What changed in this filing

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Item 1. Business

2025-03-20 compared with 2024-03-21 · 158 added, 171 removed, 248 unchanged (57% of the section changed)

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The SEC also maintains a website on the internet that contains reports, proxy and information statements and other information regarding issuers, such as us, that file electronically with the SEC.

CENTRISOL ® , CitraPure ® , Dri-Sate ® , RenalPure ® , RENASOL ® , SteriLyte ® , and Triferic ® are registered trademarks of Rockwell.

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.

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Rockwell Medical is a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products for dialysis providers worldwide.

Rockwell is a revenue-generating business.

The Company is the largest supplier of liquid bicarbonate concentrates and the second largest supplier of acid and dry 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 at freestanding outpatient dialysis centers, at hospital-based outpatient centers, at skilled nursing facilities, or in a patient’s home.

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.

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, Texas, and South Carolina totaling approximately 175,000 square feet, and manufactures dry acid concentrate mixers at its facility in Iowa.

Additionally, in July 2023, the Company purchased customer relationships, equipment and inventory from Evoqua Water Technologies related to manufacturing and sale of hemodialysis concentrates products, all of which are manufactured under a cGMP contract manufacturing agreement with a third-party organization in Minnesota.

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.

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.

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.

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.

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Rockwell Medical's key developments from 2024 include:

• In February 2023, we signed a three-year, multi-million-dollar supply agreement with the largest non-profit dialysis provider in the United States.

• In February 2023, we signed a three-year, multi-million-dollar product purchase agreement with Concerto Renal Services.

• In February 2023, we were named a 'Great Place to Work'.

• In May 2023, we expanded our geographic footprint to sell our hemodialysis concentrates products into the United Arab Emirates.

• In June 2023, we were added to the Russell Microcap ® Index.

• In June 2023, we entered into a three-year co-promotion services agreement with B.

Braun Medical Inc.

• In July 2023, we acquired the hemodialysis concentrates business from Evoqua Water Technologies.

• In September 2023, we entered into an amended and restated products purchase agreement with DaVita, Inc.

• In September 2023, we entered into a three-year product purchase agreement with Sanderling Renal Services and expanded our distribution capabilities westward into Utah.

• In October 2023, we entered into a three-year product purchase agreement with Centers for Dialysis Care.

• In October 2023, Joan Lau, Ph.D.

was appointed to the Company's board of directors.

• In October 2023, Jesse Neri joined the Company as SVP, Finance.

Rockwell Medical is focused on innovative, long-term growth strategies that enhance its products, its processes, and its people, enabling the Company to deliver exceptional value to the healthcare system and provide a positive impact on the lives of hemodialysis patients.

Rockwell is focused on growing the Company's revenue-generating business, which currently includes its portfolio of hemodialysis concentrates products.

Once the Company achieves sustainable profitability and cash flow from its revenue-generating business, it plans to consider investments in higher-value, longer-term products to develop a broader kidney care products portfolio.

HEMODIALYSIS CONCENTRATES

• In January 2024, we amended and restated our loan and security agreement (the "Amendment") with Innovatus.

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.

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.

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.

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.

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.

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.

The NDAs for Triferic and its approved presentations were not discontinued for safety reasons, but instead were discontinued due to its limited market adoption, unfavorable reimbursement, and the absence of interest from other companies to license or acquire Triferic despite Rockwell's significant effort to partner the program.

In the fourth quarter of 2022, we reacquired the distribution rights to our hemodialysis concentrates products from Baxter Healthcare Corporation ("Baxter") and terminated the exclusive distribution agreement dated October 2, 2014 (as amended, the “Distribution Agreement”) through which Baxter was our exclusive agent for commercializing our hemodialysis concentrate and ancillary products in the U.S.

to clinics other than DaVita and various foreign countries.

Under the Distribution Agreement, Rockwell manufactured all hemodialysis concentrates products and provided customer service and order delivery to

nearly all U.S.

Following the reacquisition of these rights, we sold, and continue to sell, our hemodialysis concentrates products directly to dialysis clinics throughout the U.S.

and around the world.

Additionally, Rockwell was able to independently price its products, eliminate costs associated with manufacturing covenants, improve manufacturing efficiencies and realize the full benefits from those improvements, and develop, in-license, or acquire new products to develop a broader kidney care products portfolio.

For the reacquisition of our distribution rights, we were required to pay Baxter a fee which was paid in two equal installments on January 1, 2023 and April 1, 2023.

In July 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”).

As part of the Purchase Agreement, the Company purchased customer relationships, equipment and inventory from Evoqua, which were related to the manufacturing and sale of hemodialysis concentrates products, all of which were manufactured under a CMA with a third-party CMO.

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.

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.

The First Amendment also split the second deferred payment into four quarterly installments to be paid from July 2025 through April 2026.

The CMA expired December 31, 2024, after which the Company discontinued CENTRISOL and RENASOL and will only manufacture Rockwell Medical hemodialysis concentrates from its own facilities, which the Company believes will reduce its overall production costs.

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'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 hemodialysis concentrates products are used to sustain a patient's life by removing toxins and balancing electrolytes in a dialysis patient’s bloodstream.

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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.

All of our concentrate products are manufactured according to Association for the Advancement of Medical Instrumentation ("AAMI") guidelines and cGMP regulations.

All of our concentrate products are manufactured according to the Association for the Advancement of Medical Instrumentation ("AAMI") guidelines and cGMP regulations.

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.

We believe we can achieve this by growing our business through the addition of new customers, expanding our territory coverage, increasing the efficiency by which Rockwell produces its products, and pricing our products appropriately to drive profitability.

We believe we can achieve this by growing our business through the addition of new customers, expanding our territory coverage, increasing the efficiency by which we produce our products, and pricing our products appropriately to drive profitability.

Our Products:

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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.

In each setting, a dialysis machine dilutes concentrated solution, such as Rockwell’s concentrate products, with purified water.

The resulting solution is called dialysate.

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CitraPure Citric Acid Concentrate

Our CitraPure Concentrate 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, and as a dry powder acid concentrate for use with our Dry Acid Concentrate Mixer in 25-gallon cases.

Dri-Sate Dry Acid Concentrate

Our Dri-Sate Concentrate is an acetic acid-based product.

Dri-Sate is packaged as a dry powder acid concentrate for use with our Dry Acid Concentrate Mixer in 25-gallon cases.

RenalPure Liquid Acid Concentrate

Our RenalPure Liquid Concentrate is an acetic acid-based product and is packaged in 55-gallon drums and in one-gallon jugs (sold in cases of four).

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.

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.

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.

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

RenalPure bicarbonate is a dry powder mixed on-site at the clinic and is packaged in bulk and individual treatment sizes.

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

SteriLyte bicarbonate is a liquid packaged in cases of four one-gallon jugs (sold in cases of four) and is used mainly in acute care settings.

CENTRISOL and RENALSOL Hemodialysis Concentrates

Our CENTRISOL hemodialysis concentrates consist of acid and bicarbonate formulations suitable for 45X dilution three-stream hemodialysis devices.

Our RENASOL acid and bicarbonate concentrates are compatible with 36X dilution devices.

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.

CENTRISOL and RENASOL Hemodialysis Concentrates

CENTRISOL hemodialysis concentrates consist of acid and bicarbonate formulations suitable for 45X dilution three-stream hemodialysis devices.

RENASOL acid and bicarbonate concentrates are compatible with 36X dilution devices.

CENTRISOL and RENASOL liquid acids are packaged in 55-gallon drums or in one-gallon jugs (sold in cases of four).

CENTRISOL and RENASOL bicarbonate concentrates are packaged as liquid in one-gallon jugs (sold in cases of four) or as dry powder in bulk and individual treatment sizes.

In July 2023, the Company acquired the hemodialysis concentrates business from Evoqua.

Under the terms of the agreement, Rockwell Medical acquired Evoqua's concentrates business which included all contracts, intellectual property, U.S.

Food and Drug Administration 510(k) clearances, and assets primarily associated with, and related to, Evoqua's concentrates business nationwide, including CENTRISOL and RENASOL liquid and powder bicarbonate and liquid acid.

Effective December 31, 2024, the Company discontinued CENTRISOL and RENASOL in conjunction with the termination of its contract manufacturing agreement with a third-party contract manufacturing organization and transitioned customers over to Rockwell Medical's hemodialysis concentrates products.

Dry Acid Concentrate Mixer

Our Dry Acid Concentrate Mixer is designed for our CitraPure and Dri-Sate Dry Acid products and enables the clinic to mix acid concentrate on-site.

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.

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.

Ancillary Products

We offer certain ancillary products to selected customers including testing supplies, 5% acetic acid cleaning solution, 5% and 2% citric acid descaler, filtration salts, and other items used by hemodialysis providers.

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.

Market Opportunity:

Rockwell's vision is to become the leading global supplier of all hemodialysis concentrates.

Today, 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.

According to an independent research report that Rockwell commissioned from L.E.K.

Consulting LLC in 2022, the hemodialysis concentrates market in the United States is anticipated to grow to approximately $500 million by 2026, up from $380 million in 2022.

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.

Consulting LLC in 2022, the hemodialysis concentrates market in the U.S.

is projected to grow to approximately $560 million by 2028, up from $450 million in 2024.

This is driven primarily by an increasing number of patients suffering from end-stage kidney disease.

Hemodialysis concentrates represent a large market opportunity for which we believe Rockwell's products are well-positioned to meet the needs of patients.

Rockwell is one of only two suppliers that has the manufacturing scalability and transportation infrastructure to service the more than 12,000 individual purchasing facilities (including outpatient dialysis clinics and hospitals) in the United States along with select international markets.

Rockwell is a leading supplier that has the scalability to manufacture and deliver to the more than 12,000 individual purchasing facilities (including outpatient dialysis clinics and hospitals) in the United States along with select international markets.

Sales and Marketing:

On November 9, 2022, Rockwell reacquired its distribution rights to its hemodialysis concentrates products from Baxter Healthcare Corporation ("Baxter") and agreed to terminate the exclusive distribution agreement dated October 2, 2014.

Exclusivity and other provisions associated with the distribution agreement terminated November 9, 2022 and the remaining operational elements of the agreement terminated December 31, 2022.

Rockwell agreed to provide certain services to a group of Baxter customers until March 31, 2023.

Under the exclusive distribution agreement, Baxter distributed and commercialized Rockwell’s hemodialysis concentrates products in the United States and certain other countries.

Rockwell manufactured all hemodialysis concentrates products and provided customer service and order delivery to nearly all U.S.

Following the reacquisition of these rights, Rockwell is now able to sell its hemodialysis concentrates products directly to dialysis clinics throughout the United States and around the world.

Additionally, Rockwell is now able to independently price its products, eliminate costs associated with manufacturing covenants, improve manufacturing efficiencies and realize the full benefits from those improvements, and develop, in-license, or acquire new products to develop a broader kidney care products portfolio.

This is expected to improve Rockwell's overall profitability and set the Company on a positive growth trajectory.

On June 29, 2023, the Company announced that it entered into a three-year co-promotion services agreement with B.

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.

The Company concentrates its efforts on increasing the Company's market share, broadening its product portfolio, right-sizing the Company's product pricing, improving gross margins, and growing the business through organic and inorganic growth and other business development opportunities.

The Company also has a three-year co-promotion services agreement, which was announced in June 2023, with B.

Braun Medical Inc.

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Braun as an independent, non-exclusive representative to promote the Company's hemodialysis concentrates products to dialysis providers in the United States with a focus on the west coast.

All terms of the sale of any Rockwell product, including price, delivery schedule, and terms and conditions, are set by Rockwell at the Company's sole discretion.

All terms of the sale of any Rockwell product, including price, delivery schedule, and other terms and conditions, are set by Rockwell at the Company's sole discretion.

All orders are directed to, and processed by, Rockwell.

Braun receives a fee for any sales generated by its promotional efforts.

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 Acquisition").

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 manufacturing and selling of hemodialysis concentrates products, all of which are manufactured under a contract manufacturing agreement with a third-party organization .

On September 18, 2023, Rockwell and our long-time partner, DaVita, a leading provider of kidney care, entered into an Amended and Restated Products Purchase Agreement (the "Amended Agreement"), which amends and restates the Product Purchase Agreement, dated July 1, 2019, as amended, under which the Company supplies DaVita with certain dialysis concentrates.

Under the Amended Agreement, the Company and DaVita agreed to an increase in product pricing, effective September 1, 2023 and a one-time payment to Rockwell on or after December 1, 2023.

The term of the Amended Agreement will expire on December 31, 2024.

DaVita will have the right, in its sole discretion upon written notice to the Company given no later than September 30, 2024, to further extend the term through December 31, 2025.

In the event of such an extension, product pricing will be increased for the extended term.

In addition, DaVita is required to provide the Company with nine-month purchasing forecasts and a commitment to purchase at least the forecasted amounts.

In the event that DaVita does not meet its forecasts, it is required to pay the Company for the amount forecasted, purchase additional product, or the Company may terminate the Amended Agreement.

Upon expiration or termination of the Amended Agreement, and upon request by DaVita, the Company has agreed to provide transition services to DaVita during a transition period.

In 2023, Rockwell entered into several long-term product purchase agreements, which include supply and purchasing commitments from certain parties.

These agreements include the largest non-profit dialysis provider in the United States;

Concerto Renal Services, the largest provider of dialysis in skilled nursing facilities in the United States;

Sanderling Renal Services, Inc., a full-service provider of in-center, home dialysis and renal telemedicine services focusing on patients in rural and underserved communities across the United States;

Centers for Dialysis Care, the largest non-profit, independent outpatient

dialysis provider in Northeast Ohio;

Houston Methodist, a leading health system and academic medical center;

Dialyze Direct, a leading provider of home dialysis services in the skilled nursing facility setting;

and Outset Medical (Nasdaq:OM), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis with its Tablo ® Hemodialysis System, which is FDA-cleared for use from the hospital to the home.

We also supply dialysis concentrates to distributors serving a number of foreign countries, primarily in the Americas and the Pacific Rim.

Nipro Medical Corporation is the primary distributor of our dialysis concentrates in certain countries in Latin America that were not covered under the Distribution Agreement.

Dialysate concentrates accounted for approximately 97 .2 % of our revenue for the year ended December 31, 2023, of which approximately 91.5% was to distributors and customers for use in the United States.

We currently operate in one market segment, the hemodialysis market, which involves the manufacture, sale and distribution of hemodialysis products to hemodialysis clinics, including pharmaceutical, dialysis concentrates, dialysis kits and other ancillary products used in the dialysis process.

DaVita, accounted for 47% of our concentrate sales in 2023 and 46% of our concentrate sales in 2022.

Our accounts receivable from this customer were $2.1 million and $1.9 million as of December 31, 2023 and 2022, respectively.

In July 2019, we entered into the Products Purchase Agreement with DaVita, with an initial term expiring on December 31, 2023.

On April 6, 2022, the Company and DaVita entered into a Securities Purchase Agreement (the “SPA”), which provided for the issuance by the Company of up to $15 million of preferred stock to DaVita (see "Preferred Stock" section in Note 12 below).

On September 18, 2023, we entered into the Amended Agreement with DaVita under which the Company supplies DaVita with certain dialysis concentrates.

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.

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.

Rockwell's customer mix is diverse, with most customer sales concentrations under 10%.

However, one customer, DaVita, accounted for 45% of our total net product sales in 2024 and 47% of our total net product sales in 2023.

Our accounts receivable from DaVita was $1.7 million and $2.1 million as of December 31, 2024 and 2023, respectively.

No other current customer accounted for more than 10% of sales in any of the last two years.

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.

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.

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.

However, 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 and include considerations of a potential contract extension and/or future volume commitments by DaVita to Rockwell.

While there can be no assurance that these discussions will yield a successful outcome for Rockwell, the Company is continuing to work closely with DaVita to support its clinics and its patients.

See "Material Agreements" below for more information on the Amended Agreement.

No other customers accounted for more than 10% of our sales in any of the last three years.

DaVita and Nipro Medical Corporation 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.

See Item 1A “Risk Factors” for a discussion of certain risks related to our key customers.

In December 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 will supply Fresenius with the Company's liquid bicarbonate hemodialysis concentrates product, SteriLyte.

The Fresenius Agreement will remain in effect for three years with the option to renew for two additional one-year periods.

In August 2024, the Company entered into a distribution agreement with Nipro, a subsidiary of Nipro Corporation Japan and a leader in the global healthcare and medical device industry, under which Rockwell Medical will supply 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.

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.

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 the Dominican Republic;

and Atlantic Medical International, Bermuda's leading supplier of medical products and equipment for the acute and continuing care markets.

We supply dialysis concentrates to distributors serving a number of foreign countries, primarily in the Americas and the Pacific Rim.

The majority of our international sales in each of the last two years were sales to domestic distributors that were resold to end users outside the United States.

Our total international sales, including sales made through domestic distributors for resale outside the United States, aggregated 9% and 9% of our overall sales in 2023 and 2022, respectively.

See Item 1A “Risk Factors” for a discussion of certain risks related to our foreign sales.

In the United States, our principal competitor for concentrate products is Fresenius Medical Care NA (“Fresenius”), 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.

Our total international sales, including sales made through domestic distributors for resale outside the United States, aggregated 9% of our overall sales in both 2024 and 2023.

Our major 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.

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.

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, 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.

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Fresenius and Rockwell are the two major dialysis concentrate suppliers in the United States.

Nipro provides the dialysis marketplace with hemodialysis systems, dialyzers, AVF needles, bloodline tubing sets, concentrates and other renal accessories.

Since it was established in 1996, Nipro has expanded its presence in the United States through acquisitions and organic growth.

Quality Assurance and Control:

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We operate under FDA regulations and place significant emphasis on providing quality products and services to our customers.

We have established an organizational structure and quality system procedures to ensure our device products are

designed and produced to meet product quality requirements and FDA guidelines.

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.

Dialysis products are manufactured and tested using validated equipment and defined process

controls to ensure rigorous conformance to specifications.

To assure quality and consistency of our dialysis concentrates, analytical testing is performed using validated instrument methods to verify that the chemical properties and microbial limits of each product lot comply with the specifications required by industry standards.

Our concentrates are labeled per FDA's Labeling and Packaging Control Requirements, including a Unique Device Identifier ("UDI") code, to ensure traceability of distributed products.

Our quality program activities also include qualification and ongoing assessments of suppliers of raw materials, packaging components and finished goods, and quality management reviews designed to inform management of key issues that may affect the quality of products, assess the effectiveness of our quality systems, and identify areas for improvement.

Our quality program activities also include qualification and ongoing assessments of suppliers of raw materials, packaging components, services and finished goods, and quality management reviews designed to inform management of key issues that may affect the quality of products, assess the effectiveness of our quality systems, and identify areas for improvement.

The raw materials and packaging materials for our hemodialysis concentrates, the components for our hemodialysis kits and the ancillary hemodialysis products we distribute are generally available from several potential suppliers.

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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.

Rockwell distribution and delivery operated under the Distribution Agreement on behalf of Baxter for domestic business.

On November 9, 2022, Rockwell reacquired its distribution rights to its hemodialysis concentrates products from Baxter and agreed to terminate the exclusive distribution agreement dated October 2, 2014.

Exclusivity and other provisions associated with the distribution agreement terminated November 9, 2022 and the remaining operational elements of the agreement terminated December 31, 2022.

Rockwell agreed to provide certain services to a subgroup of Baxter's customers until March 31, 2023.

Triferic (dialysate) and Triferic AVNU are indicated to maintain hemoglobin in patients undergoing hemodialysis.

We began commercializing Triferic and Triferic AVNU in the United States in the second half of 2019 and in early 2021, respectively.

In 2022, Rockwell undertook a strategic review of Triferic's viability in the United States.

Triferic 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.

Due to its limited market adoption, unfavorable reimbursement, and absence of interest from other companies to license or acquire Triferic despite Rockwell's significant effort to partner the program, the Company discontinued its New Drug Applications ("NDAs") for Triferic and Triferic AVNU in the United States in the fourth quarter of 2022.

Sustaining Triferic commercially in the United States resulted in losses to Rockwell annually.

The decision to discontinue the NDAs was not made lightly as the Company realizes the direct impact this action had on patients using the products.

Triferic and its approved presentations were not discontinued for safety reasons.

Rockwell continues to support its partners outside the United States that have exclusive license agreements to develop and commercialize Triferic.

MATERIAL AGREEMENTS

Distribution Agreement with Baxter

Pursuant to the Exclusive Distribution Agreement dated October 2, 2014 (as amended, the “Distribution Agreement”), Baxter was our exclusive agent for commercializing our hemodialysis concentrate and ancillary products in the United States to clinics other than DaVita and various foreign countries for an initial term of 10 years ending October 2, 2024.

We retained sales, marketing and distribution rights for our hemodialysis concentrate products for our international customers and in those countries in which we had an established commercial presence.

In the fourth quarter of 2022, Rockwell reacquired its distribution rights to its hemodialysis concentrates products from Baxter and terminated the Distribution Agreement.

Rockwell was required to pay Baxter a fee for the reacquisition of its distribution rights.

This fee was paid in two equal installments on January 1, 2023 and April 1, 2023.

Following the reacquisition of the distribution rights, Rockwell is now able to sell its hemodialysis concentrates products to dialysis clinics throughout the United States and around the world.

Products Purchase Agreement with DaVita

On September 18, 2023, Rockwell and our long-time partner, DaVita, a leading provider of kidney care, entered into the Amended Agreement.

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.

The term of the Amended Agreement will expire on December 31, 2024.

DaVita will have the right, in its sole discretion upon written notice to the Company given no later than September 30, 2024, to further extend the term through December 31, 2025.

In the event of such an extension, product pricing will be increased for the extended term.

In addition, DaVita is required to provide the Company with nine-month purchasing forecasts and a commitment to purchase at least the forecasted amounts.

In the event that DaVita does not meet its forecasts, it is required to pay the Company for the amount forecasted, purchase additional product, or the Company may terminate the Amended Agreement.

Upon expiration or termination of the Amended Agreement, and upon request by DaVita, the Company has agreed to provide transition services to DaVita during a transition period.

The term of the Amended Agreement was scheduled to expire on December 31, 2024.

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.

However, 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 and include discussions of a potential contract extension and/or future volume commitments by DaVita to Rockwell.

While there can be no assurance that these discussions will yield a successful outcome for Rockwell, the Company is continuing to work closely with DaVita to support its clinics and its patients.

Product License Agreements

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Ajay Gupta, who is the former Executive Vice President and Chief Scientific Officer of the Company.

Pursuant to the Charak MSA, the parties entered into three additional agreements described below related to the license of certain soluble ferric pyrophosphate (“SFP”) intellectual property owned by Charak, as well as the Employment Agreement (defined below).

The Charak MSA provided for a payment of $1,000,000 to Dr.

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The Charak Amendment amends the royalty payments due to Charak under the 2002 Agreement such that the Company is liable to pay Charak royalties on net sales by the Company of products developed under the license, which includes the Company’s Triferic product, at a specified rate until December 31, 2021 and thereafter at a reduced rate from January 1, 2022 until February 1, 2034.

In addition, the Company is required to pay Charak a percentage of any sublicense income during the term of the agreement, which amount shall not be less than a minimum specified percentage of net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid patent claim, on a country-by-country basis, and not be less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid patent claim, on a country-by-country basis.

In addition, the Company

is required to pay Charak a percentage of any sublicense income during the term of the agreement, which amount shall not be less than a minimum specified percentage of net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid patent claim, on a country-by-country basis, and not be less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid patent claim, on a country-by-country basis.

Also pursuant to the Charak MSA, the Company and Charak entered into a Commercialization and Technology License Agreement Triferic IV, dated as of October 7, 2018 (the “IV Agreement”), under which Charak granted the Company an exclusive, sublicensable, royalty-bearing license to SFP for the purpose of commercializing certain intravenous-delivered products incorporating SFP for the treatment of iron disorders worldwide for a term that expires on the later of February 1, 2034 or upon the expiration or termination of a valid claim of a licensed patent.

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During the term of the TPN Agreement, the Company is liable to pay Charak a base royalty on net sales and an additional royalty on net sales while there exists a valid claim of a licensed patent, on a country-by-country basis.

The Company shall also pay to Charak a percentage of

any sublicense income received during the term of the TPN Agreement, which amount shall not be less than a minimum royalty on net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and not be less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid claim, on a country-by-country basis.

The Company shall also pay to Charak a percentage of any sublicense income received during the term of the TPN Agreement, which amount shall not be less than a minimum royalty on net sales of the licensed products by the sublicensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and not be less than a lower rate of the net sales of the licensed products by the sublicensee in jurisdictions where there exists no valid claim, on a country-by-country basis.

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 approvals including medical devices.

We hold several FDA product clearances for medical devices.

The testing, manufacture and sale of our hemodialysis concentrates and the ancillary products we distribute are subject to regulation by numerous governmental authorities, principally the FDA and corresponding state and foreign agencies.

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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.

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 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.

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.

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Medical device types that the FDA has not previously classified as Class I, II, or III are automatically classified into Class III regardless of the level of risk they pose.

The Food and Drug Administration Modernization Act of 1997 established a new route to market for low to moderate risk medical devices that are automatically placed into Class III due to the absence of a predicate device, called the “Request for Evaluation of Automatic Class III Designation,” or the de novo classification procedure.

predicate device, called the “Request for Evaluation of Automatic Class III Designation,” or the de novo classification procedure.

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.

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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.

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.

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.

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.

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The IDE must be approved in advance by the FDA for a specified number of patients, unless the product candidate is deemed a non-significant risk device and is eligible for more abbreviated IDE requirements.

Clinical trials for a significant risk device may begin once the IDE application is approved by the FDA and

appropriate IRBs at the clinical trial sites.

Clinical trials for a significant risk device may begin once the IDE application is approved by the FDA and appropriate IRBs at the clinical trial sites.

Submission of an IDE will not necessarily result in the ability to commence clinical trials, and although the FDA’s approval of an IDE allows clinical testing to go forward for a specified number of subjects, it does not bind the FDA to accept the results of the trial as sufficient to prove the product’s safety and efficacy, even if the trial meets its intended success criteria.

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After the FDA permits a device to enter commercial distribution, numerous regulatory requirements continue to apply.

These include:

These may include, as applicable:

• establishment registration and device listing with the FDA;

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• post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device.

Additionally, manufacturers are subject to unannounced inspections by the FDA to determine compliance with the QSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use.

Additionally, manufacturers are subject to unannounced or unscheduled inspections by the FDA to determine compliance with the QSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, handling, storage, and distribution of finished devices intended for human use.

The QSR also requires, among other things, maintenance of a device master file, device history file, and complaint files.

Manufacturers are subject to periodic scheduled or unscheduled inspections by the FDA.

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 discovery of previously unknown problems with products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or approval or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls.

In addition, the FDA can issue warning letters or untitled 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 regard to medical devices that present unreasonable risks of substantial harm to the public health.

The FDA may also initiate action for civil penalties and/or criminal prosecution of such violations.

There are also certain requirements of state, local, and foreign governments that we must comply with in the manufacturing and marketing of our products.

We will need to maintain customer complaint files, record all lot numbers of disposable products, and conduct periodic audits to assure compliance with applicable regulations.

We place special emphasis

on customer training and advise all customers that device operation should be undertaken only by qualified personnel.

In addition to laws and regulations in the United States, we are subject to a variety of laws and regulations in other jurisdictions governing, among other things, clinical trials and any commercial sales and distribution of our product candidates.

Postmarket Requirements—EU

The regulatory review process varies from country to country and may in some cases require the submission of clinical data.

Our international sales are subject to regulatory requirements in the countries in which our product candidates are sold.

In addition, the EU has adopted the EU Medical Device Regulation (EU 2017/745) (the “EU MDR”) which imposes stricter requirements for the marketing and sale of medical devices than in the United States, including in the area of clinical evaluation requirements, quality systems and post-market surveillance.

The transition period provided for in the EU MDR for existing CE certifications issued under the previous Medical Devices Directive will end on May 26, 2024.

For certain medical devices, the transition period was extended, ending between December, 31, 2026 and December 31, 2028, depending on the class of the device and the fulfillment of certain additional conditions.

(Regulation (EU) 2023/607).

Complying with these regulations may require us to incur significant expenditures.

Failure to meet these regulatory requirements could adversely impact our business in the EU and other regions that tie their product registrations to the EU requirements.

We are also subject to numerous federal, state and local laws relating to such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control, transportation and disposal of hazardous or potentially hazardous substances.

Our hemodialysis concentrate products and other ancillary devices are subject the FDA 510(k) requirements.

We have 510(k) clearance from the FDA to market hemodialysis concentrates in both liquid and powder form.

In addition, we have received 510(k) clearance for our Dry Acid Concentrate Mixer.

We must comply with the FD&C Act and related laws and regulations, including cGMP, to retain 510(k) clearances.

We cannot assure you that we will be able to maintain our 510(k) clearances from the FDA to manufacture and distribute our products.

If we fail to maintain our 510(k) clearances, we may be required to cease manufacturing and/or distributing our products, which would have a material adverse effect on our business, financial condition and results of operations.

If any of our FDA clearances are denied or rescinded, sales of our products in the United States would be prohibited during the period we do not have such clearances.

We maintain customer complaint files, record lot numbers of products, and conduct periodic audits to assure compliance with applicable regulations.

We place special emphasis on customer training and advise all customers that device operation should be undertaken only by qualified personnel.

In addition to laws and regulations in the United States, we are subject to a variety of laws and regulations in other jurisdictions governing, among other things, any commercial sales and distribution of our product candidates.

Other Government Regulations

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Each year, CMS will select and negotiate a preset number of high-spend drugs and biologics that are covered under Medicare Part B and Part D that do not have generic or biosimilar competition.

These price negotiations began in 2023.

On August 29, 2023, HHS announced the list of the first ten drugs subject to price negotiations.

These price negotiations occurred in 2024.

In January 2025, CMS announced a list of 15 additional Medicare Part D drugs that will be subject to price negotiations.

The IRA also provides a new “inflation rebate” covering Medicare patients that took effect in 2023 and is intended to counter certain price increases in prescriptions drugs.

The inflation rebate provision will require drug manufacturers to pay a rebate to the federal government if the price for a drug or biologic under Medicare Part B and Part D increases faster than the rate of inflation.

The inflation rebate provision requires drug manufacturers to pay a rebate to the federal government if the price for a drug or biologic under Medicare Part B and Part D increases faster than the rate of inflation.

Notwithstanding these provisions, the IRA’s impact on commercialization and competition remains largely uncertain.

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• 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 soliciting, receiving, offering or providing remuneration, directly or indirectly, where one purpose is to induce either the referral of an individual for, or the purchase order or recommendation of, any item or services for which payment may be made under a federal healthcare program such as the Medicare and Medicaid programs.

• 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.

The term remuneration has been interpreted broadly to include anything of value.

government has interpreted this law broadly to apply to the marketing and sales activities of medical device manufacturers;

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federal consumer protection and unfair competition laws, which broadly regulate marketplace activities that potentially harm customers;

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.

• 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.

The approval procedures for the marketing of our products in foreign countries vary from country to country, and the time required for approval may be longer or shorter than that required for FDA approval.

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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 several foreign countries.

Most such applications have resulted in registration of such trademarks and service marks.

As of December 31, 2023, we owned or had the rights to 6 issued patents (4 U.S.

and 2 foreign) and 1 pending foreign application.

Patents and patent applications owned or licensed by us include claims to FPC in both dialysate and IV

compositions, formulations and methods of making and parenteral nutritional compositions including Triferic.

As of December 31, 2024 we owned or had the rights to, 4 iss ued U.S.

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.

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We are committed to a safe workplace for our employees and have implemented health and safety management processes into our operations.

In response to the COVID-19 pandemic, we continue to follow the CDC protocol for safe return-to-work for affected employees and remain steadfast in our efforts to keep employees healthy and protected.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business