Good day, ladies and gentlemen, and welcome to the Rockwell Medical Third Quarter 2014 Earnings Call. [Operator Instructions] As a reminder, this call is being recorded. I would now like to turn the call over to Mr. Paul Arndt. You may begin.

Thank you, Michelle. Good afternoon, everyone, and thank you for attending the Rockwell Medical Third Quarter 2014 Financial Results Conference Call. I am Paul Arndt, Managing Director from LifeSci Advisors. On the call this afternoon are Rob Chioini, Founder, Chairman and Chief Executive Officer; and Tom Klema, Chief Financial Officer. Before we begin, I'd 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 the regulatory process for Triferic, including review of the Triferic NDA; the FDA's decision on whether to approve Triferic; 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, November 10, 2014, 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 Medical's website at www.rockwellmed.com. [Operator Instructions] I'll now turn the call over to Rob Chioini, Founder, Chairman and CEO of Rockwell Medical.

Thanks, Paul. Good afternoon, thank you for joining us. Today, I will briefly cover our third quarter results then provide an update on our clinical and strategic progress. Joining me on the call today will be our Chief Financial Officer, Tom Klema, along with Drs. Pratt and Gupta, in light of our recent successful FDA Advisory Committee Meeting. Starting with the third quarter numbers. We had a strong quarter, sales were up 5% over last year. And sequentially, sales were up 5.5% over the second quarter. The gross profit increased 39% over last year's third quarter and was up 30% over the first 9 months of 2014. We continue to see positive trends. As we discussed in previous calls, conversion to CitraPure as the standard of care concentrate product, coupled with liquid to dry product conversion, continues to drive improved operating results. This, along with our efforts to reduce costs will have a positive impact on our margins and our gross profits. Gross profit in 2014 is up $1.4 million and our gross profit margins are up 3 percentage points. Loss for the quarter was $4 million, $9.2 million less than last year's third quarter. R&D was $1.3 million, $9.3 million less than Q3 last year. As mentioned previous, we continue to expect R&D expense to be in the $1.5 million range. Year-to-date loss was $14.9 million, significantly less than the $40.5 million last year. R&D is $27.5 million less year-to-date. Overall, we are pleased with our progress and results for the quarter. Also, as you may know, we received $43 million in cash in early October. This was in addition to the $12 million in cash and investments we had at the end of September. So our cash and liquidity status is very solid. Regarding our partnership with Baxter.…

Thank you, Rob, and good afternoon. I'd like to provide you with a review of our third quarter and year-to-date financials and results. Starting with sales for the quarter. Sales in the third quarter were $13.7 million, an increase of 5% compared to the third quarter last year. Sequentially, sales increased 5.5% over the second quarter. International sales were $0.5 million or 39.4% higher than the third quarter last year and domestic sales increased 1.3%, which was net of a 0.9% decrease attributable to accounts acquired by a competitor in a prior period. Product mix continues to migrate to our higher margin CitraPure product line, with CitraPure representing 65% of acid concentrate gallons sold in the third quarter compared to 39.7% in the third quarter last year. Product mix continued to move away from liquid products to more cost-effective dry products, attributing to improving gross profit margins while moderating the increase in sales. Our gross profit increased dollar-for-dollar with our sales compared to the third quarter last year. For our 9-month sales. Sales for the first 9 months were $39.7 million, an increase of 3.5% compared to the first 9 months of last year. International sales were up $1 million or 24.5%. Domestic sales were up $300,000 or 1%. Product mix improved in the first 9 months of 2014, largely due to the conversion of our CitraPure products. CitraPure products accounted for 63.5% of acid concentrate gallons sold in the first 9 months of the year compared to 23.7% last year. Our product mix continued to shift to dry acid products from liquid acid products, resulting in higher gross profit while moderating the increase in the sales. On our gross profit. Our gross profit margin in the third quarter increased 4 percentage points to 16.5% from 12.5% in the third…

[Operator Instructions] Our first question comes from Charles Haff of Craig-Hallum.

My first question is regarding ESA-sparing. So it sounds like the AdCom was encouraging the company to look into further studies. I'm wondering if you've committed or decided whether or not to pursue a Phase III study showing ESA-sparing like you had for the Phase II PRIME results?

So Charles, this is Rob. We haven't decided to pursue another ESA-sparing study at this time. That's something we'll talk about internally and consider. But I want to make the point that our view has been that having ESA reduction on the indication would have been nice to have. But with or without it, we expect to have the same exact success of Triferic adoption in the marketplace.

I understand. Okay. And then in terms of Calcitriol, so it sounds like you're good to go in terms of your inventory here and launching in the first quarter of '15, what type of ramp do you think we should expect for Calcitriol?

That's a question I'll be able to give you a better answer on as we get into the first quarter. Right now, today, my concern is that we may have more demand than supply which obviously is a nice thing to have but it's a double-edged sword. So maybe we could circle back in Q1 and we can talk about what we might see with the ramp.

Okay. So we're just kind of need to wait until we get some actual results and kind of see how the market develops? Or I mean, what type of forecast have you kind of baked in when you set the inventory levels with your manufacturing partners? Is there some kind of base safety stock that we could count on being converted to revenues? Or is it just way too early?

Well, it's way too early. But keep in mind what we've talked about in the past with this market. You've got about 9 or so providers that control 85% of the market. So for example, if you've got one of the big ones, you're looking at anywhere from 20 million to 30 million vials a year just for 1 customer. And so as we approach launch, and where what we're doing is we're trying to manage the inventory with 1 of 9 customers, really. Not that we don't want to service the rest of the 15%, but we've got to be careful on how we launch because we might take up a customer that's got such great need for the product that it could put a real strain on our supply.

And would you -- I'm assuming that you've had conversations with all 9 at this point. How would you kind of characterize the level of interest from those 9 big players?

I would characterize it, just like I said in my call, we've got strong demand for the product. I think any product in this space, as most people understand it, it can lower cost per treatment and it's equivalent or better then you're probably going to have a very, very good demand for the product.

Okay. And then back to Triferic for a minute. Obviously, you have some ESA-sparing benefits as shown by the clinical studies. But I'm trying to figure out in terms of pricing of Triferic where that value may be manifested. I mean, do you anticipate pricing this product equivalent with IV iron, or would it be at a premium to IV iron? Or how should we think about how aggressive you want to be in penetrating this product in the market, or maybe on the margin side?

Well, I mean, we're clearly going to be aggressive with any product that we sell. That's just our nature. We're going to be aggressive. We're going to try to get as much business as possible. But what we'll do what is we've always done with all our other products, including CitraPure. CitraPure is a great example. We'll show the clinical benefit. We'll work that into a reduction in cost per treatment. And then we'll price the product at a premium where the provider can still lower their cost per treatment. But I'm not going to get into specific numbers on how we'll price the product.

Our next question comes from Jim Malloy of Summer Street.

Could you talk a little bit about, knowing that the panel -- the FDA doesn't always follow the panel, but an 8 to 3 vote is certainly a nice indication of how the panel suggests the FDA should go. Can you talk a little bit about your confidence of going into January? And then, again, you mentioned the ESA-sparing, nice to have, not necessary to have. What impact could that have? Do you think, on sales, is it something that at some point you'll say, "You know what, let's run that trial and see if we can get that ESA-sparing in there?"

I'll answer the first question and let Ray answer the first part of that. Yes, we don't -- I don't view that we'll have any better or worse impact when we launch based on having ESA in the indication. The PRIME study speaks for itself. The CRUISE studies also demonstrate an ESA-sparing effect. I think Ray would tell you, our guess is that the PRIME study will find its way onto the label somehow, some of the data, it just won't be any indication. And then I'll say again that we're in an industry where any little bit of savings makes a big difference. But as far as your -- the first part of your question, I'll let Ray answer that.

Yes. This is Ray, and can you repeat the first part of the question again because I think we're sort of mixing in things but...

Yes, sure. Just knowing the FDA doesn't always follow the panel, but an 8 to 3 vote is certainly a high level of confidence for a positive panel. And your thoughts going into the panel or going into the PDUFA date.

Yes. I mean, actually, we can't really speculate on the FDA. But again, we're at the -- in the panel discussions and everything. It was very clear that they agreed with a lot of our approaches, and that we have a high degree of confidence that we will be successful.

And then any discussions, well, maybe hard to talk about on a call like this, but any discussions with Baxter? Or should we expect any discussion that might come up regarding Calcitriol and Triferic? Are those 2 that make sense for Baxter or those something that's just outside of what they even look at?

So I'll defer Jim to your first comment that it's not something we can go into a -- in discussion with you.

Okay. And then maybe -- it's the last question. I know you mentioned gross margins going up with the Baxter deal and top line. Is there a percentage change on the top line? Do you expect to come down or number change you expect '14 to '15 the change with the Baxter that will go down but gross margins will go up? How do you see the top line changing?

Jim, I would expect the top line sales to decrease by a bit below $10 million on an annualized basis.

Got it. And then, ultimately's, was there -- again, this may be something you can't discuss on a call like this as well, or any call really, but do you think there's an appetite for Baxter at some point just to reach out or pick up Rockwell entirely? Or again is that something that isn't their business? They wouldn't be doing that.

Well, I can't really go into any kind of answer on those kind of questions.

Our next question comes from Ling Wang of Chardan Capital.

Can you give us some color on how do you expect the potential launch for Triferic to unfold, I guess? This is a paradigm shift kind of therapy and the clinical benefit is definitely there. That need is there. But given the client base is so concentrated, how do you -- I mean, how should we be thinking about the adoptions to unfold? I mean, do you expect large -- I mean, with any client kind of initial large adoption or stage-by-stage? I mean, can you give us some color there?

Well, I mean, the most I can say there is we anticipate an aggressive launch and high demand for the product. I think some of the larger chains would most likely evaluate it for a period of time. And I think there'll also be some smaller chains and smaller clinics that would just adopt to it immediately. I think it'd be very similar to, again, I'll reference to our CitraPure product. When we launched that product, we had some customers that just moved to it right away and our largest customer did a 6-month evaluation with that product. That was maybe even a little relatively more new than iron because no one had used -- although citrate's been around forever, nobody had used it and completely removed acetate. So they had to get some data on it. I think with our clinical studies and 2 years worth of participation from a lot of the big customers in the country, they have a familiarity with the product that I think will be helpful when they -- if and when they decide to do an evaluation. But I just see some doing an evaluation and some not and we'll be pretty aggressive. And I think again in this market, like you mentioned, it's concentrated and then like I mentioned earlier, it's driven on reducing costs and improving clinical benefit and we believe Triferic does both.

Great. And also, can you also comment on the manufacturing of Triferic? I mean, if the approval occurs in time, how long does it take you to actually launch the product?

Well, there's really nothing I can comment on the manufacturing at this point. I think we'll have a better idea as we get into the first quarter what that launch might look like in terms of time to the market.

I see. And also, Rob, any feedback you might get from your clients about the PRIME data? How do they deal the ESA-sparing part of the jury [ph] based on the PRIME data?

I don't want to -- I can't speak for any of them. But we haven't had any negative feedback on the ESA-sparing data. And it is data that everybody is very focused on in terms of if you can get any kind of reduction in ESA or any other drug for that matter. But as we know, ESA is very expensive. It's very beneficial.

Our next question comes from Annabel Samimy of Stifel. Annabel Samimy - Stifel, Nicolaus & Company, Incorporated, Research Division: I just wanted to ask you about, I guess, some of the conversations at the panel. It seemed that the FDA statisticians were really hung up on the randomized controlled portion of the trial and I guess this forced artificial environment. And they didn't seem to be focused at all on the open-label part, and so I guess will they be looking at that totality of that data? And in conversations or in your conversations with the FDA, if you've been having conversations, do you get a sense that they are looking at that totality of the data given the limited focus they had on the panel?

Ray, why don't you go ahead?

Yes. I mean, yes. They had to be focused on the primary end point which was in the randomized controlled parts of the study and rightly so. But they have all of the available data from the open-label studies, the PRIME studies and all the other studies we've done. And so, again, that's -- they will -- it's not just the statistician, it's the clinical reviewer, it's the whole clinical team that makes the decision there. So again, we were very, very happy and pleased with the fact that the Advisory Committee understood the -- in fact, many of them really understood the difficulty in doing this type of trial that nobody has ever done before. And I think that we'll just wait and see and work together with the FDA for a successful outcome. Annabel Samimy - Stifel, Nicolaus & Company, Incorporated, Research Division: Okay, that's good to know. Is there any further data that you need to be providing to them at this point? Any additional safety data that you could provide? Or do they have everything they need at this point?

At this point, the FDA has everything that we have. Annabel Samimy - Stifel, Nicolaus & Company, Incorporated, Research Division: Okay. And just another question with regard to the design. It seemed that -- actually, almost seemed puzzled about the design, or at least the statisticians did. And I guess, why -- what was the source of this puzzlement if it was established with their input?

Go ahead, Rob.

Yes, I was going to say. We didn't get that. I mean, if you listened to the presentation that the FDA let off with, they clearly stated in their presentation that they had input with the design and that it was unique. And so we didn't get that there was a lot of puzzlement with it. But obviously, it's different than a lot of other studies. So as you saw in that meeting, in that panel, we had -- there needed to be some clarity and people had to understand the design and the maintenance therapy and how it was set up, and with ESA being held and -- I mean, that's how we viewed it, Annabel. Annabel Samimy - Stifel, Nicolaus & Company, Incorporated, Research Division: Okay, all right. No, that's fair enough. Okay, just One last question. I guess, it's more housekeeping stuff. Can you just tell us, with the $50 million equity investment, the $8 million from the cash -- I'm sorry, from the warrants. What should we expect your share count to be going forward? I just wanted to make sure we have that calculation right. And what was the share count for this quarter for that matter because we don't have that.

So we finished the quarter with approximately 41 million shares. And then with the additional shares we issued, we have 43.6 million currently outstanding -- 43.6 million currently outstanding. Annabel Samimy - Stifel, Nicolaus & Company, Incorporated, Research Division: That's including all the other issue...

The shares issued related to the warrants and the Baxter.

We have a follow-up question from Charles Haff of Craig-Hallum.

Just some clarification on the manufacturing of Triferic. I would assume the FDA would want to legitimize or just make -- do their inspections of the manufacturing facility. But it sounds like you're [ph] still haven't decided on the manufacturing of Triferic. Can you just give us more color on that because I would think the FDA inspection would be including manufacturing.

So we have, as I stated, 1 primary and 2 others. All 3 of those facilities have been FDA-inspected.

Okay. Sorry I missed that detail.

Is that Calcitriol or Triferic, Charles?

Triferic.

Oh, Triferic. Okay. So for Triferic, we've got -- the contract manufacturers for Triferic have also been inspected -- FDA-inspected. So same answer, different drug.

At this time, I'd like to turn the call back over to Rob Chioini for any further remarks.

Thank you. We just want to thank you for joining us today and we appreciate your time and continued support.