Full Press Release Details
KORU MEDICAL SYSTEMS ANNOUNCES RECORD Q1 2025
FINANCIAL RESULTS AND RAISES 2025 REVENUE GUIDANCE
MAHWAH, NJ - May 7, 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 first quarter ended March 31, 2025.
| 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.
| 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.
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.
| 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
| 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
| 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
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
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