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]

Financial Performance - KORU Medical Systems Inc. reported a quarterly loss of $0.03 per share, consistent with the Zacks Consensus Estimate, compared to a loss of $0.03 per share a year ago [1] - The company posted revenues of $8.18 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 6.86%, and up from $7 million in the same quarter last year [2] - Over the last four quarters, KORU Medical has surpassed consensus EPS estimates three times and topped consensus revenue estimates four times [2][3] Stock Performance - KORU Medical shares have increased by approximately 21% since the beginning of the year, while the S&P 500 has gained 25.5% [3] - The current Zacks Rank for KORU Medical is 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.04 on revenues of $8.01 million, and for the current fiscal year, it is -$0.13 on revenues of $32.28 million [7] - The estimate revisions trend for KORU Medical is mixed, and future earnings expectations will depend on management's commentary during the earnings call [3][4] Industry Context - The Medical - Instruments industry, to which KORU Medical belongs, is currently ranked in the top 26% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

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]

Financial Data and Key Metrics Changes - Second-quarter revenues reached $8.4 million, representing a 22% increase compared to the same period in 2023 [5][18] - Gross margin improved to 65%, an increase of 890 basis points year-over-year, marking the fourth consecutive quarter with margins above 60% [19][20] - Ending cash balance as of June 30 was $10.5 million, with cash usage of $300,000 in the quarter, an improvement of $1.9 million over the prior year [20][21] Business Line Data and Key Metrics Changes - Core business revenues grew 20%, driven by SCIG market growth and geographic expansion [5] - Domestic core revenue increased by 14% to $6.2 million, while international core business grew 46% year-over-year to $1.6 million [18] - Novel Therapies revenue was $600,000, a 50% improvement compared to the prior year, driven by clinical trial orders [19] Market Data and Key Metrics Changes - The U.S. SCIg market is projected to grow in the mid to high single digits, with KORU holding a leadership position [12] - International sales saw a strong performance with 46% growth, excluding distributor stocking, normalized growth was approximately 20% [9][18] - The overall SCIg market recorded six consecutive quarters of growth, indicating an increase in new patient starts [9] Company Strategy and Development Direction - The company is focused on achieving cash flow breakeven by the fourth quarter of 2024 and has raised its full-year revenue and gross margin guidance [6][22] - Strategic growth pillars include protecting and growing the core domestic SCIg business, expanding internationally, and broadening relevance through Novel Therapies [8][16] - The company aims to leverage partnerships with pharmaceutical companies and distributors to enhance market penetration and drive growth [15][50] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow breakeven and highlighted strong momentum in both domestic and international markets [6][26] - The approval of expanded labels for SCIg drugs is expected to facilitate easier patient transitions to SCIg therapy, potentially increasing market share [13][35] - The company anticipates continued growth in the Novel Therapies pipeline, with multiple drugs approaching approval [16][25] Other Important Information - The company received regulatory clearance for the FreedomEdge infusion system in Japan, marking a significant milestone for international expansion [6][10] - A new organizational structure was announced, promoting Chris Pazdan to COO to enhance operational focus and alignment [7] Q&A Session Summary Question: What is the current status of prefilled syringe penetration? - Management indicated that CSL has launched their prefilled syringe platform, which is compatible with KORU devices, and market uptake is strengthening [27] Question: Will KORU pursue CUVITRU clearance in other geographies? - Management confirmed that they are cleared for CUVITRU in the U.S. and Japan, with plans to seek further approvals in Latin America and Asia Pacific [31] Question: How will the expanded label for XEMBIFY impact the business? - Management noted that the new label allows patients to start directly on SCIg, which is expected to simplify the transition and potentially increase market share [34] Question: What is the strategy for entering the Japanese market? - Management is working on establishing distributor relationships and anticipates that Japan will become a significant market over time, primarily focusing on consumables [36] Question: What is driving the outperformance in the first half of the year? - Management attributed growth to a combination of new patient starts, strong performance in both domestic and international markets, and business development efforts in Novel Therapies [40] Question: What are the commercialization plans for new Novel Therapies? - Management emphasized the importance of partnerships with pharmaceutical companies for launch plans and targeting specific clinics for new drug introductions [47] Question: Any updates on the potential expansion into Canada? - Management is in discussions with pharmaceutical partners and expects to launch in Canada in early 2025 [49]

KORU Medical Systems Inc. (KRMD) came out with a quarterly loss of $0.02 per share versus the Zacks Consensus Estimate of a loss of $0.04. This compares to loss of $0.05 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 50%. 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 su ...

EXHIBIT 99.1 KORU MEDICAL SYSTEMS, INC. ANNOUNCES 2024 Q2 FINANCIAL RESULTS, A RECORD QUARTER WITH 22% REVENUE GROWTH; RAISES FULL YEAR 2024 GUIDANCE MAHWAH, NJ – August 7, 2024 – 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, 2024 a ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 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. (Exact name of registrant as specified in its charter) Delaware 13-3044880 ...

KORU Medical Systems, Inc. (NASDAQ:KRMD) Q1 2024 Earnings Conference Call May 1, 2024 4:30 PM ET Company Participants Louisa Smith - The Gilmartin Group Linda Tharby - President & Chief Executive Officer Tom Adams - Chief Financial Officer Conference Call Participants Frank Takkinen - Lake Street Capital Markets Chase Knickerbocker - Craig-Hallum William Wood - B. Riley Securities Caitlin Cronin - Canaccord Genuity Joseph Downing - Piper Sandler Operator Greetings and welcome to the KORU Medical Systems' Fi ...