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]

KORU Medical Systems (KRMD) Q4 2024 Earnings Call March 12, 2025 04:30 PM ET Company Participants Louisa Smith - PrincipalLinda Tharby - President and CEOTom Adams - Chief Financial OfficerMichaela Smith - Equity Research Conference Call Participants Chase Knickerbocker - Senior Equity Research Analyst - HealthcareFrank Takkinen - Senior Research AnalystJason Bednar - Senior Research AnalystAnderson Schock - Research Analyst Operator Greetings, and welcome to the Coram Medical Systems Fourth Quarter and Ful ...

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, 2024 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. (Address of principal executive offices) (Zip Code) (845)-469-2042 Registrant's telephone n ...

Financial Results - KORU Medical Systems, Inc. announced preliminary financial results for the fiscal quarter and year ended December 31, 2024[4]. - The financial results are based on current estimates and are subject to change pending completion of closing and review procedures[5]. - The company has not provided specific financial figures in the current report but will disclose them in future filings[5]. Investor Relations - An investor presentation was posted on January 13, 2025, which may be used for presentations to investors and analysts[7]. - The press release and investor presentation are available on the company's investor relations website[7]. - The company has not committed to publicly updating or revising the information provided in the report[7]. Company Classification and Trading - The company is classified as an emerging growth company under the Securities Act of 1933[4]. - The company is headquartered in Mahwah, NJ, and its common stock is traded on The Nasdaq Stock Market under the symbol KRMD[4]. Report Details - The report does not include any liabilities under Section 18 of the Exchange Act[6]. - The report was signed by Linda Tharby, President and CEO, on January 13, 2025[11].

Company Overview - KORU Medical Systems Inc. (KRMD) currently holds a Momentum Style Score of A, indicating strong momentum potential [3] - The company has a Zacks Rank of 2 (Buy), suggesting favorable investment conditions [4] Price Performance - KRMD shares have increased by 3.28% over the past week, outperforming the Zacks Medical - Instruments industry, which rose by 1.15% [6] - Over the past month, KRMD's price change is 2.76%, while the industry average is 3.26% [6] - In the last quarter, KRMD shares rose by 40.41%, and over the past year, they have increased by 93.4%, significantly outperforming the S&P 500, which moved 5.86% and 27.32% respectively [7] Trading Volume - KRMD's average 20-day trading volume is 106,547 shares, which serves as a useful price-to-volume baseline [8] Earnings Outlook - In the past two months, one earnings estimate for KRMD has moved higher, while none have moved lower, resulting in a consensus estimate increase from -$0.14 to -$0.13 [10] - For the next fiscal year, two estimates have been revised upwards with no downward revisions [10] Conclusion - Given the strong momentum indicators and positive earnings outlook, KRMD is positioned as a promising investment opportunity [12]

Financial Data and Key Metrics Changes - The company reported third quarter revenues of $8.2 million, representing a 17% increase year-over-year, marking the third consecutive quarter of double-digit revenue growth [9][31] - The ending cash balance was $8.8 million, reflecting a 60% reduction in year-to-date cash usage compared to the same period in 2023 [11][36] - Gross margins improved to 63.4%, a 140 basis point increase year-over-year, driven by improved margins from non-recurring engineering services and an increase in average selling prices [10][35] Business Line Data and Key Metrics Changes - Domestic core revenues reached $6.4 million, showing a 12% year-over-year growth, while international core business grew 5% year-over-year, with a significant 38% growth year-to-date [32][33] - Novel Therapies revenue totaled $600,000, representing a 276% increase year-over-year, driven by progress in collaborations and strong product sales for clinical trials [34][18] Market Data and Key Metrics Changes - The domestic core business outpaced the overall SCIG market, which grew in the high single-digit range for the seventh consecutive quarter [13][64] - International growth, excluding residual effects from prior stocking orders, would have normalized to about 25% [15] Company Strategy and Development Direction - The company is focused on protecting and growing its domestic core SCIG business, expanding internationally, and broadening its relevance with Novel Therapies [12] - The company anticipates a 510(k) submission for its next-generation device in mid-2025, which is expected to have no material impact on 2025 revenues [14][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow breakeven in the fourth quarter and expects a strong end to 2024 [41][46] - The company is raising its revenue guidance for the second consecutive quarter, now targeting a range of $32.75 million to $33.25 million for the year [42][43] Other Important Information - The company has zero debt and access to a $10 million long-term credit facility for potential strategic investments [39] - The company is seeing strong underlying demand in the SCIG market, with increasing patient diagnoses and a shift towards subcutaneous therapy [64] Q&A Session Summary Question: Insights on the next-generation pump delay - Management clarified that the delay was related to consumables, with the new pump expected to launch in early 2025, and they do not foresee a material impact on revenues [49][50] Question: Sales reps and territories status - The company has expanded its commercial sales force in the U.S. to five people and works with 26 distributors internationally [51][52] Question: 2025 growth drivers - Management refrained from providing specific numbers for 2025 but highlighted strong growth in the U.S. core business, international expansion, and consistency in Novel Therapies revenues as key drivers [55][57] Question: Updates on 510(k) filings and SCIG market commentary - The company anticipates concurrent filings for two drugs and a new device by mid-2025, with a positive outlook on the SCIG market growth [61][64] Question: Prefilled syringe adoption and commercialization in Japan - Prefilled syringe adoption is at about 30%, and the company is making progress in Japan, expecting sales to begin early in 2025 [66][68]

KORU Medical Systems Inc. (KRMD) came out with a quarterly loss of $0.03 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.03 per share a year ago. These figures are adjusted for nonrecurring items. A quarter ago, it was expected that this company would post a loss of $0.04 per share when it actually produced a loss of $0.02, delivering a surprise of 50%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. KORU Medical Systems Inc., whic ...

KORU Medical Systems Q3 2024 Earnings Call November 13, 2024 1 Forward-Looking Statements 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 the existence and timing of potential drug launches, the success and timing of our novel therapies collaborations, our future financial performance (including but not limited t ...

Financial Performance - The company reported net revenues of $8.2 million for Q3 2024, a 16.8% increase from $7.0 million in Q3 2023, driven by a 11.7% growth in domestic core and a 275.6% increase in novel therapies[64]. - Gross profit for Q3 2024 was $5.2 million, up 19.4% from $4.3 million in Q3 2023, with a gross margin of 63.4%, compared to 62.0% in the prior year[65]. - Operating expenses for Q3 2024 increased to $6.9 million, a 12.3% rise from $6.1 million in Q3 2023, primarily due to higher selling, general, and administrative expenses[66]. - The company reported a net loss of $1.58 million for Q3 2024, compared to a net loss of $1.37 million in Q3 2023, reflecting an increase in operating expenses[72]. - For the nine months ended September 30, 2024, total net revenues reached $24.8 million, a 16.3% increase from $21.3 million in the same period in 2023[73]. - Gross profit increased by $3.4 million, or 27.4%, to $15.8 million for the nine months ended September 30, 2024, compared to $12.4 million in the same period in 2023[75]. - Net loss decreased by $1.8 million to $4.5 million for the nine months ended September 30, 2024, representing a 28.2% improvement from a net loss of $6.3 million in the same period in 2023[78]. Revenue Breakdown - Domestic core revenues for the nine months ended September 30, 2024, were $18.6 million, a 9.9% increase from $16.9 million in the prior year[73]. - International core revenues increased by 38.4% to $4.5 million for the nine months ended September 30, 2024, driven by higher consumable and pump volumes[73]. - Novel therapies revenues for the nine months ended September 30, 2024, increased by 46.3% to $1.7 million, attributed to Phase III clinical trial orders and milestone completions[73]. - Koru Medical Systems reported a revenue increase of 15% year-over-year, reaching $12 million for the quarter[94]. - Koru Medical Systems anticipates a revenue guidance of $50 million for the upcoming fiscal year, representing a 25% increase compared to the previous year[94]. Operational Efficiency - The company’s gross margin for the nine months ended September 30, 2024, was not specified but reflects overall growth in gross profit driven by increased sales[74]. - Gross margin improved to 63.6% in the first nine months of 2024, up from 58.0% in the same prior year period, driven by increased manufacturing efficiencies[75]. - Koru Medical Systems reported a gross margin of 60%, reflecting improved operational efficiencies[94]. Expenses and Cash Flow - Total operating expenses rose by $0.2 million, or 0.9%, to $20.6 million for the nine months ended September 30, 2024, compared to $20.4 million in the same period in 2023[76]. - Cash on hand was $8.8 million as of September 30, 2024, with expectations that it will be sufficient to meet requirements for at least the next twelve months[79]. - Net cash used in operating activities was $1.3 million for the nine months ended September 30, 2024, a significant decrease from $6.0 million in the same period in 2023[84]. - Net cash used in investing activities was $1.4 million for the nine months ended September 30, 2024, primarily for capital expenditures related to new consumables production lines[86]. Future Outlook and Strategy - The company continues to face uncertainties related to global health crises, inflation, and regulatory compliance, which may impact future performance[60]. - The company plans to continue investing in research and development and manufacturing equipment to support future growth and product quality[79]. - Future capital requirements may vary and could necessitate drawing on credit facilities or raising additional capital[81]. - Koru Medical Systems is investing $3 million in R&D for new product development, focusing on innovative medical delivery systems[94]. - Koru Medical Systems plans to expand its market presence in Europe, targeting a 30% increase in sales in that region over the next year[94]. - The company is exploring potential acquisition opportunities to enhance its product portfolio and market reach[94]. - The company has launched a new product line that is expected to contribute an additional $5 million in revenue over the next two quarters[94]. - The company is implementing a new marketing strategy aimed at increasing brand awareness, with a budget allocation of $1 million for the next quarter[94].

Financial Performance - Third quarter 2024 net revenues were $8.2 million, a 17% increase compared to the prior year period[2] - Core business growth (U.S. and International) was 11%, while novel therapies growth reached 276% over the prior year[2] - Gross profit for Q3 2024 was $5.2 million, a 19% increase year-over-year, with a gross margin of 63.4%, up 140 basis points[4] - Full year 2024 net revenue guidance raised to $32.75 - $33.25 million, representing growth of 15% - 17% over the prior year[7] - Full year 2024 gross margin guidance increased to 62% - 63%, an improvement of 340 - 440 basis points over the prior year[7] - Novel therapies revenues for Q3 2024 were $0.6 million, a 275.6% increase year-over-year, driven by clinical trial orders[3] - Net revenues for the three months ended September 30, 2024, were $8,179,977, representing a 16.8% increase from $7,003,198 in the same period of 2023[14] - Gross profit for the nine months ended September 30, 2024, was $15,769,038, up 27.0% from $12,377,336 in the prior year[14] Expenses and Losses - Total operating expenses for Q3 2024 were $6.9 million, a 12.3% increase over the prior year, primarily due to new hires and bonus accruals[5] - Net loss for Q3 2024 was $1.6 million, compared to a net loss of $1.4 million in the prior year[6] - Total operating expenses for the nine months ended September 30, 2024, were $20,625,736, slightly up from $20,449,761 in the previous year[15] - The company reported a net loss of $(1,580,817) for the three months ended September 30, 2024, compared to $(1,368,262) in the same period of 2023[14] - The net operating loss for the nine months ended September 30, 2024, was $(4,856,698), an improvement from $(8,072,425) in the same period of 2023[14] Cash Flow and Assets - Year-to-date cash burn improved by 60% to $2.7 million, with an ending cash balance of $8.8 million[2] - Cash and cash equivalents at the end of the period were $8,806,310, down from $10,772,178 a year earlier, indicating a decrease of 18.2%[15] - The company experienced a net cash used in operating activities of $(1,259,333) for the nine months ended September 30, 2024, compared to $(5,989,358) in the same period of 2023, showing a significant improvement[15] - Total assets as of September 30, 2024, were $27.39 million, down from $28.46 million at the end of 2023[11] Equity and Valuation - Total stockholders' equity decreased to $17,733,480 as of September 30, 2024, down from $20,353,771 at the end of 2023, reflecting a decline of 12.9%[13] - A deferred tax asset valuation allowance of $0.3 million was excluded from the third quarter ended 2024, while no allowance was necessary in the third quarter ended 2023[18] Research and Development - Research and development expenses for the three months ended September 30, 2024, were $1,533,845, a 18.6% increase from $1,293,256 in the same period of 2023[14] Earnings Per Share - Reported diluted earnings per share (EPS) for September 2024 was $(0.03), compared to $(0.10) in September 2023[17] - Non-GAAP adjusted diluted EPS for September 2024 was $(0.01), down from $(0.05) in September 2023[17] Other Financial Metrics - Non-GAAP adjusted EBITDA for the nine months ended September 30, 2024, was $(1,747,407), an improvement from $(5,067,749) in the same period of 2023[16] - The company incurred reorganization charges related to leadership team severance expenses in 2024, impacting non-GAAP measures[19] - Stock-based compensation expense was recorded, with non-cash compensation expected to recur in future periods[20]