KORU Medical Systems (KRMD) FY Conference August 13, 2025 10:30 AM ET Speaker0Alright. Good morning, everyone, and welcome to this year's Canaccord Genuity Global Growth Conference. My name is Caitlin Cronin, and I'm on the medical device team here at Canaccord Genuity. Coru Medical is joining us today, and they're a medical device company focused on innovative portable solutions for the drug delivery market. We're very pleased to be joined today by Linda Tharby, President and CEO, as well as Tom Adams, CFO ...

KORU Medical Systems (KRMD) Q2 2025 Earnings Call August 06, 2025 04:30 PM ET Speaker0Hello and welcome to the Kuru Medical Systems Second Quarter twenty twenty five Financial Results Conference Call and Webcast. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to Louisa Smith of the Gilmartin Group.Please go ahead.Speaker1Thank you, Judit ...

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 ...

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, 2025 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) 100 Corporate Drive ...

EXHIBIT 99.1 KORU MEDICAL SYSTEMS ANNOUNCES Q2 2025 FINANCIAL RESULTS, INCLUDING RECORD DOUBLE-DIGIT REVENUE, AND RAISES 2025 REVENUE GUIDANCE MAHWAH, NJ – August 6, 2025 – KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on development, manufacturing, and commercialization of innovative and patient- centric large volume subcutaneous infusion solutions, today reported financial results for the second quarter ended June 30, 2025. Financ ...

KORU Medical Systems (KRMD) Q1 2025 Earnings Call May 07, 2025 04:30 PM ET Company Participants Louisa Smith - PrincipalLinda Tharby - President, Director & CEOTom Adams - Chief Financial OfficerCaitlin Cronin - Director Conference Call Participants Frank Takkinen - Senior Research AnalystChase Knickerbocker - Senior Equity Research Analyst - HealthcareJason Bednar - Research AnalystAnderson Schock - Research Analyst Operator Greetings, and welcome to KORU Medical Systems first quarter twenty twenty five ea ...

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]

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, including, but not limited to, timing of 510(k) clearances and financial guidance for fiscal 2025. Forward-looking statements discuss the Company's current expectations and projections relating to its financial position, results of operations, plans, objectives, future ...

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)