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What changed in ROCKWELL MEDICAL, INC.'s 10-K — 2024 vs 2025

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Paragraph-level year-over-year comparison of ROCKWELL MEDICAL, INC.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+289 added−341 removedSource: 10-K (2026-03-26) vs 10-K (2025-03-20)

Top changes in ROCKWELL MEDICAL, INC.'s 2025 10-K

289 paragraphs added · 341 removed · 209 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

67 edited+33 added−87 removed41 unchanged
Biggest changeDevice Classification Under the FD&C Act, medical devices are classified into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each medical device and the extent of control needed to provide reasonable assurances with respect to safety and effectiveness. 11 Table of Contents Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be reasonably assured by adherence to General Controls, which require compliance with the applicable portions of the FDA’s Quality System Regulation ("QSR"), facility registration and product listing, reporting of adverse events and malfunctions, and appropriate, truthful and non-misleading labeling and promotional materials.
Biggest changeDevice Classification Under the FD&C Act, medical devices are classified into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each medical device and the extent of regulatory control needed to provide reasonable assurances of safety and effectiveness.
Class II devices are those that are subject to the General Controls, as well as Special Controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. These Special Controls can include performance standards, patient registries, FDA guidance documents, and post-market surveillance.
Class II devices are those that are subject to the General Controls, as well as Special Controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. These Special Controls can include performance standards, post market surveillance, patient registries, and FDA guidance documents.
The QSR also requires, among other things, maintenance of a device master file, device history file, and complaint files. Manufacturers are also subject to periodic scheduled inspections by the FDA. A failure to maintain compliance with the QSR requirements could result in the shut-down of, or restrictions on, manufacturing operations and the recall or seizure of products.
The QSR also requires, among other things, maintenance of a device master record, device history file, and complaint files. Manufacturers are also subject to periodic scheduled inspections by the FDA. A failure to maintain compliance with the QSR requirements could result in the shut-down of, or restrictions on, manufacturing operations and the recall or seizure of products.
Moreover, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA; • the federal Civil Monetary Penalties Law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier; • the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which, in addition to privacy protections applicable to healthcare providers and other entities, prohibits, among other things, executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; • the federal Physician Payments Sunshine Act which requires certain applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under certain federal healthcare programs, to monitor and report to CMS, certain payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors); certain other healthcare providers, including physician assistants and nurse practitioners, and teaching hospitals; as well as ownership and investment interests held by physicians and their immediate family members; • U.S. federal consumer protection and unfair competition laws, which broadly regulate marketplace activities that potentially harm customers; and • state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to item or services reimbursed by any third-party payor, including commercial insurers, state laws requiring device companies to comply with specific compliance standards, restrict payments made to healthcare providers and other potential referral sources, and report information related to payments and other transfers of value to healthcare providers or marketing expenditures, and state laws related to insurance fraud in the case of claims involving private insurers.
Moreover, the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA; • the federal Civil Monetary Penalties Law, which prohibits, among other things, offering or transferring remuneration to a federal healthcare beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier; • the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which, in addition to privacy protections applicable to healthcare providers and other entities, prohibits, among other things, executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; • the federal Physician Payments Sunshine Act which requires certain applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under certain federal healthcare programs, to monitor and report to CMS, certain payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors); certain other healthcare providers, including physician assistants and nurse 13 Table of Contents practitioners, and teaching hospitals; as well as ownership and investment interests held by physicians and their immediate family members; • U.S. federal consumer protection and unfair competition laws, which broadly regulate marketplace activities that potentially harm customers; and • state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers, state laws requiring device companies to comply with specific compliance standards, restrict payments made to healthcare providers and other potential referral sources, and report information related to payments and other transfers of value to healthcare providers or marketing expenditures, and state laws related to insurance fraud in the case of claims involving private insurers.
The Company is a leading supplier of liquid and dry, acid and bicarbonate concentrates for dialysis patients in the United States. Hemodialysis is the most common form of end-stage kidney disease treatment and is usually performed in freestanding outpatient dialysis centers, hospital-based outpatient centers, skilled nursing facilities, or a patient’s home.
The Company is a supplier of liquid and dry, acid and bicarbonate concentrates for dialysis patients in the United States. Hemodialysis is the most common form of end-stage kidney disease treatment and is usually performed in freestanding outpatient dialysis centers, hospital-based outpatient centers, skilled nursing facilities, or a patient’s home.
Under the Amended Agreement, the Company and DaVita agreed to an increase in product pricing, effective September 1, 2023 and a one-time payment of $0.4 million to Rockwell on or after December 1, 2023. The term of the Amended Agreement was scheduled to expire on December 31, 2024.
Under the Amended Agreement, the Company and DaVita agreed to an increase in product pricing, effective September 1, 2023 and a one-time payment of $0.4 million to the Company on or after December 1, 2023. The term of the Amended Agreement was scheduled to expire on December 31, 2024.
Clinics using our dry acid concentrate products realize numerous advantages, including lower cost per treatment, reduced storage space requirements, reduced number of deliveries and more flexibility in scheduling deliveries, while enabling us to reduce distribution and warehousing costs. 7 Table of Contents Ancillary Products We offer essential ancillary products to select customers including 5% acetic acid cleaner, citric acid descaler, water softener salt pellets, and other supplies used by hemodialysis providers.
Clinics using our dry acid concentrate products realize numerous advantages, including lower cost per treatment, reduced storage space requirements, reduced number of deliveries and more flexibility in scheduling deliveries, while enabling us to reduce distribution and warehousing costs. 6 Table of Contents Ancillary Products We offer essential ancillary products to select customers including 5% acetic acid cleaner, citric acid descaler, water softener salt pellets, and other supplies used by hemodialysis providers.
On September 18, 2023, Rockwell and DaVita entered into an Amended and Restated Products Purchase Agreement (the "Amended Agreement"), which amended and restated the Product Purchase Agreement, dated July 1, 2019, as amended, under which the Company supplies DaVita with certain dialysis concentrates.
On September 18, 2023, Rockwell and DaVita entered into an Amended Agreement, which amended and restated the Product Purchase Agreement, dated July 1, 2019, as amended, under which the Company supplies DaVita with certain dialysis concentrates.
Other restrictions under applicable federal and state healthcare laws and regulations may include the following: • the federal Physician Self-Referral Law, which prohibits a physician from making referrals for certain designated health services payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship, and prohibits the entity from presenting or causing to be presented claims to Medicare for those referred services; 15 Table of Contents • the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, receiving, offering or paying remuneration, to induce, or in return for, either the referral of an individual, or the purchase or recommendation of an item or service for which payment may be made under any federal healthcare program, such as the Medicare and Medicaid programs.
Other restrictions under applicable federal and state healthcare laws and regulations may include the following: • the federal Physician Self-Referral Law, which prohibits a physician from making referrals for certain designated health services payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship, and prohibits the entity from presenting or causing to be presented claims to Medicare for those referred services; • the federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, receiving, offering or paying remuneration, to induce, or in return for, either the referral of an individual, or the purchase or recommendation of an item or service for which payment may be made under any federal healthcare program, such as the Medicare and Medicaid programs.
OUR BUSINESS Rockwell's mission is to provide dialysis clinics and the patients they serve with the highest quality products supported by the best customer service in the industry. Hemodialysis is the most common form of end-stage kidney disease treatment and is typically performed in freestanding outpatient dialysis centers, hospital-based outpatient centers, skilled nursing facilities, or a patient’s home.
OUR BUSINESS Rockwell's core business is to provide dialysis clinics and the patients they serve with the highest quality products supported by the best customer service in the industry. Hemodialysis is the most common form of end-stage kidney disease treatment and is typically performed in freestanding outpatient dialysis centers, hospital-based outpatient centers, skilled nursing facilities, or a patient’s home.
Some Class I devices also require premarket clearance by the FDA through the 510(k) premarket notification process described below. Most Class I products are exempt from the premarket notification requirements.
Some Class I devices also require premarket clearance by the FDA through the 510(k) premarket notification process described below. However, most Class I products are exempt from the premarket notification requirements.
In particular, please read our definitive proxy statement, which will be filed with the SEC in connection with our 2025 annual meeting of stockholders, our quarterly reports on Form 10-Q and any current reports on Form 8-K that we may file from time to time.
In particular, please read our definitive proxy statement, which will be filed with the SEC in connection with our 2026 annual meeting of stockholders, our quarterly reports on Form 10-Q and any current reports on Form 8-K that we may file from time to time.
These may include, as applicable: • establishment registration and device listing with the FDA; • the FDA’s QSR, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, production, control, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures during all aspects of the manufacturing process; • labeling regulations, unique device identification requirements and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label uses; • advertising and promotion requirements; • Restrictions on sale, distribution or use of a device; • PMA annual reporting requirements; • PMA approval or clearance of a 510(k) for certain product modifications; • medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur; • medical device correction and removal reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FD&C Act that may present a risk to health; 14 Table of Contents • recall requirements, including a mandatory recall if there is a reasonable probability that the device would cause serious adverse health consequences or death; • an order of repair, replacement or refund; • device tracking requirements; and • post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device.
These may include, as applicable: • establishment registration and device listing with the FDA; • the FDA’s QSR, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, production, control, supplier/contractor selection, complaint handling, documentation and other quality assurance procedures during all aspects of the manufacturing process; • labeling regulations, unique device identification requirements and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label uses; • advertising and promotion requirements; • Restrictions on sale, distribution or use of a device; • PMA annual reporting requirements; • PMA supplements or submission of a new 510(k) for certain production modifications; • medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to recur; • medical device correction and removal reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FD&C Act that may present a risk to health; • recall requirements, including a mandatory recall if there is a reasonable probability that the device would cause serious adverse health consequences or death; • an order of repair, replacement or refund; • device tracking requirements; and • post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device.
In addition, the FDA can issue warning letters, impose injunctions, suspend regulatory clearance or approvals, ban certain medical devices, detain or seize adulterated or misbranded medical devices, order repair, replacement or refund of these devices, and require notification of health professionals and others with regard to medical devices that present unreasonable risks of substantial harm to the public health.
In addition, the FDA can issue warning letters, impose injunctions, suspend regulatory clearance or approvals, ban certain medical devices, detain or seize adulterated or misbranded medical devices, order repair, replacement or refund of these devices, and require notification of health professionals and others with 12 Table of Contents regard to medical devices that present unreasonable risks of substantial harm to the public health.
PMA supplements often require submission of the same 13 Table of Contents type of information as an initial PMA, except that the supplement is limited to information needed to support any changes from the device covered by the approved PMA and may or may not require as extensive technical or clinical data or the convening of an advisory panel, depending on the nature of the proposed change.
PMA supplements often require submission of the same type of information as an initial PMA, except that the supplement is limited to information needed to support any changes from the device covered by the approved PMA and may or may not require as extensive technical or clinical data or the convening of an advisory panel, depending on the nature of the proposed change.
Each case of dry product produces 25 gallons of CitraPure liquid acid concentrate. Dri-Sate Acid Concentrate Rockwell Medical's Dri-Sate concentrate is an acetic acid-based product. Dri-Sate is packaged as a dry powder acetic acid concentrate to be used exclusively with Rockwell Medical's Dry Acid Concentrate Mixer.
Dri-Sate Acid Concentrate Rockwell Medical's Dri-Sate concentrate is an acetic acid-based product. Dri-Sate is packaged as a dry powder acetic acid concentrate to be used exclusively with Rockwell Medical's Dry Acid Concentrate Mixer. Each case of Dri-Sate dry product produces 25 gallons of RenalPure liquid acetic acid concentrate. RenalPure Acid Concentrate Rockwell Medical's RenalPure concentrate is an acetic acid-based product.
The small percentage of chronic dialysis patients who receive their treatment at home are referred to as “home” dialysis patients. In each setting, a dialysis machine dilutes concentrated solution, such as Rockwell’s concentrate products, with purified water. The resulting solution is called dialysate.
The small percentage of chronic dialysis patients who receive their treatment at home are referred to as “home” dialysis patients. In each 5 Table of Contents setting, a dialysis machine dilutes concentrated solution, such as Rockwell’s concentrate products, with purified water. The resulting solution is called dialysate.
Market Opportunity: Rockwell is the leading supplier of liquid bicarbonate concentrates and the second largest supplier of acid and dry bicarbonate concentrates for dialysis patients in the United States. Based on an independent research report that the Company commissioned from L.E.K.
Market Opportunity: Rockwell is the leading supplier of liquid bicarbonate concentrates and one of the largest suppliers of acid and dry bicarbonate concentrates for dialysis patients in the United States. Based on an independent research report that the Company commissioned from L.E.K.
This represents a large market opportunity for which we believe Rockwell's products are well-positioned to meet the needs of patients. Rockwell manufactures hemodialysis concentrates under current Good Manufacturing Practices ("cGMP") regulations at its three facilities in Michigan, South Carolina, and Texas and manufactures dry acid concentrate mixers at its facility in Iowa.
This represents a large market opportunity for which we believe Rockwell's products are well-positioned to meet the needs of patients. Rockwell manufactures hemodialysis concentrates under current Good Manufacturing Practices ("cGMP") regulations at its two facilities in Michigan and Texas and manufactures dry acid concentrate mixers at its facility in Iowa.
We have established an organizational structure and quality system procedures to ensure our device products are designed and produced to meet both product quality requirements and FDA requirements. The Grapevine, Texas facility is certified to ISO 13485:2016. Dialysis products are manufactured and tested using validated equipment and defined process 9 Table of Contents controls to ensure rigorous conformance to specifications.
We have established an organizational structure and quality system procedures to ensure our device products are designed and produced to meet both product quality requirements and FDA requirements. The Grapevine, Texas facility is certified to ISO 13485:2016. Dialysis products are manufactured and tested using validated equipment and defined process controls to ensure rigorous conformance to specifications.
CENTRISOL ® , CitraPure ® , Dri-Sate ® , RenalPure ® , RENASOL ® , SteriLyte ® , and Triferic ® are registered trademarks of Rockwell Medical. This Annual Report on Form 10-K contains references to our trademarks and trademarks belonging to other entities.
CitraPure ® , Dri-Sate ® , RenalPure ® , and SteriLyte ® are registered trademarks of Rockwell Medical. This Annual Report on Form 10-K contains references to our trademarks and trademarks belonging to other entities.
A predicate device is a legally-marketed device that is not subject to premarket approval, i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for which a PMA is not required, a device that has been reclassified from Class III to Class II or I, or a device that was found substantially equivalent through the 510(k) process.
A predicate device is a device that is legally marketed in the United States and is not subject to premarket approval, including (i) a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for which a PMA is not required, (ii) a device that has been reclassified from Class III to Class II or I, or (iii) a device that was found substantially equivalent through the 510(k) process.
Dialysate concentrates accounted for 100% of our revenue for the year ended December 31, 2024, of which approximately 90.9% was to distributors and customers for use in the United States.
Dialysate concentrates accounted for 100% of our revenue for the year ended December 31, 2025, of which approximately 88% of our sales was to distributors and customers for use in the United States.
However, since medical practice and governmental regulations differ across regions, further testing may be needed to support market introduction in some foreign countries. Some foreign regulatory agencies may require additional studies involving patients located in their countries. Even after foreign approvals are obtained, further delays may be encountered before products may be marketed.
However, since medical practice and governmental regulations differ across regions, further testing may be needed to support market introduction in some foreign countries. Some foreign regulatory agencies may require additional studies involving patients located in their countries.
Dry Acid Concentrate Mixer Rockwell Medical's Dry Acid Concentrate Mixer is designed and 510(k) approved exclusively for Rockwell Medical's CitraPure and Dri-Sate dry acid products and enables the clinic to mix acid concentrate on-site.
Dry Acid Concentrate Mix System Rockwell Medical's Dry Acid Concentrate Mix System is 510(k) approved for exclusive use with Rockwell Medical's CitraPure and Dri-Sate dry acid products and enables the clinic to mix acid concentrate on-site.
RenalPure Bicarbonate Concentrate Rockwell Medical's RenalPure bicarbonate concentrate is a dry powder mixed on-site at the clinic and is packaged in bulk and individual treatment sizes. SteriLyte Bicarbonate Concentrate Rockwell Medical's SteriLyte bicarbonate is a liquid packaged in one-gallon jugs (sold in cases of two and four) and is mainly used in acute care settings.
RenalPure is packaged as a liquid acid concentrate in 55-gallon drums and in one-gallon jugs (sold in cases of two and four). RenalPure Bicarbonate Concentrate Rockwell Medical's RenalPure bicarbonate concentrate is a dry powder mixed on-site at the clinic and is packaged in bulk and individual treatment sizes.
Prior to the expiration, the Company received written notice from DaVita, notifying the Company that DaVita intended to extend the term of the Amended Agreement through December 31, 2025 (the "Extension Term"). Product pricing was increased for the Extension Term.
Prior to the expiration, the Company received written notice from DaVita, notifying the Company that DaVita intended to extend the term of the Amended Agreement through December 31, 2025 (the "Extension Term"). Product pricing was increased for the Extension Term. DaVita subsequently indicated that it would completely transition to another supplier by mid-2025.
Prior to the expiration, the Company received written notice from DaVita that DaVita intended to extend the term of the Amended Agreement through December 31, 2025 (the "Extension Term"). Product pricing was increased for the Extension Term.
Prior to the expiration, the Company received written notice from DaVita that DaVita intended to extend the term of the Amended Agreement through December 31, 2025 (the "Extension Term"). Product pricing was increased for the Extension Term. DaVita subsequently indicated that it would completely transition to another supplier by mid-2025.
Through the PMA application process, the applicant must submit data and information demonstrating reasonable assurance of the safety and effectiveness of the device for its intended use to the FDA’s satisfaction. 510(k) Pathway To obtain 510(k) clearance, a premarket notification must be submitted under Section 510(k) of the FD&C Act demonstrating that the proposed device is “substantially equivalent” to a predicate device.
Through the PMA application process, the applicant must submit data and information demonstrating reasonable assurance of the safety and effectiveness of the device for its intended use to the FDA’s satisfaction. 510(k) Pathway To obtain marketing authorization for certain Class II and some Class I medical devices, a manufacturer must submit a premarket notification to the FDA under Section 510(k) of the FD&C Act demonstrating that the proposed device is “substantially equivalent” to a legally marketed predicate device.
MATERIAL AGREEMENTS Products Purchase Agreement with DaVita On September 18, 2023, Rockwell and DaVita entered into the Amended Agreement, which amended and restated the Product Purchase Agreement, dated July 1, 2019, as amended, under which the Company supplies DaVita with certain dialysis concentrates.
We deliver our hemodialysis concentrates products and mixers internationally solely utilizing third-party carriers and distribution partners. MATERIAL AGREEMENTS Products Purchase Agreement with DaVita On September 18, 2023, Rockwell and DaVita entered into the Amended Agreement, which amended and restated the Product Purchase Agreement, dated July 1, 2019, as amended, under which the Company supplies DaVita with certain dialysis concentrates.
CitraPure Citric Acid Concentrate Rockwell Medical's CitraPure c oncentrate is citric acid-based and 100% acetate-free. CitraPure is packaged as a liquid acid concentrate in 55-gallon drums and one-gallon jugs sold in cases of four. CitraPure is also packaged as a dry powder acid concentrate to be used exclusively with Rockwell Medical's Dry Acid Concentrate Mixer.
CitraPure is packaged as a liquid acid concentrate in 55-gallon drums and one-gallon jugs sold in cases of four. CitraPure is also packaged as a dry powder acid concentrate to be used exclusively with Rockwell Medical's Dry Acid Concentrate Mixer. Each case of dry product produces 25 gallons of CitraPure liquid acid concentrate.
PATENTS, TRADEMARKS AND TRADE SECRETS We have several trademarks and service marks used on our products and in our advertising and promotion of our products, and we have applied for registration of such marks in the United States and foreign countries.
Many countries require additional governmental approval for price reimbursement under national health insurance systems. PATENTS, TRADEMARKS AND TRADE SECRETS We have several trademarks and service marks used on our products and in our advertising and promotion of our products, and we have applied for registration of such marks in the United States and foreign countries.
GOVERNMENT REGULATION We are regulated by the FDA under the Federal Food, Drug and Cosmetic Act (the "FD&C Act"), as well as by other federal, state and local agencies. We hold several FDA product clearances for medical devices.
The Second Amendment also provides for a price increase on the products sold under the Amended Agreement for the Second Extension Term. GOVERNMENT REGULATION We are regulated by the FDA under the Federal Food, Drug and Cosmetic Act (the "FD&C Act"), as well as by other federal, state and local agencies. We hold several FDA product clearances for medical devices.
We generally negotiate pricing and approximate material quantities for our chemicals on an annual basis and utilize blanket purchase orders with monthly release schedules to meet our needs for production. See Item 1A “Risk Factors” for a discussion of certain risks related to our key suppliers.
We generally negotiate pricing and approximate material quantities for our chemicals on an annual basis and utilize blanket purchase orders with monthly release schedules to meet our needs for production.
During 2024, the Company transitioned customers acquired through the Purchase Agreement over to Rockwell Medical's hemodialysis concentrates products. Rockwell Medical continues to focus on driving growth and identifying opportunities that have the potential to improve the Company's performance so we can serve more patients, clinics, and major medical centers around the world.
Rockwell Medical continues to focus on driving growth and identifying opportunities that have the potential to improve the Company's performance so we can serve more patients, clinics, and major medical centers around the world.
New PMAs or PMA supplements may be required for modifications to the manufacturing process, equipment or facility, quality control procedures, sterilization, packaging, expiration date, labeling, device specifications, components, materials or design of a device that has been approved through the PMA process.
The PMA process can be expensive, uncertain, and lengthy and a number of devices for which the FDA approval has been sought by other companies have never been approved by the FDA for marketing. 11 Table of Contents New PMAs or PMA supplements may be required for modifications to the manufacturing process, equipment or facility, quality control procedures, sterilization, packaging, expiration date, labeling, device specifications, components, materials or design of a device that has been approved through the PMA process.
We have included our website in this Annual Report on Form 10-K solely as an inactive textual reference, and content from or that can be accessed through our website is not part of, or incorporated by reference into, this Annual Report on Form 10-K. 4 Table of Contents SIGNIFICANT 2024 HIGHLIGHTS Rockwell Medical's key developments from 2024 include: • In January 2024, we amended and restated our loan and security agreement (the "Amendment") with Innovatus.
We have included our website in this Annual Report on Form 10-K solely as an inactive textual reference, and content from or that can be accessed through our website is not part of, or incorporated by reference into, this Annual Report on Form 10-K.
OUR STRATEGY Rockwell Medical is focused on innovative, long-term growth strategies that deliver exceptional value to the healthcare system and provide a positive impact on the lives of hemodialysis patients.
("DaVita"), extending the term through December 31, 2026. As part of the amendment, product pricing will be increased for the extended term. OUR STRATEGY Rockwell Medical is focused on innovative, long-term growth strategies that deliver exceptional value to the healthcare system and provide a positive impact on the lives of patients.
The patient’s physician chooses the proper concentrations required for each patient based on such patient’s needs. 6 Table of Contents In addition to using concentrate products during every in-center treatment, a dialysis provider also uses other products, such as blood tubing, fistula needles, dialyzers, drugs, specialized component kits, dressings, cleaning agents, filtration salts, and other supplies, some of which we sell.
In addition to using concentrate products during every in-center treatment, a dialysis provider also uses other products, such as blood tubing, fistula needles, dialyzers, drugs, specialized component kits, dressings, cleaning agents, filtration salts, and other supplies, some of which we sell. CitraPure Citric Acid Concentrate Rockwell Medical's CitraPure c oncentrate is citric acid-based and 100% acetate-free.
Human Capital As of December 31, 2024, we had 244 employees, substantially all of whom are full time employees. Our arrangements with our employees are not governed by any collective bargaining agreement. Our employees are employed on an “at‑will” basis. Our key human capital management objectives are to identify, recruit, integrate, retain and motivate our new and existing employees.
Our arrangements with our employees are not governed by any collective bargaining agreement. Our employees are employed on an “at‑will” basis. Our key human capital management objectives are to identify, recruit, integrate, retain and motivate our new and existing employees. We believe that our compensation and benefit programs are appropriately designed to attract and retain qualified talent.
The loss of any significant accounts could have a material adverse effect on our business, financial condition and results of operations. See Item 1A “Risk Factors” for a discussion of certain risks related to our key customers and a discussion of certain risks related to our foreign sales.
Our significant customers are important to our business, financial condition and results of operations. The loss of any significant accounts could have a material adverse effect on our business, financial condition and results of operations.
Competition: In the United States, our principal competitors for concentrate products are Fresenius and Nipro. Fresenius is a vertically integrated manufacturer and marketer of dialysis devices, drugs and supplies and operator of dialysis clinics, which has substantially greater financial, technical, manufacturing, marketing, and research and development resources than we do.
Fresenius is a vertically integrated manufacturer and marketer of dialysis devices, drugs and supplies and operator of dialysis clinics, which has substantially greater financial, technical, manufacturing, marketing, and research and development resources than we do. Fresenius, through its Fresenius Kidney Care division, operates approximately 2,600 clinics and treats approximately 37% of the in-center hemodialysis patients in the United States.
Following receipt of a PMA, the FDA conducts an administrative review to determine whether the application is sufficiently complete to permit a substantive review. If it is not, the agency will refuse to file the PMA. If it is, the FDA will accept the application for filing and begin the review.
Following receipt of a PMA, the FDA conducts an initial administrative review to determine whether the application is sufficiently complete to permit a substantive review. If the FDA determines that the PMA is incomplete, it may refuse to file the PMA. If the application is filed, the FDA begins an in-depth substantive review.
The FDA may require postmarket surveillance for certain devices approved under a PMA or cleared under a 510(k) notification, such as implants or life-supporting or life-sustaining devices used outside a device user facility, devices where the failure of which would be reasonably likely to have serious adverse health consequences, or devices expected to have significant use in pediatric populations.
The FDA has authority to require postmarket surveillance for certain devices, including devices that are permanent implants, life-supporting or life-sustaining devices used outside a device user facility, or devices the failure of which would be reasonably likely to have serious adverse health consequences.
Patents owned or licensed by us include claims to ferric pyrophosphate citrate ("FPC") in both dialysate and IV compositions, formulations and methods of making and parenteral nutritional compositions, including Triferic. We have allowed several Charak-licensed and Company-owned patents and applications that are not material to our business to lapse.
Most such applications have resulted in registration of such trademarks and service marks. As of December 31, 2025, we owned or had the rights to, patents that include claims to ferric pyrophosphate citrate ("FPC") in both dialysate and IV compositions, formulations and methods of making and parenteral nutritional compositions, including Triferic. None of these are material to our business.
Fresenius services clinics owned by others with its products where it commands a market leading position in its key product lines. Fresenius manufactures its concentrates in its own regional manufacturing facilities. Fresenius and Rockwell are the two major dialysis concentrate suppliers in the United States.
Fresenius also manufactures and sells a full range of renal products, including dialysis machines, dialyzers, concentrates, and other supplies used in hemodialysis. Fresenius services clinics owned by others with its products where it commands a market leading position in its key product lines. Fresenius manufactures its concentrates in its own regional manufacturing facilities. Fresenius is also a Rockwell customer.
We are committed to a safe workplace for our employees and have implemented health and safety management processes into our operations.
Additionally, we grant equity awards to enable directors, officers, senior and manager-level employees to share in the performance of the Company. We are committed to a safe workplace for our employees and have implemented health and safety management processes into our operations.
Our concentrate products are diluted with purified water on-site at the clinic in the dialysis machine, creating dialysate, which works to clean the patient’s blood. A key element of our dialysis business strategy going forward is to improve the strength of our concentrates business.
Our concentrate products are diluted with purified water on-site at the clinic in the dialysis machine, creating dialysate, which works to clean the patient’s blood. Rockwell currently provides a portfolio of hemodialysis concentrates products to 294 customers, including all five of the leading dialysis providers in the United States.
Therefore, these devices are subject to the PMA application process, which is generally more costly and time-consuming than the 510(k) process.
The safety and effectiveness of Class III devices cannot be reasonably assured solely by the General Controls and Special Controls described above. Therefore, these devices are subject to the Premarket Approval ("PMA") application process, which is generally more costly and time-consuming than the 510(k) process.
To be “substantially equivalent,” the proposed device must have the same intended use as the predicate device, and either have the same technological characteristics as the predicate device or have different technological characteristics and not raise different questions of safety or effectiveness than the predicate device. Clinical data is sometimes required to support substantial equivalence.
To establish “substantial equivalence,” the proposed device must have the same intended use as the predicate device, and either (i) the same technological characteristics as the predicate device or (ii) different technological characteristics that don't raise different questions of safety or effectiveness than the predicate device and are supported by appropriate data demonstrating that the device is at least as safe and effective as the predicate.
Dialysate generally contains dextrose, sodium chloride, calcium, potassium, magnesium, sodium bicarbonate, and citric acid or acetic acid.
Dialysate generally contains dextrose, sodium chloride, calcium, potassium, magnesium, sodium bicarbonate, and citric acid or acetic acid. The patient’s physician chooses the proper concentrations required for each patient based on such patient’s needs.
Most Class II devices are subject to premarket review and clearance by the FDA. Premarket review and clearance by the FDA for Class II devices is accomplished through the 510(k) premarket notification process.
Most Class II devices are subject to premarket review and clearance by the FDA, which is accomplished through the 510(k) premarket notification process. Class III devices include those deemed by the FDA to pose the greatest risk such as life-supporting or life-sustaining devices, or implantable devices, and devices found not substantially equivalent following the 510(k) process.
The FDA considers a PMA or PMA supplement to have been voluntarily withdrawn if an applicant fails to respond to an FDA request for information ( e.g. , major deficiency letter) within a total of 360 days.
If an applicant fails to adequately respond to an FDA request for additional information ( e.g. , major deficiency letter) within the time specified by the FDA (generally up to 180 days per deficiency letter) the FDA may consider the PMA withdrawn.
To create and maintain a successful work environment, we offer a comprehensive package of additional benefits that support the physical and mental health and wellness of all of our employees and their families. Additionally, we grant equity awards to enable directors, officers, senior and manager-level employees to share in the performance of the Company.
Employees receive an annual base salary and are eligible to earn a performance-based merit increase and cash bonuses. To create and maintain a successful work environment, we offer a robust package of additional benefits that support the physical and mental health and wellness of our employees and their families.
After a device receives 510(k) clearance, any modification, including modification to or deviation from design, manufacturing processes, materials, packaging and sterilization that could significantly affect its safety or effectiveness, or that would constitute a new or major change in its intended use, may require a new 510(k) clearance or, depending on the modification, could require a PMA application.
After a device receives 510(k) clearance, the manufacturer must assess whether any modification to the device — including changes to design, materials, manufacturing processes, software, labeling, packaging, sterilization and intended use — requires submission of a new 510(k) or, in some circumstances, a PMA.
If the FDA determines that the device is not “substantially equivalent” to a predicate device, or if the device is automatically classified into Class III, the device sponsor must then fulfill the much more rigorous premarketing requirements of the PMA process, or seek reclassification of the device through the de novo process.
If the FDA determines that the device is not “substantially equivalent” to a predicate device, the device is automatically classified into Class III by operation of law, unless and until it is reclassified.
No other current customer accounted for more than 10% of sales in any of the last two years.
Rockwell's customer mix is diverse, with most customer sales concentrations under 10%. However, one customer, DaVita, accounted for 16% of our total net product sales in 2025 and 45% of our total net product sales in 2024. No other current customer accounted for more than 10% of sales in either of the last two years.
The Nipro Agreement will remain in effect for two years with the option to extend the agreement for an additional one-year period. Nipro is the primary distributor of our dialysis concentrates in certain countries in Latin America. In 2024, Rockwell Medical also entered into several other multi-year product purchase agreements, which include supply and purchasing commitments from certain parties.
One notable new product purchase agreement was with Innovative Renal Care, one of the largest dialysis service providers in the United States, which will remain in effect for three years with the option to extend for an additional one-year period. Rockwell Medical also worked to renew and expand existing product purchase agreements.
Sales and Marketing: Rockwell Medical's commercial organization supports the Company's vision to focus its efforts on enhancing its revenue-generating business and driving the Company towards sustainable profitability.
Sales and Marketing: Our commercial organization supports the Company's vision to focus its efforts on driving Rockwell Medical towards sustainable profitability. Our commercial team is focused on expanding revenue within our current customer base and seeking to grow revenue through the addition of new accounts to increase Rockwell's overall market share within the hemodialysis concentrates sector.
In August 2022, Congress passed the Inflation Reduction Act (“IRA”), which authorizes the U.S. Department of Health and Human Services to negotiate prices of certain drugs with participating manufacturers in federal healthcare programs. The IRA provides Centers for Medicare & Medicaid Services ("CMS") with significant new authorities intended to curb drug costs and to encourage market competition.
In August 2022, Congress passed the Inflation Reduction Act (“IRA”), which, among other things, authorizes CMS to negotiate prices of certain drugs and imposes inflation-based rebates on drug manufacturers.
The results of clinical testing may be unfavorable, or, even if the intended safety and efficacy success criteria are achieved, may not be considered sufficient for the FDA to grant marketing approval or clearance of a product candidate. Postmarket Requirements—U.S. After the FDA permits a device to enter commercial distribution, numerous regulatory requirements continue to apply.
Postmarket Requirements—U.S. After the FDA permits a device to enter commercial distribution, numerous regulatory requirements continue to apply.
In approving a PMA, as a condition of approval, the FDA may also require some form of postmarket studies or postmarket surveillance, whereby the applicant follows certain patient groups for a number of years and makes periodic reports to the FDA on the clinical status of those patients when necessary to protect the public health or to provide additional or longer term safety and effectiveness data for the device.
As a condition of PMA approval, the FDA may require post-approval studies or postmarket surveillance to gather additional long-term safety and effectiveness data.
Before approving or denying a PMA, an FDA advisory panel may review the PMA at a public meeting and provide the FDA with the committee’s recommendation on whether the FDA should approve the submission, approve it with specific conditions, or not approve it.
In connection with its review, the FDA may refer the PMA to an advisory panel of independent experts for review and recommendation at a public meeting. Although the FDA considers the panel’s recommendation, it is not bound by it.
The de novo classification procedure allows a manufacturer whose novel device is automatically classified into Class III to request down-classification of its medical device into Class I or Class II on the basis that the device presents low or moderate risk, rather than requiring the submission and approval of a PMA application.
The de novo classification process provides a pathway for certain novel devices presenting low to moderate risk to be classified into Class I or Class II, rather than being subject to the PMA requirements applicable to Class III devices.
During this review period, the FDA may request additional information or clarification of information already provided, and the FDA may issue a major deficiency letter to the applicant, requesting the applicant’s response to deficiencies communicated by the FDA.
By statute the FDA has 180 days to review a filed PMA; however, the review process typically extends beyond this period, often significantly, due to the complexity of the submission, requests for additional information, and other factors. During this review period, the FDA may issue deficiency letters requesting additional data or clarification.
Distribution and Delivery Operations: The majority of our domestic dialysis concentrate products are delivered through our subsidiary, Rockwell Transportation, Inc., which operates a fleet of trucks used to deliver products to our customers.
See Item 1A “Risk Factors” for a discussion of certain risks related to our key suppliers. 8 Table of Contents Distribution and Delivery Operations: We deliver the majority of our hemodialysis concentrates products and mixers to dialysis clinics and hospitals throughout the United States via our subsidiary, Rockwell Transportation, Inc., which operates a fleet of trucks used to deliver products to our customers, with the remaining hemodialysis concentrates products and mixers being transported via other third-party carriers and distribution partners.
Under the FDASIA, the FDA is required to classify the device within 120 days following receipt of the de novo application, though in practice the process may take significantly longer.
The FDA is required by statute to classify the device within 120 days of receipt of the de novo request; however, the review process often exceeds this timeframe due to requests for additional information and interactive review.
Removed
Additionally, through its asset acquisition of customer relationships, equipment and inventory related to the manufacturing and sale of hemodialysis concentrates products from Evoqua Water Technologies in July 2023, the Company manufactured hemodialysis concentrates under a contract manufacturing agreement ("CMA") with a third-party contract manufacturing organization ("CMO") in Minnesota until the CMA expired on December 31, 2024.
Added
The Company previously operated a manufacturing and warehouse facility in South Carolina, but the Company concluded manufacturing at that facility in the third quarter of 2025 as part of its ongoing efforts to streamline operations and improve efficiency.
Removed
Since the CMA's expiration, the Company only manufactures Rockwell Medical hemodialysis concentrates through its own facilities. Prior to the expiration of the CMA, the Company transitioned customer relationships acquired through the Purchase Agreement (as defined below) over to Rockwell Medical's hemodialysis concentrates products.
Added
SIGNIFICANT 2025 HIGHLIGHTS Rockwell Medical's key developments from 2025 include: • In February 2025, we added a single-use bicarbonate cartridge to our hemodialysis concentrates product portfolio that is 510(k) approved by the FDA and comes in two sizes, 720 grams and 900 grams. • In February 2025, we achieved the 'Great Place to Work' certification from Great Place to Work ® for the third year in a row. 4 Table of Contents • In June 2025, we maintained our membership on the Russell Microcap ® Index for the third year in a row. • In July 2025, we signed a multi-year product purchase agreement with Innovative Renal Care, one of the largest dialysis service providers in the United States. • In September 2025, Heather Hunter was promoted to Chief Operating Officer. • In September 2025, we were named a Fortune 'Best Workplaces in Manufacturing & Production' in the small & medium category for the second year in a row. • In the fourth quarter of 2025, we added 30 new customers in the western portion of the United States.
Removed
Under the terms of the Amendment, Rockwell Medical reduced the interest rate on, and extended the loan maturity date for, the term loans from March 2025 to January 2029. The Amendment provided an option for the Company to make interest-only payments for 30 months, or up to 36 months if certain conditions were met.
Added
As a result, the western U.S. accounts for more than 10% of our customer clinic footprint. • In November 2025, we named Rashad Brown as Vice President, Manufacturing and Supply Chain. • In November 2025, we appointed Joe Dawson to the Company's board of directors. • In December 2025, we amended our Amended and Restated Product Purchase Agreement (the "Amended Agreement") dated September 18, 2023 with DaVita, Inc.
Removed
The Company satisfied those conditions and will now make interest-only payments for the full 36 months. • In March 2024, we achieved the 'Great Place to Work' certification from Great Place to Work ® for the second year in a row. • In April 2024, we expanded our distribution capabilities in the western U.S. by entering into a product purchase agreement with one of the largest health systems in the Mountain West region. • In April 2024, we expanded our geographic footprint by distributing our hemodialysis concentrates products in the Dominican Republic and Bermuda through BioNuclear and Atlantic Medical International, respectively. • In May 2024, Tim Chole was promoted to Chief Commercial Officer. • In June 2024, we maintained our membership on the Russell Microcap ® Index for the second year in a row. • In August 2024, we launched a convenience pack, which includes two 1-gallon pre-mixed containers of one of our hemodialysis concentrate products, RenalPure or SteriLyte, offering a number of advantages for home patients and acute facilities. • In August 2024, we partnered with HydroCare, a leading provider of state-of-the-art dialysis water systems to healthcare facilities globally, to purchase and install our dry acid concentrate mix system in dialysis water rooms. • In August 2024, we renewed our supply agreement with aQua Dialysis and expanded our distribution to all aQua Dialysis Texas-based clinics. • In August 2024, we executed a distribution agreement with Nipro Medical Corporation ("Nipro") through which we will supply Nipro with our liquid and dry acid and bicarbonate hemodialysis concentrates, as well as our dry acid concentrates mixer, for which Nipro has the right to distribute our products globally, excluding the U.S. • In September 2024, we announced that we entered into a product purchase agreement with one of the leading at-home and acute care dialysis providers in the U.S. • In September 2024, we were named a Fortune 'Best Workplaces in Manufacturing & Production' in the small & medium category. • In September 2024, we entered into a distribution agreement with Nephro Group Dialysis Centers ("Nephro"), the largest dialysis provider in the Philippines, under which we will be Nephro's exclusive supplier for all dry hemodialysis concentrates products, including CitraPure acid and RenalPure bicarbonate. • In December 2024, Jesse Neri was promoted to Chief Financial Officer. • In December 2024, we entered into a multi-year product purchase agreement with the world's leading provider of dialysis products and services.
Added
Rockwell’s business strategy is centered on three core elements: 1) Create a profitable, leading hemodialysis concentrates business servicing hemodialysis centers in the United States and internationally; 2) Build a diversified portfolio of renal care or other medical products that integrate into our business infrastructure; and 3) Seek the next advancement in renal care to drive innovative treatments for patients.
Removed
In 2022, Rockwell undertook a strategic review of its business to identify short- and long-term value drivers that would improve the Company's financial position, maximize revenue, and unlock the value of its manufacturing and distribution capabilities. The Company focused its efforts on growing its revenue-generating hemodialysis concentrates business, pausing further investment in capital-intensive pharmaceutical development programs, and achieving profitability.
Added
Our Products: There are over 490,000 patients in the United States who undergo dialysis treatment each year, increasing 1% to 3% annually. Patients undergoing dialysis typically receive treatment three times per week, or approximately 156 times per year. Each treatment consumes approximately three gallons of concentrates which translates to 230 million gallons of concentrates used annually in the United States.
Removed
In connection with this strategic review, we discontinued our New Drug Applications ("NDAs") in the U.S. for Triferic (dialysate) and Triferic AVNU in the fourth quarter of 2022. Sustaining Triferic commercially in the U.S. resulted in losses to Rockwell annually.
Added
SteriLyte Bicarbonate Concentrate Rockwell Medical's SteriLyte bicarbonate is a liquid packaged in one-gallon jugs (sold in cases of two and four) and is mainly used in acute care settings. Bicarbonate Cartridges Rockwell Medical's single-use, premium grade bicarbonate cartridge contains sodium bicarbonate concentrate powder and is packaged in either 720 grams or 900 grams disposable canisters.
Removed
Triferic, which was indicated to maintain hemoglobin in patients undergoing hemodialysis, was launched into a very competitive marketplace with well-entrenched products and a lack of consensus regarding unmet medical needs for dialysis patients with anemia.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeIf we are unable to raise additional capital on attractive terms, or at all, we may be unable to grow our operations. • We face competition in the concentrates market and have large competitors with substantial resources. • Our business is highly regulated, resulting in additional expense and risk of noncompliance that can materially and adversely affect our business, results of operations, financial position and cash flows. • Our business operations may subject us to numerous commercial disputes, claims, lawsuits and/or investigations. • Our business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises, cybercrime, political crises, geopolitical events, such as the crisis in Ukraine and the Middle East, or other macroeconomic conditions, which could have a material and adverse effect on our results of operations and financial condition.
Biggest changeOur business is highly regulated, resulting in additional expense and risk of noncompliance that can materially and adversely affect our business, results of operations, financial position and cash flows. • Our business operations may subject us to numerous commercial disputes, claims, lawsuits and/or investigations. • Our business could be adversely affected by economic downturns, inflation, increases in interest rates, natural disasters, public health crises, cybercrime, political crises, geopolitical events, such as the crisis in Ukraine and the Middle East, or other macroeconomic conditions, which could have a material and adverse effect on our results of operations and financial condition. • Our A&R Loan Agreement (as defined below) with Innovatus contains certain covenants that could adversely affect our operations and, if an event of default were to occur, we could be forced to repay the outstanding indebtedness sooner than planned and possibly at a time when we do not have sufficient capital to meet this obligation.
In particular, we may face claims related to the safety of our products, intellectual property matters, employment matters, tax matters, commercial disputes, competition, sales and marketing practices, environmental matters, personal injury, insurance coverage and acquisition or divestiture‑related matters. A counterparty may assert claims that we do not believe are meritorious, but we nonetheless need to defend.
In particular, we may face claims related to the safety of our products, intellectual property matters, employment matters, tax matters, commercial or financial disputes, competition, sales and marketing practices, environmental matters, personal injury, insurance coverage and acquisition or divestiture‑related matters. A counterparty may assert claims that we do not believe are meritorious, but we nonetheless need to defend.
Our A&R Loan Agreement with Innovatus contains certain covenants that could adversely affect our operations and, if an event of default were to occur, we could be forced to repay the outstanding indebtedness sooner than planned and possibly at a time when we do not have sufficient capital to meet this obligation.
Our Loan Agreement with Innovatus contains certain covenants that could adversely affect our operations and, if an event of default were to occur, we could be forced to repay the outstanding indebtedness sooner than planned and possibly at a time when we do not have sufficient capital to meet this obligation.
Routine business actions we take under our contractual arrangements with purchasers or individual clinics, such as price increases or discontinuation of supply to customers who fail to pay us on time or at all, could mean that our customers may need to find alternative sources of supply and may not be able to serve their patients.
Routine business actions we take under our contractual arrangements with customers or individual clinics, such as price increases or discontinuation of supply to customers who fail to pay us on time or at all, could mean that our customers may need to find alternative sources of supply and may not be able to serve their patients.
While our fixed costs would be reduced by such actions, we may not be able to realize the full amount of that reduction if our variable costs (such as transportation) increase and we are unable to pass along those increases to our customers.
While we expect that our fixed costs would be reduced by such actions, we may not be able to realize the full amount of that reduction if our variable costs (such as transportation) increase and we are unable to pass along those increases to our customers.
These provisions, among other things: • establish a staggered Board divided into three classes serving staggered three-year terms, such that not all members of the board will be elected at one time; • authorize our Board to issue new series of preferred stock without stockholder approval and create, subject to applicable law, a series of preferred stock with preferential rights to dividends or our assets upon liquidation, or with superior voting rights to our existing common stock; • disallow our stockholders to fill vacancies on our board; • establish advance notice requirements for nominations for election to our Board or for proposing matters that can be acted upon by stockholders at our annual stockholder meetings; • permit our Board to establish the number of directors between three and fifteen; • provide that stockholders can remove directors only for cause and only upon the approval of not less than a majority of all outstanding shares of our voting stock; • require the approval of not less than a majority of all outstanding shares of our voting stock to amend our bylaws and specific provisions of our certificate of incorporation; and • limit the jurisdictions in which certain stockholder litigation may be brought.
These provisions, among other things: • establish a staggered Board divided into three classes serving staggered three-year terms, such that not all members of the board will be elected at one time; • authorize our Board to issue new series of preferred stock without stockholder approval and create, subject to applicable law, a series of preferred stock with preferential rights to dividends or our assets upon liquidation, or with superior voting rights to our existing common stock; • disallow our stockholders to fill vacancies on our board; • establish advance notice requirements for nominations for election to our Board or for proposing matters that can be acted upon by stockholders at our annual stockholder meetings; • permit our Board to establish the number of directors between three and fifteen; 26 Table of Contents • provide that stockholders can remove directors only for cause and only upon the approval of not less than a majority of all outstanding shares of our voting stock; • require the approval of not less than a majority of all outstanding shares of our voting stock to amend our bylaws and specific provisions of our certificate of incorporation; and • limit the jurisdictions in which certain stockholder litigation may be brought.
We do not currently have a full renal product portfolio to leverage as a comprehensive or bundled offering to providers, as we do not sell dialysis machines, certain dialysis machine-related disposables, nor certain pharmaceutical products used as part of dialysis treatments.
We do not currently have a full renal product portfolio to leverage as a comprehensive or bundled offering to providers, as we do not sell dialysis machines, certain dialysis machine-related disposables, or certain pharmaceutical products used as part of dialysis treatments.
Additionally, the Loan Agreement contains customary representations and warranties and affirmative covenants, subject to customary carve outs, and includes financial covenants related to liquidity and actual hemodialysis products revenue (measured on a biannual basis).
Additionally, the A&R Loan Agreement contains customary representations and warranties and affirmative covenants, subject to customary carve outs, and includes financial covenants related to liquidity and actual hemodialysis products revenue (measured on a biannual basis).
We are highly dependent on the operations, sales, product development, and business development expertise of the principal members of our management, operations and sales team. We have hired executive-level employees who are leading our development and operational initiatives.
We are highly dependent on the operations, sales, product development, and business development expertise of the principal members of our management, operations and sales team. We have hired executive-level employees who are leading our operational and functional initiatives.
The A&R Loan Agreement includes a financial covenant that requires actual consolidated revenue from the sale and supply of hemodialysis products for the trailing six-month period (ended on the date when tested), to be not less than 85.0% of the projections for the same period and, beginning with the quarter ending September 30, 2024, actual consolidated revenue from the sale and supply of hemodialysis products for the trailing six-month period (ended on the date when tested), to be not less than 80.0% of the projections for the same period.
The A&R Loan Agreement includes a financial covenant that required actual consolidated revenue from the sale and supply of hemodialysis products for the trailing six-month period (ended on the date when tested), to be not less than 85.0% of the projections for the same period and, beginning with the quarter ending September 30, 2024, actual consolidated revenue from the sale and supply of hemodialysis products for the trailing six-month period (ended on the date when tested), to be not less than 80.0% of the projections for the same period.
If we infringe the rights of a third party, we could be prevented from manufacturing and selling products, forced to pay damages, compelled to license technology from the party claiming infringement and lose the opportunity to license our technology to others and collect royalty payments, any of which could have a material adverse effect on our business.
If we infringe the rights of a third party, we could be prevented from manufacturing and selling products, forced to pay damages, compelled to license intellectual property from the party claiming infringement and lose the opportunity to license our technology to others and collect royalty payments, any of which could have a material adverse effect on our business.
On January 2, 2024, we amended and restated the Loan Agreement (the “A&R Loan Agreement”) to provide for the continuation of term loans initially borrowed under the Loan Agreement, in an aggregate outstanding principal amount of $8.0 million as of the effective date and $8.5 million as of December 31, 2024 .
On January 2, 2024, we amended and restated the Loan Agreement (the “A&R Loan Agreement”) to provide for the continuation of term loans initially borrowed under the Loan Agreement, in an aggregate outstanding principal amount of $8.0 million as of the effective date and $8.8 million as of December 31, 2025.
For example, on November 10, 2022, we entered into the Second Amendment to Loan Agreement under which we: (i) prepaid an aggregate principal amount 18 Table of Contents of $5.0 million in outstanding term loans in one installment on November 14, 2022; and (ii) agreed to make interest-only payments until September 2023 (at which time we resumed scheduled debt payments) in consideration for certain modifications to the financial covenants under the Loan Agreement.
For example, on November 10, 2022, we entered into the Second Amendment to Loan Agreement under which we: (i) prepaid an aggregate principal amount of $5.0 million in outstanding term loans in one installment on November 14, 2022; and (ii) agreed to make interest-only payments until September 2023 (at which time we resumed scheduled debt payments) in consideration for certain modifications to the financial covenants under the Loan Agreement.
Specifically, until DaVita owns less than 50% of its investment, the Company may only incur additional debt in the form of a purchase money loan, a working capital line of up to $5 million or to refinance existing debt, unless DaVita consents.
Specifically, until DaVita owns less than 50% of its investment, we may only incur additional debt in the form of a purchase money loan, a working capital line of up to $5 million or to refinance existing debt, unless DaVita consents.
Increased inflation rates can adversely affect us by increasing our costs, including labor and employee benefit costs. We have experienced and may in the future experience disruptions as a result of such macroeconomic conditions and the occurrence of natural disasters and public health crises, including delays or difficulties in manufacturing sufficient quantities of materials.
Increased inflation rates can adversely affect us by increasing our costs, including labor and employee benefit costs. We have experienced and may in the future experience disruptions as a result of such macroeconomic conditions and the occurrence of natural disasters and public health crises, including delays or difficulties in manufacturing sufficient quantities of materials and significant cost increases.
Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management and day-to-day business operations. Many of our employees and certain of our directors were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors.
Even if we are 23 Table of Contents successful in defending against these claims, litigation could result in substantial costs and be a distraction to management and day-to-day business operations. Many of our employees and certain of our directors were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors.
The payment of dividends is within the discretion of our Board of Directors and depends upon our earnings, capital requirements, financial condition and requirements, future prospects, restrictions in future financing agreements, business conditions and other factors deemed relevant by the Board. We intend to retain earnings and any cash resources to finance our operations.
The payment of dividends is within the discretion of our Board of Directors and depends upon our earnings, capital requirements, financial condition and requirements, future prospects, restrictions in future financing agreements, 25 Table of Contents business conditions and other factors deemed relevant by the Board. We intend to retain earnings and any cash resources to finance our operations.
In addition, as part of our business strategy, we may seek to acquire or in-license products or product candidates that we believe are a complementary fit with our business, as well as other product or product candidates that we believe have substantial development potential. We may not be able to identify such opportunities.
In addition, as part of our business strategy, we may seek to acquire or in- 17 Table of Contents license products or product candidates that we believe are a complementary fit with our business, as well as other product or product candidates that we believe have substantial development potential. We may not be able to identify such opportunities.
Moreover, changes in applicable regulatory requirements could significantly increase the costs of our operations, which we may not be able to recover under our fixed price contracts. Our business operations may subject us to numerous commercial disputes, claims, lawsuits and/or investigations.
Moreover, changes in applicable regulatory requirements could significantly increase the costs of our operations, which we may not be able to recover under our fixed price contracts. 22 Table of Contents Our business operations may subject us to numerous commercial disputes, claims, lawsuits and/or investigations.
A few customers account for a substantial portion of the end user sales of our concentrate products. The loss of any of these customers could materially and adversely affect our business, results of operations, financial position and cash flows. Sales of our medical device products are highly concentrated among a few customers.
A small group of customers account for a substantial portion of the end user sales of our concentrate products. The loss of any of these customers could materially and adversely affect our business, results of operations, financial position and cash flows. Sales of our medical device products are highly concentrated among a small group of customers.
The A&R Loan Agreement requires that we make interest-only payments for thirty months, or up to thirty-six months if certain conditions are met. Those conditions were satisfied in 2024, and the Company may make interest only payments for thirty-six months. The loan will mature on January 1, 2029, unless repaid earlier.
The A&R Loan Agreement requires that we make interest-only payments for thirty months, or up to thirty-six months if certain conditions are met. Those conditions were satisfied in 2024, and the Company may make 20 Table of Contents interest only payments for thirty-six months. The loan will mature on January 1, 2029, unless repaid earlier.
We have limited capital resources and will likely need additional funding to operate and expand our business . If we are unable to raise additional capital on attractive terms, or at all, we may be unable to sustain our operations. We have limited capital resources, a cumulative deficit of approximately $397.7 million since inception and we may incur further losses.
We have limited capital resources and will likely need additional funding to expand our business. If we are unable to raise additional capital on attractive terms, or at all, we may be unable to sustain our operations. We have limited capital resources and a cumulative deficit of approximately $403.0 million since inception and we may incur further losses.
In addition, our reputation could be damaged by such sanctions or product liability litigation and that could harm our business 25 Table of Contents reputation and marketing ability. Any such sanctions or litigation could also hurt our ability to retain product liability insurance or make such insurance more expensive.
In addition, our reputation could be damaged by such sanctions or product liability litigation and that could harm our business reputation and marketing ability. Any such sanctions or litigation could also hurt our ability to retain product liability insurance or make such insurance more expensive.
However, we do not carry specific hazardous waste insurance coverage and our property and casualty and general liability insurance policies specifically exclude coverage for damages and fines arising from hazardous waste exposure or contamination.
However, we do 19 Table of Contents not carry specific hazardous waste insurance coverage and our property and casualty and general liability insurance policies specifically exclude coverage for damages and fines arising from hazardous waste exposure or contamination.
The testing, manufacture, distribution, sale and delivery of the products we manufacture directly, or that are manufactured by or for our distribution partners, are subject to extensive regulation by the U.S. Food and Drug Administration ("FDA") and by other federal, state and foreign authorities, including, with respect to our transportation operations, the U.S. Department of Transportation ("DOT").
Our business is highly regulated. The testing, manufacture, distribution, sale and delivery of the products we manufacture directly, or that are manufactured by or for our distribution partners, are subject to extensive regulation by the U.S. Food and Drug Administration ("FDA") and by other federal, state and foreign authorities, including, with respect to our transportation operations, the U.S.
We could experience a business interruption, monetary loss, intentional theft of confidential information or reputational damage, including damage to key customer and partner relationships, from system failures, espionage attacks, malware, ransomware or other cyber-attacks. Such cyber-security breaches may compromise our system infrastructure or lead to data leakage, either internally or at our contractors or consultants.
We could experience a business interruption, monetary loss, intentional theft of confidential information or reputational damage, including damage to key customer and partner relationships, from system failures, espionage attacks, malware, phishing, social engineering, ransomware or other cyber-attacks. Such cyber-security breaches may compromise our system infrastructure or lead to data leakage, either internally or at our customers or business partners.
This may result in increased purchasing leverage for providers across all dialysis product categories and increased pricing pressure on all suppliers to the industry. 22 Table of Contents Our medical device products are life sustaining and any failure to supply them to our customers and resulting scrutiny related to such circumstances could negatively impact our reputation and stock price.
This may result in increased purchasing leverage for providers across all dialysis product categories and increased pricing pressure on all suppliers to the industry. Our medical device products are life-sustaining and any failure to supply them to our customers could result in scrutiny and negatively impact our reputation and stock price.
The occurrence of any of these events could cause a significant adverse impact on our business, prospects and share price. • Our existing capital resources may not be adequate to finance our operating cash requirements beyond the length of time that we have estimated and additional capital that we may need to operate or expand our business may not be available. 17 Table of Contents • We have limited capital resources and will likely need additional funding to operate and expand our business.
The occurrence of any of these events could cause a significant adverse impact on our business, prospects and share price. • Our existing capital resources may not be adequate to finance our operating cash requirements in the future and additional capital that we may need to operate or expand our business may not be available. • We have limited capital resources and will likely need additional funding to operate and expand our business.
Our production and other processes are somewhat manual, which introduces risk of error and may result in rising production costs. The production of our hemodialysis concentrates products is somewhat manual and involves considerable unskilled labor. The manual nature of production can introduce the risk of error.
Certain aspects of our production and other processes are manual, which introduces risk of error and may result in rising production costs. Certain aspects of the production of our hemodialysis concentrates products are manual and involve considerable unskilled labor. The manual nature of production can introduce the risk of error.
In addition, third parties may engage in trading strategies that result in intentional volatility to and control over our stock price. Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies. These broad market fluctuations may also adversely affect the trading price of our common stock.
In addition, third parties may engage in trading strategies that result in intentional volatility to and control over our stock price. Moreover, the stock markets in general have experienced substantial volatility that has often been unrelated to the operating performance of individual companies.
Unless we are able to further automate our production processes, our costs may continue to increase and we may be unable to recover those rising costs or may lose customers altogether, which could negatively impact on our financial position.
Unless we are able to further automate our production processes, our costs may continue to increase and we may be unable to recover those rising costs or may lose customers altogether if they are unwilling to pay higher prices, which could negatively impact our financial position.
If a third party believes that one of our products infringes on the third party’s patent, it may sue us even if we have received our own patent protection for the technology.
If a third party believes that one of our products infringes on the third party’s intellectual property, it may sue us even if we or our manufacturer have received protection for the technology.
A significant portion of our costs relate to chemicals and other raw materials and transportation, which are out of our control, and we may not be able to recover a portion of such costs due to provisions in our agreements with our customers that cap price increases.
A significant portion of our costs relate to chemicals and other raw materials and transportation and we have no control over the price of such materials and services. We may not be able to recover a portion of such costs due to provisions in our agreements with our customers that cap price increases.
If one of our employees was accidentally injured from the use, storage, handling or disposal of these materials or wastes, the medical costs related to his or her treatment would be covered by our workers’ compensation insurance policy.
In addition, we cannot entirely eliminate the risk of accidental injury or contamination from these materials or wastes. If one of our employees was accidentally injured from the use, storage, handling or disposal of these materials or wastes, the medical costs related to his or her treatment would be covered by our workers’ compensation insurance policy.
If the current cycle shifts toward providers preferring longer-term agreements across a wide range of dialysis-related products, our business could suffer due to lost sales.
If the current cycle shifts toward customers preferring bundled contracts across a wide range of dialysis-related products, our business could suffer due to lost sales.
Accordingly, we and our partners must continue to expend time, money and effort in all areas to achieve and maintain regulatory compliance. We are also required to report certain adverse reactions and production problems, if any, to applicable regulatory authorities.
While the finding was not serious, management expended time and effort on the correction. Accordingly, we and our partners must continue to expend time, money and effort in all areas to achieve and maintain regulatory compliance. We are also required to report certain adverse reactions and production problems, if any, to applicable regulatory authorities.
Similarly, the ongoing military conflict between Russia and 28 Table of Contents Ukraine and the conflict in the Middle East have created extreme volatility in the global capital markets and may have further global economic consequences, including disruptions of the global supply chain.
Similarly, the ongoing military conflict between Russia and Ukraine, the conflict in the Middle East, trade disruptions due to tariffs and threats to global alliances have created extreme volatility in the global capital markets and may have further global economic consequences, including disruptions of the global supply chain.
Our revenue growth and profitability projections are subject to many assumptions regarding our future operations, including that we are successful in expanding to new territories, that we successfully license and launch new product offerings, that we are able to add new profitable business, increase our prices to keep up with inflation, and that we do not experience significant disruptions to the manufacturing or distribution of our products, among other assumptions.
Our financial projections, including without limitation those relating to profitability and operating cash flow, are subject to many assumptions regarding our future operations, including that we are successful in selectively automating our operations, that we successfully license, launch or acquire new product offerings, that we are able to add new profitable business, increase our prices to keep up with inflation, and that we do not experience significant disruptions to the manufacturing or distribution of our products, among other assumptions.
Our existing capital resources may not be adequate to finance our operating cash requirements for the length of time that we have estimated and additional capital that we may need to operate or expand our business may not be available.
Our existing capital resources may not be adequate to finance our operating cash requirements in the future and additional capital that we may need to operate or expand our business may not be available.
Our ability to use our NOLs to offset potential future taxable income and related income taxes that would otherwise be due is dependent upon our generation of future taxable income before the expiration dates of the NOLs.
We have substantial net operating loss carryforwards ("NOLs") available to reduce future taxable income. Our ability to use our NOLs to offset potential future taxable income and related income taxes that would otherwise be due is dependent upon our generation of future taxable income before the expiration dates of the NOLs.
If the results of any new product initiative are materially worse than expected, it could have a material adverse effect on our business, results of operations, financial position and cash flows. We have in-licensed rights to certain patents that cover Triferic.
If the results of any new product initiative are materially worse than expected, it could have a material adverse effect on our business, results of operations, financial position and cash flows.
While we have been in compliance with the minimum closing bid price requirement since that time, there can be no assurance that we will be able to maintain compliance with the minimum bid price requirement going forward. 27 Table of Contents If our common stock were delisted by Nasdaq, we could face significant material adverse consequences, including: • a limited availability of market quotations for our common stock; • reduced liquidity with respect to our common stock; • a determination that our shares are “penny stock,” which will require brokers trading in our shares to adhere to more stringent shares, and which may limit demand for our common stock among certain investors; • a limited amount of news and analyst coverage for our company; and • a decreased ability to issue additional securities or obtain additional financing in the future.
If our common stock were delisted by Nasdaq, we could face significant material adverse consequences, including: • a limited availability of market quotations for our common stock; • reduced liquidity with respect to our common stock; • a determination that our shares are “penny stock,” which will require brokers trading in our shares to adhere to more stringent shares, and which may limit demand for our common stock among certain investors; • a limited amount of news and analyst coverage for our company; and • a decreased ability to issue additional securities or obtain additional financing in the future.
Our revenue growth and profitability projections are based on various assumptions that may not come to fruition.
Our financial projections are based on various assumptions that may not come to fruition.
The hemodialysis business experiences market cycles of customers seeking bundled and unbundled product offerings. Several of our competitors offer broad renal product portfolios and utilize a bundling approach when contracting with dialysis providers and hospitals.
If our customers move back to entering into long-term bundled product contracts with suppliers, our business could suffer. The hemodialysis business experiences market cycles of customers seeking bundled and unbundled product offerings. Several of our competitors offer broad renal product portfolios and utilize a bundling approach when contracting with dialysis providers and hospitals.
This may result in increased governmental or other scrutiny on our business. Such actions could also result in reputational harm to us and have a negative impact on our stock price. We may not be successful in expanding our business or in our business development efforts related to in-licensing, acquisitions or other business collaborations.
This may result in increased governmental or other scrutiny on our business. Such actions could also result in reputational harm to us and have a negative impact on our stock price.
In addition, as of December 31, 2024, there were 695,749 shares issuable upon the exercise of then-outstanding and exercisable stock options, 1,190,498 shares issuable upon the exercise of then-outstanding stock options that were not yet exercisable, and 3,984,484 shares issuable upon the exercise of then-outstanding and exercisable warrants.
In addition, as of December 31, 2025, there were 1,170,397 shares issuable upon the exercise of then-outstanding and exercisable stock options, 2,106,167 shares issuable upon the exercise of then-outstanding stock options that were not yet exercisable, and 3,984,484 shares issuable upon the exercise of then-outstanding and exercisable warrants.
In addition, weather-related events may jeopardize our ability to deliver our products as required by our contracts. A weak or declining United States or global economy, or changes in U.S. trade policies, including tariffs and other trade restrictions or the threat of such actions, could also strain our suppliers, possibly resulting in supply disruption.
A weak or declining United States or global economy, or changes in U.S. trade policies, including tariffs and other trade restrictions or the threat of such actions, could also strain our suppliers, possibly resulting in supply disruption.
Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous medical device, pharmaceutical and biotechnology companies for similar personnel. Finding production associates for our manufacturing facilities and truck drivers for our transportation division has also presented challenges for us.
Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous medical device, pharmaceutical and biotechnology companies for similar personnel.
That would result in lost revenue for the Company and may negatively impact our financial position and results of operations. 21 Table of Contents Unfavorable weather, economic conditions or supply shortages could materially and adversely affect our business, financial condition or results of operations.
Any inability to pass along costs, decrease in demand or loss of customers would result in lost revenue for the Company and may negatively impact our financial position and results of operations. Unfavorable weather, economic conditions or supply shortages could materially and adversely affect our business, financial condition or results of operations.
In the fall of 2024, we were notified by our largest customer that it would be moving a substantial portion (and possibly all) of its business to another concentrates supplier in 2025.
In the fall of 2024, we were notified by our largest customer that it would be moving a substantial portion of its business to another concentrates supplier in 2025. While we continue to sell to that customer, sales are now substantially reduced compared to before 2025.
We expect that if we continue to be subject to the limitations on price increases in our contracts, increasing costs and decreasing volumes may continue to negatively impact our profit margins and materially and adversely affect our financial position. A portion of our customers do not have contracts with us and buy products strictly on a purchase order basis.
We expect that if we continue to be subject to the limitations on price increases in our contracts, increasing costs and decreasing volumes may continue to negatively impact our profit margins and materially and adversely affect our financial position and results of operations.
RISKS RELATED TO LEGAL AND REGULATORY Our business is highly regulated, resulting in additional expense and risk of noncompliance that can materially and adversely affect our business, results of operations, financial position and cash flows. Our business is highly regulated.
If we are unsuccessful in one or more of those efforts, we may not be able to achieve our financial projections. RISKS RELATED TO LEGAL AND REGULATORY Our business is highly regulated, resulting in additional expense and risk of noncompliance that can materially and adversely affect our business, results of operations, financial position and cash flows.
In addition, there has, in the past, been a nationwide shortage of diesel fuel in the United States, which we use to run our delivery trucks.
In addition, we have experienced a nationwide shortage of diesel fuel in the United States or a significant increase in the price of diesel fuel, which we use to run our delivery trucks.
This may make us more vulnerable to takeovers that are completed without the approval of our Board and/or without giving us the ability to prohibit or delay such takeovers as effectively. 29 Table of Contents Our certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders' ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Our certificate of incorporation provides that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between us and our stockholders, which could limit our stockholders' ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Our business and operations would suffer in the event of a security breach, system failure, invasion, corruption, destruction or interruption of our or our business partners’ critical information technology systems or infrastructure.
Such a consolidation could have a material and adverse effect on our business, financial condition and results of operations. 18 Table of Contents Our business and operations would suffer in the event of a security breach, system failure, invasion, corruption, destruction or interruption of our or our business partners’ critical information technology systems or infrastructure.
In addition, we will need to restructure our operations to reduce our overhead in the short term, which could impact our ability to expand our business in the longer term should we be able to attract enough business to replace the revenue gap left by the loss.
The recent restructuring of our operations could impact our ability to expand our business in the longer term should we be able to attract enough business to replace the revenue gap left by the loss of our largest customer.
These factors include, but are not limited to: 19 Table of Contents • our ability to enter into new contracts and negotiate favorable terms with current and future customers; • our ability to increase our prices to keep up with inflation; • whether we experience significant input costs for, or disruptions to, the manufacturing or distribution of our products; • whether we expand into new territories; and • whether we develop and launch new product offerings.
These factors include, but are not limited to: • our ability to enter into new contracts and negotiate favorable terms with current and future customers; • our ability to increase our prices to keep up with inflation; • whether we experience significant input costs for, or disruptions to, the manufacturing or distribution of our products; • whether we expand into new territories; and • whether we develop and launch new product offerings. 21 Table of Contents If we are required to raise additional capital to fund our operations, such equity financings may be dilutive to our stockholders and newly issued securities may have rights, preferences or privileges senior to those of holders of our common stock.
We use hazardous materials, which could be dangerous to human health and safety or the environment. Our operations also produce hazardous waste products. Federal, state and local laws and regulations govern the use, generation, manufacture, storage, handling and disposal of these materials and wastes.
We use hazardous materials, and any claims relating to improper handling, storage or disposal of these materials could be time consuming or costly. We use hazardous materials, which could be dangerous to human health and safety or the environment. Our operations also produce hazardous waste products.
As of December 31, 2024, we had approximately $21.6 million of cash, cash equivalents and investments available-for-sale, and working capital of $22.9 million. Net cash provided by operating activities for the year ended December 31, 2024 was approximately $4.2 million.
As of December 31, 2025, we had approximately $25.0 million of cash, cash equivalents and investments available-for-sale, and working capital of $28.6 million. Net cash used in operating activities for the year ended December 31, 2025 was approximately $0.7 million.
The information and data processed and stored in our technology systems, and those of our strategic partners, contract research organizations, contract manufacturers, suppliers, distributors or other third parties for which we depend to operate our business, may be vulnerable to loss, damage, denial-of-service, unauthorized access or misappropriation. 23 Table of Contents To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, including protected health information or personal data of employees or former employees, we could be subject to legal claims or proceedings, liability under laws and regulations governing the protection of health and other personally identifiable information and related regulatory penalties.
To the extent that any disruption or security breach were to result in a loss of, or damage to, our data or applications, or inappropriate disclosure of confidential or proprietary information, including protected health information or personal data of employees or former employees, we could be subject to legal claims or proceedings, liability under laws and regulations governing the protection of health and other personally identifiable information and related regulatory penalties.
In that case, the trading price of our common stock could fall, and you may lose all or part of the money you paid to buy our common stock.
If any of these risks actually occur, our business, financial condition or results of operations would likely suffer. In that case, the trading price of our common stock could fall, and you may lose all or part of the money you paid to buy our common stock.
We cannot predict, and no assurances can be given as to, the outcome or timing of any matters relating to actions by activist stockholders or the ultimate impact on our business, results of operations, financial position and cash flows. 26 Table of Contents RISKS RELATED TO OUR COMMON STOCK The market price of our common stock has fluctuated in the past, and is likely to continue to be volatile, which could subject us to litigation.
We cannot predict, and no assurances can be given as to, the outcome or timing of any matters relating to actions by activist stockholders or the ultimate impact on our business, results of operations, financial position and cash flows.
In addition to Fresenius, Nipro may be seeking to increase its market share of the domestic concentrates market, which, if successful, could have an impact upon our market share and profitability. In addition, certain national medical products distributors have recently expanded their logistical capabilities to reach the outpatient dialysis space, which may also have an impact on the competitive landscape.
In addition to Fresenius, Nipro may be seeking to increase its market share of the domestic concentrates market, which, if successful, could have an impact upon our market share and profitability.
Even if we are able to enter into business development arrangements, they could have a negative impact on our business and our profitability. We may seek to make further acquisitions or enter into business development arrangements in our concentrates business to expand our customer base or geographic footprint.
We may seek to make acquisitions or enter into business development arrangements in our concentrates business to expand our customer base or geographic footprint.
While we expect to have sufficient capital through 12 months from the date of this filing, there is uncertainty beyond that period. Our ability to fund our planned activities will be dependent upon our ability to acquire new customers, execute on business development plans, raise additional capital, control our costs and maintain or increase our gross margin on sales.
Our ability to fund our planned activities will be dependent upon our ability to acquire new customers or grow revenues from existing customers, execute on business development plans, raise additional capital, control our costs and maintain or increase our gross margin on sales.
Such a shortage has, and in the future may again result in, an increase in the cost of diesel fuel or lack of availability of diesel fuel and we would need to find another way to deliver our products to clinics. If we are unable to do so, we could be in breach of our contracts.
An increase in the cost of diesel fuel or lack of availability of diesel fuel could significantly increase our costs or require us to find another way to deliver our products to clinics, including through use of third-party freight. If we are unable to do so, we could be in breach of our contracts.
In addition, in some areas, we have a single source of raw materials, which makes us particularly sensitive to cost increases. Transportation also comprises a significant portion of our costs. In the past, we have been adversely affected by a general shortage in commercial truckers in the United States and significant increases in labor and fuel costs.
In the past year, raw materials costs have increased significantly, due to short supply and excess demand. In addition, in some regions, we have a single source of raw materials, which makes us particularly sensitive to cost increases. Transportation also comprises a significant portion of our costs.
As a result, we moved our listing to The Nasdaq Capital Market and effected an 11-for-1 reverse stock split in May 2022 to regain compliance.
As a result, we moved our listing to The Nasdaq Capital Market and effected an 11-for-1 reverse stock split in May 2022 to regain compliance. While this reverse stock split addressed the listing deficiency, there can be no assurance that we will be able to maintain compliance with the minimum bid price requirement going forward.
Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may impair the operation of our business and any development or expansion efforts. In addition, we cannot entirely eliminate the risk of accidental injury or contamination from these materials or wastes.
Federal, state and local laws and regulations govern the use, generation, manufacture, storage, handling and disposal of these materials and wastes. Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may impair the operation of our business and any development or expansion efforts.
Others are under contract, but the agreements may not contain purchasing minimums. In addition, if we do have contracts with our customers, some allow for price increases only once per year. In situations where we are able to increase prices to keep up with our costs, we may lose customers if such customers are unwilling to pay higher prices.
A portion of our customers do not have contracts with us and buy products strictly on a purchase order basis. Others are under contract, but the agreements may not contain purchasing minimums. In addition, if we do have contracts with our customers, some allow for price increases only once per year.
The Federal Reserve has raised interest rates multiple times in response to concerns about inflation and it may raise them again. Higher interest rates, coupled with reduced government spending and volatility in financial markets, may increase economic uncertainty and affect consumer spending.
Higher interest rates, coupled with reduced government spending and volatility in financial markets, may increase economic uncertainty and affect consumer spending.
Before medical devices, such as our concentrate products or the bicarbonate cartridge we distribute, can be commercially marketed in the United States, the FDA must give either premarket approval or 510(k) clearance. After a product is approved, regulatory authorities may impose significant restrictions on a product’s indicated uses or marketing or requirements for potentially costly post-marketing studies.
Department of Transportation ("DOT"). Before medical devices, such as our concentrate products or the bicarbonate cartridge we distribute, can be commercially marketed in the United States, the FDA must give either premarket approval or 510(k) clearance.
Item 1A. Risk Factors. Investing in our common stock involves a high degree of risk and there can be no assurance that our future results will meet expectations. You should carefully consider the risks and uncertainties described below, together with all of the other information contained in this Annual Report on Form 10-K, before purchasing our common stock.
Item 1A. Risk Factors. Investing in our common stock involves a high degree of risk and there can be no assurance that our future results will meet expectations.
If we are unsuccessful in one or more of those efforts, we may not be able to achieve our projected growth and profitability. RISKS RELATED TO OUR BUSINESS We face competition in the concentrates market and have large competitors with substantial resources.
If we are unable to raise additional capital on attractive terms, or at all, we may be unable to grow our operations. RISKS RELATED TO OUR BUSINESS We face competition in the concentrates market and have large competitors with substantial resources.
The holders of these options and warrants are likely to exercise them when we would otherwise be able to obtain additional capital on more favorable terms than those provided by the options and warrants. We may fail to qualify for continued listing on Nasdaq, which could make it more difficult for our stockholders to sell their shares.
The holders of these options and warrants are likely to exercise them when we would otherwise be able to obtain additional capital on more favorable terms than those provided by the options and warrants. Our ability to use our net operating loss carryforwards to offset potential taxable income and related income taxes that would otherwise be due may be limited.
Our inability to satisfy this financial covenant or cure any breach would constitute an event of default.
Those projections were amended to account for the lost revenue from DaVita when it moved to a different supplier. Our inability to satisfy this financial covenant or cure any breach would constitute an event of default.
In addition, labor costs have been steadily rising, and our manufacturing process is labor intensive, which increases our costs to produce our products. These costs have tended to rise from year to year and are likely to continue to rise in the future. In the past year, raw materials costs have increased significantly, due to short supply and excess demand.
In addition, labor costs have been steadily rising, and our manufacturing process is labor intensive, which increases our costs to produce our products.
The loss of any of these significant customers could materially and adversely affect our business, results of operations, financial position and cash flows. 20 Table of Contents Market dynamics in our concentrates business have resulted in fluctuating volumes that could lead to the implementation of cost-saving measures that would have a material and adverse effect on our business.
Market dynamics in the concentrates business have resulted in fluctuating volumes that could lead to the implementation of cost-saving measures that would have a material and adverse effect on our business. Volumes have fluctuated in our concentrates business due to changes in patient census and cost saving measures implemented by our customers, including switching to single-use bicarbonate canisters and bags.
Volumes have fluctuated in our concentrates business due to the reduction in patient census and cost saving measures by our customers, including switching to single-use bicarbonate canisters. If these volumes decrease substantially, we may be forced to further consolidate our operations and curtail our activities to lower our fixed costs.
If volumes decrease substantially, we may be forced to further consolidate our operations and curtail our activities to lower our fixed costs.
In addition, our failure to comply with applicable regulations with respect to our concentrates products could constitute a breach of our Amended and Restated Products Purchase Agreement with DaVita (the “Amended Agreement”), providing DaVita with various remedies that would be material and adverse to us.
In addition, our failure to comply with applicable regulations with respect to our concentrates products could constitute a breach of our customer agreements.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThese processes are managed and monitored by our Director of Technology and Information Systems and supported by our outsourced IT managed services provider, under the supervision of our Chief Corporate Affairs Officer, and include mechanisms, controls, technologies, systems, and other processes designed to prevent or mitigate data loss, theft, misuse, or other security incidents or vulnerabilities affecting the data and maintain a stable and secure information technology environment.
Biggest changeThese processes are managed and monitored by our Director of Technology and Information Systems and supported by our outsourced IT managed services provider, under the supervision of our Chief Operating Officer, and include mechanisms, controls, technologies, systems, and other processes designed to prevent or mitigate data loss, theft, misuse, or other security incidents or vulnerabilities affecting the data and maintain a stable and secure information technology environment. 27 Table of Contents Our Chief Operating Officer, who reports directly to the Chief Executive Officer, and our Director of Technology and Information Systems, together with our other executive officers, are responsible for assessing and managing cybersecurity risks.
For more information regarding cybersecurity risks that we face and potential impacts on our business related thereto, see the risk factor titled, “Our business and operations would suffer in the event of a security breach, system failure, invasion, corruption, destruction or interruption of our or our business partners’ critical information technology systems or infrastructure.” 30 Table of Contents Risk Management and Strategy Rockwell Medical believes that the Company maintains an IT and security program appropriate for a company its size, taking into account its operations and risks.
For more information regarding cybersecurity risks that we face and potential impacts on our business related thereto, see the risk factor titled, “Our business and operations would suffer in the event of a security breach, system failure, invasion, corruption, destruction or interruption of our or our business partners’ critical information technology systems or infrastructure.” Risk Management and Strategy Rockwell Medical believes that the Company maintains an IT and security program appropriate for a company its size, taking into account its operations and risks.
The Board, as a whole and at the Audit Committee level, has oversight for the most significant risks facing the Company and for the Company's processes to identify, prioritize, assess, manage, and mitigate those risks. The Audit Committee, which is composed solely of independent directors, has been designated by the Company's Board to oversee cybersecurity risks.
The Board, as a whole and at the Audit Committee level, has oversight for the most significant risks facing the Company and for the Company's processes to identify, prioritize, assess, manage, and mitigate those risks. The Audit Committee, which is comprised solely of independent directors, has been designated by the Company's Board to oversee cybersecurity risks.
As one of the critical elements of the Company's overall ERM approach, the Company's cybersecurity program is focused on the following key areas: Governance The Board's oversight of cybersecurity risk management is supported by the Audit Committee of the Board (the "Audit Committee"), which regularly interacts with the Company's Chief Corporate Affairs Officer.
As one of the critical elements of the Company's overall ERM approach, the Company's cybersecurity program is focused on the following key areas: Governance The Board's oversight of cybersecurity risk management is supported by the Audit Committee of the Board (the "Audit Committee"), which regularly interacts with the Company's Chief Operating Officer.
Third-Party Risk Management The Company maintains a comprehensive, risk-based approach to identifying and overseeing cybersecurity risks presented by third parties, including vendors, service providers and other external users of the Company’s systems, as well as the systems of third parties that could adversely impact our business in the event of a cybersecurity incident affecting those third-party systems.
Third-Party Risk Management 28 Table of Contents The Company maintains a risk-based approach to identifying and overseeing cybersecurity risks presented by third parties, including vendors, service providers and other external users of the Company’s systems, as well as the systems of third parties that could adversely impact our business in the event of a cybersecurity incident affecting those third-party systems.
We conduct continuous automated phishing simulation campaigns which can trigger additional training for personnel on how to recognize social engineering attempts (e.g., phishing, smishing, vishing, etc.). We 31 Table of Contents track performance on phishing exercises to help us monitor the awareness of our employees and inform future training priorities.
We conduct automated phishing simulation campaigns which can trigger additional training for personnel on how to recognize social engineering attempts (e.g., phishing, smishing, vishing, etc.). We track performance on phishing exercises to help us monitor the awareness of our employees and inform future training priorities.
The Audit Committee and the Board receive updates on cybersecurity and IT matters and related risk exposures from the Company's Chief Corporate Affairs Officer and other members of Management on cybersecurity risks on at least a semi-annual basis.
The Audit Committee and the Board receive updates on cybersecurity and IT matters and related risk exposures from the Company's Chief Operating Officer and other members of Management on cybersecurity risks on at least a semi-annual basis.
Collaborative Approach The Company has implemented a comprehensive, cross-functional approach to identifying, preventing, and mitigating cybersecurity threats and incidents, while also implementing controls and processes that provide for the prompt escalation of certain cybersecurity incidents so that decisions regarding the public disclosure and reporting of such incidents can be made by Management in a timely manner.
Collaborative Approach The Company has implemented a cross-functional approach intended to identify, prevent, and mitigate material cybersecurity threats and incidents, while also implementing controls and processes that provide for the prompt escalation of certain cybersecurity incidents so that decisions regarding the public disclosure and reporting of such incidents can be made by Management in a timely manner.
Removed
Our Chief Corporate Affairs Officer, who reports directly to the Chief Executive Officer, and our Director of Technology and Information Systems, who has three decades of experience managing and leading cybersecurity oversight, together with our other executive officers, are responsible for assessing and managing cybersecurity risks.
Removed
Each member of Management holds undergraduate and graduate degrees in their respective fields and have extensive experience managing risks at the Company and at similar companies, including risks arising from cybersecurity threats.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeIn addition, Rockwell occupied 4,100 square feet of office space in Hackensack, New Jersey. This lease was subleased on December 15, 2021 and expired on October 31, 2024. We use each of our facilities to manufacture and warehouse our products. All such facilities and their contents are covered under various insurance policies which management believes provide adequate coverage.
Biggest changeAll such facilities and their contents are covered under various insurance policies which management believes provide adequate coverage. We use the office space in Wixom, Michigan as our principal administrative office.
We expect that we may need additional manufacturing capacity and distribution facilities to meet our business requirements and anticipate they will be available on commercially available terms.
We expect that we may need additional manufacturing capacity and distribution facilities to meet our business requirements and anticipate they will be available on commercially available terms. 29 Table of Contents
We use the office space in Wixom, Michigan as our principal administrative office. We believe that our existing leased properties are adequate and suitable for the conduct of our business and that our capital resources are sufficient to purchase, lease or construct any additional facilities required to meet our expected long-term growth needs.
We believe that our existing leased properties are adequate and suitable for the conduct of our business and that our capital resources are sufficient to purchase, lease or construct any additional facilities required to meet our expected long-term growth needs.
Item 2. Properties. We lease a 51,000 square foot facility and a 17,500 square foot facility in Wixom, Michigan under a lease expiring in August 2027. During the year ended December 31, 2024, the lease for the Wixom facilities was extended by three years to August 2027, which was accounted for as a lease modification.
Item 2. Properties. We lease a 51,000 square foot manufacturing, office and warehouse facility and an additional 17,500 square foot office and warehouse facility in Wixom, Michigan under a lease expiring in August 2027. We use the office space in Wixom, Michigan as our principal administrative office.
Removed
As a result of this modification, the operating lease right of use asset and lease liabilities increased by $1.5 million. We also lease two other manufacturing facilities, a 51,000 square foot facility in Grapevine, Texas under a lease expiring in December 2025 and a 57,000 square foot facility in Greer, South Carolina under a lease expiring in February 2026.
Added
We lease a second 51,000 square foot manufacturing, office and warehouse facility in Grapevine, Texas under a lease that now expires in February 2031. Upon expiration of the original lease for this facility in December 2025, the Company extended the lease for an additional 62 months.
Added
During the year ended December 31, 2025, we entered into a lease for a 16,800-square foot storage facility in Allentown, Pennsylvania, that expires in April 2030. Previously, we leased a 57,000 square foot manufacturing and warehouse facility in Greer, South Carolina.
Added
In the third quarter of 2025, we concluded manufacturing in that facility in preparation for the lease expiry in February 2026 as part of the Company's ongoing efforts to streamline operations and improve efficiency. We use each of our facilities to manufacture and warehouse our products.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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Biggest changeThe resolution of these pending proceedings is not expected to have a material effect on our operations or consolidated financial statements in the period in which they are resolved. Information pertaining to legal proceedings is provided under the heading “Litigation” in Note 15, Commitments and Contingencies, to the consolidated financial statements and is incorporated by reference herein. Item 4.
Biggest changeThe resolution of these pending proceedings is not expected to have a material effect on our operations or consolidated financial statements in the period in which they are resolved. Information pertaining to legal proceedings is provided under the heading “Litigation” in Note 14, Commitments and Contingencies, to the consolidated financial statements and is incorporated by reference herein. Item 4.
Mine Safety Disclosures. Not applicable. 32 Table of Contents PART II
Mine Safety Disclosures. Not applicable. 30 Table of Contents PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is listed on The Nasdaq Capital Market under the trading symbol “RMTI”. Holders As of February 28, 2025, there wer e 45 holders of record of our common stock.
Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities. Market Information Our common stock is listed on The Nasdaq Capital Market under the trading symbol “RMTI”. Holders As of February 28, 2026, there were 30 holder s of record of our common stock.

Item 7. Management's Discussion & Analysis

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

41 edited+17 added−29 removed22 unchanged
Biggest changeGross profit increased by $8.8 million during the year ended December 31, 2024 compared to the year ended December 31, 2023 driven by $9.6 million of improved gross margin to existing customers driven primarily by price increases, $1.8 million from a special large order of premium-priced product by DaVita, partially offset by $1.5 million and $1.1 million of gross profit for the year ended December 31, 2023 associated with deferred license revenue recognition related to the terminations of the Baxter Distribution Agreement and the Wanbang Agreement, respectively.
Biggest changeGross profit decreased by $5.8 million during the year ended December 31, 2025 compared to the year ended December 31, 2024 driven by (i) a $6.7 million decrease in product sales, which includes $1.8 million from a special large order of premium-priced product to DaVita during the year ended December 31, 2024 that did not repeat in 2025, (ii) an increase of $1.0 million in additional manufacturing costs and (iii) an increase of $0.4 million in severance expense, partially offset by a price adjustment of $2.0 million for DaVita purchases for the year ended December 31, 2025 and a $0.3 million decrease in facility transition costs.
Cash Provided By Financing Activities Net cash provided by financing activities was $7.3 million during the year ended December 31, 2024.
Net cash provided by financing activities was $7.3 million during the year ended December 31, 2024.
Certain accounting estimates, including those concerning revenue recognition, impairments of long‑lived assets, and deferred consideration are considered to be critical in evaluating and understanding our financial results because they involve inherently uncertain matters and their application requires the most difficult and complex judgments and estimates. These are described below.
Certain accounting estimates, including those concerning revenue recognition, impairments of long‑lived assets, goodwill, and deferred consideration are considered to be critical in evaluating and understanding our financial results because they involve inherently uncertain matters and their application requires the most difficult and complex judgments and estimates. These are described below.
Specifically, until DaVita holds less than 50% of its original investment in the Company's Convertible Series X Preferred Stock, the Company may only incur additional debt in the form of a purchase money loan, a working capital line of up to $5 million or to refinance existing debt, unless DaVita consents.
Specifically, until DaVita holds less than 50% of its original investment in the Company's Convertible Series X Preferred Stock, the Company may only incur additional debt in the form of a purchase money loan, a working capital line of up to $5.0 million or to refinance existing debt, unless DaVita consents.
The Company is a leading supplier of liquid and dry, acid and bicarbonate concentrates for dialysis patients in the United States. Hemodialysis is the most common form of end-stage kidney disease treatment and is typically performed in freestanding outpatient dialysis centers, hospital-based outpatient centers, skilled nursing facilities, or a patient’s home.
The Company is a supplier of liquid and dry, acid and bicarbonate concentrates for dialysis patients in the United States. Hemodialysis is the most common form of end-stage kidney disease treatment and is usually performed in freestanding outpatient dialysis centers, hospital-based outpatient centers, skilled nursing facilities, or a patient’s home.
The actual amount of cash that we will need to execute our business strategy is subject to many factors, including, but not limited to the ability to meet our revenue forecasts, including those from DaVita, as well as the costs associated with our manufacturing and transportation operations related to our concentrate business.
The actual amount of cash that we will need to execute our business strategy is subject to many factors, including, but not limited to the ability to meet our revenue forecasts, as well as the costs associated with our manufacturing and transportation operations related to our concentrate business.
The change in cash provided by operating activities during the current period as compared to cash used in operating activities in the prior period was primarily due to (i) a decrease in net loss of approximately $8.0 million, (ii) an increase in cash provided by changes in current balance sheet accounts in the ordinary course of business of approximately $5.7 million, primarily due to increases of $7.3 million from accounts receivable, net and $3.8 million from deferred license revenue, partially offset by decreases of $2.1 million from accounts payable and $1.5 million from inventory and (iii) an increase in cash provided from non-cash adjustments.
The change in cash used in operating activities during the current period as compared to cash provided by operating activities in the prior period was primarily due to (i) an increase in net loss of approximately $4.8 million and (ii) an increase in cash used from non-cash adjustments, partially offset by (iii) a decrease in cash used by changes in current balance sheet accounts in the ordinary course of business of approximately $0.1 million, primarily due to decreases of $3.1 million from inventory and $0.8 million from accounts payable, partially offset by increases of $2.7 million from accounts receivable, net, $0.6 million from accrued and other liabilities and $0.4 million from deferred license revenue.
Cash Used In Investing Activities Net cash used in investing activities was $4.9 million during the year ended December 31, 2024 . The net cash used was due to $5.9 million in purchases of our available-for-sale investments and $1.0 million for the purchase of equipment, offset by proceeds from the sale of our available-for-sale investments of $2.0 million .
The net cash used in investing activities was due to $24.2 million in purchases of our available-for-sale investments and $0.5 million for the purchase of equipment, partially offset by proceeds from the sale of our available-for-sale investments of $16.2 million. Net cash used in investing activities was $4.9 million during the year ended December 31, 2024.
Impairment losses are then measured by comparing the fair value of assets to their carrying amounts. For the years ended December 31, 2024 and 2023, there were no impairments of long-lived assets. Goodwill and Intangible Assets Goodwill is the excess of purchase price over the fair value of identified net assets of businesses acquired.
Impairment losses are then measured by comparing the fair value of assets to their carrying amounts. For the years ended December 31, 2025 and 2024, there were no impairments of long-lived assets. 36 Table of Contents Goodwill and Intangible Assets Goodwill is the excess of purchase price over the fair value of identified net assets of businesses acquired.
Global Economic Considerations The global macroeconomic environment is uncertain and could be negatively affected by, among other things, changes in U.S. trade policies, including tariffs and other trade restrictions or the threat of such actions, instability in the global capital and credit markets, recent bank failures in the United States, supply chain weaknesses, and instability in the geopolitical environment, including as a result of the Russian invasion of Ukraine, the Middle East conflict and other political tensions, and the occurrence of natural disasters and public health crises.
Global Economic Considerations The global macroeconomic environment is uncertain and could be negatively affected by, among other things, changes in U.S. trade policies, including tariffs and other trade restrictions or the threat of such actions, instability in the global capital and credit markets, supply chain weaknesses, and instability in the geopolitical environment, including as a result of the Russian invasion of Ukraine, the Middle East conflicts and other political tensions, and the occurrence of natural disasters and public health crises.
On January 2, 2024, the Company's Loan and Security Agreement (the “Loan Agreement”) with Innovatus Life Sciences Lending Fund I, LP (“Innovatus”) was amended to include, among other things, an interest-only period for 30 months, or up to 36 months if certain conditions are met, and extend the maturity date to January 1, 2029.
On January 2, 2024, we amended our Loan and Security Agreement (the "Loan Agreement") with Innovatus Life Sciences Lending Fund I, LP (“Innovatus”) to include, among other things, an interest only period of 30 months, or up to 36 months if certain conditions are met, and to extend the maturity date to January 1, 2029.
We believe our ability to fund our activities in the long term will be highly dependent upon (i) our ability to execute on the growth strategy of our hemodialysis concentrates business and maintain sales with existing customers, (ii) our ability to achieve sustained profitability, including successfully reducing expenses to account for the lost DaVita business, and (iii) our ability to identify, develop, in-license, or acquire new products in developing our renal care product portfolio.
We believe our ability to fund our activities in the long term will be highly dependent upon (i) our ability to execute on the growth strategy of our hemodialysis concentrates business and maintain sales with existing customers, (ii) our ability to achieve sustained profitability and (iii) our ability to identify, develop, in-license, or acquire new products in developing our product portfolio.
Liquidity and Capital Resources Since inception, we have incurred significant net losses and have funded our operations primarily through revenue from commercial products, proceeds from the issuance of debt and equity securities and payments from partnerships. On December 31, 2024, we had an accumulated deficit of approximately $397.7 million and stockholders’ equity of $32.6 million.
Liquidity and Capital Resources Since inception, we have incurred significant net losses and have funded our operations primarily through revenue from commercial products, proceeds from the issuance of debt and equity securities and payments from partnerships. On December 31, 2025, we had an accumulated deficit of approximately $403.0 million and stockholders’ equity of $37.0 million.
Cash Provided By (Used In) Operating Activities Net cash provided by operating activities was $4.2 million for the year ended December 31, 2024 compared to net cash used in operating activities of $9.4 million for the year ended December 31, 2023.
Net Cash (Used In) Provided by Operating Activities Net cash used in operating activities was $0.7 million for the year ended December 31, 2025 compared to net cash provided by operating activities of $4.2 million for the year ended December 31, 2024.
Net cash provided by financing activities was $11.3 million during the year ended December 31, 2023.
Net Cash Provided By Financing Activities Net cash provided by financing activities was $4.3 million during the year ended December 31, 2025.
Cost of Sales and Gross Profit Cost of sales during the year ended December 31, 2024 was $84.0 million, resulting in gross profit of $17.5 million, compared to cost of sales of $74.9 million and a gross profit of $8.7 million during the year ended December 31, 2023.
Cost of Sales and Gross Profit Cost of sales during the year ended December 31, 2025 was $57.6 million, resulting in gross profit of $11.7 million, compared to cost of sales of $84.0 million and a gross profit of $17.5 million during the year ended December 31, 2024.
Product revenue for the year ended December 31, 2024 was $101.4 million compared to product revenue of $79.8 million for the year ended December 31, 2023.
Product revenue for the year ended December 31, 2025 was $68.9 million compared to product revenue of $101.4 million for the year ended December 31, 2024.
See Note 3 to our consolidated financial statements included in this Annual Report on Form 10‑K for additional information.
For further information on our ATM Facility, see Note 11 to our consolidated financial statements in this Annual Report on Form 10-K.
Net cash used in investing activities was $3.0 million during the year ended December 31, 2023.
Net Cash Used In Investing Activities Net cash used in investing activities was $8.5 million during the year ended December 31, 2025.
Shipping and handling costs associated with outbound freight related to contracts with customers are accounted for as a fulfillment cost and are included in cost of sales when control of the goods transfers to the customer. Deferred License Revenue - Upfront fees received under distribution and license agreements have been deferred as a contract liability.
Shipping and handling costs associated with outbound freight related to contracts with customers are accounted for as a fulfillment cost and are included in cost of sales when control of the goods transfers to the customer.
Additionally, the Company's plans may include raising capital, if needed, by using the $21.1 million remaining under our Sales Agreement, dated April 8, 2022, with Cantor Fitzgerald & Co. acting as sales agent (as amended, the “ATM facility”), which provides for the offer and sale of up to an aggregate of $25.0 million of shares of the Company's common stock through the sales agent, or other methods or forms of financings, subject to existing limitations.
Additionally, the Company's plans may include raising capital, if needed, by using the $13.1 million remaining under our at-the-market facility ("ATM Facility"), which provides for the offer and sale of up to an aggregate of $25.0 million of shares of the Company's common stock through the sales agent, or other methods or forms of financings, subject to existing limitations.
Other Expense Total other expense for the years ended December 31, 2024 and December 31, 2023 was $1.1 million and $1.8 million, respectively, which was driven by interest expense of $1.3 million and $2.3 million for the years ended December 31, 2024 and December 31, 2023, respectively, related to our debt facility (See Note 17 to our consolidated financial statements included in this Annual Report on Form 10-K for additional information on our debt facility), partially offset by $0.1 million and $0.2 million of interest income, respectively, as well as realized gains on available-for-sale of investments of $0.1 million and $0.3 million, respectively.
The $0.1 million decrease was primarily due to increases of $0.5 million of stock-based compensation expense and $0.3 million of employee compensation, offset by decreases of $0.6 million of administrative expense and $0.3 million of professional fees. 33 Table of Contents Other Expense Total other expense for the years ended December 31, 2025 and December 31, 2024 was $0.6 million and $1.1 million, respectively, which was driven by interest expense of $1.1 million and $1.3 million, respectively, related to our debt facility (See Note 16 in the consolidated financial statements included in this Annual Report on Form 10-K), partially offset by $0.2 million and $0.1 million of interest income, respectively, as well as realized gains on available-for-sale of investments of $0.3 million and $0.1 million, respectively.
All significant estimates, judgments and assumptions are developed based on the best information available to us at the time made and are regularly reviewed and updated when necessary. Actual results could differ from these estimates.
These accounting principles require us to make estimates, judgments and assumptions that affect the reported amounts of revenues, expenses, assets, liabilities, and contingencies. All significant estimates, judgments and assumptions are developed based on the best information available to us at the time made and are regularly reviewed and updated when necessary. Actual results could differ from these estimates.
The net cash provided by financing activities was primarily due to the gross proceeds from the issuance of common stock in connection with the ATM facility of $10.2 million, partially offset by the cash paid in connection with the Evoqua Asset Acquisition of $1.6 million during the year ended December 31, 2024 .
The net cash provided by financing activities was primarily due to the gross proceeds from the issuance of common stock in connection with the ATM facility of $10.2 million, partially offset by the cash paid in connection with the Evoqua Asset Acquisition of $1.6 million during the year ended December 31, 2024 . 35 Table of Contents Contractual Obligations and Other Commitments We generally expect to satisfy our material cash requirements, including contractual obligations and commitments, with cash on hand and cash provided by operating activities.
Prior to the expiration, the Company received written notice from DaVita, notifying the Company that DaVita intended to extend the term of the Amended Agreement through December 31, 2025 (the "Extension Term"). Product pricing was increased for the Extension Term.
Prior to the expiration, the Company received written notice from DaVita that DaVita intended to extend the term of the Amended Agreement through December 31, 2025 (the "Extension Term"). Subsequently, DaVita indicated that it would completely transition to another supplier, subject to further discussions between Rockwell and DaVita. Product pricing was increased for the Extension Term.
Results of Operations The following table summarizes our operating results for the periods presented below (dollars in thousands): For the Year Ended December 31, 2024 % of Revenue 2023 % of Revenue % Change Net Sales $ 101,489 $ 83,612 21.4 % Cost of Sales 84,005 82.8 % 74,908 89.6 % 12.1 % Gross Profit 17,484 17.2 % 8,704 10.4 % 100.9 % Research and Product Development 19 — % 1,107 1.3 % (98.3) % Selling and Marketing 2,749 2.7 % 2,125 2.5 % 29.4 % General and Administrative 14,108 13.9 % 12,142 14.5 % 16.2 % Operating Income (Loss) $ 608 0.6 % $ (6,670) (8.0) % (109.1) % Net Sales During the year ended December 31, 2024, our net sales were $101.5 million compared to net sales of $83.6 million during the year ended December 31, 2023.
As a result, the western U.S. now accounts for more than 10% of the Company's customer clinic footprint. 32 Table of Contents Results of Operations The following table summarizes our operating results for the periods presented below (dollars in thousands): For the Year Ended December 31, 2025 % of Revenue 2024 % of Revenue % Change Net Sales $ 69,258 $ 101,489 (31.8) % Cost of Sales 57,563 83.1 % 84,005 82.8 % (31.5) % Gross Profit 11,695 16.9 % 17,484 17.2 % (33.1) % Research and Product Development — — % 19 — % (100.0) % Selling and Marketing 2,354 3.4 % 2,749 2.7 % (14.4) % General and Administrative 14,032 20.3 % 14,108 13.9 % (0.5) % Operating (Loss) Income $ (4,691) (6.8) % $ 608 0.6 % (871.5) % Net Sales During the year ended December 31, 2025, our net sales were $69.3 million compared to net sales of $101.5 million during the year ended December 31, 2024.
The net cash used was primarily due to the $12.4 million of cash paid in connection with the Evoqua Asset Acquisition, $5.7 million in purchases 37 Table of Contents of our available-for-sale investments and $0.3 million for the purchase of equipment, offset by proceeds from the sale of our available-for-sale investments of $15.3 million .
The net cash used in investing activities was due to $5.9 million in purchases of our available-for-sale investments and $1.0 million for the purchase of equipment, offset by proceeds from the sale of our available-for-sale investments of $2.0 million.
Conversely, when regulatory approval already exists or is probable, revenue is recognized at the point in time that the estimated product sales under the agreement occur. Impairment of Long-lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable.
Impairment of Long-lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amounts may not be recoverable.
Even if we are able to raise sufficient capital, such financings may only be available on unattractive terms, or result in significant dilution of stockholders’ interests and, in such event, the market price of our common stock may decline. 36 Table of Contents Management evaluated its going concern by reviewing the Company's operational plans, which include executing on the projected financial information, including price increases, acquisition of new customers, projected growth of margins and cost containment activities.
Even if we are able to raise sufficient capital, such financings may only be available on unattractive terms, or result in significant dilution of stockholders’ interests and, in such event, the market price of our common stock may decline.
The increase of $0.6 million is primarily due to higher employee compensation expenses. 35 Table of Contents General and Administrative Expense General and administrative expenses were $14.1 million during the year ended December 31, 2024 compared with $12.1 million during the year ended December 31, 2023.
General and Administrative Expense General and administrative expenses were $14.0 million during the year ended December 31, 2025 compared with $14.1 million during the year ended December 31, 2024.
(“DaVita”) entered into an Amended and Restated Products Purchase Agreement (the "Amended Agreement"), which amended and restated the Product Purchase Agreement, dated July 1, 2019, as amended, under which the Company supplies DaVita with certain dialysis concentrates.
("DaVita") entered into an Amended and Restated Products Purchase Agreement ("the Amended Agreement"), under which the Company supplies DaVita with certain dialysis concentrates. The term of the Amended Agreement was scheduled to expire on December 31, 2024.
As of December 31, 2024, we had approximately $21.6 million of cash, cash equivalents and investments available-for-sale, and working capital of $22.9 million. Net cash provided by operating activities for the year ended December 31, 2024 was approximately $4.2 million. On July 10, 2023, Armistice Capital Master Fund Ltd.
As of December 31, 2025, we had approximately $25.0 million of cash, cash equivalents and investments available-for-sale, and net working capital of $28.6 million. Net cash used in operating activities for the year ended December 31, 2025 was approximately $0.7 million.
This represents a large market opportunity for which we believe Rockwell's products are well-positioned to meet the needs of patients. Rockwell manufactures hemodialysis concentrates at its facilities in Michigan, South Carolina, and Texas.
This represents a large market opportunity for which we believe Rockwell's products are well-positioned to meet the needs of patients. Rockwell's products are vital to vulnerable patients with end-stage kidney disease.
Approximately 37% of research and development expenses for the year ended December 31, 2023 were comprised of severance costs. Selling and Marketing Expense Selling and marketing expenses were $2.7 million during the year ended December 31, 2024 compared with $2.1 million during the year ended December 31, 2023.
Selling and Marketing Expense Selling and marketing expenses were $2.4 million during the year ended December 31, 2025 compared with $2.7 million during the year ended December 31, 2024. The decrease of $0.4 million is due to $0.2 million of lower marketing costs and a $0.2 million decrease in employee compensation and recruiting expense.
Critical Accounting Estimates and Judgments Our consolidated financial statements and accompanying notes are prepared in accordance with accounting principles generally accepted in the United States of America. These accounting principles require us to make estimates, judgments and assumptions that affect the reported amounts of revenues, expenses, assets, liabilities, and contingencies.
See Notes 13, 14, 15, and 16 to the consolidated financial statements included elsewhere in this Form 10-K for further details. Critical Accounting Estimates and Judgments Our consolidated financial statements and accompanying notes are prepared in accordance with accounting principles generally accepted in the United States of America.
The Company delivers the majority of its hemodialysis concentrates products and mixers to dialysis clinics throughout the United States and internationally, utilizing its own delivery trucks and third-party carriers. Rockwell has developed a core expertise in manufacturing and delivering hemodialysis concentrates, and has built a longstanding reputation for reliability, quality, and excellent customer service.
The Company previously operated a manufacturing and warehouse facility in South Carolina, but the Company concluded manufacturing at that facility in the third quarter of 2025 as part of its ongoing efforts to streamline operations and improve efficiency. 31 Table of Contents Rockwell delivers the majority of its hemodialysis concentrates products and mixers to dialysis clinics throughout the United States and internationally, utilizing its own delivery trucks and third-party carriers.
The net cash provided by financing activities was primarily due to the net proceeds from issuance of equity securities of $14.9 million, primarily comprised of gross proceeds from the issuance of common stock of $13.8 million in connection with Armistice's exercise of the Prior Warrant, offset by payments on the Company's debt, short term note payable, and finance leases which aggregated $3.5 million during the year ended December 31, 2023 .
The net cash provided by financing activities was primarily due to the net proceeds from the issuance of common stock in connection with the ATM facility of $7.8 million, partially offset by $2.4 million of earn-out payments in connection with the Company’s 2023 acquisition of certain customer relationships, equipment, and inventory from Evoqua Water Technologies LLC ("Evoqua") (the "Evoqua Asset Acquisition") during the year ended December 31, 2025 .
The Company satisfied those conditions and will now make interest-only payments for the full 36 months. See Note 17 to our consolidated financial statements included in this Annual Report on Form 10-K for additional information.
The Company is subject to certain covenants and cure provisions under the Loan Agreement. As of December 31, 2025, the Company is in compliance with all covenants. See Note 16 to our consolidated financial statements included in this Annual Report on Form 10-K for additional information.
Rockwell provides the hemodialysis community with products controlled by a Quality Management System regulated by the U.S. Food and Drug Administration ("FDA"). Rockwell is ISO 13485 Certified and adheres to current Good 33 Table of Contents Manufacturing Practices ("cGMP") and the Association for Advancement of Medical Instrumentation ("AAMI") standards.
Rockwell is ISO 13485 Certified and adheres to current Good Manufacturing Practices ("cGMP") and Association for Advancement of Medical Instrumentation ("AAMI") standards. Rockwell manufactures hemodialysis concentrates at its facilities in Michigan and Texas, and manufactures its dry acid concentrate mixers at its facility in Iowa.
Net sales of non-product revenue were not material during the year ended December 31, 2024 compared to $3.8 million during the year ended December 31, 2023, which was the result of $2.3 million and $1.5 million of deferred license revenue recognition related to the terminations of distribution and license agreements with Wanbang and Baxter Healthcare Corporation ("Baxter") (respectively, the “Wanbang Agreement” and the “Baxter Distribution Agreement”) during the year ended December 31, 2023.
Net sales of non-product revenue were $0.3 million for the year ended December 31, 2025 from the recognition of the remaining deferred license revenue associated with Sun Pharmaceutical Industries Ltd. ("Sun Pharma"), Jeil Pharmaceutical Co., Ltd. ("Jeil Pharma") and Drogsan Pharmaceuticals ("Drogsan Pharma"). Net sales of non-product revenue were not material during the year ended December 31, 2024.
The Fresenius Agreement will remain in effect for three years with the option to renew for two additional one-year periods. Additionally, during the year ended December 31, 2024, Rockwell Medical entered into several other multi-year product purchase agreements, which include supply and purchasing commitments from certain parties.
One notable new product purchase agreement was with Innovative Renal Care, one of the largest dialysis service providers in the United States, which will remain in effect for three years with the option to extend for an additional one-year period. Rockwell Medical also worked to renew and expand existing product purchase agreements.
Removed
On July 10, 2023, the Company executed and consummated the transactions contemplated by an Asset Purchase Agreement (the "Purchase Agreement") with Evoqua Water Technologies LLC ("Evoqua") (the “Evoqua Asset Acquisition”).
Added
We are an established leader in manufacturing and delivering high-quality hemodialysis concentrates and dialysates, along with certain ancillary products, to dialysis providers and distributors in the United States and abroad. Rockwell provides the hemodialysis community with products controlled by a Quality Management System regulated by the U.S. Food and Drug Administration ("FDA").
Removed
Subject to the terms and conditions of the Purchase Agreement, at the closing of the transaction (the “Closing”), the Company purchased customer relationships, equipment and inventory from Evoqua, which were related to the manufacturing agreement ("CMA") with a third-party contract manufacturing organization ("CMO") located in Minnesota.
Added
Rockwell has developed a core expertise in manufacturing and delivering hemodialysis concentrates, and has built a longstanding reputation for reliability, quality, and excellent customer service. Our commercial organization supports the Company's vision to focus its efforts on driving Rockwell Medical towards sustainable profitability.
Removed
Total consideration was $17.4 million, comprising a cash payment at Closing of $12.4 million (inclusive of transaction costs) and two $2.5 million deferred payments.
Added
Our commercial team is focused on expanding revenue within our current customer base and seeking to grow revenue through the addition of new accounts to increase Rockwell's overall market share within the hemodialysis concentrates sector.
Removed
On July 12, 2024, the Company and Evoqua executed an amendment to the Purchase Agreement (the "First Amendment"), which stipulated that the first deferred payment would be partially offset by $0.3 million to reimburse the Company for certain expenses incurred following the close of the Evoqua Asset Acquisition and split the first deferred payment into four quarterly installments to be paid through April 2025.
Added
We focus on creating long-term partnerships with customers, securing appropriate pricing for our products, and delivering high-quality product to our customers for use with their patients.
Removed
The First Amendment also split the second deferred payment into four quarterly installments to be paid from July 2025 through April 2026. See Note 4 to our consolidated financial statments included in this Annual Report on Form 10-K for additional information.
Added
We currently operate in one market segment, the hemodialysis market, which involves the manufacturing, sale and distribution of hemodialysis products to hemodialysis clinics, including dialysis concentrates, dialysis kits and other ancillary products used in the dialysis process. On September 18, 2023, Rockwell and DaVita, Inc.
Removed
The CMA with the CMO expired on December 31, 2024 after which the Company will only manufacture Rockwell Medical hemodialysis concentrates through its own facilities. Prior to the expiration of the CMA, the Company transitioned customer relationships acquired through the Purchase Agreement over to Rockwell Medical's hemodialysis concentrates products.
Added
Additionally, DaVita agreed to quarterly, non-refundable payments totaling $2.0 million to ensure supply continuity for products purchased during the year ended December 31, 2025. These quarterly, non-refundable payments of $2.0 million were recorded as revenue during the year ended December 31, 2025.
Removed
On August 7, 2023, Rockwell was informed by Wanbang Biopharmaceuticals Co., Ltd. (“Wanbang”), the Company’s commercialization partner in China for Triferic, that the main efficacy results of Wanbang’s clinical trial for Triferic (dialysate) compared with placebo were not obtained and Wanbang will not bring the product forward to registration.
Added
While DaVita did significantly reduce its product purchases from Rockwell, it did not completely transition its business to a different supplier.
Removed
As a result, the remaining $2.1 million of deferred license revenue was recorded into revenue, and the related portion of long-term inventory of $1.1 million was reserved. On September 18, 2023, Rockwell and DaVita, Inc.
Added
On December 31, 2025, the Company and DaVita entered into a second amendment (the "Second Amendment") to the Amended Agreement which extended the term of the Amended Agreement by one additional year to December 31, 2026 (the "Second Extension Term").
Removed
Under the Amended Agreement, the Company and DaVita agreed to an increase in product pricing, effective September 1, 2023 and a one-time payment of $0.4 million to Rockwell on or after December 1, 2023. The term of the Amended Agreement was scheduled to expire on December 31, 2024.
Added
The Second Amendment also provides for a price increase on the products sold under the Amended Agreement for the Second Extension Term. In 2024, Rockwell continued to upgrade its manufacturing equipment to streamline production and improve margins, renegotiated pricing with key suppliers, and entered into several multi-year customer purchase agreements.
Removed
DaVita subsequently indicated that it will completely transition to another supplier by mid-2025, subject to further discussions between Rockwell and DaVita, which are ongoing. We believe that this will result in the loss of almost half of our sales volume and $34 million in revenue compared to 2024.
Added
In 2025, the Company continued to right-size the organization, including the closure of the Greer facility, to enhance operational efficiency and support long-term growth, while meeting customer demand. Throughout the year, Rockwell Medical signed several new long-term product purchasing agreements with university medical centers, kidney centers and hospital systems.
Removed
On August 21, 2024, the Company entered into a distribution agreement with Nipro Medical Corporation ("Nipro"), a subsidiary of Nipro Corporation Japan and a leader in the global healthcare and medical device industry, under which Rockwell Medical supplies Nipro with the Company's liquid and dry acid and bicarbonate hemodialysis concentrates, as well as its dry acid concentrates mixer, for which Nipro has the right to distribute the Company's products globally, excluding the United States.
Added
One notable expansion was with the largest provider of dialysis in skilled nursing facilities in the United States. This product purchase agreement is in effect for three years with the option to renew for one additional year and includes supply and purchasing minimums. Additionally in 2025, the Company added new customers in the western portion of the United States.
Removed
The Nipro Agreement will remain in effect for two years with the option to extend the agreement for an additional one-year period. Nipro is the primary distributor of our dialysis concentrates in certain countries in Latin America.
Added
The decrease of $32.5 million was primarily due to a $34.6 million reduction in sales to DaVita, partially offset by an increase of $2.1 million from price increases to other existing customers and sales to new customers. DaVita represented 16% and 45% of net sales for the years ended December 31, 2025 and 2024, respectively.
Removed
On December 16, 2024, the Company entered into a product purchase agreement (the "Fresenius Agreement") with Fresenius Medical Care NA (“Fresenius”), the world's leading provider of dialysis products and services, under which the Company supplies Fresenius with the Company's liquid bicarbonate hemodialysis concentrates product, SteriLyte.
Added
Management evaluated its going concern by reviewing the Company's operational plans, which include executing on the projected financial information, including price increases, acquisition of new customers, projected growth of margins and cost containment activities.
Removed
These agreements were with, but not limited to: HydroCare, a leading provider of state-of-the-art dialysis water systems to healthcare facilities globally; Nephro Group Dialysis Centers, the largest dialysis provider in the Philippines; one of the largest health systems in the Mountain West region of the United States; BioNuclear, a distributor of Rockwell's hemodialysis concentrates products within 34 Table of Contents the Dominican Republic; and Atlantic Medical International, Bermuda's leading supplier of medical products and equipment for the acute and continuing care markets.
Added
On July 4, 2025, the U.S. enacted P.L. 119-21, a U.S. federal statute passed by the 119th United States Congress that includes tax and spending policies (the “Act”), which contains a broad range of tax reform provisions affecting businesses, 34 Table of Contents including extending or reinstating certain provisions of the 2017 Tax Cuts and Jobs Act, tax relief measures, modifications of certain energy tax credits granted under the Inflation Reduction Act and limits on various tax deductions, among other key provisions.
Removed
The increase of $21.6 million was primarily due to $6.2 million from customers added through the Evoqua Asset Acquisition, $6.4 million from a special large order of premium-priced product by DaVita, as well as $9.1 million of increased sales and price increases to existing customers.
Added
The Company evaluated the Act and concluded it will not have a material impact on its consolidated financial statements.
Removed
Research and Product Development Expense Research and product development expenses were $19,000 for the year ended December 31, 2024 compared with $1.1 million during the year ended December 31, 2023. The decrease of $1.1 million is due to the decision to pause all research and development related to Triferic in 2023.
Added
Certain distributors deduct distribution service fees from amounts due to the Company. These fees, along with chargebacks arising from contracted pricing arrangements with certain end customers, are recorded as reductions of revenue.
Removed
The $2.0 million increase was primarily due to $1.5 million of additional compensation expense, $0.2 million of increased administrative costs and $0.3 million increase in amortization of intangible assets.
Added
Chargebacks represent the difference between the distributor’s acquisition cost and the lower contracted price offered to the end customer, and are estimated and recorded as a reduction of revenue at the time of the initial sale to the distributor.
Removed
(“Armistice”) exercised its warrant to purchase 9,900,990 shares of common stock with an exercise price of $1.39 per share (the "Prior Warrant") and the Company received gross proceeds of approximately $13.8 million. See Note 12 to the consolidated financial statements included elsewhere in this Form 10-K for further details. On July 10, 2023, the Company completed the Evoqua Asset Acquisition.
Removed
Total consideration was $17.4 million, comprising a cash payment at Closing of $12.4 million (inclusive of transaction costs) and two $2.5 million deferred payments.
Removed
On July 12, 2024, the Company and Evoqua executed the First Amendment, which stipulated that the first deferred payment would be partially offset by $0.3 million to reimburse the Company for certain expenses incurred following Closing and split the first deferred payment into four quarterly installments to be paid through April 2025.
Removed
The First Amendment also split the second deferred payment into four quarterly installments to be paid from July 2025 through April 2026. See Note 4 to our consolidated financial statements statements included in this Annual Report on Form 10-K for additional information.
Removed
On January 2, 2024 the Loan Agreement was amended to include, among other things, an interest only period for 30 months, or up to 36 months if certain conditions are met, and extend the maturity date to January 1, 2029. The Company is subject to certain covenants and cure provisions under its Loan Agreement with Innovatus.

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