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].

Core Insights - Sustained outperformance in MedTech requires structural demand drivers, improving execution, and clear earnings visibility rather than just short-term market rallies [2][6] - A select group of MedTech stocks, including TransMedics (TMDX), KORU Medical Systems (KRMD), and Cardinal Health (CAH), have significantly outperformed the S&P 500, which rose 19.3% over the past year [3][8] TransMedics (TMDX) - TMDX shares increased by 89.8% over the past year, driven by the adoption of its Organ Care System (OCS) and the expansion of its National OCS Program (NOP) [7][10] - The company reported revenues of $143.8 million in Q3 2025, reflecting a 32% year-over-year growth, with service revenues rising 35% [9][10] - The Zacks Consensus Estimate for 2026 sales is $723.8 million, indicating approximately 20.5% growth, with plans for European expansion [10][11] KORU Medical Systems (KRMD) - KRMD achieved a 45.5% stock growth over the past year, with Q3 2025 revenues of $10.4 million, marking a 27% year-over-year increase [13][15] - Core SCIg revenues grew about 30%, supported by international expansion and market share gains, despite a dip in U.S. revenues due to inventory adjustments [14][15] - The Zacks Consensus Estimate for 2026 sales is $49 million, implying 20.2% growth, with ongoing advancements in non-Ig drug collaborations [15][16] Cardinal Health (CAH) - CAH stock surged by 35.3% over the past year, with Q1 fiscal 2026 revenues of $64 billion, up 22% year-over-year, and earnings per share of $2.55, representing 36% growth [18][20] - The Pharmaceutical and Specialty Solutions segment led performance, with 23% revenue growth and 26% profit growth [19][20] - Management raised full-year fiscal 2026 earnings per share guidance to $9.65-$9.85, indicating 17-20% growth, while also returning $500 million to shareholders [20][21]

Core Insights - KORU Medical Systems, Inc. (KRMD) has submitted a 510(k) premarket notification to the FDA for its FreedomEDGE infusion system to deliver PHESGO, a breast cancer treatment, subcutaneously instead of intravenously, marking a significant regulatory and strategic milestone for the company [2][5] Company Developments - The FDA clearance submission for FreedomEDGE aligns with KRMD's long-term growth strategy to transition oncology care from intravenous to subcutaneous drug delivery, potentially improving efficiency for infusion centers and easing the workload for nurses [3][7] - The successful clearance and commercialization of the FreedomEDGE system could expand KRMD's addressable market by establishing a subcutaneous delivery platform for oncology biologics, moving beyond its traditional immunology treatments [5][8] - The FreedomEDGE system aims to simplify the treatment process for infusion centers by addressing challenges such as complicated treatment steps and time constraints, thereby enhancing patient comfort and operational efficiency [9][10] Market Context - The subcutaneous drug delivery devices market is projected to be valued at $33.56 billion by 2025, with a CAGR of 7.62% through 2034, driven by the increasing prevalence of chronic diseases and the adoption of subcutaneous delivery devices [11]

Core Viewpoint - KORU Medical Systems, Inc. has appointed Eric Schiller as Chief Technology Officer, effective December 29, 2025, bringing over 25 years of leadership experience in research and development [1] Company Overview - KORU Medical is a leading medical technology company focused on developing, manufacturing, and commercializing innovative and patient-centric large volume subcutaneous infusion solutions [1] Leadership Change - The appointment of Eric Schiller is expected to enhance the company's technological capabilities and innovation in the medical technology sector [1] Future Outlook - The company aims to leverage Schiller's extensive experience to drive advancements in its product offerings and improve patient care solutions [1]

KORU Medical Systems FY Conference Summary Company Overview - **Company**: KORU Medical Systems (NasdaqCM: KRMD) - **Industry**: Medical Technology (Med Tech) Key Points and Arguments 1. Growth Performance - KORU Medical achieved over 20% growth year-to-date in 2025, driven primarily by international expansion and a strong U.S. market performance [2][3][4] - The international business more than doubled, with significant contributions from prefill expansion technology [2][4] 2. U.S. Market Dynamics - The U.S. business is growing at approximately 10-15%, supported by an 8-10% growth in the primary immune deficiency patient population [3][8] - The company anticipates adding four new drugs to its label, which will further increase patient usage of its systems in early to mid-2026 [3][4] 3. New Product Launches - KORU plans to file for a new pump in the first half of 2026, which is expected to enhance market share and average selling price (ASP) opportunities [6][24] - A pilot study in oncology clinics showed a 97% preference for KORU's platform among nurses, with a market launch anticipated in the second half of 2026 [4][24] 4. Market Growth Projections - The overall U.S. market for immunoglobulin therapy is projected to grow at 8-10%, with only 20% of the population currently on subcutaneous therapy, indicating significant growth potential [8][9] - The company expects to see a doubling of the patient opportunity if secondary immunodeficiency treatments receive reimbursement in the U.S. [9][11] 5. Competitive Landscape - KORU's primary competitor in the U.S. is a privately held company called EMED, which offers mechanical pumps at lower prices [16][19] - In Europe, KORU is gaining market share due to the incompatibility of existing electronic pumps with prefill technology [17][19] 6. Revenue Growth Strategy - KORU anticipates generating an additional $8 million in revenue through U.S. and international growth, as well as new drug launches [20][21] - The company expects international segment growth to exceed 30% [21] 7. Gross Margin Outlook - Current gross margins are projected between 61-63%, with expectations to improve to over 65% in the long term through new product launches and international expansion [31][46] - The company is focused on capital allocation towards gross margin improvement while maintaining top-line growth [46][49] 8. Cash Flow and Capital Allocation - KORU achieved positive cash flow and EBITDA, marking a significant milestone [49] - The company is exploring PFT collaborations to increase market share and revenue potential [50] 9. Regulatory and Market Entry Considerations - KORU does not anticipate significant disruptions from government shutdowns affecting FDA discussions or timelines for new product approvals [53][58] - The company is proactively managing the transition to new products to avoid market pauses or destocking issues [60] Additional Important Insights - The company is seeing a fivefold increase in the number of drugs in development for subcutaneous therapy compared to five years ago, indicating a growing market [18] - KORU's pricing strategy is expected to reflect a lift due to new product launches, with the new pump priced competitively against electronic pumps [41][42]

Core Insights - Several small-cap healthcare and biotech companies experienced significant price increases in after-hours trading following earnings updates or upcoming financial disclosures [1] Company Summaries - MacroGenics, Inc. (MGNX) saw a 10.2% rise to $1.62 after hours, recovering from a 3.29% decline during the regular session. The company reported a third-quarter net income of $16.8 million, or $0.27 per share, down from $56.3 million, or $0.90 per share, year-over-year. Revenue fell to $72.8 million from $110.7 million [2] - SELLAS Life Sciences Group, Inc. (SLS) advanced 9.4% to $1.63 in after-hours trading. The company narrowed its quarterly net loss to $6.8 million, or $0.06 per share, compared to $7.1 million, or $0.10 per share, in the prior-year quarter. As of September 30, 2025, SELLAS reported cash and equivalents of approximately $44.3 million [3] - Standard BioTools Inc. (LAB) increased by 4.24% to $1.23 after hours, despite no official press releases or updates on Wednesday. The stock had closed slightly lower during the regular session [4] - KORU Medical Systems, Inc. (KRMD) gained 8.47% to $4.10 after hours, following a 1.34% increase earlier in the day. The company reported a narrower net loss of $0.8 million for the third quarter, compared to $1.6 million in the prior-year period. Revenue rose 27.2% to $10.4 million. KORU also raised its full-year revenue guidance to a range of $40.5 million - $41.0 million and reaffirmed its gross margin outlook of 61%-63% [5] - Hyperfine, Inc. (HYPR) climbed 8.18% to $1.19 after hours. No new announcements were made on Wednesday, but the company is scheduled to release its third-quarter results on Thursday, with analysts anticipating a loss of $0.10 per share and revenue of $3.52 million [6] - Wave Life Sciences Ltd. (WVE) added 5.68% to reach $7.35 in after-hours trading. The company reported a third-quarter net loss of $53.9 million, an improvement from $61.8 million in the prior-year quarter. Revenue for the period was $7.6 million, compared to a negative revenue figure of ($7.7) million last year [7]

Core Insights - KORU Medical Systems, Inc. reported a quarterly loss of $0.02 per share, better than the Zacks Consensus Estimate of a loss of $0.03, marking an earnings surprise of +33.33% [1] - The company achieved revenues of $10.4 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 7.07% and showing a year-over-year increase from $8.18 million [2] - The stock has underperformed the market, losing approximately 3.1% year-to-date compared to the S&P 500's gain of 16.4% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.02 on revenues of $10.52 million, and for the current fiscal year, it is -$0.08 on revenues of $40.1 million [7] - The estimate revisions trend for KORU Medical Systems was mixed prior to the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] Industry Context - The Medical Info Systems industry, to which KORU Medical Systems belongs, is currently ranked in the top 20% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Another company in the same industry, Phreesia, is expected to report a quarterly loss of $0.01 per share, reflecting a year-over-year change of +96%, with revenues projected at $120.19 million, up 12.5% from the previous year [9][10]

Financial Data and Key Metrics Changes - KORU Medical Systems achieved revenue of over $10 million for the second consecutive quarter, representing a 27% year-over-year growth, driven by a 30% increase in the core subcutaneous immunoglobulin (SCIG) business [4][16] - Gross profit grew by 21% year-over-year, with a gross margin of 60.2%, a decrease of 320 basis points from the prior year due to higher manufacturing costs and geographical customer mix [5][18] - The company raised its full-year revenue guidance to $40.5-$41 million, indicating a growth of approximately 20%-22% [5][21] Business Line Data and Key Metrics Changes - The SCIG business grew by 30%, supported by international expansion and strong patient growth, while the U.S. SCIG business represented the largest recurring revenue base [4][6] - International revenue grew by 230%, with the company increasing its international market share from approximately 10% to 15%-20% in the underlying $60 million OUS SCIG market [16][8] - The company has nine active collaborations with potential new drugs expected to be added to its system by the end of 2026, with a commercial potential of up to $10 million by the end of 2028 [11][12] Market Data and Key Metrics Changes - The SCIG market is projected to grow approximately 9% annually over the next five years, outpacing the IVIG segment, with significant headroom for expansion due to increasing diagnoses of secondary immunodeficiency [6][7] - The oncology infusion consumables market is projected to grow from approximately $60 million in 2025 to $138 million by 2030, indicating a significant opportunity for KORU [15] Company Strategy and Development Direction - KORU is focused on expanding its pipeline and broadening its label through new collaborations, including two new PFT collaborations announced during the quarter [5][10] - The company aims to penetrate oncology infusion centers, with a successful U.S.-based oncology study validating its value proposition in this market [5][14] - KORU's strategy includes partnering with pharmaceutical companies to accelerate adoption and growth in the subcutaneous market [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the business's momentum, highlighting robust growth in both U.S. and international markets, and reaffirmed guidance for gross margins and cash flow from operations [5][22] - The company anticipates continued growth driven by international opportunities and a strong SCIG market, with expectations to end the year with at least $8.2 million in cash [21][22] Other Important Information - The company reported a positive adjusted EBITDA and generated positive cash flow, reflecting disciplined operating expense management [5][19] - KORU's cash usage has decreased to $1.1 million year-to-date, representing a 60% decrease from the previous year [20] Q&A Session Summary Question: Feedback on oncology pilot study and reimbursement model - Management reported high satisfaction rates among nurses and patients, with 70% of nurses able to multitask during administration, and confirmed that existing reimbursement codes cover the administration of drugs using a pump [26][28] Question: Guidance for Q4 and 2026 outlook - Management indicated a strong acceleration in revenues expected for the second half of the year, with a split of approximately 70% U.S. business and 23-24% international business for Q4 [29][30] - For 2026, management is optimistic about growth opportunities, indicating a number starting with a two for revenue guidance [31] Question: Opportunities in the EU and market dynamics - Management highlighted significant growth potential in the EU driven by prefilled conversions, estimating a $10 million-$20 million opportunity overall [32][33] Question: Gross margin expectations - Management aims to maintain gross margins in the range of 61-63% while working towards a long-term goal of 65% [36][37] Question: Japan market entry and growth cadence - Management reported initial sales in Japan and indicated that while it remains a growth driver, the broader prefill opportunity is prioritized [39][43]

Financial Performance - KORU Medical Systems achieved record Q3 revenues of $10.4 million, a 27% increase compared to the prior year period, driven by the Core SCIg business[6, 20] - The company reported a net loss of $0.8 million but achieved a positive adjusted EBITDA of $0.09 million and generated $0.4 million in cash during Q3[6] - KORU Medical Systems is raising its 2025 revenue guidance to $40.5-$41.0 million, representing a growth of 20%-22%, and reiterating a gross margin of 61%-63%[6] Market and Growth Opportunities - The US SCIg market is forecasted to grow at 9%+ through 2029[8] - KORU Medical Systems has grown its international market share from approximately 10% to approximately 15-20% since 2024, with significant room for further penetration in the ~$60 million global SCIg market[11] Pipeline and Outlook - KORU Medical Systems has 7 collaborations/opportunities with Ig manufacturers, targeting a $450 million Total Ig TAM (Total Addressable Market)[12] - The company plans for 4 new drug additions on the KORU Freedom Infusion System by 2026, expanding internationally and pursuing drug labels independently, targeting a $1.8 billion Total TAM[13] - KORU Medical Systems is progressing with its strategic oncology infusion market entry initiative, with an anticipated market entry in 4Q25/1Q26, targeting a ~$138 million 2025 TAM[18, 19]

Financial Performance - For the three months ended September 30, 2025, net revenues increased to $10,402,163, representing a 27.2% growth compared to $8,179,977 for the same period in 2024[12] - Gross profit for the three months ended September 30, 2025, was $6,264,571, up from $5,185,991 in the prior year, indicating a gross margin improvement[12] - The net loss for the three months ended September 30, 2025, was $777,966, a decrease from the net loss of $1,580,817 in the prior year, showing improved financial performance[12] - For the nine months ended September 30, 2025, the net loss was $2,151,070, a decrease of 52.2% compared to a net loss of $4,505,490 for the same period in 2024[15] - Net loss for Q3 2025 decreased to $0.8 million, a 50.8% improvement compared to a net loss of $1.6 million in Q3 2024[85] - Net loss decreased by $2.4 million to $2.2 million, representing a 52.3% improvement compared to the prior year[92] Revenue Breakdown - Total revenue for the three months ended September 30, 2025, was $10,402,163, an increase of 27.3% compared to $8,179,977 for the same period in 2024[41] - Domestic revenue for the three months ended September 30, 2025, was $6,706,639, a decrease of 4.5% from $7,022,811 in 2024, while international revenue increased significantly to $3,695,524 from $1,157,166[41] - For the nine months ended September 30, 2025, total revenue reached $30,232,038, up 21.5% from $24,807,864 in 2024[41] - Domestic core revenues decreased by 5.0% to $6.1 million, while international core revenues surged by 229.6% to $3.7 million[79] - Domestic core revenues rose by 8.6% to $20.1 million, while international core revenues surged by 82.9% to $8.3 million[86] Expenses and Costs - Operating expenses for the three months ended September 30, 2025, totaled $7,132,250, compared to $6,889,288 in the same period of 2024, reflecting a 3.5% increase[12] - Selling, general and administrative expenses increased by $1.5 million, or 9.7%, primarily due to higher compensation and legal fees[89] - Research and development expenses decreased by $0.9 million, or 21.7%, due to lower project spending and severance-related expenses[90] - The company incurred tariff-related charges of $0.1 million during Q3 2025, expecting a gross margin impact of less than 100 basis points annually[77] Assets and Liabilities - Total current assets as of September 30, 2025, were $19,419,296, slightly up from $19,132,410 as of December 31, 2024[9] - Cash and cash equivalents decreased to $8,464,019 as of September 30, 2025, down from $9,580,947 at the end of 2024[9] - Total liabilities as of September 30, 2025, were $10,638,701, up from $10,404,836 as of December 31, 2024, reflecting an increase in financial obligations[10] - Total stockholders' equity decreased to $16,464,825 as of September 30, 2025, from $16,813,679 as of December 31, 2024, indicating a decline in shareholder value[10] - Total stockholders' equity as of September 30, 2025, was $16,464,825, a decrease from $20,353,771 at the end of 2024[17] Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2025, was $632,351, a reduction from $1,259,333 in the prior year[15] - The company had a net decrease in cash and cash equivalents of $1,116,928 for the nine months ended September 30, 2025, compared to a decrease of $2,675,930 in the same period of 2024[15] - Cash on hand was approximately $8.5 million as of September 30, 2025, with inventory increasing by $1.6 million to $4.4 million[93][94] - Net cash used in investing activities was $0.5 million, primarily for manufacturing equipment purchases[100] - Net cash gained from financing activities was $0.04 million, mainly from employee stock option exercises[101] Stock-Based Compensation - The company reported stock-based compensation expense of $1,740,727 for the nine months ended September 30, 2025, compared to $1,924,131 in the same period of 2024[15] - Total stock-based compensation expense for time-vested stock options was $775,966 for the nine months ended September 30, 2025[50] - The company issued 183,881 shares of stock-based compensation during the nine months ended September 30, 2025[17] - The company has $3,210,584 of unrecognized compensation cost related to unvested employee restricted stock awards, RSUs, and PSUs, expected to be recognized over a weighted-average period of 26 months[57] Loans and Credit Facilities - The company entered into a loan agreement providing for a $5,000,000 revolving credit facility and a $5,000,000 term loan facility, with no outstanding borrowings as of September 30, 2025[58] Asset Management - The company has recognized total property and equipment of $8,283,277 as of September 30, 2025, an increase from $7,763,422 as of December 31, 2024[44] - The company did not record any impairment losses for the three or nine months ended September 30, 2025, indicating stable asset performance[43] Lease Obligations - Operating lease costs for the three months ended September 30, 2025, were $130,785, compared to $116,772 in 2024, reflecting an increase in lease expenses[60] - The weighted average remaining lease term for operating leases decreased from 5.1 years in 2024 to 4.3 years in 2025[62] - Total undiscounted lease payments amounted to $3.6 billion, with total lease liabilities at $3.1 billion for operating leases[62]