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Edited Transcript of RMTI earnings conference call or presentation 9-May-19 8:30pm GMT

Q1 2019 Rockwell Medical Inc Earnings Call

WIXOM May 26, 2019 (Thomson StreetEvents) -- Edited Transcript of Rockwell Medical Inc earnings conference call or presentation Thursday, May 9, 2019 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Angus W. Smith

Rockwell Medical, Inc. - CFO

* Stuart Paul

Rockwell Medical, Inc. - President, CEO & Director

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Conference Call Participants

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* David Michael Bouchey

IFS Securities, Inc., Research Division - Head of Healthcare Research

* Edward D. Marks

H.C. Wainwright & Co, LLC, Research Division - Research Analyst

* Judy DiClemente

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Presentation

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Operator [1]

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Good afternoon, ladies and gentlemen, and welcome to the Rockwell Medical 2019 Q1 Results Call. (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.

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Judy DiClemente, [2]

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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 IV Triferic; the potential market opportunity for IV Triferic and other Rockwell products; pricing and reimbursement status for IV Triferic, Dialysate Triferic; and other Rockwell products, including eligibility for add-on reimbursements 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 concentrates 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's Investor Relations 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 CEO, Stuart Paul. Stuart?

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Stuart Paul, Rockwell Medical, Inc. - President, CEO & Director [3]

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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 at our Triferic portfolio, Dialysate Triferic. And before the end of the second quarter, we expect to file a new drug application, or NDA, for IV 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've built to support it. We believe our Triferic platform has the potential to transform the management of anemia in hemodialysis patients. There are over to 2 million people who receive hemodialysis across the globe, including more than 450,000 here in the U.S. And because all hemodialysis patients lose 5 to 7 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 and independent dialysis organizations that treat roughly 25% of the hemodialysis patients in the U.S.

To give you a sense for the potential volume in this segment, according to DOPPS, roughly 80% of patients receive traditional IV iron. And more than 75% have ferritin levels that exceeded industry guidelines, and 50% have ferritin levels in excess of 800, which is 1 guidepost used in the anemia protocols of certain dialysis providers. We expect to expand our focus to include the large dialysis organizations next year following the introduction of IV Triferic, if approved, which we estimate would increase the potential patient pool for Triferic by fourfold. And we believe that Triferic has the potential to become a key component of the standard of care for anemia in this patient population, which based on our estimates, will translate into a peak market opportunity of $400 million in the U.S. alone.

The current standard of care for anemia management and hemodialysis patients includes traditional IV iron and ESA's, erythropoiesis-stimulating agents. However, these therapeutics are costly and has been associated with significant complications.

By contrast, Triferic delivers the iron and hemoglobin maintenance that hemodialysis patients need without the risks associated with other therapeutics. Triferic mimics natural iron homeostasis, and its physiologic mechanism of action donates iron directly and completely to transferrin. Its ability to deliver effective hemoglobin maintenance without increasing ferritin levels makes it a particularly attractive proactive iron maintenance therapy. And with a safety profile that is similar to placebo, Triferic offers an on-label method for hemoglobin maintenance.

Turning to our launch activities. Much of the last 6 months was a dedicated to ramping up, planning for and supporting this week's commercial launch. We have hired a top-notch team of sales representatives, nurse educators, and medical science liaisons to focus on our potential customers with a strategic accounts team providing support at some of the larger customers. And we expect to ramp our total sales head count to approximately 25 by at the end of 2019.

Our key programs for 2019 will include: engagement with key opinion leaders to support peer-to-peer medical education programs, advancements of our publication strategy to provide real-world evidence of the benefits of Triferic, and enhanced presence at key industry conferences. And In addition, we will deploy our experienced sales and medical personnel to engage with potential customers and key centers of excellence, while rolling out digital promotion to increase our share of voice.

To provide you with some of the specifics to our activities to date, last month, we attended the American Nephrology Nurses Association Conference in Dallas, where we held a training meeting for the sales force. We conducted a focus group of clinical administrators and sponsored a symposium on Triferic to over 400 attendees. The session entitled Breaking the Mold: Challenging Current Protocols in Iron Management in CKD Patients on Dialysis, was a combination of a presentation by a physician, who is currently using Triferic in a major academic institution and a patient advocate for the product.

We were very gratified by the turnout and interest from these health care providers. In addition, we continued to engage with key opinion leaders across the industry, both at medical and commercial advisory board meetings our company held at the Annual Dialysis Conference in March, also in Dallas.

Evidence that our marketing efforts are already having a positive impact can actually be seen in the recent Spherix survey results. Spherix Global Insights is an independent health care research firm that specializes in renal, autoimmune, neurologic, and rare disease markets. In its recent quarterly survey of dialysis centers, there was a notable spike from Q4 to Q1 in the number of respondents who agreed that Triferic was a more physiologic approach to treat iron deficiency than traditional IV iron in hemodialysis patients. This is a solid early indicator. And as we continue to expand our sales and marketing efforts, we look to build greater awareness of Triferic’s benefits and potential impact on the market.

Also of note, we recently signed an agreement with a medium-sized dialysis organization to receive data from their use of Triferic in the sample program and going forward. And we're in the process of collecting that data and analyzing it for publication. We're also receiving and analyzing data from additional sample size to potentially supplement our publication strategy, and we believe that real-world evidence is critical to our strategy and making Triferic the standard of care.

We feel confident in our ability to execute on our strategic commercialization plans and to build out the therapeutic portfolio of products for Triferic. We also understand that there'll be some challenges as we set out to change the mindsets and behaviors in hemodialysis clinics, and adoption will likely take place over the course of time. So for 2019, our key goals are: to increase awareness of Triferic, educate providers and patients about the medical and potential pharmacoeconomic benefits of Triferic, and gain adoption in key centers of excellence. And based on the sales cycle of dialysis clinics, we do not expect to see material sales during the second quarter.

Now I'd like to walk you through our pricing strategy for Dialysate Triferic, starting with the pricing metrics for the existing standard of care. Traditional IV iron in ESA's are reimbursed within the CMS bundled payment regime for hemodialysis, and the leading traditional IV iron product, iron sucrose, has an ASP equivalent to about $5 per hemodialysis treatment. The other key component of the current standard of care ESA's are priced at the equivalent of approximately $25 to $40 per treatment according to Medicare ASP and MedPAC data. So dialysis clinics are spending a combined $30 to $45 per dialysis treatment on these anemia management strategies.

Turning to Dialysate Triferic. We have set the list or WAC price for the powder packet presentation at $8 per treatment, and the list price for the liquid ampoule product is $9.50 per treatment. Importantly, due to customer discounts, reserves of product returns and other potential gross to net discounts, list price is not a reflection of the actual price we expect to realize on sales of Triferic, as an example, iron sucrose cells at a WAC to ASP discount of approximately 40%. And we believe our list prices for Dialysate Triferic reflect the value that the therapy can bring to patients in dialysis clinics through improved clinical outcomes and potential reduction in the use of ESA's and traditional IV iron, at the same time, ensuring proper access to this important therapeutic. As a reminder, Dialysate Triferic will be reimbursed within the CMS bundle payment for dialysis.

On April 26, the Centers for Medicare and Medicaid Services, or CMS, issued a preliminary recommendation, which if finalized, would establish a new level to health care common procedure coding system, or HCPCS code or J-code, in this case, J-1444 for the Dialysate Triferic powder packet. If finalized, this preliminary recommendation would result in a unique J-code for the powder packet that would be separate from the existing J-code, J-1443, that describes Dialysate Triferic solution. We're very pleased about this potential or this preliminary recommendation from CMS, which if finalized, would help provide additional clarity for coding and claims processing in connection with distinct Triferic products. Even with a separate J-code for the powder packet, it will be reimbursed within the Medicare bundle.

Now let me turn to the IV formulation of Triferic. In the next several weeks, we plan to file a 505(b)1 New Drug Application with the FDA for IV Triferic, which was developed pursuant to a Special Protocol Assessment or SPA. As part of the SPA, the FDA indicated that an equivalence approach to Dialysate Triferic will be acceptable for review. The NDA is supported by data from our equivalency study, which demonstrated that IV Triferic delivers the same quantity of iron to patients as Dialysate Triferic. And in March, we presented positive data from 2 separate studies, one evaluating IV Triferic, and the other evaluating a peritoneal dialysate or PD formulation of Triferic at the Annual Dialysis Conference. And of note, the IV Triferic study demonstrated equivalents between IV Triferic and Dialysate Triferic and will support our upcoming NDA filing. The infrastructure that we're building to support Dialysate Triferic will lay the groundwork for advancing this extension of the Triferic portfolio, if approved. And we anticipate that subject to CMS approval, IV Triferic will be eligible for reimbursement under the Transitional Drug Add On Payment Adjustment, or TDAPA, meaning it would be eligible for separate payments for 24 months.

So let me now turn to the global opportunity for Triferic. We believe the opportunity for IV Triferic is especially compelling as many dialysis clinics in large global markets, such as Europe and China, predominantly use dialysis monitors that utilize dry bicarbonate cartridges or bags and thus the existing protocols would integrate easily with IV Triferic.

As a reminder, our strategy for the developments and commercialization of Triferic outside the U.S. is to identify and work with partners to bring this needed therapeutic to market. And over the last few months, we have made significant progress. In China, where the hemodialysis population exceeds 300,000 and is growing rapidly, our partner Wanbang Biopharmaceutical has initiated 2 PK studies, and both of these studies have now completed enrollment, and we expect the results shortly. Following the completion of these studies, we expect to have the equivalent of our pre-NDA meeting with the CFDA. And depending on the outcome of that meeting, our partner, Wanbang, may be in a position to file for regulatory approval later in 2019. Our agreement with Wanbang provides for up to $35 million of regulatory and sales days milestone payments, including $8 million upon approval, plus a royalty of net sales in the low- to mid-20% range.

And in Europe, we're continuing to work to identify and advance discussions with potential partners. We recently completed market research for Europe, and among other things, the research gave us important insights into how clinicians might adopt Triferic and the potential pricing dynamics in key European countries. Overall, the research indicated that we have an attractive market opportunity for Triferic in the EU. And we believe this research will support our partnering activities.

We're also in active discussions regarding a license for Triferic in Japan, another attractive market with a hemodialysis patient population of more than 300,000. For both the EU and Japan, we expect that these partnership agreements, if completed, would include a mix of upfront payments, milestone payments and royalties payable to us.

In Canada, our dossier for IV Triferic is nearly ready to be filed. Our licensing agreement there provides us with an opportunity to realize the majority of the economics on sales of Triferic in Canada.

Turning now to our concentrate business. Through the first quarter of 2019, concentrates account for substantially all of our current sales. We supply significant amounts of concentrates to key players in the dialysis industry, including Baxter and DaVita, and having a seat at the table of these strategic players is key to further development opportunities with both companies around our therapeutic portfolio. We're also currently exploring opportunities to improve the economics of the concentrates business, including potential price increases, operating efficiencies and expansion of our customer base actually, both in the U.S. and internationally. And in summary, we're excited about the opportunities we have ahead of us and the progress that we have made with Triferic.

I'll now turn the call over to our CFO, Angus Smith, to review our first quarter financials. Angus?

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Angus W. Smith, Rockwell Medical, Inc. - CFO [4]

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Thank you, Stuart. Net sales during the first quarter of 2019 were $15.6 million compared to sales of $14.9 million during the 3 months ended March 31, 2018, an increase of 4%. The increase was primarily due to higher domestic dialysis 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 increased 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 3 months ended March 31, 2018, partially offset by a growth 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 costs to prepare for the commercial launch of Triferic and an increase in sales and marketing head count .

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 were $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 a $40 million after-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.

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Stuart Paul, Rockwell Medical, Inc. - President, CEO & Director [5]

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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 in 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?

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Questions and Answers

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Operator [1]

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(Operator Instructions) And your first question comes from the line of David Bouchey from IFS Securities.

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David Michael Bouchey, IFS Securities, Inc., Research Division - Head of Healthcare Research [2]

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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?

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Stuart Paul, Rockwell Medical, Inc. - President, CEO & Director [3]

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Dave, thanks for the question. Great to hear from you. Yes, 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'd 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. It's 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.

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David Michael Bouchey, IFS Securities, Inc., Research Division - Head of Healthcare Research [4]

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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?

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Angus W. Smith, Rockwell Medical, Inc. - CFO [5]

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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 size and detail them on Triferic and provide them with medical education. So all of that, every clinic is a little bit different. Some may be faster, some may take longer. But I think on average, we see that taking 3 to 4 months to -- from the time we first make a call to when they will have the therapy on formulary and in the protocol. So as a result of that, even for some of our sample size, that's going to have to take place. So as a result of that, what we're looking at -- what we said publicly that we're not expecting material sales in the second quarter.

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David Michael Bouchey, IFS Securities, Inc., Research Division - Head of Healthcare Research [6]

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

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Angus W. Smith, Rockwell Medical, Inc. - CFO [7]

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Well obviously, inventory, we carry at cost. I think as of 3/31 our finished goods was primarily ampoules. So obviously, you won't -- even 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 established since -- made the powder pack and ready to go. They both cost -- they cost -- it's different cost to manufacture them. So the cost of goods for powder packet versus ampoules won't really dictate or have any influence on what the sales of those products are.

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David Michael Bouchey, IFS Securities, Inc., Research Division - Head of Healthcare Research [8]

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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?

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Stuart Paul, Rockwell Medical, Inc. - President, CEO & Director [9]

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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 -- in my comments of reps. And we're talking about very experienced -- that have been in the renal sector and other successful launches and 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 a 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 roll out 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 and 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 continue as hemoglobin global maintenance on label.

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David Michael Bouchey, IFS Securities, Inc., Research Division - Head of Healthcare Research [10]

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Okay. So the fact that you guys 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?

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Stuart Paul, Rockwell Medical, Inc. - President, CEO & Director [11]

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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 more sophisticated strategic accounts management model that layers over that and is capable of negotiating in contract management at the LDOs and the MDOs.

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David Michael Bouchey, IFS Securities, Inc., Research Division - Head of Healthcare Research [12]

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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 data that you got or our collecting and analyzing from the 3 sample clinics?

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Stuart Paul, Rockwell Medical, Inc. - President, CEO & Director [13]

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Yes. There are 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 a time for us to put 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 nephrologists and patients as a critical new therapeutic.

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David Michael Bouchey, IFS Securities, Inc., Research Division - Head of Healthcare Research [14]

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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 for Triferic?

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Stuart Paul, Rockwell Medical, Inc. - President, CEO & Director [15]

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Yes. No. We're expecting the majority of them to transition on. So we're still going through IRVs, the sites have to go through their own institutional review boards in 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. It will 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 feeds into our own models.

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David Michael Bouchey, IFS Securities, Inc., Research Division - Head of Healthcare Research [16]

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Well I know in my conversations with medical directors for dialysis clinics, they've mentioned that -- that are on a 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 out the IV form of Triferic?

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Stuart Paul, Rockwell Medical, Inc. - President, CEO & Director [17]

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Yes. I think it's very important, and I think, we're working on 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. We -- 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 sparring benefit from Triferic. So I think the key for the Davita's, some of the MDOs and the larger customers is going to be to continue the 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 evolve in their protocols.

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David Michael Bouchey, IFS Securities, Inc., Research Division - Head of Healthcare Research [18]

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

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Stuart Paul, Rockwell Medical, Inc. - President, CEO & Director [19]

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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 understand and challenge all the areas. Again, it is an NDA 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 too prematurely. We want to be eligible for TDAPA, and so given that this is a 505(b) pathway under an SPA and then the FDA has got experience in approving 2 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.

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David Michael Bouchey, IFS Securities, Inc., Research Division - Head of Healthcare Research [20]

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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 what the -- an update on the status for that? And the timing for that?

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Angus W. Smith, Rockwell Medical, Inc. - CFO [21]

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

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David Michael Bouchey, IFS Securities, Inc., Research Division - Head of Healthcare Research [22]

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Okay. And the last question, I just want to make sure the -- 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 deal versus buying them on -- through the stock exchange? Can you explain a little bit more about what that ATM is utilized for?

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Angus W. Smith, Rockwell Medical, Inc. - CFO [23]

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Yes. I mean I think that -- 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's 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 will also see in the 10-Q, we raised about $2.3 million in the month of April on the facility on really just a couple of -- 2, 3 trading days. So it's an interesting facility for us to maintain financial flexibility. But it's -- in our view, it doesn't create any limitation on institutional buying for the stock.

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David Michael Bouchey, IFS Securities, Inc., Research Division - Head of Healthcare Research [24]

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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.

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Angus W. Smith, Rockwell Medical, Inc. - CFO [25]

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Well, they could do either, right? Some companies have had success using the ATM to build large orders, particularly for illiquid stocks. But that's not to say all institutional buying is going through the ATM. In fact, we would believe that most institutional buying 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 -- there -- I think there's still going to be normal trading activity out there that happens in the open market.

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David Michael Bouchey, IFS Securities, Inc., Research Division - Head of Healthcare Research [26]

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What are your blackout periods?

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Angus W. Smith, Rockwell Medical, Inc. - CFO [27]

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Well, I mean there's normal blackout periods around when we have quarterly results in hand and in around any other kind of material, any time we have, or are in possession of material nonpublic information. So we're sort of continuously assessing that.

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Operator [28]

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Your next question comes from the line of Raghuram Selvaraju from H.C Wainwright.

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Edward D. Marks, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [29]

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This is Edward Marks on for Ram. Just in one of the previous questions, you were talking about the filing -- the NDA filing for IV Triferic. I'm just wondering what your projected review time would be once you file that NDA.

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Stuart Paul, Rockwell Medical, Inc. - President, CEO & Director [30]

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Yes. Thanks for joining us today. Again, under an SPA agreement with the FDA with the 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 1/1/20. And so we're just -- given the fact that the FDA has already approved 2 of our prior formulations, we just want to be diligent and optimize our overall approach. So that's the approach to timing and filing that -- essentially that we're taking.

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Edward D. Marks, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [31]

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Okay. 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 IV Triferic around this time next year?

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Stuart Paul, Rockwell Medical, Inc. - President, CEO & Director [32]

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I think right now what we're saying and what we said before is that we're targeting IV to the larger players, and so that kind of lends itself more to the strategic accounts resource base 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 doing this. So I think we're in a 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 nephrologist start to understand what a significant opportunity Triferic is and potentially paradigm shifting therapeutic it is that we make sure that we put sufficient medical resources in place, and we're doing that. And -- which as I said, comprises a mix of medical science liaisons in the field that report up to our Chief Medical Officer who touch all of the customer accounts as well as agencies in support around publications and even help economics going forward.

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Edward D. Marks, H.C. Wainwright & Co, LLC, Research Division - Research Analyst [33]

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Excellent. Congratulations on launching.

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Angus W. Smith, Rockwell Medical, Inc. - CFO [34]

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Thank you.

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Stuart Paul, Rockwell Medical, Inc. - President, CEO & Director [35]

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Thanks, and regards to Ram.

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Operator [36]

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

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Stuart Paul, Rockwell Medical, Inc. - President, CEO & Director [37]

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Okay. Well thanks once again everyone for joining this afternoon. And we look forward to being in touch with you at the next earnings call. Thanks so much.

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Operator [38]

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