Good afternoon, ladies and gentlemen, and welcome to the Rockwell Medical 2019 Q1 Results Call. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host Ms. Judy DiClemente. Please go ahead.

Thank you, Sarah. Welcome to Rockwell Medical's first quarter 2019 earnings results call. This is Judy DiClemente of In-Site Communications, the Investor Relations representative for Rockwell Medical. With me on today's call are: Stuart Paul, President and Chief Executive Officer; and Angus Smith, Chief Financial Officer of Rockwell Medical. 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. 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 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 call 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's SEC filings, many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include statements about the preliminary recommendation of CMS relating to a unique J-code for the Triferic Powder Packet; timing and success of our planned NDA submission for I.V. Triferic; the potential market opportunity for I.V. Triferic and other Rockwell products; pricing and reimbursement status for I.V. Triferic, Dialysate Triferic and other Rockwell products, including eligibility for add-on reimbursement under TDAPA; liquidity and capital resources; expected duration of Rockwell's existing working capital; success of our recently announced commercialization plans for Dialysate Triferic; and the timing and success of our efforts to renegotiate economic terms of our concentrate business Rockwell 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 Investor Relation's webpage. This call is being recorded on May 9, 2019 for audio rebroadcast and can also be accessed on the same webpage. The call will be followed by a question-and-answer session. At this time, I would like to turn the conference call over to Rockwell's CEO, Stuart Paul. Stuart?

Thank you, Judy. Good afternoon everyone and thank you for joining our call. This is truly an exciting time for Rockwell, so I'm happy to have this opportunity to update you on our progress today. I'd like to begin by discussing the overall opportunity we have for Triferic. Triferic is a therapeutic platform that we believe has the potential to transform anemia management across the globe. It's a novel therapy that mimics the body's natural process of iron absorption that we believe can be applied for the treatment of anemia in a number of different disease states. Rockwell has developed multiple formulations of Triferic for the treatment of anemia in hemodialysis patients. And earlier this week, we announced the commencement of U.S. commercial sales of the first formulation in Triferic portfolio Dialysate Triferic. And before the end of the second quarter, we expect to file a new drug application, or NDA, for I.V. Triferic. We're pleased that Dialysate Triferic is now commercially available and physicians have access to the first and only FDA approved therapy indicated to replace iron and maintain hemoglobin. Let me start with this week's launch of our Dialysate Triferic formulation and the commercial and medical education infrastructure that we built to support it. We believe our Triferic platform has the potential to transform the management of anemia in hemodialysis patients. There are over two million people who receive hemodialysis across the globe including more than 450,000 here in the U.S. and because all hemodialysis patients lose five to seven milligrams of iron at each dialysis treatment. We believe Triferic is appropriate for substantially all of these patients. We are executing a phased launch of Dialysate Triferic. First to centers of excellence in the U.S., and our sample sites and then more broadly to the medium, small…

Thank you, Stuart. Net sales during the first quarter of 2019 were $15.6 million compared to sales of $14.9 million during the three months ended March 31, 2018, an increase of 4%. The increase was primarily due to higher domestic dialysate concentrate sales to Baxter and an increase in international sales. Cost of sales during the first quarter of 2019 were $14.6 million resulting in gross profit of $1 million for the period compared to cost of sales of $15.7 million and a gross loss of $700,000 during the first quarter of 2018. Gross profit increase in the first quarter of 2019 compared to the first quarter of 2018 due primarily to an inventory reserve for Triferic of $2.2 million for the three months ended March 31, 2018, partially offset by a gross profit decrease in our dialysis concentrates products. The decrease in gross profit for our dialysis concentrates products was primarily attributable to increased labor, materials and overhead costs partially offset by increased net sales. Selling and marketing expenses were $3.1 million in the first quarter of 2019 compared to approximately $200,000 in the first quarter of 2018. The increase was due primarily to marketing cost to prepare for the commercial launch of Triferic and an increase in sales and marketing headcount. General and administrative expenses were $6.2 million in the first quarter of 2019 compared to $3.1 million in the first quarter of 2018. The increase was driven primarily by the reversal of certain accruals related to stock compensation and bonuses during the prior year period as well as an increase in annual reporting and consulting fees. Research and product development expenses were approximately $500,000 in the first quarter of 2019 compared with $1.7 million in the first quarter of 2018. The decrease was due primarily to a reduction in clinical trial and other product development costs. Net loss for the first quarter of 2019 was $8.7 million, or $0.15, per basic and diluted share compared with a loss of $5.5 million or $0.11 per basic and diluted share in the first quarter of 2018. Net cash used in operating activities was $5.4 million for the first quarter of 2019. As of March 31, 2019, we had approximately $27.8 million of cash, cash equivalents and investments available for sale and working capital of approximately $24.5 million. In March, we filed $40 million at the market equity offering, which we believe provides us added financial flexibility to execute our strategy. We are under no obligation to use the facility and our plan is to use it opportunistically and judiciously. With that, I will now turn the call back to Stuart.

Thank you, Angus. The commencement of commercial sales of Dialysate Triferic marks a significant milestone for the company as we advance our goal of transforming the current standard of care for anemia management and hemodialysis patients around the world. We view Triferic as a platform technology that can be applied in a number of disease states effectively shifting the existing treatment paradigm. Our efforts are focused on accelerating adoption of Triferic and ensuring that the important benefits to our customers and patients are well understood. With our strong management team, medical advisory board and patent portfolio, we are fully committed to addressing this unmet medical need while delivering value to our shareholders. We’ll now open up the call to questions. Operator?

[Operator Instructions] And your first question comes from line of David Bouchey from IFS Securities. Please go ahead.

Hi, guys. Congratulations on getting the launch of the dialysate version of Triferic. I understand you guys are in Boston at the National Kidney Foundation Spring Clinical Meetings. And can you kind of give us some color about what the launch of Triferic is? How that is being perceived at that meeting?

Hey, Dave. Thanks for the question. Great to hear from you. It’s Stuart. So, yes, we're actually at NKF and we are with an exhibition booth and the team is here officially launching Dialysate Triferic at this conference. We've actually already transacted sales out in the field, but it's really exciting. All of the new positioning, messaging, graphics and all the work that the agencies that we brought on board. They've done a great job is being unveiled, starting with the opening this afternoon and tonight and then into the next couple of days. So, it's an exciting time for the company and you'll see that even on our website for Triferic, the new materials and messaging and platform can be accessed.

All right. You mentioned that you don't expect to see significant sales this quarter because of the cycles for the dialysis clinic. Can you kind of explain that a little bit more?

Sure, sure, David. It’s Angus speaking. Thanks for the question. When you're implementing a new therapy into an anemia management protocol, it takes time both getting the therapy on formulary and changing the protocols. And obviously there's lead time for us just to get to site centers detail them on Triferic and provide them with medical education. So all of that – every clinic a little bit different, some may be faster, some may take longer, but I think on average we see that taking three to four months to – from the time we first make a call to win – we'll have the therapy on formulary and in the protocol. So, as a result of that, even for some of our sample sites that's going to have to take place. So as a result of that, we're looking at what we said publicly that we’re not expecting material sales in the second quarter.

All right. You mentioned the list price for the powder version is $8 and the ampoule version is $9. How much of your inventories ampoule versus powder? So how much can we expect sales of each to be?

Well, obviously in inventory we carry it at cost. I think as of 3/31, our finished goods were primarily ampoules. So I would say you won't see – I mean if you're just looking at the balance sheet, you're not going to see much in the way of powder pack there as of 3/31. We've [indiscernible] since made the powder packet and ready to go.

Okay.

They both cost different costs to manufacture them. So, I think what – the cost of goods for powder packet versus ampoules would won't really dictate or have any influence on what the sales of those products are.

All right, and you mentioned that the sales force will be – sales and training force will be 25 people by the end of the year. How big is it now? And is it mostly the technical training people or the dedicated sales force? What – how does that break out?

We're approaching about the halfway critical point I'd say in the field organization, but we've got a good mix as I mentioned on the – on my comments of reps. We're talking about very experienced that have been in the renal sector and other successful launches in company scenarios. And so, we've really – I hope have stacked the deck a bit with the talent that we brought on board. So the reps, the nurse educators, the medical science liaisons, we actually keep the firewall between the sales force and the MSLs, which report up into our Chief Medical Officer, Dr. Pratt. But they're necessary in terms of educating. We really are putting a significant premium on medical education because one of the real interesting features of Triferic is that nephrologists largely did not know much about it. And that's actually very good news. And as we rollout our educational efforts this year, that's why we're not talking a lot about sales and revenue guidance and we're actually talking more about some very important components of driving the awareness in understanding of what Triferic is, how it works and why it carries the wonderful safety and physiologic profile that it does. And at the same time delivers constant and continuous hemoglobin maintenance on label.

Okay. So the fact that you got to do a lot of work on educating doctors about Triferic. That leaves you room to scale up your expectations then as more doctors get more familiar with it.

It does. It does. But when you look at the U.S. market in particular keep in mind that a significant amount of the U.S. market is driven by the large and medium sized chains, right. So, I would basically say you could think of our field organization as a tiger team and then we have a more sophisticated strategic accounts management model that layers over that and is capable of negotiating and contract management at the LDOs and the MDOs.

Well, you did mention that you just signed an agreement with a mid-tier dialysis clinic provider to collect and provide you some of the real world data. What is the status on the date that you've got or are collecting and analyzing from the free sample clinics?

Yeah, there're probably about 20 to 25 clinics that are still in the sample program, including some very prestigious centers of excellence across the country. I’d say over time we've had a total of about 50 to 60 clinics that have participated in the program. We're reasonably satisfied with the performance of Triferic in those sites and the data that are coming forward. I just think it takes a bit of time for us to get that out into publications, but we're working on that. I would say, what's really important is that they've helped us to differentiate the product, understand the therapeutic opportunity, which is a great opportunity for patients. And really have helped us to begin positioning it now with nephrologist and patients as a critical new therapeutic.

Okay. So you had at one-time as many as 60 clinics in the free sample program. Now, you've got about 20 to 25. How many of those are transitioning to paying Triferic?

Yeah, we're expecting the majority of them to transition on. So we're still going through IRBs. The sites have to go through their own institutional review boards in the case of hospitals. But at this point as Angus said, we're not really focusing on guidance around revenues and uptake in the second quarter. We’re going to take some time to bring all these accounts on board. But we're doing it in a phased manner and I think in a very progressive ramp up that that feeds into our own models.

Well, I know in my conversations with medical directors for dialysis clinics, they've mentioned that that are on the free sample program, they've mentioned about a 50% reduction in hospitalization rates, which they can attribute to Triferic. And on this week's conference call, DaVita mentioned that reducing hospitalization rates is one of their focus points, at least from their outgoing CEO’s point of view. How important do you think having that data will be in a year's time when you're trying to get DaVita to take up the I.V. form of Triferic?

Yeah, I think it's very important and I think we're working it. And we actually have quite a significant stockpile of data already and have held our own medical advisory board meetings. We brought on new key opinion leaders. I think we've really seeded the medical advisory with some of the top nephrologists in the country that are really driving the standard of care, examining how we can improve the standard of care and look for new paradigms. And I believe that they all see a significant ESA sparing benefit from Triferic. So, I think the key for the DaVitas, some of the MDOs and the larger customers are going to be to continue to build some real world data in their sites and continue to work with them to perfect and finesse how the therapy can be adopted and evolved in their protocols.

All right. And you mentioned that in several more weeks, you're going to be filing the NDA for the I.V. version of Triferic. What is holding you back from filing that now sooner?

I just like to do my diligence. I wasn't here when the whole dossier was put together, but I'm very satisfied with what I've seen. I brought in external consultants, who have been deep diving the NDA and helping us to understand and challenge all the areas. Again, it is an SPA with the FDA. So we're very happy and pleased about that. I would say the main issue is we just want to make sure that we don't see an approval to prematurely. We want to be eligible for TDAPA. And so given that this is a 505(b) pathway under an SPA and FDA has got experience in approving two prior versions of our formulations that there's always the chance this could go quite fast. And so, we just want to be diligent about our approach to getting through the FDA's requirements and the timing that is optimal for TDAPA with CMS.

Understood. And can you tell me what is I believe that there is a pediatric trial that you are planning to undergo. Can you give me an update on the status for that, the timing for that?

Sure. So we're going to get started on that in the second quarter. You'll see in the 10-Q filing that that we've signed a contract with CRO and – but we'll be ramping up that study. So, it's going to get started very soon.

Okay. The last question, I just want to make sure at the market deal that you've got. Can you explain or clarify a little bit more because I've been getting some people that are wondering if you have an institutional investor, who is interested in purchasing shares of Rockwell, why wouldn't they just wait and buy those shares through you – at the market a deal versus buying them on – no through the stock exchange. Can you explain a little bit more about what that ATM is utilized for?

Yeah, I mean, I think – I mean, one way to answer that question would be to say that we're not in the market with that program every day and there's no guarantee we will be. It is completely at our discretion. So, I don't think having the facility in place prevents an institution from buying stock on the open market. What we've said is our plan is to use the facility judiciously and opportunistically over time to help us maintain our financial flexibility. And we did – you'll also see in the 10-Q. We've raised about $2.39 in the month of April on the facility on really just a couple of – two, three trading days. So, it's an interesting facility for us to maintain financial flexibility, but it's – in our view doesn't create any limitation on institutional buying for the stock.

So if an institutional investor wanted to buy a block of shares, their go to method of doing it would not be to go to the bankers running this ATM. It would be to go to the market.

Well, they could do either, right. Some companies have had success using the ATM to fill large orders, putting out particularly for liquid stocks, but that's not to say all institutes buying is going to go through the ATM. And in fact we would view that that most institutional buying would likely – would likely be done through open market purchases. And we have blackout periods on the ATM. And like I said, we’re not in the market on a daily basis. So, it's – I think there's still going to be normal trading activity out there that that happens in the open market.

What are you black out periods?

Well, I mean, there's normal blackout periods around when we have quarterly results in hand and then around any other kind of material – anytime we have or in possession of material non-public information. So we're sort of continuously assessing that.

Okay. All right, thanks. I think I've gotten almost all the questions that I have answered and hopefully there are other people online and have more questions. Thank you.

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

Good afternoon. This is Edward Marks on for Ram. Just in one of the previous questions you're talking about the filing – the NDA filing for I.V. Triferic. I'm just wondering what your projected review time would be once you file that NDA?

Yeah, thanks for joining us today. Again, under an SPA agreement with FDA with a 505(b) pathway and considering some of the comments I alluded to in the earlier part of the call, I think we would expect that it could take in the range of 10 months that wouldn't be unreasonable. But also as I just mentioned, during the earlier part of the Q&A, we want to be – we want to optimize obviously the timing of the filing versus the potential for approval to be eligible for TDAPA. We would want to see the approval come after one, one of 20. And so, we're just giving the fact that FDA has already approved two of our prior formulations. We just want to be diligent and optimize our overall approach. So – but that's the approach to timing and filing that – essentially that we're taking.

Okay. Thank you. And then it sounds like you have a very large infrastructure in place for pushing out Dialysate Triferic into the market. You're going to be ramping up throughout the rest of this year. I'm just wondering what additional resources might be needed to support launching I.V. Triferic around this time next year.

Yeah, I think right now what we're saying and what we said before is that we're targeting I.V. to the larger players and so that kind of lends itself more to the strategic accounts resource space that that we put in place within Rockwell Medical. So I think we're in very good position from the standpoint of managing the larger players where I'm personally at the table as well as Anne Boardman, who is our Vice President of Sales and Strategic Accounts. We have a lot of experience in this area and have worked in other company environments going us. So I think we're in pretty good shape there. We're going to continue to build our medical education focus. That's very important to me and to our board and our company, particularly since as nephrologists start to understand what a significant opportunity Triferic is and potentially paradigm shifting therapeutic is that we make sure that we put sufficient medical resources in place. And we're doing that. And as I said, comprises a mix of medical science liaisons in the field that report out to our chief medical officer and who touch all of the customer accounts as well as agencies and support around the publications and even health economics going forward.

Excellent. Well, that's all for me. Congratulations on launching. Thank you for taking the questions.

Great, thanks and regards to Ram.

We’ll do.

I'm showing no further questions at this time. I would like to turn the conference back to Stuart Paul for closing comments.

Okay, well, thanks once again everyone for joining this afternoon and we'll look forward to being in touch with you at the next earnings call. Thanks so much.

Ladies and gentlemen, this concludes today's conference. Thank you for your participation. Have a wonderful day. You may all now disconnect.