Good afternoon, ladies and gentlemen, and thank you for standing by. And welcome to the Rockwell Medical 2020 First Quarter Results Call. At this time, all participants’ lines are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today’s conference is being recorded. [Operator Instructions] I would now like to hand the conference over to your speaker today, Ms. Claudia Styslinger, Investor Relations. Please go ahead, ma’am.

Welcome to Rockwell Medical’s first quarter 2020 earnings results call. This is Claudia Styslinger 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; Angus Smith, Chief Financial Officer; Dr. Marc Hoffman, Chief Medical Officer; and Tim Chole, Vice President of Marketing. 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 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’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 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 page. This call is being recorded on May 11, 2020 for audio rebroadcast and can also be accessed on the same webpage. At this time, I would like to turn the conference call over to Rockwell’s Chief Executive Officer, Dr. Russell Ellison. Russell?

Thank you, Claudia. Good afternoon, everyone, and thank you for your time today. It is an honor to be with you in my new role as President and CEO or Rockwell Medical, in addition to my continuing role on the Board of Directors. My charge as CEO is to maximize the potential on our 2 FDA approved products Triferic Dialysate and Triferic AVNU for patients and shareholders by developing Rockwell Medical into a more medically- and scientifically-driven company, which will drive adoption of our products in dialysis and the strategic identification and pursuit of new indications for Triferic and other diseases. I look forward to providing you with an update on our business on our call. Today, we will address our commitment to the hemodialysis community, particularly in light of the COVID-19 pandemic; findings from the Triferic real-world data and retrospective analysis; progress on the commercialization of our 2 FDA approved products; other pertinent corporate updates and a review of our financials; and then, we’ll open up to Q&A. Before we dive in, I want to give you some perspective as to why I joined Rockwell and my vision for the future. Through my role as a Consultant and Board Member, I’ve gained in-depth knowledge of Rockwell and its product. Based on this knowledge and my decades of medical and executive experience in pharma and biotech, I am particularly excited about the potentially transformational attributes of our ferric pyrophosphate citrate or FPC technology platform. As you know, Triferic is the first commercial product from our FPC platform. And I believe Triferic is unlike any other iron product in the market today. It delivers 100% immediately bioavailable iron for patients, unimpeded by inflammation. By virtue of this mechanism of action, I believe our FPC platform holds the potential to deliver meaningful…

Thank you, Russell. I’m excited to be presenting the initial readout from our real-world data program today. As Russell mentioned, the collection analysis and presentation of real-world data is incredibly important for Rockwell. But first, let me put this in the context of the overall program. As Russell mentioned, we are now collecting data from 12 dialysis clinics in the U.S. and one of my top priorities since joining the company has been to develop a plan to collect and analyze these data. We believe that the output from this program has the potential to enhance the commercial, medical and business development discussions that are critical to driving adoption for Triferic across the globe in years to come. Today’s presentation is just the first of what we hope will be several meaningful readouts from this program. Today, I will be presenting data from an independent dialysis clinic that adopted Triferic in early 2017. The clinic has approximately 65 patients at any given point in time and provided us with various clinical, lab, drug utilization and quality of life metrics for their patients before and after they adopted Triferic. We are presenting data from a baseline period of 3 months prior to their switch to Triferic to 18 months following the adoption of Triferic. In randomized well-controlled clinical trials like those used to generate registration data, patients are selected using highly specific eligibility criteria, which are not fully reflective of real-world practice. In contrast, real-world data is uncontrolled and unfiltered. The data presented here is all-comer data representing the real-world experience at this site. This is not constrained by clinical trial protocols or schedules, or any patient selection criteria, nor did Rockwell have any input into the clinics and immune management practices. In fact, it included patients who would traditionally be…

Thanks, Marc. I’m Tim Chole, Vice President of Marketing at Rockwell. I joined the company in December 2019. I’ve spent more than 23 years in the pharmaceutical and medical device industry, including some experience serving as marketing head for the IV iron portfolio at Watson pharmaceuticals, where we launched Ferrlecit, a traditional IV iron product that’s used to treat anemia and dialysis patients. So with that introduction, I’ll dive into some of the details of our Triferic Dialysate metrics for the first quarter. As of March 31, 2020, we had nearly 2,000 contracted patients on therapy are representing approximately 300,000 annualized treatments. In the quarter, we signed 4 new contracts with dialysis clinics to adopt Triferic Dialysate. The conversion to new contracts, particularly from our MDO contract were impacted by the emergence of the COVID-19 pandemic in the U.S. in March. With our MDO customer, we had 8 clinics trained on Triferic administration and approved for adoption in mid-March that held off on converting, so that as for all dialysis clinics, they could focus on protocols to protect their staff and patients in the face of the COVID crisis. And we had another 4 clinics in the queue for administration training in March that were not able to complete the training due to the pandemic. Our active or committed evaluation programs with independent dialysis clinics and small dialysis chains now represent 36 clinics and more than 2,250 patients. That’s a 260% increase from December 31, 2019. So we’re very pleased with the strong performance of the program during the first quarter. And the increase in the number of clinics committed to these programs is largely attributable to the progress we’re making with prospective customers who own multiple clinics. Evaluation programs have now been active for 3 full quarters since product…

Thank you, Tim. Turning now to our first quarter results. The more fulsome description of our results can be accessed in both the press release we issued this afternoon, as well as our 10-Q filing for the quarter. And I would encourage investors to read our detailed disclosures for a more complete understanding of our financial results. I’d like to start by highlighting our liquidity position as of the end of the first quarter, which is as strong as it has been in several years. During the fourth quarter of last year, we embarked on a plan to position the company to improve our balance sheet and provide us with capital we need to execute on our business plan, and achieve the milestones that we believe will create shareholder value. To that end, we were successful in attracting over $30 million of capital to Rockwell during the first quarter, most of which was non-dilutive. We ended the quarter with cash, cash equivalents and investments available for sale of $48.9 million, compared to approximately $26 million on December 31, 2019. Cash used in operating activities was $6.5 million during the first quarter of 2020. The balance sheet was strengthened by a debt financing agreement with Innovatus Capital Partners announced in March 2020, as well as the underwritten public offering of the company’s common stock in February 2020 for gross proceeds of approximately $8.1 million before deducting underwriting discounts. We drew $22.5 million on the loan facility at closing and have access to another $12.5 million, subject to the satisfaction of certain milestones and conditions. Additionally, we have approximately $35 million remaining under our at-the-market equity offering facility, pursuant to which we may sell, at such times and amounts that we deem appropriate, shares of common stock to support our business plan,…

Thank you, Angus. I’ll now open up the line to questions.

Hi. Thanks for taking my questions and congratulations on the progress during the quarter. Firstly, can you talk about where you see IV Triferic with Dialysate Triferic fitting into the treatment paradigm, once they are both launched? Any change from the prior strategy? And then, secondly, how should we think about revenue conversion once the trial period with the clinics are over? Would these clinics be converting their whole operations to your product? Or would it be just for certain patients? Thank you.

Yeah, thanks a lot. I didn’t quite catch your second question. But Marc will take your first one – sorry, Tim will take your first one, and then, perhaps after that, if you could repeat the second part of your question.

Great. This is Tim. Yes, I’m happy to take the question. So, thank you for that question. We believe the opportunity for IV Triferic or Triferic AVNU is significant. About 25% of the current U.S. market, we estimate utilizes solid bicarbonate systems, which is about 20 million hemodialysis treatments per year. And that number is increasing as clinics shifts to machines that use solid bicarb technology. And that’s really where we will be focusing for promotion of Triferic AVNU for patients that are treated there. Our current customers are all using liquid bicarbonate with Triferic Dialysate. And they’re quite happy with the convenience that they get from this formulation and mixing with our powder packet. And we don’t anticipate those customers to be interested in the IV formulation. So really, we separate these 2 target markets and look at this as incremental opportunity for Triferic AVNU.

And what was the second part of your question? I’m sorry about that.

So post the evaluation programs that you have implemented are clinics shifting the standard operating procedure to cross to Triferic or would this be on a sort of patient-by-patient basis, where they decide to go forward with Triferic?

I’ll take this. Actually, they’re shifting to have – with rare exceptions, to have multiple managements of iron going on in the same clinic. It’s ergonomically difficult for them. So they do like to be consistent across all patients unless there is a specific medical reason for a given patient not to do it; hence, the idea of the Evaluation Program and hence the idea of having protocols created for that clinic by that clinic to use Triferic. And it’s those protocols that have been somewhat delayed by the COVID epidemic, because they’re so focused on preventing infection in their staff and their patients and the protocols around that.

Great, thank you very much.

Okay.

Thank you. And our next question comes from Ram Selvaraju with HC Wainwright. Your line is open.

Hi, this is Blair Cohen on for Ram. Just one for me, what is the receptivity been like thus far for Triferic AVNU among physicians and dialysis providers?

Tim?

Yeah, sure. Thanks for that question. So we have many customers that have expressed interest in Triferic AVNU. And as I mentioned, we are just beginning to create awareness of this product, following the FDA approval amongst our customer base. The interest really is coming from customers that utilize exclusively solid bicarbonate technology and have a strong interest in Triferic. The benefits it can bring because of its unique pharmacokinetic profile, but haven’t been able to use the product. So we do have a pipeline of customers that are interested for that reason. And again, now with Triferic AVNU as soon as we start the evaluation programs, we’ll be able to start using it. So receptivity has been good. And again, we’re just starting to generate awareness about the approval, and expand our efforts and talking to customers in preparation for the evaluation programs.

Perfect. Thanks, guys.

Thank you. And I’m showing no further questions. I’d like to turn the call back to Dr. Ellison for closing remarks.

Yes, thank you. And thanks, everybody, for participating. It’s been a privilege to present our quarterly update to you. And I want to thank my colleagues, Marc, Tim and Angus for their participation, and you for your time and attention. And I look forward to the next opportunity to update you on our company. Have a great day and stay safe.

Ladies and gentlemen, this concludes today’s conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.