KORU Medical Systems, Inc.

MAHWAH, N.J.--(BUSINESS WIRE)--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. Recent Highlights 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. 2025 Guidance 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. Non-GAAP Measures This press release includes the non-GAAP financial measures “adjusted diluted EPS” and “adjusted EBITDA” that are not in accordance with, nor an alternate to, generally accepted accounting principles and may be different from non-GAAP measures used by other companies. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Non-GAAP financial measures should not be considered a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. They are limited in value because they exclude charges that have a material effect on KORU Medical’s reported results and, therefore, should not be relied upon as the sole financial measures to evaluate the Company’s financial results. Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results. Reconciliations of the Company’s non-GAAP measures are included at the end of this press release. 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. BALANCE SHEETS 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 (UNAUDITED) 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 (UNAUDITED) 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 (UNAUDITED) 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 (UNAUDITED) A reconciliation of our non-GAAP measures is below: Three Months Ended Nine Months Ended Reconciliation of GAAP Net (Loss) September 30, September 30, to Non-GAAP Adjusted EBITDA: 2025 2024 2025 2024 GAAP Net Loss $ (777,966 ) $ (1,580,817 ) $ (2,151,070 ) $ (4,505,490 ) Reorganization Charges — 396,926 — 496,255 Depreciation and Amortization 204,482 227,785 631,326 677,019 Interest Income, Net (74,567 ) (112,997 ) (226,698 ) (364,183 ) Tax Expense (Refund) (150 ) — 17,206 — Stock-based Compensation Expense 737,398 634,608 1,850,732 1,948,992 Non-GAAP Adjusted EBITDA $ 89,197 $ (434,495 ) $ 121,496 $ (1,747,407 ) Weighted average number of common shares 46,238,819 45,851,019 46,140,347 45,791,756 Three Months Ended Nine Months Ended Reconciliation of Reported Diluted EPS September 30, September 30, to Non-GAAP Adjusted Diluted EPS: 2025 2024 2025 2024 Reported Diluted Earnings Per Share $ (0.02 ) $ (0.03 ) $ (0.05 ) $ (0.10 ) Reorganization Charges — 0.01 — 0.01 Depreciation and Amortization — — 0.01 0.01 Interest Income, Net — — — (0.01 ) Tax Expense (Refund) — — — — Stock-based Compensation Expense 0.02 0.01 0.04 0.04 Non-GAAP Adjusted Diluted Earnings Per Share $ (0.00 ) $ (0.01 ) $ (0.00 ) $ (0.05 ) *Numbers presented are rounded to the nearest whole cent Reorganization Charges. We have excluded the effect of reorganization charges in calculating our non-GAAP measures. In 2024 we incurred severance expenses related to the reorganization of the leadership team, which we would not have otherwise incurred in periods presented as part of continuing operations. Stock-based Compensation Expense. We have excluded the effect of stock-based compensation expense in calculating our non-GAAP measures. We record non-cash compensation expenses related to grants of equity-based awards for executives, employees, consultants, and directors. Depending upon the size, timing and the terms of the grants, the non-cash compensation expense may vary significantly but is expected to recur in future periods.

DENVER & MAHWAH, N.J.--(BUSINESS WIRE)--ForCast Orthopedics, Inc. and KORU Medical Systems, Inc. (NASDAQ: KRMD) today jointly announced an agreement leveraging KORU Medical’s FreedomEDGE® infusion system as part of ForCast’s technology platform for the treatment of periprosthetic joint infection (PJI). PJI is a rare but serious complication of joint replacement procedures, and is challenging to treat because the infecting bacteria adhere to the prothesis and can form a protective biofilm which is resistant to standard systemic antibiotics. KORU Medical’s FreedomEDGE pump will provide the infusion technology to support ForCast’s proprietary delivery system for PJI treatment, known as WIIS (Wearable Intra-Articular Infusion System), in anticipation of initiating a clinical trial in 2026. “We are excited to kick off this development program with KORU,” said Peter Noymer, PhD, Executive Chairman and CEO of ForCast. “After reviewing the entire landscape of infusion pump technologies available, it became clear that KORU’s products were best suited for partnering with our WIIS platform and for meeting the needs of PJI patients.” ForCast’s lead program, FC001, has received both Orphan Drug Designation and Qualified Infectious Disease Program (QIDP) designation from the US Food & Drug Administration, which enable eligibility for Fast-Track Designation and Priority Review. “We look forward to working with ForCast and helping them achieve their mission to modernize the standard of care for PJI,” said Linda Tharby, President and CEO of KORU Medical. “Supporting such a novel delivery system highlights the utility of the Freedom System and we are proud to be a trusted supplier for our valued partners.” About ForCast Orthopedics ForCast Orthopedics is a development-stage company pioneering the treatment of periprosthetic joint infection (PJI) with targeted antibiotic therapy. ForCast’s mission is to modernize the standard of care for PJI and improve quality of life for the growing population of joint replacement patients. 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, including but not limited to the success of KORU Medical technology supporting WIIS and timing to complete the clinical readiness assessment. Actual results may differ materially from these statements due to potential risks and uncertainties such as 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 which is 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 September 18, 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.

MAHWAH, N.J.--(BUSINESS WIRE)--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 first quarter ended March 31, 2025. Recent Highlights First quarter 2025 net revenues of $9.6 million, an 18% increase over the prior year period Core business (Domestic and International) net revenues of $9.4 million, a 21% increase over the prior year period Gross profit of $6.0 million, a 19% increase over the prior year period, and gross margin of 62.8%, a 50-basis point improvement over the prior year period Ending cash balance of $8.7 million and quarterly cash usage of $0.8 million Announcing plans to submit for FDA 510(k) clearance for 2 commercialized drugs with the Freedom Infusion System™ in 2025 Raising full year 2025 revenue guidance to $38.5 – $39.5 million from prior range of $38.0 - $39.0 million; reiterating full year gross margin guidance of 61% - 63%, and positive cash flow from operations for full year 2025 “We are off to a strong start this year, with over 20% growth in our core business driven by new patient starts and continued market share gains both domestically and internationally, all contributing to the expansion of our recurring revenue base,” said Linda Tharby, President and CEO of KORU Medical. “We are also advancing our novel therapies pipeline and announcing plans to submit two previously commercialized drugs for 510(k) clearance with the Freedom Infusion system by year-end. Despite a challenging macroeconomic backdrop, the positive momentum in our business gives us confidence in our ability to deliver through the remainder of the year, and we are raising our full-year revenue guidance accordingly.” 2025 First Quarter Financial Results Three Months Ended March 31, Change from Prior Year % of Net Revenues 2025 2024 $ % 2025 2024 Net Revenues Domestic Core $ 6,927,964 $ 5,953,865 $ 974,099 16.4 % 71.9 % 72.6 % International Core 2,428,662 1,790,483 638,179 35.6 % 25.2 % 21.8 % Total Core 9,356,626 7,744,348 1,612,278 20.8 % 97.1 % 94.5 % Pharma Services and Clinical Trials 278,449 453,450 (175,001 ) (38.6 %) 2.9 % 5.5 % Total $ 9,635,075 $ 8,197,798 $ 1,437,277 17.5 % 100 % 100 % Total net revenues increased $1.4 million, or 17.5%, to $9.6 million for the three months ended March 31, 2025, as compared to $8.2 million in the prior year period. Domestic core revenues were $6.9 million, an increase of 16.4% over the prior year period, primarily due to higher pump and 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 $2.4 million, an increase of 35.6% over the prior year period, primarily due to higher pump and consumable volumes, driven by geographical expansion and a tender win with an Ig pharma partner. International growth was impacted by approximately $0.4 million of distributor stocking to support expansion, compared to $0.3 million of distributor stocking in the prior year as a result of the BSI regulatory review process. Pharma services and clinical trials net revenues were $0.3 million, a decrease of 38.6% over the prior year period, primarily due to lower clinical trial revenue. Gross profit increased $0.9 million, or 18.5%, to $6.0 million in the three months ended March 31, 2025, as compared to $5.1 million in the prior year period. Gross margin increased to 62.8% in the three months ended March 31, 2025, as compared to 62.3% in the prior year period. The increase in gross margin was primarily driven by favorable changes in product revenue mix. Total operating expenses for the first quarter of 2025 were $7.3 million, an increase of $0.2 million, or 3.2%, over the prior year period driven by increases in compensation-related expenses for temporary staff to support product development and legal fees, partially offset by lower severance and research and development expenses. Net loss decreased $0.8 million in the three months ended March 31, 2025, as compared to the prior year period, primarily driven by an increase in gross profit of $0.9 million, driven by increased revenues, partially offset by operating expense increases of $0.2 million. Adjusted EBITDA for the first quarter of 2025 was ($0.2) million, or ($0.00) per diluted share, compared to adjusted EBITDA of ($0.9) million, or ($0.02) per diluted share, for the 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 $8.7 million as of March 31, 2025, reflecting cash usage of $0.8 million in the first quarter of 2025. 2025 Guidance Raising full year 2025 net revenues guidance to $38.5 - $39.5, representing growth of 15% - 17% from prior range of $38.0 - $39.0 million Reiterating full year 2025 gross margin guidance of 61% - 63% Reiterating positive cash flow from operations for full year 2025 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, May 7, 2025, at 4:30 PM ET. To participate in the call, please dial (877) 407-0784 (domestic) or (201) 689-8560 (international). The live webcast will be available on the IR Calendar on the News/Events page of the Investors section of KORU Medical’s website. Non-GAAP Measures This press release includes the non-GAAP financial measures “adjusted diluted EPS” and “adjusted EBITDA” that are not in accordance with, nor an alternate to, generally accepted accounting principles and may be different from non-GAAP measures used by other companies. These non-GAAP measures are not based on any comprehensive set of accounting rules or principles. Non-GAAP financial measures should not be considered a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. They are limited in value because they exclude charges that have a material effect on KORU Medical’s reported results and, therefore, should not be relied upon as the sole financial measures to evaluate the Company’s financial results. Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results. Reconciliations of the Company’s non-GAAP measures are included at the end of this press release. 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 Novel Therapies 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, timing of 510(k) clearances and 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 May 7, 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. BALANCE SHEETS March 31, December 31, 2025 2024 (UNAUDITED) ASSETS CURRENT ASSETS Cash and cash equivalents $ 8,735,834 $ 9,580,947 Accounts receivable less allowance for credit losses of $0 as of March 31, 2025 and December 31, 2024 5,949,411 5,720,750 Inventory 3,278,646 2,803,669 Other receivables 321,167 277,193 Prepaid expenses 713,970 749,851 TOTAL CURRENT ASSETS 18,999,028 19,132,410 Property and equipment, net 4,533,949 4,290,515 Intangible assets, net of accumulated amortization of $475,891 and $458,538 as of March 31, 2025 and December 31, 2024, respectively 716,326 730,279 Operating lease right-of-use assets 2,867,894 2,966,341 Other assets 98,970 98,970 TOTAL ASSETS $ 27,216,167 $ 27,218,515 LIABILITIES AND STOCKHOLDERS’ EQUITY CURRENT LIABILITIES Accounts payable $ 2,013,578 $ 1,649,969 Accrued expenses 3,977,987 3,924,184 Note payable 137,180 271,152 Other liabilities 110,097 29,269 Accrued payroll and related taxes 1,038,717 811,401 Financing lease liability – current 117,105 115,587 Operating lease liability – current 404,613 400,258 TOTAL CURRENT LIABILITIES 7,799,277 7,201,820 Financing lease liability, net of current portion 174,259 202,613 Operating lease liability, net of current portion 2,897,600 3,000,403 TOTAL LIABILITIES 10,871,136 10,404,836 STOCKHOLDERS’ EQUITY Common stock, $0.01 par value, 75,000,000 shares authorized, 49,561,498 and 49,377,617 shares issued 46,140,996 and 45,957,115 shares outstanding as of March 31, 2025, and December 31, 2024, respectively 495,615 493,776 Additional paid-in capital 50,277,053 49,581,303 Treasury stock, 3,438,526 and 3,438,526 shares as of March 31, 2025 and December 31, 2024, respectively, at cost (3,882,494 ) (3,882,494 ) Accumulated deficit (30,545,143 ) (29,378,906 ) TOTAL STOCKHOLDERS’ EQUITY 16,345,031 16,813,679 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 27,216,167 $ 27,218,515 KORU MEDICAL SYSTEMS, INC. STATEMENTS OF OPERATIONS (UNAUDITED) Three Months Ended March 31, 2025 2024 NET REVENUES $ 9,635,075 $ 8,197,798 Cost of goods sold 3,588,740 3,094,500 Gross Profit 6,046,335 5,103,298 OPERATING EXPENSES Selling, general and administrative 5,959,374 5,357,620 Research and development 1,114,609 1,475,674 Depreciation and amortization 217,357 231,370 Total Operating Expenses 7,291,340 7,064,664 Net Operating Loss (1,245,005 ) (1,961,366 ) Non-Operating Income/(Expense) Gain/(Loss) on currency exchange 5,588 (11,479 ) Loss on disposal of fixed assets, net — (300 ) Interest income, net 73,180 37,187 TOTAL OTHER INCOME 78,768 25,408 LOSS BEFORE INCOME TAXES (1,166,237 ) (1,935,958 ) Income Tax Benefit — — NET LOSS $ (1,166,237 ) $ (1,935,958 ) NET LOSS PER SHARE Basic & Diluted $ (0.03 ) $ (0.04 ) WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING Basic & Diluted 45,981,826 45,712,224 KORU MEDICAL SYSTEMS, INC. STATEMENTS OF CASH FLOWS (UNAUDITED) For the Three Months Ended March 31, 2025 2024 CASH FLOWS FROM OPERATING ACTIVITIES Net Loss $ (1,166,237 ) $ (1,935,958 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense and warrant expense 697,590 699,718 Depreciation and amortization 217,357 231,370 Loss on disposal of fixed assets — 300 Non-cash lease adjustments — (5,497 ) Changes in operating assets and liabilities: Accounts receivable (228,661 ) (607,125 ) Inventory (474,977 ) 333,989 Prepaid expenses and other assets (8,094 ) 387,880 Other liabilities 80,828 (54,867 ) Accounts payable 363,608 798,992 Accrued payroll and related taxes 227,316 56,500 Accrued expenses 53,803 (252,022 ) NET CASH USED IN OPERATING ACTIVITIES (237,467 ) (346,720 ) CASH FLOWS FROM INVESTING ACTIVITIES Purchases of property and equipment (443,438 ) (133,083 ) Purchases of intangible assets (3,400 ) (0 ) NET CASH USED IN INVESTING ACTIVITIES (446,838 ) (133,083 ) CASH FLOWS FROM FINANCING ACTIVITIES Payments on insurance finance indebtedness (133,973 ) (155,313 ) Payments on finance lease liability (26,835 ) (26,807 ) NET CASH USED IN FINANCING ACTIVITIES (160,808 ) (182,120 ) NET DECREASE IN CASH AND CASH EQUIVALENTS (845,113 ) (661,923 ) CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 9,580,947 11,482,240 CASH AND CASH EQUIVALENTS, END OF PERIOD $ 8,735,834 $ 10,820,317 Supplemental Information Cash paid during the periods for: Interest $ 5,385 $ 12,296 Income taxes $ — $ — KORU MEDICAL SYSTEMS, INC. SUPPLEMENTAL INFORMATION (UNAUDITED) A reconciliation of our non-GAAP measures is below: Three Months Ended Reconciliation of GAAP Net Loss March 31, to Non-GAAP Adjusted EBITDA: 2025 2024 GAAP Net Loss $ (1,166,237 ) $ (1,935,958 ) Depreciation and Amortization 217,357 231,369 Interest (Income), Net (73,180 ) (37,187 ) Reorganization Charges — 99,329 Litigation Expense 133,411 Stock-based Compensation Expense 697,590 699,718 Adjusted EBITDA $ (191,059 ) $ (942,729 ) Weighted average number common shares 45,981,826 45,712,224 Three Months Ended Reconciliation of Reported Diluted EPS March 31, to Non-GAAP Adjusted Diluted EPS: 2025 2024 Reported Diluted Earnings Per Share $ (0.03 ) $ (0.04 ) Depreciation and Amortization — 0.01 Interest (Income)/Expense, Net — — Reorganization Charges — — Litigation Expense — — Stock-based Compensation Expense 0.02 0.02 Adjusted Diluted Earnings Per Share $ 0.00 $ (0.02 ) *Numbers presented are rounded to the nearest whole cent and percentage Reorganization Charges. We have excluded the effect of reorganization charges in calculating our non-GAAP measures. In 2024 and 2025 we incurred severance expenses related to the reorganization of the leadership team, which we would not have otherwise incurred in periods presented as part of continuing operations. Stock-based Compensation Expense. We have excluded the effect of stock-based compensation expense in calculating our non-GAAP measures. We record non-cash compensation expenses related to grants of options and restricted shares for executives, employees and consultants, and grants of shares to our board of directors. Depending upon the size, timing and the terms of the grants, the non-cash compensation expense may vary significantly but will recur in future periods. Litigation Expense. We have excluded the effect of litigation expense in calculating our non-GAAP measures. In the first quarter 2025 we incurred legal fees with respect to a claim filed by the Company alleging patent infringement, which we would not have otherwise incurred in the period presented as part of continuing operations.