10q10k10q10k.net
KORU Medical Systems, Inc.

KORU Medical Systems, Inc.KRMD财报

Nasdaq · 医疗保健 · 外科及医疗仪器和设备

KORU Medical Systems, Inc. is a specialized medical technology company that designs, manufactures, and distributes innovative ambulatory infusion systems and supporting disposable products. It caters to healthcare providers and patients across home care, clinical trial, and acute care segments worldwide, with a focus on enhancing the safety and comfort of specialty medication delivery.

What changed in KORU Medical Systems, Inc.'s 10-K — 2024 vs 2025

Top changes in KORU Medical Systems, Inc.'s 2025 10-K

173 paragraphs added · 163 removed · 127 edited across 5 sections

Item 1. Business

Business — how the company describes what it does

23 edited+7 added−4 removed75 unchanged
We aim to achieve this by expanding our leadership and market penetration in the domestic and international subcutaneous immunoglobulin (SCIg) market while extending our expertise into emerging subcutaneous drug therapies. Both SCIg and novel drug therapies will leverage our Freedom Infusion System and upcoming innovations within the platform, supporting healthcare providers in delivering optimized, efficient, and patient-friendly infusion solutions.
We aim to achieve this by expanding our leadership and market penetration in the domestic and international subcutaneous immunoglobulin (SCIg) market while extending our expertise into emerging subcutaneous drug therapies. Both SCIg and novel drug therapies will leverage our FREEDOM System and upcoming innovations within the platform, supporting healthcare providers in delivering optimized, efficient, and patient-friendly infusion solutions.
Device Classification and Clearance Except where an exemption applies, each new or significantly modified medical device we seek to commercially distribute in the U.S. will require either a premarket notification to the FDA requesting permission for commercial distribution under Section 510(k) of the Federal Food, Drug and Cosmetic Act (“FFDCA”), also known as a 510(k) clearance, approval of a pre-market approval (“ra”) application, or as part of a drug-device combination product through a Biologics License Application (“BLA”) or New Drug Application (“NDA”).
Device Classification and Clearance Except where an exemption applies, each new or significantly modified medical device we seek to commercially distribute in the U.S. will require either a premarket notification to the FDA requesting permission for commercial distribution under Section 510(k) of the Federal Food, Drug and Cosmetic Act (“FFDCA”), also known as a 510(k) clearance, approval of a pre-market approval application, or as part of a drug-device combination product through a Biologics License Application (“BLA”) or New Drug Application (“NDA”).
These laws include: - 6 - Table of Contents • the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs.
These laws include: - 7 - Table of Contents • the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual for, or the purchase, order or recommendation of, any good or service for which payment may be made under federal healthcare programs, such as the Medicare and Medicaid programs.
By reducing the complexity of infusions, improving workflow efficiencies, and supporting economic sustainability for providers, we help ensure that SCIg therapy remains a viable and preferred option for a growing number of patients. - 3 - Table of Contents Through ongoing clinical and product innovation, strategic partnerships, and commercial excellence, we will continue to expand our presence in the SCIg market.
By reducing the complexity of infusions, improving workflow efficiencies, and supporting economic sustainability for providers, we help ensure that SCIg therapy remains a viable and preferred option for a growing number of patients. - 4 - Table of Contents Through ongoing clinical and product innovation, strategic partnerships, and commercial excellence, we will continue to expand our presence in the SCIg market.
We cannot predict with any certainty how future reforms to Federal regulations may impact our business. See “ITEM 1A. RISK FACTORS.” - 5 - Table of Contents Under the PMA application process, the applicant must demonstrate that the device is safe and effective for its intended use.
We cannot predict with any certainty how future reforms to Federal regulations may impact our business. See “ITEM 1A. RISK FACTORS.” - 6 - Table of Contents Under the PMA application process, the applicant must demonstrate that the device is safe and effective for its intended use.
The remaining 85% of our consumable supply is sourced from Command Medical Products, Inc. (“Command”), a contract manufacturing organization with operations in Nicaragua. Our ability to meet customer demand depends, in part, on our ability to obtain timely and adequate delivery of components for our products.
The remaining amount of our consumable supply is sourced from Command Medical Products, Inc. (“Command”), a contract manufacturing organization with operations in Nicaragua. Our ability to meet customer demand depends, in part, on our ability to obtain timely and adequate delivery of components for our products.
We do not use significant amounts of hazardous materials in the assembly of our products. - 7 - Table of Contents COMPETITION AND THE MARKET Competition for the FREEDOM System includes electronic (volumetric) pumps, elastomeric (infuser) pumps, and fully mechanical pumps as well as other types of pumps.
We do not use significant amounts of hazardous materials in the assembly of our products. - 8 - Table of Contents COMPETITION AND THE MARKET Competition for the FREEDOM System includes electronic (volumetric) pumps, elastomeric (infuser) pumps, and fully mechanical pumps as well as other types of pumps.
In our goal to expand into novel therapies outside of SCIg, we estimate that at least 100 large-volume drugs, greater than 2ml, are in clinical development utilizing subcutaneous infusion, with approximately 20% greater than 10ml.
In our goal to expand into novel therapies outside of SCIg, we estimate that at least 170 large-volume drugs, greater than 2ml, are in clinical development utilizing subcutaneous infusion, with approximately 20% greater than 10ml.
Novel therapies revenues consist of Product Revenue for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in the drug development process as well as non-recurring engineering services (“NRE”) revenues (including product innovation, testing and registration services) received from biopharmaceutical companies to ready or customize the FREEDOM System for clinical and commercial use across multiple drug categories.
Pharma services and clinical trials revenues consist of Product Revenue for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in the drug development process as well as non-recurring engineering services (“NRE”) revenues (including product innovation, testing and registration services) received from biopharmaceutical companies to ready or customize the FREEDOM System for clinical and commercial use across multiple drug categories.
Pazdan joined KORU Medical in 2021 as Vice President of Quality Assurance and Regulatory Affairs before being promoted to Senior Vice President of Operations in 2022, and subsequently to Chief Operating Officer in July 2024. As Chief Operating Officer, Mr. Pazdan oversees Research & Development, Manufacturing, Sourcing, Supply Chain, Quality, Regulatory and Project Management. Prior to joining KORU, Mr.
Pazdan joined KORU Medical in September 2021 as Vice President of Quality Assurance and Regulatory Affairs before being promoted to Senior Vice President of Operations in 2022, and subsequently to Chief Operating Officer in July 2024. As Chief Operating Officer, Mr. Pazdan oversees Manufacturing, Sourcing, Supply Chain, Quality, Regulatory and Project Management. Prior to joining KORU, Mr.
Specialty pharmacies, home infusion providers, and distributors are our primary sales contacts, although we provide education and training materials to clinicians, patients, and patient advocates both in the field and online. - 4 - Table of Contents MANUFACTURING AND RAW MATERIALS We currently manufacture 100% of our pump product volume and approximately 15% of our consumables volume at our Mahwah, NJ facility.
Specialty pharmacies, home infusion providers, and distributors are our primary sales contacts, although we provide education and training materials to clinicians, patients, and patient advocates both in the field and online. - 5 - Table of Contents MANUFACTURING AND RAW MATERIALS We currently manufacture 100% of our pump product volume and a portion of our consumables volume at our Mahwah, NJ facility.
PATENTS AND INTELLECTUAL PROPERTY We have patents and other intellectual property that we believe protect the FREEDOM System, and we continue to file patent applications in connection with our research and development activities. As of December 31, 2024, we own 14 U.S. Patents and 34 foreign patents.
PATENTS AND INTELLECTUAL PROPERTY We have patents and other intellectual property that we believe protect the FREEDOM System, and we continue to file patent applications in connection with our research and development activities. As of December 31, 2025, we own 15 U.S. Patents and 26 foreign patents.
Our revenues are derived from three business sources: (i) domestic core (which consists of US and Canada), (ii) international core, and (iii) novel therapies.
Our revenues are derived from three business sources: (i) domestic core (which consists of US and Canada), (ii) international core, and (iii) pharma services and clinical trials.
To reinforce our leadership in SCIg, we have identified key market trends driving its continued growth, including: • Increasing diagnoses of Primary Immunodeficiency Diseases (PIDD) , which frequently require immunoglobulin (Ig) treatment. • Expansion of on-label SCIg indications , including Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Secondary Immunodeficiency Diseases (SIDD), and additional conditions currently in clinical development. • Growth in SCIg treatment options , such as the introduction of Cutaquig® and Xembify® in the United States and Europe, along with the planned launches of Cuvitru® and HyQvia® in Japan. • Ongoing biopharmaceutical investment in SCIg therapies , including prefilled syringe formats designed to enhance ease of use and expand patient eligibility for SCIg treatment. • Increasing availability of donated plasma , which supports the growing global supply of Ig medications. • Patient preference and cost-effectiveness of at-home SCIg therapy , which offers a favorable side effect profile and health economic advantages compared to intravenous Ig (IVIg) treatment.
To reinforce our leadership in SCIg, we have identified key market trends driving its continued growth, including: • Increasing diagnoses of Primary Immunodeficiency Diseases (PIDD) , which frequently require immunoglobulin (Ig) treatment. • Expansion of on-label SCIg indications , including Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Secondary Immunodeficiency Diseases (SIDD), and additional conditions currently in clinical development. • Growth in SCIg treatment options ; KORU is well positioned to lead the global transition to prefilled syringe delivery across major drug brands, with a focus on improving the SCIg patient experience. • Ongoing biopharmaceutical investment in SCIg therapies , including prefilled syringe formats designed to enhance ease of use and expand patient eligibility for SCIg treatment. • Increasing availability of donated plasma , which supports the growing global supply of Ig medications. • Patient preference and cost-effectiveness of at-home SCIg therapy , which offers a favorable side effect profile and health economic advantages compared to intravenous Ig (IVIg) treatment.
HUMAN CAPITAL RESOURCES As of December 31, 2024, we had 80 full time employees, including 3 international employees. As of December 31, 2024, approximately 49% of the Company’s workforce was female and approximately 31% of the Company’s employees in managerial roles were female. Approximately 43% were minorities (non-White) in the Company workforce as of December 31, 2024.
HUMAN CAPITAL RESOURCES As of December 31, 2025, we had 73 full time employees, including 4 international employees. As of December 31, 2025, approximately 48% of the Company’s workforce was female and approximately 41% of the Company’s employees in managerial roles were female. Approximately 38% were minorities (non-White) in the Company workforce as of December 31, 2025.
The needle sets are available in 26- and 24-gauge sizes and feature unique design elements specific to subcutaneous self-administration. Precision Flow Rate Tubing is designed for repeatable flow rates without allowing unrestricted flow. The tubing regulates the flow rate and infusion time for various applications when used with the FREEDOM System.
HIgH-Flo Subcutaneous Safety Needle Sets are an important element of the FREEDOM System. The needle sets are available in 26- and 24-gauge sizes and feature unique design elements specific to subcutaneous self-administration. Precision Flow Rate Tubing is designed for repeatable flow rates without allowing unrestricted flow.
The fundamental patents protecting our drug delivery systems extend until 2039 and beyond. - 8 - Table of Contents EXECUTIVE OFFICERS The following table sets forth certain information with respect to our executive officers as of March 12, 2025: Name Age Position / Held Since Linda Tharby 56 Chief Executive Officer and President (since April 2021) Tom Adams 52 Chief Financial Officer, Secretary and Treasurer (since August 2023) Christopher Pazdan 42 Chief Operating Officer (since July 2024) Ken Miller 56 Chief Commercial Officer (since November 2023) Executive officers hold office at the discretion of the Board of Directors.
EXECUTIVE OFFICERS The following table sets forth certain information with respect to our executive officers as of March 12, 2026: - 9 - Table of Contents Name Age Position / Held Since Linda Tharby 57 Chief Executive Officer and President (since April 2021) Tom Adams 53 Chief Financial Officer, Secretary and Treasurer (since August 2023) Christopher Pazdan 43 Chief Operating Officer (since July 2024) Adam Kalbermatten 42 Chief Commercial Officer (since July 2025) Eric Schiller 52 Chief Technology Officer (since December 2025) Executive officers hold office at the discretion of the Board of Directors.
We spent $5.3 million and $5.7 million on research and development for the years ended December 31, 2024 and 2023, respectively. We intend to make additional investments in research and development for a “next-generation” infusion pump and consumable system as well as for future innovation.
We spent $4.4 million and $5.3 million on research and development for the years ended December 31, 2025 and 2024, respectively. We intend to make ongoing investments in research and development for our infusion pumps, consumable systems, and accessories, as well as for future innovation.
It is expected that patient access to SCIg will expand as new drugs are developed, existing drugs are approved and/or marketed in new countries, and existing drugs receive new indications. HIgH-Flo Subcutaneous Safety Needle Sets are an important element of the FREEDOM System.
It is expected that patient access to SCIg will expand as new drugs are developed, existing drugs are approved and/or marketed in new countries, and existing drugs receive new indications. The FREEDOM System is also approved in the US for the administration by healthcare professionals of RYSTIGGO, a novel biologic, for the treatment of generalized myasthenia (gMG).
Our products are sold principally through a small number of distributors so our specialty pharmacy customers receive the benefit of remote inventory management and one-stop shopping. We sell the majority of our products through three distributors in the U.S. and three distributors outside the U.S.
SALES AND DISTRIBUTION The FREEDOM System is sold through both direct sales and medical device distributors to pharmaceutical companies, specialty pharmacy customers and home infusion providers. Our products are sold principally through a small number of distributors so our specialty pharmacy customers receive the benefit of remote inventory management and one-stop shopping.
Each tubing set provides a different level of flow restriction and consistently delivers medication with low residual volume to minimize drug waste. SALES AND DISTRIBUTION The FREEDOM System is sold through both direct sales and medical device distributors to pharmaceutical companies, specialty pharmacy customers and home infusion providers.
The tubing regulates the flow rate and infusion time for various applications when used with the FREEDOM System. Each tubing set provides a different level of flow restriction and consistently delivers medication with low residual volume to minimize drug waste.
As of December 31, 2024, these six distributors comprised approximately 75% of our net revenues with one of our U.S. distributors contributing approximately 35%.
We sell the majority of our products through three distributors in the U.S. and six distributors outside the U.S. As of December 31, 2025, these nine distributors comprised approximately 77% of our net revenues with one of our U.S. distributors contributing approximately 29%.
In addition, we have 10 pending U.S. patent applications and 10 foreign patent applications.
In addition, we have 8 pending U.S. patent applications and 18 foreign patent applications. The fundamental patents protecting our drug delivery systems extend until 2039 and beyond.
Removed
Miller joined KORU Medical in November 2023 as Chief Commercial Officer. Mr. Miller has over 30 years of extensive expertise and experience in leading high-performing teams in commercialization and marketing strategy, international expansion, and driving sustainable growth and profitability. As Chief Commercial Officer, Mr. Miller has oversight of the global commercial function, including U.S. and International sales and marketing organizations.
Added
Kalbermatten joined Koru Medical Systems as Chief Commercial Officer in July 2025, bringing more than 20 years of commercial leadership experience across the medical device and pharmaceutical industries. Adam has a proven track record of accelerating growth, scaling businesses, and building high-performing teams, all while delivering innovative, customer-centric solutions.
Removed
He was President & CEO of NASCO HealthCare from October 2018 through January 2023. At NASCO, he transformed sales & marketing, and led the consolidation of NASCO’s manufacturing footprint which delivered year-over-year double digit revenue and EBITDA growth.
Added
Prior to Koru, Adam served as Vice President and General Manager of the Advanced Drug Delivery Systems business at Becton Dickinson (“BD”) until 2025. He previously served as Chief Executive Officer of ZebraSci, a drug-device combination product development firm, between 2019-2022, where he led a successful turnaround and growth strategy, resulting in the company’s acquisition by BD.
Removed
Prior to NASCO, Ken spent 7 years at BD with his last role as the Worldwide President Diabetes Care where he led the transition from a product focus to a full-service diabetes management solution provider. Ken also held leadership roles in marketing, sales, and business development with Novo Nordisk, Adams Respiratory Therapeutics, and Roche Laboratories.
Added
Earlier in his career, Adam held global leadership and engineering roles at both Terumo Corporation and BD between 2005 and 2019. 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 from Columbia Business School. Mr.
Removed
He 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. - 9 - Table of Contents
Added
Schiller joined Koru Medical Systems as Chief Technology Officer in December 2025, bringing more than 25 years of experience in medical devices and drug-device combination products. He has deep expertise across product development, engineering, supply chain, and lifecycle management.
Added
Prior to joining Koru, Eric held senior leadership roles at Sanofi between 2021 and 2025, most recently serving as Global Head of Device Development Portfolio, where he oversaw more than 80 pipeline assets across Specialty Care, General Medicine, and Vaccines, with approximately 40 planned launches by 2030.
Added
Earlier in his career, Eric held leadership positions at Bristol Myers Squibb, Celgene, Becton Dickinson, and Saint-Gobain, where he led global commercialization efforts and advanced innovative drug-delivery technologies.
Added
Eric holds an MBA from Seton Hall University and a Bachelor of Science in Mechanical Engineering from the New Jersey Institute of Technology and is a named inventor on multiple U.S. patents. - 10 - Table of Contents

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

66 edited+37 added−28 removed180 unchanged
That transition period was extended to May 2021 due to the COVID-19 pandemic. In 2023, the transition period was extended further to December 2028 for Class IIa products. The CE mark required to sell medical devices in the EU is affixed following conformity assessment and either approval from an appointed independent notified body or through self-certification by the manufacturer.
That transition period was extended to May 2021 due to the COVID-19 pandemic. In early 2023, the transition period was further extended to December 2028 for class IIa products. The CE mark required to sell medical devices in the EU is affixed following conformity assessment and either approval from an appointed independent notified body or through self-certification by the manufacturer.
Market acceptance of our biopharma customers’ product candidates, if they receive approval, depends on a number of factors, including the: - 17 - Table of Contents • efficacy and safety of the product candidates; • clinical indications for which the product candidates are approved; • acceptance by physicians, patients and the medical community of the product candidates as a safe and effective treatment; • potential and perceived advantages of the product candidates over alternative treatments; • safety of the product candidates seen in a broader patient group; • prevalence and severity of any side effects; • product labeling or product insert requirements of the FDA or other regulatory authorities; • timing of market introduction of the product candidates as well as competitive products; • cost of treatment in relation to alternative treatments; • availability of coverage and adequate reimbursement and pricing by third party payers and government authorities; • relative convenience and ease of administration; and • effectiveness of the pharmaceutical companies’ sales and marketing efforts.
Market acceptance of our biopharma customers’ product candidates, if they receive approval, depends on a number of factors, including the: • efficacy and safety of the product candidates; • clinical indications for which the product candidates are approved; • acceptance by physicians, patients and the medical community of the product candidates as a safe and effective treatment; • potential and perceived advantages of the product candidates over alternative treatments; • safety of the product candidates seen in a broader patient group; • prevalence and severity of any side effects; • product labeling or product insert requirements of the FDA or other regulatory authorities; • timing of market introduction of the product candidates as well as competitive products; • cost of treatment in relation to alternative treatments; • availability of coverage and adequate reimbursement and pricing by third party payers and government authorities; • relative convenience and ease of administration; and • effectiveness of the pharmaceutical companies’ sales and marketing efforts.
During the Transition Period, negotiations between the UK and the EU continued in relation to the future customs and trading relationship between the UK and the EU following the expiration of the Transition Period. Due to the current COVID-19 global pandemic, negotiations between the UK and the EU were delayed.
During the Transition Period, negotiations between the UK and the EU continued in relation to the future customs and trading relationship between the UK and the EU following the expiration of the Transition Period. Due to the COVID-19 global pandemic, negotiations between the UK and the EU were delayed.
These fluctuations may adversely affect our results of operations and financial conditions and our stock price. - 21 - Table of Contents Future material impairments in the value of our long-lived assets could negatively affect our operating results. We review our long-lived assets, including identifiable intangible assets and property, plant and equipment, for impairment.
These fluctuations may adversely affect our results of operations and financial conditions and our stock price. - 23 - Table of Contents Future material impairments in the value of our long-lived assets could negatively affect our operating results. We review our long-lived assets, including identifiable intangible assets and property, plant and equipment, for impairment.
Risks Related to Ownership of Our Common Stock There may be circumstances in which the interests of our significant stockholders could be in conflict with your interests as a stockholder. Three stockholders, together with their respective affiliates, beneficially own approximately 13%, 10%, and 9% of our outstanding common stock, respectively.
Risks Related to Ownership of Our Common Stock There may be circumstances in which the interests of our significant stockholders could be in conflict with your interests as a stockholder. Three stockholders, together with their respective affiliates, beneficially own approximately 13%, 9%, and 8% of our outstanding common stock, respectively.
Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business and may harm our reputation and financial results. - 14 - Table of Contents Personal injuries relating to the use of our products can also result in significant product liability claims being brought against us.
Any corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time and capital, distract management from operating our business and may harm our reputation and financial results. Personal injuries relating to the use of our products can also result in significant product liability claims being brought against us.
The adoption of some or all of these proposals could have a material adverse effect on our business, results of operations, financial condition and cash flows. Issues with product quality could have an adverse effect upon our business, subject us to regulatory actions, cause a loss of customer confidence in us or our products, among other negative consequences.
The adoption of some or all of these proposals could have a material adverse effect on our business, results of operations, financial condition and cash flows. - 15 - Table of Contents Issues with product quality could have an adverse effect upon our business, subject us to regulatory actions, cause a loss of customer confidence in us or our products, among other negative consequences.
If adequate funds are not available from the foregoing sources, we may consider additional strategic financing options, or we may be required to delay, reduce the scope of, or eliminate our research or development and/or some of our commercialization efforts. - 19 - Table of Contents We are required to comply with certain financial and operating covenants under our credit facility.
If adequate funds are not available from the foregoing sources, we may consider additional strategic financing options, or we may be required to delay, reduce the scope of, or eliminate our research or development and/or some of our commercialization efforts. We are required to comply with certain financial and operating covenants under our credit facility.
Misappropriation or other loss of our intellectual property from any of the foregoing would have an adverse effect on our competitive position and may cause us to incur substantial litigation costs. - 15 - Table of Contents We need to attract and retain key employees to be competitive.
Misappropriation or other loss of our intellectual property from any of the foregoing would have an adverse effect on our competitive position and may cause us to incur substantial litigation costs. We need to attract and retain key employees to be competitive.
Any decline in the price of our common stock may encourage short sales, which could place further downward pressure on the price of our common stock and may impair our ability to raise additional capital through the sale of equity securities. - 24 - Table of Contents You may find it difficult to sell our common stock.
Any decline in the price of our common stock may encourage short sales, which could place further downward pressure on the price of our common stock and may impair our ability to raise additional capital through the sale of equity securities. You may find it difficult to sell our common stock.
However, on December 24, 2020, the negotiators from the EU and UK reached an agreement on a new partnership. This agreement sets out the - 22 - Table of Contents rules that apply between the EU and the UK as of January 1, 2021.
However, on December 24, 2020, the negotiators from the EU and UK reached an agreement on a new partnership. This agreement sets out the rules that apply between the EU and the UK as of January 1, 2021.
If we were unable to sell through the distributors outside the U.S., we would have to find other distributors or broaden our customer base and expand direct relationships with customers. Other distributors may not be available or may not agree to arrangements that are commercially reasonable.
If we were unable to sell through the distributors outside the U.S., we would have to find other distributors or broaden our customer base and expand direct - 11 - Table of Contents relationships with customers. Other distributors may not be available or may not agree to arrangements that are commercially reasonable.
In addition, former employees may develop products that are competitive with ours or capitalize on customer relationships developed while employed with us, subject to their continuing obligations under confidentiality agreements and - 11 - Table of Contents other restrictive covenants that may survive their employment.
In addition, former employees may develop products that are competitive with ours or capitalize on customer relationships developed while employed with us, subject to their continuing obligations under confidentiality agreements and other restrictive covenants that may survive their employment.
We may need additional funding in the future, and if we are unable to raise capital when needed, we may be forced to delay, reduce or eliminate our product development, commercial efforts, or sales efforts. Producing and marketing our developed products is costly.
Risks Related to Our Financial Position We may need additional funding in the future, and if we are unable to raise capital when needed, we may be forced to delay, reduce or eliminate our product development, commercial efforts, or sales efforts. Producing and marketing our developed products is costly.
Approximately 20% of our net revenues in the year ended December 31, 2024, came from our operations outside the U.S., and we intend to continue to pursue growth opportunities in foreign markets.
Approximately 26% of our net revenues in the year ended December 31, 2025, came from our operations outside the U.S., and we intend to continue to pursue growth opportunities in foreign markets.
Regardless of whether an active and liquid public market exists, negative fluctuations in our actual or anticipated operating results will likely cause the market price of our common stock to fall, making it more difficult for you to sell our common stock at a favorable price, or at all. ITEM 1B. UNRESOLVED STAFF COMMENTS Not applicable.
Regardless of whether an active and liquid public market exists, negative fluctuations in our actual or anticipated operating results will likely cause the market price of our common stock to fall, making it more difficult for you to sell our common stock at a favorable price, or at all.
Because stock options granted under our equity compensation plans will generally only be exercised when the exercise price for such option is below the then market value of the common stock, the exercise of such options or the issuance of shares will cause dilution to the book value per share of our common stock and to existing and new investors. - 23 - Table of Contents There has been volatility in the price of shares of our common stock.
Because stock options granted under our equity compensation plans will generally only be exercised when the exercise price for such option is below the then market value of the common stock, the exercise of such options or the issuance of shares will cause dilution to the book value per share of our common stock and to existing and new investors.
Future events or decisions may lead to asset impairments and/or related charges. Certain non-cash impairments may result from a change in our strategic goals, business direction or other factors relating to the overall business environment. Material impairment charges could negatively affect our results of operations. Actions of activist stockholders could have an adverse effect on our business.
Future events or decisions may lead to asset impairments and/or related charges. Certain non-cash impairments may result from a change in our strategic goals, business direction or other factors relating to the overall business environment. Material impairment charges could negatively affect our results of operations.
In addition, the regulatory approval is held by the pharmaceutical manufacturer, not KORU. - 12 - Table of Contents We cannot guarantee that we will be able to obtain or maintain FDA 510(k) clearance or premarket approval for our new products or enhancements or modifications to existing products (including the use of our FREEDOM System with therapies not covered by the existing FDA clearance), and the failure to maintain approvals or clearances, or obtain approval or clearance could have a material adverse effect on our business, results of operations, financial condition and cash flows.
We cannot guarantee that we will be able to obtain or maintain FDA 510(k) clearance or premarket approval for our new products or enhancements or modifications to existing products (including the use of our FREEDOM System with therapies not covered by the existing FDA clearance), and the failure to maintain approvals or clearances, or obtain approval or clearance could have a material adverse effect on our business, results of operations, financial condition and cash flows.
As a result of these and other risks described herein that are inherent in the development and sale of therapeutic agents, pharmaceutical companies may never successfully develop or successfully commercialize their drugs, or the commercialization of their drugs may be abandoned or severely limited, which may limit our profitability with respect to biopharma customers with drugs or drug-device combination products including those drugs and our device, and we may not be successful in achieving commercial scale production and sales of our injectable drug delivery systems in combination with certain drugs.
As a result of these and other risks described herein that are inherent in the development and sale of therapeutic agents, pharmaceutical companies may never successfully develop or successfully commercialize their drugs, or the commercialization of their drugs may be abandoned or severely limited, which may limit our profitability with respect to biopharma customers with drugs or drug-device combination products including those drugs and our device, and we may not be successful in achieving commercial scale production and sales of our injectable drug delivery systems in combination with certain drugs. - 16 - Table of Contents Certain of the injectable therapies being targeted for use with our products are not approved but are in various phases of clinical development.
We sell most of our products through a small number of distributors, three in the U.S. and three outside the U.S. As of December 31, 2024, these six distributors comprised approximately 75% of our net revenues with one U.S. distributor contributing 35%.
We sell most of our products through a small number of distributors, three in the U.S. and six outside the U.S. As of December 31, 2025, these nine distributors comprised approximately 77% of our net revenues with one U.S. distributor contributing 29%.
Medical devices which have a valid CE certificate to the current Medical Device Directives (issued before May 2021), as do all of our current products, can continue to be sold until December 2028 or until the CE certificate expires, whichever comes first, providing there are no significant changes as defined in Article 120 of EU MDR.
Medical devices which have a valid CE certificate to the current Medical Device Directives (issued before May 2021), as do all of our current products, can continue to be sold until December 2028 or until the CE certificate expires, whichever comes first, providing there are no significant changes as defined in Article 120 of EU MDR. - 19 - Table of Contents The MDR was published in May 2017 with a 3-year transition period.
Since our common stock was listed on the Nasdaq Capital Market on October 17, 2019, it has traded between $1.82 per share to $12.84 per share.
There has been volatility in the price of shares of our common stock. Since our common stock was listed on the Nasdaq Capital Market on October 17, 2019, it has traded between $1.82 per share to $12.84 per share.
In the U.S., our device products are subject to clearance or approval by FDA under the FFDCA. Before we can market a new medical device, or a new use of, new claim for, or significant modification to, an existing product, we must first receive either 510(k) clearance or approval of a PMA application from the FDA, unless an exemption applies.
Before we can market a new medical device, or a new use of, new claim for, or significant modification to, an existing product, we must first receive either 510(k) clearance or approval of a PMA application from the FDA, unless an exemption applies.
From time to time, we may be subject to proposals by stockholders urging us to take certain corporate actions. If activist stockholder activities ensue, our business could be adversely affected because responding to proxy contests and reacting to other actions by activist stockholders can be costly and time-consuming, disrupt our operations and divert the attention of management and our employees.
If activist stockholder activities ensue, our business could be adversely affected because responding to proxy contests and reacting to other actions by activist stockholders can be costly and time-consuming, disrupt our operations and divert the attention of management and our employees.
Our stock price is subject to wide fluctuations in response to a variety of factors, including: • quarterly variations in operating results; • announcement of new products or customers by our competitors; • changes in financial estimates by securities analysts; • trading volume on the Nasdaq Capital Market; • announcements related to litigation; • general economic conditions; or • other events or factors that are beyond our control.
Our stock price is subject to wide fluctuations in response to a variety of factors, including: • quarterly variations in operating results; • announcement of new products or customers by our competitors; • changes in financial estimates by securities analysts; • trading volume on the Nasdaq Capital Market; • announcements related to litigation; • general economic conditions; or • other events or factors that are beyond our control. - 24 - Table of Contents In addition, the stock market has experienced significant price and volume fluctuations that have particularly affected the trading prices of equity securities of many biotechnology companies.
Events such as a delay in product development, increases in litigation expenses, changes to our expectations or strategy or even a relatively small revenue shortfall may cause financial results for a period to be below our expectations or projections.
Our operating results and financial condition may fluctuate from quarter to quarter and year to year for a number of reasons. Events such as a delay in product development, increases in litigation expenses, changes to our expectations or strategy or even a relatively small revenue shortfall may cause financial results for a period to be below our expectations or projections.
Any significant changes in the political, economic, financial, competitive, legal and regulatory or reimbursement conditions where we conduct, or plan to expand, our international operations may have a material impact on our business, financial condition or results of operations.
Sanctions and export restrictions may continue to proliferate, leading to greater uncertainty in emerging and growth markets. Any significant changes in the political, economic, financial, competitive, legal and regulatory or reimbursement conditions where we conduct, or plan to expand, our international operations may have a material impact on our business, financial condition or results of operations.
We do not have long-term agreements in place with any of our suppliers, with the exception of a five- year agreement with Command which we entered in 2020. Due to regulatory requirements relating to the qualification of suppliers, we are not likely to be able to establish additional or replacement sources on a timely basis or without excessive cost.
We do not have long-term agreements in place with any of our suppliers, with the exception of an agreement with Command that expires December 31, 2026, subject to renewal. Due to regulatory requirements relating to the qualification of suppliers, we are not likely to be able to establish additional or replacement sources on a timely basis or without excessive cost.
A downturn in global economic conditions could adversely affect our operations. Deterioration in the global economic environment, particularly in countries with government-sponsored healthcare systems, may cause decreased demand for our products and increased competition, which could result in lower sales volume and downward pressure on the prices for our products, longer sales cycles, and slower adoption of new technologies.
Deterioration in the global economic environment, particularly in countries with government-sponsored healthcare systems, may cause decreased demand for our products and increased competition, which could result in lower sales volume, lower end-user demand through changes to payor reimbursement, and downward pressure on the prices for our products, longer sales cycles, and slower adoption of new technologies.
In addition, perceived uncertainties as to our future direction, strategy or leadership created as a consequence of activist stockholder initiatives may result in the loss of potential business opportunities, harm our ability to attract new investors, customers, employees, and joint venture partners, and cause our stock price to experience periods of volatility or stagnation.
In addition, perceived uncertainties as to our future direction, strategy or leadership created as a consequence of activist stockholder initiatives may result in the loss of potential business opportunities, harm our ability to attract new investors, customers, employees, and joint venture partners, and cause our stock price to experience periods of volatility or stagnation. - 25 - Table of Contents General Risk Factors Natural disasters, war and other events could adversely affect our suppliers and customers.
Frequently, regulatory approval may first be obtained in a foreign country prior to application in the U.S. due to differing regulatory requirements; however, other countries, such as China for example, require approval in the country of origin or legal manufacturer first.
Some countries do not have medical device regulations, but in most foreign countries, medical devices are regulated. Frequently, regulatory approval may first be obtained in a foreign country prior to application in the U.S. due to differing regulatory requirements; however, other countries, such as China for example, require approval in the country of origin or legal manufacturer first.
Recent increases in U.S. minimum wage requirements, as well as those imposed by the state of New York and New Jersey will increase our costs for employees to support those operations, reduce our margins and negatively impact our profit. President Trump has indicated his willingness to increase the use of tariffs by the U.S. to accomplish certain U.S. policy goals.
Recent increases in U.S. minimum wage requirements, as well as those imposed by the state of New York and New Jersey will increase our costs for employees to support those operations, reduce our margins and negatively impact our profit.
In addition, we are subject to the risk that one or more of our insurers may become insolvent and become unable to pay claims that may be made in the future.
Our insurance coverage may not provide adequate protection against actual losses. In addition, we are subject to the risk that one or more of our insurers may become insolvent and become unable to pay claims that may be made in the future.
The failure to receive product approval clearance on a timely basis, suspensions of regulatory clearances, seizures or recalls of products, physician advisories or other field actions, or the withdrawal of product approval by the FDA or by comparable agencies in foreign countries could have a material adverse effect on our business, financial condition or results of operations.
The failure to receive product approval clearance on a timely basis, suspensions of regulatory clearances, seizures or recalls of products, physician advisories or other field actions, or the withdrawal of product approval by the FDA or by comparable agencies in foreign countries could have a material adverse effect on our business, financial condition or results of operations. - 18 - Table of Contents Governmental regulations outside the U.S. have also, and may continue to, become increasingly stringent and common.
If there is not an adequate supply of drugs requiring administration by medical devices such as those provided by us or alternative therapies are developed, our sales may suffer and/or our products may become obsolete.
If there is not an adequate supply of drugs requiring administration by medical devices such as those provided by us or alternative therapies are developed, our sales may suffer and/or our products may become obsolete. The size of the markets for our products and any future products may be smaller than we estimate and may decline.
We take precautions to safeguard our facility, including acquiring insurance, adopting health and safety protocols and utilizing off-site storage of computer data. Our insurance may not cover our losses in any particular case. In addition, regardless of the level of insurance coverage, damage to our facility may harm our business, financial condition and operating results.
We take precautions to safeguard our facility, including acquiring insurance, adopting health and safety protocols and utilizing off-site storage of computer data. Our insurance may not cover our losses in any particular case.
We expect this global regulatory environment will continue to evolve, which could impact our ability to obtain future approvals for our products or could increase the cost and time to obtain such approvals in the future. Healthcare policy changes and industry cost-containment measures could result in downward pricing pressure for our products and limit our sales.
We expect this global regulatory environment will continue to evolve, which could impact our ability to obtain future approvals for our products or could increase the cost and time to obtain such approvals in the future.
Governmental regulations outside the U.S. have also, and may continue to, become increasingly stringent and common. Penalties for regulatory non-compliance could be severe, including fines and revocation or suspension of a company’s EU device approval, ability to distribute products and criminal sanctions. Future foreign governmental laws and regulations may have a material adverse effect on us.
Penalties for regulatory non-compliance could be severe, including fines and revocation or suspension of a company’s EU device approval, ability to distribute products and criminal sanctions. Future foreign governmental laws and regulations may have a material adverse effect on us. In addition, exported devices are subject to the regulatory requirements of each country to which the device is exported.
Most of our customers, and those to whom our customers supply medical devices, rely on third-party payers, including government programs and private health insurance plans, to reimburse some or all the cost of the medical devices we manufacture.
Healthcare policy changes and industry cost-containment measures could result in downward pricing pressure for our products and limit our sales. Most of our customers, and those to whom our customers supply medical devices, rely on third-party payers, including government programs and private health insurance plans, to reimburse some or all the cost of the medical devices we manufacture.
Any negative change in the public’s perception of the prospects of medical device companies could further depress our stock price regardless of our results.
These fluctuations have often been unrelated or disproportionate to the operating performance of these companies. Any negative change in the public’s perception of the prospects of medical device companies could further depress our stock price regardless of our results.
Although we believe we currently have adequate capital to fulfill our near-term funding needs, we may need to raise additional capital in the future in order to execute our business plan and help us fund the development and commercialization of new products.
Although we believe we currently have adequate capital to fulfill our near-term funding needs, we may need to raise additional capital in the future in order to execute our business plan and help us fund the development and commercialization of new products. - 22 - Table of Contents We may finance future cash needs through public or private equity offerings and may also use debt financings or strategic collaboration and licensing arrangements.
We may finance future cash needs through public or private equity offerings and may also use debt financings or strategic collaboration and licensing arrangements. We may seek to access the public or private equity markets whenever conditions are favorable, even if we do not have an immediate need for additional capital.
We may seek to access the public or private equity markets whenever conditions are favorable, even if we do not have an immediate need for additional capital.
In addition, we are subject to the U.S. Foreign Corrupt Practices Act and similar anti-corruption laws outside the U.S. Actual or alleged violation of these laws by our employees, consultants, sales agents or distributors could subject us to investigations by the U.S. or foreign governments, significant criminal or civil sanctions and other liabilities, and damage our reputation.
Actual or alleged violation of these laws by our employees, consultants, sales agents or distributors could subject us to investigations by the U.S. or foreign governments, significant criminal or civil sanctions and other liabilities, and damage our reputation. - 20 - Table of Contents Risks Related to Economic Conditions Our distribution network and other operations outside the U.S. subject us to certain risks.
We will continue to monitor inflation trends and will make adjustments to our business as necessary. Brexit may impact our business in the United Kingdom. One of our two most significant international distributors is located in the United Kingdom (“UK”), and the other is in Finland, a member of the European Union (“EU”).
Brexit may impact our business in the United Kingdom. One of our two most significant international distributors is located in the United Kingdom (“UK”), and the other is in Finland, a member of the EU.
Therefore, we must be compliant with applicable legislation in order to identify our devices with the UKCA mark and continue to market and sell our devices in Great Britain beyond June 30, 2030. We could be adversely affected, directly or indirectly, by the effects of an increased focus on environmental, social and governance issues.
Therefore, we must be compliant with applicable legislation in order to identify our devices with the UKCA mark and continue to market and sell our devices in Great Britain beyond June 30, 2030.
Our ability to recruit such talent will depend on a number of factors, including compensation and benefits, work location and work environment. There can be no assurance that we will be successful in attracting or retaining such personnel and the failure to do so could have a material adverse effect on our business, financial condition and results of operations.
There can be no assurance that we will be successful in attracting or retaining such personnel and the failure to do so could have a material adverse effect on our business, financial condition and results of operations. - 14 - Table of Contents Recent immigration enforcement actions in the U.S. could impact our operations or the operations of our suppliers and vendors, and the ability to retain talented personnel.
If we are unable to obtain sufficient insurance coverage at an acceptable cost or otherwise, or if the amount of any claim against us exceeds the coverage under our policies, we may face significant expenses. Rising inflation increases economic uncertainty and may require us to raise prices in order to maintain our operating margins.
If we are unable to obtain sufficient insurance coverage at an acceptable cost or otherwise, or if the amount of any claim against us exceeds the coverage under our policies, we may face significant expenses. ITEM 1B. UNRESOLVED STAFF COMMENTS Not applicable.
In particular, elective procedures and exams were delayed or cancelled, there were significant reductions in physician office visits, and hospitals postponed or canceled capital purchases as well as limited or eliminated services.
In response to the COVID-19 pandemic, governments around the world imposed measures designed to reduce the transmission of COVID-19 and individuals responded to the fear of contracting COVID-19. In particular, elective procedures and exams were delayed or cancelled, there were significant reductions in physician office visits, and hospitals postponed or canceled capital purchases as well as limited or eliminated services.
If competitors develop more effective or affordable products or achieve earlier patent protection or product commercialization for new products than we do, our operations will likely be adversely affected. We are subject to costly and complex laws and governmental regulations and any adverse regulatory action may materially adversely affect our financial condition and business operations.
If competitors develop more effective or affordable products or achieve earlier patent protection or product commercialization for new products than we do, our operations will likely be adversely affected.
There can be no assurance that we will be able to continue to maintain such insurance, or obtain comparable insurance at a reasonable cost, if at all.
Although we carry insurance at levels customary for companies in our industry, such coverage may become unavailable or be inadequate to cover all liabilities we may incur. There can be no assurance that we will be able to continue to maintain such insurance, or obtain comparable insurance at a reasonable cost, if at all.
For much of the past two years, inflation rates have risen or held steady at rates not seen in a generation or more.
Rising inflation increases economic uncertainty and may require us to raise prices in order to maintain our operating margins. For much of the past two years, inflation rates have risen or held steady at rates not seen in a generation or more.
MDR also significantly modifies and increases the compliance requirements for the industry and will require significant investment in the near future to implement. - 16 - Table of Contents If our devices are commercialized as part of a drug-delivery combination product we, as the manufacturer of the device component of that combination product, we are subject to unannounced and preapproval inspections by the FDA of our manufacturing facility to determine our compliance with QSR and cGMP.
The FDA has broad post-market and regulatory enforcement powers. If our devices are commercialized as part of a drug-delivery combination product we, as the manufacturer of the device component of that combination product, we are subject to unannounced and preapproval inspections by the FDA of our manufacturing facility to determine our compliance with QSR and cGMP.
There can be no assurance that we will receive the required approvals for new products or modifications to existing products on a timely basis or that any approval will not be subsequently withdrawn or conditioned upon extensive post market study requirements. - 13 - Table of Contents Our global regulatory environment is becoming increasingly stringent and unpredictable, which could increase the time, cost and complexity of obtaining regulatory approvals for our products, as well as the clinical and regulatory costs of supporting those approvals.
There can be no assurance that we will receive the required approvals for new products or modifications to existing products on a timely basis or that any approval will not be subsequently withdrawn or conditioned upon extensive post market study requirements.
These outcomes may in turn result in customers transitioning to available competitive products, loss of market share, negative publicity, reputational damage, loss of customer confidence or other negative consequences (including a decline in stock price). - 18 - Table of Contents Our failure to comply with laws and regulations relating to reimbursement of healthcare products may subject us to penalties and adversely impact our reputation, business, results of operations, financial condition and cash flows.
These outcomes may in turn result in customers transitioning to available competitive products, loss of market share, negative publicity, reputational damage, loss of customer confidence or other negative consequences (including a decline in stock price). Interruption of our manufacturing or our contract manufacturing operations could adversely affect our business.
A weakening of economic conditions in the U.S. and/or abroad may also adversely affect our suppliers, which could result in interruptions in supply.
A weakening of economic conditions in the U.S. and/or abroad may also adversely affect our suppliers, which could result in interruptions in supply. Further, sanctions, tariffs, or other measures that restrict international trade, as well as instability resulting from global conflicts, could negatively affect our business operations and results.
MDR also significantly modifies and increases the compliance requirements for the industry and will require significant investment by us in the near future to implement.
MDR also significantly modifies and increases the compliance requirements for the industry and will require significant investment by us in the near future to implement. If we are unable to comply with the MDR by December 2028, we will not be able to sell our products in the EU, which will materially impact our net revenues.
We can lose the protection afforded by these intellectual property assets through patent expirations, legal challenges or governmental action.
Our success depends to a significant degree on our ability to obtain and enforce patents, both in the U.S. and in other countries. We can lose the protection afforded by these intellectual property assets through patent expirations, legal challenges or governmental action.
Our insurance coverage may be inadequate to cover all the liabilities we may incur. We face the risk of exposure to liability claims if any product that we develop causes injury. Although we carry insurance at levels customary for companies in our industry, such coverage may become unavailable or be inadequate to cover all liabilities we may incur.
Even claims without merit could subject us to adverse publicity and require us to incur significant legal fees. Our insurance coverage may be inadequate to cover all the liabilities we may incur. We face the risk of exposure to liability claims if any product that we develop causes injury.
Even claims without merit could subject us to adverse publicity and require us to incur significant legal fees. If we are unable to protect our patents or other proprietary rights, or if we infringe the patents or other proprietary rights of others, our competitiveness and business prospects may be materially damaged.
If we are unable to protect our patents or other proprietary rights, or if we infringe the patents or other proprietary rights of others, our competitiveness and business prospects may be materially damaged. Patent and other proprietary rights are essential to our business. We own patents, trade secrets, trademarks and/or other intellectual property rights related to many of our products.
In some circumstances, adverse events could also cause delays in regulatory approval of new products or the imposition of post-market approval requirements. We are subject to lawsuits. We have been and may be party to lawsuits, settlement discussions, mediations, arbitrations and other disputes, including patent and product liability claims, whether brought by companies, individuals or governmental authorities.
We are subject to lawsuits. We have been and may be party to lawsuits, settlement discussions, mediations, arbitrations and other disputes, including patent and product liability claims, whether brought by companies, individuals or governmental authorities. These matters may result in a loss of patent protection, reduced revenue, incurrence of significant liabilities and diversion of our management’s time, attention and resources.
If we are unable to compete successfully in our highly competitive industry, our business and financial condition may be adversely affected. We operate in a single market – infusion – and are dependent upon our success in that market.
We operate in a single market – infusion – and are dependent upon our success in that market.
Further, sanctions, tariffs, or other measures that restrict international trade, as well as instability resulting from global conflicts, could negatively affect our business operations and results. - 20 - Table of Contents We are subject to foreign currency exchange risk. A portion of our revenues is currently, and we expect in the future to be, derived from international operations.
We will continue to monitor inflation trends and will make adjustments to our business as necessary. We are subject to foreign currency exchange risk. A portion of our revenues is currently, and we expect in the future to be, derived from international operations.
Geopolitical developments related to various global conflicts are sources of uncertainty and may cause disruptions to global or regional markets, supply chains or operations in the regions. Sanctions and export restrictions may continue to proliferate, leading to greater uncertainty in emerging and growth markets.
Geopolitical developments related to various global conflicts are sources of uncertainty and may cause disruptions to global or regional markets, supply chains or operations in the regions. Such global conflicts include, but are not limited to, Russia’s invasion of Ukraine in 2022, uncertainty in the Middle East region, increasing tensions between China and Taiwan, and U.S. military operations in Venezuela.
The financial and operating covenants under the credit facility may limit our ability to borrow funds or capital, including for general corporate purposes and strategic acquisitions. We may experience difficulties resulting from our relatively new and evolving management structure and executive team. We have made a number of changes to our management structure throughout the organization in recent years.
The financial and operating covenants under the credit facility may limit our ability to borrow funds or capital, including for general corporate purposes and strategic acquisitions. Changes in tax or labor laws or exposure to additional income tax liabilities could increase our costs and reduce our margins.
If we cannot adequately mitigate foreign currency exchange rates, our revenues and profit may suffer. Our distribution network and other operations outside the U.S. subject us to certain risks.
If we cannot adequately mitigate foreign currency exchange rates, our revenues and profit may suffer. A government shutdown may have a material adverse impact on our business and results of operations. The Company is subject to various federal regulations and various federal agency oversight.
Removed
The MDR was published in May 2017 with a 3-year transition period. That transition period was extended to May 2021 due to the COVID-19 pandemic. In early 2023, the transition period was further extended to December 2028 for class IIa products.
Added
Our estimates of the total addressable market for our products are based on a number of internal and third-party estimates and assumptions, including, without limitation, the assumed prices at which we can sell our products in those markets.
Removed
The CE mark required to sell medical devices in the EU is affixed following conformity assessment and either approval from an appointed independent notified body or through self-certification by the manufacturer. The selected pathway to CE marking is based on product risk classification.
Added
While we believe our assumptions and the data underlying our estimates are reasonable, these assumptions and estimates may not be correct and the conditions supporting our assumptions or estimates may change at any time, thereby reducing the predictive accuracy of these underlying factors.
Removed
CE marking indicates conformity to the applicable essential requirements of the relevant Medical Device Directives and in the future to the general safety and performance requirements for the new MDR.
Added
As a result, our estimates of the annual total addressable market for our products may prove to be incorrect.
Removed
If we are unable to comply with the MDR by December 2028, we will not be able to sell our products in the EU, which will materially impact our net revenues. - 10 - Table of Contents Interruption of our manufacturing or our contract manufacturing operations could adversely affect our business.
Added
If the actual number of patients with indications who would benefit from our products, the price at which we can sell our products or the annual total addressable market for our products is smaller than we have estimated, it may impair our prospective market and revenue opportunity.
Removed
In response to the COVID-19 pandemic, governments around the world have imposed measures designed to reduce the transmission of COVID-19 and individuals continue to respond to the fear of contracting COVID-19.
Added
In addition, regardless of the level of insurance coverage, damage to our facility may harm our business, financial condition and operating results. - 12 - Table of Contents If we are unable to compete successfully in our highly competitive industry, our business and financial condition may be adversely affected.
Removed
In addition, exported devices are subject to the regulatory requirements of each country to which the device is exported. Some countries do not have medical device regulations, but in most foreign countries, medical devices are regulated.
Added
If a cybersecurity incident was to occur, it could cause substantial disruption to our information systems and breaches of our security systems which could harm our business, customer relations and financial condition. We collect and store sensitive data in the regular course of business on our networks and on third-party controlled applications.
Removed
These matters may result in a loss of patent protection, reduced revenue, incurrence of significant liabilities and diversion of our management’s time, attention and resources. Our insurance coverage may not provide adequate protection against actual losses.
Added
Such sensitive information includes our intellectual property and proprietary business information, information about our customers, suppliers and business partners, and personally identifiable information of our customers and employees. The secure processing, maintenance and transmission of this information is critical to our operations and business strategy.

… 51 more changes not shown on this page.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

2 edited+0 added−0 removed4 unchanged
In addition, the Company is in the process of implementing a program for all team members to participate in ongoing training and awareness programs that include periodic assessments to drive adoption and awareness of cybersecurity processes and controls.
In addition, the Company is in the process of implementing a program for all team members to participate in ongoing training and awareness programs that include periodic assessments to drive adoption and awareness of cybersecurity processes and controls. - 26 - Table of Contents We promote a company-wide culture of cybersecurity risk management intended to protect the confidentiality, integrity, and availability of our critical systems and the information contained therein.
We promote a company-wide culture of cybersecurity risk management intended to protect the confidentiality, integrity, and availability of our critical systems and the information contained therein. No risks from cybersecurity threats or previous cybersecurity incidents have materially affected, or are reasonably likely to materially affect, our business strategy, financial condition or results of operations.
No risks from cybersecurity threats or previous cybersecurity incidents have materially affected, or are reasonably likely to materially affect, our business strategy, financial condition or results of operations.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

3 edited+0 added−0 removed3 unchanged
We currently intend to use all available funds for our business operations. - 25 - Table of Contents We are authorized to issue 77,000,000 shares of capital stock, of which 75,000,000 are designated common stock, $0.01 par value per share, and 2,000,000 are designated preferred stock.
We currently intend to use all available funds for our business operations. We are authorized to issue 77,000,000 shares of capital stock, of which 75,000,000 are designated common stock, $0.01 par value per share, and 2,000,000 are designated preferred stock.
Securities Authorized for Issuance Under Equity Compensation Plans Information relating to our equity compensation plans as of December 31, 2024, under which our equity securities were authorized for issuance, is included in Item 12 of Part III of this Annual Report and such information is incorporated herein by reference. ITEM 6. RESERVED
Securities Authorized for Issuance Under Equity Compensation Plans Information relating to our equity compensation plans as of December 31, 2025, under which our equity securities were authorized for issuance, is included in Item 12 of Part III of this Annual Report and such information is incorporated herein by reference. - 27 - Table of Contents ITEM 6. RESERVED
As of March 12, 2025, 45,957,115 shares of our common stock were issued and outstanding held by approximately 431 stockholders of record. There were no shares of preferred stock issued and outstanding. Dividend Policy We have never declared or paid cash dividends on our capital stock.
As of March 12, 2026, 46,370,432 shares of our common stock were issued and outstanding held by approximately 368 stockholders of record. There were no shares of preferred stock issued and outstanding. Dividend Policy We have never declared or paid cash dividends on our capital stock.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

33 edited+2 added−4 removed23 unchanged
Our future capital requirements may vary from those currently planned and will depend on many factors, including our rate of sales growth, the timing and extent of spending on various strategic initiatives including research and development, our international expansion, the timing of new product introductions, market acceptance of our solutions, and overall economic conditions including inflation and the potential impact of global supply imbalances on the global financial markets.
Our future capital requirements may vary from those currently planned and will depend on many factors, including our rate of sales growth, the timing and extent of spending on various strategic initiatives including research and development, our international expansion, the timing of new product introductions, market acceptance of our solutions, and overall economic conditions including inflation, tariffs, and the potential impact of global supply imbalances on the global financial markets.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis of our financial condition and results of operations should be read together with our consolidated financial statements and related notes included under ITEM 8 of this Annual Report on Form 10-K. This discussion contains forward-looking statements about our business and operations.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion and analysis of our financial condition and results of operations should be read together with our consolidated financial statements and related notes included under ITEM 7 of this Annual Report on Form 10-K. This discussion contains forward-looking statements about our business and operations.
To the extent that current and anticipated future sources of liquidity are or are expected to be insufficient to fund our future business activities and requirements, we may be required to draw on our new credit facility or seek additional equity or debt financing sooner.
To the extent that current and anticipated future sources of liquidity are or are expected to be insufficient to fund our future business activities and requirements, we may be required to draw on our credit facility or seek additional equity or debt financing sooner.
Novel therapies consist of Product Revenue for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in the drug development process as well as non-recurring engineering services (“NRE”) revenues (including testing and registration services) received from biopharmaceutical companies to ready or customize the FREEDOM System for clinical and commercial use across multiple drug categories.
Pharma services and clinical trials consist of Product Revenue for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in the drug development process as well as non-recurring engineering services (“NRE”) revenues (including testing and registration services) received from biopharmaceutical companies to ready or customize the FREEDOM System for clinical and commercial use across multiple drug categories.
Novel therapies revenues consist of product revenues from our infusion system (syringe drivers, tubing and needles) for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in the drug development process as well as non-recurring engineering services revenues (“NRE”) received from biopharmaceutical companies to ready or customize the FREEDOM System for clinical and commercial use.
Pharma services and clinical trials revenues consist of product revenues from our infusion system (syringe drivers, tubing and needles) for feasibility/clinical trials (pre-clinical studies, Phase I, Phase II, Phase III) of biopharmaceutical companies in the drug development process as well as non-recurring engineering services revenues (“NRE”) received from biopharmaceutical companies to ready or customize the FREEDOM Infusion System for clinical and commercial use.
Continued execution on our longer-term strategic plan may require the Company to draw on our credit facility, take on additional debt, raise capital through issuance of equity, or a combination.
Continued execution on our longer-term strategic plan may require the Company to draw on our credit facility, take on additional debt, raise capital through issuance of equity, or utilize a combination of the above.
ACCOUNTING PRONOUNCEMENTS NOT YET ADOPTED Refer to “NOTE 1 — NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES” in the accompanying “Notes to Financial Statements” appearing in this Annual Report on Form 10-K. - 30 - Table of Contents ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Not applicable.
ACCOUNTING PRONOUNCEMENTS NOT YET ADOPTED Refer to “NOTE 1 — NATURE OF OPERATIONS AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES” in the accompanying “Notes to Financial Statements” appearing in this Annual Report on Form 10-K. ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK Not applicable.
The input method that we use is based on costs incurred. Contracts are often modified to account for changes in contract specifications and requirements. Contract modifications exist when the modification either creates new, or changes existing, enforceable rights and obligations.
The input method that we use is based on costs incurred. - 31 - Table of Contents Contracts are often modified to account for changes in contract specifications and requirements. Contract modifications exist when the modification either creates new, or changes existing, enforceable rights and obligations.
As of December 31, 2023, the Company has recognized a contract asset of zero which is included in other accounts receivable in the accompanying balance sheet. Inventory Inventories of raw materials are stated at the lower of standard cost, which approximates average cost, or market value including allocable overhead.
As of December 31, 2025, the Company has recognized a contract asset of $319,955 which is included in other accounts receivable in the accompanying balance sheet. Inventory Inventories of raw materials are stated at the lower of standard cost, which approximates average cost, or market value including allocable overhead.
LIQUIDITY AND CAPITAL RESOURCES Our principal source of liquidity is our cash on hand of $9.6 million as of December 31, 2024. Our principal source of operating cash inflows is from sales of our products in our core business, NRE services, and clinical trial products to our customers.
LIQUIDITY AND CAPITAL RESOURCES Our principal source of liquidity is our cash on hand of $8.9 million as of December 31, 2025. Our principal source of operating cash inflows is from sales of our products in our core business, clinical trial products, and NRE services to our customers.
Our principal cash outflows relate to the purchase and production of inventory, funding of research and development, and selling, general and administrative expenses. To develop new products, support future growth, achieve operating efficiencies, and maintain product quality, we are continuing to invest in research and development, innovation, and equipment. Operating expenses for the 2024 fiscal year were $27.8 million.
Our principal cash outflows relate to the purchase and production of inventory, selling, general and administrative expenses, and funding of research and development, to develop new products, support future growth, achieve operating efficiencies, and maintain product quality, we are continuing to invest in research and development, innovation, and equipment. Operating expenses for the 2025 fiscal year were $28.6 million.
There can be no assurance the Company will be able to obtain the financing or raise the capital required to fund its operations or planned expansion.
There can be no assurance the Company will be able to obtain the financing or raise the capital required to fund its operations or growth opportunities.
Actual results may differ significantly from these estimates under different assumptions, judgments, or conditions. - 29 - Table of Contents Revenue Recognition Our revenues are derived from three business sources: (i) domestic core (which consists of US and Canada), (ii) international core, and (iii) novel therapies.
Actual results may differ significantly from these estimates under different assumptions, judgments, or conditions. Revenue Recognition Our revenues are derived from three business sources: (i) domestic core (which consists of US and Canada), (ii) international core, and (iii) pharma services and clinical trials.
Net cash used in investing activities of $0.8 million for the year ended December 31, 2023, was for capital expenditures for research and development and manufacturing equipment Financing Activities Net cash used in financing activities of $0.2 million for the year ended December 31, 2024 was primarily due to payments on our note payable for insurance premium financing, partially offset by new borrowings for a subsequent insurance premium financing agreement.
Net cash used in financing activities of $0.2 million for the year ended December 31, 2024 was primarily due to payments on our note payable for insurance premium financing, partially offset by new borrowings for a subsequent insurance premium financing agreement.
Operating expenses for the year ended December 31, 2024, were $27.8 million, up from $27.0 million for the same period last year.
Operating expenses for the year ended December 31, 2025, were $28.6 million, up from $27.8 million from the same period last year.
Our revenues derive from three business sources: (i) domestic core (which consists of US and Canada), (ii) international core, and (iii) novel therapies.
Our revenues derive from three business sources: (i) domestic core (which consists of US and Canada), (ii) international core, and (iii) pharma services and clinical trials.
Gross profit, for the year ended December 31, 2024, was $21.3 million, an increase of 27.7% or $4.6 million from the same period last year. Gross margin was 63.4% for the year ended December 31, 2024, an increase from 58.6% from the prior year. We define gross margin as gross profit stated as a percentage of net revenues.
Gross profit for the year ended December 31, 2025, was $25.6 million, an increase of 20.0% or $4.3 million from the same period last year. Gross margin was 62.3% for the year ended December 31, 2025, a decrease from 63.4% from the prior year. We define gross margin as gross profit stated as a percentage of net revenues.
Domestic core growth of 12.3% was primarily driven by volume growth in pumps and consumables attributed to overall SCIg market growth and new account share gains. International core growth of 31.5% was driven by overall SCIg market growth, increased penetration in several established EU markets, and the entry into multiple new geographic markets.
Domestic core growth of 11.0% was primarily driven by volume in consumables and pumps attributed to subcutaneous immunoglobulin (SCIg) market growth and new account share gains. International core growth of 80.0% was primarily driven by SCIg market growth, increased penetration in several established EU markets, and entry into multiple new geographic markets.
Our inventory position was $2.8 million at December 31, 2024, which reflects a decrease of $0.7 million from December 31, 2023. We expect that our cash on hand and cash flows from operations will be sufficient to meet our requirements at least through the next twelve months.
Our inventory position was $3.7 million at December 31, 2025, which reflects an increase of $0.9 million from December 31, 2024. - 29 - Table of Contents We expect that our cash on hand and cash flows from operations will be sufficient to meet our requirements at least through the next twelve months.
Our three operating leases have remaining lease terms of 7.7 years, 4.1 years, and 3.4 years, respectively. Our three finance leases have remaining lease terms of 2.4 years, 2.0 years, and 3.8 years, respectively.
Lease Commitments We have finance and operating leases for our corporate office and certain office and computer equipment. Our three operating leases have remaining lease terms of 6.7 years, 3.1 years, and 2.4 years, respectively. Our three finance leases have remaining lease terms of 1.4 years, 1.0 years, and 2.8 years, respectively.
Cash Flows The following table summarizes our cash flows: Year Ended December 31, 2024 Year Ended December 31, 2023 Net cash used in operating activities $ (319,718 ) $ (4,892,553 ) Net cash used in investing activities $ (1,333,042 ) $ (814,597 ) Net cash used in financing activities $ (248,533 ) $ (218,867 ) Operating Activities Net cash used in operating activities was $0.3 million for the year ended December 31, 2024.
Cash Flows The following table summarizes our cash flows: Year Ended December 31, 2025 Year Ended December 31, 2024 Net cash used in operating activities $ 462,405 $ (319,718 ) Net cash used in investing activities $ (949,790 ) $ (1,333,042 ) Net cash used in financing activities $ (221,350 ) $ (248,533 ) Operating Activities Net cash produced from operating activities was $0.5 million for the year ended December 31, 2025.
Operating Expenses Our selling, general and administrative, research and development and depreciation and amortization expenses for the years ended December 31, 2024, and 2023 are as follows: Years Ended December 31, Change from Prior Year 2024 2023 $ % Selling, general and administrative $ 21,631,674 $ 20,365,617 $ 1,266,057 6.2% Research and development 5,257,942 5,742,254 (484,312 ) (8.4)% Depreciation and amortization 888,473 870,390 18,083 2.1% Total Operating Expense $ 27,778,089 $ 26,978,261 $ 799,828 3.0% Selling, general and administrative expenses increased $1.3 million, or 6.2%, to $21.6 million, during the year ended December 31, 2024 compared with the same period last year, primarily due to a $1.7 million increase in compensation and benefits-related bonus accrual and sales commission related to year over year company performance, partially offset by lower recruiting expenses and liability insurance costs.
Operating Expenses Our selling, general and administrative, research and development and depreciation and amortization expenses for the years ended December 31, 2025, and 2024 are as follows: Years Ended December 31, Change from Prior Year 2025 2024 $ % Selling, general and administrative $ 23,378,807 $ 21,631,674 $ 1,747,133 8.1% Research and development 4,387,214 5,257,942 (870,728 ) (16.6)% Depreciation and amortization 810,500 888,473 (77,973) (8.8)% Total Operating Expense $ 28,576,521 $ 27,778,089 $ 798,432 2.9% Selling, general and administrative expenses increased $1.7 million, or 8.1%, to $23.4 million, during the year ended December 31, 2025 compared with the same period last year, primarily due to an increase in compensation and benefits-related bonus accrual, sales commission related to year over year company performance, and legal fees, partially offset by lower consulting expenses.
Net cash used in financings activities of $0.2 million for the year ended December 31, 2023, due to payments on our note payable for insurance premium financings, partially offset by the borrowings for the insurance premium financing, and $0.1 million for payments on our finance leases.
Financing Activities Net cash used in financing activities of $0.2 million for the year ended December 31, 2025 was primarily due to payments on our note payable for insurance premium financing, partially offset by new borrowings for a subsequent insurance premium financing agreement. The insurance premium financing note was also paid off early, without penalty, during the period.
Depreciation and amortization expense remained flat at $0.9 million during the year ended December 31, 2024, as compared to $0.9 million during the same period in 2023, primarily driven by capital spending related to projects.
Depreciation and amortization expense decreased $0.1 million, or 8.8%, to $0.8 million, during the year ended December 31, 2025, as compared with the same period last year, primarily driven by asset retirement and decreased capital spending.
The Company ended the 2024 fiscal year with $33.6 million in net revenues, an 18.0% increase compared with $28.5 million in the same period last year driven by growth in our core domestic and international business of 12.3% and 31.5% respectively, and further driven by a 61.9% increase in our novel therapies business.
The Company ended the 2025 fiscal year with $41.1 million in net revenues, a 22.2% increase compared with $33.6 million in the same period last year driven by growth in our domestic core and international core businesses of 11.0% and 80.0% respectively, partially offset by a 5.6% decrease in our pharma services and clinical trials business net revenues.
Net Loss Years Ended December 31, Change from Prior Year 2024 2023 $ % Net Loss $ (6,066,633 ) $ (13,741,062 ) $ 7,674,429 55.9% - 27 - Table of Contents Our net loss decreased $7.7 million in the year ended December 31, 2024 compared with the same period last year, mostly driven by lower net operating losses of $3.8 million as a result of our gross profit improvement of 27.7%, and an operating expense increase of 3%.
Net Loss Years Ended December 31, Change from Prior Year 2025 2024 $ % Net Loss $ (2,637,926 ) $ (6,066,633 ) $ 3,428,707 56.5% Our net loss decreased $3.4 million or 56.5% in the year ended December 31, 2025 compared with the same period last year, driven by higher gross profit of $4.3 million, partially offset by an increase in operating expense of $0.8 million.
Further contributing to this change were the establishment of an allowance for non-realization of deferred tax assets of $4.0 million, stock-based compensation of $2.8 million, depreciation and amortization of $0.9 million, and a loss on disposal of fixed assets of $0.1 million. - 28 - Table of Contents Investing Activities Net cash used in investing activities of $1.3 million for the year ended December 31, 2024, was driven by capital expenditures for manufacturing equipment related to our production line for our next generation consumables.
Net cash used in investing activities of $1.3 million for the year ended December 31, 2024, was driven by capital expenditures for manufacturing equipment related to our production line for our next generation consumables.
RESULTS OF OPERATIONS Year Ended December 31, 2024 compared to Year Ended December 31, 2023 Net Revenues The following table summarizes our net revenues for the years ended December 31, 2024 and 2023: - 26 - Table of Contents Years Ended December 31, Change from Prior Year % of Net Revenues 2024 2023 $ % 2024 2023 Net Revenues Domestic Core $ 25,214,613 $ 22,446,519 $ 2,768,094 12.3% 74.9% 78.7% International Core 6,043,979 4,596,097 1,447,882 31.5% 18.0% 16.1% Total Core 31,258,592 27,042,616 4,215,976 15.6% 92.9% 94.8% Novel Therapies 2,387,871 1,475,050 912,821 61.9% 7.1% 5.2% Total $ 33,646,463 $ 28,517,666 $ 5,128,797 18.0% 100% 100% Total net revenues increased $5.1 million, or 18.0%, to $33.6 million, for the year ended December 31, 2024, as compared with the same period last year.
RESULTS OF OPERATIONS Year Ended December 31, 2025 compared to Year Ended December 31, 2024 Net Revenues The following table summarizes our net revenues for the years ended December 31, 2025 and 2024: Years Ended December 31, Change from Prior Year % of Net Revenues 2025 2024 $ % 2025 2024 Net Revenues Domestic Core $ 27,992,436 $ 25,214,613 $ 2,777,823 11.0% 68.1% 74.9% International Core 10,881,183 6,043,979 4,837,204 80.0% 26.5% 18.0% Total Core 38,873,619 31,258,592 7,615,027 24.4% 94.5% 92.9% Pharma Services and Clinical Trials 2,253,747 2,387,871 (134,124 ) (5.6)% 5.5% 7.1% Total $ 41,127,366 $ 33,646,463 $ 7,480,903 22.2% 100% 100% Total net revenues increased $7.5 million, or 22.2%, to $41.1 million, for the year ended December 31, 2025, as compared with the same period last year.
Debt and Borrowing Capacity Refer to “NOTE 5 — DEBT OBLIGATIONS” in the accompanying “Notes to Financial Statements” appearing in this Annual Report on Form 10-K for further details regarding debt and borrowing capacity. Lease Commitments We have finance and operating leases for our corporate office and certain office and computer equipment.
In addition, we had payments for taxes related to net share settlement of equity awards of $0.1 million. - 30 - Table of Contents Debt and Borrowing Capacity Refer to “NOTE 5 — DEBT OBLIGATIONS” in the accompanying “Notes to Financial Statements” appearing in this Annual Report on Form 10-K for further details regarding debt and borrowing capacity.
Gross Profit Our gross profit for the years ended December 31, 2024, and 2023 is as follows: Years Ended December 31, Change from Prior Year 2024 2023 $ % Gross Profit $ 21,331,858 $ 16,708,282 $ 4,623,576 27.7% Gross Margin 63.4% 58.6% Gross profit increased $4.6 million, or 27.7%, to $21.3 million, in the year ended December 31, 2024, compared to the same period in 2023 driven by the increase in net revenues of $5.1 million coupled with significant gross margin improvement.
Pharma services and clinical trials net revenues decreased $0.1 million, or 5.6%, driven by lower NRE collaborations revenues resulting from the timing of project milestones partially offset by higher clinical trial orders when compared to the prior year. - 28 - Table of Contents Gross Profit Our gross profit for the years ended December 31, 2025, and 2024 is as follows: Years Ended December 31, Change from Prior Year 2025 2024 $ % Gross Profit $ 25,604,079 $ 21,331,858 $ 4,272,221 20.0% Gross Margin 62.3% 63.4% Gross profit increased $4.3 million, or 20.0%, to $25.6 million, in the year ended December 31, 2025, compared to the same period in 2024 driven by the increase in net revenues of $7.5 million partially offset by an increase in manufacturing costs.
Research and development expenses decreased $0.5 million, or 8.4%, to $5.3 million, during the year ended December 31, 2024 compared with the same period last year, primarily due to lower overall project spend driven by timing, partially offset by CTO severance costs and an increase in compensation and benefits-related bonus accrual related to year over year company performance.
Research and development expenses decreased $0.9 million, or 16.6%, to $4.4 million, during the year ended December 31, 2025 compared with the same period last year, primarily due to lower compensation and benefit expense and CTO severance expenses from the prior year, partially offset by higher temporary labor expenses for product development.
Gross margin increased to 63.4% in the year ended 2024 compared to 58.6% for the year ended 2023, primarily driven by increased manufacturing productivity, improved margin on product revenue mix, and increases in average selling prices versus the prior year.
Gross margin decreased to 62.3% in the year ended 2025 compared to 63.4% for the year ended 2024, primarily driven by higher materials costs, tariff-related charges, and geographic sales mix from outside the United States, partially offset by higher average selling prices in the US market.
Net cash used in operating activities of $4.9 million for the year ended December 31, 2023 was primarily due to the net loss of $13.7 million, plus cash flows used to reduce accrued expenses of $1.2 million primarily from the payment of 2023 employee bonuses, and a decrease in accounts payable of $1.4 million.
Further contributing to this change were non-cash items of $3.4 million including stock-based compensation expense of $2.7 million, depreciation and amortization expense of $0.8 million, and partially offset by a $0.1 million decrease in non-cash leasing liabilities. Net cash used in operating activities was $0.3 million for the year ended December 31, 2024.
Removed
Novel therapies net revenues increased $0.9 million, or 61.9%, driven primarily by an increase in NRE collaborations and an increase in clinical trial supply shipments when compared to the prior year.
Added
This net cash produced was primarily due to the net loss of $2.6 million, an increase in inventory of $0.9 million, an increase in accounts receivable of $0.5 million, and an increase in prepaids and other assets of $0.2 million, offset by an increase in accrued expenses for 2025 bonuses and payroll of $0.6 million, and an increase in accounts payable of $0.6 million.
Removed
In the prior year we established an allowance for the non-realization of deferred tax assets which reversed a tax benefit of $4.0 million, partially offsetting in the current year was lower interest income of $0.1 million driven by a lower cash balance coupled with lower yields.
Added
Investing Activities Net cash used in investing activities of $0.9 million for the year ended December 31, 2025, was driven by capital expenditures for manufacturing equipment related to our production line for our next generation consumables and infusion pumps.
Removed
Partially offsetting these increases were cash flows generated from a decrease in inventory of $2.9 million, a decrease in accounts receivable of $0.5 million, and other changes in working capital of $0.4 million.
Removed
In addition, we had payments for taxes related to net share settlement of equity awards of $0.1 million.

Other KRMD 10-K year-over-year comparisons