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Rockwell Medical, Inc. (RMTI)

Q3 2012 Earnings Call· Thu, Nov 8, 2012

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Transcript

Operator

Operator

Thank you, and welcome to Rockwell Medical's Third Quarter 2012 Conference Call. We appreciate your continued interest in the company. Today, from Rockwell, are Rob Chioini, Chairman and CEO; and Tom Klema, Chief Financial Officer. Before we get started, I would like to remind everyone that this conference call may contain forward-looking statements. All forward-looking statements involve risks and uncertainties, including, without limitation, the risks detailed in the company's filings and reports with the Securities and Exchange Commission. Such statements are only predictions and actual results may differ materially than those projected. I will now turn the call over to Mr. Rob Chioini, Chairman and CEO of Rockwell.

Robert Chioini

Management

Thank you. Good afternoon. Thank you for joining us. I will cover 4 areas with you today. The first is third quarter numbers, second is our SFP clinical progress, third is Calcitriol and our progress on commercial launch and fourth is our financial resources. Let's start with the quarter. We had a solid third quarter. Third quarter 2012 sales revenue was $12.7 million, an increase of 6% over the third quarter of 2011. Sequentially, sales increased 4.7% from the previous quarter. Gross profit was up 19.6% over the third quarter of 2011. Gross profit margins increased to 13%. We expect continued sales and margin growth in our operating business going forward. R&D for the third quarter was $16.2 million. As we stated on the last call, we expected R&D expense to peak in the third quarter. The increase in R&D expense was largely a result of faster enrollment in our long-term safety study. The safety study is needed for FDA approval, and we had anticipated the enrollment cost would occur over a few quarters, but the study enrolled much faster than our clinical team expected, and as a result, the bulk of the enrollment cost occurred in the third quarter. Net loss for the quarter was $17.9 million compared to net loss of $5 million in the third quarter of 2011. Third quarter loss was due primarily to our clinical work for our lead drug candidate, SFP. Cash and cash equivalents at the end of the third quarter were $11.3 million. We expect our business operations, excluding R&D, to continue to be cash flow positive and to build momentum through 2013. Now let's turn to our SFP clinical progress. As you know, earlier this year, we completed patient enrollment in both of our Phase III clinical studies for delivering SFP-iron…

Thomas Klema

Management

Thank you, Rob, and good afternoon. I'll provide a financial review of the third quarter, as well as our financial position and cash resources. In reviewing our sales, sales in the third quarter increased to $12.7 million compared to $12 million in the third quarter last year. Sales increased $700,000 or 6%, the result of both domestic and international sales increasing over 2011. Sequentially, our sales increased 4.7% or $600,000 versus Q2. Sales in the first 9 months of 2012 were $36.8 million compared to $37.1 million in the first 9 months of 2011 with $300,000 decrease in sales during the first 9 months attributable to lower international sales from one international distributor for the first 9 months of 2011. Otherwise, international sales increased $600,000, while domestic sales increased by $0.5 million. Domestic sales were up $0.5 million, higher than the first 9 months last year due to customers converting to our Dry Acid Concentrate product line, which offers a lower cost per treatment. The Dry Acid product line reduces our sales, but improves our gross profit margins by reducing shipping and transportation costs. On the gross profit, our margins in the third quarter of 2012 increased to 13% compared to 11.5% in the third quarter last year, an increase of 1.5 percentage points. Gross profit dollars in the third quarter increased by 19.6% to $1.6 million, an increase of $300,000 compared to the third quarter last year. This increase in gross profit was due to new business, improving product mix, increased sales of dry acid concentrate products and reduced operating expenses compared to the third quarter last year. For the 9 months ended September 30, gross profit increased -- into -- increased to $5 million compared to $4.1 million in the first 9 months last year. Gross profit margins…

Operator

Operator

[Operator Instructions] Our first question comes from the line of Carol Werther with Summer Street.

Carol Werther

Analyst

I'd like to ask about the CRUISE trials. I think that the labels on the ESAs change during the trial, the range of hemoglobin, might that affect the result in any way?

Robert Chioini

Management

No, good question, Carol, but that was back in a year ago June. So not this last June, a year ago June 24, 2011. And when that change came out, we worked with the investigators and the participants altered or amended the protocol and had the IRBs rereview the protocol and approve it. And so all those changes have been accounted for.

Operator

Operator

Our next question comes from the line of Annabel Samimy with Stifel, Nicolaus.

Annabel Samimy

Analyst · Stifel, Nicolaus.

In terms of CRUISE-1 and CRUISE-2, you mentioned that you -- earlier that you expected CRUISE-1 to read out before CRUISE-2. Is that still on track?

Robert Chioini

Management

We believe that will be the case. We expect CRUISE-1 to read out before CRUISE-2. We'll know more as we get closer to the end of the study.

Annabel Samimy

Analyst · Stifel, Nicolaus.

Okay. And kind of on a more macro level, considering the recent election win for Obama, do you think that has any kind of play out into the dialysis market in terms of making reimbursement of it tighter?

Robert Chioini

Management

No, we don't see any impact to reimbursement in ESRD from the election.

Operator

Operator

Our next question comes from the line of Daniel Bailey with Rochester Wealth Management.

Dan Bailey

Analyst · Rochester Wealth Management.

I know you were out at the ASN Conference last week. I was hoping that maybe you could give us a recap of your activities out there.

Robert Chioini

Management

Well, we didn't present any data to ASN. The ASN is always an important meeting. It's an international meeting. We have a lot of business development-type meetings and activities going on, and it was a very effective week for us.

Dan Bailey

Analyst · Rochester Wealth Management.

So that was just basically a good networking event for you then.

Robert Chioini

Management

Yes, it's a good networking event. It's a good business development event, and you also -- we also have an exhibit where we have our products on display.

Operator

Operator

Our next question comes from the line of Ritu Baral with Canaccord.

Whitney Ijem

Analyst · Canaccord.

This is Whitney on for Ritu. I dropped off the call for a second so forgive me if I -- if this is repeat. But do you have any data on the baseline ESA doses in the CRUISE trials?

Robert Chioini

Management

We don't have any data that we share at this point.

Whitney Ijem

Analyst · Canaccord.

Okay. Do you have a range that you're expecting at all? Or do you expect it to be range of dose baseline in terms of [ph] trial start?

Robert Chioini

Management

No, I mean, we really have no information at this time.

Whitney Ijem

Analyst · Canaccord.

Okay, okay. Do you expect it to be equal to Phase II or lower?

Robert Chioini

Management

I really can't give you an answer on that. So the best answer is if you've got another question, we should move on to that.

Whitney Ijem

Analyst · Canaccord.

Okay. And then, again, forgive me if you already answered this, but is there any more information on the timing of the Calcitriol NDA?

Robert Chioini

Management

So yes, you must have missed the -- as we stated on the call, our manufacturing -- our stability batch is going to be manufactured this coming week. The NDA is already approved so we just need an approval on the manufacturing facility.

Operator

Operator

[Operator Instructions] I'm showing no other questions. I'll turn it back to management for any closing statements.

Robert Chioini

Management

Great, thank you. Thank you for joining us today. We appreciate your time and your continued support.

Operator

Operator

Ladies and gentlemen, this does conclude today's conference. You all may disconnect, and have a good day.