Paul J. Arndt - Former Senior Manager of Investor Relations Robert L. Chioini - Founder, Chairman, Chief Executive Officer, President and Member of Stock Option Committee Thomas E. Klema - Chief Financial Officer, Principal Accounting Officer, Vice President of Finance, Secretary and Treasurer Raymond Dennis Pratt - Chief Medical Officer.

Charles Haff - Craig-Hallum Capital Group LLC, Research Division James F. Molloy - Summer Street Research Partners Ling Wang - Chardan Capital Markets, LLC, Research Division Annabel Samimy - Stifel, Nicolaus & Company, Incorporated, Research Division.

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. On October 2, we entered into an exclusive commercialization agreement with Baxter.

I laid out the structure of this transaction previously, but I want to reiterate a few key points. The deal does not include Triferic or Calcitriol. It is exclusive to our concentrate asset. We continue to own and operate the business. Our customer service group takes and processes orders and our transportation group routes and delivers product.

Additionally, we will also continue to co-promote in support of Baxter. All costs to manage customer orders and deliveries are passed on to Baxter at a slight markup. This effectively eliminates our costs and risk on fuel and transportation. Gross margins begin in line with current margins and increase each year thereafter.

Cost increases are passed on to Baxter as well. We intend to expand our manufacturing and sales footprint in the West. We will receive $10 million to build a manufacturing facility which will service customers in the West and which we will continue to own and operate.

Interest expense will be reduced with the repayment of debt by the end of 2014, which is a meaningful amount of interest cost that will now flow in the RMTI's net profit. In summary, this deal brought us significant cash and enables us to increase margins and expand more rapidly in both the U.S.

and internationally, utilizing Baxter's global market presence and infrastructure. It increases revenue growth and immediate gross and operating margin expansion. Combined with the multiple cash investments by Baxter, this is a very strong and high-value partnership.

And Rockwell continues to operate and increase its brand presence in the concentrate market. Now let's talk about Triferic. Most of you, by now, are aware of the positive outcome from the FDA Advisory Committee meeting that was held last Thursday.

We obviously are extremely pleased with the panel's 8 to 3 vote in favor of Triferic to treat iron loss and maintain hemoglobin in hemodialysis patients. The efficacy and safety studies formed a convincing body of evidence showing that Triferic works as proposed.

And the totality of the data support the clinical benefit, safety profile and unmet medical need. We are very excited to bring this important drug to the market and we look forward to working with the agency in accomplishing this goal. Our PDUFA date is January 24, 2015.

Based on their comments during the meeting, it appeared the majority of the panel members agreed that Triferic effectively delivered iron and maintain hemoglobin.

We are also extremely pleased that the nephrologists on the panel, in particular, support our belief that the current medical practice of using IV iron to address maintenance therapy is not satisfactory.

We heard discussion about the limitations and risks of IV iron use, including infections and the need to replace iron in this patient population in a physiological and safe manner.

So as we start thinking about commercializing Triferic and the positioning of the product in the marketplace, we are convinced that there is a genuine unmet need that Triferic addresses. With respect to ESA-sparing in the PRIME study, we note that the panel was not asked to vote on the inclusion of this claim in our indication.

And while the data from the PRIME study are positive and provides solid evidence on the ESA-sparing effect of Triferic, the panel noted that it was a single trial.

We view the CRUISE studies as further supportive evidence that Triferic is able to reduce the need for ESA as the placebo arm showed hemoglobin concentration declining when the ESA dose was held constant. This means that to keep hemoglobin stable in the placebo arms, the ESA dose needed to be increased.

The 0.36 gram per deciliter difference between Triferic and placebo in the CRUISE studies is about equivalent to the same ESA decrease we saw in the PRIME study because the decrement in hemoglobin in both studies was similar. So we view all 3 studies, the PRIME and 2 CRUISE as compelling data showing Triferic is able to reduce ESA.

However, we are currently certainly supportive of the panel's view that further study would be valuable in further exploring this benefit. I would like to take this opportunity to thank my entire clinical team, including Drs.

Pratt, Gupta, Lynn [ph] and Fishbane who did an exceptional job in preparing and presenting our clinical data and addressing the questions from the FDA in the panel.

On the heels of this positive majority vote from the Advisory Committee in favor of Triferic to treat iron loss and maintain hemoglobin in hemodialysis patients, we have a body of work that is now in the public domain and that clearly demonstrates what Triferic is, how it works and why it is so special, and that Triferic has the potential to become the standard of care for iron delivery for dialysis patients in the U.S.

once approved by the FDA. This would be the first FDA-approved maintenance iron therapy. As we think about post-FDA approval and positioning Triferic in the market, the AdCom meeting provided us an excellent platform to educate dialysis providers and patients about Triferic, its use and its potential benefits as an iron maintenance therapy.

The briefing book, the slide presentation and the discussion that followed were and will continue to be an ideal vehicle for educating potential customers about how Triferic can address their needs and provide important clinical benefits.

As you know, dialysis providers are very interested in improving patient outcomes and reducing their cost per treatment. And the Triferic clinical data has clearly shown that it accomplished both.

Our many years of success in launching new products into the renal market, coupled with the first-ever maintenance iron therapy able to address the ongoing iron loss in dialysis patients and the potential clinical and pharmacoeconomic benefits included give us great confidence that we will have rapid uptake in sales upon commercial launch of Triferic.

Regarding our Calcitriol launch, we have a solid prelaunch demand. We have one manufacturer producing product, while 2 others are in the process of starting production. Our current launch plan is to start supplying customers in Q1. We anticipate solid commercial success with Calcitriol.

Regarding our ongoing business development efforts, we continue to evaluate numerous opportunities both out-licensing and in-licensing. In our discussions, our goal is to obtain the highest-value partner and economics. I will now turn the call over to Tom for his comments on the financial results..

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 quarter last year. Gross profit in the third quarter of 2014 was $2.3 million, an increase of 39% or $600,000 compared with the third quarter last year.

A more favorable product mix of higher margin products, particularly CitraPure product and our dry acid product, was the primary driver behind the increased gross profit margins. Gross profit was $6 million in the first 9 months of 2014 compared to $4.6 million in the first 9 months of last year, an increase of 29.8%.

Gross profit margin for the first 9 months of 2014 was 15%, compared to 12% for the first 9 months of last year. The increase in gross profit was primarily due to the increase of the favorable impact of higher sales of our CitraPure product, strong sales of our other higher-margin products and our efforts to reduce our operating costs. On SG&A.

Expense for the third quarter was $4.1 million compared to $3.4 million last year. Noncash equity compensation was $1.9 million in both quarters. Increased costs for personnel, marketing and intellectual property expenses related to preparation of our anticipated drug product launches accounted for the increase.

SG&A expense for the first 9 months was $12.4 million compared to $10.5 million in the first 9 months of last year. Noncash equity compensation expense was $6.3 million compared to $5.9 million in the first 9 months of last year.

We also incurred higher personnel, marketing and related costs in support of current and prospective changes in business activity related to our anticipated drug product launches. On R&D. Our third quarter expense fell to $1.3 million compared to $10.6 million last year.

And for the 9 months, our expense was $6.1 million compared to $33.6 million for the first 9 months of last year.

Lower spending as a function of completion of the Triferic clinical trials and the progression of the related regulatory review process, future R&D development and product costs spending on Triferic is expected to continue to look like the current levels in the next quarter or 2.

The net loss for the quarter was $4.0 million or $0.10 per share compared to $13.2 million or $0.34 per share in the third quarter last year. Net loss decreased $9.2 million from the third quarter last year. Net loss was $14.9 million for the 9 months compared to the loss of $40.5 million in the first 9 months of last year.

Net loss decreased $25.5 million and R&D decreased $27.5 million. The net loss for the first 3 quarters was $0.37 per share compared to $1.32 last year. So on liquidity and capital resources -- turning to our capital resources.

We had $12 million in cash and investments at the end of the third quarter, which was slightly more than the $11.9 million in cash we had at the end of second quarter. In addition, as we've discussed, we received $43 million in cash in early October, giving us over $55 million in combined cash resources.

We received $8 million in proceeds from the exercise of warrants in early October. And as you also may be aware, Baxter Healthcare Corporation invested $15 million in Rockwell common shares, receiving 1.3 million shares at $11.39 per share.

Baxter paid us $20 million in consideration for an exclusive dialysis concentrate distribution agreement, including sales and marketing of our dialysis concentrate solutions, primarily in the United States and in select foreign markets.

I want to take a moment to provide some perspective around the Baxter distribution agreement and what we expect going forward. In the fourth quarter, we expect our results to look just as they have historically. In 2015, it is our expectation that we will see our reported gross profit increase on our concentrate business licensed to Baxter.

Our sales will be lower but our costs will also be lower as Baxter will be responsible for transportation and delivery of the concentrates. We will recognize revenue related to the $20 million upfront fee from Baxter over the term of the license agreement.

We anticipate our reported gross profit to be approximately $1.2 million higher on our domestic concentrate business in 2015 vis-a-vis 2014 on an apples-to-apples basis.

Our future gross profit is anticipated to increase over time due to both guaranteed increasing gross profit margins as well as due to higher unit volumes from both domestic and international expansion.

We expect our overall domestic and global concentrate sales to increase in the long term as a result of the expanded marketing channel provided by Baxter as well as the anticipated expansion of our manufacturing operations in the Western United States as a result of the distribution agreement.

As we look forward and as we think about our cash requirements, our future cash requirements for our operations are anticipated to be primarily related to working capital for the launch of Triferic and Calcitriol. We expect our drug launches to require only modest amounts of incremental personnel resources beyond those already in place.

We also anticipate significantly lower spending on research and development for the remainder of 2014, and for the 2015 research and development spending to be at or below 2014 levels at this time. Upon commercialization of Triferic and Calcitriol, we anticipate a significant improvement in cash flow and to achieve a profitable level of operations.

We plan to retire our existing long-term debt later this year. This will eliminate the interest expense from our P&L which, in the first 9 months of 2014 has been a $2.6 million expense. We intend to eliminate that lability from our balance sheet and the associated interest expense from our P&L for 2015.

We believe our cash resources are sufficient to meet our foreseeable requirements at this time. In addition, we may also realize cash upon licensing of our products outside the United States or other business arrangements we may make related to our drug products. I'll now turn the call back to our operator for Q&A..

[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..

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..

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..

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..

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..

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..

Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Everyone, have a great day..