Key Takeaways KRMD gains EU MDR certification for the Freedom60 pump and FreedomEDGE system, enabling wider EU rollout.Certification supports rising adoption of prefilled syringes in SCIg therapy and home infusion use.Approval boosts KRMD's growth outlook via recurring consumables demand and market expansion.KORU Medical Systems, Inc. (KRMD) recently announced that its Freedom60 Infusion Pump — along with an adapter designed for 50 mL prefilled syringes — has secured certification under the European Union M ...

分组1 - KORU Medical Systems, Inc. reported a quarterly loss of $0.01 per share, better than the Zacks Consensus Estimate of a loss of $0.02, representing an earnings surprise of +50.00% [1] - The company posted revenues of $10.9 million for the quarter ended December 2025, surpassing the Zacks Consensus Estimate by 0.05% and showing an increase from $8.84 million year-over-year [2] - KORU Medical Systems has surpassed consensus EPS estimates three times over the last four quarters and topped consensus revenue estimates four times in the same period [2] 分组2 - The stock has underperformed, losing about 22.4% since the beginning of the year, compared to a 1% decline in the S&P 500 [3] - The company's earnings outlook is crucial for investors, with current consensus EPS estimates at -$0.01 on $11.47 million in revenues for the coming quarter and -$0.01 on $49.4 million in revenues for the current fiscal year [7] - The Zacks Industry Rank indicates that the Medical Info Systems sector is in the bottom 41% of over 250 Zacks industries, suggesting potential challenges for stock performance [8]

Financial Data and Key Metrics Changes - Revenue for Q4 2025 was $10.9 million, marking a 23% year-over-year growth, and full-year revenue reached $41.1 million, a 22% increase from $33.6 million in 2024 [9][22][23] - The company achieved positive cash flow from operations for both Q3 and Q4, and for the full year, with cash ending at $8.9 million [11][25] - Gross margin for the full year was 62.3%, with a slight reduction of 30 basis points year-over-year due to higher material costs [24][25] Business Line Data and Key Metrics Changes - Domestic core business grew 18% year-over-year in Q4, while international core business saw a significant growth of 71% [9][22] - The PST business decreased by 30% year-over-year, attributed to the timing of contract milestones [22][23] - The recurring global patient base increased by approximately 20% to 59,000 chronic SCIG patients [14] Market Data and Key Metrics Changes - The SCIG market grew approximately 10% in 2025, with KORU's domestic and international core businesses outperforming this growth [9][12] - In Europe, KORU's market share increased from 10% to 20%, with a total addressable market of approximately $50 million [16][35] - The company anticipates significant growth opportunities in the oncology market with the entry of new drugs [29][68] Company Strategy and Development Direction - KORU is focused on three strategic pillars: protecting and growing the core domestic business, expanding internationally, and enabling more drugs to reach more patients [12][62] - The company is diversifying its business with new drug collaborations and entering new therapeutic areas, including oncology [10][15] - The shift from hospital to home care is seen as a significant opportunity for large volume subcutaneous infusion [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, projecting 2026 revenue guidance of $47.5 million to $50 million, representing a growth of 15%-22% [11][26] - The company is prepared for geopolitical risks and anticipates a ramp-up in revenue in the second half of 2026 [27] - Management highlighted the importance of operational excellence programs to maintain margins and manage costs effectively [28] Other Important Information - Linda Tharby announced her retirement effective June 30, 2026, with Adam Kalbermatten set to succeed her as CEO [4][5] - The company received EU MDR certification for the Freedom60 system, enabling the conversion from vials to prefilled syringes [10][16] Q&A Session Summary Question: What does the Freedom60 product do for the market? - The Freedom60 product opens up a $50 million total addressable market in Europe, with significant share gain potential [35][36] Question: Can you provide more detail on the guidance composition? - The guidance range is influenced by the speed of prefill conversions and new drug approvals, with potential impacts from geopolitical factors [64][66] Question: How is the company positioned in Japan? - Japan is seen as a significant market opportunity, with both pumps and consumables approved, and potential growth driven by prefilled syringes [68][70]

Financial Data and Key Metrics Changes - Revenue for Q4 2025 was $10.9 million, marking a 23% year-over-year growth, and full-year revenue reached $41.1 million, a 22% increase from $33.6 million in 2024 [9][22][23] - The company achieved positive cash flow from operations for the full year, with cash ending at $8.9 million, reflecting a cash usage of $700,000 [11][25] - Gross margin for the full year was 62.3%, with a slight reduction of 30 basis points year-over-year due to higher material costs [24][25] Business Line Data and Key Metrics Changes - Domestic core business grew 18% year-over-year in Q4, while international core business saw a significant growth of 71% [9][22] - The PST business experienced a 30% decline year-over-year, attributed to the timing of contract milestones [22][23] Market Data and Key Metrics Changes - The domestic SCIG market grew approximately 10% in 2025, while KORU's domestic core business outperformed this with an 18% growth [9][22] - Internationally, KORU's market share in Europe increased from 10% to 20%, with an overall European SCIG pump and consumables market valued at approximately $50 million [16][36] Company Strategy and Development Direction - KORU is focused on expanding its core domestic business, increasing international presence, and enabling more drugs to reach patients [11][12] - The company aims to capture additional market share in the SCIG market, which is projected to grow at 8%-10% over the next five years [12][31] - New collaborations and drug approvals are expected to drive future growth, including entry into oncology markets [15][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, with 2026 revenue guidance set at $47.5 million to $50 million, representing a growth of 15%-22% [11][26] - The company is prepared for geopolitical risks and anticipates a ramp-up in revenue in the latter half of 2026 due to new product introductions and market expansions [27][66] Other Important Information - Linda Tharby announced her retirement effective June 13, 2026, with Adam Kalbermatten set to succeed her as CEO [4][5] - The company received EU MDR certification for the Freedom60 system, enabling further market penetration in Europe [10][30] Q&A Session Summary Question: What does the Freedom60 product do for the market? - The Freedom60 product opens up a $50 million total addressable market in Europe, with significant share gain potential [35] Question: Can you provide more detail on the guidance range? - The guidance range reflects potential faster prefill conversions and new drug approvals, with geopolitical factors also considered [65] Question: How is the company positioned in Japan? - Japan is seen as a significant market opportunity, with both pumps and consumables approved, and growth expected as prefilled syringes gain traction [70]

Financial Data and Key Metrics Changes - Revenue for Q4 2025 was $10.9 million, marking a 23% year-over-year growth, and full-year revenue reached $41.1 million, a 22% increase from $33.6 million in 2024 [20][22] - The company achieved positive cash flow from operations for both Q3 and Q4, and for the full year, with cash ending at $8.9 million [10][24] - Gross margin for the full year was 62.3%, with a slight reduction due to higher material costs and tariffs [23] Business Line Data and Key Metrics Changes - Domestic core business grew 18% year-over-year in Q4, while international core business saw an impressive growth of 71% [20][22] - The PST business decreased by 30% year-over-year due to milestone-based revenue recognition timing [21] - The recurring global patient base increased by approximately 20% to 59,000 patients [12] Market Data and Key Metrics Changes - The SCIG market grew approximately 10% in 2025, with KORU's domestic and international core businesses outperforming this growth [8][20] - In Europe, KORU's market share in the SCIG pump and consumables market increased from 10% in 2024 to 20% in 2025 [15] - The overall European SCIG market is valued at approximately $50 million, with significant growth potential as the market shifts from vial-based delivery to prefilled syringes [15][16] Company Strategy and Development Direction - KORU is focused on three strategic pillars: protecting and growing the core domestic business, expanding internationally, and enabling more drugs to reach more patients [10][31] - The company aims to diversify its business with new product developments and collaborations, including entry into oncology and nephrology markets [12][13] - KORU plans to leverage its strong position in the SCIG market, which is projected to grow at 8%-10% over the next five years [11][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, with 2026 revenue guidance set at $47.5 million to $50 million, representing a growth of 15%-22% [10][25] - The company is prepared for geopolitical risks and anticipates a ramp-up in revenue in the second half of 2026 as new products are introduced [26] - Management highlighted the importance of operational excellence programs to offset external cost pressures [27] Other Important Information - The CEO announced retirement effective June 30, 2026, with the Chief Commercial Officer set to succeed [4][5] - KORU received EU MDR certification for the Freedom60 system, enabling prefilled syringe compatibility, which is expected to enhance market penetration [9][29] Q&A Session Summary Question: What does the Freedom60 product do for the market? - The Freedom60 opens up a $50 million total addressable market in Europe, with significant share gain potential as the company moves from 10% to 20% market share [35] Question: Can you provide more detail on the guidance range? - The guidance range is influenced by the speed of prefill conversions and new drug approvals, with potential impacts from geopolitical factors [66] Question: What is the growth opportunity in Japan? - Japan is seen as a significant market with potential for half a million to a million-dollar opportunity as the market shifts towards home care [70]

KORU Medical Systems Q4 & FY 2025 Earnings Call March 12, 2026 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 perfor ...

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, 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) Delaware 13-3044880 (State or other ...

Core Viewpoint - KORU Medical Systems, Inc. (KRMD) is experiencing significant selling pressure, with an 18.1% decline over the past four weeks, but is now positioned for a potential trend reversal as it enters oversold territory, supported by analyst expectations of better earnings than previously predicted [1]. Group 1: Technical Indicators - The Relative Strength Index (RSI) is a momentum oscillator that indicates whether a stock is oversold, with readings below 30 typically signaling this condition [2]. - KRMD's current RSI reading is 28.55, suggesting that the heavy selling pressure may be exhausting itself, indicating a potential trend reversal [5]. Group 2: Fundamental Analysis - There is strong consensus among sell-side analysts that earnings estimates for KRMD have increased by 50% over the last 30 days, which often correlates with price appreciation in the near term [7]. - KRMD holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further indicating a potential turnaround [8].

Core Viewpoint - KORU Medical Systems, Inc. (KRMD) experienced a significant stock price increase of 5.6% due to positive investor sentiment following FDA clearance for its FreedomEDGE infusion system, which enhances the delivery of large-volume subcutaneous drugs [1][2]. Financial Performance - The company is projected to report a quarterly loss of $0.02 per share, reflecting a year-over-year improvement of 33.3%. Expected revenues are $10.89 million, representing a 23.2% increase from the same quarter last year [3]. - The consensus EPS estimate for KORU Medical Systems has remained stable over the past 30 days, indicating no recent revisions in earnings estimates, which typically correlate with stock price movements [4]. Industry Context - KORU Medical Systems is part of the Zacks Medical Info Systems industry, where Claritev Corporation (CTEV) also operates. CTEV's stock closed 2.3% higher but has seen a decline of 19.9% over the past month [4].

Financial Results Announcement - KORU Medical Systems, Inc. announced preliminary financial results for the fiscal quarter and year ended December 31, 2025[4]. - The results are based on current estimates and are subject to change pending completion of closing and review procedures[5]. - The press release detailing these results was issued on January 12, 2026[4].