Good afternoon, ladies and gentlemen, and welcome to the Rockwell Medical 2020 Q3 Results Call. As a reminder, this conference call is being recorded. At this time, I would like to introduce Claudia Styslinger, IR. Please go ahead.

Welcome to Rockwell Medical's third quarter 2020 earnings results call. 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; Tim Chole, Vice President of Marketing; and Dr. Marc Hoffman, Chief Medical Officer who will be joining us for Q&A. Before we begin, I wanted to note that certain matters we will discuss may constitute forward-looking statements within the meaning of the federal securities laws, including, but not limited to, Rockwell Medical's intention to commercialize Triferic Dialysate, Triferic AVNU and any future products based upon Rockwell’s ferric pyrophosphate platform. Words such as may, might, will, should, believe, expect, anticipate, estimate, continue, could, potential, predict, forecast, project, plan, intend or similar expressions or statements regarding intent, belief or current expectations are forward-looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release and which are subject to inherent uncertainty. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in Rockwell Medical's SEC filings, many of which are beyond our control and subject to change. Actual results could be materially different. Accordingly, you should not place undue reliance on these forward-looking statements. Rockwell Medical expressly disclaims any obligation to update or alter any statements, whether as a result of new information, future events or otherwise, except as required by law. This conference call can be accessed on Rockwell Medical's Investor Relations Web page. This call is being recorded on November 9, 2020, 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, Claudia. Good afternoon everyone and thank you for your time today. On today’s call, we will address our vision and our strategy to build value for the company, two new potential indications for our FPC platform and our next steps for each, continued progress on the commercialization of our first FDA approved product, Triferic Dialysate, our preparations for the upcoming launch of our second FDA approved product, Triferic AVNU, an update on our international partnering activities, and other pertinent corporate updates and a review of our financials. And then we'll take questions from covering analysts and we'll answer some of the questions we've received by email. Rockwell Medical is focused on transforming the treatment of iron deficiency and anemia around the world to improve outcomes for patients. Our vision is to establish a new standard of care for patients suffering with iron deficiency and iron deficiency anemia. Iron deficiency anemia afflicts the subset of 2 billion people worldwide, who are nutritionally iron deficient and in the United States alone, approximately 10 million people are iron deficient, including 5 million who have iron deficiency anemia. Patients suffering from iron deficiency anemia can experience extreme fatigue, dizziness, and reduced cardiac function. Current treatment options have limitations because elemental iron is toxic and iron absorption and availability to cells is tightly regulated by the body by the hormone hepcidin, iron deficiency is challenging to effectively manage orally due to poor absorption and side effects, and intravenous iron is often required in many situations. However, current IV forms of iron or IONP release iron into white blood cells and then the liver, which slowly releases iron to the transport protein transferrin, which makes the iron available to cells. This release can be substantially reduced by hepcidin in inflammatory situations, such as dialysis.…

Thank you, Russell. In the third quarter, we continued to make important progress in the commercialization of Triferic Dialysate despite the challenges of the COVID-19 pandemic. As of the end of the third quarter, we increased the number of contracted patients to approximately 3,400 which translates to an annualized treatment volume of approximately 500,000, a meaningful increase compared to last quarter. The overall growth in Triferic sales was lower than expected, primarily due to the restrictions dialysis clinics have levied on in-person visits from our field staff. However, we are pleased with the results our sales and clinical nurse educator teams have produced by leveraging virtual engagement tactics to complete training programs and close contracts. In the quarter, certain U.S. geographies continued to relax restrictions which have allowed us to reengage with more clinics and get back on track with planned in-person training programs. We are continuing to monitor the increase in COVID-19 cases happening this fall, and we will adapt as needed. With real world data on hand and experience from the first year of the Triferic launch, we have instituted a number of new initiatives in the third quarter. First, we're encouraging clinics to move straight to purchase contracts and bypass the evaluation process when possible. Second, we have adopted a more aggressive pricing strategy. While these combined efforts are recent and implementation has been slowed by COVID-19, they have allowed us to shorten the overall sales cycle for Triferic in some cases. Third, we have introduced new promotional and educational programs to jumpstart a much needed increase in broader awareness of Triferic and its place in the management of anemia in dialysis. New programs include a non-branded disease awareness education campaign for both nephrologists and dialysis nurses, a refresh Triferic promotional speaker program series and a clinical…

Thanks, Tim. As Dr. Ellison mentioned earlier, our partner Wanbang Biopharmaceuticals is making great progress in China. We hope to soon announce the first patient that has been enrolled in the pivotal study when some logistical issues with shipping have been resolved. Access to hemodialysis in China has been continuing to increase at a rapid rate in recent years with over 600,000 hemodialysis patients in China, it is the largest single market in the world. Earlier this year, we entered into a partnership with Sun Pharma for the rights to commercialize Triferic in India. India is also an attractive market with over 120,000 hemodialysis patients. Sun is working to get regulatory approval for launch from the Indian Central Drugs Standard Control Organization’s technical committee. We entered into an exclusive license agreement with Jeil Pharmaceutical Company in the third quarter for the rights to commercialize Triferic in South Korea. South Korea represents a sizeable and growing market opportunity with over 78,000 patients receiving hemodialysis annually. We believe that Jeil is an ideal partner. They will be responsible for all regulatory and commercialization activities. Jeil advised us that it will not require a clinical trial in advance of approval, so we anticipate sales to begin in early 2022. Of course, this is subject to regulatory approval in Korea. We are also making progress in discussions with potential partners in other key markets like Japan, Europe and Latin America. Now turning to our third quarter results. We ended the third quarter with a strong liquidity position in anticipation of uncertainty and increased volatility in the capital markets due to the elections, COVID-19, the economy. We have the foresight to raise capital in September. This raise allows us to continue to execute on our growth strategy without worrying about having to raise cash during…

Thanks, Russell. We've made significant progress in the third quarter across many fronts and we continue to drive value creation for our company now, early next year and into the future across three concurrent tracks; maximizing U.S. sales with Triferic and soon to be launched Triferic AVNU, expanding the global commercial reach of Triferic through our key partners, and strategically developing new indications for our FPC platform, beginning with patients requiring home infusion therapy. In the U.S., we continue to drive adoption of Triferic Dialysate despite COVID-19 headwinds, and we expect to see a reacceleration of adoption of Triferic when the COVID-19 pandemic begins to resolve. And we are making final preparations for the commercial launch of Triferic AVNU expected soon. In China, our partner Wanbang Biopharmaceuticals is about to enroll the first patient in its pivotal Phase 3 trial in Triferic. In India, our partner Sun Pharma submitted all regulatory appeal process documents for its approval for marketing. Sun Pharma is navigating the next steps due to the country's temporary suspension of regulatory review due to COVID-19. And in South Korea, we entered into an exclusive license agreement with Jeil Pharmaceutical Company in the third quarter for the rights to commercialize Triferic in that country, where a clinical trial is not expected to be required prior to marketing. We're progressing home infusion as the priority new indication for our FPC platform, with submission of our clinical development plan to FDA expected in Q4 2020 and a Type C meaning expected in Q1 2021. We ended the quarter in a strong financial position to enable our execution of our three parallel strategies for value creation. With that, we'd now like to address some questions that we’ve received by email. The first set of questions were regarding the stock price performance and whether we believe it reflects the value of the company. Now, I can't really talk about stock price. But we can talk about value. We're driving, as I said, value creation across three concurrent tracks; maximizing U.S. sales of Triferic Dialysate and soon to be launched Triferic AVNU, expanding the global commercial reach of Triferic through our key partners, and strategically developing new indications for our FPC platform. And we're confident that our strategy will build value as we move through these milestones that we have laid out. And most programs do have potentially multiple value-driven milestones. Another set of questions address the performance of Triferic Dialysate in the quarter and the progress we are making in face of headwinds from the COVID-19 pandemic. I think Tim has addressed this already, but perhaps, Tim, you have more comments on this.

Yes. Thanks, Russell. Just to reiterate, certainly Q3 growth for Triferic was lower than we expected and that was primarily due to the restrictions from COVID and dialysis clinics not only restricting in-person visits but also being resistant to making protocol changes during this time. But we have implemented virtual engagement tactics and we have been pleased with our field force embrace of these tactics, and it is helping us to continue making progress. As I mentioned, as geographies relax restrictions and they did relax restrictions in quarter three that allowed us to reengage in many cases. And the real world data we have on hand allows us to encourage clinics to move straight to purchase contracts, in some cases, where they see the data and do not need an evaluation process. And along with and more aggressive pricing strategy, we see a shortened overall sales cycle for Triferic. Definitely once COVID starts to move towards resolution, which is an uncertainty, but at that time we do expect the trajectory of Triferic sales to improve.

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

[Operator Instructions]. Our first question comes from Brandon Folkes of Cantor Fitzgerald. Your line is open.

Hi. Thanks for taking the questions. Can you hear me?

Yes.

Awesome. Hi, everyone. Just two. Ahead of the ongoing full commercial launch in 1Q '21, can you talk about any gating factors that are still required or needed to get through before launch or that may sort of have an impact on the timing of launch? Sorry, three if I may. In terms of the home infusion Type C meeting, can you provide any additional – or are you able to provide any additional color in terms of where in 1Q we could expect this? And then lastly, gross margin in the quarter seemed to be a lot better than we've seen in the past. Any color on that? Thank you.

Okay. So, Tim, maybe you want to – wait a minute. Brandon, sorry, let me take the Type C meeting question. That's pretty straightforward. We expect this probably in the late February, early March. That would be our estimate. Tim, do you want to address one of those questions?

Yes. I can speak to the AVNU launch. So the delay that we saw was minor, was related to, as I mentioned, scheduling of the production of packaging with our supplier in Europe. Certainly, there could always be further delays, but for the moment we do not anticipate any further manufacturing issues. And there are no other, I would say, barriers to introduction. And on that basis we're comfortable with the expectation of commercial delivery in the first quarter.

Okay. Brandon, I think you had one other question.

Yes. Just on the gross margin. Just looking at it, it seems to be a lot higher than we experienced last year and the beginning of this year. So any color in terms of that or is it just product mix from –

Mostly product mix. But, Russell, do you have any further comments on that?

Well, one thing is we are trying to make our processes more efficient and cost effective. So, hopefully, the early stages of that were being seen here, but I think it's one of the focuses we're going to be taking going forward as well to hopefully try to have not only a gross margin, but also net margin that is as efficient as possible, so we can take excess costs out of it. So stay tuned for that. That is a process that we're going at very, very heavily right now.

Great. Thank you very much.

Our next question comes from Ram Selvaraju of H.C. Wainwright. Your line is open.

Thanks so much for taking my questions. Just to start with a few questions on the international developments of Triferic. Can you give us a sense of how long Wanbang is expected to take to reach full enrollment in the pivotal Triferic trial in China, or if they haven't given you any real guidance regarding that timeline?

Marc, can you talk about this, maybe give some more details about Triferic?

Sure. Thank you for the question. So, as you heard from Russell, we are anticipating a start of the study sometime early next year. And depending on the speed of enrollment, we should have a fully subscribed study sometime in the first half of 2023.

Okay. And then with respect to the situation in India, do you have any sense of what the Indian regulators are looking for with regard to when they would rescind the suspension of regulatory review due to COVID-19, or that's likely to persist indefinitely?

That's a very good question. And I wish I really had a firm answer for that, but I don't. This seemed to be very much related to the incidences rate of cases, which as you know in India was really bad. And we haven't certainly got any guidance about what sort of incidence rate would allow regulatory meetings to happen and that sort of thing. So we really don't know. So the good news is, we don't know that it's going to be a very long time. But the bad news is, we don't know that it's going to be a short time either. So we're just waiting to hear from the authorities and Sun Pharma, which is a pretty major company in India and is really very connected with the authorities. And I'm sure that as soon as they open up or start to open up, we should be able to get a meeting.

Okay. And then can you just very quickly provide us with any kind of updated metrics regarding a, the evaluation programs on Triferic AVNU and when you expect those evaluation programs to effectively close following the formal rollout of the product? And then secondly, if you can comment on what the status is of the real world data program with dialysis?

Okay. Tim, do you want to take the first two questions, and I'll answer the last one?

Yes, absolutely. So thanks for the question. Our first evaluation programs started only in early October. So for now, it's too early for us to really report comprehensively on how this is going to go and how many clinics are going to adopt. But we have done heavy promotion on the program among eligible customers in our target segments in various channels, as mentioned, as well through our ASN, American Society Nephrology Congress, which occurred in October to increase awareness of the program. The length of the evaluations vary based on what I explained earlier, which is our negotiation with clinics about evaluation program length versus cost of product. So we're trying to accelerate the sales cycle there. But early to say what the results are there. We certainly will apply learnings from the evaluation program to our commercial launch in the first quarter.

And the real world data question is a good one. We've been – we've contracted a firm to do an in-depth dive on the United States renal disease service dataset as provided by ResDAC, which is current. And we've very recently received that dataset. It takes a while to get it. And so we'll be evaluating multiple clinics with about a 9-month to 12-month tenure of using the product. So we should have MD information in the ResDAC dataset that’s pretty comprehensive and includes also outcomes data such as hospitalizations and deaths and so on, as well as dialysis, drug and device input. So we should have a very nice dataset, we hope, certainly in the first quarter next year, as we're analyzing it now. But I would hope that that would be earlier in the first quarter than not.

Great. Thank you very much.

This concludes our question-and-answer session. I'll now pass the call back to Russell Ellison for closing remarks.

Thank you all for joining us this afternoon, in these interesting times for taking the time to be on this call, and we look forward to following up with many of you in the coming days and weeks. So thanks very much.

Ladies and gentlemen, this does conclude the conference. You may now disconnect. Everyone, have a great day.