What changed in this filing

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Item 7. Management’s Discussion and Analysis

2022-04-08 compared with 2021-03-31 · 73 added, 71 removed, 139 unchanged (51% of the section changed)

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Overview and Recent Developments

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 significant potential to lead to transformative treatments for iron deficiency in multiple disease states, that we believe could 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.

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 requires us to generate compelling clinical data in each of our programs.

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, while concurrently refining our dialysis business to drive incremental growth and efficiencies.

We plan to leverage and build on the foundation provided by our current dialysis business serving kidney dialysis centers by developing a pipeline of additional potential drug therapies in multiple disease states.

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

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

In 2021, we intend to advance our FPC platform strategy by starting a Phase II trial for the treatment of iron deficiency anemia in patients outside of dialysis, who are receiving intravenous medications in the home infusion setting.

In our 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 program in these patients in 2022.

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

In late 2021, we filed an IND with the United Stated Food and Drug Administration ("FDA") with the goal to advance our FPC platform strategy by starting 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 that the home infusion setting is a natural path for expansion of our platform as many of the patients suffer from diseases that are 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 in clinical trials.

Results of Operations

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Cost of Sales 64,351 103.9 % 59,472 95.6 % 8.2

Gross Profit 2,725 4.4 2,839 4.6 (4.0)

Gross (Loss) Profit (2,420) (3.9) 2,725 4.4 (188.8)

Research and Product Development 6,835 11.0 7,092 11.4 (3.6)

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General and Administrative 15,348 24.8 16,182 26.0 (5.2)

Settlement Expense, net of Reimbursement — — 430 0.7 (100.0)

Operating Loss $ (30,336) (49.0) % $ (28,420) (45.7) % 6.7 %

During the year ended December 31, 2021, our net sales were $61.9 million compared to net sales of $62.2 million during the year ended December 31, 2020 .

Net sales of hemodialysis concentrates to dialysis providers and distributors in the United States and abroad were $61.1 million for the year ended December 31, 2020 compared to $60.8 million for the year ended December 31, 2019.

The increase of $0.3 million was primarily due to increase in sales to our domestic customers offset by a decrease in international sales.

Net sales of Triferic (dialysate) were approximately $1.1 million for the year ended December 31, 2020 compared to $0.5 million for the year ended December 31, 2019.

For each year ended December 31, 2020 and 2019, Triferic net sales included approximately $0.2 million of deferred revenue recognized under the Company’s license in the People’s Republic of China with Wanbang.

Net sales of hemodialysis concentrates to dialysis providers and distributors in the United States and abroad were $60.8 million for the year ended December 31, 2021 comp ared to $61.1 million f or the year ended December 31, 2020.

Net sales of Triferic (dialysate) remained flat at approximately $1.1 million for the years ended December 31, 2021 and 2020.

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

Under the DaVita Amendment, the Company and DaVita agreed to a price increase, effective May 1, 2022.

Based the DaVita Amendment and assuming steady sales volumes, the Company expects a double digit increase in concentrates revenue year-over-year.

Cost of Sales and Gross Profit

Cost of sales during the year ended December 31, 2020 was $59.5 million, resulting in gross profit of $2.7 million during the year ended December 31, 2020, compared to cost of sales of $58.5 million and a gross profit of $2.8 million during the year ended December 31, 2019.

Gross profit decreased by $0.1 million during the year ended December 31, 2020 compared to the year ended December 31, 2019, due primarily to an increase in labor and material costs of $0.3 million to address protocols put in place from the ongoing COVID-19 pandemic.

Gross profits are primarily related to our concentrates business at this time.

The Company anticipates that potential future sales of Triferic will positively impact future gross profits.

Cost of sales during the year ended December 31, 2021 was $64.4 million, resulting in gross loss of $2.4 million, compared to cost of sales of $59.5 million and a gross profit of $2.7 million during the year ended December 31, 2020.

Gross profit decreased by $5.1 million during the year ended December 31, 2021 compared to the year ended December 31, 2020 due to significant inflationary pressures related to the concentrates segment.

The Company has sought to mitigate these inflationary pressures by increasing product costs and by renegotiating certain terms of its supply contract with DaVita in the DaVita Amendment, one of the Company's largest customers, to be able to pass through a significant portion of inflationary costs.

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

Research and Product Development Expense

Research and product development expenses were $6.8 million for the year ended December 31, 2021 compared with $7.1 million during the year ended December 31, 2020.

The increase of $0.2 million is related to clinical trials and other product development expenses for Triferic.

The Company is continuing to invest in its medical and scientific programs to support the continued data and phase 4 clinical programs for Triferic in dialysis and the advancement of our FPC technology platform.

The decrease of $0.3 million is related to timing of costs for clinical trials and other product development expenses for our FPC platform.

We are continuing to invest in our medical and scientific programs to support the advancement of our FPC technology platform.

Selling and Marketing Expense

Selling and marketing expenses were $5.7 million during the year ended December 31, 2021 compared with $7.9 million during the year ended December 31, 2020.

The decrease of $1.2 million is due primarily to the decrease in marketing costs of $2.3 million, partially offset by an increase in costs associated with hiring, training and educating new employees of

$1.1 million.

The fluctuation in these costs are mainly due to the timing of the Triferic (dialysate) launch in the third quarter of 2019.

We expect lower quarter-to-quarter fluctuations in sales and marketing costs going forward.

The decrease of $2.1 million is du e a decrease in marketing spend for our Triferic products and a headcount reduction.

General and Administrative Expense

General and administrative expenses were $15.3 million during the year ended December 31, 2021 compared with $16.2 million during the year ended December 31, 2020.

The $4.8 million decrease was driven primarily by decreases to stock compensation, legal, recruiting and consulting fees, partially offset by an increase in labor costs.

The decrease in stock compensation primarily relate to the resignation of our former President and Chief Executive Officer, Stuart Paul, in April 2020 and former Chief Financial Officer effective July 2020.

Settlement Expense

Settlement expense was $0 for the year ended December 31, 2020, compared to $0.4 million in for the year ended December 31, 2019.

Settlement expense for the year ended December 31, 2019 reflected the terms of the confidential settlement agreement and mutual release entered into in August 2018 relating to the Company’s former Chief Executive Officer, and Director, Robert Chioini, former Chief Financial Officer, Thomas Klema, and a former and then current director.

The $0.9 million decrease was driven primarily by a decrease in labor of $0.8 million, recruiting of $0.3 million and legal costs of $0.4 million, partially offset by increases to D&O insurance premiums of $0.3 million, FDA fees of $0.2 million, and investor relation costs of $0.1 million.

Other Income (Expense)

Other income for the year ended December 31, 2020 was $246,000, consisting of interest income of $238,000 and $8,000 of realized gains on investments.

Other income for the year ended December 31, 2019 was $422,000, consisting of $392,000 of interest income and $30,000 of realized gains on investments.

Other expense for the year ended December 31, 2020 was $2.7 million, consisting of warrant modification expense of $0.8 million and interest expense of $1.9 million related to our debt facility (see Note 15 for more information on our debt facility).

Other expense for the year ended December 31, 2019 was $25,000 of interest expense.

Other income for the year ended December 31, 2021 consisted of $22,000 of interest income.

Ot her income for the year ended December 31, 2020 was $246,000, consisting of interest income of $238,000 and $8,000 of realized gains on investments.

Other expense for the year ended December 31, 2021 w as $2.4 million, consisting of interest expense related to our debt facility (see Note 15 to the financial statements for more information on our debt facility).

Other expense for the year ended December 31, 2020 was $2.7 million, consisting of warrant modification expense of $0.8 million and i nterest expense of $1.9 million related to our debt facility (see Note 15 to the financial statements for more information on our debt facility).

Liquidity and Capital Resources

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Net cash used in operating activities for the year ended December 31, 2021 was approximately $33.5 million.

Based on the currently available working capital, capital raise and debt financing noted above, 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.

In February 2020, the Company sold 3,670,212 shares of its common stock for proceeds of $8 million, net of issuance costs.

On March 16, 2020, the Company closed a debt financing transaction with net proceeds at closing of approximately $21.2 million, net of fees and expenses (See Note 15 for further detail).

On September 23, 2020, the Company sold 23,178,809 shares of its common stock for proceeds of $32.7 million, net of issuance costs (see Note 11 for further detail).

During the year ended December 31, 2020, the Company sold 1,128,608 shares of its common stock as part of its sales agreement with Cantor Fitzgerald & Co.

for proceeds of $2.3 million, net of issuance costs.

Approximately $32.3 million remains available for sale under this facility.

See Note 11 for further detail.

The Company expects it will require additional capital to sustain its operations and make the investments it needs to execute its strategic plan, including the commercialization of Triferic (dialysate) and Triferic AVNU in dialysis, generating additional data for Triferic in dialysis, developing FPC for iron deficiency anemia in patients undergoing home infusion and for progressing our pipeline development program of new indications for our 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.

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.

Prior to filing our Form 10-K for the year ended December 31, 2021, the Company had experienced significant inflationary pressures in its dialysis concentrates business, particularly in recent months, which has resulted in an accelerated operating loss associated with this business line.

As a result of these inflationary pressures, and in light of the fact that the Company's concentrates business continued to operate at a loss in 2021, the Company sought to renegotiate certain terms of its supply contracts with the Company’s two largest customers in an effort to allow the Company to stabilize its concentrates business.

These factors raised substantial doubt about the Company’s ability to continue as a going concern and depended, in part, on the degree of success in addressing inflationary pressures affecting the Company’s 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.

On April 6, 2022, the Company entered into the DaVita Amendment, which restructures the supply relationship with DaVita, which management expects to result in improved financial performance of the Company’s concentrates business.

The Company also entered into a securities purchase agreement with DaVita, which provides for an investment of up to $15 million 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 to be funded subject to the Company raising $15 million in additional capital by June 30, 2022.

The Company’s existing liquidity, taking into account the two executed agreements described above and implementing increases to product pricing, containing certain costs, and reducing expenses, management believes that the Company has sufficient capital to fund its operations and is sufficient to fund its operations and anticipated capital expenditures for the next 12 months.

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 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, the Company will need to obtain additional equity or debt financing.

In particular, the DaVita Amendment provides that the Company must raise an additional $15 million equity investment by June 30, 2022 and maintain a minimum cash balance 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 cannot assume that any additional equity or debt financing will be available on favorable terms, if at all.

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.

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 that 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 16 for further detail).

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.

Quarantines, shelter-in-place, executive and similar government orders and the recent surge in infections domestically have negatively impact our sales and marketing activities, particularly as our sales representatives are unable to interact with current and potential customers to the same extent as before onset of the COVID-19 pandemic.

If we are unable to avoid an event of default, any required repayments could have an adverse effect on our liquidity (See Note 16 to the financial statements for more information on our debt facility).

operations of third parties upon whom we rely.

Quarantines, shelter-in-place, executive and similar government orders and the recent surge in infections domestically have negatively impact our sales and marketing activities.

Our international business development activities have also be negatively impacted by COVID-19, especially with the recent surge in infections and resulting quarantines or shelter-in-place orders.

Depending on the severity of the impact on our sales and marketing efforts, the success of our commercial launch of Triferic AVNU could be delayed.

The COVID-19 pandemic, the recent domestic and international surge in infections and resulting global disruptions have caused significant volatility in financial and credit markets.

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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.

In particular, our Baxter Agreement prohibits us from entering into a contract that would encumber the assets used in our concentrate business without the prior written consent of Baxter.

Due to the fact that the assets used in our concentrate business currently constitute a substantial portion of the tangible assets we own other than our drug inventory, we may not be able to, or we may find it difficult, to obtain secured debt financing without the consent of Baxter.

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, and 2) our ability to commercialize and increase adaptation of Triferic (dialysate) and Triferic AVNU.

Both of these strategies is 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 have sustained commercial success with Triferic (dialysate) and Triferic AVNU.

If our planned clinical program is delayed or fails or if our commercialization of Triferic (dialysate) and/or Triferic AVNU should fail to increase sales, 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.

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 or our other significant commercial contract in the concentrate business cannot be restructured in way that is beneficial to Rockwell or our if ability to find a commercial partner for Triferic (dialysate) and/or Triferic AVNU should fail, 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.

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Net cash used in operating activities was $33.5 million for the year ended December 31, 2021.

The net loss for this period was higher than net cash used in operating activities by $1.3 million, which was primarily attributable to non-cash expenses of $4.2 million, consisting primarily of $1.5 million of amortization of the right to use assets, $0.8 million of depreciation and amortization, $0.8 million of warrant modification expense, $0.5 million of stock-based compensation, $0.3 million of inventory reserves, $0.3 million of debt financing cost amortization and accretion of discount , and a $3.0 million net change in assets and liabilities.

The net loss for this period was less than net cash used in operating activities by $0.9 million, which was primarily attributable to non-cash expenses of $4.0 million, consisting primarily of $1.8 million of amortization of the right to use assets, $0.7 million of depreciation and amortization, $0.9 million of stock-based compensation, $0.1 million of inventory reserves, $0.4 million of debt financing cost amortization and accretion of discount, and a $4.8 million net change in assets and liabilities.

Net cash used in operating activities was $29.6 million for the year ended December 31, 2020.

The net loss for this period was higher than net cash used in operating activities by $6.8 million, which was primarily attributable to non-cash

expenses of $8.8 million, consisting primarily of $5.0 million of stock-based compensation, $1.9 million of amortization of the right to use assets, $1.3 million of inventory reserves, $0.8 million of depreciation and amortization, and a $2.0 million net change in assets and liabilities.

The net loss for this period was higher than net cash used in operating activities by $1.3 million, which was primarily attributable to non-cash expenses of $4.2 million, consisting primarily of $1.5 million of amortization of the right to use assets, $0.8 million of depreciation and amortization, $0.8 million of warrant modification expense, $0.5 million of stock-based compensation, $0.3 million of inventory reserves, $0.3 million of debt financing cost amortization and accretion of discount, and a $3.0 million net change in assets and liabilities.

Cash Provided by (Used in) Investing Activities

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The net cash provided was primarily due to the purchase of investments available-for-sale of $26.1 million, offset by $26.9 million sale of our available-for-sale investments and $0.5 million for the purchase of equipment.

Net cash used in investing activities was $4.7 million during the year ended December 31, 2019.

The net cash used was primarily due to the purchase of investments available-for-sale of $41.7 million, offset by $38.3 million sale of our available-for-sale investments, $0.6 million for the purchase of equipment and $0.8 million for the purchase of research and development licenses acquired from a related party.

Cash Provided by Financing Activities

Net cash provided by financing activities was $63.3 million during the year ended December 31, 2020.

The net cash provided was primarily due to net proceeds of $40.7 million and $2.3 million from the sale of our common stock, related to our public offerings and our at-the market offerings, respectively, net proceeds of $21.2 million from the term loan, partially offset by payment of $0.8 million related to a short term note payable.

Net cash provided by investing activities was $3.2 million during the year ended December 31, 2020.

The net cash provided was primarily due to the purchase of investments available-for-sale of $29.3 million, offset by $33.6 million sale of our available-for-sale investments and $1.0 million for the purchase of equipment.

Cash (Used in) Provided by Financing Activities

Net cash used in financing activities was $2.2 million during the year ended December 31, 2021.

The net cash used in was primarily due to payments on the Company's debt and short term note payable.

Net cash provided by financing activities was $63.3 million during the year ended December 31, 2020.

The net cash provided was primarily due to net proceeds of $17.3 million and $5.1 million from the sale of our common stock, related to our public offering and our at-the market offerings, respectively, partially offset by payment of $1.1 million related to a short term note payable.

Off‑Balance Sheet Arrangements

We do not have any off‑balance sheet arrangements that have or are reasonably likely to have a material effect on our financial condition.

The net cash provided was primarily due to net proceeds of $40.7 million and $2.3 million from the sale of our common stock in our public offerings and our at-the market offerings, respectively, net proceeds of $21.2 million from our term loan, partially offset by payment of $0.8 million related to a short term note payable.

Critical Accounting Estimates and Judgments

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The carrying amount of trade accounts receivable is reduced by an allowance for doubtful accounts that reflects our best estimate of accounts that may not be collected.

We review outstanding trade accounts receivable balances and based on our assessment of expected collections, we estimate the portion, if any, of the balance that may not be collected as well as a general valuation allowance for other accounts receivable based primarily on historical experience.

We review outstanding trade accounts receivable balances and based on our assessment of expected collections, we estimate the portion, if any, of the

balance that may not be collected as well as a general valuation allowance for other accounts receivable based primarily on historical experience.

All accounts or portions thereof deemed to be uncollectible are written off to the allowance for doubtful accounts.

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The upfront fee was recorded as deferred revenue and is being recognized as revenue based on the agreement term.

The Company recognized revenue of approximately $0.2 million and $0.3 million for the years ended December 31, 2020 and 2019, respectively.

The Company recognized revenue of approximately $0.2 million for both of the years ended December 31, 2021 and 2020.

Deferred revenue related to the Wanbang Agreement totaled $2.5 million and $2.7 million for the years ended December 31, 2021 and 2020, respectively.

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The upfront fee was recorded as deferred revenue and is being recognized as revenue based on the agreement term.

The Company recognized revenue of approximately $10,000 during the year ended December 31, 2020.

Deferred revenue related to the Sun Pharma Agreement totaled $90,000 as of December 31, 2020.

The Company recognized revenue of approximately $10,000 for both of the years ended December 31, 2021 and 2020.

Deferred revenue related to the Sun Pharma Agreement totaled $80,000 and $90,000 as of December 31, 2021 and 2020, respectively.

On September 7, 2020, the Company entered into a license and supply agreements with Jeil Pharma (the "Jeil Pharma Agreements"), for the rights to commercialize Triferic (dialysate) (ferric pyrophosphate citrate) in South Korea.

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The upfront fee was recorded as deferred revenue and is being recognized as revenue based on the agreement term.

The Company recognized revenue of $10,000 and $2,500 during the year ended December 31, 2021 and 2020, respectively.

Deferred revenue related to the Jeil Pharma Agreement totaled $187,500 and $197,500 as of December 31, 2021 and 2020, respectively.

On June 2021, the Company entered into license and supply agreements with Drogsan Pharma (the "Drogsan Agreements"), for the rights to commercialize Triferic (dialysate) and Triferic AVNU in Turkey.

Under the terms of the Drogsan Agreements, Drogsan Pharma will be the exclusive commercialization partner for Triferic (dialysate) and Triferic AVNU in Turkey.

In consideration for the license, the Company received an upfront fee of $0.15 million, and will be eligible for milestone payment and royalties on net sales.

A Joint Alliance Committee, comprised of members from the Company and Drogsan Pharma, will guide the execution for Triferic (dialysate) and Triferic AVNU in Turkey.

Drogsan Pharma will be responsible for all regulatory approval and commercialization activities, and the Company will supply the product to Drogsan Pharma for Turkey.

The upfront fee will be recorded as deferred revenue and will be recognized as revenue based on the agreement term.

The Company recognized revenue of $7,500 during the year ended December 31, 2021.

Deferred revenue related to the Jeil Pharma Agreement totaled $197,500 as of December 31, 2020.

Deferred revenue related to the Drogsan Agreements totaled approximately $0.1 million as of December 31, 2021.

Stock-Based Compensation

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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 7. Management’s Discussion and Analysis