Good day, and welcome to the Rockwell Medical fourth quarter and full year 2015 earnings conference call. Today's conference is being recorded. At this time, I would like to turn the conference over to Mr. Paul Arndt of LifeSci Advisors. Please go ahead.

Thank you, Angela, and good afternoon, everyone. Thank you for attending the Rockwell Medical fourth quarter and yearend 2015 financial results conference call. I am Paul Arndt, Managing Director of LifeSci Advisors. On the call this afternoon are Rob Chioini, Founder, Chairman and CEO; 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 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 Securities and Exchange Commission. Any forward-looking statements made on this conference call speak only as of today's date, Monday, February 29, 2016, 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 in listen-only. The call will be followed by a brief question-and-answer session. I will now turn the call over to Rob Chioini, Founder, Chairman and CEO of Rockwell Medical.

Thank you, Paul. Good afternoon to everyone joining us on the call. Today I will update you on our commercial progress with Triferic in the U.S., our license agreement with our partner Wanbang pharma for commercialization of Triferic and Calcitriol in China, our global business development progress, our Triferic IND submission to treat a rare orphan disease and commercial availability of Calcitriol in the U.S. Then I will turn the call over to Tom, who will discuss the financials, after which we will take your questions. A summary of our financial result. Sales were $14.1 million in Q4, slightly lower compared with Q4 2014. For the year, 2015 sales were $55.4 million, up 2.1% or $1.2 million compared to 2014. We anticipated sales for the year to be lower due to customer invoicing, shifting to Baxter, for our distribution agreement. But not all customer contracts have been assigned to Baxter and Rockwell is still doing some customer invoicing. Our loss in Q4 showed a $600,000 improvement over Q4 last year, $5.8 million versus $6.4 million. Overall, our loss for 2015 showed a $7 million improvement or a reduction over 2014, $14.4 million versus $21.3 million. We improved our loss per share for the year $0.23, $0.29 in 2015 versus $0.52 in the prior year. Now, I will update on our Triferic commercial progress in the U.S. We've been making solid progress and we continue to execute on the various tasks that are required for any new product to succeed. Marketing and education to customers is obviously a key component. With Triferic, our four distinct target groups, doctors, nurse administrators, technicians, whoever see the bicarb mixing process and corporate purchasing personnel, each group has questions related to their area of work and all get their answers. While the normal sales process…

Well, thank you, Rob, and good afternoon. I'll provide you with a review of our fourth quarter results and our yearend financials. On sales, our fourth quarter sales were $14.1 million, $315,000 or 2.2% lower than the fourth quarter last year. Our fourth quarter domestic concentrate sales under our distribution agreement with Baxter increased 4.7% or approximately $600,000. International sales were at approximately the same level as last year, while contract manufacturing sales were $900,000 lower. Our drug sales were not material in the fourth quarter. Total sales in 2015 were $55.4 million, a $1.2 million or 2.1% increase over 2014. Our domestic concentrate business sales increased 4.2% or $1.9 million in 2015 compared to 2014. Our international concentrate sales increased 1.3% in 2015 over 2014. Our net revenue from third-party contract manufacturing decreased $1 million in 2015 compared to 2014. Our net sales of Triferic were immaterial for 2015. Our 2015 sales largely reflect a lower distributor prices paid by Baxter. We anticipated a greater sales decrease over 2015, as customer contracts were assigned to Baxter. However, not all contracts have been assigned as of yet. Our 2015 sales were favorably impacted by the recognition of deferred license revenue under the distribution agreement of $2.1 million in 2015 compared to $500,000 last year. The gross profit; in the fourth quarter gross profit was $2.1 million compared to $2.6 million in the fourth quarter last year. Fourth quarter gross profit was affected by a reduction in contract manufacturing. Additionally, investment was made to our quality system, including implementation of FDA mandated utilization of our concentrate products. Gross profit increased to $8.9 million in 2015, up $400,000 or 4.6% compared to 2014. Gross profit margins were 16.1% compared to 15.8% last year. Gross profit was favorably impacted by recognition of deferred…

[Operator Instructions] And we will take our first question from Annabel Samimy with Stifel.

I just want to understand something. If I heard you correctly, you're not really going to be launching Triferic, until you get approval of this powder, this new packaging, and it doesn't seem like you have any kind of agreement on reimbursement from CMS, so for this x bundle type of reimbursement, so are you also not going to be able to price Triferic, until you have agreement with CMS, because this is already a year plus after launch, and I guess, I'm little bit surprised that you can't seem to launch this product at all?

So I'd spread off and I'd say, we launched the product in September. And at that time, the clarity that we had on the reimbursement was the bundle. And then in November after CMS -- CMS was in a quiet period up till November, it became clear that we have an opportunity to secure a different type of reimbursement, which I explained on the call, was transitional. So the drug was launched. As far as the packaging goes, the ampules are what are being used currently. The ampules will continue to be used until the powder packet is available. I'm limited on what I can share in terms of pricing, as we're in the midst of being in discussions with CMS on this transitional payment. I mentioned on the call that there's no formal process, there is nothing where you submit. You have to wait x number of days. It's a fluid process and we're working on it as we speak. So we continue to do the work with customers both large and small. And at the same time, we continue to do the work on reimbursement. It's obviously important to have that reimbursement squared away sooner than later.

I guess, one, with your launch, we think there is some kind of arrangement that you have come to with some dialysis provider. In fact last quarter, you had mentioned, or at some point in last quarter or so you had talked about having reached some or have supplied one of the top four dialysis providers with some drug for pilot work or for some kind of work. Can you just detail what you've actually delivered -- if you've delivered any? If anyone has come to any kind of arrangement with you, has expressed interest? Is there anything or any kind of movement on this product at all, because we don't have any kind breakout from the earnings, I mean, from the revenue numbers. And frankly, there's also seem to be [ph] acquired a little bit by the Baxter agreement with the dialysis concentrates, which I thought kind of should have been already adjusted in terms of the cost of sales. So I guess I'm a little confused as to what is actually in the $14.1 million number that's gone down now?

Well, all right, so you had a lot in there. Patients are receiving the drug. We have seen data. We see how the drug works. And with no surprise, it's working well. The pilot process that we talked about with the LDL on the last call is ongoing, as is the process with CMS. And we keep moving forward, but as we do so, we're trying to get some finality to the reimbursement, because that obviously plays an important role into the commercial process. As far as Baxter sales go, the way that it works is Baxter is going to take over invoicing for customers on the concentrate business. They started doing that, I think a quarter or maybe two after the deal was done. And so they're invoicing for a good portion of the customers and we're still invoicing for some of the customers as that process continue, so that's why you didn't see maybe a more significant drop in the concentrate sales. I mean that's just part of the business. As we work through these things, we give you clarity on them. As we get more clarity on the sales and the Baxter invoicing, we'll see it in the numbers and we'll give you more clarity on it.

At this time, we are now going to go ahead and conclude today's question-and-answer session. I am now going to turn the call back over to Rob Chioini with closing remarks. End of Q&A

Thank you for calling in today. And we appreciate your support.