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Rockwell Medical, Inc. (RMTI)

Q4 2011 Earnings Call· Thu, Mar 1, 2012

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Transcript

Operator

Operator

Thank you, and welcome to the Rockwell Medical's Fourth Quarter 2011 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 uncertainty, 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 would now turn the call over to Mr. Rob Chioini, Chairman and CEO of Rockwell.

Robert Chioini

Management

Good morning. Thank you for joining us. This morning, I will briefly cover fourth quarter operating results and I will update our SFP clinical study progress as well as our Calcitriol progress. Fourth quarter of 2011 revenue was just under $12 million, and gross profit was $1.5 million. Sequentially, fourth quarter 2011 revenue was essentially the same and gross profit was up slightly from third quarter 2011. Gross profit margins increased 1.5 percentage points sequentially. For the year, revenue was $49 million and gross profit was $5.6 million. As we've mentioned to each quarter this year, our sales and gross profit in 2011 was affected by a single international distributor, who did not order the same amount of product as they did in 2010. Net loss for the quarter was $9 million compared to a net loss of $1.7 million in the fourth quarter last year. R&D spending increased significantly in Q4. We spent $7.9 million compared to just $1.7 million in Q4 2010. The R&D spending was expected and reflects the accelerated patient enrollment in our 3 ongoing clinical studies. Cash and investments at the end of the fourth quarter were $17.5 million compared to $20.2 million in the previous quarter of this year. Regarding our cash, we just increased our position significantly from a recent stock financing that netted $16.2 million. Our pro forma cash balance is therefore approximately $33.7 million post-financing. The financing is targeted for clinical development and provides the company an ample cushion for any unexpected costs that may arise prior to SFP commercial market entry. The financing was done by high-quality institutional investment funds and we are pleased with their participation and support of Rockwell. Now turning to SFP clinical progress. As you know, our CRUISE studies and our PRIME study have been ongoing…

Thomas Klema

Management

Thank you, Rob, and good morning everyone. I'll provide a financial review of the fourth quarter and the full year, as well as our financial position and cash resources. As a brief overview, our sales for the fourth quarter were $11.9 million, $2.4 million less than last year's fourth quarter due mainly to lower international sales from a single distributor. As a result of these lower international sales, coupled with inflationary pressures, our gross profit dollars were $800,000 less compared to last year's fourth quarter. Our fourth quarter R&D costs increased to $7.9 million in Q4, compared to $4.2 million in Q3. This was due to accelerated enrollment in our CRUISE and PRIME studies. Overall, our fourth quarter loss was $9 million, of which $7.9 million was R&D. For the quarter, we had non-cash charges for equity compensation of $1.25 million. Our cash and cash equivalents, including short-term investments, decreased by $2.7 million from the end of the third quarter. Exercise of warrants and options in the third quarter netted approximately $900,000. For all of 2011, our sales finished the year at $49 million compared to $59.6 million in 2010, again, due mainly to low international sales to a single distributor. Gross profit decreased $4.2 million, R&D costs were $17.8 million in 2011, while our total loss was $21.4 million, and we had $4.4 million of non-cash charges for equity compensation. In reviewing our sales, sales were $11.9 million in the fourth quarter, compared to $14.3 million the fourth quarter of last year. International sales were down $1.5 million, domestic sales were up $600,000 due largely to dry acid conversions. We also had a one-time R&D grant of $0.25 million in 2010 that did not recur in 2011. During 2011, our customers continued to convert to our dry acid concentrate…

Operator

Operator

[Operator Instructions] Our first question comes from Annabel Samimy with Stifel, Nicolaus.

Annabel Samimy

Analyst

I have a lot of financial questions, I think. First, with Calcitriol. You've mentioned that you're going to launch it in the second half. Can you help us understand the ramp there? Is it different than a typical drug ramp? Would you expect the acceleration -- what kind of cost would you incur with that ramp or is it just pure operating leverage?

Robert Chioini

Management

It's pure operating leverage, we expect the cost to be minimal. We expect the ramp will be rather swift based on our current customer base which we'll go after and target first, and actually have been doing now for several months.

Annabel Samimy

Analyst

Okay, great. And then on R&D, that operating leverage, I mean, is this $7 million the new run rate for R&D at this point? Is it going to offset all the operating leverage you have from that in Calcitriol ramp -- launch?

Robert Chioini

Management

The R&D expense should continue to operate in the sort of $7 million range, maybe a little bit more for a quarter or 2, and then it should reach its peak and then begin to diminish as the year goes on and as the trial begins to conclude.

Annabel Samimy

Analyst

And then for gross margin expectations. With the conversion to your new dialysate, what can we assume for gross margins into this year? If you have any, can you frame the case plan increase from that product mix?

Robert Chioini

Management

What was the last part of that question? Can we reframe what?

Annabel Samimy

Analyst

Can you quantify the expansion of gross margin with the product mix shift to your higher margin dialysate?

Robert Chioini

Management

Right, right. So are you talking about our dry acid product?

Annabel Samimy

Analyst

Yes, yes.

Robert Chioini

Management

So the dry acid product gives us a better margin. I defer to Tom here, but I think we're probably going to be dependent on some of the other costs. The inflationary cost that we might run into, gas being the most important, probably be in that 12% to 16% range.

Annabel Samimy

Analyst

So at 16% gross margin range or gross profit improvement? I imagine it's first margin -- I'm sorry, cost of goods [ph] range? Or I'm sorry, gross margin range?

Robert Chioini

Management

Yes, I think on the concentrate business, we'll continue to operate in the similar range to what we have historically over last year or 2. And then as we add the Vitamin-D volumes, that will have a large impact on improving our margins because of the difference in margin between the drugs and the concentrates.

Operator

Operator

[Operator Instructions] Our next question comes from Frances Wong with Canaccord Genuity.

Frances Wong

Analyst · Canaccord Genuity.

I have a question about CRUISE and PRIME data timing. Do you expect to announce PRIME study data before CRUISE or do you expect them to come out around the same time?

Robert Chioini

Management

PRIME data will come out approximately 3 months or 4 months before CRUISE data.

Frances Wong

Analyst · Canaccord Genuity.

Okay. And do you see any trends in iron management and bundling now that bundling has been out for a year? Has the market changed as you expected?

Robert Chioini

Management

Yes, I mean, going into the bundle, many of the dialysis providers had changed protocols on managing anemia and the most -- the 2 most significant changes were trying to reduce EPO and trying to increase iron use. And I think both of those things have happened to a certain extent.

Frances Wong

Analyst · Canaccord Genuity.

Okay. And do you see any price movements of your competitor Vitamin-D product?

Robert Chioini

Management

So there's 2 brand name Vitamin-D products, Hectorol and Zemplar, and then there's Calcitriol, which is that the generic version. Zemplar and Hectorol, at this time, pretty much split the market. The differences with Zemplar, you need 4 to 6 micrograms per treatment, and with Hectorol you need on average, 2 to 4, but with Calcitriol you only need 1 to 1.5. So Calcitriol on a per treatment basis, which is the way we'll price it in the marketplace, will be able to give the provider an edge or a reduction in cost.

Operator

Operator

I'm showing no further questions at this time. I would now like to turn the conference back to Rob Chioini for closing remarks.

Robert Chioini

Management

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

Operator

Operator

Ladies and gentlemen, this concludes today's conference. Thank you for your participation and have a wonderful day.