MAHWAH, N.J.--(BUSINESS WIRE)--KORU Medical Systems, Inc. (NASDAQ: KRMD) ("KORU Medical†or the "Company†), a leading medical technology company focused on developing, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, today announced the appointment of Eric Schiller as Chief Technology Officer, effective December 29, 2025. Eric joins KORU Medical with more than 25 years of leadership experience across research & development,. ...

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]

KORU Medical Systems Q3 2025 Earnings Call November 12, 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 performa ...

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]

Revenue Performance - Total net revenues increased by $2.2 million, or 27.2%, to $10.4 million for Q3 2025 compared to $8.2 million in Q3 2024[4] - Domestic core revenues were $6.1 million, a decrease of 5.0% year-over-year, while international core revenues surged by 229.6% to $3.7 million[4] - Net revenues for the three months ended September 30, 2025, were $10,402,163, representing a 27.3% increase from $8,179,977 in the same period of 2024[21] Profitability - Gross profit rose by $1.1 million, or 20.8%, to $6.3 million, with a gross margin of 60.2%[6] - The reported net loss improved to $0.8 million, a 51% reduction from the prior year, with positive adjusted EBITDA of $0.09 million, a 121% improvement[5] - Gross profit for the nine months ended September 30, 2025, was $18,786,676, up 19.3% from $15,769,038 in 2024[21] - The net loss for the nine months ended September 30, 2025, was $2,151,070, a decrease of 52.2% from $4,505,490 in 2024[21] - GAAP Net Loss for Q3 2025 was $777,966, compared to a loss of $1,580,817 in Q3 2024[30] - Non-GAAP Adjusted EBITDA for Q3 2025 was $89,197, an improvement from a loss of $434,495 in Q3 2024[30] Expenses - Total operating expenses for Q3 2025 were $7.1 million, a 3.5% increase from the prior year, primarily due to higher compensation and legal fees[7] - Operating expenses for the three months ended September 30, 2025, totaled $7,132,250, an increase of 3.5% compared to $6,889,288 in 2024[21] - Research and development expenses for the nine months ended September 30, 2025, were $3,242,505, a decrease of 21.8% from $4,143,751 in 2024[21] Cash Position - Cash and cash equivalents stood at $8.5 million as of September 30, 2025, reflecting a cash generation of $0.4 million during the quarter[9] - Ending cash balance for the full year 2025 is projected to be greater than $8.2 million, with positive cash flow from operations[13] - Cash and cash equivalents at the end of the period were $8,464,019, down from $8,806,310 at the end of September 2024[23] - The company reported a net cash used in operating activities of $632,351 for the nine months ended September 30, 2025, compared to $1,259,333 in 2024[23] Shareholder Metrics - The basic and diluted net loss per share for the three months ended September 30, 2025, was $(0.02), compared to $(0.03) in the same period of 2024[21] - The weighted average number of common shares outstanding for the three months ended September 30, 2025, was 46,238,819, slightly up from 45,851,019 in 2024[21] - Reported Diluted Earnings Per Share for Q3 2025 was $(0.02), compared to $(0.03) in Q3 2024[30] - Non-GAAP Adjusted Diluted Earnings Per Share for Q3 2025 was $(0.00), an improvement from $(0.01) in Q3 2024[30] Future Outlook - The company raised its full-year 2025 revenue guidance to $40.5 - $41.0 million, indicating a year-over-year growth of 20% - 22%[5] - Gross margin is expected to improve in Q4 2025 despite a decrease from 63.4% in the prior year[6] - The company announced two new pharmaceutical collaborations aimed at expanding patient reach[3] Other Income and Expenses - The total other income for the three months ended September 30, 2025, was $89,563, down from $122,480 in 2024[21] - Stock-based Compensation Expense for Q3 2025 was $737,398, up from $634,608 in Q3 2024[30] - Depreciation and Amortization for Q3 2025 was $204,482, compared to $227,785 in Q3 2024[30] - Interest Income, Net for Q3 2025 was $(74,567), down from $(112,997) in Q3 2024[30] - Tax Expense (Refund) for Q3 2025 was $(150), with no tax expense recorded in Q3 2024[30]

Core Insights - Cirtec Medical has appointed Shar Matin as the new Chief Executive Officer, effective September 2, 2025, bringing over 25 years of experience in the medical technology sector [1][2] - Shar Matin previously served as CEO of Cordis, where he led significant transformations and acquisitions, demonstrating a strong track record in business scaling and innovation [2][3] - The Cirtec Board expressed gratitude to outgoing CEO Brian Highley for his leadership over the past decade, highlighting his role in transforming Cirtec into an industry leader [3] Company Overview - Cirtec Medical specializes in the design, development, and manufacturing of complex Class II and III medical devices, focusing on active implant systems and interventional devices [4] - The company has extensive in-house capabilities and operates 11 global facilities, aiming to expedite time to market and reduce risk for its partners [4] - Cirtec Medical collaborates with customers across various therapies, including cardiology, neurology, and orthopedics, ensuring high quality and performance throughout the product lifecycle [4]

Summary of Coru Medical's Conference Call Company Overview - **Company Name**: Coru Medical Systems (KRMD) - **Industry**: Medical Device, specifically focused on drug delivery systems - **Core Product**: Innovative portable solutions for large volume drug delivery, allowing patients to self-administer medications at home instead of in hospitals [1][3][4] Key Points and Arguments Market Position and Growth - Coru Medical is a leader in large volume drug delivery, servicing over 45,000 patients with a recurring revenue model [5][6] - The company has received FDA approval for subcutaneous delivery in home settings since 2017, with a focus on chronic patients [5][6] - The global addressable market for subcutaneous immunoglobulin is estimated at $450 million, with a potential total addressable market of $2 billion for new drugs in development [11][13] Financial Performance - Revenue guidance for the year has been raised to $39.5 million to $40.5 million, indicating an 18% to 25% growth, with 75% of revenue being recurring [7][18] - The company reported a 21% overall growth and a 19% growth in its domestic core business, driven by conversions to pre-filled syringes [14][18] - Net losses have improved by 53% year-over-year, with a current net loss of $1.4 million [19] Product Development and Pipeline - Coru Medical has 10 collaborations with pharmaceutical companies to expand into various drug therapies, including nephrology, gastroenterology, and oncology [6][13] - The company has a pipeline of 10 new drugs, with four expected to be cleared in the next 6 to 12 months [15][52] - New product launches include a flow controller and a new pump designed for pre-filled syringes, enhancing patient convenience [16][40] International Expansion - International growth accounted for about 50% of the company's growth in the last quarter, with ambitions to increase market share from 10-15% to 50-60% in various regions [30][38] - Japan is identified as a significant emerging market, with plans to launch there by 2026 [36][38] Challenges and Risks - The company faces potential destocking issues in the U.S. market due to distributor inventory initiatives [27][28] - There is a need to navigate the complexities of reimbursement and payment structures in oncology, which is a new area for the company [47] Future Outlook - Coru Medical aims for sustainable growth of over 20%, driven by the expanding IG market, chronic patient base, new products, and international expansion [21][22] - The company is focused on maintaining cash flow positivity while investing in new product development [18][40] Additional Important Insights - The company has over 70 global patents on its Freedom system, providing a competitive edge in the market [6] - A five-year retrospective study showed a 97% adherence rate among patients using their system, indicating strong customer satisfaction [10] - The company is exploring additional drug indications, such as iron chelation antibiotics, which could provide low-risk growth opportunities [49][50] This summary encapsulates the key points discussed during the conference call, highlighting Coru Medical's market position, financial performance, product pipeline, international expansion efforts, challenges, and future outlook.