6 • Freedom60 with PFS is preferred by 78% of patients • 70% of patients are on >50 mL 15 Total Collaborations | +1/-1 in Q3 2023 $2.5B TAM(1) | 2M(2) Global Patient Population 2025 7 8 9 Submitted for regulatory approval 10 Back Order $0.3 $7.8 $7.0 (10%) $5.9 $5.8 $1.1 $1.1 $0.2 $0.8 Q3 2022 Q3 2023 Novel Therapies International Core • Decreased 2% y/y, +6% YTD • Lower consumable volumes as compared to prior year when a $0.3M backorder was cleared. • Outpaced U.S. Rx script declines driven by increased vo ...

Financial Performance - The company reported net revenues of $7.0 million for Q3 2023, a decrease of 9.8% compared to $7.8 million in Q3 2022, primarily due to a $0.6 million decline in novel therapies revenues [83]. - Domestic core revenues decreased by 2.1% to $5.77 million, while international core revenues fell by 2.8% to $1.07 million, driven by lower consumable volumes and a prior year tender order [85]. - The company reported a net loss of $1.37 million for Q3 2023, an increase of 11.6% from a net loss of $1.23 million in Q3 2022, attributed to decreased revenues and increased operating expenses [91]. - For the nine months ended September 30, 2023, total net revenues increased by 3.8% to $21.33 million, driven by a 6.2% increase in domestic core revenues [93]. - The net loss decreased by $409,382, or 6.1%, to $6,275,033 for the nine months ended September 30, 2023, primarily due to an increase in net revenues of $0.8 million [100]. Gross Profit and Margins - Gross profit for Q3 2023 was $4.34 million, flat compared to $4.32 million in Q3 2022, with gross margin increasing to 62.0% from 55.7% due to production efficiencies [86]. - Gross profit for the nine months ended September 30, 2023, was $12.38 million, a 9.6% increase from $11.29 million in the same period last year, with gross margin at 58.0% [94]. Operating Expenses - Operating expenses rose to $6.1 million in Q3 2023, up from $5.9 million in the same period last year, primarily due to a $0.4 million increase in research and development expenses [84]. - Selling, general and administrative expenses decreased by 3.1% to $15.35 million for the nine months ended September 30, 2023, primarily due to prior year restructuring costs [96]. - Research and development expenses increased by 34.4% to $4.45 million for the nine months ended September 30, 2023, reflecting support for innovation efforts [96]. - Research and development expenses increased by $1.1 million, or 34.4%, for the nine months ended September 30, 2023, compared to the same period last year [98]. - Depreciation and amortization expense rose by 60.7% to $642,050 for the nine months ended September 30, 2023, compared to $399,479 in the same period of 2022 [99]. Cash Flow and Liquidity - Cash and cash equivalents on hand were $10.8 million as of September 30, 2023, serving as the principal source of liquidity [102]. - Net cash used in operating activities was $5.99 million for the nine months ended September 30, 2023, primarily due to the net loss and changes in working capital [107]. - Net cash used in investing activities was $606,209 for the nine months ended September 30, 2023, primarily for capital expenditures related to research and development [110]. - Net cash used in financing activities was $40,512 for the nine months ended September 30, 2023, reflecting payments on note payable and finance leases [111]. - The company anticipates that cash on hand and cash flows from operations will be sufficient to meet requirements for at least the next twelve months [106]. Future Outlook - The company anticipates continued challenges in novel therapies revenues due to the timing of clinical trial orders and market conditions [79]. - A tax benefit of $1.5 million was recorded during the nine months ended September 30, 2023, resulting from the net loss [101]. - Inventory position decreased by $1.7 million to $4.7 million as of September 30, 2023, compared to December 31, 2022 [103].

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 For the Quarterly Period Ended June 30, 2023 or [_] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________. Commission File Number: 0-12305 KORU MEDICAL SYSTEMS, INC. (Exact name of registrant as specified in its charter) Delaware 13-3044880 ...

KORU Medical Systems, Inc. (NASDAQ:KRMD) Q1 2023 Earnings Conference Call May 4, 2023 4:30 PM ET Company Participants Gregory Chodaczek - Gilmartin Group Linda Tharby - President, CEO & Director Thomas Adams - Interim CFO, Secretary & Treasurer Conference Call Participants Jason Bednar - Piper Sandler & Co. Alexander Nowak - Craig-Hallum Operator Greetings, and welcome to the KORU Medical Systems First Quarter 2023 Earnings Call. During the presentation, all participants will be in a listen-only mode. After ...

PART I. FINANCIAL INFORMATION [Financial Statements (Unaudited)](index=2&type=section&id=ITEM%201.%20Financial%20Statements%20(Unaudited)) KORU Medical Systems reported Q1 2023 revenue of $7.4 million, a net loss of $2.4 million, decreased total assets, and increased cash used in operations [Balance Sheets](index=2&type=section&id=Balance%20Sheets) Total assets decreased to $38.3 million as of March 31, 2023, driven by reduced cash, with corresponding declines in liabilities and equity Balance Sheet Summary (Unaudited) | Balance Sheet Items | March 31, 2023 (USD) | December 31, 2022 (USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $12,224,865 | $17,408,257 | | Total Current Assets | $25,214,658 | $29,801,636 | | Total Assets | $38,253,980 | $42,332,443 | | **Liabilities & Equity** | | | | Total Current Liabilities | $4,524,217 | $6,958,940 | | Total Liabilities | $8,457,680 | $11,006,480 | | Total Stockholders' Equity | $29,796,300 | $31,325,963 | [Statements of Operations](index=3&type=section&id=Statements%20of%20Operations) Q1 2023 net sales grew 18.4% to $7.4 million, gross profit increased, but gross margin slightly declined, resulting in a narrowed net loss of $2.4 million Statements of Operations Summary (Unaudited) | Metric | Three Months Ended March 31, 2023 (USD) | Three Months Ended March 31, 2022 (USD) | | :--- | :--- | :--- | | Net Sales | $7,392,605 | $6,244,330 | | Gross Profit | $4,147,035 | $3,622,305 | | Total Operating Expenses | $7,203,863 | $6,748,820 | | Net Operating Loss | ($3,056,828) | ($3,126,515) | | Net Loss | ($2,410,885) | ($2,537,514) | | Net Loss Per Share (Basic & Diluted) | ($0.05) | ($0.06) | [Statements of Cash Flows](index=4&type=section&id=Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly increased to $4.7 million in Q1 2023, leading to a $5.2 million net decrease in cash and equivalents Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2023 (USD) | Three Months Ended March 31, 2022 (USD) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | ($4,660,583) | ($1,752,072) | | Net Cash Used in Investing Activities | ($283,837) | ($752,602) | | Net Cash Used in Financing Activities | ($238,972) | ($252,968) | | Net Decrease in Cash | ($5,183,392) | ($2,757,642) | | Cash and Cash Equivalents, End of Period | $12,224,865 | $22,577,247 | [Statements of Stockholders' Equity](index=5&type=section&id=Statements%20of%20Stockholders'%20Equity) Total stockholders' equity decreased to $29.8 million by March 31, 2023, primarily due to the net loss, partially offset by stock-based compensation - Stockholders' equity decreased by approximately **$1.5 million** during the quarter, from **$31,325,963** to **$29,796,300**[17](index=17&type=chunk) - The primary reason for the decrease in equity was the net loss of **$2,410,885**[17](index=17&type=chunk) [Notes to Financial Statements](index=6&type=section&id=Notes%20to%20Financial%20Statements) The notes detail accounting policies, revenue recognition, stock-based compensation, debt obligations, and comprehensive lease liabilities - The company's revenues are derived from three sources: domestic core, international core, and novel therapies. For Q1 2023, domestic sales constituted **85% of total revenues**, consistent with Q1 2022[36](index=36&type=chunk)[41](index=41&type=chunk) - As of March 31, 2023, the company had **$3.9 million** in total unrecognized compensation cost related to its 2015 stock option plan, expected to be recognized over a weighted-average period of **45 months**[59](index=59&type=chunk) - The company has a **$3.5 million** revolving line of credit with Keybank, with no amount outstanding as of March 31, 2023. The maturity date is **June 1, 2023**[67](index=67&type=chunk) Lease Liabilities as of March 31, 2023 | Lease Type | Total Lease Liabilities (USD) | Weighted Avg. Remaining Term | | :--- | :--- | :--- | | Operating Leases | $3,913,923 | 9.4 Years | | Finance Leases | $468,538 | 4.3 Years | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=ITEM%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management reported an 18.4% revenue increase to $7.4 million, with slight gross margin decline, increased R&D, and sufficient liquidity for the next 12 months [Overview](index=16&type=section&id=Overview) The company develops medical devices for subcutaneous drug delivery, reporting 18.4% net revenue growth in Q1 2023 and completing key manufacturing and facility transitions - Q1 2023 net revenues increased by **18.4%** to **$7.4 million** compared to **$6.2 million** in Q1 2022, with growth in all three business sources[79](index=79&type=chunk) - Completed the transition of finished goods manufacturing of needle and tubing sets to Command Medical Products, a third-party contract manufacturer[77](index=77&type=chunk) - Completed the move of its corporate headquarters and manufacturing facility to Mahwah, NJ during the first quarter of 2023[78](index=78&type=chunk) [Results of Operations](index=17&type=section&id=Results%20of%20Operations) Total net revenues increased by 18.4% in Q1 2023 across all segments, but gross margin declined to 56.1% due to higher costs, leading to a narrowed net loss of $2.4 million Net Revenues Breakdown (Q1 2023 vs Q1 2022) | Revenue Source | Q1 2023 (USD) | Q1 2022 (USD) | Change (%) | | :--- | :--- | :--- | :--- | | Domestic Core | $5,719,135 | $4,993,536 | +14.5% | | International Core | $1,097,490 | $894,942 | +22.6% | | Novel Therapies | $575,980 | $355,852 | +61.9% | | **Total** | **$7,392,605** | **$6,244,330** | **+18.4%** | - Gross profit as a percentage of revenues decreased to **56.1%** in Q1 2023 from **58.0%** in Q1 2022, primarily due to higher manufacturing costs for labor and materials[83](index=83&type=chunk) - Research and development expenses increased by **36.3%** (**$0.4 million**) due to new hires to support innovation efforts[84](index=84&type=chunk)[86](index=86&type=chunk) [Liquidity and Capital Resources](index=18&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity is primarily cash on hand, totaling $12.2 million, with management expecting sufficient resources for at least the next 12 months - The company's cash on hand was **$12.2 million** as of March 31, 2023[89](index=89&type=chunk) - Inventory increased by **$0.2 million** to **$6.6 million** at March 31, 2023, with an expectation to significantly reduce this position during the remainder of 2023[90](index=90&type=chunk) - Management expects that current cash, cash flows from operations, and available financing will be sufficient to meet requirements at least through **March 31, 2024**[92](index=92&type=chunk) [Cash Flows](index=19&type=section&id=Cash%20Flows) Net cash used in operating activities was $4.7 million in Q1 2023, primarily due to net loss and unfavorable working capital changes, with investing and financing also using cash Cash Flow Summary (Three Months Ended March 31) | Cash Flow Activity | 2023 (USD) | 2022 (USD) | | :--- | :--- | :--- | | Net cash used in operating activities | ($4,660,583) | ($1,752,072) | | Net cash used in investing activities | ($283,837) | ($752,602) | | Net cash used in financing activities | ($238,972) | ($252,968) | - The **$4.7 million** use of cash in operations in Q1 2023 was primarily due to the **$2.4 million** net loss and working capital changes, including a **$1.3 million** decrease in accrued expenses and a **$0.9 million** decrease in accounts payable[95](index=95&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=20&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 stated that there are no applicable quantitative and qualitative disclosures about market risk for this period[100](index=100&type=chunk) [Controls and Procedures](index=20&type=section&id=ITEM%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of March 31, 2023, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of **March 31, 2023**[101](index=101&type=chunk) - No material changes to the company's internal control over financial reporting occurred during the first quarter of 2023[102](index=102&type=chunk) PART II. OTHER INFORMATION [Risk Factors](index=21&type=section&id=ITEM%201A.%20Risk%20Factors) The company highlights a risk related to bank failures and financial institution instability, as its cash deposits exceed FDIC insurance limits - A key risk factor is the potential impact of bank failures, as the company's cash deposits exceed FDIC insurance limits[105](index=105&type=chunk) - A failure of a financial institution holding the company's funds could disrupt access to cash, adversely impact liquidity, and limit the ability to pay vendors[105](index=105&type=chunk) [Exhibits](index=21&type=section&id=ITEM%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including CEO/CFO certifications and Inline XBRL documents - The report includes CEO and CFO certifications as required by the Sarbanes-Oxley Act[106](index=106&type=chunk) - Interactive data files (Inline XBRL documents) are also included as exhibits[106](index=106&type=chunk)

KORU Medical Systems, Inc. (NASDAQ:KRMD) Q4 2022 Earnings Conference Call March 8, 2023 4:30 PM ET Company Participants Hannah Jeffrey - Investor Relations Linda Tharby - President and Chief Executive Officer Tom Adams - Interim Chief Financial Officer Conference Call Participants Alex Nowak - Craig-Hallum Caitlin Cronin - Canaccord Genuity Joe Downing - Piper Sandler Operator Greetings and welcome to KORU Medical Systems Fourth Quarter and Full Year 2022 Earnings Conference Call. [Operator Instructions] As ...

Revenue Sources and Growth - KORU Medical's revenues are derived from three sources: domestic core, international core, and novel therapies, with a significant focus on subcutaneous drug delivery systems [18]. - The company plans to increase penetration in the subcutaneous immunoglobulin (SCIg) market and expand into new subcutaneous drug therapies, targeting at least 100 large-volume drugs currently in clinical development [21][22]. - The company aims to increase revenue growth by investing in innovation and new product development, which requires substantial resources [69]. - The company reported net revenues of $27.9 million for the fiscal year 2022, an 18.8% increase from $23.5 million in 2021, driven by growth in all three business sources [180]. - Domestic core revenues were $21.2 million, up 11.3% from $19.0 million in 2021, while international core revenues increased by 8.0% to $4.2 million [182]. - Novel therapies revenues surged by 329.8% to $2.5 million, attributed to services performed under an NRE innovation development agreement and increased clinical trial product sales [183]. Research and Development - KORU Medical spent $5.0 million on research and development in 2022, up from $2.5 million in 2021, indicating a commitment to innovation and product development [33]. - The company aims to partner with biopharmaceutical manufacturers during clinical development to generate service revenues and product revenues post-commercialization [22]. Manufacturing and Operations - The company is transitioning manufacturing activities to a new facility in Mahwah, NJ, expected to be completed by March 2023, to enhance operational efficiency [31]. - The company plans to complete the transition of manufacturing operations to Command Medical Products by the second quarter of 2023 [178]. - Manufacturing operations are regulated by the FDA and other agencies, and any interruptions, such as transitioning to a new facility, could negatively affect future revenues and operating income [76]. - The company is building product inventory to ensure service continuity during the transition to the new manufacturing facility [98]. Regulatory Compliance - The company recognizes the importance of regulatory compliance, with ongoing responsibilities under the FDA and other regulatory bodies to ensure product safety and effectiveness [34]. - The company is an FDA-registered medical device manufacturer and must comply with FDA's QSR and Current Good Manufacturing Practices (cGMPs) to avoid potential regulatory actions [43]. - Compliance with EU MDR regulations by December 2028 will require significant investment, and failure to comply will prevent the company from selling products in the EU, materially impacting net revenues [72][75]. - The new Medical Device Regulation (MDR) in the EU, effective May 2021, will require significant investment to implement due to increased compliance requirements [116]. - Regulatory compliance is complex and costly, and any adverse regulatory actions could materially affect the company's financial condition and operations [88][92]. Financial Performance - Gross profit for 2022 was $15.4 million, an increase of 11.6% from $13.8 million in 2021, but gross profit margin declined to 55.1% from 58.6% due to higher manufacturing costs [184]. - Operating expenses rose to $26.2 million in 2022, up from $20.8 million in 2021, primarily due to increased research and development and selling, general, and administrative costs [181]. - The company reported a net loss of $8.7 million for 2022, compared to a net loss of $4.6 million in 2021, reflecting higher operating expenses [188]. - Cash on hand as of December 31, 2022, was $17.4 million, with expectations that this will be sufficient to meet requirements through at least December 31, 2023 [189]. - The company expects cash on hand, cash flows from operations, and available credit facilities to be sufficient for at least the next 12 months [199]. Employee and Workforce - As of December 31, 2022, the company had 85 full-time employees, with approximately 53% being female and 41% being minorities [54][56]. - The company provides competitive compensation and employee benefits, including subsidized health insurance and a 401(k) plan with matching contributions [64]. - Attracting and retaining key employees is critical for competitiveness, with potential adverse effects on business if key personnel are lost [112]. Market and Competition - The company operates in a highly competitive market, facing competition from both large medical device companies and specialized firms, which may exert downward pressure on pricing [83][84]. - The company faces competition from various infusion device technologies, including electronic pumps and mechanical pumps, which influence pump selection based on safety, ease of use, and cost-effectiveness [51][53]. - Health care policy changes could result in downward pricing pressure for products, limiting sales and affecting financial results [99]. Risks and Challenges - The company faces risks related to patent protection and potential litigation, which could adversely affect competitiveness and financial condition [106]. - The company faces risks related to the supply chain, as most components and raw materials are sourced from single suppliers, which could adversely affect operations if supply is disrupted [125]. - The introduction of generic or biosimilar therapies could significantly reduce the commercial viability of brand name injectable therapies, impacting the company's revenue [124]. - The company is subject to foreign currency exchange risk, which may impact revenues derived from international operations [139]. - The company is subject to risks from cyber security breaches and data leakage, which could disrupt operations and delay product development [141]. Inventory and Assets - Inventory position was $6.4 million at December 31, 2022, reflecting a $0.3 million increase from the previous year, with expectations to reduce inventory in 2023 [191]. - The company maintains reserves for excess and obsolete inventory, which may require additional write-downs if product demand is less favorable than projected [211]. Stock and Capital - The company has never paid dividends on its common stock and does not intend to do so for the foreseeable future, focusing instead on funding growth [155]. - The stock price has fluctuated between $1.82 and $12.84 per share since its listing on the Nasdaq Capital Market on October 17, 2019 [158]. - The company may need additional capital in the future, which could result in substantial dilution for existing stockholders if equity is issued [156].

KORU Medical Systems, Inc. (NASDAQ:KRMD) Q3 2022 Earnings Conference Call November 9, 2022 4:30 PM ET Company Participants Hannah Jeffrey - The Gilmartin Group Linda Tharby - President and CEO Tom Adams - Interim Chief Financial Officer Josh Bennett - VP of Strategy and Business Development Conference Call Participants Alexander Nowak - Craig-Hallum Capital Group Caitlin Cronin - Canaccord Genuity Joseph Downing - Piper Sandler Operator Greetings, and welcome to KORU Medical Systems Third Quarter 2022 Ea ...

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 For the Quarterly Period Ended September 30, 2022 or [_] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________. Commission File Number: 0-12305 KORU MEDICAL SYSTEMS, INC. (Exact name of registrant as specified in its charter) New York 13-30 ...

KORU Medical Systems, Inc. (NASDAQ:KRMD) Q2 2022 Earnings Conference Call August 3, 2022 4:30 PM ET Company Participants Gregory Chodaczek - Gilmartin Group Linda Tharby - President, CEO & Director Tom Adams - Interim CFO and VP, Financial Planning & Analysis Conference Call Participants Connor Stevenson - Craig-Hallum Gibran Ahmed - Canaccord Jason Bednar - Piper Sandler & Co. Operator Greetings, and welcome to KORU Medical Systems Second Quarter 2022 Earnings Conference Call. [Operator Instructions]. I wo ...