
| Issuance of warrants | - | - | 52,125 | - | - | 52,125 | ||||||||||||
| Net loss | - | - | - | (1,935,958 | ) | - | (1,935,958 | ) | ||||||||||
| BALANCE, MARCH 31, 2024 | 49,143,589 | $ | 491,436 | $ | 47,717,888 | $ | (25,248,231 | ) | $ | (3,843,562 | ) | $ | 19,117,531 | |||||
| Issuance of stock-based compensation | 41,138 | 411 | 136,020 | - | (38,932 | ) | 97,500 | |||||||||||
| Compensation expense related to stock options | - | - | 401,218 | - | - | 401,218 | ||||||||||||
| Compensation related to restricted stock | 55,061 | 551 | 63,434 | - | - | 63,984 | ||||||||||||
| Issuance of warrants | - | - | 13,032 | - | - | 13,032 | ||||||||||||
| Net loss | - | - | - | (988,715 | ) | - | (988,715 | ) | ||||||||||
| BALANCE, JUNE 30, 2024 | 49,239,788 | $ | 492,398 | $ | 48,331,591 | $ | (26,236,946 | ) | $ | (3,882,493 | ) | $ | 18,704,550 | |||||
| Issuance of stock-based compensation | 36,042 | 360 | 97,140 | - | - | 97,500 | ||||||||||||
| Compensation expense related to stock options | - | - | 305,376 | - | - | 305,376 | ||||||||||||
| Compensation related to restricted stock | - | - | 193,839 | - | - | 193,839 | ||||||||||||
| Issuance of warrants | - | - | 13,032 | - | - | 13,032 | ||||||||||||
| Net loss | - | - | - | (1,580,817 | ) | - | (1,580,817 | ) | ||||||||||
| BALANCE, SEPTEMBER 30, 2024 | 49,275,830 | $ | 492,758 | $ | 48,940,978 | $ | (27,817,763 | ) | $ | (3,882,493 | ) | $ | 17,733,480 |
KORU MEDICAL SYSTEMS, INC.
SUPPLEMENTAL INFORMATION
A reconciliation of our non-GAAP measures is below: