MAHWAH, N.J., August 06, 2025--(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 second quarter ended June 30, 2025.
Financial Highlights
• | Second quarter 2025 net revenues of $10.2 million, a 21% increase over the prior year period | |
• | Core business (Domestic and International) net revenues of $9.3 million, a 19% increase over the prior year period | |
• | Pharma Services and Clinical Trials (PST) net revenues of $0.9 million, a 42% increase over the prior year period | |
• | Gross profit of $6.5 million, an 18% increase over the prior year period, and gross margin of 63.5% | |
• | Ending cash balance of $8.1 million reflective of a quarterly cash usage of $0.6 million driven by improved gross profit and increased operating leverage | |
• | Raising full year 2025 revenue guidance to $39.5 - $40.5 million, representing growth of 18% - 20%, from prior range of $38.5 - $39.5 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 $8.1 million |
Business Highlights
• | Adam Kalbermatten joins as Chief Commercial Officer, bringing 20 years of success leading drug delivery partnerships across pharma and biotech. | |
• | Freedom Infusion System™ indicated for use with recently expanded indication of Empaveli® for C3G and Primary IC-MPGN treatment. | |
• | Submitted for FDA 510(k) clearance for a commercialized rare disease biologic drug with the Freedom Infusion System™ |
"We achieved a milestone this quarter, surpassing $10 million in revenue for the first time and delivering our sixth consecutive quarter of double-digit growth," said Linda Tharby, President and CEO of KORU Medical. "Strategically, we continued to outperform the strong SCIg market through global share gains, advanced our international expansion, and submitted a 510(k) filing to add a new drug to our Freedom Infusion System. Operationally, we delivered positive adjusted EBITDA, reflecting our disciplined execution and focused capital allocation, while continuing to invest in strategic growth areas. We believe this performance positions us well to drive continued shareholder value as we scale."
2025 Second Quarter Financial Results | ||||||||||||||||||
Three Months Ended June 30, | Change from Prior Year | % of Net Revenues | ||||||||||||||||
2025 | 2024 | $ | % | 2025 | 2024 | |||||||||||||
Net Revenues | ||||||||||||||||||
Domestic Core | $ | 7,097,285 | $ | 6,156,098 | $ | 941,187 | 15.3 | % | 69.6 | % | 73.0 | % | ||||||
International Core | 2,180,111 | 1,628,191 | 551,920 | 33.9 | % | 21.4 | % | 19.3 | % | |||||||||
Total Core | 9,277,396 | 7,784,289 | 1,493,107 | 19.2 | % | 91.0 | % | 92.3 | % | |||||||||
Pharma Services and Clinical Trials | 917,404 | 645,800 | 271,604 | 42.1 | % | 9.0 | % | 7.7 | % | |||||||||
Total | $ | 10,194,800 | $ | 8,430,089 | $ | 1,764,711 | 20.9 | % | 100 | % | 100 | % | ||||||
Total net revenues increased $1.8 million, or 20.9%, to $10.2 million for the three months ended June 30, 2025, as compared to $8.4 million in the prior year period. Domestic core revenues were $7.1 million, an increase of 15.3% over the prior year period, primarily due to higher consumable volumes, driven by new patient starts and market share gains from new and existing accounts, supported by a strong underlying SCIg market. International core revenues were $2.2 million, an increase of 33.9% over the prior year period, primarily due to higher consumable and pump volumes, driven by prefill patient conversions, new patient starts, market share gains within existing markets, and entry into new geographic markets. Pharma services and clinical trials net revenues were $0.9 million, an increase of 42.1% over the prior year period, primarily driven by higher revenues from product sales for clinical trials.
Gross profit increased $1.0 million, or 18.2%, to $6.5 million in the three months ended June 30, 2025, as compared to $5.5 million in the prior year period. Gross margin decreased to 63.5% in the three months ended June 30, 2025, as compared to 65.0% in the prior year period. The decrease in gross margin was primarily driven by a favorable inventory valuation adjustment that occurred in the prior year period and tariff related charges in the current year, partially offset by volume efficiencies, and stronger margins in our pharma services and clinical trial business.
Total operating expenses for the second quarter of 2025 were $6.8 million, an increase of $0.1 million, or 1.7%, over the prior year period primarily driven by increases in recruiting expenses related to the Chief Commercial Officer search and higher temporary headcount spend related to our new product development, partially offset by lower compensation-related expenses related to timing of hiring that role.
Our net loss decreased to $0.2 million in the three months ended June 30, 2025, as compared to the prior year period, primarily driven by an increase in gross profit of $1.0 million due to increased revenues, partially offset by an operating expense increase of $0.1 million.
Adjusted EBITDA for the second quarter of 2025 was $0.3 million, or $0.01 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 $8.1 million as of June 30, 2025, reflecting cash usage of $0.6 million in the second quarter of 2025.
2025 Guidance
• | Raising full year 2025 net revenues guidance to $39.5 - $40.5 million, representing growth of 18% - 20%, from prior range of $38.5 - $39.5 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 $8.1 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, August 6, 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 August 6, 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. | |||||||
June 30, | December 31, | ||||||
2025 | 2024 | ||||||
(UNAUDITED) | |||||||
ASSETS | |||||||
CURRENT ASSETS | |||||||
Cash and cash equivalents | $ | 8,054,716 | $ | 9,580,947 | |||
Accounts receivable less allowance for credit losses of $0 as of June 30, 2025 and December 31, 2024 | 4,929,071 | 5,720,750 | |||||
Inventory | 3,947,843 | 2,803,669 | |||||
Other receivables | 161,190 | 277,193 | |||||
Prepaid expenses | 486,524 | 749,851 | |||||
TOTAL CURRENT ASSETS | 17,579,344 | 19,132,410 | |||||
Property and equipment, net | 4,370,629 | 4,290,515 | |||||
Intangible assets, net of accumulated amortization of $493,244 and $458,538 as of June 30, 2025 and December 31, 2024, respectively | 698,974 | 730,279 | |||||
Operating lease right-of-use assets | 2,768,376 | 2,966,341 | |||||
Other assets | 98,970 | 98,970 | |||||
TOTAL ASSETS | $ | 25,516,293 | $ | 27,218,515 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
CURRENT LIABILITIES | |||||||
Accounts payable | $ | 1,094,539 | $ | 1,649,969 | |||
Accrued expenses | 3,635,525 | 3,924,184 | |||||
Note payable | — | 271,152 | |||||
Other liabilities | 104,102 | 29,269 | |||||
Accrued payroll and related taxes | 688,942 | 811,401 | |||||
Financing lease liability – current | 118,647 | 115,587 | |||||
Operating lease liability – current | 409,019 | 400,258 | |||||
TOTAL CURRENT LIABILITIES | 6,050,774 | 7,201,820 | |||||
Financing lease liability, net of current portion | 145,469 | 202,613 | |||||
Operating lease liability, net of current portion | 2,793,676 | 3,000,403 | |||||
TOTAL LIABILITIES | 8,989,919 | 10,404,836 | |||||
STOCKHOLDERS’ EQUITY | |||||||
Common stock, $0.01 par value, 75,000,000 shares authorized, 49,655,459 and 49,377,617 shares issued 46,234,957 and 45,957,115 shares outstanding as of June 30, 2025, and December 31, 2024, respectively | 496,555 | 493,776 | |||||
Additional paid-in capital | 50,664,323 | 49,581,303 | |||||
Treasury stock, 3,438,526 shares as of June 30, 2025 and December 31, 2024, at cost | (3,882,494 | ) | (3,882,494 | ) | |||
Accumulated deficit | (30,752,010 | ) | (29,378,906 | ) | |||
TOTAL STOCKHOLDERS’ EQUITY | 16,526,374 | 16,813,679 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 25,516,293 | $ | 27,218,515 | |||
KORU MEDICAL SYSTEMS, INC. | |||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||
June 30, | June 30, | ||||||||||||||
2025 | 2024 | 2025 | 2024 | ||||||||||||
NET REVENUES | $ | 10,194,800 | $ | 8,430,089 | $ | 19,829,875 | $ | 16,627,887 | |||||||
Cost of goods sold | 3,719,031 | 2,950,339 | 7,307,771 | 6,044,839 | |||||||||||
Gross Profit | 6,475,769 | 5,479,750 | 12,522,104 | 10,583,048 | |||||||||||
OPERATING EXPENSES | |||||||||||||||
Selling, general and administrative | 5,384,148 | 5,319,688 | 11,343,522 | 10,677,308 | |||||||||||
Research and development | 1,194,789 | 1,134,232 | 2,309,398 | 2,609,907 | |||||||||||
Depreciation and amortization | 209,487 | 217,864 | 426,844 | 449,233 | |||||||||||
Total Operating Expenses | 6,788,424 | 6,671,784 | 14,079,764 | 13,736,448 | |||||||||||
Net Operating Loss | (312,655 | ) | (1,192,034 | ) | (1,557,660 | ) | (3,153,400 | ) | |||||||
Non-Operating Income/(Expense) | |||||||||||||||
Gain/(Loss) on currency exchange | 44,193 | (10,680 | ) | 49,781 | (22,159 | ) | |||||||||
Loss on disposal of fixed assets, net | — | — | — | (300 | ) | ||||||||||
Interest income, net | 78,951 | 213,999 | 152,130 | 251,186 | |||||||||||
TOTAL OTHER INCOME | 123,144 | 203,319 | 201,911 | 228,727 | |||||||||||
LOSS BEFORE INCOME TAXES | (189,511 | ) | (988,715 | ) | (1,355,749 | ) | (2,924,673 | ) | |||||||
Income Tax Expense | (17,356 | ) | — | (17,356 | ) | — | |||||||||
NET LOSS | $ | (206,867 | ) | $ | (988,715 | ) | $ | (1,373,105 | ) | $ | (2,924,673 | ) | |||
NET LOSS PER SHARE | |||||||||||||||
Basic & Diluted | $ | (0.00 | ) | $ | (0.02 | ) | $ | (0.03 | ) | $ | (0.06 | ) | |||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | |||||||||||||||
Basic & Diluted | 46,193,709 | 45,811,373 | 46,088,353 | 45,761,799 | |||||||||||
KORU MEDICAL SYSTEMS, INC. | ||||||||
For the Six Months Ended | ||||||||
June 30, | ||||||||
2025 | 2024 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
Net Loss | $ | (1,373,105 | ) | $ | (2,924,673 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock-based compensation expense and warrant expense | 1,113,334 | 1,314,384 | ||||||
Depreciation and amortization | 426,844 | 449,233 | ||||||
Loss on disposal of fixed assets | — | 300 | ||||||
Non-cash lease adjustments | — | (10,994 | ) | |||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable | 791,679 | (1,800,871 | ) | |||||
Inventory | (1,144,174 | ) | 892,551 | |||||
Prepaid expenses and other assets | 379,330 | 774,313 | ||||||
Other liabilities | 74,833 | (64,731 | ) | |||||
Accounts payable | (555,430 | ) | 620,498 | |||||
Accrued payroll and related taxes | (122,459 | ) | (18,691 | ) | ||||
Accrued expenses | (288,659 | ) | 433,296 | |||||
NET CASH USED IN OPERATING ACTIVITIES | (697,807 | ) | (335,385 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES | ||||||||
Purchases of property and equipment | (472,252 | ) | (257,367 | ) | ||||
Purchases of intangible assets | (3,400 | ) | (24,216 | ) | ||||
NET CASH USED IN INVESTING ACTIVITIES | (475,652 | ) | (281,583 | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
Payments on insurance finance indebtedness | (271,152 | ) | (314,344 | ) | ||||
Payments on finance lease liability | (54,084 | ) | (53,995 | ) | ||||
Payments for taxes related to net share settlement of equity awards | (27,536 | ) | (38,932 | ) | ||||
NET CASH USED IN FINANCING ACTIVITIES | (352,772 | ) | (407,271 | ) | ||||
NET DECREASE IN CASH AND CASH EQUIVALENTS | (1,526,231 | ) | (1,024,239 | ) | ||||
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD | 9,580,947 | 11,482,240 | ||||||
CASH AND CASH EQUIVALENTS, END OF PERIOD | $ | 8,054,716 | $ | 10,458,001 | ||||
Supplemental Information | ||||||||
Cash paid during the periods for: | ||||||||
Interest | $ | 7,563 | $ | 20,491 | ||||
Income taxes | $ | 17,356 | $ | — | ||||
KORU MEDICAL SYSTEMS, INC. | ||||||||||||||||||||
Three and Six Months Ended June 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 | |||||||
Three and Six Months Ended June 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 | |||||||
KORU MEDICAL SYSTEMS, INC. | ||||||||||||||||
A reconciliation of our non-GAAP measures is below: | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
Reconciliation of GAAP Net (Loss) | June 30, | June 30, | ||||||||||||||
to Non-GAAP Adjusted EBITDA: | 2025 | 2024 | 2025 | 2024 | ||||||||||||
GAAP Net Loss | $ | (206,867 | ) | $ | (988,715 | ) | $ | (1,373,105 | ) | $ | (2,924,673 | ) | ||||
Reorganization Charges | — | — | — | 99,329 | ||||||||||||
Depreciation and Amortization | 209,487 | 217,864 | 426,844 | 449,233 | ||||||||||||
Interest (Income)/Expense, Net | (78,951 | ) | (213,999 | ) | (152,130 | ) | (251,186 | ) | ||||||||
Stock-based Compensation Expense | 415,744 | 614,666 | 1,113,334 | 1,314,384 | ||||||||||||
Non-GAAP Adjusted EBITDA | $ | 339,413 | $ | (370,184 | ) | $ | 14,943 | $ | (1,312,913 | ) | ||||||
Weighted average number of common shares | 46,193,709 | 45,811,373 | 46,088,353 | 45,761,799 | ||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
Reconciliation of Reported Diluted EPS | June 30, | June 30, | ||||||||||||||
to Non-GAAP Adjusted Diluted EPS: | 2025 | 2024 | 2025 | 2024 | ||||||||||||
Reported Diluted Earnings Per Share | $ | 0.00 | $ | (0.02 | ) | $ | (0.03 | ) | $ | (0.06 | ) | |||||
Depreciation and Amortization | 0.00 | 0.00 | 0.01 | 0.01 | ||||||||||||
Stock-based Compensation Expense | 0.01 | 0.01 | 0.02 | 0.03 | ||||||||||||
Non-GAAP Adjusted Diluted Earnings Per Share | $ | 0.01 | $ | (0.01 | ) | $ | 0.00 | $ | (0.02 | ) | ||||||
*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 corporate reorganization, 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.
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Contacts
Investor Contact:
Louisa Smith
investor@korumedical.com