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Rockwell Medical, Inc. (RMTI)

Q3 2008 Earnings Call· Thu, Nov 13, 2008

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Transcript

Operator

Operator

Good day everyone and welcome to the Rockwell Medical Technologies, Inc. third quarter 2008 conference call. This call is being recorded. At this time, I would like to turn the conference over to Ms. Jessica Lloyd. Please go ahead ma’am.

Jessica Lloyd

Management

Thank you and welcome everyone to our third quarter 2008 conference call. We appreciate your continued interest in our company. I’m Jessica Lloyd from the Trout Group; and with me today is Rob Chioini, Chairman and CEO, and Tom Klema, Chief Financial Officer of Rockwell. Before we get started, I’d like to remind everyone that this conference call may contain forward-looking statements. All forward-looking statements involve risk 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 will now turn the call over to Mr. Robert Chioini, Chairman and CEO of Rockwell.

Robert Chioini

Management

Thank you, Jessica. Good afternoon. Thank you for joining us today. I’m proud to report another quarter demonstrating strong sales growth for Rockwell. Sales were $13.5 million for the quarter, a 22% increase compared to the same period in 2007. I will address Rockwell’s progress in developing our lead drug candidate SFP and then I’ll pass the call on to Tom Klema, our CFO, to explain this past quarter’s financial analysis. I do want to note that we just returned from the American Society of Nephrology Conference, which took place in Philadelphia last week, and we were pleased to experience a high level of enthusiasm and interest in SFP amongst our clinical investigators as well as nephrologists both in the US and abroad. SFP represents an innovative opportunity to physicians to effectively manage iron therapy for patients suffering from end-stage renal disease, which is a population of approximately 370,000 in the US and 1.2 million worldwide. We are making progress in the two ongoing SFP clinical studies, the NIH funded study and our FDA Phase IIb study. The NIH study is a 9-month, 30 patients, multi-site study comparing SFP and IV iron. It was examined in maintenance of hemoglobin, iron parameters, need for IV iron, and oxidative stress markers in patients receiving SFP via dialysis. We remain on schedule with patient enrollment and estimate data results in late 2009. Our FDA Phase IIb dose-ranging study is a 6-month, 25 to 30 sites study with 100 to 120 patients. The primary objectives are to evaluate both safety and efficacy of SFP in varying dose levels and to determine the optimal concentration that will maintain iron balance within the target hemoglobin range in patients undergoing hemodialysis. As in many clinical studies, enrollment has presented some challenges for us, and as a result…

Tom Klema

Management

Thank you, Rob. And I will now provide a financial review of the third quarter along with a summary of our financial position. As Rob mentioned, we experienced solid sales growth in the third quarter with sales up 22.2% over the last year’s third quarter. Sequentially, sales increased 11.1% in the third quarter compared to the second. Our net loss was $2.5 million, of which R&D was about $1 million and $750,000 was for legal settlement. There were also non-cash charges for stock options and warrants of about a third of a million, depreciation was about a $0.25 million for the quarter. The core business after adjusting for these non-cash items lost about $150,000. The primary reason for the lower gross profit and loss in the core business operations was due to distribution cost rising dramatically in the third quarter. Much of the short-term increase in distribution and transportation cost was due to record diesel fuel cost which peaked in the third quarter. However, the recent dramatic drop in diesel fuel prices should positively impact our fourth quarter gross profit margins compared to the third quarter. We expect to see an improvement in cash flow this quarter. Sales in the third quarter of 2008 were up $2.5 million and were 22.2% higher than last year’s third quarter. Sales of our dialysis concentrate product lines which represented over 95% of our sales in the third quarter increased approximately 24% compared to last year. Sequential revenue increased 11.1% over the second quarter. Sales increased $1.35 million from the second quarter and our international sales were up $1 million, with 60% of that servicing key distributors in Latin America. Sales in the first nine months of 2008 were $38.1 million for sales growth of $7 million or a 22.6% increase for the first…

Operator

Operator

(Operator instructions) We’ll have our first question from Todd Lewis [ph], South Street Capital [ph]. Todd Lewis – South Street Capital: Hey, guys. Good quarter. Thanks for taking my call. Just a quick question for you. You mentioned the potential for SFP extensions and opportunities in other markets. Are there any that you would carry higher priority in evaluating over others?

Rob Chioini

Analyst

Really, we see significant opportunity in each application I mentioned. We have already received results from a study completed at Harvard, demonstrating that SFP is the only iron soluble in TPN solution, and we are about to start a clinical study demonstrating SFP’s effectiveness in PD solution, but probably the market will move on the quickest in that group in the oral iron prescription market. We’ve done a fair amount of diligence in that area and its potential is very large. It’s a very large market in which our USP grade formulation of SFP appears to have a solid opportunity in. The oncology market is also very attractive.

Operator

Operator

(Operator instructions) We’ll go next to Laura Jennings [ph] with Strategic Investments. Laura Jennings – Strategic Investments: Hello. Thanks for taking my call. I just have a quick question. You said in the past that SFP has patents issued in the US, Europe and Japan, I believe. Do you plan on taking SFP into Europe and Japan yourself or will you look for a partner?

Rob Chioini

Analyst

We have made the decision to work with a pharma partner in those countries and we’ve already begun preliminary discussions with a few potential partners. A partnership would allow us to gain an experienced partner in a territory that they’re established in with an established clinical and marketing team, so that’s really why we’re going to go that route overseas or abroad. Laura Jennings – Strategic Investments: Thanks.

Operator

Operator

We’ll go next to Tom Andrea [ph] with TD Ameritrade. Tom Andrea – TD Ameritrade: Hello, guys. Nice quarter. I have a question. There is currently a firm out there that is looking for marketing approval on another iron drug called Ferumoxytol. I’ve got a couple of parts to this question. Are they addressing the same market in dialysis as we have? And also, should they not gain marketing approval here near-term, does that have any effect at all on Rockwell?

Rob Chioini

Analyst

Tom, the Ferumoxytol product is based on the company’s own public disclosing is primarily going to be used or targeted to Stage III and Stage IV CKD, Chronic Kidney Disease. They will, I believe – if they get approval, I believe they’ll attempt to do some business in Stage V. As far as their effect on us, whether they get approval or not, we do not think it will have an impact on SFP one way or another. It’s an IV-iron product. It has – it’s more similar to the current IV-irons on the market than it is to our product. And again, SFP is a totally different technology that will maintain iron balance as opposed to replete iron balance, which is what the IV-iron products do. Tom Andrea – TD Ameritrade: Okay. Basically, I mean, what is the difference or the method of action on the SFP versus Venofer or the different irons that are being used now? What advantages do we feel that will make the nephrologists take a look at Rockwell’s product and say, this is definitely a far superior product?

Rob Chioini

Analyst

Well, I mean, I think we’re seeing that being demonstrated currently in our clinicals but the main difference – there’s a handful of differences. The main difference is the way the product is delivered through the dialysate while the patient is sitting in the chair, getting their regular treatment. They get treatment three times a week. And currently, today, when they’re sitting in that chair, every couple of weeks, the doc will – or an anemia manager, a nurse will give them a bolus of IV-iron, and they have to take their time and do it over 15 minutes with a needle and a syringe. With SFP, the product is delivered through the dialysate. It’s replacing the blood that’s being lost during that treatment, which is about 5 mg to 7 mg of blood and therefore, maintaining the balance. It’s like dietary iron. It’s constantly maintaining their iron balance. The other difference is it does not trail up to the liver. It doesn’t store in the liver. It’s not toxic to the liver. It goes direct to the bloodstream. It also should have a significant advantage in the bundling environment that will go into effect in 2011 for CMS reimbursement. Tom Andrea – TD Ameritrade: Okay. Just a question for Tom Klema. Tom, we’ve stated here again with these narrow margins we’re looking at right now and I realize that diesel fuel and the commodity prices have had an effect. Now, going forward, when contracts renew or new contracts were writing, do we have any protection that, say, the economy covers and oil goes through the roof again, do we just have to eat that or do we have any protection or anything against it?

Tom Klema

Management

Well, Todd, I think they are sort of few things. One is on the material side, we’ve entered into shorter-term contracts and there we locked in our costs for the year ahead, so we’ve got some visibility. And then, we’ve added fuel surcharges in a number of cases with our customers and we also have kept the pricing contracts fairly short term, so we’re not exposed on a longer-term agreement with the customers. And on the fuel, it’s a bit of a rollercoaster. It looks like it’s headed to a favorable change this quarter. It looks like our cost is going to be down fairly significantly. As I mentioned, we think the overall operating cost will be down between $250,000 to $300,000 range, maybe a little bit more but it is a difficult environment. We haven’t seen high inflations since the 80s and we’ve been in a high inflation environment for the last – really for the last year here. Tom Andrea – TD Ameritrade: Okay, one last question, Tom. Are we seeing people go over from the liquid concentrate? Are they moving toward the dry seat among even existing clients or are we flat in that area?

Tom Klema

Management

No, we’ve seen a steady migration to dry. Just in really the last quarter, we saw the dry vines go up again and the liquid drum volume go down a little bit. Tom Andrea – TD Ameritrade: Okay. I think that pretty much covers what I have to say. Thanks guys.

Rob Chioini

Analyst

Thanks.

Operator

Operator

And that does conclude the question-and-answer session. I’ll turn the conference back over to Mr. Chioini for any additional or closing remarks.

Rob Chioini

Analyst

Thank you for listening today. Thanks for listening to our third quarter earnings call. We will keep you updated as we look forward to continuing success with the SFP development program. Thanks.

Operator

Operator

That does conclude today’s conference. You may disconnect at this time. We do appreciate your participation.