Financial Data and Key Metrics Changes - The company achieved record revenues of $10,200,000 in Q2 2025, representing a 21% growth year-over-year [21] - For the first half of 2025, revenue grew 19% to $19,800,000 compared to $16,600,000 in the same period of 2024 [25] - Gross margin for Q2 was 63.5%, a decline of 150 basis points year-over-year, primarily due to tariff impacts and prior year inventory adjustments [22] - Cash balance at the end of Q2 was $8,100,000, with cash usage of $600,000 during the quarter [24] Business Line Data and Key Metrics Changes - Domestic core revenues were $7,100,000, a 15% increase over the prior year, driven by new patient starts and market share gains [21] - International core business revenues reached $2,200,000, representing a 34% growth over the prior year, fueled by expansion into new geographies [21] - Pharma services and clinical trials revenues were $900,000, reflecting a 42% growth over the prior year, driven by clinical trial orders from a non-IG partner [21] Market Data and Key Metrics Changes - The company serves approximately 45,000 patients primarily on IG therapy for chronic conditions, providing a stable base of recurring revenue [7] - The total addressable market for new drugs is estimated at approximately $1,800,000,000, based on patient populations and dosing schedules [16] - The company expects continued strong growth in international markets, particularly from prefilled syringe conversions [27] Company Strategy and Development Direction - The company is focused on three growth pillars: expanding the domestic core business, international expansion, and enabling the delivery of additional drug therapies [8] - The strategy includes pursuing new drugs for the Freedom Infusion platform, with five new drugs expected to be commercialized by 2026 [14] - The company aims to sustain over 20% growth through investments in core international and new product initiatives [30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to maintain momentum through the remainder of 2025, supported by strong results and an expanding pipeline [29] - The company anticipates positive cash flow from operations for the full year 2025, with a focus on disciplined capital allocation [24][27] - Management highlighted the ongoing shift from hospital IV treatments to subcutaneous therapies as a favorable macro trend [30] Other Important Information - The FDA recently approved an expanded indication for Empivalli, creating further opportunities for the company [10] - The company has initiated a US-based oncology pilot program with over 50 patients enrolled, which will inform strategic decisions around oncology opportunities [10] Q&A Session Summary Question: Guidance expectations for domestic vs. international markets - Management indicated that international markets are driving significant growth, with expectations for continued acceleration in the second half of the year, while domestic growth may see a temporary dip due to a distributor's inventory reduction program [36][37] Question: Success factors for prefilled syringe conversions - The company noted that the conversion from vials to prefilled syringes is driven by patient preference and efficiency, with expectations for continued growth in this area [38] Question: Market share expectations in converted markets - Management stated that their market share in a specific converted market has increased to the low 20% range, with further opportunities for growth in additional markets [44] Question: Growth rates in the domestic SCIG market - The company reported high single-digit to low double-digit growth rates in the domestic SCIG market, driven by new patient starts [48] Question: Updates on product delays and next-gen pump submission - Management explained that delays in consumables were due to improvements in comfort and convenience, and they remain confident in the timeline for the next-gen pump submission by late 2025 or early 2026 [50][52] Question: Expectations for international growth and Japan launch - Management confirmed that the Japan launch is expected to contribute to revenue in 2025, with a larger impact anticipated in 2026 [83]

Q2 2025 Earnings Call August 6, 2025 1 Forward Looking Statements This presentation 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. 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. Forwa ...

Financial Performance - The company reported net revenues of $10.2 million for Q2 2025, a 20.9% increase from $8.4 million in Q2 2024, driven by a 15.3% growth in domestic core and a 33.9% growth in international core revenues[75]. - Gross profit for Q2 2025 was $6.5 million, an 18.2% increase compared to $5.5 million in Q2 2024, with a gross margin of 63.5%, down from 65.0% in the prior year due to a one-time inventory valuation adjustment[76]. - For the six months ended June 30, 2025, total net revenues increased by 19.3% to $19.8 million, with domestic core revenues rising by 15.8% to $14.0 million and international core revenues increasing by 34.8% to $4.6 million[86]. - Gross profit for the first half of 2025 was $12.5 million, an 18.3% increase from $10.6 million in the same period of 2024, with a gross margin of 63.1%[87]. - The net loss for Q2 2025 decreased to $206,867, a 79.1% improvement from a net loss of $988,715 in Q2 2024, attributed to increased gross profit[84]. - Net loss decreased by $1.6 million, or 53.1%, to $1.4 million for the six months ended June 30, 2025, driven by an increase in gross profit of $1.9 million, or 18.3%[90]. Operating Expenses - Operating expenses for Q2 2025 were $6.8 million, a slight increase of 1.7% from $6.7 million in Q2 2024, primarily due to higher selling, general, and administrative expenses[77]. - Selling, general and administrative expenses increased by $0.7 million, or 6.2%, to $11.3 million for the six months ended June 30, 2025, compared to the prior year[88]. - Total operating expenses increased by $0.3 million, or 2.5%, to $14.1 million for the six months ended June 30, 2025[88]. - Research and development expenses increased by 5.3% to $1.2 million in Q2 2025, driven by higher temporary headcount spend related to new product development[83]. - Research and development expenses decreased by $0.3 million, or 11.5%, to $2.3 million for the six months ended June 30, 2025, primarily due to lower project spending[89]. Cash Flow and Financial Position - Cash on hand was $8.1 million as of June 30, 2025, with expectations that it will be sufficient to meet requirements for at least the next twelve months[91]. - Net cash used in operating activities was $0.7 million for the six months ended June 30, 2025, compared to $0.3 million in the prior year[95]. - Net cash used in investing activities was $0.5 million for the six months ended June 30, 2025, primarily for capital expenditures related to manufacturing equipment[97]. - Net cash used in financing activities was $0.4 million for the six months ended June 30, 2025, due to payments on a note payable for insurance premium financing[98]. - Future capital requirements may vary and could necessitate drawing on credit facilities or seeking additional financing[93]. Inventory and Tariff Impact - Inventory position increased by $1.1 million to $3.9 million at June 30, 2025, compared to December 31, 2024[92]. - The company incurred tariff-related charges of $0.1 million in Q2 2025, expecting a gross margin impact of less than 100 basis points on an annualized basis[77]. Market Focus - The company is focused on expanding its market presence and enhancing its product offerings in the subcutaneous drug delivery market[73]. - The company’s revenues from pharma services and clinical trials increased by 42.1% to $0.9 million in Q2 2025, primarily due to higher revenues from product sales for clinical trials[79].

Revenue Growth - Total net revenues increased by $1.8 million, or 20.9%, to $10.2 million for Q2 2025 compared to $8.4 million in Q2 2024[5] - Domestic core revenues were $7.1 million, a 15.3% increase year-over-year, driven by higher consumable volumes and market share gains[6] - International core revenues rose to $2.2 million, a 33.9% increase from the prior year, attributed to higher consumable and pump volumes[7] - Pharma Services and Clinical Trials net revenues reached $0.9 million, a 42.1% increase over the prior year period[6] - Net revenues for the three months ended June 30, 2025, were $10,194,800, representing a 20.9% increase from $8,430,089 in the same period of 2024[25] Profitability - Gross profit increased by $1.0 million, or 18.2%, to $6.5 million, with a gross margin of 63.5%[8] - Gross profit for the six months ended June 30, 2025, was $12,522,104, up from $10,583,048 in 2024, indicating a 18.3% growth[25] - The net loss for the six months ended June 30, 2025, was $1,373,105, a decrease from $2,924,673 in 2024, reflecting a 53% improvement[27] - The company reported a basic and diluted net loss per share of $0.03 for the six months ended June 30, 2025, compared to a loss of $0.06 in 2024, showing a 50% improvement[25] Expenses - Total operating expenses for Q2 2025 were $6.8 million, a slight increase of 1.7% from the prior year[9] - Operating expenses for the three months ended June 30, 2025, totaled $6,788,424, slightly higher than $6,671,784 in 2024, marking a 1.8% increase[25] - Research and development expenses for the six months ended June 30, 2025, were $2,309,398, down from $2,609,907 in 2024, a decrease of 11.5%[25] Cash Position - Ending cash balance was $8.1 million, reflecting a quarterly cash usage of $0.6 million[12] - Cash and cash equivalents at the end of the period were $8,054,716, down from $10,458,001 at the end of June 2024, representing a decrease of 22.9%[27] Guidance and Future Outlook - The company raised its full-year 2025 revenue guidance to $39.5 - $40.5 million, representing growth of 18% - 20%[17] - Adjusted EBITDA for Q2 2025 was $0.3 million, compared to an adjusted EBITDA loss of $0.4 million in Q2 2024[11] - Non-GAAP adjusted EBITDA for the six months ended June 30, 2025, was $14,943, compared to a loss of $1,312,913 in 2024, indicating a significant turnaround[34] Share Information - The weighted average number of common shares outstanding for the three months ended June 30, 2025, was 46,193,709, compared to 45,811,373 in 2024, an increase of 0.8%[34] Product Development - The company submitted a 510(k) filing to add a new drug to the Freedom Infusion System, indicating ongoing product development efforts[4] Other Income - Total other income for the six months ended June 30, 2025, was $201,911, slightly down from $228,727 in 2024, reflecting a decrease of 11.7%[25]

Financial Data and Key Metrics Changes - Revenue for the first quarter reached $9,600,000, representing an 18% increase year-over-year [7] - Gross margin improved to 62.8%, a 50 basis point increase compared to the same period last year [8][26] - The company raised its 2025 revenue guidance to a range of $38,500,000 to $39,500,000, indicating a 15% to 17% year-over-year growth [9][29] Business Line Data and Key Metrics Changes - Domestic core revenues were $6,900,000, reflecting a 16% increase year-over-year, driven by new patient starts and market share gains [23] - International core business revenues reached $2,400,000, representing a 36% growth over the prior year [24] - Pharma services and clinical trials revenues declined by 39% to $300,000 due to lower clinical trial orders [25] Market Data and Key Metrics Changes - The overall SCIG market grew approximately 10% in Q1, while the company's domestic core business grew 16% [12] - Internationally, the company achieved 36% growth, driven by patient growth and new distributor relationships [12] - The total international SCIG total addressable market (TAM) is estimated at $60,000,000, with the company currently holding approximately a 10% share [16] Company Strategy and Development Direction - The company aims to expand its platform to support subcutaneous delivery of additional large volume drugs, capitalizing on the shift from IV to subcutaneous formulations [11] - The strategic vision includes strengthening the core business while pursuing new drug opportunities, with a focus on operational efficiencies and market expansion [10][11] - The company plans to submit two additional commercialized drugs for FDA clearance by the end of 2025, increasing its pipeline to five planned submissions [8][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for its core business, citing a resilient market growth even amid macroeconomic uncertainties [15] - The company is optimistic about its international expansion plans, targeting a market share increase to 30% to 40% over the next several years [16] - Management reiterated expectations for positive cash flow from operations in 2025, with a focus on improving operating leverage [30] Other Important Information - The company has nine active collaborations with pharmaceutical partners and plans to expand its addressable market through these partnerships [11][17] - The company is actively monitoring the changing policy environment regarding tariffs and has low exposures to tariffs due to the majority of raw materials being of US origin [27] Q&A Session Summary Question: Thoughts on adding new drugs without current partnerships - Management is excited about pursuing drugs independently, leveraging strong relationships with specialty pharmacies, and sees significant upside potential [41][43] Question: Revenue cadence throughout the year - Management expects international growth to be around 30%, with some impact from distributor stocking orders in Q2 [45][47] Question: Prefilled syringe opportunity and tender updates - Prefilled syringe penetration in the US is over 65%, with plans for further penetration outside the US [52][54] Question: Tariff impact on guidance - Tariff impacts are included in the gross margin guidance, with an estimated impact of under 100 basis points [57][84] Question: Market opportunity for new drugs - The iron chelation drug has an estimated patient base of 30,000, while the antibiotic drug has over 300,000 patients, with significant market potential [90][91]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 reached $9.6 million, an 18% increase year-over-year, marking a record for the company [7][23] - Gross margin improved to 62.8%, a 50 basis point increase compared to the same period last year [9][26] - The company raised its 2025 revenue guidance to a range of $38.5 million to $39.5 million, representing a 15% to 17% year-over-year growth [9][29] Business Line Data and Key Metrics Changes - Domestic core revenues were $6.9 million, a 16% increase year-over-year, driven by new patient starts and market share gains [23] - International core business revenues reached $2.4 million, representing a 36% growth over the prior year, driven by expansion into new geographies and a key tender win [24][12] - Pharma services and clinical trials revenues declined by 39% to $300,000 due to lower clinical trial orders [24] Market Data and Key Metrics Changes - The overall SCIG market grew approximately 10% in Q1, while the company's domestic core business grew 16% [12] - Internationally, the company achieved 36% growth, driven by patient growth and new distributor relationships in the Middle East and North Africa [12] - The total international SCIG total addressable market (TAM) is estimated at $60 million, with the company currently holding approximately a 10% share [16] Company Strategy and Development Direction - The company aims to expand its platform to support subcutaneous delivery of additional large volume drugs, capitalizing on the shift from IV to subcutaneous formulations [11] - The strategic vision includes strengthening the core business while pursuing new drug opportunities, with a focus on operational efficiencies and market expansion [10][11] - The company plans to submit two additional commercialized drugs for FDA clearance by the end of 2025, bringing the total pipeline to five planned submissions [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for the core business, citing a resilient market growth even amid macroeconomic uncertainties [15] - The company is optimistic about its international expansion plans, targeting a growth in market share from 10% to 30%-40% over the next several years [16] - Management reiterated expectations for positive cash flow from operations in 2025, with a focus on improving operating leverage [30] Other Important Information - The company has nine active collaborations with pharmaceutical partners, with a robust pipeline of 17 total opportunities [17] - The company is actively monitoring the changing policy environment regarding tariffs and supply chain impacts [27] Q&A Session Summary Question: Thoughts on adding new drugs without current partnerships - Management is excited about pursuing drugs independently, driven by strong relationships with specialty pharmacies and the potential for revenue growth with minimal investment [41][43] Question: Revenue cadence throughout the year - Management expects international revenue growth to be around 30%, with some impact from distributor stocking orders in Q2 [46][48] Question: Prefilled syringe opportunity and tender details - Prefilled syringe penetration in the US is now over 65%, with plans for further penetration outside the US [50][51] Question: Update on ePump opportunity and distributor dynamics - The company sees potential for increased volumes of consumables with e pumps, driven by new market openings and share gains [60] Question: Market opportunity for new drugs - The iron chelation drug has an estimated patient base of 30,000, while the antibiotic drug has over 300,000 patients, with significant potential for home administration [88][90]

Financial Performance & Guidance - KORU Medical achieved Q1 2025 revenues of $9.6 million, representing an 18% increase year-over-year[8] - The company's core business experienced 21% growth, driven by recurring revenues, new patient starts, share expansion, and geographic expansion[8] - Gross margin improved to 62.8%, a 50 basis points increase[7] - KORU Medical raised its 2025 revenue guidance to $38.5-$39.5 million, projecting 15%-17% growth, and reaffirmed 61%-63% gross margins, with positive cash flow from operations expected for the full year[7] Strategic Growth & Market Expansion - Domestic core business revenue grew by 16% year-over-year[12] - International core business experienced 36% year-over-year growth[12] - Approximately 75% of KORU's revenue is recurring, excluding initial pump sales and Novel Therapies service revenue[15] Pipeline & Future Catalysts - KORU Medical plans to submit for FDA 510(k) clearance with 2 commercialized drugs on the Freedom Infusion System in 2025[8] - The company has 15 pharma collaborations in total, with 2 added year-to-date in 2025[13] - KORU Medical estimates its international market share at 10% with a goal of 30-40%[19]

Revenue and Profitability - The company reported net revenues of $9.6 million for Q1 2025, a 17.5% increase from $8.2 million in Q1 2024, driven by a 16.4% growth in domestic core revenues and a 35.6% increase in international core revenues [75]. - Gross profit for Q1 2025 was $6.0 million, an 18.5% increase from $5.1 million in Q1 2024, with a gross margin of 62.8%, up from 62.3% in the prior year [76][81]. - The company experienced a net loss of $1.2 million in Q1 2025, a 39.8% improvement from a net loss of $1.9 million in Q1 2024 [85]. Expenses - Operating expenses increased to $7.3 million in Q1 2025, compared to $7.1 million in Q1 2024, primarily due to a rise in selling, general, and administrative expenses [77][83]. - Selling, general, and administrative expenses rose by 11.2% to $6.0 million in Q1 2025, driven by increased compensation-related expenses and legal fees [83]. - Research and development expenses decreased by 24.5% to $1.1 million in Q1 2025, primarily due to timing of project spending [84]. Cash Flow and Investments - Cash on hand as of March 31, 2025, was $8.7 million, with inventory increasing to $3.3 million, reflecting a $0.5 million rise from December 31, 2024 [86][87]. - Net cash used in operating activities was $0.2 million for Q1 2025, an improvement from $0.3 million in Q1 2024, primarily due to a lower net loss and changes in working capital [90][91]. - The company invested $0.4 million in capital expenditures for manufacturing equipment related to new consumables production lines in Q1 2025 [92]. - 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 [88]. Accounting and Market Risk - No significant accounting policies have been adopted that would impact the financial statements [94]. - There are no applicable quantitative and qualitative disclosures about market risk [95].

[Q1 2025 Financial & Operational Highlights](index=1&type=section&id=Q1%202025%20Financial%20%26%20Operational%20Highlights) KORU Medical achieved record Q1 2025 net revenues of **$9.6 million**, an 18% year-over-year increase, driven by 21% core business growth and new patient starts, leading to raised full-year guidance and planned 510(k) submissions [Overview](index=1&type=section&id=Recent%20Highlights) KORU Medical achieved record Q1 2025 net revenues of **$9.6 million**, an 18% year-over-year increase, driven by 21% core business growth and new patient starts, leading to raised full-year guidance and planned 510(k) submissions Q1 2025 Key Performance Indicators | Metric | Q1 2025 ($) | Change vs. Q1 2024 | | :--- | :--- | :--- | | **Net Revenues** | $9.6 million | +18% | | **Core Business Net Revenues** | $9.4 million | +21% | | **Gross Profit** | $6.0 million | +19% | | **Gross Margin** | 62.8% | +50 bps | | **Ending Cash Balance** | $8.7 million | - | | **Quarterly Cash Usage** | $0.8 million | - | - The CEO attributed the strong performance to over **20% growth** in the core business, driven by new patient starts and market share gains in both domestic and international markets[3](index=3&type=chunk) - The company announced plans to submit for FDA 510(k) clearance for two commercialized drugs with the Freedom Infusion System™ in 2025[6](index=6&type=chunk) [Q1 2025 Financial Performance Analysis](index=1&type=section&id=Q1%202025%20Financial%20Performance%20Analysis) This section analyzes the company's Q1 2025 financial results, detailing revenue drivers, profitability improvements, and cash flow position [Net Revenues](index=1&type=section&id=Net%20Revenues) Total net revenues for Q1 2025 increased **17.5% to $9.6 million**, driven by **20.8% growth in the Total Core business** to $9.4 million, despite a decrease in Pharma Services and Clinical Trials revenue Net Revenues Breakdown (Three Months Ended March 31) | Revenue Segment | 2025 ($) | 2024 ($) | Change (%) | | :--- | :--- | :--- | :--- | | Domestic Core | $6,927,964 | $5,953,865 | +16.4% | | International Core | $2,428,662 | $1,790,483 | +35.6% | | **Total Core** | **$9,356,626** | **$7,744,348** | **+20.8%** | | Pharma Services and Clinical Trials | $278,449 | $453,450 | -38.6% | | **Total Net Revenues** | **$9,635,075** | **$8,197,798** | **+17.5%** | - Domestic core revenue growth was driven by higher pump and consumable volumes from new patient starts and market share gains[4](index=4&type=chunk) - International core revenue growth was primarily due to higher volumes from geographical expansion and a tender win with an Ig pharma partner, including approximately **$0.4 million of distributor stocking**[4](index=4&type=chunk) [Profitability Analysis](index=1&type=section&id=Profitability%20Analysis) Gross profit increased **18.5% to $6.0 million** with gross margin expanding **50 basis points to 62.8%**, leading to a significant reduction in net loss to **$(1.2) million** or **$(0.03) per share** Profitability Metrics (Three Months Ended March 31) | Metric | 2025 ($) | 2024 ($) | Change ($) | | :--- | :--- | :--- | :--- | | **Gross Profit** | $6.0 million | $5.1 million | +$0.9M | | **Gross Margin** | 62.8% | 62.3% | +50 bps | | **Total Operating Expenses** | $7.3 million | $7.1 million | +$0.2M | | **Net Loss** | $(1.2) million | $(1.9) million | +$0.7M | | **Net Loss Per Share** | $(0.03) | $(0.04) | +$0.01 | - The increase in gross margin was primarily driven by favorable changes in product revenue mix[5](index=5&type=chunk) - Operating expenses increased due to higher compensation for temporary staff and legal fees, partially offset by lower severance and R&D expenses[7](index=7&type=chunk) [Cash Flow and Financial Position](index=2&type=section&id=Cash%20Flow%20and%20Financial%20Position) The company concluded Q1 2025 with **$8.7 million in cash**, reflecting **$0.8 million in cash usage**, while Adjusted EBITDA significantly improved to a loss of **$(0.2) million** - Cash and cash equivalents were **$8.7 million** as of March 31, 2025, with a cash usage of **$0.8 million** in Q1[10](index=10&type=chunk) Adjusted EBITDA (Three Months Ended March 31) | Metric | 2025 ($) | 2024 ($) | | :--- | :--- | :--- | | **Adjusted EBITDA** | ($0.2) million | ($0.9) million | | **Adjusted Diluted EPS** | $0.00 | ($0.02) | [Full Year 2025 Guidance](index=1&type=section&id=2025%20Guidance) This section outlines KORU Medical's updated financial projections for the full year 2025, including revenue, gross margin, and cash flow from operations [Updated Guidance](index=1&type=section&id=Updated%20Guidance) KORU Medical raised its full-year 2025 revenue guidance to **$38.5 million to $39.5 million** and reiterated gross margin guidance of **61% to 63%**, expecting positive cash flow from operations Full Year 2025 Guidance | Metric | Updated Guidance ($) | Prior Guidance ($) | | :--- | :--- | :--- | | **Net Revenues** | $38.5 - $39.5 million | $38.0 - $39.0 million | | **Gross Margin** | 61% - 63% (Reiterated) | 61% - 63% | | **Cash Flow from Operations** | Positive (Reiterated) | Positive | [Financial Statements](index=3&type=section&id=Financial%20Statements) This section presents the detailed financial statements, including balance sheets, statements of operations, and statements of cash flows for the reported periods [Balance Sheets](index=3&type=section&id=KORU%20MEDICAL%20SYSTEMS%2C%20INC.%20BALANCE%20SHEETS) As of March 31, 2025, total assets remained stable at **$27.2 million**, while total liabilities increased to **$10.9 million** and total stockholders' equity decreased to **$16.3 million** Selected Balance Sheet Items | Account | March 31, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | **Cash and cash equivalents** | $8,735,834 | $9,580,947 | | **Total Current Assets** | $18,999,028 | $19,132,410 | | **Total Assets** | $27,216,167 | $27,218,515 | | **Total Current Liabilities** | $7,799,277 | $7,201,820 | | **Total Liabilities** | $10,871,136 | $10,404,836 | | **Total Stockholders' Equity** | $16,345,031 | $16,813,679 | [Statements of Operations](index=4&type=section&id=KORU%20MEDICAL%20SYSTEMS%2C%20INC.%20STATEMENTS%20OF%20OPERATIONS) For Q1 2025, the company reported a net loss of **$(1.2) million** or **$(0.03) per share**, a significant improvement from the **$(1.9) million** loss in Q1 2024, driven by higher revenues and gross profit Statement of Operations Summary (Three Months Ended March 31) | Account | 2025 ($) | 2024 ($) | | :--- | :--- | :--- | | **Net Revenues** | $9,635,075 | $8,197,798 | | **Gross Profit** | $6,046,335 | $5,103,298 | | **Total Operating Expenses** | $7,291,340 | $7,064,664 | | **Net Operating Loss** | $(1,245,005) | $(1,961,366) | | **Net Loss** | $(1,166,237) | $(1,935,958) | | **Net Loss Per Share** | $(0.03) | $(0.04) | [Statements of Cash Flows](index=4&type=section&id=KORU%20MEDICAL%20SYSTEMS%2C%20INC.%20STATEMENTS%20OF%20CASH%20FLOWS) Net cash used in operating activities improved to **$(0.2) million** for Q1 2025, with total net decrease in cash of **$(0.8) million** for the quarter Cash Flow Summary (Three Months Ended March 31) | Activity | 2025 ($) | 2024 ($) | | :--- | :--- | :--- | | **Net Cash Used in Operating Activities** | $(237,467) | $(346,720) | | **Net Cash Used in Investing Activities** | $(446,838) | $(133,083) | | **Net Cash Used in Financing Activities** | $(160,808) | $(182,120) | | **Net Decrease in Cash** | $(845,113) | $(661,923) | | **Cash at End of Period** | $8,735,834 | $10,820,317 | [Supplemental Information](index=5&type=section&id=Supplemental%20Information) This section provides additional financial details, including reconciliations of GAAP to non-GAAP financial measures for a clearer understanding of underlying performance [Reconciliation of GAAP to Non-GAAP Measures](index=5&type=section&id=Reconciliation%20of%20GAAP%20to%20Non-GAAP%20Measures) This section reconciles GAAP net loss to non-GAAP Adjusted EBITDA, which improved to **$(0.2) million** in Q1 2025, and GAAP diluted EPS to non-GAAP adjusted diluted EPS, with key adjustments for stock-based compensation and litigation expenses Reconciliation of GAAP Net Loss to Non-GAAP Adjusted EBITDA | Line Item | Q1 2025 ($) | Q1 2024 ($) | | :--- | :--- | :--- | | **GAAP Net Loss** | **$(1,166,237)** | **$(1,935,958)** | | Stock-based Compensation | $697,590 | $699,718 | | Depreciation and Amortization | $217,357 | $231,369 | | Litigation Expense | $133,411 | $— | | Interest (Income), Net | $(73,180) | $(37,187) | | **Adjusted EBITDA** | **$(191,059)** | **$(942,729)** | - Non-GAAP calculations exclude the effects of reorganization charges, stock-based compensation expense, and litigation expenses related to a patent infringement claim[28](index=28&type=chunk)[29](index=29&type=chunk)[30](index=30&type=chunk)

Financial Data and Key Metrics Changes - Q4 revenues grew by 23% year-over-year, totaling $8.8 million, while full-year revenues reached $33.6 million, representing an 18% increase [13][37] - Gross margins for Q4 were 62.9%, a 260 basis point improvement from the previous year, and full-year gross margins were 63.4%, reflecting a 480 basis point improvement [39][40] - The year-end cash balance was $9.6 million, exceeding expectations, with positive cash flow generated in Q4 [15][41] Business Line Data and Key Metrics Changes - Domestic core revenues increased by 20% in Q4 and 12% for the full year, driven by strong pump and consumable volume growth [35][38] - International core revenues grew by 14% in Q4 and 32% for the full year, supported by market penetration and geographic expansion [36][38] - Novel therapies revenues reached $700,000 in Q4, marking a 122% increase, and full-year revenues were $2.4 million, a 62% growth [37][39] Market Data and Key Metrics Changes - The U.S. SCIg market grew approximately 10% in 2024, marking the eighth consecutive quarter of year-over-year growth [17] - The international SCIg market also showed strong growth, with KORU entering new geographies in the Middle East, North Africa, and Eastern Europe [20][21] - The overall large-volume subcutaneous market is rapidly expanding, with over 18 large-volume drugs in development [11] Company Strategy and Development Direction - KORU Medical aims to become a global leader in large-volume subcutaneous drug delivery, focusing on expanding its market share in both domestic and international markets [9][12] - The company is transitioning its Novel Therapies segment to Pharma Services and Clinical Trials to better reflect its business model [24][46] - KORU plans to launch three new products in 2025, enhancing patient comfort and convenience [53][56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining mid-teen growth rates in recurring revenue, driven by increased market share and new product launches [27][28] - The company anticipates operational cash flow positivity for the full year of 2025, with revenue guidance set between $38 million and $39 million [16][50] - Management noted potential supply disruptions from FDA announcements are expected to be short-term and manageable [25] Other Important Information - The company has approximately 49,000 patients, with 75% of revenues coming from recurring sources, indicating a strong recurring revenue base [26] - KORU holds about 10% share of a $60 million o-US SCIg market, indicating significant growth potential [28] Q&A Session Summary Question: Can you break down the 2025 guidance for domestic and international growth? - Management expects domestic revenue growth between 10% and 15% and international growth over 20%, with novel therapies contributing $2 million to $3 million [62] Question: What drives the above-market growth in 2025? - Growth will be driven by new geographies, increased market share, and new customer acquisitions, particularly in the international space [64][66] Question: What is the status of the oncology opportunity? - The company is focused on market assessment, reimbursement strategies, and establishing distribution partnerships for the oncology product [70] Question: Can you elaborate on the e-pump opportunity? - The e-pump market is seen as a significant growth driver, with KORU currently holding over 10% market share and plans for further penetration [82] Question: How do you view gross margin expansion with the new product portfolio? - The new consumables launch is expected to drive efficiencies and potentially increase gross margins to over 65% in the long term [85]