KORU Medical Systems (KRMD) Q1 2025 Earnings Call May 07, 2025 04:30 PM ET Speaker0 Greetings, and welcome to KORU Medical Systems first quarter twenty twenty five earnings conference call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to ...

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, including, but not limited to, timing of 510(k) clearances and financial guidance for fiscal 2025. Forward-looking statements discuss the Company's current expectations and projections relating to its financial position, results of operations, plans, objectives, future ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2025 or 100 Corporate Drive, Mahwah, New Jersey 07430 (Address of principal executive offices) (Zip Code) (845) 469-2042 [_] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________. Commission File Num ...

EXHIBIT 99.1 KORU MEDICAL SYSTEMS ANNOUNCES RECORD Q1 2025 FINANCIAL RESULTS AND RAISES 2025 REVENUE GUIDANCE MAHWAH, NJ – May 7, 2025 – 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 first quarter ended March 31, 2025. Recent Highlights "We are off to a strong ...

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 ...

Market Position and Strategy - KORU Medical focuses on developing innovative large volume subcutaneous infusion solutions, primarily targeting the subcutaneous drug delivery market regulated by the FDA[23]. - The company generates revenue from three sources: domestic core (US and Canada), international core, and novel therapies, with a focus on immunoglobulin delivery for PIDD and CIDP[24]. - KORU Medical aims to strengthen its position in the subcutaneous immunoglobulin (SCIg) market and expand into emerging subcutaneous drug therapies, leveraging the FREEDOM Infusion System[27]. - The company identifies key market trends driving SCIg growth, including increasing diagnoses of PIDD and expansion of on-label SCIg indications[29]. - KORU Medical estimates that at least 100 large-volume drugs greater than 2ml are in clinical development utilizing subcutaneous infusion, with approximately 20% being greater than 10ml[32]. - The FREEDOM System remains the market-leading delivery system in the U.S. for SCIg treatments, with increasing patient access expected as new drugs are developed[36]. - The company’s strategy includes ongoing clinical and product innovation, strategic partnerships, and commercial excellence to enhance its global market position[31]. Product Development and Innovation - The FREEDOM System is FDA 510(k) cleared and certified for several on-label subcutaneous indications, including Cutaquig®, Cuvitru®, and Hizentra®[35]. - HIgH-Flo Subcutaneous Safety Needle Sets are integral to the FREEDOM System, available in 26- and 24-gauge sizes for subcutaneous self-administration[37]. - The company invested $5.3 million and $5.7 million in research and development for the years ended December 31, 2024 and 2023, respectively, with plans for further investments in a next-generation infusion pump[43]. - The company is committed to innovation and product development, recognizing its importance for long-term success[43]. - The company’s strategy includes investing in innovation and new product development to achieve revenue growth, which requires substantial resources[73]. Regulatory and Compliance Challenges - The company faces regulatory scrutiny from the FDA and other authorities, which impacts the development, testing, and marketing of its medical devices[44]. - The company’s products are subject to ongoing regulatory compliance even after receiving FDA clearance, which can impact marketing and sales strategies[52]. - The company aims to comply with EU MDR regulations by December 2028, which will require significant investment to avoid losing the ability to sell products in the EU[75][76]. - The company is subject to extensive regulatory requirements, including compliance with the new EU Medical Device Regulation (MDR) effective May 2021, which will require significant investment to implement[116]. - Compliance with complex regulations, particularly from the FDA, is critical, and failure to maintain approvals could adversely affect financial condition and operations[90]. Financial Performance and Risks - The company does not currently intend to pay dividends on its common stock, which may affect investor attractiveness[28]. - The FREEDOM System's sales are primarily through six distributors, accounting for approximately 75% of net revenues, with one U.S. distributor contributing about 35%[40]. - The company faces significant risks related to patent litigation, which could result in loss of patent protection and substantial sales losses[107]. - The company may need additional funding in the future to support product development and commercialization efforts, which could lead to shareholder dilution if raised through equity offerings[137]. - The company’s financial results may be adversely affected by significant price increases from single-source suppliers[127]. Competition and Market Dynamics - Competition for the FREEDOM System includes various types of pumps, with key factors influencing selection being safety, cost-effectiveness, and ease of use[60]. - The company faces competition from a wide range of international and domestic companies in the infusion market, which may have greater financial and marketing resources[84]. - The company faces competition from generic and biosimilar therapies, which could significantly reduce the commercial viability of brand name injectable therapies[125]. - The medical technology industry is experiencing significant consolidation, leading to increased competition and downward pricing pressure for medical device suppliers[87]. Operational and Supply Chain Considerations - The company manufactures 100% of its pump product volume and 15% of consumables at its Mahwah, NJ facility, while 85% of consumables are sourced from Command Medical Products in Nicaragua[41]. - The company does not have binding contracts with suppliers, relying on single-source suppliers for components, which may pose risks to meeting customer demand[42]. - The company has a five-year agreement with Command established in 2020, but lacks long-term agreements with other suppliers, complicating supply chain stability[130]. - The company sources most components and raw materials from single suppliers, which poses risks to timely delivery and cost-effectiveness[126]. Human Resources and Management - As of December 31, 2024, the company employed 80 full-time employees, with approximately 49% being female and 43% being minorities[62]. - The company has a dedicated internet-based learning platform for employee training, aligning with their responsibilities and career development[63]. - The company maintains competitive compensation and benefits to attract and retain skilled labor, including health insurance and a 401(k) plan with matching contributions[64]. - The company does not maintain "key man" insurance policies, making it vulnerable to the loss of key management personnel[111]. - The company has made several changes to its management structure, which may lead to integration challenges and affect business operations[139]. External Economic Factors - The company is exposed to foreign currency exchange risks, which could affect revenues derived from international sales[144]. - The company faces risks from potential tariffs, including a 25% tariff on imports from Canada and Mexico and a 10% tariff on imports from China, which could adversely affect its financial results[142]. - Changes in tax or labor laws could increase operational costs and reduce profit margins, impacting overall financial performance[140]. - Rising inflation rates have increased economic uncertainty, potentially requiring the company to raise prices to maintain operating margins[154]. - The company faces uncertainties in the UK market due to Brexit, which may impact business operations and regulatory compliance[155]. Legal and Liability Risks - Product liability claims and lawsuits could result in significant legal costs and negatively affect the company's reputation and financial condition[104]. - Quality management is essential for maintaining customer confidence; quality issues could lead to recalls and regulatory actions, adversely impacting business[100]. - Protection of patents and proprietary rights is crucial; loss of intellectual property rights could materially damage competitiveness and business prospects[105]. Environmental and Social Considerations - Increased focus on environmental, social, and governance (ESG) issues may adversely affect the company's reputation and financial condition if not addressed appropriately[157]. - Climate change poses immediate and long-term risks, including increased operational costs and supply chain disruptions[158].

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]