KORU Medical Systems Announces Second Quarter 2026 Results and Updates Full Year 2026 Guidance
Second Quarter 2026 and Recent Highlights
-
Net revenues grew
18% over the prior year period to$12.0 million
-
Gross profit grew
20% over the prior year period to , with gross margin of$7.8 million 65.1%
-
Net income improved
222% over the prior year period to$0.25 million
- Acquired a connected monitoring technology asset, representing strategic investment to potentially enhance and differentiate the KORU platform through valuable real-time data insights into patient usage
-
Strategically shifting
U.S . oncology market entry to focus on alternative higher volume molecules and withdrawing 510(k) application for the FreedomEDGE® with Phesgo® in theU.S .
- Entered into a multi-year supply agreement to support operational strategy, product assurance, and long-term gross margin expansion
-
Refining full year 2026 guidance to include: Revenue of
-$47.5 , gross margin of$48.5 million 62% -64% , positive adjusted EBITDA, and year end cash balance of greater than$7.5 million
“We delivered record revenue, improved gross margins and generated positive net income for the quarter, all of which demonstrate our ability to drive durable and profitable growth in the subcutaneous drug delivery market,” said Adam Kalbermatten, President and CEO of KORU Medical. “We also acquired a technology asset, representing a strategic investment in connected monitoring potential to further enhance the patient experience and differentiate KORU’s value proposition to our partners.
“Looking ahead for the remainder of 2026, we expect our international core growth to moderate as we navigate regional launch dynamics in specific European markets converting to pre-filled syringes. We remain confident in the size of our international opportunity and view capturing this business only as a matter of timing. Additionally, we have withdrawn our Phesgo® 510(k) application and shifted our
2026 Second Quarter Financial Results
|
|
Three Months Ended June 30, |
|
Change from Prior Year |
|
% of Net Revenues |
|||||||||||||
|
|
2026 |
|
2025 |
|
$ |
|
% |
|
2026 |
|
2025 |
|||||||
Net Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Domestic Core |
|
$ |
7,979,558 |
|
$ |
7,097,285 |
|
$ |
882,273 |
|
|
12.4 |
% |
|
66.2 |
% |
|
69.6 |
% |
International Core |
|
|
3,469,558 |
|
|
2,180,111 |
|
|
1,289,447 |
|
|
59.1 |
% |
|
28.8 |
% |
|
21.4 |
% |
Total Core |
|
|
11,449,116 |
|
|
9,277,396 |
|
|
2,171,720 |
|
|
23.4 |
% |
|
95.0 |
% |
|
91.0 |
% |
Pharma Services and Clinical Trials |
|
|
596,304 |
|
|
917,404 |
|
|
(321,100 |
) |
|
(35.0 |
)% |
|
5.0 |
% |
|
9.0 |
% |
Total |
|
$ |
12,045,420 |
|
$ |
10,194,800 |
|
$ |
1,850,620 |
|
|
18.2 |
% |
|
100.0 |
% |
|
100.0 |
% |
Total net revenues increased
Gross profit increased
Total operating expenses increased
Net income increased
Cash and cash equivalents were
Updated 2026 Guidance
-
Narrowing full year 2026 net revenues to be between
-$47.5 , representing growth of$48.5 million 15% -18%
-
Raising full year 2026 gross margin to be between 62 -
64%
- Reiterating positive adjusted EBITDA for the full year
-
Updating year end cash balance to be greater than
to account for the technology acquisition$7.5 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 5, 2026, 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 Systems 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 Service 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 and expected operating performance for fiscal 2026. 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 “potential”, “guidance”, and “expect”. 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, ability to adapt new technology, uncertainties associated with inflation, tariffs, war and other geopolitical conflicts, customer ordering patterns, availability and costs of raw materials and labor and our ability to recover such costs, future operating results, growth of new patient starts and the Ig market, our compliance with Food and Drug Administration and foreign authority regulations and the outcome of regulatory audits, introduction and adoption of competitive products, acceptance of and demand for new and existing products, ability to penetrate new markets, success in enforcing and obtaining patents, reimbursement related risks, government regulation of the home health care industry, success of our research and development effort, expanding the market of the Freedom System, demand in the SCIg market, availability of sufficient capital if or when needed, dependence on key personnel, the impact of recent accounting pronouncements, 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, 2025, 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 August 5, 2026. 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 |
|||||||||
|
|
|
|
|
|
||||
|
|
June 30, |
|
December 31, |
|
||||
|
|
2026 |
|
2025 |
|
||||
|
|
(UNAUDITED) |
|
|
|
||||
|
|
|
|
|
|
|
|
||
ASSETS |
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
||
CURRENT ASSETS |
|
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
8,287,704 |
|
|
$ |
8,872,212 |
|
|
Accounts receivable, net |
|
|
5,027,723 |
|
|
|
5,972,252 |
|
|
Inventory, net |
|
|
4,511,126 |
|
|
|
3,678,131 |
|
|
Other receivables |
|
|
1,064,909 |
|
|
|
557,653 |
|
|
Prepaid expenses and other current assets |
|
|
622,655 |
|
|
|
908,542 |
|
|
TOTAL CURRENT ASSETS |
|
|
19,514,117 |
|
|
|
19,988,790 |
|
|
Property and equipment, net |
|
|
3,929,718 |
|
|
|
4,471,386 |
|
|
Intangible assets, net of accumulated amortization of |
|
|
1,663,318 |
|
|
|
684,841 |
|
|
Operating lease right-of-use assets |
|
|
2,755,890 |
|
|
|
2,956,192 |
|
|
Other assets |
|
|
98,970 |
|
|
|
98,970 |
|
|
TOTAL ASSETS |
|
$ |
27,962,013 |
|
|
$ |
28,200,179 |
|
|
|
|
|
|
|
|
|
|
||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
||
CURRENT LIABILITIES |
|
|
|
|
|
|
|
||
Accounts payable |
|
$ |
2,912,589 |
|
|
$ |
2,267,473 |
|
|
Accrued expenses |
|
|
2,869,568 |
|
|
|
4,828,830 |
|
|
Other liabilities |
|
|
11,068 |
|
|
|
27,722 |
|
|
Accrued payroll and related taxes |
|
|
807,832 |
|
|
|
531,972 |
|
|
Financing lease liability |
|
|
148,592 |
|
|
|
124,913 |
|
|
Operating lease liability |
|
|
430,173 |
|
|
|
413,448 |
|
|
TOTAL CURRENT LIABILITIES |
|
|
7,179,822 |
|
|
|
8,194,358 |
|
|
Financing lease liability, net of current portion |
|
|
71,409 |
|
|
|
78,675 |
|
|
Operating lease liability, net of current portion |
|
|
2,659,265 |
|
|
|
2,879,224 |
|
|
TOTAL LIABILITIES |
|
|
9,910,496 |
|
|
|
11,152,257 |
|
|
|
|
|
|
|
|
|
|
||
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
||
Common stock, |
|
|
501,724 |
|
|
|
497,909 |
|
|
Additional paid-in capital |
|
|
56,527,047 |
|
|
|
52,449,339 |
|
|
Treasury stock, 4,018,526 and 3,438,526 shares as of June 30, 2026 and December 31, 2025, respectively, at cost |
|
|
(6,405,793 |
) |
|
|
(3,882,494 |
) |
|
Accumulated deficit |
|
|
(32,571,461 |
) |
|
|
(32,016,832 |
) |
|
TOTAL STOCKHOLDERS’ EQUITY |
|
|
18,051,517 |
|
|
|
17,047,922 |
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
27,962,013 |
|
|
$ |
28,200,179 |
|
|
KORU MEDICAL SYSTEMS, INC. STATEMENTS OF OPERATIONS (UNAUDITED) |
|||||||||||||||||||||
|
|
Three Months Ended |
|
Six Months Ended |
|||||||||||||||||
|
|
June 30, |
|
June 30, |
|||||||||||||||||
|
|
|
2026 |
|
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
|||||||
|
|
|
|
|
|
|
|
|
|||||||||||||
NET REVENUES |
|
$ |
|
12,045,420 |
|
|
$ |
|
10,194,800 |
|
|
$ |
23,810,044 |
|
|
$ |
19,829,875 |
|
|||
Cost of goods sold |
|
|
|
4,199,212 |
|
|
|
|
3,719,031 |
|
|
|
8,732,447 |
|
|
|
7,307,771 |
|
|||
Gross Profit |
|
|
|
7,846,208 |
|
|
|
|
6,475,769 |
|
|
|
15,077,597 |
|
|
|
12,522,104 |
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Selling, general and administrative |
|
|
|
5,939,986 |
|
|
|
|
5,384,148 |
|
|
|
12,522,165 |
|
|
|
11,343,522 |
|
|||
Research and development |
|
|
|
1,069,200 |
|
|
|
|
1,194,789 |
|
|
|
2,385,804 |
|
|
|
2,309,398 |
|
|||
Depreciation and amortization |
|
|
|
210,031 |
|
|
|
|
209,487 |
|
|
|
407,562 |
|
|
|
426,844 |
|
|||
Total Operating Expenses |
|
|
|
7,219,217 |
|
|
|
|
6,788,424 |
|
|
|
15,315,530 |
|
|
|
14,079,764 |
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Net Operating Income / (Loss) |
|
$ |
|
626,991 |
|
|
|
|
(312,655 |
) |
|
|
(237,933 |
) |
|
|
(1,557,660 |
) |
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Non-Operating Income/(Expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Gain/(Loss) on currency exchange |
|
|
|
(22,343 |
) |
|
|
|
44,193 |
|
|
|
(45,493 |
) |
|
|
49,781 |
|
|||
Loss on disposal of fixed assets, net |
|
|
|
(406,269 |
) |
|
|
|
- |
|
|
|
(406,269 |
) |
|
|
- |
|
|||
Interest income, net |
|
|
|
59,870 |
|
|
|
|
78,951 |
|
|
|
140,866 |
|
|
|
152,130 |
|
|||
TOTAL OTHER (EXPENSE)/INCOME |
|
|
|
(368,741 |
) |
|
|
|
123,144 |
|
|
|
(310,896 |
) |
|
|
201,911 |
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
INCOME / (LOSS) BEFORE INCOME TAXES |
|
$ |
|
258,249 |
|
|
|
|
(189,511 |
) |
|
|
(548,828 |
) |
|
|
(1,355,749 |
) |
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Income Tax Expense |
|
|
|
(5,800 |
) |
|
|
|
(17,356 |
) |
|
|
(5,800 |
) |
|
|
(17,356 |
) |
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
NET INCOME/(LOSS) |
|
$ |
|
252,449 |
|
|
$ |
(206,867 |
) |
|
$ |
(554,628 |
) |
|
$ |
(1,373,105 |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
NET INCOME / (LOSS) PER SHARE |
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Basic |
|
$ |
0.01 |
|
|
$ |
(0.00 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.03 |
) |
|||||
Diluted |
|
$ |
0.01 |
|
|
$ |
(0.00 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.03 |
) |
|||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING |
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||
Basic |
|
|
|
46,083,893 |
|
|
|
|
46,193,709 |
|
|
|
46,223,623 |
|
|
|
46,088,353 |
|
|||
Diluted |
|
|
|
49,509,437 |
|
|
|
|
46,193,709 |
|
|
|
46,223,623 |
|
|
|
46,088,353 |
|
|||
KORU MEDICAL SYSTEMS, INC. STATEMENTS OF CASH FLOWS (UNAUDITED) |
|||||||
|
|
|
|||||
|
Six Months Ended |
||||||
|
June 30, |
June 30, |
|||||
|
|
2026 |
|
|
2025 |
|
|
|
|
|
|||||
CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
|||||
Net Loss |
$ |
(554,629 |
) |
$ |
(1,373,104 |
) |
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|||||
Stock-based compensation expense and warrant expense |
|
1,139,284 |
|
|
1,113,334 |
|
|
Depreciation and amortization |
|
407,561 |
|
|
426,844 |
|
|
Loss on disposal of fixed assets |
|
406,269 |
|
|
- |
|
|
Non-cash leasing charges |
|
(2,931 |
) |
|
- |
|
|
Changes in operating assets and liabilities: |
|
|
|||||
Decrease/(Increase) in accounts receivable |
|
944,529 |
|
|
805,133 |
|
|
Decrease/(Increase) in other receivables |
|
(507,257 |
) |
|
47,979 |
|
|
Decrease/(Increase) in inventory |
|
(832,996 |
) |
|
(1,144,175 |
) |
|
Decrease/(Increase) in prepaid expenses and other assets |
|
285,887 |
|
|
317,897 |
|
|
Increase/(Decrease) in accounts payable |
|
645,116 |
|
|
(555,430 |
) |
|
Increase/(Decrease) in accrued payroll and related taxes |
|
275,860 |
|
|
(122,459 |
) |
|
Increase/(Decrease) in other liabilities |
|
(16,654 |
) |
|
74,833 |
|
|
Increase/(Decrease) in accrued expenses |
|
(1,959,263 |
) |
|
(288,659 |
) |
|
NET CASH FLOWS FROM OPERATING ACTIVITIES |
|
230,776 |
|
|
(697,807 |
) |
|
|
|
|
|||||
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|||||
Purchases of property and equipment |
|
(154,070 |
) |
|
(472,252 |
) |
|
Purchases of intangible assets |
|
(461,035 |
) |
|
(3,400 |
) |
|
Capitalized software development costs |
|
(52,147 |
) |
|
- |
|
|
NET CASH FLOWS FROM INVESTING ACTIVITIES |
|
(667,252 |
) |
|
(475,652 |
) |
|
|
|
|
|||||
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|||||
Payments on insurance finance indebtedness |
|
- |
|
|
(271,152 |
) |
|
Payments for taxes related to net share settlement of equity awards |
|
(81,059 |
) |
|
(27,536 |
) |
|
Payments on finance lease liability, net of asset |
|
(66,973 |
) |
|
(54,084 |
) |
|
NET CASH FLOWS FROM FINANCING ACTIVITIES |
|
(148,032 |
) |
|
(352,772 |
) |
|
|
|
|
|||||
NET DECREASE IN CASH AND CASH EQUIVALENTS |
|
(584,508 |
) |
|
(1,526,231 |
) |
|
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD |
|
8,872,212 |
|
|
9,580,947 |
|
|
CASH AND CASH EQUIVALENTS, END OF PERIOD |
$ |
8,287,704 |
|
$ |
8,054,716 |
|
|
|
|
|
|||||
Supplemental Information |
|
|
|||||
Cash paid during the years for: |
|
|
|||||
Interest |
$ |
4,732 |
|
$ |
7,563 |
|
|
Income Taxes |
$ |
5,800 |
|
$ |
17,356 |
|
|
Non-cash Financing Activity
During the six months ended June 30, 2026, the Company acquired an intangible asset for |
|
|
|||||
See accompanying Notes to Financial Statements. |
|
|
|||||
|
|
|
|||||
KORU MEDICAL SYSTEMS, INC. SUPPLEMENTAL INFORMATION (UNAUDITED) |
||||||||||||||
Three Months Ended |
Six Months Ended |
|||||||||||||
Reconciliation of GAAP Net Income / (Loss) to Non-GAAP Adjusted EBITDA: |
June 30, |
June 30, |
||||||||||||
|
2026 |
|
|
2025 |
|
|
|
2026 |
|
|
2025 |
|
||
GAAP Net Income / (Loss) |
|
$ |
252,449 |
|
$ |
(206,867 |
) |
|
$ |
(554,628 |
) |
$ |
(1,373,104 |
) |
Depreciation and Amortization |
|
210,031 |
|
|
209,487 |
|
|
407,562 |
|
|
426,844 |
|
||
Interest (Income), Net |
|
(59,870 |
) |
|
(78,951 |
) |
|
|
(140,866 |
) |
|
(152,130 |
) |
|
Stock-based Compensation Expense |
|
|
457,773 |
|
|
415,744 |
|
|
|
1,139,284 |
|
|
1,113,344 |
|
Adjusted EBITDA |
|
$ |
860,383 |
|
$ |
339,414 |
|
|
$ |
851,351 |
|
$ |
14,953 |
|
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING |
|
|
|
|
|
|
||||||||
Basic |
|
|
46,083,893 |
|
|
46,193,709 |
|
|
|
46,223,623 |
|
|
46,088,353 |
|
Diluted |
|
49,509,437 |
|
|
46,193,709 |
|
|
|
46,223,623 |
|
|
46,088,353 |
|
|
Three Months Ended |
Six Months Ended |
|||||||||||||
Reconciliation of Reported Diluted EPS to Non-GAAP Adjusted Diluted EPS: |
June 30, |
June 30, |
||||||||||||
|
2026 |
|
|
2025 |
|
|
|
2026 |
|
|
2025 |
|
||
Reported Diluted Earnings Per Share |
|
$ |
0.01 |
|
$ |
(0.00 |
) |
|
$ |
(0.01 |
) |
$ |
(0.03 |
) |
Depreciation and Amortization |
|
0.00 |
|
|
0.00 |
|
|
0.01 |
|
|
0.01 |
|
||
Interest (Income), Net |
|
(0.00 |
) |
|
(0.00 |
) |
|
|
(0.00 |
) |
|
(0.00 |
) |
|
Stock-based Compensation Expense |
|
|
0.01 |
|
|
0.01 |
|
|
|
0.02 |
|
|
0.02 |
|
Adjusted Diluted EPS |
|
$ |
0.02 |
|
$ |
0.01 |
|
|
$ |
0.02 |
|
$ |
0.00 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20260805069380/en/
Investor Contact:
Louisa Smith
investor@korumedical.com
Source: KORU Medical Systems, Inc.