Good day and welcome to the Rockwell Medical Fourth Quarter and Full Year 2017 Earnings Conference Call. Today's call is being recorded. And at this time, I would like to turn the conference over to Paul Arndt, LifeSci Advisors. Please go ahead.

Thank you, Matt, good afternoon everyone. Thank you for attending Rockwell Medical's year-end 2017 financial results conference call. I'm Paul Arndt with LifeSci Advisors. On the call this afternoon are Rob Chioini, Founder and CEO of the Company; and Tom Klema, Chief Financial Officer. Before we begin, I would like to remind everyone that various remarks about future expectations, plans and prospects constitute forward-looking statements for the purposes of Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Rockwell cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated. Among the factors that could cause actual results to differ materially include risks and uncertainties related to Triferic, including the company's ability to successfully commercialize Triferic, manufacturing capabilities and other risk factors identified from time-to-time in reports filed with the SEC. Any forward-looking statements made on this conference call will speak only as of today's date, Thursday, March 15, 2018, and the company does not intend to update any of these forward-looking statements to reflect events or circumstances that occur after today's date. This conference call is being recorded for audio rebroadcast on Rockwell's website at www.rockwellmed.com. All participants on this call will be listen-only. The call will be followed by a brief question-and-answer session. I'd now like to turn the call over to Rob Chioini, Founder and CEO of Rockwell Medical. Rob, please go ahead.

Thank you, Paul. Good afternoon. Thank you for joining us. On the call with me today is Tom Klema, our Vice President and Chief Financial Officer and Dr. Ray Pratt, our Chief Medical Officer. We had a productive 2017. We also have a number of important updates for you today. A few highlights from the year’s financial performance; sales for the year were $57.3 million up 7.5%, gross profit was $3.1 million lower, this was due to increased drug product costs and lower concentrate profit. Net loss was $25.9 million versus $19.8 million. So let's talk Triferic. As you know from our last update, we had productive meetings with the Centers for Medicare and Medicaid Services, CMS, and also with the Center for Medicare and Medicaid Innovation, CMMI. And at their request, we prepared and submitted a proposal to the Innovation Center at CMS that highlighted the improved clinical benefits Triferic provides to patients, as well as the significant cost savings Triferic delivers to Medicare and dialysis providers. You'll recall that our analysis concluded that if 100% of the hemodialysis patients that Medicare is responsible for were given Triferic as part of their treatment protocol, Medicare would reduce their cost by well over $1 billion per year. The clinical evidence shows that these cost savings would come from significant reductions in intravenous iron, infection related in patient hospitalizations, and medications and blood transfusions among other things which also suggests clinical outcomes will be improved and patient will have a better quality of life when receiving Triferic. Clinical data has shown that Triferic delivers sufficient iron to the bone marrow and maintains hemoglobin levels in HD patients. In fact Triferic is the only FDA approved therapy with the clinical indication that states to replace iron and maintain hemoglobin. There is no…

Thank you Rob, and good afternoon. I’ll be covering the financial results for the fourth quarter and for all of 2017. Our sales in the fourth quarter were $14.8 million and were $1.4 million or 10.8% higher than the fourth quarter of last year. The increase was largely due to higher domestic concentrate sales of $1.3 million and increase of 11.2%. Our international sales were up approximately 200,000 and also up 11.2% from last year. Sequentially fourth quarter sales increased by 200,000 or 1.4% over the third quarter of this year. Sales for 2017 were $57.3 million compared to $53.3 million in 2016 an increase of $4 million or 7.5%. Our domestic concentrate sales increased $3.6 million or 7.8% and our international sales increased 400,000 or 5.8%. Our domestic concentrate sales increased $3.6 million due to increased unit volumes including new business that resulted from our agreement with Baxter. Our drug business revenue aggregated approximately 200,000 in both 2017 and 2016 which was related to recognition of license fees. The gross profit in the fourth quarter was a $1.2 million loss compared to a gross profit of $2 million in the fourth quarter last year. The $3.2 million swing in gross profit was due to inventory reserves related to our Triferic drug inventory. Drug product expenses increased $2.5 million over last year's fourth quarter and in the fourth quarter of 2017 we reserved $3.3 million of Triferic finished goods inventories that may not be sold before the respective expiration dates during 2018. Other drug costs were lower than in the fourth quarter last year. On our concentrate business gross profit was 700,000 lower than the fourth quarter of 2016. We incurred cost increases for freight that were not able to be recovered. Gross profit for 2017 in total was $3.7…

[Operator Instructions] At this time, we'll take a question from David Bouchey with IFS Securities.

I actually have several. I want to start with Tom some questions for you. You just mentioned that there is some Triferic inventory that is expected to expire in 2018. Can you tell me again how much that write-down might be and when would that happen, first quarter, second quarter or third quarter?

So David what we have is approximately 5 million of Triferic finished goods inventory. We evaluated that inventory at the end of the year and without having clear understanding of if and when CMS may give us separate reimbursement and when we could begin selling Triferic, we took a reserve at the end of the year of $3.5 million for inventory that would expire during 2018. There is approximately $1.5 million of inventory that is not reserved for that would expire in the back half of 2018. So the full amount that we're exposed to would be $1.5 million of finished goods inventory and we probably would not make that determination until later - and probably in the second quarter if were to write that off.

Got you, okay.

That's the expense. So just $1.5 million that's at risk at this point.

And Rob maybe you could explain a little bit more about the clinical trials in the U.S. for IV and IV formulation of Triferic. I’m assuming that this is an abbreviated new drug application, not a new drug application. So what you just need to show is bioequivalency and perhaps a little safety. So you're talking about some pharmacokinetic studies being done, can you tell us a little bit more about the size and scope of those trials?

I'll let Dr. Pratt give you some detail back on your question.

Yes, we conducted two pharmacokinetic studies to demonstrate how much iron is transferred with each hemodialysis to patients. And then we've made a new presentation of Triferic intravenously to match that amount. We've done a formal bioequivalence study, I shouldn’t call it a bioequivalence it’s not a true bioequivalence, but it's an equivalence study. That was adequately powered - to demonstrate the equivalence of the two formulations and we will be filing that with the FDA probably in the second quarter this year. We’re hoping to meet with the FDA to determine if this will require a full NDA review which would be a 10-month timeframe or a prior approval supplement and we don't know which way it will go. We believe it should be a prior approval supplement, but we will need to discuss that with the FDA and will hopefully have that meeting in the second quarter.

And you’re facing a similar situation in Europe where the practices are different and you have to have an IV formulation of Triferic in order to penetrate most of those markets. So I'm assuming, I believe you did meet with the EMEA this past quarter?

Yes we’ve…

And what did you learn from them?

Well we have submitted scientific advice. We had a very productive meeting to discuss some of the questions that they had and we’re still waiting for the final summary of the scientific advice. We expect that by the end of the month and once we get that and review it, we’ll be able to update on our plans for Europe.

But it's basically the same kind of issues that you're dealing with the FDA with?

I can't really say that for sure, I think that Europe is going to require a clinical trial. They've always had that and we're just in the process of discussing what the nature of that trial may be.

And so my understanding that you were in China recently. There was some news from the Chinese government very recently just the other day stating that the Chinese FDA - is now going to be incorporated into a newly created state market regulatory administration supposedly to make it more efficient in regulating the drug market in China. And it's your understanding from meeting with your Chinese partners that they will be able to get the clinical trial started a little earlier and that this may advance the launch timeline that we have now by maybe about three months?

Possibly, yes, you know we’ll know more as we get through it.

One last question for you Ray. Is it true that Rockwell has been taking ads in Nephrology Medical Journal saying basically coming soon Triferic and Calcitriol?

No, it isn't accurate. I mean what is accurate is as far as Triferic goes our marketing has been extensive for many, many months now. And we do advertise in all the trade journals as well as via the web. I think there are some advertisements for Calcitriol that say coming soon.

And those that - they're not in the medical journals but in the trade journals.

Well combination of both I believe.

And are some of these ads full page ads, they recently become full page ads?

I think most of them have been full page ad David but in general I mean if there is one specific you're interested on that, you have to point it out to me. But in general we have full page ads in the sense of marketing.

There are no more questions in the queue. I’ll now hand the call back over to Mr. Chioini for closing remarks.

Thank you for your support, and we’ll look forward to giving you an update either on the next earnings call or when we have something sooner. Thanks.