KORU Medical Systems Announces 27% Q3 Revenue Growth and Raises 2025 Revenue Guidance

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.

Investor Contact:
Louisa Smith
investor@korumedical.com

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