Earnings Labs

Rockwell Medical, Inc. (RMTI)

Q1 2012 Earnings Call· Thu, May 3, 2012

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Transcript

Operator

Operator

Good day, ladies and gentlemen. We do apologize, there were technical difficulties. We thank you and welcome to - we appreciate your continued interest in the company. Today from Rockwell is Robert Chioini, Chairman and CEO; and Tom Klema, Chief Financial Officer. Before we get started, I would like to remind everyone that this 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 report with the Securities and Exchange Commission. Such statements are only predictions, and detailed 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

Good morning. Thank you for joining us. This morning I will cover first quarter operating results and then update our clinical development progress. First quarter 2012 revenue was $12 million and gross profit was $1.6 million. Sequentially, first quarter 2012 revenue increased 1.1%, gross profit increased 5.3%, and gross profit margins improved 1.1 percentage points. Net loss for the quarter was $10.6 million compared to net loss of $2.9 million in the first quarter last year. R&D spending increased dramatically in Q1 2012. We spent $9.4 million compared to $2.4 million in Q1 2011. The R&D spending was expected and reflects our accelerated progress in our ongoing clinical studies. Cash and investments at the end of the first quarter were $25.6 million compared to $20 million in Q1 2011. We expect an additional $10.4 million in cash to come in over the remaining months this year from expiring warrants. Turning to SFP clinical progress, we released news earlier this week that our PRIME study completed patient enrollment. This is an important milestone, and we expect to have the PRIME top line results available in February 2013. As you know, the study is designed to measure markers of inflammation and oxidative stress, but primarily to capture ESA-sparing data. ESA, best known as the drug EPO from Amgen, is the most expensive drug in dialysis and reducing its use is very important to dialysis providers. If data from the PRIME study demonstrates any amount of ESA reduction, we expect it will have an even greater impact on our current projected revenues once SFP enters the marketplace. Both our efficacy studies continue to progress. The CRUISE studies are the Phase III studies needed for FDA approval and are enrolling a total of 600 patients. We estimate the CRUISE studies will complete patient enrollment…

Thomas Klema

Management

Well, thank you Rob, and good morning everyone. I will provide a financial review of the first quarter, as well as our financial position and cash resources. In reviewing our sales, sales in the first quarter were - of 2012 were $12 million, compared to $13.3 million in the first quarter of 2011. The sales decrease of $1.3 million was largely due to reduced purchase volumes from one international distributor. Domestic sales were lower than the first quarter last year, primarily due to continuing changes in product mix resulting in lower sales dollars per unit. Many customers continue to convert to our Dry Acid Concentrate product line to lower their cost. This reduces our sales, but improves our gross profit margins by reducing shipping cost. Sequentially, our sales increased to $12 million from $11.9 million or $130,000 or 1.1%. Our international sales were up about 5.5% in Q1, and domestic sales were up about 0.5% compared to the fourth quarter. Sequentially, gross profit margins increased 0.5%. Gross profit margins in the first quarter were 13.5% compared to 12.4% in the first quarter of last year, an increase of 1.1 percentage points. Gross profit dollars in the first quarter of 2012 were about the same as the first quarter last year, even with lower sales volumes and higher fuel and material cost. This was largely a result of changes to product mix, notably our Dry Acid product sales expansion and its positive impact to gross profit. Net income, our net loss for the quarter was $10.6 million compared to a loss of $2.9 million in the first quarter of last year. R&D expense for the quarter totaled $9.4 million, reflecting the accelerated pace of enrollment in our Phase III clinical studies and our other R&D efforts. Overall, compared to last year, our R&D costs were up $7.0 million, while our overall costs increased $7.6 million. Of the $600,000 decreased income not attributable to R&D, $400,000 of that retained to non-cash charges for equity compensation. Our loss per share for the first quarter of 2012 was $0.54 compared to $0.17 last year. Our cash position, including our cash and short-term investments as of March 31, were $25.6 million. Our cash and short-term investments increased $8 million since the start of 2012. Our cash and other prospective sources of cash, including expiring warrants that we anticipate will bring in an additional $10.4 million in cash, possibly more, provide us with a substantial cash position to fund our operations, our clinical development programs and to support the company’s growth initiatives. I will now turn the call back to the operator for some Q&A.

Operator

Operator

[Operator Instructions] Our first question comes from Annabel Samimy.

Annabel Samimy

Analyst

I have a few. With R&D, it’s a little bit higher than we expected, I know it’s going to go up just fine, but is this run rate now or is it going to continue to increase from here or is this a level at which we should continue to expect R&D could be?

Thomas Klema

Management

Annabel, we would expect the R&D to kind of run in this $9 million to $10 million range in the second quarter. And then as the studies have completed enrollment, it should start to decrease a bit.

Annabel Samimy

Analyst

Starting into the back half of the year? Or is that after the studies complete?

Thomas Klema

Management

After the studies have completed enrollment, which will be in the second quarter, I would expect the third quarter to start to dip a little bit.

Annabel Samimy

Analyst

Okay, all right, great. And then you mentioned that you're launching Calcitriol towards the end of the year, is there any hold-up with FDA inspecting the plant or approving the plant or is there any delay there or is it just the typical timelines that you had expected?

Robert Chioini

Management

No delays, typical timelines.

Annabel Samimy

Analyst

Okay, all right. And then a final question. There are a number of products potentially entering the ESRD space that are not direct competitors, but may change the dynamics in the marketplace. I guess for one is Zerenex, that’s a phosphate binder, and I guess their claim is that they might reduce the need for iron as well as ESAs. And then there is also Affymax’s lower cost ESA that might change the pricing calculation. Can you just help us understand how you are factoring all these things into your outlook for both SFP demand and potential pricing flexibility into the future?

Robert Chioini

Management

Sure, yes, with the first product Zerenex, you know without getting into detail, we don’t view that product as a competing product. We don’t think it will have any effect on the SFP product whatsoever. The Affymax product obviously will and has already moved the ESA pricing down a certain degree, but the reality is, is no matter what it moves it down to, it’s still a significant amount. The average price at this time is somewhere hovering around $7,000, maybe a little more. Even if that price drops 10%, 20%, it’s still a huge number. And so with the ability to spare ESA, we still would anticipate a premium on the SFP product above and beyond the current pricing structure.

Annabel Samimy

Analyst

Okay, and just on the Zerenex issue, it’s not a competing product, but I guess, they're making claims that it might change iron needs. Any views on that?

Robert Chioini

Management

Again, our view is that, that product will not ultimately have any effect on our product, and when you get a product approved by the FDA, you still have to have somebody buy it in the market. And they may get approval, but then they'll have a challenge like many other companies, and in our view, a difficult time getting market adoption. As far as it being able to spare iron, like everybody else, I guess we’d have to see data.

Operator

Operator

Our next question comes from Mike King.

Michael King

Analyst

I just wanted to pick up where Annabel left off with regard to the call yesterday with DaVita, there was a lot of questioning on their dialysis margin and costs structure. And I guess they're locked into a long-term contract with Amgen. Just wondering how you guys think about in the sense of ESA-sparing, how the - the long-term contracts with certain performance minimums and such affect their willingness and ability to use SFP?

Robert Chioini

Management

So, Mike, you’re asking if we think it will have an effect on the SFP product in terms of - for example, DaVita gets ESA-sparing from SFP, but they have a contract with Amgen and are forced to purchase...

Michael King

Analyst

Right, to get the discounts. So if they use less - if they use less, they pay a higher price that affects your - their dialysis margin per patient. So, how does that - how does your strategy factor in with that reality?

Robert Chioini

Management

Well, for me to answer that I’d have to see the DaVita contract, but my guess is, censuses changes all the time in these dialysis clinics. So patients - you have new patients coming in, old patients moving out, and there's never any locked-in volume commitment that you're unable to address based on your census. So my guess is, and I - again I haven’t seen this contract, my guess is, if they have some minimums in there, the minimums that they can easily hit and they probably take into account any kind of reduction or increase in ESA. I can’t really comment too much on that because I don’t know what the contract looks like.

Michael King

Analyst

Well, if you see it, let us know. And then can you just tell us what the weighted average shares out were for the quarter?

Thomas Klema

Management

Yes, they were right around $19 million, Mike.

Michael King

Analyst

$19 million.

Thomas Klema

Management

Yes.

Operator

Operator

Our next question comes from Carol Werther.

Carol Werther

Analyst

When - I think you have a - this data safety in monitoring board meeting this quarter for the CRUISE trial, will we hear anything about that or no - is it no news is good news?

Robert Chioini

Management

Yes. We’ll put out another press release, Carol, like we have on the first two. And I believe that meeting will happen sometime in June.

Carol Werther

Analyst

Okay, great. And then could you just discuss a little bit further what kind of deal you’re looking for with the overseas partnership?

Robert Chioini

Management

Well, so there's 2 main areas that we’ve really had our focus on, and that’s Europe and Japan. And in Europe, we may actually have more than one partner when we look at that region. But by and large, we’re looking for a company that has the wherewithal to get the product into the market. If they have regulatory experience in that market, that’s a plus, and from a structure standpoint, it’s very, very, I guess, traditional structure with a fee upfront, double-digit royalty, some milestone payments.

Carol Werther

Analyst

Okay, okay. And could you just discuss a little bit further what other limiting - rate limiting factors to get Calcitriol approved?

Robert Chioini

Management

So the only rate limiting factor is the stability data being sent into the FDA and then the FDA looking at that data and saying it meets the criteria and saying you’re approved to go into the commercial market. The Calcitriol product is an approved product, but because we’ve changed manufacturing locations, we have to make a batch at that location, we have to get stability data into the FDA, and it will either be a 30- or 90-day stability data, and that’s why the estimate moves a little bit or we give some space to that. And then once they look at that data, we expect to get a green light from them to go ahead and start selling the product.

Carol Werther

Analyst

So you don’t know whether you have to have 30-day or 90-day stability?

Robert Chioini

Management

Well we're submitting with 30, and we expect 30 will be fine. But they could come back and say we'd like to see 90.

Operator

Operator

[Operator Instructions] Our next question comes from Brian Hepburn.

Brian Hepburn

Analyst

I just had a quick question about the shelf registration that was announced the other day. I mean, do you guys see that additional funds is needed to give us a strategic market or... I mean, I just noticed it was just indicated it was for general corporate purposes. I was just wondering if you had any color on that about what those funds might be used for?

Robert Chioini

Management

Don’t anticipate needing any extra funds to get SFP to the market. It’s just sound financial business practice. We’d be fiscally irresponsible had we not done a shelf.

Brian Hepburn

Analyst

Okay. But there's no specific area targeted for those funds at this point?

Robert Chioini

Management

No. No, Brian, that’s just a tool that we’ve got in our arsenal, our treasury arsenal, if we need it down the road, or opportunities would come up, and it would -- it’s just good corporate governance to have that in place. The first opportunity we had to put it in place was last week.

Operator

Operator

Our next question comes from Dan Bailey.

Dan Bailey

Analyst

Can you give us a little bit of a guidance - and this may be difficult, but I know Mr. Pratt was brought on board to help get the SFP through, but also to potentially start working on some of the other applications. Can you kind of - can you give us a little bit of an idea on what plans you have, if any, this year to maybe start working on some of these other SFP applications?

Robert Chioini

Management

We’ve already begun some work, some preliminary work on a couple of these applications or these indications, and we'll be in a position soon to give you more detail on that, and when we are, we will.

Operator

Operator

Our next question is a follow up from Annabel Samimy.

Annabel Samimy

Analyst

Just following up on the earlier Calcitriol question, the stability of 30 or 90 days, do your timelines right now factor in a requirement of only 30-day stability or have you put in a cushion for the requirement of a 90-day stability testing? And then, do you have a batch that is going after 90-day stability so you can quickly follow with the FDA if need be?

Robert Chioini

Management

Yes, so we factor in 90 days, and we have actually 2 manufacturing sites. So we’ll have more than one batch, and then each site will have multiple batches.

Operator

Operator

I am showing no further questions at this time.

Robert Chioini

Management

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

Operator

Operator

Ladies and gentlemen, we thank you for participating in today’s conference. This concludes the call. You may now disconnect. Have a good day.