What changed in this filing

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Item 2. Management’s Discussion and Analysis

2020-08-10 compared with 2020-05-11 · 110 added, 66 removed, 129 unchanged (58% of the section changed)

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our ability to successfully launch FDA approved Triferic AVNU;

whether we can successfully execute on our business strategy;

whether we can 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.

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Overview and Recent Developments

We are a biopharmaceutical company dedicated to transforming anemia and improving outcomes for patients with anemia across the globe, with an initial focus on ESRD.

We are a biopharmaceutical company dedicated to transforming iron deficiency and iron deficiency anemia and improving outcomes for patients across the globe, with an initial focus on ESKD.

We are also a manufacturer of hemodialysis concentrates for dialysis providers and distributors in the United States and abroad.

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We are focused on developing our proprietary ferric pyrophosphate (“FPC”) therapeutic platform, and the first product developed from this platform is Triferic, the first-FDA approved product for the replacement of iron and maintenance of hemoglobin in adult hemodialysis patients.

Our mission is to develop and commercialize the FPC platform to transform the treatment of iron deficiency and anemia in a wide variety of disease states across the globe while improving patients’ lives.

Our mission is to develop and commercialize the FPC platform to transform the treatment of iron deficiency and iron deficiency anemia in a wide variety of disease states across the globe while improving patients’ lives.

Accordingly, as an initial step, we are building the foundation to become a leading medical and commercial organization in the field of dialysis.

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As a result, the Company changed its commercialization strategy to plan for the commercial launch of Triferic Dialysate with reimbursement within the bundle of payments to dialysis providers, while continuing to develop Triferic AVNU (discussed below).

We commercially launched Triferic Dialysate in the May 2019.

As of March 31, 2020, we had $0.2 million of Triferic Dialysate finished goods inventory that could expire by May 2021.

As of March 31, 2020, we also had approximately $2.6 million of API against which we have reserved $2.1 million and classified $0.3 million of API as non-current inventory.

Additionally, we have $0.3 million of raw materials for Triferic products and all is classified as non-current.

Depending on the success of our commercialization of Triferic Dialysate and Triferic AVNU, additional amounts or all of our current investment in Triferic Dialysate finished goods inventory and some or all of our API inventory may need to be written off.

Additional inventory write-offs will not have a material negative impact on our cash flow, but could have a material adverse impact on our reported results of operations and financial position.

We commercially launched Triferic Dialysate in May 2019.

Triferic AVNU (formerly I.V.

We are also developing Triferic AVNU, an intravenous injection of Triferic, for use by hemodialysis clinics in the United States as well as international markets.

On March 27, 2020, we received FDA approval for Triferic AVNU, and we intend to initiate a sample evaluation program for Triferic AVNU during the third quarter of 2020.

We are also developing Triferic AVNU, an intravenous injection formulation of Triferic, for use by hemodialysis clinics in the United States as well as international markets.

On March 27, 2020, we received FDA approval for Triferic AVNU, and we intend to initiate a sample evaluation program for Triferic AVNU during the third quarter of 2020 with commercialization expected to follow in the fourth quarter of 2020.

Triferic AVNU will be reimbursed within the existing fixed-price bundle of payments that CMS provides to dialysis providers.

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As a result of this decision, we recorded an inventory reserve reflecting the remainder of our Calcitriol inventory.

As of March 31, 2020, this reserve totaled $0.7 million.

As of June 30, 2020, this reserve totaled $0.7 million.

We are in the process of disposing of all inventory and in March 2020, we notified the FDA of our intention to withdraw the ANDA.

On May 4, 2020, the ANDA was withdrawn.

Clinical Development

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("Wanbang"), we completed two clinical pharmacology studies in China during 2019.

We expect Wanbang to initiate an additional clinical study during 2020 that is necessary to support a submission for regulatory approval in China.

We expect Wanbang to initiate an additional clinical study during 2020 that is required to support a submission for regulatory approval

In addition, pursuant to the licensing agreement with Sun Pharmaceutical Industries Ltd.

("Sun Pharma"), our licensee in India, meetings between Sun Pharma and the regulatory authorities in India have been initiated.

Sun Pharma continues to follow up with the Indian regulatory authorities to determine the requirements for approval of Triferic in India.

See "Item 1A - Risk Factors" below for a discussion of the potential impact of COVID-19 on such clinical studies.

As a post-approval requirement under the Pediatric Research Equity Act, we are required to conduct a further clinical study of the effectiveness of Triferic in a pediatric patient population.

We have reached agreement with the FDA on the design of this study and we expect to initiate enrollment in the study during 2020, assuming we have the liquidity and capital resources to do so.

We have reached agreement with the FDA and EMA on the design of this study.

We have engaged a contract research organization and are in process of selecting sites in the United States and selected EU countries.

We expect to initiate enrollment in the study during the third quarter of 2020.

We expect that the data from this study could be used as part of the overall clinical data package to support approval by the EMA, if and when we are able to complete the other clinical trials needed to support making such a filing.

Additionally, we plan on leveraging our development and regulatory experience with Triferic and believe that our FPC technology has the potential to be developed for use in other indications in which iron replacement is required.

In addition, we are assessing potential investments to evaluate other product presentations of Triferic within ESRD.

Results of Operations for the three months ended March 31, 2020 and 2019

See "Item 1A - Risk Factors" below for a discussion of the potential impact of COVID-19 on such clinical studies.

Additionally, we plan to leverage our development and regulatory experience with Triferic and believe that our FPC technology has the potential to be developed for use in other indications, in which iron replacement is required.

In addition, we are assessing potential investments to evaluate other product presentations of Triferic within ESKD.

Results of Operations for the three months ended June 30, 2020 and 2019

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

For the Quarter Ended March 31,

For the Three Months Ended June 30,

Cost of Sales

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General and Administrative

Settlement Expense, net of Reimbursement

Research and Product Development

Operating Loss

During the three months ended March 31, 2020, our net sales were $15.9 million compared to sales of $15.6 million during the three months ended March 31, 2019.

The increase of $0.3 million was primarily due to increased sales of Triferic Dialysate.

For the three months ended March 31, 2020 and 2019, Triferic net sales included approximately $0.1 million of deferred revenue recognized under the Company’s license in China with Wanbang.

Triferic Dialysate net sales for the three months ended March 31, 2020 also included approximately $0.2 million of Triferic Dialysate product sales to United States customers.

Cost of sales during the three months ended March 31, 2020 was $14.7 million, resulting in gross profit of $1.1 million during the three months ended March 31, 2020, compared to cost of sales of a $14.5 million and a gross profit of $1.0 million during the three months ended March 31, 2019.

Gross profit increased by $0.1 million in the first quarter of 2020 compared to the first quarter of 2019, due primarily to the increase in Triferic product sales of $0.2 million offset by a decrease in gross profit for our dialysis concentrate products due to increased labor and material costs.

During the three months ended June 30, 2020, our net sales were $15.9 million compared to sales of $14.8 million during the three months ended June 30, 2019.

The increase of $1.1 million was primarily due to increased sales in our dialysis concentrates products.

Triferic Dialysate net sales for the three months ended June 30, 2020 included approximately $0.2 million of Triferic Dialysate product sales to United States customers.

Triferic was launched in Q2 2019 via the sample evaluation program and there were nominal revenues for the same period in 2019.

Cost of sales during the three months ended June 30, 2020 was $15.0 million, resulting in gross profit of $0.9 million during the three months ended June 30, 2020, compared to cost of sales of a $14.1 million and a gross profit of $0.7 million during the three months ended June 30, 2019.

Gross profit increased by $0.2 million in the second quarter of 2020 compared to the second quarter of 2019, due primarily to the increase in sales of $1.0 million;

offset by an increase in labor and material costs $0.8 million to address requirements to support demand arising 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 impact the mix on our future gross profits.

Selling and Marketing Expense

Selling and marketing expenses were $2.1 million during the three months ended March 31, 2020 compared with $3.1 million during the three months ended March 31, 2019.

The decrease of $1.0 million is primarily due to a decrease in marketing costs of $1.6 million from the first quarter of 2019 to the first quarter of 2020, offset by an increase in labor costs of $0.6 million.

Sales and marketing expenses for the first quarter of 2019 included investments to prepare for the launch of Triferic Dialysate, including significant marketing, recruiting and training costs.

Selling and marketing expenses were $2.0 million during the three months ended June 30, 2020, compared with $2.2 million during the three months ended June 30, 2019.

The decrease of $0.2 million is primarily due to a decrease in marketing costs associated with the initial investment in a specialty commercial team and marketing programs to support the launch of Triferic in Q2 2019.

General and Administrative Expense

General and administrative expenses were $5.3 million during the three months ended March 31, 2020 compared with $6.2 million during the three months ended March 31, 2019.

The decrease of $0.9 million is due primarily to a decrease in stock compensation of $0.7 million, relating to a decrease in incentive compensation;

General and administrative expenses were $2.9 million during the three months ended June 30, 2020, compared with $5.5 million during the three months ended June 30, 2019.

The decrease of $2.6 million is due primarily to a decrease in stock compensation of $2.0 million, relating to a decrease in incentive compensation from forfeited equity awards associated with the departure of our former President and Chief Executive Officer in April 2020;

a decrease in legal expense of $0.7 million, relating to previous litigation that has since been resolved;

a decrease in consulting expense of $0.4 million;

partially offset by an increase in director and officer insurance premiums of $0.2 million;

an increase in headcount and director costs of $0.4 million;

and, an increase in facilities, depreciation and amortization of $0.1 million, relating primarily to the Company’s new office in New Jersey.

partially offset by an increase of $1.2 million for severance pay related to the same former President and Chief Executive Officer.

Research and Product Development Expense

Research and product development expenses were $1.8 million for the three months ended March 31, 2020 compared with $0.5 million during the three months ended March 31, 2019.

The increase was due primarily to investments we are making in our medical platform to support the development and the global launch of Triferic, including medical, scientific and technical staffing costs and consulting expenses.

We expect our research and product development expenses to increase in the future due to additional clinical development of our FPC technology platform, innovations in administration of Triferic, the continuation of the pediatric clinical trial described above (preparation for which began in the third quarter of 2019), and an increase in headcount to support medical education efforts for Triferic.

Other income for the three months ended March 31, 2020 was $0.2 million, consisting of interest income of $171,100 and $1,929 of realized gains on investments.

Other income for the three months ended March 31, 2019 was $131,000, consisting of $117,000 of interest income and $14,000 of realized gains on investments.

Other expense for the three months ended March 31, 2020 was $101,951, consisting of interest expense related to our Term Loan (defined below) of $80,907, interest expense related to insurance note financing of $16,365 and foreign currency loss of $4,679.

No interest expense was recorded for the three months ended March 31, 2019.

We expect interest expense to increase due to the Term Loan, which was entered into in March 2020.

See Note 17 of the condensed consolidated financial statements at March 31, 2020.

Research and product development expenses were $1.6 million for the three months ended June 30, 2020, compared with $3.0 million during the three months ended June 30, 2019.

The decrease of $1.4 million was due primarily to the payment for the Triferic AVNU NDA application fee of $1.3 million in Q2 2019.

The Company is continuing to invest in its medical and scientific programs to support the global launch of Triferic and the advancement of our FPC technology platform.

Other Income (Expense)

Other income for the three months ended June 30, 2020 was $68,815, consisting of interest income of $66,750 and $2,065 of realized gains on investments.

Other income for the three months ended June 30, 2019 was $78,611, consisting of $74,476 of interest income and $4,135 of realized gains on investments.

Other expense for the three months ended June 30, 2020 was $1.4 million, consisting of interest expense of $0.5 million related to our debt facility (see Note 15 for more information on our debt facility) and warrant modification expense of $0.8 million.

No interest expense was recorded for the three months ended June 30, 2019.

Results of Operations for the six months ended June 30, 2020 and 2019

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

For the Six Months Ended June 30,

Cost of Sales

Selling and Marketing

General and Administrative

Settlement Expense, net of Reimbursement

Research and Product Development

Operating Loss

During the six months ended June 30, 2020, our net sales were $31.8 million compared to sales of $30.4 million during the six months ended June 30, 2019.

The increase of $1.4 million was primarily due to higher domestic dialysis concentrate sales of $1.0 million and an increase in Triferic Dialysate sales of approximately $0.4 million compared to the six months ended June 30, 2019.

Triferic was launched in the second quarter of 2019 via the sample evaluation program and there were nominal revenues for the same period in 2019.

Gross Profit (Loss)

Cost of sales during the six months ended June 30, 2020 was $29.8 million, resulting in gross profit of $2.0 million during the six months ended June 30, 2020, compared to cost of sales of $28.7 million and a gross profit of $1.7 million during the six months ended June 30, 2019.

Gross profit increased by $0.3 million during the six months ended June 30, 2020 compared to the six months ended June 30, 2019.

The increase was due primarily to a gross margin increase of $0.3 million in our Triferic Dialysate product in 2020.

In comparison, the launch and sales of Triferic Dialysate occurred in the second quarter of 2019 and had no to minimal impact during the six months ended June 30, 2019.

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

The Company anticipates that potential future sales of Triferic will impact the mix on our future gross profits.

Selling and Marketing Expense

Selling and marketing expenses were $4.1 million during the six months ended June 30, 2020, compared with $5.3 million during the six months ended June 30, 2019.

The decrease of $1.2 million is due primarily to the decrease in marketing costs of $2.0 million, partially offset by an increase in costs associated with hiring, training and educating new employees of $0.8 million.

The fluctuation in these costs are mainly due to the timing of the Triferic Dialysate launch in the second quarter of 2019.

We expect those costs to level off quarter over quarter going forward.

General and Administrative Expense

General and administrative expenses were $8.1 million during the six months ended June 30, 2020, compared with $11.7 million during the six months ended June 30, 2019.

The $3.6 million decrease was driven primarily by decreases to stock compensation, legal, recruiting and consulting fees, partially offset by an increase in labor costs.

The increase in labor costs and decrease in stock compensation primarily relate to the resignation of our former President and Chief Executive Officer in April 2020.

Research and Product Development Expense

Research and product development expenses was $3.4 million for both the six months ended June 30, 2020 and 2019.

Research and development expenses for the six months ended June 30, 2020 included clinical trials and other product development expenses of $1.2 million for Triferic, compared to $0.7 million during the six months ended June 30, 2019.

The Company is continuing to invest in its medical and scientific programs to support the global launch of Triferic and the advancement of our FPC technology platform.

Settlement Expense, net of Reimbursement

Settlement expense was nil for the six months ended June 30, 2020, compared to $0.4 million in for the six months ended June 30, 2019.

Settlement expense for the six months ended June 30, 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, Robert Chioini, former Chief Financial Officer, Thomas Klema, and a former and then current director.

Other Income (Expense)

Other income for the six months ended June 30, 2020 was $241,821, consisting of interest income of $237,827 and $3,994 of realized gains on investments.

Other income for the six months ended June 30, 2019 was $210,025, consisting of $192,002 of interest income and $18,023 of realized gains on investments.

Other expense for the six months ended June 30, 2020 was $1.5 million, consisting of warrant modification expense of $0.8 million and interest expense of $0.6 million related to our debt facility (see Note 15 for more information on our debt facility).

No interest expense was recorded for the six months ended June 30, 2019.

Liquidity and Capital Resources

As of March 31, 2020, we had approximately $48.9 million of cash, cash equivalents and investments available-for-sale, and working capital of $46.1 million.

Net cash used in operating activities for the three months ended March 31, 2020 was approximately $6.5 million.

As of June 30, 2020, we had approximately $40.0 million of cash, cash equivalents and investments available-for-sale, and working capital of $40.0 million.

Net cash used in operating activities for the six months ended June 30, 2020 was approximately $16.2 million.

On March 22, 2019, the Company entered into a sales agreement with Cantor Fitzgerald & Co.

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The Company paid approximately $0.3 million in commissions and offering fees related to the sale of the common stock.

As of March 31, 2020, approximately $34.6 million remains available for issuance under this facility.

During the six months ended June 30, 2020, the Company sold 987,716 of shares of its common stock pursuant to the Sales Agreement with the Agent for proceeds of $2.0 million, net of issuance costs.

As of June 30, 2020, approximately $32.6 million remains available for sale under this facility.

On February 4, 2020, the Company entered into an underwriting agreement with Cantor Fitzgerald & Co., as underwriter, pursuant to which the Company agreed to issue and sell up to 3,670,212 shares of its common stock, which included 478,723 shares optional shares that may be sold pursuant to an over-allotment option granted to the underwriters.

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On March 16, 2020, Rockwell Medical, Inc.

and the lenders party thereto, pursuant to which Innovatus, as a lender, agreed to make certain term loans to the Company in the aggregate principal amount of up to $35.0 million (the “Term Loans”).

and Rockwell Transportation, Inc., as Borrowers, entered into a Loan and Security Agreement (the "Loan Agreement") with Innovatus Life Sciences Lending Fund I, LP (“Innovatus”), as collateral agent and the lenders party thereto, pursuant to which Innovatus, as a lender, agreed to make certain term loans to the Company in the aggregate principal amount of up to $35.0 million (the “Term Loans”).

Funding of the first $22.5 million tranche was completed on March 16, 2020.

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The Company has the option, under certain circumstances, to add 1.00% of such interest rate amount to the then outstanding principal balance in lieu of paying such amount in cash.

For the three months ended March 31, 2020 and 2019, interest expense amounted to $80,907 and nil, respectively.

For the six months ended June 30, 2020 and 2019, interest expense amounted to $0.6 million.

The Loan Agreement is secured by all assets of the Company and Rockwell Transportation, Inc.

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The Loan Agreement contains customary representations and warranties and covenants, subject to customary carve outs, and includes financial covenants related to liquidity and trailing twelve months sales of Triferic, with the latter beginning with the period ending December 31, 2020, or September 30, 2020 if the Company draws the second tranche of $5.0 million.

As of March 31, 2020, we were in compliance with all the reporting and financial covenants.

As of June 30, 2020, we were in compliance with all the reporting and financial covenants.

However, if the Company is unable to maintain compliance with the reporting and financial covenants in the future, the Company could experience an event of default under the Loan Agreement, which would negatively impact the Company’s liquidity.

For more information, see the risk factor entitled “Our Loan Agreement with Innovatus contains certain covenants that could adversely affect our operations and, if an event of default were to occur, we could be forced to repay the outstanding indebtedness sooner than planned and possibly at a time when we do not have sufficient capital to meet this obligation.

The occurrence of any of these events could cause a significant adverse impact on our business, prospects and share price.” in “Item 1A-Risk Factors.”

Based on the 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.

The Company will require additional capital to sustain its operations and make the investments it needs to execute upon its longer-term business plan, including the launch and further development of Triferic Dialysate and Triferic AVNU.

The Company will require additional capital to sustain its operations and make the investments it needs to execute upon its longer-term business plan, including the commercial launch and medical education programs of Triferic Dialysate and Triferic AVNU, and the further development of our FPC pipeline programs.

If the Company is unable to generate sufficient revenue from its existing long-term business plan, the Company will need to obtain additional equity or debt financing.

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If our launch of Triferic Dialysate and/or Triferic AVNU is unsuccessful or our commercial launch does not proceed as planned, 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.

If we are unable to raise the required capital, we may be required 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 $6.5 million for the three months ended March 31, 2020.

The net loss for this period was higher than net cash used in operating activities by $1.4 million, which was primarily attributable to non-cash expenses of $1.6 million, consisting primarily of $0.9 million of stock-based compensation, $0.4 million of amortization of the right to use assets, $0.2 million of depreciation and amortization, and a ($0.1) million net change in assets and liabilities.

Net cash used in operating activities was $5.4 million for the three months ended March 31, 2019.

The net loss for this period was higher than net cash used in operating activities by $3.3 million, which was primarily attributable to non-cash expenses of $2.2 million, consisting of $1.5 million of stock-based compensation, $0.5 million of amortization of the right to use assets, $0.2 million of depreciation and amortization, and a $1.1 million net changes in assets and liabilities.

Cash Provided by Investing Activities

Net cash provided by in investing activities was $2.6 million during the three months ended March 31, 2020.

Net cash used in operating activities was $16.2 million for the six months ended June 30, 2020.

The net loss for this period was lower than net cash used in operating activities by $1.3 million, which was primarily attributable to non-cash expenses of $1.6 million, consisting primarily of $0.8 million of warrant modification expense, $0.7 million of amortization of the right to use assets, $0.4 million of depreciation and amortization, ($0.5) million of stock-based compensation and a ($2.9) million net change in assets and liabilities.

Net cash used in operating activities was $15.8 million for the six months ended June 30, 2019.

The net loss for this period was higher than net cash used in operating activities by $3.2 million, which was primarily attributable to non-cash expenses of $4.5 million, consisting of $3.0 million of stock-based compensation, $1.0 million of amortization of the right to use assets, $0.4 million of depreciation and amortization, and a ($1.4) million net change in assets and liabilities.

Cash Provided by (Used In) Investing Activities

Net cash provided by investing activities was $0.7 million during the six months ended June 30, 2020.

The net cash provided was primarily due to the sales of our available-for-sale investments of $17.5 million, offset by $16.5 million used for the purchase of investments available-for-sale and $0.3 million for the purchase of equipment.

Net cash provided by investing activities was $3.6 million during the three months ended March 31, 2019.

The cash provided was primarily due to the sale of our available-for-sale investments of $12.8 million, offset by $8.8 million used for the purchase of investments available-for-sale, $0.13 million for the purchase of equipment and $0.3 million for the purchase of research and development licenses acquired from a related party.

Net used in investing activities was $3.8 million during the six months ended June 30, 2019.

The cash used was primarily due to the purchase of our available-for-sale investments of $21.8 million, offset by $18.8 million provided by the sale of investments

available-for-sale, $0.5 million for the purchase of research and development licenses acquired from a related party and $0.3 million for the purchase of equipment.

Cash Provided by Financing Activities

Net cash provided by financing activities was $29.6 million during the three months ended March 31, 2020.

The net cash provided was primarily due to net proceeds of $22.1 million related to the Loan Agreement and $8.0 million from the Offering;

offset by $0.6 million of payments related short-term note payable.

Net cash provided by financing activities was $0.1 million during the three months ended March 31, 2019.

Additionally, we established an at-the-market offering facility pursuant to which we have the ability to sell from time to time up to $40 million of common stock in at-market transactions.

Net cash provided by financing activities was $30.4 million during the six months ended June 30, 2020.

The net cash provided was primarily due to net proceeds of $21.2 million related to the Loan Agreement and $8.0 million and $2.0 million from the sale of our common stock, related to our public offering and our at-the market offering, respectively.

Net cash provided by financing activities was $18.3 million during the six months ended June 30, 2019.

The net cash provided was primarily due to net proceeds of $16.1 million and $2.1 million from the sale of our common stock, related to our public offering and our at-the market offering, respectively.

COVID-19 Impact

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

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

Depending on the severity of the impact on our sales and marketing efforts, the timing of our commercial launch of Triferic AVNU could be adjusted into the first quarter of 2021.

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

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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 March 31, 2020.

See Note 3 of the condensed consolidated financial statements at June 30, 2020.

Quantitative and Qualitative Disclosures about Market Risk

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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-Q

Item 2. Management’s Discussion and Analysis