Annonce • May 20
Koru Medical Systems Presents Real World Data on the Benefits of the Freedomedge Syringe Infusion System KORU Medical Systems, Inc. presented its latest research at the Oncology Nursing Society Congress, May 13-17. The poster at ONS was titled, “Reducing Ergonomic Strain During Subcutaneous Monoclonal Antibody Administration.” The ONS abstract evaluated nursing workflow, nurse experience, and patient-reported outcomes after implementing KORU Medical's FreedomEDGE infusion system for subcutaneous drug administration across four community infusion centers in the United States. The findings demonstrated: Efficiency- 100% of doses successfully administered with infusion times aligned with clinical guidelines. Reduced Strain- Nurses experienced significantly less strain after implementing pump assisted or tubing-needle set assisted drug administration. High Satisfaction- Both nurses (4.85/5) and patients (4.92/5) reported high satisfaction levels. Workflow advantages- Nurses reported ability to multitask during 80% of pump infusions. KORU Medical’s FREEDOM Syringe Infusion System enables, simplifies, and enhances the delivery of large-volume subcutaneous drugs. Supporting drug products with various requirements for viscosity, flow rate, and delivered drug volume from 5mL-50mL+, the Freedom System is market proven with: 15+ years of patient self-administration in the home. 59,000+ patients and over 3M infusions annually. 97% adherence rate and 9 on-label subcutaneous drugs. Approval in 30+ countries. Reported Earnings • May 07
First quarter 2026 earnings released: US$0.017 loss per share (vs US$0.025 loss in 1Q 2025) First quarter 2026 results: US$0.017 loss per share (improved from US$0.025 loss in 1Q 2025). Revenue: US$11.8m (up 22% from 1Q 2025). Net loss: US$807.1k (loss narrowed 31% from 1Q 2025). Revenue is forecast to grow 15% p.a. on average during the next 3 years, compared to a 8.0% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 38% per year but the company’s share price has only increased by 4% per year, which means it is significantly lagging earnings growth. Annonce • Apr 16
KORU Medical Systems, Inc. to Report Q1, 2026 Results on May 06, 2026 KORU Medical Systems, Inc. announced that they will report Q1, 2026 results on May 06, 2026 Annonce • Apr 10
KORU Medical Systems, Inc., Annual General Meeting, May 19, 2026 KORU Medical Systems, Inc., Annual General Meeting, May 19, 2026. Location: 100 corporate drive, mahwah, nj 07430, United States Reported Earnings • Mar 15
Full year 2025 earnings: EPS exceeds analyst expectations Full year 2025 results: US$0.057 loss per share (improved from US$0.13 loss in FY 2024). Revenue: US$41.1m (up 22% from FY 2024). Net loss: US$2.64m (loss narrowed 56% from FY 2024). Revenue was in line with analyst estimates. Earnings per share (EPS) surpassed analyst estimates by 9.1%. Revenue is forecast to grow 15% p.a. on average during the next 3 years, compared to a 7.9% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 27% per year but the company’s share price has only increased by 4% per year, which means it is significantly lagging earnings growth. Price Target Changed • Mar 13
Price target increased by 8.8% to US$6.80 Up from US$6.25, the current price target is an average from 5 analysts. New target price is 59% above last closing price of US$4.28. Stock is up 55% over the past year. The company is forecast to post a net loss per share of US$0.03 next year compared to a net loss per share of US$0.081 last year. Annonce • Feb 27
KORU Medical Systems, Inc. to Report Q4, 2025 Results on Mar 12, 2026 KORU Medical Systems, Inc. announced that they will report Q4, 2025 results on Mar 12, 2026 Annonce • Jan 30
KORU Medical Systems Receives FDA 510(k) Clearance for Delivery of RYSTIGGO®? (rozanolixizumab-noli), Expanding Label for FreedomEDGE®? Infusion System KORU Medical Systems, Inc. announced that the Company received U.S. Food and Drug Administration (FDA) clearance for use of the KORU Medical FreedomEDGE®? infusion system to deliver RYSTIGGO®? (rozanolixizumab-noli), a therapy commercialized globally by UCB, Brussels, Belgium. The clearance for the FreedomEDGE®? label includes indicated administration by a healthcare professional, increasing flexibility and access for patients living with generalized myasthenia (gMG). RYSTIGGO®®? is a novel biologic approved to treat adults with generalized myasthenia gravis (gMG), a rare, chronic autoimmune disorder that affects communication between nerves and muscles. RYSTIGGO™? is administered as a weekly infusion of 3mL-6mL of drug over 15-30 minutes for 6 weeks, with subsequent treatment cycles based on clinical evaluation. KORU Medical's Freedom Infusion System enables, simplifies, and enhances the delivery of large-volume subcutaneous drugs. Supporting drug products with various requirements for viscosity, flow rate, and delivered drug volume from 5mL-50mL+, the Freedom System is market proven with: 15+ years of patient self-administration in the home; 45,000+ patients and over 2M infusions annually; 97% adherence rate and 9 on-label subcutaneous drugs distributed across 30+ countries. Annonce • Dec 31
KORU Medical Systems Announces 510(k) Submission for Clearance of the FreedomEDGE®? System with a Commercialized Oncology Biologic KORU Medical Systems, Inc. announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking clearance for the use of KORU Medical's FreedomEDGE®? infusion system to subcutaneously administer PHESGO®? (pertuzumab/trastuzumab/hyaluronidase-zzxf), a co-formulated therapy for HER2+ breast cancer. The submission represents a key milestone in KORU Medical's strategy to expand the use of the FreedomEDGE®? system beyond its current immunoglobulin (Ig) indications and into the broader oncology infusion center market. The increasing shift from intravenous (IV) to subcutaneous (SC) drug delivery for cancer therapies allows for faster drug administration, reduced patient chair time, and aligns with a movement towards a more efficient care model. However, despite these advances, infusion centers continue to face unmet needs related to nursing satisfaction with drug administration, including workflow complexity associated with treatment protocol, time constraints for set up and physical discomfort for both patients and nurses during infusions. The FreedomEDGE®? system is designed to address these challenges by enabling consistent, controlled large-volume SC delivery while supporting more streamlined clinical workflows. KORU Medical anticipates a market entry upon FDA 510(k) clearance. KORU Medical's Freedom Infusion System enables, simplifies, and enhances the delivery of large-volume subcutaneous drugs. Supporting drug products with various requirements for viscosity, flow rate, and delivered drug volume, the Freedom System is market proven with: 15+ years on the market; 45,000+ patients and over 2M infusions annually; 97% adherence rate and 8 on-label Subcutaneous drugs across 30+ countries. Price Target Changed • Dec 22
Price target increased by 11% to US$6.25 Up from US$5.65, the current price target is an average from 5 analysts. New target price is approximately in line with last closing price of US$6.07. Stock is up 54% over the past year. The company is forecast to post a net loss per share of US$0.07 next year compared to a net loss per share of US$0.13 last year. Annonce • Dec 17
KORU Medical Systems, Inc. Appoints Eric Schiller As Chief Technology Officer, Effective December 29, 2025 KORU Medical Systems, Inc. appointed 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, device engineering, drug–device combination product development, supply chain strategy, and end-to-end product lifecycle management. He most recently served as Global Head of Device Development Portfolio at Sanofi, where he built and led a global team, advanced connected and reusable delivery platforms, drove multiple regulatory and launch-readiness initiatives, and oversaw more than 80 pipeline assets across Specialty Care, General Medicine and Vaccines. Prior to Sanofi, Eric spent more than a decade at Bristol-Myers Squibb and Celgene in roles spanning device development, biologics commercialization, and global product strategy, where he supported launches for major immunology and hematology assets including therapies requiring complex injection and infusion delivery systems, and implemented programs that improved reliability, patient adherence, and supply continuity. His earlier engineering career at Becton Dickinson and Saint-Gobain included development of next-generation syringe platforms and quality, safety, and process-improvement initiatives. Mr. Schiller holds an MBA with a management concentration from Seton Hall University and a Bachelor of Science in Mechanical Engineering from the New Jersey Institute of Technology. He is an inventor on more than a dozen U.S. patents in injection devices, safety systems, and drug-delivery components. Major Estimate Revision • Nov 19
Consensus estimates of losses per share improve by 12% The consensus outlook for earnings per share (EPS) in fiscal year 2025 has improved. 2025 revenue forecast increased from US$39.9m to US$40.7m. EPS estimate increased from -US$0.08 per share to -US$0.07 per share. Medical Equipment industry in the US expected to see average net income growth of 15% next year. Consensus price target broadly unchanged at US$5.56. Share price rose 19% to US$4.45 over the past week. Annonce • Nov 18
KORU Medical Systems to Present Promising Results on the Use of the FreedomEDGE Syringe Infusion System in Infusion Centers at ESID/EHA/SIOPE Focused Symposium 2025 KORU Medical Systems, Inc. announced that the Company will present its latest research at the ESID/EHA/SIOPE Focused Symposium 2025 in Vienna, Austria, November 18-20. The poster presentation, titled "Comparing Mechanical Pump and Manual Push for Short- duration Subcutaneous Infusions: A Nursing Preference Survey Study," highlights results from a multicenter evaluation conducted by KORU Medical across nine hospitals in Denmark. The study compared KORU Medical's FreedomEDGE Infusion System with traditional healthcare provider manual push techniques for short-duration subcutaneous infusions in oncology and immunology settings, evaluating nurse satisfaction, patient experience, usability, and workflow efficiency. The study results demonstrated: High nurse satisfaction - 91% found the system easier to use, 91% reported faster setup time, 81% experienced reduced hand strain, and 97% reported increased time for patient interaction; High patient satisfaction with 73% observing improved comfort; 97% of respondents would recommend the FreedomEDGE Infusions. The growing adoption of subcutaneous oncology therapies presents both an opportunity and a challenge for infusion centers worldwide. With nurse resources under increasing strain, the FreedomEDGE infusion System offers a scalable, hands-free alternative that maintains safety and patient comfort while improving workflow efficiency. KORU Medical anticipates filing a 510(k) submission to the FDA for use with a commercialized oncology drug in either the fourth quarter of 2025 or in the first quarter of 2026. KORU Medical's Freedom Syringe Infusion System enables, simplifies, and enhances the delivery of large-volume subcutaneous drugs. Supporting drug products with various requirements for viscosity, flow rate, and delivered drug volume from 5mL-50mL+, the Freedom System is market proven with: 15+ years of patient self-administration in the home; 45,000+ patients and over 2M infusions annually; 97% adherence rate and 8 on-label subcutaneous drugs; Distributed across 30+ countries. The ESID-EHA-SIOPE Symposium 2025 brings together experts from the European Society for Immunodeficiencies (ESID), the European Hematology Association (EHA), and the European Society for Paediatric Oncology (SIOPE) to provide a comprehensive platform for exploring how immunodeficiencies can influence hematologic and oncologic conditions and vice versa, how each specialty offers unique insights that contribute to improving diagnosis, treatment, and management strategies. Reported Earnings • Nov 14
Third quarter 2025 earnings: EPS and revenues exceed analyst expectations Third quarter 2025 results: US$0.017 loss per share (improved from US$0.034 loss in 3Q 2024). Revenue: US$10.4m (up 27% from 3Q 2024). Net loss: US$778.0k (loss narrowed 51% from 3Q 2024). Revenue exceeded analyst estimates by 7.6%. Earnings per share (EPS) also surpassed analyst estimates by 29%. Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 8.4% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 16% per year and the company’s share price has also increased by 16% per year. Annonce • Nov 13
KORU Medical Systems, Inc. Revises Earnings Guidance for the Year 2025 KORU Medical Systems, Inc. revised earnings guidance for the year 2025. The company is raising full year 2025 net revenues guidance to $40.5 million - $41.0 million, representing year-over-year growth of 20% - 22%, from prior range of $39.5 million - $40.5 million. Annonce • Nov 05
KORU Medical Systems, Inc. Announces Development Agreement for Innovation in Subcutaneous Immunoglobulin Infusion Systems KORU Medical Systems, Inc. announced a development agreement with a global pharmaceutical company. The agreement allows for broad collaboration on next-generation infusion systems in subcutaneous immunoglobulin (SCIg) therapy for both commercial drugs and clinical programs. The agreement is for KORU Medical to support the qualification of an infusion system that can accommodate both vials and prefilled syringes (PFS). KORU Medical's Freedom60®? and FreedomEDGE®? infusion pumps were the first devices to be 510(k) cleared for use with prefilled syringes. The innovative system will be developed using KORU Medical's infusion technology along with SCHOTT TOPPAC®? polymer syringes. KORU Medical's FREEDOM Syringe Infusion System enables, simplifies, and enhances the delivery of large-volume subcutaneous drugs. Supporting drug products with various requirements for viscosity, flow rate, and delivered drug volume from 5mL-50mL+, the Freedom System is market proven with: 15+ years of patient self-administration in the home; 45,000+ patients and over 2M infusions annually; 97% adherence rate and 8 on-label subcutaneous drugs2; Distributed across 30+ countries. Buy Or Sell Opportunity • Oct 28
Now 20% undervalued Over the last 90 days, the stock has risen 15% to US$4.01. The fair value is estimated to be US$5.01, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 10% over the last 3 years. Earnings per share has grown by 5.4%. Revenue is forecast to grow by 35% in 2 years. Earnings are forecast to grow by 99% in the next 2 years. Annonce • Oct 23
KORU Medical Systems, Inc. to Report Q3, 2025 Results on Nov 12, 2025 KORU Medical Systems, Inc. announced that they will report Q3, 2025 results on Nov 12, 2025 Buy Or Sell Opportunity • Oct 13
Now 21% undervalued Over the last 90 days, the stock has risen 38% to US$4.07. The fair value is estimated to be US$5.13, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 10% over the last 3 years. Earnings per share has grown by 5.4%. Revenue is forecast to grow by 35% in 2 years. Earnings are forecast to grow by 99% in the next 2 years. Buy Or Sell Opportunity • Sep 22
Now 21% undervalued Over the last 90 days, the stock has risen 13% to US$4.02. The fair value is estimated to be US$5.11, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 10% over the last 3 years. Earnings per share has grown by 5.4%. Revenue is forecast to grow by 35% in 2 years. Earnings are forecast to grow by 99% in the next 2 years. Buy Or Sell Opportunity • Sep 05
Now 20% undervalued Over the last 90 days, the stock has risen 32% to US$4.06. The fair value is estimated to be US$5.10, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 10% over the last 3 years. Earnings per share has grown by 5.4%. Revenue is forecast to grow by 35% in 2 years. Earnings are forecast to grow by 99% in the next 2 years. Reported Earnings • Aug 08
Second quarter 2025 earnings released: US$0.004 loss per share (vs US$0.022 loss in 2Q 2024) Second quarter 2025 results: US$0.004 loss per share (improved from US$0.022 loss in 2Q 2024). Revenue: US$10.2m (up 21% from 2Q 2024). Net loss: US$206.9k (loss narrowed 79% from 2Q 2024). Revenue is forecast to grow 15% p.a. on average during the next 3 years, compared to a 8.3% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has increased by 5% per year but the company’s share price has increased by 17% per year, which means it is tracking significantly ahead of earnings growth. New Risk • Aug 07
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$207k net loss in 2 years). Share price has been volatile over the past 3 months (11% average weekly change). Annonce • Aug 07
KORU Medical Systems, Inc. Raises Earnings Guidance for the Year 2025 KORU Medical Systems, Inc. raising earnings guidance for the year 2025. For the year, the company raising full year 2025 revenue guidance to $39.5 - $40.5 million, representing growth of 18% - 20%, from prior range of $38.5 - $39.5 million. Annonce • Jul 17
KORU Medical Systems, Inc. to Report Q2, 2025 Results on Aug 06, 2025 KORU Medical Systems, Inc. announced that they will report Q2, 2025 results on Aug 06, 2025 Annonce • Jul 08
KORU Medical Systems Appoints Adam Kalbermatten as Chief Commercial Officer, Effective July 28, 2025 KORU Medical Systems, Inc. announced the appointment of Adam Kalbermatten as Chief Commercial Officer, effective July 28, 2025. Adam brings over two decades of commercial leadership experience in the medical device and pharmaceutical industries, with a proven track record of scaling businesses, building high-performing teams, and delivering customer-focused innovation. As Chief Commercial Officer, he will oversee all aspects of KORU Medical’s global commercial strategy—including marketing, sales, market access, and pharmaceutical customer engagement. Adam joins KORU Medical from Becton Dickinson (BD), where he most recently served as Vice President and General Manager, Advanced Drug Delivery Systems, leading growth initiatives across the injectable drug delivery platform. Prior to BD, Adam served as Chief Executive Officer of ZebraSci, a specialized provider of analytical and drug device combination product development services to pharmaceutical companies, where he led a successful turnaround and growth strategy resulting in an eventual acquisition of the company by BD. He also held global leadership roles at Terumo Medical Corporation, including Worldwide Director of Marketing and Worldwide Director of Business Development, where he helped shape the company’s global drug delivery strategy. Adam holds a Bachelor of Engineering in Mechanical Engineering and a Master of Engineering in Engineering Management from Stevens Institute of Technology, and an MBA with concentrations in Finance and Healthcare from Columbia Business School. Board Change • Jun 01
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 5 experienced directors. 1 highly experienced director. Director Ed Wholihan was the last director to join the board, commencing their role in 2023. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • May 10
First quarter 2025 earnings: EPS in line with analyst expectations despite revenue beat First quarter 2025 results: US$0.025 loss per share (improved from US$0.042 loss in 1Q 2024). Revenue: US$9.64m (up 18% from 1Q 2024). Net loss: US$1.17m (loss narrowed 40% from 1Q 2024). Revenue is forecast to grow 14% p.a. on average during the next 3 years, compared to a 8.1% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has fallen by 7% per year but the company’s share price has increased by 15% per year, which means it is well ahead of earnings. New Risk • May 09
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: US$6.1m Forecast net loss in 2 years: US$1.7m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$1.7m net loss in 2 years). Share price has been volatile over the past 3 months (12% average weekly change). Annonce • May 08
Koru Medical Systems, Inc. Raises Earnings Guidance for Full Year 2025 KORU Medical Systems, Inc. raised earnings guidance for full year 2025. For the period the company raising revenue guidance to $38.5 million to $39.5 million from prior range of $38.0 million to $39.0 million. Annonce • Apr 23
KORU Medical Systems, Inc., Annual General Meeting, May 14, 2025 KORU Medical Systems, Inc., Annual General Meeting, May 14, 2025. Location: 100 corporate drive, mahwah, nj 07495, United States Annonce • Apr 17
KORU Medical Systems, Inc. to Report Q1, 2025 Results on May 07, 2025 KORU Medical Systems, Inc. announced that they will report Q1, 2025 results on May 07, 2025 Annonce • Apr 09
KORU Medical Systems, Inc. Announces Executive Changes On April 3, 2025, Kenneth Miller resigned his employment and position as Chief Commercial Officer of KORU Medical Systems, Inc. (the “Company”), effective immediately, to pursue a Chief Executive Officer role at an organization that does not compete with the Company. KORU Medical would like to thank Mr. Miller for his contributions to the Company and recognize the instrumental role he played in establishing and implementing strategic commercial growth priorities during his tenure. Rob Cannon will lead the Company’s commercial operations for the Core business until a succeeding Chief Commercial Officer is named. Mr. Cannon has served as the Company’s Vice President of Sales for North America since November 2021 and has over 30 years of experience in sales across the healthcare industry, including11 years with McKesson, a healthcare supply chain management company specializing in providing pharmaceuticals and healthcare services across the globe, where he led the strategy, planning and implementation of sales, and marketing strategies focused on specialty pharma and home infusion channels. The Company has retained the services of an executive search firm to commence the search for a new Chief Commercial Officer. New Risk • Apr 08
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$98.3m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. This is currently the only risk that has been identified for the company. Recent Insider Transactions Derivative • Mar 20
President notifies of intention to sell stock Linda Tharby intends to sell 30k shares in the next 90 days after lodging an Intent To Sell Form on the 19th of March. If the sale is conducted around the recent share price of US$2.83, it would amount to US$85k. For the year to December 2021, Linda's total compensation was 79% salary and 21% non-salary. Since March 2024, Linda has owned 1.82m shares directly. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Major Estimate Revision • Mar 19
Consensus EPS estimates fall by 19% The consensus outlook for fiscal year 2025 has been updated. 2025 expected loss increased from -US$0.086 to -US$0.102 per share. Revenue forecast unchanged at US$38.4m. Medical Equipment industry in the US expected to see average net income growth of 18% next year. Consensus price target of US$5.70 unchanged from last update. Share price fell 11% to US$2.92 over the past week. Reported Earnings • Mar 13
Full year 2024 earnings: Revenues and EPS in line with analyst expectations Full year 2024 results: US$0.13 loss per share (improved from US$0.30 loss in FY 2023). Revenue: US$33.6m (up 18% from FY 2023). Net loss: US$6.07m (loss narrowed 56% from FY 2023). Revenue is forecast to grow 14% p.a. on average during the next 3 years, compared to a 7.7% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has fallen by 19% per year but the company’s share price has only fallen by 3% per year, which means it has not declined as severely as earnings. Annonce • Mar 13
KORU Medical Systems, Inc. Provides Earnings Guidance for the Full Year of 2025 KORU Medical Systems, Inc. provided earnings guidance for the full year of 2025. For the full year of 2025, the company expects net revenues guidance of $38.0 - $39.0 million, representing growth of 13% - 16% over the prior year. Annonce • Feb 20
KORU Medical Systems, Inc. to Report Q4, 2024 Results on Mar 12, 2025 KORU Medical Systems, Inc. announced that they will report Q4, 2024 results on Mar 12, 2025 Annonce • Jan 31
KORU Medical Systems Announces Phase III Clinical Trial Collaboration for a New Drug Indication in Nephrology KORU Medical Systems announced a collaboration with a global pharmaceutical manufacturer on a Phase III clinical trial for an expanded indication of a commercialized drug therapy. The expanded indication is intended to treat a rare renal disorder in a population of approximately 30,000 patients with a projected 300,000 annual infusions. This announcement highlights an additional collaboration between KORU Medical and its partners in the development of novel therapies and enhanced drug delivery experiences for patients living with rare conditions. The Phase III trial aims to assess the safety, efficacy, and performance of the drug to treat patients with complications from kidney transplants. Annonce • Jan 16
KORU Medical Systems, Inc. Announces Preliminary Unaudited Revenues Guidance for the Fourth Quarter and Full Year Ended December 31, 2024 KORU Medical Systems, Inc. announced preliminary unaudited revenues guidance for the fourth quarter and full year ended December 31, 2024. Preliminary, unaudited fourth quarter 2024 net revenues expected to be $8.9 million, representing growth of 23% over the prior year period.
Preliminary, unaudited full year 2024 net revenues expected to be $33.7 million, representing growth of 18% over the prior year. Reported Earnings • Nov 15
Third quarter 2024 earnings: EPS and revenues exceed analyst expectations Third quarter 2024 results: US$0.034 loss per share (further deteriorated from US$0.03 loss in 3Q 2023). Revenue: US$8.18m (up 17% from 3Q 2023). Net loss: US$1.58m (loss widened 16% from 3Q 2023). Revenue exceeded analyst estimates by 6.1%. Earnings per share (EPS) also surpassed analyst estimates by 10.0%. Revenue is forecast to grow 15% p.a. on average during the next 3 years, compared to a 8.2% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has fallen by 32% per year but the company’s share price has only fallen by 2% per year, which means it has not declined as severely as earnings. Price Target Changed • Nov 14
Price target increased by 17% to US$4.10 Up from US$3.50, the current price target is an average from 5 analysts. New target price is 33% above last closing price of US$3.08. Stock is up 40% over the past year. The company is forecast to post a net loss per share of US$0.13 next year compared to a net loss per share of US$0.30 last year. Annonce • Nov 14
KORU Medical Systems, Inc. Raises Earnings Guidance for the Full Year 2024 KORU Medical Systems, Inc. raised earnings guidance for the full year 2024. For the full year, the company expects net revenue to be in the range of $32.75 million to $33.25 million, representing growth of 15% to 17%; increased from previously issued guidance of $32.0 to $32.5 million, or 12% to 14%. Annonce • Oct 24
KORU Medical Systems, Inc. to Report Q3, 2024 Results on Nov 13, 2024 KORU Medical Systems, Inc. announced that they will report Q3, 2024 results on Nov 13, 2024 Major Estimate Revision • Aug 14
Consensus estimates of losses per share improve by 20% The consensus outlook for earnings per share (EPS) in fiscal year 2024 has improved. 2024 revenue forecast increased from US$31.8m to US$32.2m. EPS estimate increased from -US$0.166 per share to -US$0.133 per share. Medical Equipment industry in the US expected to see average net income growth of 17% next year. Consensus price target up from US$3.50 to US$3.60. Share price rose 8.5% to US$2.31 over the past week. New Risk • Aug 08
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$97.5m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$3.1m net loss in 2 years). Market cap is less than US$100m (US$97.5m market cap). Reported Earnings • Aug 08
Second quarter 2024 earnings: EPS and revenues exceed analyst expectations Second quarter 2024 results: US$0.022 loss per share (improved from US$0.055 loss in 2Q 2023). Revenue: US$8.43m (up 22% from 2Q 2023). Net loss: US$988.7k (loss narrowed 60% from 2Q 2023). Revenue exceeded analyst estimates by 11%. Earnings per share (EPS) also surpassed analyst estimates by 52%. Revenue is forecast to grow 15% p.a. on average during the next 3 years, compared to a 8.2% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has fallen by 38% per year but the company’s share price has only fallen by 11% per year, which means it has not declined as severely as earnings. Annonce • Aug 08
KORU Medical Systems, Inc. Revises Revenue Guidance for the Full Year 2024 KORU Medical Systems, Inc. revised revenue guidance for the full year 2024. Raising full year 2024 net revenue guidance to $32.0 - $32.5, representing growth of 12-14%; increased from previously issued guidance of $31.2 - $32.2 million, or 10% to 13%. Raising full year 2024 gross margin guidance to 61% - 62%; increased from previously issued guidance of 59% - 61%. Annonce • Jul 25
KORU Medical Systems, Inc Announces Executive Changes KORU Medical Systems, Inc. announced the promotion of Christopher Pazdan, to Chief Operating Officer, effective July 18, 2024. Mr. Pazdan has been with the organization since 2021, and last served as the Company’s Senior Vice President of Operations overseeing Quality, Regulatory, Operations, Supply Chain and Project Management. In his role as COO, Chris will also oversee the Research and Development organization and be responsible for the Company’s product development pipeline and innovation efforts. Chris joined KORU Medical Systems in 2021, as Vice President of Quality Assurance and Regulatory Affairs. In 2022, he was promoted to Senior Vice President of Operations, which included leading manufacturing, supply chain and the project management office. Chris brings more than 20 years of experience in the medical device industry including leadership roles at Hill-Rom and Becton Dickinson (formerly CareFusion/Cardinal Health) across a variety of strategic functions and roles. As part of this transition, Brian Case, Chief Technology Officer, will be leaving the Company on September 16, 2024. Annonce • Jul 18
KORU Medical Systems, Inc. to Report Q2, 2024 Results on Aug 07, 2024 KORU Medical Systems, Inc. announced that they will report Q2, 2024 results at 4:00 PM, US Eastern Standard Time on Aug 07, 2024 Annonce • Jul 02
KORU Medical Systems Receives Regulatory Clearance for FreedomEdge Infusion System in Japan KORU Medical Systems, Inc. announced that its FreedomEdge System has received regulatory clearance in Japan for the delivery of multiple drugs, including CSL Behring's Hizentra subcutaneous immunoglobulin (SCIg), Takeda Pharmaceutical's Cuvitru SCIg, and Sobi's Aspaveli paroxysmal nocturnal hemoglobinuria (PNH). The regulatory milestone marks a significant advancement in patient care in Japan, providing patients and healthcare providers with access to cutting-edge treatment options for Subcutaneous Immunoglobulin therapy (SCIg) and Paroxysmal Nocturnal Hemoglobinuria (PNH). the FreedomEdge System, known for its reliability, precision, and patient-friendly design, offers convenient and efficient administration of large volume subcutaneous therapies at home and in the clinic. The FreedomEdge System is designed to meet the diverse needs of patients and healthcare professionals, offering customizable features for personalized treatment experiences. Its compact and portable design allows for flexibility in treatment administration, enabling patients to manage their therapy effectively in various settings. Annonce • Jun 06
KORU Medical Systems, Inc. Announces Collaboration with Global Pharmaceutical Company to Initiate Feasibility Study with Its Freedom Infusion System for FDA and EMA Approved Subcutaneous Oncology Biologic Drug KORU Medical Systems, Inc. announced a collaboration with a global pharmaceutical company to initiate a feasibility study with KORU Medical’s Freedom Infusion System for an FDA and EMA approved subcutaneous oncology biologic drug, that is currently being delivered via a manual syringe administration by a healthcare professional. The Freedom System is a purely mechanical ambulatory drug delivery device with 11 drugs approved on the label and over 40,000 patients globally. The system is designed to deliver large volumes of biologic medications from 2mL to over 100mL subcutaneously. The Freedom System is capable of allowing patients to self-administer their therapy at home and/or by healthcare professionals in a clinic setting. Major Estimate Revision • May 08
Consensus EPS estimates fall by 15% The consensus outlook for fiscal year 2024 has been updated. 2024 expected loss increased from -US$0.137 to -US$0.158 per share. Revenue forecast unchanged at US$31.8m. Medical Equipment industry in the US expected to see average net income growth of 18% next year. Consensus price target of US$3.50 unchanged from last update. Share price rose 4.1% to US$2.26 over the past week. Annonce • May 03
KORU Medical Systems, Inc. reaffirms Financial Guidance for the Full Year of 2024 ·KORU Medical Systems, Inc. reaffirmed financial guidance for the full year of 2024. For the period, the company expects net revenue between $31.2 and $32.2 million, representing growth of 10% to 13% over the prior year. Reported Earnings • May 02
First quarter 2024 earnings: Revenues exceed analysts expectations while EPS lags behind First quarter 2024 results: US$0.042 loss per share (improved from US$0.053 loss in 1Q 2023). Revenue: US$8.20m (up 11% from 1Q 2023). Net loss: US$1.94m (loss narrowed 20% from 1Q 2023). Revenue exceeded analyst estimates by 8.8%. Earnings per share (EPS) missed analyst estimates by 14%. Revenue is forecast to grow 15% p.a. on average during the next 3 years, compared to a 8.1% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has fallen by 43% per year but the company’s share price has only fallen by 12% per year, which means it has not declined as severely as earnings. Annonce • Apr 19
KORU Medical Systems, Inc. to Report Q1, 2024 Results on May 01, 2024 KORU Medical Systems, Inc. announced that they will report Q1, 2024 results on May 01, 2024 Annonce • Mar 29
KORU Medical Systems, Inc., Annual General Meeting, May 09, 2024 KORU Medical Systems, Inc., Annual General Meeting, May 09, 2024, at 08:00 Eastern Daylight. Location: 100 Corporate Drive, Mahwah New Jersey United States Agenda: To consider election of directors; to consider Advisory approval of the compensation of the Company’s executive officers; to consider ratification of the appointment of independent registered public accountants; to consider approval of the 2024 Omnibus Equity Incentive plan; and to consider transaction of any other business that may properly come before the meeting. Reported Earnings • Mar 14
Full year 2023 earnings: EPS misses analyst expectations Full year 2023 results: US$0.30 loss per share (further deteriorated from US$0.19 loss in FY 2022). Revenue: US$28.5m (up 2.2% from FY 2022). Net loss: US$13.7m (loss widened 59% from FY 2022). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 67%. Revenue is forecast to grow 16% p.a. on average during the next 3 years, compared to a 7.8% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has fallen by 48% per year but the company’s share price has only fallen by 16% per year, which means it has not declined as severely as earnings. Annonce • Mar 14
KORU Medical Systems, Inc. Provides Earnings Guidance for the Full Year 2024 KORU Medical Systems, Inc. provided earnings guidance for the full year 2024. For the year, the company expected net revenue between $31.2 and $32.2 million, representing growth in the range of 10% to 13%. Annonce • Mar 12
KORU Medical Systems, Inc. Announces A Feasibility Study to Enter Ambulatory Infusion Settings with A Commercialized Biologic KORU Medical Systems, Inc. announced a collaboration with a global pharmaceutical manufacturer to initiate a feasibility study with KORU's Freedom Infusion System for an already commercialized rare disease therapy. Upon successful completion of the feasibility study, KORU Medical intends to develop a customized Freedom System that will deliver this large volume therapy via subcutaneous administration. Healthcare providers administer this rare disease drug in the growing ambulatory infusion center (AIC) and ambulatory infusion suite (AIS) setting in the United States and the hospital setting in the European Union. Annonce • Feb 22
KORU Medical Systems, Inc. to Report Q4, 2023 Results on Mar 13, 2024 KORU Medical Systems, Inc. announced that they will report Q4, 2023 results on Mar 13, 2024 Major Estimate Revision • Nov 15
Consensus EPS estimates upgraded to US$0.18 loss, revenue downgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$31.0m to US$28.2m. 2023 losses expected to reduce from -US$0.206 to -US$0.178 per share. Medical Equipment industry in the US expected to see average net income growth of 25% next year. Consensus price target down from US$4.30 to US$3.80. Share price was steady at US$2.30 over the past week. Annonce • Nov 11
Koru Medical Systems, Inc. Appoints Kenneth Miller as Chief Commercial Officer Kenneth Miller, age 55, has been appointed by KORU Medical Systems, Inc. (the “Company”) to serve in the newly created position of Chief Commercial Officer commencing November 6, 2023. Mr. Miller brings over 30 years of experience in leading teams in commercialization and marketing strategy and international expansion. Mr. Miller served as President and CEO of NASCO Healthcare Inc. from 2018 to January 2023. Prior to that, Mr. Miller served in various roles at Becton Dickinson from 2011 to 2018 with his last role as the Worldwide President Diabetes Care. He also held leadership roles in marketing, sales, and business development with Novo Nordisk Inc., Adams Respiratory Therapeutics, Inc., and Roche Laboratories. Mr. Miller earned his Bachelor of Arts in Business Management from State University of New York at Albany and his Master of Business Administration from The University of Chicago, Booth School of Business. New Risk • Nov 10
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$99.9m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (US$5.6m net loss in 2 years). Market cap is less than US$100m (US$99.9m market cap). Reported Earnings • Nov 10
Third quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2023 results: US$0.03 loss per share (further deteriorated from US$0.027 loss in 3Q 2022). Revenue: US$7.00m (down 9.8% from 3Q 2022). Net loss: US$1.37m (loss widened 12% from 3Q 2022). Revenue missed analyst estimates by 12%. Earnings per share (EPS) exceeded analyst estimates by 40%. Revenue is forecast to grow 12% p.a. on average during the next 3 years, compared to a 7.8% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, earnings per share has fallen by 51% per year but the company’s share price has only fallen by 19% per year, which means it has not declined as severely as earnings. Annonce • Nov 08
KORU Medical Systems, Inc. Receives FDA 510(k) Clearance for FREEDOM60 Infusion System With Hizentra 50 ML Prefilled Syringes KORU Medical Systems, Inc. announced that it received U.S. Food and Drug Administration (FDA) clearance for use of the FREEDOM60(R) Infusion System with Hizentra(R) 50 mL prefilled syringes (PFS). The FREEDOM(TM) Infusion System is the first and only infusion system cleared for use with prefilled syringes and, given the majority of patients are prescribed doses of 50 mL or greater, this clearance for FREEDOM60(R) significantly expands the benefits of PFS use, especially for those diagnosed with conditions requiring significantly higher doses of immunoglobulin. When using prefilled syringes with the FREEDOM(TM) Infusion System, KORU Medical has demonstrated that patients can experience up to an 80% reduction in drug preparation tasks when compared to using vials. The FDA approved the Hizentra(R) 50 mL prefilled syringe in April 2023, and CSL Behring has announced an early 2024 availability. Hizentra(R) is the most prescribed subcutaneous immunoglobulin and the first to be available in prefilled syringes. Annonce • Oct 26
KORU Medical Systems, Inc. to Report Q3, 2023 Results on Nov 08, 2023 KORU Medical Systems, Inc. announced that they will report Q3, 2023 results on Nov 08, 2023 Board Change • Oct 13
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Director Ed Wholihan was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Aug 10
Second quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2023 results: US$0.055 loss per share (improved from US$0.065 loss in 2Q 2022). Revenue: US$6.94m (up 5.9% from 2Q 2022). Net loss: US$2.50m (loss narrowed 15% from 2Q 2022). Revenue missed analyst estimates by 4.0%. Earnings per share (EPS) exceeded analyst estimates by 12%. Revenue is forecast to grow 13% p.a. on average during the next 3 years, compared to a 7.8% growth forecast for the Medical Equipment industry in the US. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 27 percentage points per year, which is a significant difference in performance. Annonce • Aug 10
KORU Medical Systems, Inc. Updates Revenue Guidance for the Full Year 2023 KORU Medical Systems, Inc. updated revenue guidance for the full year 2023. For the year, the company reducing net revenue guidance to $31.0 million - $32.5 million, representing growth in the range of 11%-17% from prior guidance of $32.5 million - $33.5 million, representing growth in the range of 17-20%. Price Target Changed • Aug 03
Price target decreased by 10% to US$4.33 Down from US$4.83, the current price target is an average from 3 analysts. New target price is 70% above last closing price of US$2.55. Stock is down 5.6% over the past year. The company is forecast to post a net loss per share of US$0.20 next year compared to a net loss per share of US$0.19 last year. Annonce • Aug 01
KORU Medical Systems, Inc. to Report Q2, 2023 Results on Aug 09, 2023 KORU Medical Systems, Inc. announced that they will report Q2, 2023 results on Aug 09, 2023 Annonce • Jul 11
KORU Medical Systems, Inc. Announces 510(K) Submission for Freedom60®? Infusion System with Hizentra®? 50 Ml Preilled Syringes KORU Medical Systems, Inc. announced that it has submitted a 510(k) premarket notification submission to the U.S. Food and Drug Administration for the use of its FREEDOM60®? Infusion System with Hizentra®? 50 mL prefilled syringes. The FDA approved the 50 mL Hizentra prefilled syringe in April 2023. Hizentra is the most prescribed subcutaneous immunoglobulin and the first to be available in prefilled syringes. Annonce • Jun 28
KORU Medical Systems, Inc. Names Andrew LaFrence as Chief Financial Officer -KORU Medical Systems, Inc. announced the appointment of Andrew D. C. LaFrence as its Chief Financial Officer, effective July 10, 2023. Andy LaFrence joins KORU Medical bringing over 39 years of finance and accounting experience, including a track record of successfully executing and influencing growth-oriented business and M&A strategies, scaling businesses, developing and managing a global team of finance and accounting professionals, as well as leadership in tax, risk management and information technology. He joins the Company from Vyant Bio, Inc, an innovative biotechnology company reinventing drug discovery for complex neurodevelopmental and neurodegenerative disorders, where he served as CFO from 2021 to 2023. Prior to that Andy held CFO roles at Surmodics, Inc. and several biotech and drug development companies. Andy spent the first 26 years of his professional career at KPMG where he led the Minneapolis office Life Sciences practice for over 10 years. Andy is a CPA with a BS in Accounting from Illinois State University. 