KORU Medical Systems Announces Record Q1 2025 Financial Results and Raises 2025 Revenue Guidance
Recent Highlights
-
First quarter 2025 net revenues of
$9.6 million 18% increase over the prior year period -
Core business (Domestic and International) net revenues of
$9.4 million 21% increase over the prior year period -
Gross profit of
$6.0 million 19% increase over the prior year period, and gross margin of62.8% , a 50-basis point improvement over the prior year period -
Ending cash balance of
$8.7 million $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 $38.0 $39.0 million 61% -63% , and positive cash flow from operations for full year 2025
“We are off to a strong start this year, with over
2025 First Quarter Financial Results |
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Three Months Ended March 31, |
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Change from Prior Year |
% of Net Revenues |
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|
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2025 |
|
2024 |
|
$ |
% |
2025 |
|
2024 |
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Net Revenues |
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|
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|
|
|
|
|
|
|
|
|
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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
Gross profit increased
Total operating expenses for the first quarter of 2025 were
Net loss decreased
Adjusted EBITDA for the first quarter of 2025 was
Cash and cash equivalents were
2025 Guidance
-
Raising full year 2025 net revenues guidance to
$38.5 $39.5 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 |
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March 31, |
December 31, |
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2025 |
2024 |
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(UNAUDITED) |
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ASSETS |
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CURRENT ASSETS |
|
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|
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|
|||
Cash and cash equivalents |
|
$ |
8,735,834 |
|
$ |
9,580,947 |
|
|
Accounts receivable less allowance for credit losses of |
|
|
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 |
|
|
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 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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CURRENT LIABILITIES |
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|
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|
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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 |
|
|
|
|
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|
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STOCKHOLDERS’ EQUITY |
|
|
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|
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Common stock, |
|
|
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) |
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Three Months Ended |
||||||
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|
March 31, |
||||||
|
|
2025 |
2024 |
|||||
|
|
|
|
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|
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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 |
|
|
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OPERATING EXPENSES |
|
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|
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Selling, general and administrative |
|
|
5,959,374 |
|
|
5,357,620 |
|
|
Research and development |
|
|
1,114,609 |
|
|
1,475,674 |
|
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Depreciation and amortization |
|
|
217,357 |
|
|
231,370 |
|
|
Total Operating Expenses |
|
|
7,291,340 |
|
|
7,064,664 |
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Net Operating Loss |
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|
(1,245,005 |
) |
|
(1,961,366 |
) |
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Non-Operating Income/(Expense) |
|
|
|
|
|
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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 |
|
|
|
|
|
|
|
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LOSS BEFORE INCOME TAXES |
|
|
(1,166,237 |
) |
|
(1,935,958 |
) |
|
|
|
|
|
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|
|||
Income Tax Benefit |
|
|
— |
|
|
— |
|
|
|
|
|
|
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|
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NET LOSS |
|
$ |
(1,166,237 |
) |
$ |
(1,935,958 |
) |
|
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|
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NET LOSS PER SHARE |
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|||
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Basic & Diluted |
|
$ |
(0.03 |
) |
$ |
(0.04 |
) |
|
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WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING |
|
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|
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|||
|
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|
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|
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Basic & Diluted |
|
|
45,981,826 |
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45,712,224 |
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KORU MEDICAL SYSTEMS, INC. STATEMENTS OF CASH FLOWS (UNAUDITED) |
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For the
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March 31, |
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2025 |
2024 |
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CASH FLOWS FROM OPERATING ACTIVITIES |
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Net Loss |
|
$ |
(1,166,237 |
) |
$ |
(1,935,958 |
) |
|
Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation expense and warrant expense |
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|
697,590 |
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|
699,718 |
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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 |
) |
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CASH FLOWS FROM INVESTING ACTIVITIES |
|
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|
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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 |
) |
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CASH FLOWS FROM FINANCING ACTIVITIES |
|
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|
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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 |
) |
|
|
|
|
|
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|
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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 |
|
|
|
|
|
|
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Supplemental Information |
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Cash paid during the periods for: |
|
|
|
|
|
|||
Interest |
|
$ |
5,385 |
|
$ |
12,296 |
|
|
Income taxes |
|
$ |
— |
|
$ |
— |
|
|
KORU MEDICAL SYSTEMS, INC. SUPPLEMENTAL INFORMATION (UNAUDITED) |
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A reconciliation of our non-GAAP measures is below: |
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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 |
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|
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|
|
|
||||
|
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250507094877/en/
Investor Contact:
Louisa Smith
investor@korumedical.com
Source: KORU Medical Systems, Inc.
