Rockwell Medical Inc (RMTI) 2021 Q4 法說會逐字稿

Good afternoon, ladies and gentlemen, and welcome to the Rockwell Medical Fourth Quarter and Full Year 2020 Results Call. (Operator Instructions) As a reminder, this conference call is being recorded.

At this time, I would like to introduce Claudia Styslinger, Investor Relations. Please go ahead.

Good afternoon. This is Claudia Styslinger of Argot Partners, the Investor Relations representative for Rockwell Medical. Joining me from Rockwell Medical on today's call are Dr. Russell Ellison, President and Chief Executive Officer; Russell Skibsted, Executive Vice President, Chief Financial Officer and Chief Business Officer; Dr. Marc Hoffman, Chief Medical Officer; and Tim Chole, Senior Vice President of Sales and Marketing.

Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements about the company within the meaning of the federal securities laws, including, but not limited to, the types of statements identified as forward-looking statements and our quarterly report on Form 10-Q that was filed on November 9, 2020, our annual report on Form 10-K that we are filing today and our subsequent periodic reports filed with the SEC, which will all be available on our website in the Investor Relations section. These statements are subject to risks and uncertainties that could cause actual results to differ. Please note that these forward-looking statements reflect our opinions only as of today. Except as required by law, we specifically disclaim any obligation to update or revise these forward-looking statements in light of new information or future events. Factors that could cause actual results or outcomes to differ materially from those expressed in or implied by such forward-looking statements are discussed in greater detail in our periodic reports filed with the SEC.

This conference call can be accessed on Rockwell Medical's Investor Relations web page. This call is being recorded on March 31, 2021, for audio rebroadcast and can also be accessed on the same web page.

At this time, I would like to turn the conference call over to Rockwell Medical's Chief Executive Officer, Dr. Russell Ellison. Russell?

Good afternoon. Thank you for joining us.

2020 was an important year for us. Like most companies around the world, we faced challenges during the COVID-19 pandemic, and I'm proud of how our team stepped up. Our people created and followed strict protocols and we met our customers' demand without interruption. We have to, lives depended on it. The patients we serve do not have the option of sheltering in place. 2020 also marked a significant shift in the trajectory of our company. We are not the same company that we were even 1 year ago.

The purpose of my remarks today is to address our dedicated shareholders with whom I want to share my enthusiasm for Rockwell's future. I also want to share our expectations for the near-term and lay out in clear terms the practical plan of action that we are following to evolve Rockwell Medical into a higher-margin and more broadly diversified company.

I was first brought to Rockwell Medical by the Board in mid-2019 as a consultant to take a hard look at the company. The Board believed there was unrealized value. Let me walk you through the process.

We had 2 key foundational assets. One was our next-generation parenteral iron technology platform, Ferric Pyrophosphate Citrate, or FPC as we call it, that I believe can positively impact a broad range of patients, not only in dialysis but well beyond. The other was an asset that has been largely ignored over the past decade except by the 125,000 or so people whose lives depend on it, our concentrate business.

The discussion that began when I joined the Board and accelerated when I became CEO last April was squarely centered on how we can reimagine and reinvigorate the business and drive long-term future value, how best could we unlock the unrealized value from our 2 foundational assets. We already had a strong dialysis business. The challenge was growth because we already had a pretty large market share in concentrates.

We launched Triferic in 2019, but since Medicare determined that Triferic would be reimbursed under the fixed bundled rate, market adoption was and still is dependent on the generation of data showing improved patient outcomes and/or lower costs versus the current standard of care. Since this type of health economic evidence was not required by the FDA for the approval of Triferic, it has been necessary for us to generate these data post-approval.

As I saw it, we have 3 primary drivers or pillars for achieving accelerated higher-margin growth and thereby improve shareholder value. The first is increasing sales of Triferic in the U.S., which meant we needed to generate data. The second is getting Triferic set for sales internationally, which meant we needed to find the appropriate partners and help them with their efforts to get Triferic approved and launched in their respective countries. Third, we needed to determine the next indications for our development of our FPC platform, which required analysis.

The strategy we needed was pretty straightforward to accelerate our growth by combining the solid foundation, strength and reputation of our dialysis business with a high-growth potential from therapeutics generated from our FPC platform in multiple disease states where patients can benefit the most from an effective treatment for iron deficiency and where there are more favorable reimbursement landscapes. It was clear to me that if we are to optimize our FPC platform, we needed to become a more medically, scientifically and data-driven company. Future clinical, regulatory and commercial success requires the right people with the right experience to navigate us to the right data.

To achieve that end, we needed to accelerate the evolution of both our management and Board, providing us with greater relevant experience. We completed key executive level hires, including myself and our CFO and CBO, Russell Skibsted, and key appointments to our Board of Directors. We strengthened our team with significant medical and commercial experience in iron deficiency anemia and dialysis, including our Chief Medical Officer, Dr. Marc Hoffman; and our Senior Vice President of Sales and Marketing, Tim Chole, both of whom you will be hearing from later in this call.

This strengthened our team with drug development and commercialization expertise as well as small-cap public company finance and management expertise. And we added critical strength in the clinical nurse educator patient support space. I'm confident that these changes support and improved the execution of our strategy to be a more data-driven company, which I believe will support future commercial growth, fair reimbursement and regulatory approvals.

We've already made progress. Data were recently published by NYU that supports future adoption of Triferic in dialysis. We signed partnership agreements with established companies in both India and Korea. Our partner in China has initiated the clinical trial required for approval. We've identified the first 2 new indications, which we believe will have the biggest impact from our FPC technology, and expect to start a Phase II clinical study in one of these indications later this year. We've also begun the process of a ground-up review of our concentrate business to identify not only ways to increase efficiency, but also to increase sales.

When we think about Rockwell's business, we think of it as having 3 distinct areas of focus: First, our dialysis business, which includes concentrates and our 2 marketed Triferic products; second, our clinical development program for FPC for iron deficiency anemia in the home infusion setting; and third, the advancement of our pipeline. Currently, acute heart failure in hospitalized patients is the top priority in this pipeline.

I'll start with our dialysis business. I think it is underappreciated that Rockwell Medical is the second largest supplier of hemodialysis concentrates in the United States. We have core capabilities in the manufacture of hemodialysis concentrates under GMP in 3 facilities as well as in the logistics of delivering these products to dialysis clinics throughout most of the United States. Our reputation is based on more than 25 years of service to the kidney dialysis centers. This business generates about $60 million in annual revenue and gives us a solid foundation on which to grow. We are reviewing this business to identify potential ways to make it stronger. Certainly, this business is a core platform for our company's revenue.

The dialysis business also includes the first 2 branded products from our FPC platform, Triferic Dialysate and Triferic AVNU, which are used to maintain hemoglobin in patients undergoing hemodialysis. Our strategy for increasing adoption is to continue to generate data in clinics showing the benefits of Triferic in real-world protocols. We also plan to study Triferic in use with the innovations that are anticipated to change future medical practices in hemodialysis. For example, the introduction and adoption of potential HIF-PHIs like roxadustat, which Marc will address later on in this call. We believe that positive data from these studies would position Triferic for long-term growth. Concurrently, we are developing strategic alliance partners for development, regulatory approval and commercialization of Triferic outside of the United States, building on our progress in 2020 with our partnerships in India and South Korea.

I view today's Triferic product portfolio in dialysis as providing the foundation for a higher-margin business in the midterm. Every day that goes by with our 2 products in the market is another day of generating important new data about safety, efficacy and health economics such as potential cost savings to the health care system. These data are important because they can provide the basis for a more robust adoption of the Triferic products over time in dialysis, while supporting the case for the utility of our future potential FPC-based products in other indications.

This case leads to the next area of focus, our first new indication outside of dialysis, FPC for treating iron deficiency anemia in the home infusion setting. Many patient groups requiring home infusion therapy suffer from chronic diseases that are associated with a high incidence of iron deficiency and anemia. Patients with iron deficiency anemia can exhibit symptoms of fatigue, shortness of breath, rapid or irregular heartbeats and glossitis, all of which affect quality of life. Home infusion represents a large and rapidly growing segment of health care where we believe FPC may have distinct advantages over currently available iron replacement therapy options.

Unlike our 2 Triferic products which are priced within the capitated dialysis payment or bundle, we expect future FPC-based products to be reimbursed under the Medicare Part B scenario as separate and distinct products. The FDA has confirmed that our proposed FPC treatment for iron deficiency anemia in the home infusion setting will require a 505(b)(1) approval. Effectively, this means that we would submit a new drug application for the home infusion product that would then be eligible for a separate and distinct Medicare reimbursement code. We are on track to initiate our Phase II FPC home Infusion trial in the second half of 2021.

In our pipeline, we are exploring the use of FPC for the treatment of hospitalized patients with acute heart failure. We believe that FPC will deliver rapidly bioavailable iron to the heart and improve cardiac antigenics. This effect could help patients recover faster, resulting in shorter hospital stays and potentially fewer 30-day readmissions, which would be a meaningful reduction in health care costs and human suffering. We are on track to discuss our clinical development plans for acute heart failure with FDA in the second half of this year.

I opened today's remarks by saying Rockwell Medical is not the same company it was a year ago. What I would impress upon our loyal investors is that in 2020, the new Rockwell Medical leadership team laid out a new and specific vision for a diversified and higher-margin company. We are driving towards this vision by fortifying our core revenue base and leveraging it to build the products of tomorrow. I have every conviction that our proprietary FPC platform can yield important new innovations before long. And I thank you for your patience and your belief in our efforts to unlock the value of our company.

I'm now going to turn the call over to Tim to further discuss our dialysis business; and then to Marc, who will give additional color on our HIF-PHI and FPC opportunities; and then finally to Russell Skibsted to provide a financial update. Tim?

Thanks, Russell.

First, I would like to provide an update on the performance of the dialysis concentrates business. Rockwell Medical was built on the dialysis concentrates we manufacture and sell in the U.S. and around the world. We've grown to be one of the 2 major suppliers of dialysis concentrates in the U.S. and we have established a reputation as one of the most reliable suppliers in the business with best-in-class customer service. We were proud to maintain the highest level of customer service with no supply interruptions through the worst months of the COVID-19 pandemic and the Texas winter storm crisis.

In 2020, our focus will be on maintaining our strong presence in the market, serving our customers with excellence and implementing strategies that will create efficiencies and improve our profitability.

Our primary commercial focus in the dialysis space continues to be on growing the adoption of Triferic. As Russell mentioned, we sell Triferic in the U.S. into a dialysis market under a capitated reimbursement model with extreme price pressure. Nevertheless, Triferic is a novel product with distinct advantages for patients and clinics, and we have seen steady growth in adoption among independent dialysis providers.

During the fourth quarter, we made good incremental progress with Triferic Dialysate. We entered into new purchase agreements for Triferic with 12 additional clinics, bringing the total number of clinics on contract to 65. This means the number of contracted patients increased to approximately 4,800.

The overall results for the quarter lagged somewhat behind expectations, in part due to the continued impact of the pandemic. The surge of COVID cases in the fourth quarter proved again to be a burden for many dialysis clinics, particularly those in urban areas, which, in some cases, caused them to delay decisions about making any significant changes such as adopting new products or changing treatment protocols. Nevertheless, our experienced field force continues to find creative ways to leverage virtual engagement tools and get in front of decision-makers.

We have been learning a tremendous amount about optimizing anemia management protocols with Triferic through the gathering of real-world data from our user clinics. We focused on leveraging this real-world evidence in showing health economic outcomes.

On the strength of this evidence, our push for customers to bypass the evaluation program and move straight to purchase contracts has proven to be a successful approach. We are able to accomplish this in many cases by utilizing a value analysis toolkit to help clinics calculate the potential financial impact of adopting Triferic and by connecting potential customers with nephrology experts that are Triferic users and advocates.

We continue to believe that the publication of real-world evidence that supports the use of Triferic is the key to accelerating market adoption. To that end, we continue to collect clinical outcome and drug utilization data from customers.

In January of 2021, the outpatient dialysis program at NYU Langone Hospital Long Island independently published a report in the Journal of Critical Care Medicine. The report described an observational retrospective chart review study of 100 patients, which looked at anemia drug utilization before and after use of Triferic Dialysate. The results showed a reduction in the use of traditional IV iron and in the use of erythropoietin stimulating agents after Triferic implementation, leading to an estimated cost savings over 1 fiscal year of nearly $300,000.

Now this report from NYU provides another compelling real-world example which supports the potential pharmacoeconomic impact of Triferic. By leveraging these data and with the continued execution of our targeted promotional and educational programs, we believe we can continue to drive the long-term adoption of Triferic.

Next, I'd like to provide an update on Triferic AVNU, our new IV formulation of Triferic. And Triferic AVNU is a line extension of our Triferic portfolio, and it joins Triferic Dialysate as the only FDA-approved products with a unique anemia management indication to replace iron and maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease.

Triferic AVNU is designed for direct intravenous administration and enhances the Triferic platform by providing patients with greater access to Triferic by expanding administration options for clinics. With Triferic AVNU, Triferic can be administered as an IV infusion to patients regardless of the mode of bicarbonate delivery being used. Thus, it's more appropriate in cases where the hemodialysis clinic is using dry bicarbonate technology and our Triferic Dialysate product is not an option. This represents about 40% of the clinics in our target market segment.

Our promotional outreach to prepare the market for the commercial launch of Triferic AVNU started in the second quarter of 2020 and continued through Q4. The focus has been on introducing Triferic AVNU to customers who had expressed interest in Triferic in the past but have been unable to adopt it due to their use of dry bicarbonate technology. In cases where we have existing Triferic contracts with independent dialysis organizations, we have been working to add Triferic AVNU to agreements so that clinics within those organizations using solid bicarbonate technology will have the opportunity to use it.

The first Triferic AVNU evaluation programs began in October 2020. Interest in the program has been high among the targeted clinics. However, the number of sites to get up and running with active evaluations in Q4 was lower than expected. Many clinics found it difficult to identify a convenient method for delivering Triferic AVNU via slow infusion. We anticipated that this might be a challenge in some cases, and we have been actively working to develop alternative administration methods that can be more widely adopted. We've made significant progress and we expect to have alternative, more convenient methods to present to customers later this year.

Triferic AVNU represents a step forward for the Triferic portfolio in the U.S. As a line extension of Triferic, it provides us with an opportunity to access a new market segment and allows physicians to individualize treatment. Adoption of the product is expected to be limited until we can identify less labor-intensive methods for administration. However, we believe Triferic AVNU will help us to open more opportunities for the portfolio and help open doors for us to increase the overall adoption of Triferic Dialysate in the U.S. It's also an important breakthrough to have Triferic AVNU approved and commercialized in the U.S. as it increases our potential to find partners for Triferic outside of the U.S. where an IV form of the drug may be a preferred formulation.

With respect to the global development and commercialization of Triferic, we continue to make important progress. As we recently announced, our partner in China has enrolled its first patient in its Phase III registration trial. We signed a license agreement with Jeil Pharma in South Korea, who have filed new drug applications for Triferic Dialysate and Triferic AVNU in that country. And our new drug submission continues its review by Health Canada. Our partner in India, Sun Pharma, is working through the regulatory process with the Indian authorities, which has been delayed by COVID.

I'll now turn the call over to Marc.

Thank you, Tim.

First, I'd like to touch upon the anticipated introduction of an entirely new class of anemia management agents, the hypoxia-inducible factor prolyl hydroxylase inhibitor or HIF-PHIs, which were expected to change the management of anemia in end-stage renal disease and hemodialysis.

We plan to strategically position Triferic alongside the HIF-PHIs to provide a consistent and physiologic treatment of anemia in hemodialysis patients. Although the approval of roxadustat, the first of the HIF-PHI agents expected to become available in the U.S. has been delayed by the FDA pending an advisory committee meeting, the publicly available clinical evidence from the roxadustat Phase III trials indicates that there may be a reduced iron replacement requirement for dialysis patients treated with roxadustat. If we extrapolate these data to a real-world scenario, this requirement appears to be well within the range that can be achieved with Triferic alone administered in each dialysis session such that Triferic could be a sufficient source of iron in patients treated with the HIF-PHIs.

We are working with KOLs and members of our medical advisory board to develop a clinical trial protocol to demonstrate these synergies. The start of any such study would be contingent upon the commercial availability of roxadustat. In turn, this could represent a significant new market opportunity for our product as nephrologists rethink how they manage anemia. We look forward to providing further updates on our strategy related to the HIF-PHIs in the coming months.

Turning to our foundational work in the area of home infusion therapy, we conducted a clinical feasibility study to assess treatment and practice patterns and attitudes towards the management of iron deficiency anemia, often referred to as IDA in the home infusion population. The purpose of this study was to inform the design for future clinical protocols and the overall development program for a novel approach to iron replacement in the home infusion population.

Many patients with chronic disease requiring long-term home infusion therapy are at risk for iron deficiency anemia. Iron deficiency anemia falls into the category of the condition that is relatively simple to identify, but challenging to treat with current IV formulations. For example, IDA is estimated to occur in 40% to 55% of all patients on long-term parenteral nutrition. The American Society for Parenteral and Enteral Nutrition, or ASPEN, recommends that patients receiving home parenteral nutrition be screened regularly for anemia and treated with parenteral iron when iron is recommended by the physician.

These patients, it is important to note, are unlikely to respond to oral supplementation. While IV supplementation is more effective than oral formulations, often home infusion clinicians are reluctant to recommend IV iron treatment at home due to the formulation options that are available today.

Home infusion of traditional IV iron is limited due to the risk of hypersensitivity and concerns about incompatibility with other infused drugs that the patient may be receiving. As a result, patients may be referred to the physician for an IV iron infusion, which is costly, inconvenient and may not be available from that physician's particular practice model. Limitations with the current approach can lead to a vicious cycle of late diagnosis and inconsistent treatment.

Understanding that there are several key stakeholders in the treatment and management of IDA in home infusion patients, we surveyed U.S. physicians and pharmacists who are actively engaged with patients receiving home parenteral nutrition. These survey participants were identified in conjunction with the [only] Foundation. Outreach was conducted in cooperation with key opinion leaders in gastroenterology and home parenteral nutrition. The study was conducted in November and December of 2020. A total of 26 physician responses and 39 pharmacist responses were recorded and analyzed.

Key insights include the following: While 85% of the physicians and pharmacists recommend IV iron for home parenteral nutrition patients, oral iron remains a first-line therapy in approximately 50% of the respondents in both groups. The standard iron panel, which is iron -- total iron-binding capacity, ferritin and transferrin saturation are employed in the home infusion setting for the assessment of iron status. Our outreach validates literature reports that approximately 50% of home parenteral nutrition patients suffer from IDA. However, there was no clear consensus on treatment or practice patterns, no clear consensus for hemoglobin target to initiate therapy and no clear consensus from outreach for hemoglobin target for goal-directed therapy, and existing treatment plans are indicative of the current therapeutic options available.

The study results validated our initial assumptions that management of iron deficiency anemia in the home infusion population is suboptimal and remains an unmet clinical need. This is not surprising considering the absence of any well-controlled clinical trials of parenteral iron therapy in this patient population. Further, that a safe, effective and convenient parenteral iron therapy suited for home infusion supported by randomized clinical trials could have a dramatic impact on patient care and quality of life.

For the first time, a well-controlled randomized clinical trial will evaluate the safety and efficacy of a parenteral iron treatment, in this case FPC, delivered at home. The proposed study design incorporates the considerable knowledge and data that already exists for the FPC molecule, including an extensive safety database of more than 1.3 million administrations in a very frail hemodialysis patient population and well-established kinetics, which provides strong rationale for the doses and dose schedules that have been developed for this setting.

FPC is a true second-generation parenteral iron. It was developed to replace iron loss in patients with anemia in an entirely different way. FPC donates iron directly to circulating transferrin, bypassing any potential hepcidin blockade from inflammation, which makes it immediately bioavailable for critical body processes. It is this unique property and the safety profile of FPC that we believe make this proposed new indication and population for FPC clinically feasible and commercially attractive. We are confident that we approach this study with many of the typical questions that exist in a Phase II study already answered, which we expect to significantly de-risk the study.

As you heard from Dr. Ellison, the FDA has accepted our proposed development strategy to pursue an approval via the 505(b)(1) pathway as a novel NDA for FPC for treatment of IDA in adult patients. This will create the opportunity for a unique NDC code to be assigned and will allow us to apply for unique J codes from CMS. The agency further agreed with our approach to cross-reference nonclinical, pharmacology and toxicology from our prior INDs and does not foresee the need for additional studies in these areas.

The FDA has provided us with valuable feedback on our proposed clinical development plans, which we intend to incorporate into the next iteration of clinical protocols and FDA correspondents in dialogue. We plan to take advantage of the early consultation opportunities provided by FDA in a pre-IND meeting to further clarify study design, patient selection and study endpoints for our Phase II study of FPC for treatment of IDA in adult patients receiving home infusion therapies. As a next step, we plan to have a pre-IND meeting with the FDA where we will get feedback on the protocol and development plan. Following the successful meeting, we will initiate the clinical trial in the second half of this year.

For our pipeline indication, acute heart failure, we intend to meet with the FDA to see clarity on our proposed development strategy for FPC as a therapeutic to improve cardiac energetics in hospitalized acute heart failure patients with iron deficiency. Specifically, we want to confirm for FPC FDA's published guidance that drugs for short-term treatment for heart failure, that is less than 10 days, do not require a mortality endpoint for approval. If confirmed, this would make the clinical development program feasible for Rockwell. Following this successful dialogue, we would pursue the filing of an IND for a Phase II mechanistic proof-of-concept study. We plan to submit this meeting request during the second half of this year.

Next, I'll turn the call to Russell Skibsted for a financial overview. Russell?

Thanks, Marc.

Our net sales in 2020 were approximately $62.2 million, which was about $900,000 more than 2019. Net sales of hemodialysis concentrates were approximately $61.1 million for the year, which was roughly flat compared to 2019.

Net sales of Triferic were approximately $1.1 million for the year compared to $0.5 million in 2019. For each year, 2020 and 2019, Triferic sales included approximately $200,000 of deferred revenue related to our international partnerships. It also included approximately $2 million each year in deferred revenue related to our agreement with Baxter.

We ended the year with cash, cash equivalents and investments of approximately $58.7 million, which we believe puts us in a good position to focus on the strategic initiatives that Russell, Tim, Marc previously described.

Russell mentioned earlier that we began a process of a ground-up review of our concentrate business. After visiting each of the manufacturing facilities, I became increasingly convinced there were opportunities to make both our manufacturing and transportation operations more efficient. I also believe there are opportunities to grow this business. We have launched projects to identify ways to improve the overall profitability of these core operations, which I hope to update you on later this year.

I'll now turn the call back to Russell Ellison for his closing remarks. Russell?

Thanks, Russell.

Our company has multiple near-term commercial and development milestones coming up in 2021 and 2022. These milestones include expected progress in the global expansion of Triferic as well as the anticipated clinical development activities that we outlined on our call today for our FPC platform.

2020 was a year of reimagining our company and reinvigorating our business. Our new strategy to become a scientifically and clinically driven company is now in execution mode, and progress has been made towards our key growth drivers. I expect continued strong progress for the remainder of this year and next year as we execute against our plan to drive growth and increase value.

Now I'll turn the line over to the operator for questions.

(Operator Instructions) Our first question comes from the line of Brandon Folkes with Cantor Fitzgerald.

Congratulations on the progress in the quarter. Maybe just 3 for me. Could you just elaborate a little bit on sort of what levers you have to pull on the concentrates business margin? Obviously, you do a good amount of revenue there and it can be quite meaningful if you are able to pull that off.

Secondly, maybe just since the publication of the NYU Hospital data, one, I guess, any feedback you've had so far? And then do you expect this data to stand alone to drive uptake? Or should we think of this as maybe the first of many pieces that you think together will drive uptake?

And then lastly, on roxadustat, can you just elaborate -- obviously, a lot of questions around that at the agency right now. What can you say just in terms of -- do you expect that roxadustat approval and study being key to uptake for certain segments of the market? Or do you think you can infiltrate those segments of the market with the sort of data you're generating out of NYU?

Well, you have 3 questions there. So thank you very much for that.

On the concentrate issue, I'll turn this over to Russell, and then maybe we can take up your other 2 questions. Thanks. All right, Russell?

Great. Sure. Thanks for the question, Brandon.

As I just mentioned, the -- since joining, I visited each of the facilities. And what struck me was I think there is definitely some -- both bottom line and top line things we can do to help the margins. So what we're doing is we're embarking upon this really a ground-up analysis that we're trying to -- where we're trying to optimize the supply chain, materials handling, logistics, really the entire process to see where we can increase margins and lower costs. I think -- I mean, it's too early to say right now, but I just have a really good feeling that we're going to be able to find some efficiencies there. So -- but we will have to wait until we've completed the assessment to be able to get a little more guidance on that.

And then the other side of it is working for -- we're looking at different ways to potentially bring -- in addition to making it more efficient, looking at ways that we can increase the top line. So we have available bandwidth within our manufacturing facilities and within our logistics. So we're looking at are there ways in which we can actually make other products that we can manufacture through there that we can generate some top line on. Again, what, if any, that turns out to be, we'll have to wait until we've gone through the assessment, but I feel pretty optimistic about it.

And thanks, Russell. And Marc, do you want to address the data question?

Sure, I'd be happy. Brandon, can I just ask you to repeat the question so I can answer it in the proper context?

Sure. Okay. So on the NYU data, it looks pretty impressive on the surface. So maybe just one, any feedback you've received to date? And do you think this data will stand alone to drive uptake? Or should we think of this as one of many pieces of data -- similar pieces of data we should expect to see over the coming year that collectively will drive uptake?

And then secondly, maybe lumped into this on roxadustat, do you think that hospital data will drive uptake? Or do you -- within certain segments of the market? Or do you think that those segments of the market really are waiting for -- to get roxadustat approval in the study that you're going to run?

Great. Okay, great, yes. And thank you for the question.

So with regard to the NYU data, I think it's probably the latter of the options that you articulated, which is that we look at this as the next series of long-term real-world data or real-world evidence that we've been collecting. One of the things that was particularly appealing about this data is that this data was published independently by NYU in a journal without any input from Rockwell.

As we have had the opportunity to share this from a peer review journal, it has been very welcomed by clinics as we've shared this with the nephrology community. I think it's fair to say that with each increasing body of evidence, the story grows and it makes our story more powerful and makes the uptake more appealing, but I think we will continue to take advantage of the adoption of Triferic and the generation of new real-world evidence.

Russell, do you want me to take a stab at the roxadustat question?

See, do you want to repeat the question about roxa?

Sure. Maybe just sort of -- should we think of certain segments of the market almost being beholden to a roxa approval and running a study with the drug and that drug? Or do you think some of this data generation on this sort of cost savings, maybe -- you may be able to generate significant amounts to drive those segments of the market towards your product should roxa have a few challenges or stumbles at the FDA?

Well, let's take the scenario where they have an advisory committee and it's fine and they get approval. Between now and then, clinics are evaluating. The clinics are not yet using Triferic or evaluating whether they should want to adopt it. And we're utilizing the data that we have with respect to this in the context of the ESA. We haven't yet seen any hesitation about adopting this because clinics are waiting for roxa, if that was part of your question.

I think with respect to running a study with roxa, we wouldn't wait for the result to recommend to clinics that they use Triferic to maintain hemoglobin and replace the iron that's been lost in dialysis. That concept still applies. And whether you're using an ESA or you're using roxadustat, the rationale for Triferic is to replace the iron that's lost in hemodialysis. So -- and it's very straightforward way of doing that and very reliable in that respect. You know exactly how much iron they're getting.

So we're continuing -- we'll continue to keep on while we're running that study, assuming that roxa is approved and we can get the drug to put in a clinical trial. Meanwhile, Marc and his team is -- are working up a protocol such that they're ready to initiate this trial when roxadustat is available. I hope that answers your question.

That concludes today's question-and-answer session. Now I'll turn the line back to Dr. Ellison for closing remarks.

Well, thank you all for joining us this afternoon. We really look forward to following up with many of you in the coming days and weeks. Have a great evening.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.