What changed in this filing

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Item 1. Business

2026-03-26 compared with 2025-03-20 · 140 added, 215 removed, 191 unchanged (65% 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 Medical.

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.

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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.

The Company is a leading supplier of liquid and dry, acid and bicarbonate concentrates for dialysis patients in the United States.

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.

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.

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 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.

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.

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 2025 include:

• 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.

• 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.

• 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.

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.

("DaVita"), extending the term through December 31, 2026.

As part of the amendment, product pricing will be increased for the extended term.

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.

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;

3) Seek the next advancement in renal care to drive innovative treatments for patients.

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.

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.

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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 we produce our products, and pricing our products appropriately to drive profitability.

Rockwell currently provides a portfolio of hemodialysis concentrates products to 294 customers, including all five of the leading dialysis providers in the United States.

Our Products:

Most hemodialysis patients receive dialysis treatment three times per week, or approximately 156 times per year.

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.

Most patients who have their dialysis treatment performed at a free-standing clinic have significant and irreversible loss of kidney function.

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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.

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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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

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.

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.

Our bicarbonate cartridge is designed to be used for a single dialysis treatment on a compatible hemodialysis device and is packaged with ten cartridges in one case.

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.

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.

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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.

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.

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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.

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.

Braun"), a leader in renal therapies, including innovative, high-quality products for hemodialysis.

As part of the agreement, Rockwell designates B.

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 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.

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.

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.

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.

Rockwell currently serves 294 customers, highlighted by all five of the leading dialysis providers in the United States, including Fresenius and DaVita.

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.

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.

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

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.

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.

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.

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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.

DaVita subsequently indicated that it would completely transition to another supplier by mid-2025.

While DaVita did significantly reduce its product purchases from Rockwell, DaVita did not completely transition its business to a different supplier.

On December 31, 2025, the Company and DaVita entered into a second amendment (the "Second Amendment") to the Amended Agreement which extended the term by one additional year to December 31, 2026 (the "Second Extension Term").

The Second Amendment also provides for a price increase on the products sold under the Amended Agreement for the Second Extension Term.

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

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% of our overall sales in both 2024 and 2023.

Our major customers are important to our business, financial condition and results of operations.

In 2025, Rockwell Medical signed several new long-term product purchase agreements with university medical centers, kidney centers and hospital systems.

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.

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.

The Company also added new customers in the western portion of the United States.

As a result, the western U.S.

now accounts for more than 10% of the Company's customer clinic footprint.

We supply dialysis concentrates to distributors serving over 30 foreign countries, primarily in the Americas and the Pacific Rim.

Our total international sales accounted for approximately 12% and 9% of our total sales in 2025 and 2024, respectively.

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.

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.

In the United States, our principal competitors for concentrate products are Fresenius Medical Care NA (“Fresenius”) and Nipro Medical Corporation, a subsidiary of Nipro Corporation Japan (“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.

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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 is also a Rockwell customer.

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

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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.

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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.

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.

We deliver our hemodialysis concentrates products and mixers internationally solely utilizing third-party carriers and distribution partners.

MATERIAL AGREEMENTS

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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

We are party to a Licensing Agreement between the Company and Charak, LLC (“Charak”) dated January 7, 2002 (the “2002 Agreement”) that grants the Company exclusive worldwide rights to certain patents and information related to our Triferic products.

On October 7, 2018, we entered into a Master Services and IP Agreement (the “Charak MSA”) with Charak and Dr.

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 an employment agreement.

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

Gupta, payable in four quarterly installments of $250,000 each on October 15, 2018, January 15, 2019, April 15, 2019 and July 15, 2019, and reimbursement for certain legal fees incurred in connection with the Charak MSA.

As of December 31, 2019, all payments under the Charak MSA were paid.

Pursuant to the Charak MSA, the aforementioned parties entered into an Amendment, dated as of October 7, 2018 (the “Charak Amendment”), to the 2002 Agreement, under which Charak granted the Company an exclusive, worldwide, non-transferable license to commercialize SFP for the treatment of patients with renal failure.

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.

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.

The Company is liable to pay Charak royalties on net sales by the Company of products developed under the license at a specified rate until December 31, 2021.

From January 1, 2022 until February 1, 2034, the Company is liable to pay Charak a base royalty at a reduced rate 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 IV 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 claim, on a country-by-country basis, and no 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.

Also pursuant to the Charak MSA, the Company and Charak entered into a Technology License Agreement TPN Triferic, dated as of October 7, 2018 (the “TPN Agreement”), pursuant to which Charak granted the Company an exclusive, sublicensable, royalty-bearing license to SFP for the purpose of commercializing worldwide certain Total Parenteral Nutrition ("TPN") products incorporating SFP.

The license grant under the TPN Agreement continues 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.

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.

DaVita subsequently indicated that it would completely transition to another supplier by mid-2025.

While DaVita did significantly reduce its product purchases from Rockwell, DaVita did not completely transition its business to a different supplier.

On December 31, 2025, the Company and DaVita entered into the Second Amendment, which extended the term of the Amended Agreement by one additional year to December 31, 2026.

The Second Amendment also provides for a price increase on the products sold under the Amended Agreement for the Second Extension Term.

GOVERNMENT REGULATION

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Device 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.

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.

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 I includes devices with the lowest risk to the patient and consists of devices for which safety and effectiveness can be reasonably assured through adherence to General Controls.

General Controls require compliance with the applicable portions

of the FDA’s Quality System Regulation ("QSR"), which is being transitioned to the Quality Management System Regulation, facility registration and product listing, reporting of adverse events and malfunctions, and appropriate, truthful and non-misleading labeling and promotional materials.

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.

However, most Class I products are exempt from the premarket notification requirements.

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.

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.

Class III devices include devices deemed by the FDA to pose the greatest risk such as life-supporting or life-sustaining devices, or implantable devices, in addition to those deemed novel and not substantially equivalent following the 510(k) process.

These Special Controls can include performance standards, post market surveillance, patient registries, and FDA guidance documents.

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 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 PMA application process, which is generally more costly and time-consuming than the 510(k) process.

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.

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.

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.

Clinical data is sometimes required to support substantial equivalence.

The FDA’s 510(k) clearance pathway usually takes from three to 12 months from the date the notification is submitted, but it can take considerably longer, depending on the extent of FDA’s requests for additional information and the amount of time a sponsor takes to fulfill them.

After a 510(k) is submitted, the FDA determines whether to accept it for substantive review.

If it lacks necessary information for substantive review, the FDA will refuse to accept the 510(k) submission.

If it is accepted for filing, the FDA begins a substantive review.

By statute, the FDA is required to complete its review of a 510(k) premarket notification within 90 days of receiving the 510(k) submission.

As a practical matter, clearance often takes longer, and clearance is never assured.

Although many 510(k) premarket notifications are cleared without clinical data, the FDA may require further information, including clinical data, to make a determination regarding substantial equivalence, which may significantly prolong the review process.

If the FDA agrees that the device is substantially equivalent to a predicate device, it will grant clearance to commercially market the device.

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.

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.

The FDA requires each manufacturer to make this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination.

If the FDA requires a new 510(k) clearance or approval of a PMA application for any modifications to a previously-cleared product, the applicant may be required to cease marketing or recall the modified device until clearance or approval is received.

In addition, in these circumstances, the FDA can impose significant regulatory fines or penalties for failure to submit the requisite 510(k) or PMA application(s).

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.

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.

Prior to the enactment of the Food and Drug Administration Safety and Innovation Act of 2012 (the "FDASIA"), a medical device could only be eligible for de novo classification if the manufacturer first submitted a 510(k) premarket notification and received a determination from the FDA that the device was not substantially equivalent.

The FDASIA streamlined the de novo classification pathway by permitting manufacturers to request de novo classification directly without first submitting a 510(k) premarket notification to the FDA and receiving a not substantially equivalent determination.

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.

If the manufacturer seeks reclassification into Class II, the manufacturer must include a draft proposal for Special Controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the medical device.

In addition, the FDA may reject the reclassification petition if it identifies a legally marketed predicate device that would be appropriate for a 510(k) or determines that the device is not low to moderate risk or that General Controls would be inadequate to control the risks and Special Controls cannot be developed.

A PMA must be submitted if a device cannot be cleared through the 510(k) clearance or de novo process.

A PMA must be supported by extensive data, including, but not limited to, technical information, preclinical data, clinical trial data, manufacturing data, and labeling, to demonstrate to the FDA’s satisfaction the safety and efficacy of the device for its intended use.

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.

The FDA, by statute and by regulation, has 180 days to review a filed PMA, although the review of an application more often occurs over a significantly longer period of time.

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.

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.

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.

The FDA is not bound by the recommendations of an advisory panel, but it considers such recommendations carefully when making decisions.

Prior to approval of a PMA, the FDA may conduct a bioresearch monitoring inspection of the clinical trial data and clinical trial sites, and a QSR inspection of the manufacturing facility and processes.

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.

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.

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.

Clinical data are not always required to support a determination of substantial equivalence.

Upon submission, the FDA conducts an administrative review to determine whether the 510(k) is sufficiently complete to permit substantive review.

If the submission does not meet the applicable acceptance criteria, the FDA may refuse to accept (“RTA”) the submission.

If accepted, the FDA conducts a substantive review to determine whether the device is substantially equivalent to the identified predicate.

By statute, the FDA is required to review a 510(k) within 90 days of receipt;

however, the review timeline is frequently extended due to requests for additional information and the time required for the applicant to respond.

As a result, the time to clearance can vary significantly and may extend well beyond the statutory review period.

There can be no assurance that any 510(k) submission will be cleared by the FDA.

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.

In such case, the manufacturer must either submit and obtain approval of a PMA application or pursue reclassification of the device through the de novo classification process, if eligible.

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.

FDA regulations require a new 510(k) if a modification could significantly affect its safety or effectiveness of the device or constitutes major change in the intended use of the device.

Although manufacturers are responsible in the first instance for making this determination, the FDA may review and disagree with a manufacturer’s conclusion.

If the FDA determines that a new 510(k) clearance or PMA approval is required for a modified device that has already been marketed, the Company may be required to cease distribution, recall the device, or seek appropriate authorization, and could be subject to enforcement action, including warning letters, civil monetary penalties, or other sanctions.

Devices for which there is no legally marketed predicate device are automatically classified into Class III, regardless of risk.

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.

Under current law, a manufacturer may submit a de novo request either (i) after receiving a “not substantially equivalent” determination in response to a 510(k) submission or (ii) directly, without first submitting a 510(k), if the manufacturer determines that no legally marketed predicate device exists.

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.

If the FDA grants a de novo request, the device is classified into Class I or Class II and may be subject to General Controls and, for Class II devices, Special Controls.

The classification may also serve as a predicate for future 510(k) submissions.

If the FDA declines to grant the de novo request, the device remains classified in Class III and would require approval of a PMA application before marketing.

Class III medical devices—generally those that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury—are subject to the FDA’s Premarket Approval (“PMA”) process unless reclassified.

A PMA is required when a device cannot be authorized for marketing through the 510(k) premarket notification or de novo classification pathways.

A PMA application must be supported by valid scientific evidence demonstrating reasonable assurance of safety and effectiveness of the device for its intended use.

A PMA typically includes extensive technical, preclinical, and clinical data;

information regarding the device’s design and components;

manufacturing information;

proposed labeling;

and other information required by the FDA.

Clinical studies supporting a PMA must generally be conducted under an investigational device exemption (“IDE”) and in compliance with applicable FDA regulations.

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.

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.

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.

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 FDA also typically conducts inspections of clinical trial sites to verify data integrity and compliance with applicable regulations, as well as pre-approval inspections of manufacturing facilities to assess compliance with the Quality System Regulation.

The FDA can delay, limit, or deny approval of a PMA for many reasons, including:

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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.

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.

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 may also approve a PMA with other post-approval conditions intended to ensure the safety and effectiveness of the device, such as, among other things, restrictions on labeling, promotion, sale, distribution, and use.

Clinical Trials

Clinical trials are almost always required to support a PMA and are sometimes required for a 510(k) premarket notification.

In the United States, these trials often require submission of an application for an investigational device exemption ("IDE") if the investigation involves a significant risk device.

Some types of studies deemed to present “non-significant risk” are deemed to have an approved IDE—without affirmative submission of an IDE application to the FDA—once certain requirements are addressed and institutional review board ("IRB") approval is obtained.

The IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound.

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.

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.

All clinical trials must be conducted in accordance with the FDA’s IDE regulations that govern investigational device labeling, prohibit promotion, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators.

Clinical trials must further comply with the FDA’s Good Clinical Practices ("GCP") requirements for IRB approval and for informed consent and other human subject protections.

Required records and reports are subject to inspection by the FDA.

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.

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.

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.

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.

The FDA may also impose other post-approval requirements, including restrictions on labeling, promotion, distribution, or use of the device.

Failure to comply with PMA requirements or post-approval conditions may result in enforcement action, including withdrawal of approval, product recalls, civil monetary penalties, or other regulatory sanctions, which could materially adversely affect our business, financial condition, and results of operations.

Postmarket Requirements—U.S.

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• PMA annual reporting requirements;

• PMA approval or clearance of a 510(k) for certain product modifications;

• 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;

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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.

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.

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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, 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.

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.

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We do not expect that compliance with these regulations, including environmental laws, will have a material adverse impact on our financial condition.

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.

For the first time, CMS will be able to directly negotiate prescription drug prices and to cap out-of-pocket costs.

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.

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 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.

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.

While these provisions to not directly apply to medical devices, broader healthcare cost containment efforts or changes in reimbursement policies that may result from the IRA or similar legislation could indirectly affect demand for our products or the pricing environment in which our customers operate.

Other restrictions under applicable federal and state healthcare laws and regulations may include the following:

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• 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;

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;

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

• 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.

• 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 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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Some foreign regulatory agencies may require additional studies involving patients located in their countries.

In the European Union, medical devices are regulated under the EU Medical Device Regulation (EU) 2017/745, which imposes enhanced clinical evidence, post-market surveillance, and conformity assessment requirements.

Even after foreign approvals are obtained, further delays may be encountered before products may be marketed.

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

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.

United States Foreign

Description Issued Expiration Pending Issued Expiration Pending

Triferic (IV and Dialysate) 3 2027 - 2036 — — —

Triferic (TPN) 1 2030 — — —

Total 4 — — —

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.

We have also allowed several patents and applications that are not material to our business to lapse.

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

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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 comprehensive package of additional benefits that support the physical and mental health and wellness of all of our employees and their families.

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.

Additionally, we grant equity awards to enable directors, officers, senior and manager-level employees to share in the performance of the Company.

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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