What changed in this filing

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Item 2. Management’s Discussion and Analysis

2022-05-16 compared with 2021-11-15 · 161 added, 190 removed, 66 unchanged (84% of the section changed)

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We may also make forward-looking statements in our press releases or other public or shareholder communications.

Our forward-looking statements are subject to risks and uncertainties and include information about our expectations and possible or assumed future results of our operations.

Our forward-looking statements are subject to risks and uncertainties and include information about our current expectations and possible or assumed future results of our operations.

When we use words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,” “plan,” “potential,” “predict,” “forecast,” “project,” “intend,” or similar expressions, or make statements regarding our intent, belief, or current expectations, we are making forward-looking statements.

Our forward looking statements also include, without limitation, statements about our liquidity and capital resources;

our plans and ability to successfully commercialize our products;

our ability to successfully launch FDA-approved Triferic AVNU;

our ability to develop FPC for other indications;

our ability to continue as a going concern;

our ability to develop Ferric Pyrophosphate Citrate ("FPC") for other indications;

our ability to successfully execute on our business strategy and development of new indications;

and statements regarding our anticipated future financial condition, operating results, cash flows and business plans.

our ability to raise additional capital;

our ability to regain compliance with Nasdaq Listing Rules and maintain our Nasdaq listing;

our ability to renegotiate certain terms of our supply contracts;

our ability to successfully implement certain cost containment and cost-cutting measures and statements regarding our anticipated future financial condition, operating results, cash flows and business plans.

While we believe that our forward-looking statements are reasonable, you should not place undue reliance on any such forward-looking statements, which are based on information available to us on the date of this report or, if made elsewhere, as of the date made.

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Overview and Recent Developments

Rockwell is a commercial-stage, biopharmaceutical company developing and commercializing our next-generation parenteral iron technology platform, Ferric Pyrophosphate Citrate ("FPC"), which we believe has the potential to lead to transformative treatments for iron deficiency in multiple disease states, reduce healthcare costs and improve patients’ lives.

Rockwell Medical is a commercial-stage, biopharmaceutical company developing and commercializing our next-generation parenteral iron technology platform, Ferric Pyrophosphate Citrate ("FPC"), which we believe has the potential to lead to transformative treatments for iron deficiency in multiple disease states, reduce healthcare costs and improve patients’ lives.

We are also one of the two major suppliers of life-saving hemodialysis concentrate products to kidney dialysis clinics in the United States.

The Company has two novel, FDA approved therapies, Triferic and Triferic AVNU, which are the first two products developed from our FPC platform.

The Company is currently target marketing both products to kidney dialysis centers for their patients receiving dialysis and working to find a commercial partner to expand our commercial efforts within the United States.

This decision was based on the dynamics of the hemodialysis ("HD") market, including provider consolidation, the effects of the CMS bundled payment system and competitive product bundling tactics.

In 2021, Rockwell has been working to advance our FPC platform strategy outside of dialysis and plans to start a Phase II trial for the treatment of iron deficiency anemia in patients, who are receiving long-term and or chronic intravenous ("IV") medications for various therapeutic needs in the home infusion setting by the end of the year.

In the Company's R&D pipeline, we are also exploring FPC’s impact in the treatment of hospitalized patients with acute heart failure, with the potential to begin another Phase II trial in these patients in 2022.

The trend toward providing medical care, including the delivery of medicines, at home make the home infusion market a rapidly growing area of healthcare.

We believe that the home infusion setting is a natural path for expansion of our platform as many of the patients suffer from chronic diseases that are associated with iron deficiency and anemia.

Subsequent to our Type C and Pre-IND meeting with FDA, and incorporating their advice and feedback, we filed an IND for the treatment of iron deficiency anemia in the home-infusion setting in November 2021.

Our expectations regarding the commencement of a Phase II trial by the end of 2021 are based on the FDA's statutory obligations to respond to an IND submission within 30 calendar days.

R&D pipeline, we are also investigating FPC’s impact on iron deficiency in the treatment of hospitalized patients with acute heart failure, with the potential to begin another Phase II trial in these patients in 2022.

We are the second largest supplier of hemodialysis concentrates in the United States, with a reputation for excellent service, quality, and reliability.

We believe that this reputation, which is based on over 25 years of service to the kidney dialysis centers, combined with about $60 million in annual revenue, approximately 300 dedicated employees, expertise in manufacturing and logistics and the added expertise in pharmaceutical development and commercialization brought to the Company by recent additions to our management team, provides us with a solid foundation on which to grow.

At Rockwell Medical, we are dedicated to replacing the currently inadequate standard of care for treatment of iron deficiency in acute and chronic disease by leveraging our proprietary FPC platform technology.

We believe that our proprietary drug platform, FPC, is a next-generation parenteral iron therapeutic that has several advantages over other parenteral iron therapies.

We have two novel, FDA approved therapies, Triferic and Triferic AVNU, which are the first two products developed from our FPC platform.

We market both products to kidney dialysis centers for their patients receiving dialysis.

In late 2021, we filed an IND with the United States Food and Drug Administration ("FDA") with the goal to advance our FPC platform strategy by conducting a Phase II trial in the second half of 2022 for the treatment of iron deficiency anemia in patients outside of dialysis, who are receiving intravenous ("IV") medications in the home infusion setting.

The trend toward providing medical care, including the delivery of infused medications at home, make the home infusion market a rapidly growing area of healthcare.

We believe the home infusion setting is a natural path for expansion of our platform as many of the patients suffer from diseases associated with iron deficiency and anemia.

In our R&D pipeline, we are also investigating FPC’s impact in the treatment of hospitalized patients with acute heart failure.

At Rockwell Medical, we are dedicated to enhancing the currently sub-optimal standard of care for treatment of iron deficiency in acute and chronic disease by leveraging our proprietary FPC platform technology.

Our proprietary drug platform, FPC, is a next-generation parenteral iron therapeutic.

We believe our FPC platform has several advantages over other parenteral

iron therapies.

Importantly, it provides iron that is immediately bioavailable for critical body processes once it is administered.

It has been demonstrated to be safe and well-tolerated, with a safety profile similar to placebo.

Iron deficiency, which is often overlooked and undertreated in several illnesses because of the difficulty in treating them, can develop into a serious medical condition when left untreated.

It is a common comorbidity in many disease states, such as end-stage kidney disease, chronic kidney disease, acute heart failure, cancer and multiple chronic gastrointestinal conditions.

Iron deficiency impacts patients’ health in many ways, including through anemia, organ dysfunction, slower recovery, diminished energy and reduced quality of life.

It has been demonstrated to be safe and well-tolerated, with a safety profile similar to placebo in clinical trials.

We are the second largest supplier of hemodialysis concentrates in the United States, with a reputation for excellent service, quality, and reliability.

We believe this reputation, which is based on over 25 years of service to the kidney dialysis centers, combined with approximately $60 million in annual revenue, approximately 300 dedicated employees, expertise in manufacturing and logistics and the added expertise in pharmaceutical development and commercialization brought to the Company by recent additions to our management team, provides us with a solid foundation on which to grow.

Reverse Stock Split

On May 9, 2022, the stockholders of the Company authorized our Board of Directors to effect a reverse stock split of all outstanding shares of common stock, warrants and options.

The Board of Directors subsequently approved the implementation of a reverse stock split as a ratio of one-for-eleven shares, which became effective on May 13, 2022.

The Company’s outstanding stock options were also adjusted to reflect the one-for-eleven reverse stock split of the Company’s common stock.

Outstanding stock options were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased.

The reverse stock split resulted in an adjustment to the Series X convertible preferred stock conversion prices to reflect a proportional decrease in the number of shares of common stock to be issued upon conversion.

All share and per share data in these condensed consolidated financial statements and related notes hereto have been retroactively adjusted to the account for the effect of the reverse stock split for the three month periods ended March 31, 2022 and 2021, respectively, and the balance sheet at March 31, 2022 and December 31, 2021.

Strategy Evolution and Overview

Rockwell Medical has evolved its strategy over the past year to develop into a more medically-, scientifically- and data-driven company.

We believe future clinical, regulatory and commercial success require the right people with the right experience to navigate us to the right data.

There has been an evolution of both our management and board, providing us with greater relevant experience.

In particular, we have added board members and employees with significant medical and commercial experience in iron deficiency anemia and the dialysis sector, drug development and commercialization, small-cap public company finance and management and clinical nurse educator patient support.

We believe these changes support an improved execution of our strategy to generate data that will support future commercial growth, fair reimbursement and regulatory approvals.

Our strategy is to accelerate Rockwell’s growth by creating and developing pharmaceutical products based on our FPC technology for disease states where patients can benefit the most from an effective treatment for iron deficiency or iron deficiency anemia, while concurrently refining our dialysis business to drive incremental growth and efficiencies.

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We have preliminarily identified three disease states where we believe FPC may have the biggest impact.

Dialysis Business:

We are the second largest supplier, and one of the two major suppliers, of hemodialysis concentrates in the United States.

We manufacture, sell and deliver hemodialysis concentrates, which are used to maintain human life by removing toxins and balancing electrolytes in the dialysis patient’s bloodstream.

We have core capabilities in manufacturing hemodialysis concentrates in three facilities, totaling 159,000 square feet, located in Michigan, Texas and South Carolina.

We also have core capabilities in the logistics of delivering these products to dialysis clinics throughout most of the United States.

Our first two branded products from our FPC platform, Triferic® (dialysate) and Triferic AVNU® (IV), are used to maintain hemoglobin in patients undergoing hemodialysis.

We are building on our reputation and industry presence by commercializing them to medium and small dialysis organizations.

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

In April 2021, we received marketing approval for Triferic AVNU from Health Canada for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease, which is the first international regulatory approval for our intravenous therapy.

While we had identified a partner to commercialize the product in Canada, we recently terminated the distribution agreement with that partner and are seeking a new partner in Canada.

This may delay commercial availability of Triferic AVNU in Canada.

Our strategy for increasing Triferic adoption is to continue to generate data in clinics showing the benefits of Triferic in real world protocols.

In addition, we expect to study Triferic use with the innovations that we believe have the potential to change future

medical practices (e.g.

introduction and adoption of HIF-PHIs), subject to FDA approval.

We believe that positive data from these studies would better position Triferic for long-term growth.

As part of this initiative and due to current economic challenges, the Company has adjusted its sales and marketing efforts for Triferic and Triferic AVNU and is seeking a commercial partner within the United States.

This decision was based on the dynamics of the hemodialysis market, including provider consolidation, the effects of the CMS bundled payment system and competitive product bundling tactics.

Additionally, we are developing strategic alliance partners for development, regulatory approval and commercialization of Triferic outside of the United States.

Home Infusion Program:

We plan to initiate a clinical trial program of FPC for the treatment of iron deficiency anemia in the home-infusion setting.

Many patient groups requiring home infusion therapies suffer from chronic diseases that are associated with a high incidence of iron deficiency and anemia.

Home infusion represents a large and rapidly-growing segment of healthcare where we believe FPC may have distinct advantages over currently available iron replacement therapy options.

Pipeline Development:

We are investigating the use of our FPC platform for the treatment of iron deficiency in hospitalized patients with acute heart failure.

We believe that FPC may deliver rapidly bioavailable iron to the heart and improve cardiac energetics.

This effect could help patients recover faster, resulting in shorter hospital stays and fewer 30-day re-admissions, which would be a meaningful reduction healthcare costs and human suffering.

Our Growth Strategy

We plan to accelerate our growth by combining the solid foundation, strength and reputation of our dialysis business with the high-growth potential from therapeutics derived (or generated) from our FPC platform in multiple disease states where patients can benefit the most from an effective treatment for iron deficiency.

In parallel with continually seeking to drive incremental growth and efficiencies in our dialysis business unit, our strategy is to accelerate the growth of our business in large, higher-margin markets by creating and developing pharmaceutical products based on our proprietary FPC technology that address iron deficiency in patients who are currently under-treated.

Dialysis Business

We are one of the two major suppliers of hemodialysis concentrates in the United States.

Over the past 25 years we have developed a core expertise in manufacturing and delivering hemodialysis concentrates.

Because these concentrates are used to maintain human life by removing toxins and balancing electrolytes in the dialysis patient’s bloodstream, we manufacture them under cGMP regulations as described below.

Our concentrates are manufactured in three facilities, totaling 159,000 square feet, located in Michigan, Texas and South Carolina, from which we deliver these products to dialysis clinics throughout most of the United States.

We utilize our own delivery fleet as well as third parties.

We employ approximately 300 people in the concentrates unit of our dialysis business.

The “Rockwell Medical” name has earned a reputation for dependability, quality and service within our customer base.

This reputation was further strengthened during the recent challenges presented, not only by the COVID-19 pandemic, but also by the multitude of recent natural disasters where our team has been challenged by hurricanes, flooding and freezing, while still meeting production demands.

Our dialysis business in concentrates and our growth opportunities with FPC technology are synergistic.

We are leveraging our leadership position in the dialysis sector to commercialize our first two FPC-based products, Triferic and Triferic AVNU, which are indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease.

We commercialize the Triferic products ourselves in the United States, and are partnering with established local pharmaceutical companies for the regulatory approval and commercialization outside of the United States.

Although we have an excellent reputation for dependability and service within the dialysis sector, with concentrates and Triferic, our growth opportunities for both in the United States dialysis market are challenged by the consolidated ownership of dialysis clinics, a capitated reimbursement model and the demographics of the patient population and the limitations of our existing distribution and purchase agreements.

The two largest dialysis organizations treat approximately 73% of the patients in the United States.

One manufactures its own concentrates and IV iron and we already supply concentrates to the other.

Through our partnership with Baxter International, we currently supply concentrates to a significant percentage of the small and medium sized dialysis organizations.

In a sector such as kidney dialysis, with capitated

reimbursement for the dialysis procedure and all included inputs, new product success depends on compelling data demonstrating improved patient outcomes and/or pharmacoeconomics versus the current standard of care in practice in the clinics.

Once Medicare determined that Triferic and Triferic AVNU would be reimbursed under the fixed bundled rate, market adoption became more dependent on the generation of these data, which were not required for the drug's approval from the FDA.

Notwithstanding the growth limitations mentioned above, we have made progress and continue to be confident that Triferic has the potential to be the treatment of choice for the maintenance of hemoglobin in dialysis patients.

To this end, we have increased our efforts in generating real world data in clinics with current protocols, which we believe will help with the adoption of Triferic and Triferic AVNU as these results are developed and disseminated over time, and have adjusted our sales and marketing efforts while seeking a commercial partner within the United States with a bigger footprint to expand commercialization of both products.

In addition, we believe the hemodialysis industry may experience a great deal of change over the next several years.

We plan to take the steps necessary to generate the data necessary to potentially allow Triferic and Triferic AVNU to benefit from these new innovations, such as the potential approval of a class of drugs, known as hypoxia-inducible factor prolyl hydroxylase inhibitors ("HIF-PHIs"), as well as the new, solid-state dialysis equipment in development.

We are planning to study Triferic in combination with these potential new innovations as they become available.

A key element of our dialysis business strategy is to also improve the strength of our concentrates business by creating efficiencies and enhancing our manufacturing and transportation operations.

We have launched projects to identify ways to improve the overall profitability of these core operations.

Specifically, we are reviewing our entire supply chain to identify opportunities for improvement, prioritizing initiatives that will have the largest impact on long-term efficiency, profitability and growth.

Home Infusion

Our growth strategy is to go beyond our foundational business in dialysis by leveraging the pre-clinical, clinical pharmacology and safety data from Triferic.

We are planning development of an FPC-based therapeutic for iron deficiency to be given in the home infusion setting.

According to the National Home Infusion Association, the number of patients served by home infusion therapy has grown from approximately 800,000 in 2010 to over 3,000,000 in 2019.

The home infusion setting is expected to continue to expand, which has been further accelerated by the COVID-19 pandemic and the desire to reduce or eliminate hospital and or clinic exposure.

Our strategy is to go beyond our foundational business in dialysis by leveraging the efficacy and safety data from Triferic in new therapeutic settings.

Subject to having sufficient capital resources, we are planning to develop an FPC-based therapeutic for iron deficiency to be delivered in the home infusion setting.

The number of patients served by home infusion therapy grew from approximately 800,000 in 2010 to over 3,000,000 in 2019.

The home infusion setting is expected to continue this rapid expansion, which has been accelerated by the COVID-19 environment.

Many patient groups requiring home infusion therapies suffer from diseases that are associated with an incidence of iron deficiency and anemia.

For example, it is estimated that 40% to 55% of all home parenteral nutrition patients have iron deficiency anemia.

We believe, based on our data with hemodialysis patients, FPC as a home infusion therapy for iron deficiency anemia may have distinct advantages over currently available iron replacement therapy options.

We plan on initiating a Phase II trial in home infusion patients with iron deficient anemia by the end of 2021, subject to the clearance of our IND, to confirm the dose and duration of FPC treatment.

We expect data from the trial in the second quarter of 2023.

For example, it is estimated that 40%-55% of all home parenteral nutrition patients are iron deficient.

We believe, based on our data from hemodialysis patients, FPC as a home infusion therapy for iron deficiency anemia may have distinct advantages over currently available iron replacement therapy options.

Based on further feedback received in December 2021 from the FDA, we have made plans to initiate a Phase 2 clinical study in home infusion patients with iron deficient anemia to confirm the dose and duration of FPC treatment.

We expect to commence this study in 2022, subject to having sufficient working capital to fund this study, and would expect to have top-line data from the trial approximately 12-18 months following commencement of the study.

Pipeline Development:

In our R&D pipeline, we are also exploring FPC’s impact in the treatment of iron deficiency in hospitalized heart failure patients.

In our R&D pipeline, we are also exploring FPC’s impact in the treatment of hospitalized heart failure patients.

More than one million people in the United States are hospitalized each year for acute heart failure.

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We believe that FPC may deliver rapidly bioavailable iron to the heart and improve cardiac energetics during hospitalization.

This effect could help patients recover faster resulting in improved function, shorter hospital stays and fewer 30-day re-admissions.

This effect could help patients recover faster resulting in shorter hospital stays and fewer 30-day re-admissions.

If so, these outcomes would translate into a meaningful reduction in healthcare costs and human suffering.

We expect to communicate with the FDA in the first half of 2022 regarding a development pathway for this indication.

We continue exploring other potential patient populations for application of our technology.

We are considering disease states where patients can benefit the most from an effective treatment for iron deficiency, and where the development path, cost estimates and reimbursement are the most favorable.

Results of Operations for the Three Months Ended September 30, 2021 and 2020

Dialysis Business:

We are one of the two major suppliers of hemodialysis concentrates in the United States.

Over the past 25 years we developed a core expertise in manufacturing and delivering hemodialysis concentrates.

Because these concentrates are used to maintain human life by removing toxins and balancing electrolytes in the dialysis patient’s bloodstream, we manufacture them under cGMP regulations.

Our concentrates are manufactured in three facilities, totaling

159,000 square feet, located in Michigan, Texas and South Carolina, from which we deliver these products to dialysis clinics throughout most of the United States.

We utilize our own delivery fleet as well as third parties.

We employ approximately 300 people in the concentrates unit of our dialysis business.

We believe that the Company has earned a reputation for dependability, quality and service within our customer base.

This reputation was further strengthened during the recent challenges presented, not only by the COVID-19 pandemic, but also by supply chain disruptions due to recent natural disasters, in which our team has been challenged by hurricanes, flooding and freezing, while still meeting production demands.

During the recent shortage in dialysis concentrates, the Company was able to fill the supply gaps for many clinics because they had not received deliveries of certain products from other suppliers.

We believe our dialysis business in concentrates and our opportunities with FPC technology are synergistic.

Our first two branded products from our FPC platform, Triferic® (dialysate) and Triferic AVNU® (IV), are used 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.

While we had identified a partner to commercialize the product in Canada, we terminated the distribution agreement with that partner and are seeking a new partner in Canada.

This may delay commercial availability of Triferic AVNU in Canada.

Our strategy for increasing Triferic adoption is to continue to generate data in clinics showing the benefits of Triferic in real world protocols We scaled back our commercial organization in 2021, but we are working to maintain our current customer base in the United States while we seek a commercialization partner.

We are also seeking to partner with established local and regional pharmaceutical companies for regulatory approval and commercialization in markets outside of the United States.

Despite our market position, we believe our growth opportunities for our concentrates business and Triferic in the U.S.

dialysis market are challenged by the consolidated ownership of dialysis clinics, a capitated reimbursement model and the demographics of the dialysis patient population.

The two largest dialysis organizations treat approximately 72% of the patients in the United States.

One manufactures its own concentrates and IV iron, and we have an existing agreement to supply concentrates to the other.

Through our partnership with Baxter Healthcare Corporation, a subsidiary of Baxter International, Inc.

("Baxter"), we currently supply concentrates to a significant percentage of the small and medium sized independent dialysis organizations.

In a sector like kidney dialysis, with capitated reimbursement for the dialysis procedure and all included inputs, new product success depends on compelling data demonstrating improved patient outcomes and/or pharmacoeconomics versus the current standard of care in practice in the clinics.

Once Medicare determined Triferic and Triferic AVNU would be reimbursed under the fixed bundled rate for dialysis treatment, market adoption became more dependent on the generation of these data, which were not required for the drug's approval by the FDA.

Notwithstanding the growth limitations mentioned above, we continue to believe Triferic has the potential to be an important option for the maintenance of hemoglobin in dialysis patients.

To this end, we have continued our efforts in generating real world data in clinics with current protocols, which we believe will help with the adoption of Triferic and Triferic AVNU as these results are developed and disseminated over time.

In addition, we are seeking a partner to help us further commercialize Triferic.

A key element of our dialysis business strategy is to also improve the strength of our concentrates business by creating efficiencies and enhancing our manufacturing and transportation operations and to fully recoup manufacturing and shipping expenses so this business has the potential to be profitable.

To date, our concentrates business has operated at a loss, with the loss accelerating recently as inflationary pressures have increased our manufacturing and operating costs, while we have limited ability to pass these costs along to certain customers.

We undertook discussions with our largest customers to renegotiate our existing supply contracts in an effort to improve the profitability of this business line.

On April 6, 2022, we entered into a strategic arrangement with our long-time partner, DaVita, Inc.

("DaVita"), a leading provider of kidney care, to enable the Company to stabilize its concentrates business.

The strategic intent of this agreement is to make sure Rockwell Medical is on stable financial footing because it is one of the two major suppliers of dialysis concentrates in the U.S.

The amended agreement provides a stronger financial arrangement, encompassing pricing, cost sharing and joint efforts in supply chain improvement and cost cutting, with the goal of having the Company’s concentrates business operate profitably in the future.

In addition to the amended agreement, DaVita entered into an agreement pursuant to which it will invest up to $15 million in preferred stock in two equal tranches.

The first tranche of $7.5 million was funded on April 7, 2022.

The second $7.5 million tranche is to be funded subject to the Company raising $15 million additional capital by June 30, 2022.

We are also in discussions with our other major customer to renegotiate certain terms of that agreement.

In addition, we are reviewing our entire supply chain to

identify opportunities for improvement, prioritizing initiatives that will have the largest impact on long-term efficiency, profitability and growth.

Results of Operations for the Three Months Ended March 31, 2022 and 2021

The following table summarizes our operating results for the periods presented below (dollars in thousands):

For the Three Months Ended September 30,

For the Three Months Ended March 31,

2022 % of Revenue 2021 % of Revenue % Change

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Operating Loss $ (6,626) (41.1) % $ (7,182) (46.4) % (7.7) %

During the three months ended September 30, 2021, our net sales were $16.0 million compared to net sales of $15.3 million during the three months ended September 30, 2020.

The increase of $0.7 million was primarily due to an increase in sales of dialysis concentrates products from our international customers.

Cost of sales during the three months ended September 30, 2021 was 16.3 million, resulting in gross loss of $0.3 million during the three months ended September 30, 2021, compared to cost of sales of $14.9 million and a gross profit of $0.3 million during the three months ended September 30, 2020.

Gross profit decreased by $0.6 million ma inly due to an increase in costs related to protocols implemented because of the ongoing COVID-19 pandemic, as well as increases in shipping, fuel and labor costs.

We expect our gross profit to continue to decrease due to increasing labor and fuel costs for transportation, which we have a limited our ability to recover such costs due to the terms of our agreements with our larger customers.

Research and Product Development Expense

Research and product development expenses were $1.2 million for the three months ended September 30, 2021, compared with $1.7 million during the three months ended September 30, 2020.

The decrease of $0.5 million was primarily due to timing of investments we are continuing to make in our medical and scientific programs to support the continued advancement of our FPC technology platform.

Selling and Marketing Expense

Selling and marketing expenses were $1.5 million during the three months ended September 30, 2021, compared with $1.7 million during the three months ended September 30, 2020.

The decrease of $0.2 million is primarily due t o a decrease in marketing costs related to Triferic (dialysate).

General and Administrative Expense

General and administrative expenses were $3.9 million during the three months ended September 30, 2021, compared with $3.6 million during the three months ended September 30, 2020.

The increase of $0.3 million is due primarily to an increase in the insurance costs.

Other Income (Expense)

Other income for the three months ended September 30, 2021 was nil.

Other income for the three months ended September 30, 2020 was $6,000, consisting primarily of realized gain on investments and interest income.

Other expense for the three months ended September 30, 2021 was $0.6 million of interest expense related to our debt facility (see Note 15 for more

information on our debt facility).

Other expense for the three months ended September 30, 2020 was $0.7 million of interest expense related to our debt facility.

Results of Operations for the Nine Months Ended September 30, 2021 and 2020

The following table summarizes our operating results for the periods presented below (dollars in thousands):

For the Nine Months Ended September 30,

2021 % of Revenue 2020 % of Revenue % Change

Net Sales $ 46,599 $ 47,033 (0.9) %

Cost of Sales 46,788 100.4 % 44,693 95.0 % 4.7

Gross Profit (189) (0.4) 2,340 5.0 (108.1)

Research and Product Development 5,445 11.7 5,183 11.0 5.1

Selling and Marketing 4,860 10.4 5,738 12.2 (15.3)

General and Administrative 11,483 24.6 11,767 25.0 (2.4)

Operating Loss $ (21,977) (47.2) % $ (20,348) (43.3) % 8.0 %

During the nine months ended September 30, 2021, our net sales were $46.6 million compared to net sales of $47.0 million during the nine months ended September 30, 2020.

The decrease of $0.4 million wa s primarily due to a decrease in sales of dialysis concentrates products in the United States the resulted from the COVID-19 pandemic.

Cost of sales during the nine months ended September 30, 2021 was $46.8 million, resulting in gross loss of $0.2 million during the nine months ended September 30, 2021, compared to cost of sales of a $44.7 million and a gross profit of $2.3 million during the nine months ended September 30, 2020.

Gross profit decreased by $2.5 million ma inly due to a decrease in concentrate sales and an increase in costs related to protocols implemented because of the ongoing COVID-19 pandemic, as well as increases in shipping, fuel and labor costs.

During the three months ended March 31, 2022, our net sales were $16.1 million compared to net sales of $15.5 million during the three months ended March 31, 2021.

The increase of $0.7 million was primarily due to an increase in sales of dialysis concentrates products from Baxter and our international customers.

We expect our concentrate sales to continue to grow due to the restructuring of the supply contract with DaVita.

Cost of sales during the three months ended March 31, 2022 was $16.9 million, resulting in gross loss of $0.8 million during the three months ended March 31, 2022, compared to cost of sales of $15.1 million and a gross profit of $0.4 million during the three months ended March 31, 2021.

Gross profit decreased by $1.2 million due to significant inflationary pressures related to the concentrates segment.

As noted in Note 17 to the condensed consolidated financial statements included elsewhere in this Form 10-Q, the Company has renegotiated certain terms of its supply contract with DaVita Inc.

("DaVita"), one of the Company's largest customers, to be able to pass through a significant portion of inflationary costs and increases in pricing.

As a result of these changes, the Company expects an improvement in margins for the remainder of 2022.

Research and Product Development Expense

Research and product development expenses were $5.4 million for the nine months ended September 30, 2021, compared with $5.2 million during the nine months ended September 30, 2020.

Th is increase of $0.2 million is primarily due to continued investments we are making in our medical and scientific programs to support the continued advancement of our FPC technology platform.

Research and product development expenses were $1.6 million and $1.8 million for the three months ended March 31, 2022 and 2021, respectively.

Research and product development expenses decreased by $0.2 million due to labor cost reductions.

The Company expects research and development costs will increase due to the Company's pipeline initiatives.

Selling and Marketing Expense

Selling and marketing expenses were $4.9 million during the nine months ended September 30, 2021, compared with $5.7 million during the nine months ended September 30, 2020.

The decrease of $0.8 mil lion is primarily due to a headcount reduction in the quarter.

Selling and marketing expenses were $0.5 million during the three months ended March 31, 2022, compared with $1.9 million during the three months ended March 31, 2021.

The decrease of $1.4 million is due to a decrease in marketing spent for our Triferic products and a headcount reduction.

General and Administrative Expense

General and administrative expenses were $11.5 million during the nine months ended September 30, 2021, compared with $11.8 million during the nine months ended September 30, 2020.

The decrease of $0.3 million is due primarily t o a decrease of $0.5 million from the completion of severance pay related to our former President and Chief Executive Officer (CEO), a decrease in legal costs of $0.4 million, relating to previous litigation that has since been resolved;

a decrease in recruiting fees of $0.3 million;

partially offset by an increase of $0.3 million in insurance premiums;

and an increase of $0.9 million for stock compensation.

General and administrative expenses were $3.8 million during the three months ended March 31, 2022, compared with $3.9 million during the three months ended March 31, 2021.

The decrease of $0.1 million is due primarily to a decrease in audit and other related accounting costs of $0.2 million and a decrease in outside consulting costs of $0.2 million, offset by an increase in legal expense of $0.3 million due to costs related to contract restructuring, annual meeting preparation and securities purchase agreement review.

Other Income (Expense)

Other income for the nine months ended September 30, 2021 was $17,000, consisting primarily of interest income.

Other income for the nine months ended September 30, 2020 was $0.2 million, consisting primarily of interest income.

Other expense for the nine months ended September 30, 2021 was $1.8 million of interest expense related to our debt facility (see Note 15 for more information on our debt facility).

Other expense for the nine months ended September 30, 2020 was $2.1 million, consisting of warrant modification expense of $0.8 million and interest expense of $1.3 million related to our debt facility.

Other income for the three months ended March 31, 2022 was nil.

Other income for the three months ended March 31, 2021 was $11,000, consisting primarily of interest income.

Other expense for the three months ended March 31, 2022 was $0.5 million of interest expense related to our debt facility (see Note 14 to the condensed consolidated financial statements included

elsewhere in this Form 10-Q for more information on our debt facility).

Other expense for the three months ended March 31, 2021 was $0.6 million of interest expense related to our debt facility.

Liquidity and Capital Resources

Since inception, Rockwell has incurred significant net losses and has funded its operations primarily through revenue from commercial products, proceeds from the issuance of debt and equity securities and payments from partnerships.

At September 30, 2021, Rockwell had an accumulated deficit of approximately $361.1 million and stockholders' equity of $11.1 million.

As of September 30, 2021, Rockwell had approximately $33.2 million of cash, cash equivalents and investments available-for-sale, and working capital of $24.3 million.

Net cash used in operating activities for the nine months ended September 30, 2021 was approximately $24.5 million.

Based on the currently available working capital, the adjustments made to sales and marketing efforts for Triferic and Triferic AVNU and the implementation of key efficiency initiatives within our concentrates business, management believes the Company currently has sufficient funds to meet its operating requirements for at least the next twelve months from the date of the filing of this report.

The Company expects it will require additional capital to sustain its operations and make the investments it needs to execute its strategic plan developing FPC for iron deficiency anemia in patients undergoing home infusion and for progressing our pipeline development program of new indications for its FPC platform.

If the Company is unable to generate sufficient revenue from sales of its commercial products and from partnerships, the Company will need to obtain additional equity or debt financing.

Currently, because the Company’s public float is less than $75 million, we are subject to the baby shelf limitations under our current registration statement on Form S-3, which limit the amount we may offer under our Form S-3.

This could limit our ability to raise capital under this registration statement.

Additionally, the Company has received a delisting notification letter from the Nasdaq Stock Market ("Nasdaq") regarding compliance with minimum bid requirements.

The notification letter states that the Company has 180 calendar days, or until December 8, 2021, to regain compliance with Nasdaq Listing Rule 5450(a)(1).

To regain compliance, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of 10 consecutive business days at any time prior to December 8, 2021.

In the event that the Company does not regain compliance by December 8, 2021, the Company may be eligible for additional time to reach compliance with the minimum bid price requirement.

The Company is working on a plan to meet the minimum compliance requirements set forth by Nasdaq.

Based on the above, if the Company attempts to obtain additional debt or equity financing, the Company cannot assume that such financing will be available on favorable terms, if at all.

In addition, the Company is subject to certain covenants and cure provisions under its Loan Agreement with Innovatus.

As of the date of this report, the Company is in compliance with all covenants.

Going Concern

Since inception, the Company has incurred significant net losses and have funded our operations primarily through revenue from commercial products, proceeds from the issuance of debt and equity securities and payments from partnerships.

At March 31, 2022, we had an accumulated deficit of approximately $377.2 million and stockholders' deficit of $4.8 million.

As of March 31, 2022, we had approximately $9.9 million of cash and cash equivalents, and working capital of $5.2 million.

Net cash used in operating activities for the three months ended March 31, 2022 was approximately $9.8 million.

The Company has experienced significant inflationary pressures in its dialysis concentrates business, particularly within the last six months, which have resulted in an accelerated operating loss associated with this business line.

These factors raise substantial doubt about the Company’s ability to continue as a going concern and depend, in part, on the degree of success in the Company's ability to address inflationary pressures affecting the concentrates business, as well as the Company’s ability to contain costs, raise additional working capital and remain in compliance with financial and operating covenants under the Company’s secured loan.

Management's plans are described below.

On April 6, 2022, the Company and DaVita entered into an amendment (the "Amendment") to the Products Purchase Agreement, dated July 1, 2019, under which the Company supplies DaVita with certain dialysis concentrates.

Under the Amendment, the Company and DaVita agreed to a price increase, effective May 1, 2022, as well as the pass-through of certain inflationary costs, determined on a quarterly basis.

Certain costs are subject to a cap.

The Amendment also requires the Company to implement certain cost containment and cost-cutting measures.

The Amendment contains certain covenants with respect to the Company’s ongoing operations, including a minimum cash covenant of $10 million, or we will be in default under the Products Purchase Agreement.

An event of default could result in termination of that agreement.

The Company also entered into an equity investment agreement with one of the contracting parties for up to $15 million of investment in two tranches of $7.5 million each.

The first tranche of $7.5 million was funded on April 7, 2022.

The second $7.5 million tranche is to be funded subject to the Company raising $15 million in additional capital by June 30, 2022.

In addition, any debt financing is limited by the terms of our Securities Purchase Agreement with DaVita.

Specifically, until DaVita owns less than 50% of its investment, the Company may only incur additional debt in the form of a purchase money loan, a working capital line of up to $5 million or to refinance existing debt, unless DaVita consents.

On April 8, 2022, the Company entered into a sales agreement with Cantor Fitzgerald & Co.

(the “Agent”), pursuant to which the Company may offer and sell from time to time shares up to $12,200,000 of Company’s common stock through the Agent.

The offering and sale of shares has been registered under the Securities Act of 1933, as amended, pursuant to the Company’s Registration Statement on Form S-3 (File No.

333-259923) (the “Registration Statement”), which was originally filed with the SEC on September 30, 2021 and declared effective by the SEC on October 8, 2021, the base prospectus contained within the Registration Statement, and a prospectus supplement that was filed with the SEC on April 8, 2022.

The Company has started to implement cost cutting measures as noted in previous filings focusing mainly within sales and marketing.

The Company expects it will require additional capital to sustain its operations and make the investments it needs to execute its strategic plan in developing FPC for iron deficiency anemia in patients undergoing home infusion therapy and for progressing our pipeline development program of new indications for our FPC platform.

If the Company is unable to generate sufficient cash flows from operations as described above or obtain additional equity or debt financing, the Company intends to implement further cost cutting measures which may include headcount reductions across multiple areas and reductions in general and administrative expenses.

Based on these plans, Management believes the substantial doubt about the Company’s ability to continue as a going concern has been alleviated.

If the Company attempts to obtain additional debt or equity financing, the Company cannot assume that such financing will be available on favorable terms, if at all.

In addition, the Company is subject to certain covenants and cure provisions under our Loan Agreement with Innovatus.

As of the date of this report, the Company believes it will either be able to satisfy such covenants or, in the event of a breached covenant, exercise cure provisions to avoid an event of default.

If we are unable to avoid an event of default, any required repayments could have an adverse effect on our liquidity (See Note 14 to the condensed consolidated financial statements included elsewhere in this Form 10-Q for more information on our debt facility).

The COVID-19 pandemic and resulting domestic and global disruptions have adversely affected our business and operations, including, but not limited to, our sales and marketing efforts and our research and development activities, and the

operations of third parties upon whom we rely.

Our international business development activities have also been negatively impacted by COVID-19.

The COVID-19 pandemic and the resulting inflation, surges in infections and resulting global disruptions have caused significant volatility in financial and credit markets.

We have utilized a range of financing methods to fund our operations in the past;

however, current conditions in the financial and credit markets may limit the availability of funding, refinancing or increase the cost of funding.

Due to the rapidly evolving nature of the global situation, it is not possible to predict the extent to which these conditions could adversely affect our liquidity and capital resources in the future.

The actual amount of cash that we will need to execute our business strategy is subject to many factors, including, but not limited to, the expenses and revenue associated with the commercial operations in the United States and internationally (with partners);

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the timing and expenditures associated with the development programs including our FPC technology for home infusion and potentially acute heart failure;

the costs associated with our manufacturing and transportation operations related to our concentrate business;

any potential accelerated amortization under the Loan Agreement in the event of a failure to satisfy operating covenants..

and the costs associated with our manufacturing and transportation operations related to our concentrate business.

We may elect to raise capital in the future through one or more of the following:

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and (ii) strategic transactions, including potential alliances and collaborations focused on markets outside the United States, as well as potential combinations (including by merger or acquisition) or other corporate transactions.

We believe that our ability to fund our activities in the long term will be highly dependent upon 1) our ability to execute on the development of the FPC platform for new therapies, 2) our ability to seek a partner to expand commercialization and increase adoption of Triferic (dialysate) and Triferic AVNU, and 3) our ability to improve profitability in our concentrate business.

These strategies are subject to significant risks and uncertainties such that there can be no assurance that we will be successful is achieving approval of FPC in a new therapeutic area or that we will be able to find a suitable partner and have sustained commercial success with Triferic (dialysate) and Triferic AVNU or be able to improve our profitability due to the current economic environment and the limitations of certain agreements.

If our planned clinical program is delayed or fails or if Triferic (dialysate) and/or Triferic AVNU sales fail to increase or we cannot increase the profitability of our concentrate business, we may be forced to implement cost-saving measures that may potentially have a negative impact on our activities and potentially the results of our research and development programs.

Even though we began commercialization of Triferic (dialysate) and Triferic AVNU as planned, if the results are unsuccessful, we may be unable to secure the additional capital that we will require to continue our research and development activities and operations, which could have a material adverse effect on our business.

If we are unable to raise the required capital, we may be forced to curtail all of our activities and, ultimately,

cease operations.

We believe that our ability to fund our activities in the long term will be highly dependent upon 1) our ability to execute on the development of the FPC platform for new therapies, 2) our ability to restructure our other significant commercial contract within our concentrate business, and 3) our ability to find a commercial partner to commercialize and increase adaptation of Triferic (dialysate) and Triferic AVNU.

All of these strategies are subject to significant risks and uncertainties such that there can be no assurance that we will be successful is achieving approval of FPC in a new therapeutic area, that we will be successful in restructuring our commercial agreements in our concentrate business or that we will be able to find a commercial partner and have sustained commercial success with Triferic (dialysate) and Triferic AVNU.

If our planned clinical program is delayed or fails, if our other significant commercial contract in the concentrate business cannot be restructured in a way that is beneficial to Rockwell or if our ability to find a commercial partner for Triferic (dialysate) and/or Triferic AVNU fails, we may be forced to implement cost-saving measures that may potentially have a negative impact on our activities and potentially the results of our research and development programs.

If we are unable to raise the required capital, we may be forced to curtail all of our activities and, ultimately, cease operations.

Even if we are able to raise sufficient capital, such financings may only be available on unattractive terms, or result in significant dilution of stockholders’ interests and, in such event, the market price of our common stock may decline.

Cash Used in Operating Activities

Net cash used in operating activities was $24.5 million for the nine months ended September 30, 2021 compared to net cash used in operating activities of $21.1 million for the nine months ended September 30, 2020.

The increase in cash used from operating activities during the current period was primarily due to changes in current balance sheet accounts in the ordinary course of business of approximately $3.6 million, including an increase in net accounts receivable of $1.9 million and an increase in accounts payable and accrued expense of approximately $0.2 million.

Cash Provided by Investing Activities

Net cash used in investing activities was $0.2 million during the nine months ended September 30, 2021 compared to net cash provided by investing activities of $2.6 million for the nine months ended September 30, 2020.

The net cash used in investing activities during the nine months ended September 30, 2021 was primarily due to sales and purchase of available-for-sale investments during the quarter.

Cash (Used in) Provided by Financing Activities

Net cash used in financing activities was $0.6 million during the nine months ended September 30, 2021 compared to the net cash provided by financing activities of $63.3 million for the nine months ended September 30, 2020.

The net cash used during the nine months ended September 30, 2021 was primarily due to the payments on the Company's short term note payable.

Net cash used in operating activities was $9.8 million for the three months ended March 31, 2022 compared to net cash used in operating activities of $12.5 million for the three months ended March 31, 2021.

The decrease in cash used from operating activities during the current period was primarily due to changes in current balance sheet accounts in the ordinary course of business of approximately $2.7 million, including an increase in inventory of $1.5 million and an increase in net accounts receivable of $1.2 million.

Cash Provided by (Used in) Investing Activities

Net cash provided by investing activities was $9.1 million during the three months ended March 31, 2022 compared to net cash used in investing activities of $0.5 million for the three months ended March 31, 2021.

The net cash provided by investing activities during the three months ended March 31, 2022 was primarily due to sales and purchase of available-for-sale investments during the quarter.

All investments available-for-sale have been liquidated as of March 31, 2022.

Cash Used in Financing Activities

Net cash used in financing activities was $2.7 million during the three months ended March 31, 2022 compared to the net cash provided by financing activities of nil for the three months ended March 31, 2021.

The net cash used during the three months ended March 31, 2022 was primarily due to the payments on the Company's debt and short term note payable.

COVID-19 Impact

The COVID-19 pandemic and resulting global disruptions, particularly in the supply chain and labor market, among other areas, have adversely affected our business and operations, including, but not limited to, our sales and marketing efforts and our research and development activities, our plant and transportation operations and the operations of third parties upon whom we rely.

Quarantines, shelter-in-place, executive and similar government orders may negatively impact our plant and transportation operations and remaining sales and marketing activities.

Any vaccine hesitancy among our labor force could also disrupt our business if workers become ill or need to quarantine due to illness or exposure to the virus.

The Company's international business development activities may also continue to be negatively impacted by COVID-19, especially with the recent surge in infections internationally, ongoing international travel restrictions and quarantines or shelter-in-place orders.

Further, any vaccine hesitancy among our labor force could also disrupt our business if workers become ill or need to quarantine due to illness or exposure to the virus.

The Company's international business development activities may also continue to be negatively impacted by COVID-19.

The COVID-19 pandemic and resulting global disruptions have caused and may continue to cause significant volatility in financial and credit markets.

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Due to the evolving nature of the global situation, it is not possible to predict the extent to which these conditions could adversely affect our liquidity and capital resources in the future.

Contractual Obligations and Other Commitments

See Note 12 to the condensed consolidated financial statements included elsewhere in this Form 10-Q for additional disclosures.

There have been no other material changes from the Contractual Obligations and Other Commitments disclosed in Note 14 to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2021.

Critical Accounting Policies and Significant Judgments and Estimates

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We have evaluated all recently issued accounting pronouncements and believe such pronouncements do not have a material effect our financial statements.

See Note 3 of the condensed consolidated financial statements at September 30, 2021.

See Note 3 to the condensed consolidated financial statements included elsewhere in this Form 10-Q.

Quantitative and Qualitative Disclosures about Market Risk

ROCKWELL MEDICAL, INC.

AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

Per §229.305 of Regulation S-K, the Company, designated a Smaller Reporting Company as defined in §229.10(f)(1) of Regulation S-K, is not required to provide the disclosure required by this Item.

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-Q

Item 2. Management’s Discussion and Analysis