Good afternoon, ladies and gentlemen, and welcome to the Rockwell Medical Third Quarter 2021 Results Conference Call. As a reminder, this conference is being recorded. At this time, I would like to introduce Jason Finkelstein, Investor Relations. Please go ahead..

Good afternoon. This is Jason Finkelstein 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; and 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, will be available for Q&A.

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 in our quarterly report on Form 10-Q that was filed today; our annual report on Form 10-K that was filed on March 31, 2021; and our subsequent periodic reports filed with the SEC, which will be available on our website in the Investor Relations section.

These statements are subject to risks and uncertainties that can cause actual results to differ. Please note that these forward-looking statements reflect our opinions and expectations 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 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?.

Thank you, Jason. Good afternoon, and thank you for joining us. In the third quarter of 2021, we continued to progress our strategy with improvements on the solid foundation and reputation of our dialysis business, combined with advancement in the development of our FPC platform outside of dialysis.

Driven by returning growth in dialysis concentrates products, Rockwell delivered a strong third quarter, which saw an increase in net sales versus both the second quarter of 2021 and the third quarter of last year. Our concentrates business continues to perform to our expectations, both domestically and internationally.

We're in the process of exploring, expanding this business geographically in the U.S. We are very pleased to have achieved an important development milestone with the submission of an IND for FPC for patients receiving infusion therapy at home.

As you may recall in June, we submitted a pre-IND meeting request to FDA to gain feedback on our Phase II clinical trial proposal. The proposed randomized, placebo-controlled study is expected to evaluate 2-dosing regimens of FPC versus placebo, one for the treatment of iron deficiency anemia and the other for the maintenance of hemoglobin.

We have initiated preliminary study activities in an anticipation of the clearance of our IND on or about December 9. Home infusion therapy is a service model that allows patients requiring regular infusions of medications to be treated in the comfort of their own homes.

For clarity, when we refer to home infusion, we are not referring to home hemodialysis. This is a large, rapidly growing segment of health care with more than 3.2 million patients as of 2019. Many patient groups requiring home infusion therapies suffer from chronic diseases that are associated with a high incidence of iron deficiency and anemia.

For example, it's estimated that 40% to 55% of all home parenteral nutrition patients are iron deficient. Current treatment patterns can be inadequate for patients on home infusion therapy with iron deficiency anemia, causing them to suffer extreme fatigue and can result in serious health risk, such as poor immune function and heart failure.

While it's premature to estimate the market for FPC in these patient populations, we believe that up to 700,000 patients receiving home infusion therapy in the U.S. may benefit from a safe and effective way to treat iron deficiency, which may suggest an addressable market opportunity of up to $600 million.

We'll have more to say about the market opportunity in home infusion after our IND clears, and we begin our clinical trial. I'll now turn to our recent business development and accomplishments as they pertain to our existing dialysis business, which is comprised of revenue from both Triferic and our concentrates.

Our partners continue to progress in their efforts to gain regulatory approval and begin commercialization in FPC in their respective countries. We believe international sales of Triferic will be a strong source of revenue and value in the coming years, as dialysis payer models in many countries outside of the U.S.

are more accommodating for innovative products. We recently presented new real evidence from an observational analysis program at multiple clinics, which are part of a Mid-Sized Dialysis Organization, or MDO, at the American Society of Nephrology Kidney Week 2021 in San Diego, California.

Results confirmed findings from our prior real-world evidence publications foremost that the integration of Triferic into anemia management protocols results in the reduction of IV iron utilization and total iron usage. The results are relevant not only for patients and caregivers, but for dialysis clinics and the medical community.

And we believe that the results can further strengthen Triferic's position as an important part of the treatment arsenal for patients on hemodialysis. Triferic revenue in the third quarter was essentially flat versus the second quarter.

One of our customers was acquired and allowed their contract with us to expire, but we were able to largely offset these losses by securing Triferic agreements with new clinics and an improved average selling price or ASP, which stabilized revenue for the quarter.

Triferic continues to experience headwinds in our efforts to accelerate adoption in the U.S. dialysis market. Changes in medical practice and dialysis are slow to occur and are evidence-based. And as previously disclosed, Triferic is sold into a heavily competitive space with capitated reimbursement and bundled offerings from our competitors.

In the face of these continued headwinds, we have decided to shift our commercial strategy for Triferic and Triferic AVNU in the United States. As part of this initiative, we've adjusted our sales and marketing efforts and are working to find a sales partner to expand our commercial efforts within the United States.

We expect that alignment with a partner will bring commercial strength needed to more effectively compete in the environment of consolidated for-profit dialysis provider organizations and large vertically integrated competitive suppliers.

We continue to believe Triferic is a safe, efficacious, important and innovative therapeutics for the maintenance of hemoglobin in patients on hemodialysis.

While we are committed to the continued commercialization of Triferic in the U.S., we will be intentional about future commercial spending as we acknowledge the challenges we are facing in the present environment. With that, I'll turn the call to Russell Skibsted for a brief financial overview.

Russell?.

Thanks, Russell. We ended the third quarter of 2021, with cash, cash equivalents and investments of approximately $33.2 million, which was in line with our expectations and which we believe keeps us in a position to drive our company's strategic initiatives.

During the third quarter, our net sales were $16 million compared to $15.3 million in the third quarter of 2020 and $15.1 million in the second quarter of this year.

Net sales of hemodialysis concentrates were approximately $15.7 million during the quarter, which was about $713,000 higher compared to the third quarter of the prior year and about $845,000 higher in the second quarter of this year.

We're starting to see the expected uptick in concentrate sales as the impact of COVID subsides with increased sales, both domestically and internationally. Total sales of Triferic were approximately $280,000 for the quarter, which was roughly flat versus the sales of Triferic in the third quarter of 2020 and the second quarter of 2021.

Net cash used in operating activities was $7.1 million for the quarter, which compared to $4.9 million in the second quarter. Our third quarter cash was higher than normal due to both seasonal and timing factors.

Our use of cash in the third quarter was in line with our expectations, reflecting seasonal timing, some nonrecurring costs related to our cost savings efforts, the impact of COVID and the beginning of the impact of some of our efficiency initiatives.

We have completed most of our analysis related to our supply chain and logistics projects and are now prioritizing the short, mid- and longer-term initiatives that we intend to pursue. I expect to have more to share about this after the first of the year. I'll now turn the call back to Russell Ellison for his closing remarks.

Russell?.

Thanks, Russell. I'll conclude by saying that considering the large opportunities ahead of us and the steady revenue we have seen from our dialysis business, which includes sales of our concentrate products, I consider Rockwell Medical very much a development-stage biopharmaceutical company with a stable base of revenue-generating products.

We're working to advance our dialysis business alongside the exciting opportunity to develop FPC for home infusion patients with iron deficiency anemia and the potential program in hospitalized patients with acute heart failure. Thank you for joining our call today and for your interest in Rockwell Medical.

I want to thank our shareholders for your patience and belief in our efforts to unlock the value of this company. I'll now turn the line over to the operator for questions. Thank you..

[Operator Instructions] And our first question comes from Ram Selvaraju with H.C. Wainwright. Your line is now open..

Can you hear me?.

Yes, we can hear you, Ram..

Yes. So firstly, I was wondering if you could talk a little bit about the clinical development initiatives and the context in which you anticipate those are likely to be carried out, given all of the ongoing uncertainties surrounding the evolution of the pandemic; the well-documented impact that has had on other clinical development programs.

How do you see the pandemic impacting your envisaged clinical development activities? Do you see that impact effectively becoming muted in the course of the coming months?.

That's a great question, Ram. And I'll take a stab at it first and then turn it over to Marc Hoffman, our Chief Medical Officer. But ironically, the first development program we're embarking on is the use of Ferric Pyrophosphate Citrate to treat iron deficiency anemia in the home infusion setting.

And in the home infusion setting, you really don't have, ironically, the constraints of bringing people into a clinic to get their medication as part of the trial. They get this at home. And the visits of the home health care aid to set this up is basically part of their routine management.

So ironically, doing a home infusion trial in the COVID pandemic, even though the pandemic is waning to some extent, is remarkably largely unaffected. So we're fortunate that we're doing it -- that we're doing that trial in this context.

Marc, do you want to comment a little more on that?.

Sure, Russell. So I would agree with absolutely everything that Russell has just stated and just take this step further and say that, number one, the pandemic is what the home infusion visit is actually one of the perceived benefits of this study is not having to go into a clinic or a hospital to receive therapy.

So that's one of the things that we see downstream as a benefit.

The other is that coming in where we are on the pandemic, it's actually given a number of the clinical research organizations the opportunity to build and fine-tune this type of study design, where the patients are being seen and there's more remote data entry and less touch for data collection and patient management.

So we're actually benefiting from this in many ways..

And I would add on the heart failure trial, first, we have to have a little discussion with FDA, particularly about their requirements for the reduced time requirements for short-term trials -- for short-term treatments in acute heart failure.

They put out guidance that you don't really require -- you're not really required to show an impact on mortality or the lack of an impact. And that makes the overall program much more tractable. But we do want to confirm that with FDA before we start the heart failure trial.

I would say one impact of the pandemic is that face-to-face meetings with FDA just don't happen anymore, at least they haven't been. And you can get a phone call, which is not bad. But by and large, communications by correspondent. So I think I'm quite used to actually going down to Washington to be and sitting with them.

And that's been a little different now. I don't really know what the overall impact has been, but it certainly is different. So that's really it. And even when we do congestive heart failure, that will be in hospitalized patients, so to really have to be there.

And hopefully, by the time we start that trial, we'll be more out of the woods than we are now with respect to the impact of COVID on hospitals..

That's very helpful, very nuanced answer.

Secondly, I was wondering, in the context of your shift in strategy and you're seeking of a partner, is this going to be a situation in which there is maybe bifurcated scenario envisageable where you continue the development in these indications for which you expect to conduct clinical development programs, but a partner potentially takes on the responsibility of moving forward with the commercially available product offerings? Or is it a situation where you are envisaging a partner effectively coming in and supporting both aspects, the clinical development programs as well as the commercial product offering?.

That's a really good point, Ram, and I'm sorry we weren't as clear as we could have been about that. But basically, yes, we're focused on the commercialization of Triferic in the United States. We're not anticipating, at this point, partnering our two development programs.

Post Phase II or when you have -- we have completed Phase II data, that would be certainly a very good option for the heart failure indication. And I don't know at this point. I can't really say about home infusion. It depends on how big that Phase III program would have to be, et cetera.

But right now, what we've been referring to in the call today is partnering the commercialization of Triferic in the U.S..

Okay. And lastly, prior announcements have involved quite a number of ex U.S., ex European international developments, and there's clearly interest in and relevance of Triferic, Triferic AVNU in those markets.

So I was wondering if you are anticipating any noteworthy developments on the international front, whether those are from a commercial launch or a partnership deal announcement standpoint.

And with what time frame -- with what timing kinetics those might potentially accrue, those might potentially mature? And if you have any color around which specific regions, whether those are Asia Pac or LATAM, Far East, et cetera, there might be some additional value-driving catalysts. If you could comment on that, please..

A great point.

R2 [ph], do you want to address this?.

Sure. Sure. I can take that. Thanks, Ram. Thanks for the question. I would say that there -- it's a big question.

As Russell mentioned earlier on in his prepared comments, it's interesting because in some of the countries outside of the U.S., actually, we think they're better markets and way better reimbursement than we would have in the U.S., for instance, China, which is the largest dialysis market in the world.

But -- and so both with India and with China, the programs are underway. They're on schedule with their plans. We would expect to see data from the clinical trial in China. I think we're looking at probably the first half of 2023. And then from there, it goes through the regulatory process before launch.

But I think the -- in terms of timing when we're going to see, hear something, I would think that we're waiting for word from the Korean authorities on the NDA submission that our partner, Jeil, submitted earlier this year. And that I would think would probably be our first product launch provided they get the okay from the authority.

So we're -- I know we're doing a lot of preparation work right now behind the scenes, trying to get ready for that launch in anticipation of that launch. So we'll keep our fingers crossed..

Thank you..

This concludes the Q&A session. Now I'll turn the line back to Dr. Ellison for closing remarks..

Well, thank you all for joining us on this call, and I just want to thank you for your continued support and faith in this company and our efforts to be successful. And I look forward to our next call with you for the next quarter. Thanks very much..

This concludes today's conference call. Thank you for participating. You may now disconnect..