Good afternoon, ladies and gentlemen, and welcome to the Rockwell Medical Fourth Quarter and Full Year 2020 Results Call. At this time all participant lines are in listen-only mode. [Operator Instructions] After the presentation there will be a question-and-answer session. [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 Argo 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 in 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 and/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 webpage. This call is being recorded on March 31, 2021, for audio rebroadcast and can also be accessed on the same webpage. 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 one 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 two 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…

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 two 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 2021, 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 Trifericin 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 and 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…

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-PHI, which are expected to change the management of anemia in end stage renal disease in haemodialysis. We plan to strategically position Triferic alongside the HIF-PHI to provide a consistent and physiologic treatment of anemia in haemodialysis 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 3 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 at each dialysis session, such that Triferic could be a sufficient source of iron in patients treated with the HIF-PHI. 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 nephrologist we think how they manage anemia. We look forward to providing further updates on our strategy related to HIF-PHI 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-home infusion population. The purpose of this study was to inform the design for future clinical protocols and…

Thanks Marc. Our net sales in 2020 were approximately $62.2 million, which was about $900,000 more than 2019. Net sales of haemodialysis concentrates were approximately $61.1 million for the year, which was roughly flat compared to 2019. Net sales to 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 toward 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 line up Brandon Folkes with Cantor Fitzgerald.

Hi. Thanks for taking my questions and congratulations on the progress in the quarter. Maybe just three from 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] [ph] good amount of revenue there. And, it can be quite meaningful if you're 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, 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 in study being key to uptake for certain segments of the market? Or do you think you can infiltrate those segments of the market with this sort of data you're generating out of NYU? Thank you.

Well, you have three questions there. So, thank you very much for that. On the concentrates issue, I'll turn this over to Russell. And then maybe we can take off your other two questions. Thanks. Russell?

Sure. Thanks for the question, Brandon. As I just mentioned, 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, 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 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. But we will have to wait until we've completed the assessment to be able to give a little more guidance on that. And then the other side of it is working through -- 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 other ways in which we can actually make other 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.

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

Sure, I’d be happy too. Brandon, could I just ask you to repeat the question, so I can answer in this [Indiscernible].

So, on the NYU data, it looks pretty impressive on the surface. Maybe just, one, any feedback you've received to-date. And do you think this data will standalone to drive uptake? Or should we think of this as one of many pieces of data, some of the pieces of data that we should expect to see over the coming year that collectively will drive that uptake? And then secondly, maybe lumped into this on roxadustat do you think that hospital data will drive uptake within certain segments of the market or do you think that those segments of the market really are waiting for get roxa approval in study that you're going to run? Thank you.

Okay, great. 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 with 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 the Journal without any input from Rockwell, as we have had the opportunity to share this from a peer review journal. It has been very welcome 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?

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 the roxa approval and running a study with your drug in that [drug] [ph]? 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 [indiscernible] with the FDA?

Well, let's take the scenario where they have an advisory committee and its 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 roxadustat, if that was part of your question. I think with respect to running a study with roxa, we wouldn't wait for the results 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 haemodialysis. And it's very straightforward way of doing that and very reliable in that respect, 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 then we can get the drug to put in a clinical trial. Meanwhile, Marc and his team are working out the protocols such that they're ready to initiate this trial and roxadustat available. I hope that answers your question.

It does. That was very helpful. Thank you very much.

Thanks, Brandon.

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.