KORU Medical Systems, Inc. Files 2023 Annual Report (10-K)

TL;DR

<b>KORU Medical Systems, Inc. has filed its annual 10-K report for the fiscal year ending December 31, 2023.</b>

AI Summary

KORU Medical Systems, Inc. (KRMD) filed a Annual Report (10-K) with the SEC on March 13, 2024. KORU Medical Systems, Inc. filed its 2023 10-K report on March 13, 2024. The filing covers the fiscal year ending December 31, 2023. The company was formerly known as REPRO MED SYSTEMS INC, with a name change on July 3, 1992. KORU Medical Systems, Inc. is classified under SIC code 3841 (Surgical & Medical Instruments & Apparatus). The company's principal business address is 100 Corporate Drive, Mahwah, NJ 07430.

Why It Matters

For investors and stakeholders tracking KORU Medical Systems, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of KORU Medical Systems, Inc.'s financial performance, business operations, and risk factors for the fiscal year 2023. Investors and stakeholders can use this report to assess the company's financial health, strategic direction, and potential future performance.

Risk Assessment

Risk Level: low — KORU Medical Systems, Inc. shows low risk based on this filing. The risk level is assessed as low because the provided text is a standard 10-K filing header and does not contain specific financial performance data or forward-looking statements that would indicate significant risks.

Analyst Insight

Review the full 10-K filing to understand KORU Medical Systems, Inc.'s detailed financial results, operational strategies, and risk disclosures for fiscal year 2023.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-13 — Filing Date (Date the report was filed)
• 1992-07-03 — Name Change Date (Date of former company name change)
• 3841 — SIC Code (Standard Industrial Classification for Surgical & Medical Instruments & Apparatus)

Key Players & Entities

• KORU Medical Systems, Inc. (company) — Filer name
• REPRO MED SYSTEMS INC (company) — Former company name
• 100 Corporate Drive, Mahwah, NJ 07430 (address) — Business and mailing address
• 3841 (industry_code) — Standard Industrial Classification
• 2023-12-31 (date) — Fiscal year end
• 2024-03-13 (date) — Filing date

FAQ

Industry Context

KORU Medical Systems, Inc. operates within the Surgical & Medical Instruments & Apparatus industry, indicated by its SIC code 3841.

Regulatory Implications

The filing is a Form 10-K, an annual report required by the U.S. Securities and Exchange Commission (SEC) for public companies.

What Investors Should Do

1. Thoroughly review the complete 10-K filing for detailed financial statements and management's discussion and analysis.
2. Analyze the risk factors section to understand potential challenges and uncertainties facing KORU Medical Systems, Inc.
3. Compare the 2023 results with previous years to identify trends in revenue, profitability, and other key financial metrics.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-03-13: Filing Date — Date KORU Medical Systems, Inc. submitted its 10-K report.

Year-Over-Year Comparison

This is the initial filing header information provided; comparative data from a previous filing is not available in this extract.

Key Financial Figures

• $0.01 — nge on which registered common stock, $0.01 par value KRMD The Nasdaq Stock Marke
• $5.7 million — enhance our product portfolio. We spent $5.7 million and $5.0 million on research and develo
• $5.0 million — ct portfolio. We spent $5.7 million and $5.0 million on research and development for the yea

Filing Documents

• form_10-k.htm (10-K) — 771KB
• ex_23-1.htm (EX-23) — 3KB
• ex_31-1.htm (EX-31) — 7KB
• ex_31-2.htm (EX-31) — 7KB
• ex_32-1.htm (EX-32) — 3KB
• ex_32-2.htm (EX-32) — 3KB
• mmq_logo-footer.jpg (GRAPHIC) — 46KB
• mmq_logo-header.jpg (GRAPHIC) — 37KB
• 0001161697-24-000139.txt (&nbsp;) — 4850KB
• krmd-20231231.xsd (EX-101.SCH) — 47KB
• krmd-20231231_cal.xml (EX-101.CAL) — 50KB
• krmd-20231231_def.xml (EX-101.DEF) — 144KB
• krmd-20231231_lab.xml (EX-101.LAB) — 370KB
• krmd-20231231_pre.xml (EX-101.PRE) — 275KB
• form_10-k_htm.xml (XML) — 603KB

Business

Business 1 Item 1A.

Risk Factors

Risk Factors 8 Item 1B. Unresolved Staff Comments 23 Item 2.

Properties

Properties 24 Item 3.

Legal Proceedings

Legal Proceedings 24 Item 4. Mine Safety Disclosures 24 PART II Item 5. Market for the Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 24 Item 6.

Selected Financial Data

Selected Financial Data 24 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 25 Item 7A.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 30 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 30 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosures 49 Item 9A.

Controls and Procedures

Controls and Procedures 49 Item 9B. Other Information 49 Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 49 PART III Item 10. Directors, Executive Officers, and Corporate Governance 50 Item 11.

Executive Compensation

Executive Compensation 50 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 50 Item 13. Certain Relationships and Related Transactions, and Director Independence 50 Item 14. Principal Accountant Fees and Services 50 PART IV Item 15. Exhibits and Financial Statement Schedules 51 Item 16. Form 10-K Summary 52

Signatures

Signatures 53 - ii - Table of Contents PART I Throughout this report, the "Company," "KORU Medical," "KORU," "we," "us" or "our" refer to KORU Medical Systems, Inc.

FORWARD LOOKING STATEMENTS

FORWARD LOOKING STATEMENTS This Annual Report on Form 10-K contains "forward-looking Exchange Act of 1934, as amended. Forward-looking statements can be identified by words such as: "mission," "believe," "plan," "goal," "intend," "seek," "expect," "will," and similar references to future periods. Examples of forward-looking statements include, among others, Resources" in Management's Discussion and Analysis of Financial Condition and Results of Operations under Item 7 of this Form 10-K, and statements regarding success of our EU certification appeal, completion of a next-generation pump and consumable system, compliance with EU MDR, 2024 expenses, needs for additional capital, capital investments, plans for expansion of our share position and products, and increase in patient SCIg prescriptions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, readers should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, those discussed in this Annual Report o

BUSINESS

ITEM 1. BUSINESS OUR BUSINESS KORU Medical develops, manufactures and commercializes innovative and patient-centric large volume subcutaneous infusion solutions primarily for the subcutaneous drug delivery market as governed by the United States Food and Drug Administration (the "FDA") quality and regulatory system and international standards for quality system management. Our focus is primarily concentrated on our mechanical infusion products, the FREEDOM Infusion Systems (which we refer to as the "FREEDOM System" when used with one or more accessories), which include the FREEDOM60 Syringe Driver, the FreedomEdge Syringe Driver, HIgH-Flo Subcutaneous Safety Needle Sets and Precision Flow Rate Tubing. Our revenues are derived from three business sources: (i) domestic core (which consists of US and Canada), (ii) international core, and (iii) novel therapies. Our core domestic and international revenues consist of sales of our syringe drivers, tubing and needles ("Product Revenue") for the delivery of subcutaneous drugs that are FDA cleared for use with the FREEDOM System, with the primary delivery for immunoglobulin to treat Primary Immunodeficiency Diseases ("PIDD") and Chronic Inflammatory Demyelinating Polyneuropathy ("CIDP"). Novel therapies revenues consist of Product Revenue for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in the drug development process as well as non-recurring engineering services ("NRE") revenues (including product innovation, testing and registration services) received from biopharmaceutical companies to ready or customize the FREEDOM System for clinical and commercial use across multiple drug categories. OUR MISSION Our mission is to improve the quality of life of patients around the world by delivering innovative, effective, and easy-to-use drug delivery systems that can be used at home or alternate site settings, for patient self-administration of drug therapy. -

View Full Filing

View this 10-K filing on SEC EDGAR