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 ...

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, 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 13-3044880 (State or other ...

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 ...

| --- | --- | --- | --- | |-------|-----------------------------------------------------------|-------|-------| | | | | | | | | | | | | | | | | | Q2 2022 Earnings Call August 3, 2022 KORU Medical Systems | | | | | | | | 1 Forward-Looking Statements 2 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 regarding our expectations for future performance, including but not limited to our future reve ...

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, 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 13-3044880 ...

Financial Data and Key Metrics Changes - KORU Medical Systems reported net revenues of $6.2 million for Q1 2022, a 15% increase year-over-year, marking the second consecutive quarter of double-digit growth [9][19] - Gross profit increased by $400,000 or 12.1%, while gross margin decreased by 150 basis points to 58% due to higher manufacturing costs and the dilutive impact of increased NRE revenues [21][24] - Net loss for Q1 2022 was $2.5 million or negative $0.06 per diluted share, compared to a net loss of $1.3 million or negative $0.03 per diluted share in Q1 2021 [24] Business Line Data and Key Metrics Changes - Domestic core business revenues increased by 13.2% year-over-year, driven by higher pump and consumable sales [19] - Novel Therapies revenues increased to over $350,000 for Q1 2022, primarily due to pre-commercialization revenues from pharmaceutical pipeline deal expansions [9][19] - International core revenues decreased by 8.6% year-over-year due to changes in ordering patterns from smaller distributors [9][20] Market Data and Key Metrics Changes - The overall SCIg drug market growth increased from 1% in Q4 2021 to 7% in Q1 2022, indicating a market recovery as patients return to regular therapy [9] - The prefilled syringe market penetration increased to 5% from 3.4% in the previous quarter, driven by label expansions [14] Company Strategy and Development Direction - The company aims to increase core SCIg penetration and expand into Novel Therapies, with a strategic plan rolled out in December 2021 [10][11] - KORU Medical is expanding its international presence, recently signing a distribution agreement with iExpert in Germany, a significant SCIg market [11][16] - The company is focused on innovation and product development, with plans for a next-generation pump and improvements to the FreedomEdge platform [18][35] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the recovery of the U.S. market and the potential for double-digit growth, driven by the rebound in patient diagnoses and therapy cadence [27][41] - The company tightened its revenue guidance for 2022 to $26.5 million to $27 million, reflecting confidence in market growth and pipeline expansion [27][28] - Management highlighted the importance of label expansions and international agreements as key drivers for future growth [29][41] Other Important Information - The company is on track to move to a new building location in Mahwah, New Jersey, on June 1, 2022, and has strengthened its executive team with the hiring of a new Chief Technology Officer [11][18] - KORU Medical ended the quarter with $22.6 million in cash, indicating strong capitalization to support strategic initiatives [25] Q&A Session Summary Question: Impact of prefilled syringes on overall subcu penetration - Management noted a 0.5 point improvement in overall subcu penetration and a 40% growth in pump orders, attributing part of this growth to the FreedomEdge pump cleared for prefilled syringes [33] Question: Updates on new pump developments and product pipeline - Management confirmed ongoing innovation efforts, including improvements to the FreedomEdge platform and plans for a next-generation pump [35] Question: Feedback from specialty pharmacies regarding prefilled syringes - Management reported positive feedback regarding the ease of use of prefilled syringes and ongoing efforts to train pharmacies and patients [36] Question: Future developments of the Novel Therapies pipeline and international progress - Management highlighted the importance of the U.S. market recovery, Novel Therapies pipeline expansion, and the new distribution agreement in Germany as key factors for achieving growth targets [40] Question: Contribution from the recent 510(k) approval for EMPAVELI - Management indicated that the approval is expected to significantly enhance the promotion of the FreedomEdge pump and contribute to revenue growth [42]