KORU Medical Systems (KRMD) Q1 2025 Earnings Call May 07, 2025 04:30 PM ET Company Participants Louisa Smith - PrincipalLinda Tharby - President, Director & CEOTom Adams - Chief Financial OfficerCaitlin Cronin - Director Conference Call Participants Frank Takkinen - Senior Research AnalystChase Knickerbocker - Senior Equity Research Analyst - HealthcareJason Bednar - Research AnalystAnderson Schock - Research Analyst Operator Greetings, and welcome to KORU Medical Systems first quarter twenty twenty five ea ...

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 ...

Revenue and Profitability - The company reported net revenues of $9.6 million for Q1 2025, a 17.5% increase from $8.2 million in Q1 2024, driven by a 16.4% growth in domestic core revenues and a 35.6% increase in international core revenues [75]. - Gross profit for Q1 2025 was $6.0 million, an 18.5% increase from $5.1 million in Q1 2024, with a gross margin of 62.8%, up from 62.3% in the prior year [76][81]. - The company experienced a net loss of $1.2 million in Q1 2025, a 39.8% improvement from a net loss of $1.9 million in Q1 2024 [85]. Expenses - Operating expenses increased to $7.3 million in Q1 2025, compared to $7.1 million in Q1 2024, primarily due to a rise in selling, general, and administrative expenses [77][83]. - Selling, general, and administrative expenses rose by 11.2% to $6.0 million in Q1 2025, driven by increased compensation-related expenses and legal fees [83]. - Research and development expenses decreased by 24.5% to $1.1 million in Q1 2025, primarily due to timing of project spending [84]. Cash Flow and Investments - Cash on hand as of March 31, 2025, was $8.7 million, with inventory increasing to $3.3 million, reflecting a $0.5 million rise from December 31, 2024 [86][87]. - Net cash used in operating activities was $0.2 million for Q1 2025, an improvement from $0.3 million in Q1 2024, primarily due to a lower net loss and changes in working capital [90][91]. - The company invested $0.4 million in capital expenditures for manufacturing equipment related to new consumables production lines in Q1 2025 [92]. - The company anticipates that cash on hand and cash flows from operations will be sufficient to meet requirements for at least the next twelve months [88]. Accounting and Market Risk - No significant accounting policies have been adopted that would impact the financial statements [94]. - There are no applicable quantitative and qualitative disclosures about market risk [95].

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]