What changed in this filing

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Item 1A. Risk Factors

2022-11-14 compared with 2022-08-15 · 52 added, 42 removed, 6 unchanged (94% of the section changed)

1 unchanged sentence

There have been no material changes to the risk factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2021 under "Item 1A - Risk Factors" except as noted below.

We rely on third party suppliers for raw materials and packaging components of our drug products.

We may not be able to obtain the raw materials and proper components we need, or the cost of the materials or components may be higher than expected, any of which could impair our production or commercialization of drug products and have a material adverse effect on our business, results of operations and financial position.

We may not be able to obtain the raw materials or packaging components we need, or the price of such materials or components may rise significantly, for a variety of reasons, including but not limited to:

• a business interruption, including a force majeure, cyber-attack, labor strike at a supplier, a COVID-related halt or slowdown of supply of raw materials or production of components;

• global supply chain delays or disruptions;

• regulatory requirements or action by regulatory agencies or others against a supplier, including delays in receiving necessary approvals;

• failure of a supplier to comply with cGMP standards, which could result in quality or product failures, adulteration, contamination and/or recall;

• adverse financial or other strategic developments at or affecting a supplier;

• termination or disagreement over the terms and conditions of the supply contract by a supplier or our inability to comply with the minimums in such an agreement;

• unexpected demand for or shortage of raw materials or packaging components;

• unexpected increases in our product demand.

Some of the suppliers for our raw materials or packaging components are single-source suppliers.

If those suppliers were unable to supply us for any reason, including the reasons mentioned above, we could experience cost increases or supply interruptions.

For example, we have had disputes with our API supplier for Triferic.

In January 2022, we received an invoice for a penalty payment because we failed to meet certain minimum order requirements under our agreement with them.

Any dispute that may arise could result in the termination of the supply agreement or loss of API that is stored at our supplier.

We also experienced repeated batch failures as a result of quality issues at our other Triferic manufacturer and our packaging manufacturer has notified us that they will no longer supply packaging due to low volumes and our compliance requirements.

Finding an alternative source can be expensive and take a substantial amount of time, especially when regulatory approval is required to qualify the supplier.

If we are unable to obtain our raw materials and packaging components and are not able to establish alternative supply sources, or if the prices for such items increase substantially, our CMOs may not be able to produce the desired quantities of our drug products and our expected gross profit margins may be materially adversely affected.

Our drug and concentrate businesses are highly regulated, resulting in additional expense and risk of noncompliance that can materially and adversely affect our business, results of operations, financial position and cash flows.

Our businesses are highly regulated.

The testing, manufacture, sale and delivery of the products we manufacture directly or through third party CMOs are subject to extensive regulation by the FDA and by other federal, state and foreign authorities, including, with respect to our transportation operations, the U.S.

Department of Transportation.

Before drug product candidates or medical devices, such as our concentrate products, can be commercially marketed in the United States, the FDA must give either premarket approval or 510(k) clearance.

After a product is approved, regulatory authorities may impose significant restrictions on a product’s indicated uses or marketing or requirements for potentially costly post-marketing studies.

Our drug products are subject to ongoing regulatory requirements for labeling, packaging, storage, advertising, promotion, sampling, record- keeping and reporting of safety and other post-market information.

In addition, manufacturers and their facilities are required to comply with extensive FDA requirements, including ensuring that quality control and manufacturing procedures conform to current cGMP and applicable state laws.

As such, we and our CMOs are subject to continual review and periodic inspections to assess compliance with cGMP and state laws.

For example, the FDA recently conducted a routine GMP inspection of one of our manufacturing facilities and issued Form FDA-483 report with four observations, for which the inspector classified Voluntary Action Indicated.

The Company expects to submit a voluntary corrective action plan by August 24, 2022.

While none of the findings were serious, management time and effort will be necessary for the correction and the FDA may not be satisfied with our response.

Accordingly, we and our partners must continue to expend time, money and effort in all areas to achieve and maintain regulatory compliance.

We are also required to report certain adverse reactions and production problems, if any, to applicable regulatory authorities and to comply with requirements concerning advertising and promotion for our drug products or product candidates.

If non-compliant inventory is sold or if a regulatory agency determines that we are not compliant with any applicable regulatory requirements, we may be subject to warnings from, or enforcement action by, state and federal government authorities, which may include penalties, fines, injunctions, recall or seizure of products, suspension of production, denial of future regulatory approvals, withdrawal or suspension of existing regulatory approvals, operating restrictions, injunctions and criminal prosecution.

If regulatory sanctions are applied, the value of our Company and our operating results could be materially and adversely affected.

For example, such actions could cause our customers to doubt the safety or efficacy of our products, which could adversely impact our business.

Even a voluntary Class III recall, which is a recall of products for a defect that is unlikely to result in adverse health consequences, can have an adverse impact on the Company due to the costs of the recall or the reactions of customers.

We recently conducted a Class III recall in our concentrates business due to the degradation of secondary seals on some of our bottles of concentrates, which consumed management time and effort.

Our business could also be adversely affected by delays in obtaining necessary regulatory approvals and any restrictions placed by the FDA on our intended marketing or the use of our drug products.

Our failure to comply with applicable regulations could also result in product liability litigation against us.

In addition, our failure to comply with applicable regulations with respect to our concentrate products could constitute a breach by us of the Distribution Agreement, providing Baxter with various remedies that would be material and adverse to us.

Moreover, changes in applicable regulatory requirements could significantly increase the costs of our operations, which, if such higher costs result in price increases that exceed the thresholds specified in the Distribution Agreement, could give Baxter the right to terminate the Distribution Agreement.

Our reacquisition of distribution rights for our concentrates products from Baxter through the termination of our Exclusive Distribution Agreement has many attendant risks and may not result in the financial outcome we expect.

We recently terminated our Exclusive Distribution Agreement with Baxter and reacquired the distribution rights related to our concentrates products for Baxter’s portfolio of clinics.

Our Distribution Agreement with Baxter enabled us to charge Baxter an amount above cost for our concentrates products, while limiting us to a capped percentage of sales for the transportation costs associated with delivering those products.

When we assume full responsibility for selling and delivering our concentrates products to Baxter customers and any other customers we may add, we will bear all financial and other risk associated with the business.

We may lose former Baxter customers if we need to increase the prices of our concentrates products due to rising costs or for other reasons.

In addition, since we agreed to charge these customers a fixed cost through the transition period which ends on December 31, 2022 (and for a certain portfolio of customers, through March 31, 2023), we may lose money if those fixed costs do not cover our actual costs.

We also may be unable to renegotiate unprofitable contracts with certain customers.

Each of these scenarios could result in the business we reacquired generating less revenue or less profit than we expect and could adversely impact our financial condition or results of operations.

Unfavorable weather, economic conditions or supply shortages could adversely affect our business, financial condition or results of operations.

Our results of operations could be adversely affected by general weather conditions, as well as conditions in the United States and global economy and in the global financial markets.

A severe weather or other geological event in our locations or those of our suppliers, or prolonged economic downturn or persistent inflation have and could continue to result in a variety of risks to our business, including our ability to recover our costs or to raise additional capital when needed on acceptable terms, if at all.

In addition, weather-related events may jeopardize our ability to deliver our products as required by our contracts.

For example, after Hurricane Ian severely damaged parts of the Florida Gulf Coast, many roads and bridges were destroyed.

While we were able to make our deliveries after the storm, that may not always be the case.

A weak or declining United States or global economy could also strain our suppliers, possibly resulting in supply disruption.

In addition, due to macro-economic conditions in the global economy, there have been shortages in raw materials, parts and fuel that we need to run our business.

Recently, our suppliers have experienced shortages in bicarbonate and acid, which are components of our dialysis concentrates, and parts needed for our equipment to make certain of our products.

Diesel fuel is also in short supply in the United States and our delivery trucks run on diesel.

While we have been able to minimize the impact of these disruptions to date, there can be no assurance that will continue.

Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.

We have been and may continue to be affected materially and adversely by increases in raw material and transportation costs and may be unable to recover certain costs due to provisions in our material contracts.

A significant portion of our costs relates to chemicals and other raw materials and transportation, which such costs are out of our control, and we may not be able to recover a portion of such costs due to provisions in our material contracts with

Baxter and DaVita.

The costs of chemicals and other raw materials are subject to price volatility based on supply and demand and are highly influenced by the overall level of economic activity in the United States and abroad.

These costs have tended to rise from year to year and are likely to continue to rise in the future.

In the past year, raw materials costs have increased significantly, due to short supply and excess demand.

Transportation also comprises a significant portion of our costs.

We have been adversely affected by a general shortage in commercial truckers in the United States and significant increases in labor and fuel costs.

In addition, as mentioned above, there is now a nationwide shortage of diesel fuel in the United States, which we use to run our delivery trucks.

If that shortage is not rectified, the cost of diesel fuel could rise or diesel fuel could be unavailable and we would need to find another way to deliver our products to clinics.

If we are unable to do so, we could be in breach of our contracts.

Our Product Purchase Agreement (“Product Agreement”) with DaVita provides for a fixed price to DaVita, with limited increases from year to year, regardless of the increases in raw materials costs.

As a result, we have in the past been unable to fully recover our costs for the products we sell to DaVita (including transportation costs).

This has had and could in the future have a material and adverse impact on our financial position.

On April 6, 2022, we entered into an amendment to the Products Purchase Agreement under which we agreed to a price increase, effective May 1, 2022, as well as the pass-through of certain costs, determined on a quarterly basis.

Certain costs are subject to a cap.

If our costs exceed those caps, we may be unable to fully recover our costs or if costs increase in excess of an overall cap, the Products Purchase Agreement may be subject to termination by DaVita.

We expect that if we continue to be subject to the limitations in the agreements with our customers, the increasing costs may continue to negatively impact our profit margins and materially and adversely affect our financial position.

We may become the target of litigation, which is costly and time-consuming to defend.

We have in the past been subject to litigation and it is possible that legal proceedings could be brought against us in the future based upon decisions we make regarding our strategy or otherwise.

Litigation can be costly and time-consuming and the results of complex legal proceedings are difficult to predict.

These lawsuits assert types of claims that, if resolved against us, could give rise to substantial damages, and an unfavorable outcome or settlement of these lawsuits, or any future lawsuits, could have a material adverse effect on our business, financial condition, results of operations and/or stock price.

Even if any future lawsuits are not resolved against us, the costs of defending such lawsuits may be material to our business and our operations.

Moreover, these lawsuits may divert our Board and our management’s attention from the operation of our business.

Current and future legislation may increase the difficulty and cost for us, and any collaborators, to obtain marketing approval of and commercialize our drug candidates and affect the prices we, or they, may obtain.

Heightened governmental scrutiny over the manner in which manufacturers set prices for their marketed products has resulted in several recent Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for products.

We expect that additional state and federal healthcare reform measures will be adopted in the future, particularly in light of the new presidential administration, any of which could limit the amounts that federal and state governments will pay for healthcare therapies, which could result in reduced demand for our product candidates or additional pricing pressures.

Most recently, on August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (“IRA”), which, among other provisions, included several measures intended to lower the cost of prescription drugs and related healthcare reforms.

We cannot be sure whether additional legislation or rule making related to the IRA will be issued or enacted, or what impact, if any, such changes will have on the profitability of any of our drug candidates, if approved for commercial use, in the future.

Our revenue growth and profitability projections are based on various assumptions that may not come to fruition.

Our revenue growth and profitability projections are subject to many assumptions regarding our future operations, including that we are successful in expanding to new territories, that we successfully develop and launch new product offerings, that we are able to increase our prices to keep up with inflation, and that we do not experience significant disruptions to the manufacturing or distribution of our products, among other assumptions.

If we are unsuccessful in one or more of those efforts, we may not be able to achieve our projected growth and profitability.

Unregistered Sales of Equity Securities and Use of Proceeds.

3 unchanged sentences

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 1A. Risk Factors