KORU Medical Systems(KRMD)
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KORU Medical Systems(KRMD) - 2021 Q1 - Earnings Call Transcript
2021-05-12 23:28
KORU Medical Systems (NASDAQ:KRMD) Q1 2021 Earnings Conference Call May 12, 2021 4:30 PM ET Company Participants Greg Chodaczek - Investor Relations Linda Tharby - President and Chief Executive Officer Karen Fisher - Chief Financial Officer Conference Call Participants Alex Nowak - Craig-Hallum Capital Group Kyle Rose - Canaccord Operator Greetings. Welcome to the KORU Medical Systems First Quarter 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer ...
KORU Medical Systems(KRMD) - 2021 Q1 - Quarterly Report
2021-05-12 20:06
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 0-12305 REPRO MED SYSTEMS, INC. (Exact name of registrant as specified in its charter) New York 13-3044880 For the Quarterly Period Ended March 31, 2021 or [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________. ( ...
KORU Medical Systems(KRMD) - 2020 Q4 - Earnings Call Transcript
2021-03-24 00:14
Repro Med Systems, Inc. (NASDAQ:KRMD) Q4 2020 Results Conference Call March 23, 2021 4:30 PM ET Company Participants Greg Chodaczek - Senior Vice President, The Equity Group, Inc. Jim Beck - Interim CEO Linda Tharby - President & Chief Executive Officer Karen Fisher - Chief Financial Officer Conference Call Participants Alex Nowak - Craig-Hallum Capital Group Kyle Rose - Canaccord Matthew O'Brien - Piper Jaffray Operator Greetings and welcome to the KORU Medical Systems Fourth Quarter 2020 Earnings Conferen ...
KORU Medical Systems(KRMD) - 2020 Q4 - Annual Report
2021-03-23 20:01
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 0-12305 REPRO MED SYSTEMS, INC. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) (IRS Employer Identification No.) ...
Repro Med Systems (KRMD) Investor Presentation - Slideshow
2020-11-18 17:49
NASDAQ: KRMD New Life, New Beginnings KORU | TM Investor Presentation November 2020 NASDAQ: KRMD FORWARD-LOOKING STATEMENTS / NON-GAAP MEASURES This presentation contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as : "expect," "plan," "goals," "believe," "intend," "see," "could," "should," and similar references to future periods. Examples of forward-l ...
KORU Medical Systems(KRMD) - 2020 Q3 - Quarterly Report
2020-11-12 21:38
PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=ITEM%201.%20Financial%20Statements%20(Unaudited)) Unaudited Q3 2020 financial statements reveal significant asset growth, a net loss from increased expenses, and substantial cash inflow from equity issuance [Balance Sheets](index=3&type=section&id=Balance%20Sheets) As of Sep 30, 2020, total assets significantly increased to $45.4 million, driven by cash from an equity offering, with corresponding growth in equity Balance Sheet Summary (as of Sep 30, 2020 vs. Dec 31, 2019) | Metric | Sep 30, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $32,433,811 | $5,870,929 | | Total Current Assets | $42,648,042 | $11,881,323 | | Total Assets | $45,434,452 | $13,881,861 | | **Liabilities & Equity** | | | | Total Current Liabilities | $5,361,430 | $2,406,289 | | Total Liabilities | $5,493,073 | $2,645,781 | | Total Stockholders' Equity | $39,941,379 | $11,236,080 | [Statements of Operations](index=4&type=section&id=Statements%20of%20Operations) Q3 2020 saw decreased net sales and net income, while nine-month sales increased but resulted in a net loss due to higher operating and litigation expenses Q3 2020 vs Q3 2019 Performance | Metric | Q3 2020 | Q3 2019 | Change (%) | | :--- | :--- | :--- | :--- | | Net Sales | $6.1M | $6.6M | (8.1%) | | Gross Profit | $3.9M | $4.4M | (10.1%) | | SG&A Expenses | $3.1M | $2.4M | 26.0% | | Litigation Expenses | $675 | $0.9M | (99.9%) | | R&D Expenses | $0.4M | $0.2M | 129.3% | | Net Income | $0.2M | $0.7M | (61.8%) | Nine Months 2020 vs 2019 Performance | Metric | Nine Months 2020 | Nine Months 2019 | Change (%) | | :--- | :--- | :--- | :--- | | Net Sales | $20.1M | $16.9M | 18.8% | | Gross Profit | $12.6M | $10.9M | 15.9% | | SG&A Expenses | $9.0M | $7.0M | 29.6% | | Litigation Expenses | $2.45M | $2.48M | (1.4%) | | R&D Expenses | $0.9M | $0.5M | 109.7% | | Net (Loss)/Income | ($0.4M) | $0.6M | (158.6%) | [Statements of Cash Flows](index=5&type=section&id=Statements%20of%20Cash%20Flows) Nine-month cash flow from operations turned positive, investing activities used $1.0 million, and financing provided $26.6 million from equity, significantly boosting cash reserves Cash Flow Summary (Nine Months Ended Sep 30) | Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net Cash from Operating Activities | $968,437 | ($502,014) | | Net Cash from Investing Activities | ($1,007,539) | $1,389,281 | | Net Cash from Financing Activities | $26,601,984 | $502,958 | | **Net Increase in Cash** | **$26,562,882** | **$1,390,225** | | **Cash at End of Period** | **$32,433,811** | **$5,129,028** | [Notes to Financial Statements](index=8&type=section&id=Notes%20to%20Financial%20Statements) Notes detail accounting policies, including a $2.2 million non-cash litigation settlement, a $26.5 million equity offering, and a subsequent five-year manufacturing agreement - The company settled litigation with competitor EMED, resulting in a **non-cash expense of $2.2 million** in the second quarter of 2020. The settlement involved issuing restricted stock units and an option to purchase common stock[53](index=53&type=chunk) - In June 2020, the company completed an equity offering, selling over 3.5 million shares of common stock and raising **net proceeds of $26.5 million** after discounts and expenses[75](index=75&type=chunk) - Subsequent to the quarter end, on November 11, 2020, the company entered into a **five-year Manufacturing and Supply Agreement** with Command Medical Products, Inc. to manufacture and supply subassemblies, needle sets, and tubing products[76](index=76&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q3 2020 sales decline and nine-month net loss due to litigation and expenses, offset by strengthened liquidity from a $26.5 million capital raise, with COVID-19 impact remaining uncertain - The company's operations have been modified due to COVID-19, with non-production staff working remotely. The pandemic's ultimate impact on product demand and financial results remains uncertain, with potential negative effects on new prescriptions for PIDD and CIDP[84](index=84&type=chunk) - The company's liquidity position is **strong, with $32.4 million in cash** as of September 30, 2020, bolstered by **net proceeds of $26.5 million** from a recent capital raise. Management believes this is sufficient to fund operations and strategic initiatives for the next 12 months[102](index=102&type=chunk)[109](index=109&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Q3 2020 saw an 8.1% sales decline and reduced net income, while nine-month sales grew 18.8% but resulted in a net loss due to a 25.5% increase in operating expenses, including a litigation settlement Q3 2020 vs Q3 2019 Results Summary | Metric | Q3 2020 | Q3 2019 | Change (%) | | :--- | :--- | :--- | :--- | | Net Sales | $6.1M | $6.6M | (8.1%) | | Gross Profit | $3.9M | $4.4M | (10.1%) | | SG&A Expenses | $3.1M | $2.4M | 26.0% | | Litigation Expenses | $675 | $0.9M | (99.9%) | | R&D Expenses | $0.4M | $0.2M | 129.3% | | Net Income | $0.2M | $0.7M | (61.8%) | Nine Months 2020 vs 2019 Results Summary | Metric | Nine Months 2020 | Nine Months 2019 | Change (%) | | :--- | :--- | :--- | :--- | | Net Sales | $20.1M | $16.9M | 18.8% | | Gross Profit | $12.6M | $10.9M | 15.9% | | SG&A Expenses | $9.0M | $7.0M | 29.6% | | Litigation Expenses | $2.45M | $2.48M | (1.4%) | | R&D Expenses | $0.9M | $0.5M | 109.7% | | Net (Loss)/Income | ($0.4M) | $0.6M | (158.6%) | [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity is strong with $32.4 million cash, boosted by a $26.5 million capital raise, with operating activities generating $1.0 million cash and financing providing $26.6 million - Net cash from operating activities was **$1.0 million** for the nine months ended Sep 30, 2020, compared to a use of **$0.5 million** in the prior year period. The improvement was largely due to non-cash charges for stock-based compensation and litigation settlement (**$2.5 million**)[103](index=103&type=chunk)[104](index=104&type=chunk) - Net cash from financing activities was **$26.6 million** for the nine months ended Sep 30, 2020, primarily from a **$26.5 million capital raise**, net of expenses[103](index=103&type=chunk)[107](index=107&type=chunk) [Non-GAAP Financial Measures](index=22&type=section&id=Non-GAAP%20Financial%20Measures) The company uses Adjusted EBITDA, defined as net income before specific adjustments, as a non-GAAP measure, which was $3.9 million for the nine months ended September 30, 2020 Reconciliation of GAAP Net Income/(Loss) to Non-GAAP Adjusted EBITDA | Metric | Nine Months 2020 | Nine Months 2019 | | :--- | :--- | :--- | | GAAP Net (Loss)/Income | ($377,435) | $644,606 | | Income Tax Expense | $316,200 | $189,265 | | Depreciation and Amortization | $297,801 | $252,594 | | Litigation | $2,446,747 | $2,481,471 | | Stock Option Expense | $1,011,140 | $640,775 | | Other Adjustments | $192,840 | $516,221 | | **Non-GAAP Adjusted EBITDA** | **$3,936,885** | **$4,624,932** | - Management uses Adjusted EBITDA as a supplemental measure for internal planning, forecasting, and evaluating performance, and it is a significant criterion for determining annual cash incentive compensation[112](index=112&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=ITEM%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is marked as not applicable - Not applicable[120](index=120&type=chunk) [Item 4. Controls and Procedures](index=24&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2020, with no material changes to internal control over financial reporting - The Principal Executive Officer and Principal Financial Officer concluded that the Company's disclosure controls and procedures were **effective** as of September 30, 2020[121](index=121&type=chunk) - No changes in internal control over financial reporting occurred during the third quarter of 2020 that have materially affected, or are reasonably likely to materially affect, these controls[122](index=122&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=25&type=section&id=ITEM%201.%20Legal%20Proceedings) The company is not currently involved in material legal proceedings, with prior litigation against EMED Technologies Corporation having been dismissed - The company is not currently a party to any legal proceedings that are believed to be **material to its financial condition**[127](index=127&type=chunk) - The report refers to a prior filing for details on the **dismissed case with competitor EMED Technologies Corporation**[128](index=128&type=chunk) [Item 1A. Risk Factors](index=25&type=section&id=ITEM%201A.%20Risk%20Factors) The COVID-19 pandemic is a significant risk factor, posing uncertainties for business operations, financial results, supply chain, and product demand, with its long-term impact remaining highly uncertain - The **COVID-19 pandemic** is identified as a significant risk factor that could adversely affect the company's business and financial condition[130](index=130&type=chunk) - Key uncertainties include the impact on employees, supply chain disruptions, delays in clinical trials, and changes in customer purchasing patterns and new prescriptions[130](index=130&type=chunk) - The pandemic has led to significant disruption of global financial markets, which could reduce the company's ability to access capital and negatively affect liquidity[130](index=130&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=26&type=section&id=ITEM%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company issued common stock to directors for compensation and restricted stock units/options to EMED as part of a litigation settlement, all as unregistered sales - The company issued an aggregate of **6,681 shares of common stock** to its non-employee directors for the three months ended September 30, 2020, as part of their compensation[132](index=132&type=chunk) - As part of the litigation settlement with EMED, the company issued **95,238 restricted stock units** (vested May 21, 2020), another **95,238 restricted stock units** (vesting Jan 1, 2021), and an option to purchase up to **400,000 shares**[134](index=134&type=chunk) [Item 6. Exhibits](index=26&type=section&id=ITEM%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including a manufacturing agreement and Sarbanes-Oxley certifications - A key exhibit filed is the **Manufacturing and Supply Agreement** dated November 11, 2020, between the company and Command Medical Products[138](index=138&type=chunk) - Standard certifications from the CEO and CFO under Sections 302 and 906 of the Sarbanes-Oxley Act were also filed as exhibits[138](index=138&type=chunk)
KORU Medical Systems(KRMD) - 2020 Q3 - Earnings Call Presentation
2020-11-05 19:55
NASDAQ: KRMD New Life, New Beginnings KORU | TM Q3 2020 Financial Results November 4, 2020 NASDAQ: KRMD FORWARD-LOOKING STATEMENTS / NON-GAAP MEASURES This presentation contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as : "expect," "plan," "goals," "believe," "intend," "see," "could," "should," and similar references to future periods. Examples of fo ...
KORU Medical Systems(KRMD) - 2020 Q3 - Earnings Call Transcript
2020-11-05 03:02
Repro Med Systems, Inc. (NASDAQ:KRMD) Q3 2020 Earnings Conference Call November 4, 2020 9:00 AM ET Company Participants Devin Sullivan - Senior Vice President, The Equity Group, Inc. Donald Pettigrew - President and Chief Executive Officer Karen Fisher - Chief Financial Officer Conference Call Participants Alexander Nowak - Craig-Hallum Capital Group LLC Matthew O'Brien - Piper Sandler & Co. Kyle Rose - Canaccord Genuity Group Inc. Raghuram Selvaraju - H.C. Wainwright & Co. Alex Silverman - AWM Investment C ...
KORU Medical Systems(KRMD) - 2020 Q2 - Earnings Call Transcript
2020-08-09 14:49
Repro Med Systems, Inc. (NASDAQ:KRMD) Q2 2020 Earnings Conference Call August 5, 2020 9:00 AM ET Company Participants Devin Sullivan - Senior Vice President, Equity Group Don Pettigrew - President and Chief Executive Officer Karen Fisher - Chief Financial Officer Conference Call Participants Alex Nowak - Craig-Hallum Capital Group Matthew O'Brien - Piper Sandler Kyle Rose - Canaccord Genuity Operator Greetings and welcome to the KORU Medical's Systems Second Quarter 2020 Financial Results Conference Call. [ ...
KORU Medical Systems(KRMD) - 2020 Q2 - Quarterly Report
2020-08-05 20:31
PART I [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Unaudited Q2 2020 financial statements show total assets grew to **$47.7 million** due to cash, with a **$1.1 million net loss** from a litigation settlement [Balance Sheets](index=3&type=section&id=Balance%20Sheets) As of June 30, 2020, total assets increased to **$47.7 million** from **$13.9 million**, primarily due to a rise in cash and cash equivalents to **$38.1 million** Balance Sheet Comparison (in thousands) | Account | June 30, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | **Total Current Assets** | $45,306 | $11,881 | | Cash and cash equivalents | $38,129 | $5,871 | | **Total Assets** | **$47,711** | **$13,882** | | **Total Current Liabilities** | $8,296 | $2,406 | | Line of credit payable | $3,500 | $0 | | **Total Liabilities** | **$8,463** | **$2,646** | | **Total Stockholders' Equity** | **$39,247** | **$11,236** | [Statements of Operations](index=4&type=section&id=Statements%20of%20Operations) Q2 2020 net sales grew **44.1%** to **$7.7 million**, but a **$2.3 million** litigation expense led to a **$1.1 million net loss** Quarterly Performance (Three Months Ended June 30, in dollars) | Metric | 2020 | 2019 | | :--- | :--- | :--- | | Net Sales | $7,708,904 | $5,348,812 | | Gross Profit | $4,909,880 | $3,475,664 | | Litigation Expense | $2,346,914 | $1,124,947 | | Net (Loss)/Income | $(1,076,038) | $78,183 | | Diluted EPS | $(0.03) | $0.00 | Semi-Annual Performance (Six Months Ended June 30, in dollars) | Metric | 2020 | 2019 | | :--- | :--- | :--- | | Net Sales | $14,038,913 | $10,323,090 | | Gross Profit | $8,698,090 | $6,523,618 | | Net (Loss)/Income | $(626,610) | $(7,207) | | Diluted EPS | $(0.02) | $0.00 | [Statements of Cash Flows](index=5&type=section&id=Statements%20of%20Cash%20Flows) For the six months ended June 30, 2020, cash from operations was **$2.7 million**, with **$30.1 million** from financing, increasing total cash to **$38.1 million** Cash Flow Summary (Six Months Ended June 30, in dollars) | Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net Cash from Operating Activities | $2,707,549 | $(1,483,909) | | Net Cash from Investing Activities | $(513,273) | $1,532,487 | | Net Cash from Financing Activities | $30,064,144 | $19,811 | | **Net Increase in Cash** | **$32,258,420** | **$68,389** | | **Cash at End of Period** | **$38,129,349** | **$3,807,192** | [Notes to Financial Statements](index=6&type=section&id=Notes%20to%20Financial%20Statements) Notes detail the May 2020 EMED litigation settlement via non-cash equity, a **$3.5 million** credit line expansion, and a June 2020 public offering raising **$26.5 million** - The company designs, manufactures, and markets proprietary portable medical devices for the ambulatory infusion market[14](index=14&type=chunk) - On May 26, 2020, the company settled all litigation with competitor EMED, involving an equity payment including restricted stock units and an option to purchase **400,000 shares**, providing KORU Medical with freedom to operate under EMED's patent portfolio[41](index=41&type=chunk)[53](index=53&type=chunk) - The company increased its revolving line of credit with KeyBank to **$3.5 million** in April 2020 and drew the full amount[67](index=67&type=chunk)[69](index=69&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=15&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes **44%** Q2 2020 net sales growth to at-home infusion demand, despite a **$1.1 million** net loss from a **$2.2 million** litigation expense, while liquidity was significantly strengthened by a **$26.5 million** equity offering and **$3.5 million** credit line draw [Overview](index=16&type=section&id=Overview) Key Q2 2020 events include settling EMED litigation for **$2.2 million** (non-cash), raising **$26.5 million** from an equity offering, drawing the full **$3.5 million** from a credit line, and achieving **44%** net sales growth to **$7.7 million** due to at-home infusion demand - Settled all litigation with EMED through a non-cash agreement, recognizing a **$2.2 million** expense[84](index=84&type=chunk) - Raised **$26.5 million** in net proceeds from an equity offering in June 2020[85](index=85&type=chunk) - Q2 2020 net sales reached **$7.7 million**, a **44%** increase from the prior year, driven by demand for at-home infusion therapy and response to COVID-19 uncertainties[86](index=86&type=chunk) [Results of Operations](index=17&type=section&id=Results%20of%20Operations) Q2 2020 net sales rose **44.1%** to **$7.7 million**, but gross margin declined to **63.7%** due to COVID-related overtime, and operating expenses surged **74.3%** primarily from a **$2.2 million** non-cash litigation settlement Net Sales (Three Months Ended June 30, in dollars) | Region | 2020 | 2019 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Domestic | $6,745,810 | $4,569,226 | $2,176,584 | 47.6% | | International | $963,094 | $779,586 | $183,508 | 23.5% | | **Total** | **$7,708,904** | **$5,348,812** | **$2,360,092** | **44.1%** | - Gross margin for Q2 2020 was **63.7%**, down from **65.0%** in Q2 2019, mainly due to overtime costs related to COVID-19 absenteeism[91](index=91&type=chunk) - Litigation expenses for Q2 2020 increased by **$1.2 million** year-over-year, primarily due to a non-cash expense of **$2.2 million** from the EMED settlement[93](index=93&type=chunk) Net Sales (Six Months Ended June 30, in dollars) | Region | 2020 | 2019 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Domestic | $12,086,676 | $8,452,791 | $3,633,885 | 43.0% | | International | $1,952,237 | $1,870,299 | $81,938 | 4.4% | | **Total** | **$14,038,913** | **$10,323,090** | **$3,715,823** | **36.0%** | [Liquidity and Capital Resources](index=19&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2020, liquidity was strong with **$38.1 million** in cash, boosted by a **$26.5 million** stock offering and **$3.5 million** credit line draw, with cash from operations positive at **$2.7 million** for the first six months - Principal source of liquidity is cash on hand of **$38.1 million** as of June 30, 2020, which includes **$26.5 million** from a recent capital raise and a **$3.5 million** draw on its line of credit[103](index=103&type=chunk) - The litigation settlement with EMED was a non-cash transaction involving the issuance of equity, which resulted in a **$2.2 million** expense in Q2 2020[105](index=105&type=chunk) Cash Flow Summary (Six Months Ended June 30, in dollars) | Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net cash provided by/(used in) operating activities | $2,707,549 | $(1,483,909) | | Net cash (used in)/provided by investing activities | $(513,273) | $1,532,487 | | Net cash provided by financing activities | $30,064,144 | $19,811 | [Non-GAAP Financial Measures](index=21&type=section&id=Non-GAAP%20Financial%20Measures) The company uses Adjusted EBITDA, a non-GAAP measure, to supplement GAAP results, reporting **$1.8 million** for Q2 2020 (up from **$1.5 million**) and **$3.0 million** for the six-month period (up from **$2.4 million**) Reconciliation of GAAP Net (Loss)/Income to Non-GAAP Adjusted EBITDA (in dollars) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2020** | **2019** | **2020** | **2019** | | GAAP Net (Loss)/Income | $(1,076,038) | $78,183 | $(626,610) | $(7,207) | | Litigation Expenses | $2,346,914 | $1,124,947 | $2,446,072 | $1,617,462 | | Stock Option Expense | $363,851 | $194,765 | $664,817 | $316,640 | | **Non-GAAP Adjusted EBITDA** | **$1,759,964** | **$1,490,504** | **$3,038,998** | **$2,418,502** | - Adjustments to calculate Adjusted EBITDA include excluding expenses for litigation, stock options, discontinued products, and manufacturing initiatives, which management believes provides a better understanding of ongoing business performance[119](index=119&type=chunk)[120](index=120&type=chunk)[122](index=122&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company has indicated that this section is not applicable for the reporting period - The company states that Quantitative and Qualitative Disclosures About Market Risk are not applicable[125](index=125&type=chunk) [Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2020, with no material changes to internal control over financial reporting during the quarter - The Principal Executive Officer and Principal Financial Officer concluded that the company's disclosure controls and procedures were effective as of June 30, 2020[126](index=126&type=chunk) - No material changes were made to the company's internal control over financial reporting during the quarter ended June 30, 2020[127](index=127&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=23&type=section&id=Item%201.%20Legal%20Proceedings) In May 2020, the company successfully resolved all litigation with EMED Technologies Corporation through an equity payment, gaining freedom to operate under EMED's patent portfolio and dismissing all claims - On May 26, 2020, the company announced a settlement of all litigation with its competitor, EMED Technologies Corporation, which had been ongoing since 2013[128](index=128&type=chunk) - The settlement agreement provides KORU Medical with freedom to operate under EMED's patent portfolio, dismissal of all litigation, and involved an equity payment by KORU Medical to EMED[128](index=128&type=chunk) [Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) The COVID-19 pandemic is highlighted as a material risk factor, potentially adversely affecting business operations, employee health, supply chain, and financial condition, including manufacturing disruptions and liquidity impacts - The COVID-19 pandemic is identified as a significant risk factor that could adversely affect business, operations, and financial condition[138](index=138&type=chunk) - Specific pandemic-related risks include disruptions to the supply chain, limitations on the ability to manufacture products, reduced sales force effectiveness due to travel restrictions, and potential negative impacts on liquidity from financial market disruption[138](index=138&type=chunk)[139](index=139&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=25&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During the quarter, the company issued unregistered securities, including **7,999** common shares to directors, **710,000** shares from executive option exercises, and **95,238** restricted stock units plus an option for **400,000** shares to EMED as part of a settlement - Issued an aggregate of **17,188** shares of common stock to non-employee directors during the six-month period ended June 30, 2020, as part of their compensation[140](index=140&type=chunk) - Issued **95,238** restricted stock units and an option to purchase up to **400,000** shares to EMED as part of the litigation settlement on May 20, 2020[142](index=142&type=chunk) [Exhibits](index=25&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including SOX certifications from the Principal Executive and Financial Officers, and Interactive Data Files (XBRL) of the financial statements - The report includes certifications from the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act[146](index=146&type=chunk) - Interactive Data Files (XBRL) are furnished as Exhibit 101[145](index=145&type=chunk)[146](index=146&type=chunk)