Rockwell Medical, Inc. (RMTI) Q2 2013 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen, and welcome to the Rockwell Medical Technologies Incorporated Second Quarter Earnings Conference Call. [Operator Instructions] I would now like to introduce your host for today's conference call, Mr. Paul Arndt. You may begin, sir.

Thank you, Kevin, and good afternoon, and thank you for attending the Rockwell Medical Second Quarter Earnings Conference Call. I'm Paul Arndt, with LifeSci Advisors. On the call this afternoon are Rob Chioini, CEO and Chairman of Rockwell; Ray Pratt, Chief Medical 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 our actual results to differ materially from those indicated. Among the factors that could cause our actual results to differ materially include risks related to the timing for submission of the NDA, and whether the FDA will accept such submissions for review, following submission and ultimately approve them; whether the FDA will concur with our interpretation of our Phase III study results or the conduct of the study; our ability to successfully and cost effectively complete clinical trials, submit new drug applications and obtain marketing approvals for SFP; top line results are based on a preliminary analysis of then available data, both safety and efficacy, and there is a risk that such findings and conclusions could change following a more comprehensive review of the data; our ability to meet and dispute the development timelines for SFP due to clinical trial results, manufacturing, capabilities or other factors; uncertainties related to the regulatory process and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements made on this conference call speak only as of today's date, Thursday, August 1, 2013, and we do 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's website, www.rockwellmed.com. [Operator Instructions] I'll now turn the call over to Rob Chioini, Founder, Chairman and CEO of Rockwell Medical.

Thank you, Paul. Good afternoon. Thank you for joining us today. Today, I will briefly cover our second quarter numbers and then provide a corporate update, including the highlights of the successful CRUISE-1 Phase III study data released July 11. Joining me on the call today will be Dr. Ray Pratt, our Chief Medical Officer, who'll provide further comments on SFP and the CRUISE study; and Tom Klema, our Chief Financial Officer, who will discuss our financial results. Then we will be available to answer questions. Starting with the second quarter numbers. Sales increased 7.1% up to $13 million compared to $12.1 million in Q2 last year. CitraPure sales climbed significantly, increasing 61% over the last quarter. CitraPure is an innovative concentrate product that contains no acetate. Acetate is the buffering agent used in a traditional concentrate product. CitraPure completely removes acetate and replaces it with citrate. As a result, CitraPure improves patient outcomes and makes patients feel better. Citrate lowers providers' cost for treatment. We expect that within the next 12 months or so, the great majority of our customers will be purchasing CitraPure. Gross profit for the quarter was $1.7 million, consistent with last year. We expect our sales and profit to move higher going forward. Research and development cost was $10.2 million. Net loss for the quarter was $11.9 million, consistent with last year. $2.5 million left in Q1. Net loss is a result of our clinical development work for SFP. We expect the R&D burn to continue to decrease as we complete clinical development. We had $41 million in cash at the end of the quarter. Our cash resources include $57.7 million in combined debt and equity financing. We are fully funded to SFP commercialization. We expect our business operations, excluding R&D, to continue to be cash flow positive and to build momentum through 2013. Now to clinical. We have completed 2 Phase III studies, CRUISE-1 and CRUISE-2. On July 11, we released positive clinical data from the pivotal CRUISE-1 study of SFP, our iron delivery drug for iron replacement and hemodialysis patients. The CRUISE-1 study met its primary endpoint and achieved statistical significance with a p-value of 0.011. SFP also met key secondary endpoints, including maintenance of hemoglobin, maintenance of reticulocyte hemoglobin, and an increase in serum iron pre to post treatment without an increase in ferritin. Additionally, SFP also demonstrated excellent safety data. There were no differences in frequency or severity between the SFP and placebo group, with respect to AEs or serious adverse events. Overall, the adverse events reported were consistent with those that would be expected in a chronic hemodialysis population. CRUISE-1 delivered exceptional Phase III efficacy and safety data, and we feel confident in obtaining similar results from the CRUISE-2 study and gaining FDA market approval for SFP. Last week, we announced CRUISE-2 completed patient dosing. Our clinical team is now locking the data. We anticipate top line results in September. We then will package these 2 trials with other SFP clinical data and submit the New Drug Application to the FDA. Our goal is to submit the NDA 4 to 6 months after announcing the CRUISE-2 data. The CRUISE-1 and expected CRUISE-2 results, coupled with the recent positive PRIME study data, demonstrate that SFP effectively delivers iron and maintains hemoglobin without increasing iron stores and reduces ESA use by a significant 35%. ESA sales in 2012 were $2 billion. SFP has ability to reduce that cost by $700 million. SFP has shown it is able to deliver significant clinical and economic benefit. This exceptional study data supports our belief that SFP will set a new paradigm in iron therapy treatment for hemodialysis patients. We believe SFP is positioned to become the new standard of care in iron therapy, and we expect it to severely disrupt the current IV iron market in dialysis. Now for an update on Calcitriol. Calcitriol is our FDA-approved generic vitamin D injection. We're waiting on the FDA to review our manufacturing data, and then we will begin selling Calcitriol in the market. We expect FDA manufacturing approval to occur shortly. We are very confident in Calcitriol's potential. Due to the lowest-cost vitamin D therapy compared to the 2 current branded drugs, we anticipate gaining sales from not only our existing customer base, but from the total $350 million U.S. market. The launch in marketing effort will require minimal additional SG&A expense. We expect Calcitriol will enable us to increase our sales and profit margins considerably while strengthening our existing business, and will provide further leverage to our planned operating of SFP once FDA approved. The other important news in Q2 was that we expanded our business with DaVita by signing a new multi-year national product supply agreement. The supply agreement covers a 5-year period and includes a significant increase in a number of DaVita dialysis clinics that will purchase Rockwell products. That also further strengthens our long-standing relationship with DaVita. On the business development front, we have been very active. We were active prior to Phase III CRUISE-1 data, but since then, our activity dramatically increased. Our discussions covered licensing SFP, as well as Calcitriol and CitraPure, and they involve many different geographies and structures. Our goal is to find the right partner or partners in the right geographies and maximize value for our shareholders. 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 second quarter and year-to-date results, along with our liquidity and capital resources. I'll start with our financials for the quarter and our second quarter sales. Sales in the second quarter totaled $13 million, a healthy 7.1% increase over last year's second quarter. Both our international and domestic sales increased led by our CitraPure product lines. CitraPure continues to grow among current and new customers, and increased 61% over the last quarter. Sequentially, sales increased 5.3% from the first quarter. Both domestic and international sales increased at about the same level. For the 6 months ended June 30, sales increased 4.8% or $1.2 million over the first half of 2012. Gross profit in the second quarter of 2013 and 2012 was $1.7 million, gross profit margins were 13% compared to 14.2% in the second quarter last year. For the first half of 2013, gross profit was $3 million, gross profit margins were 11.7%. Gross profit margins were affected by higher raw material and government regulatory cost compared to last year. We anticipate that gross margins will be positively impacted by higher product prices and an improved product mix going forward. On SG&A. SG&A costs in Q2 were $3.2 million compared to $2.8 million in the second quarter of 2012. Noncash equity compensation was $1.6 million compared to $1.4 million last year. SG&A for the first 6 months of 2013 was $7.1 million compared to $5.7 million in the first 6 months of 2012. Noncash equity compensation was $3.9 million in the first half of 2013 compared to $2.9 million in the first half of 2012. On research and development. Our costs were $10.2 million compared to $10.9 million in the second quarter last year. Sequentially, R&D decreased by $2.5 million from $12.7 million in the first quarter of 2013, reflective of the completion of studies in the Phase III clinical program. We expect the R&D burn to continue to decrease as we complete our clinical development work. R&D for the 6 months ending in June was $23 million compared to $20.3 million in the first half of last year. Net loss for the quarter for both 2013 and 2012 was $11.9 million and net loss for the 6 months was $27.2 million compared to $22.5 million last year. Now turning to capital resources. We completed $57.7 million in combined debt and equity financing during the second quarter. We had $41 million in cash at the end of the quarter and our current assets were $49.3 million, while our current liabilities were $16.8 million. We believe our cash resources are adequate to commercially launch SFP. We expect our business operations to continue to improve in 2013. We anticipate continued successful penetration in CitraPure and a successful launch of Calcitriol, resulting in an increase in our operating income and cash flow. We expect to see our operating income to improve significantly in 2014. That's the extent of the financial comments. I will now turn the call over to Dr. Pratt, who will update us on the CRUISE-1 data.

Thank you, Tom. I want to point out that the results I will discuss are top line data. Much of it is what I covered on the July 11 call. We expect to present the results of the CRUISE-1 and CRUISE-2 studies at the upcoming American Society of Nephrology Meeting in November of this year. We continue to be thrilled with the outstanding clinical results from our Phase III CRUISE-1 efficacy study. The study was well designed and well run, and again, we extend our thanks to all the investigative sites and patients, whose participation made these results possible. The CRUISE-1 study was designed to show that SFP, administered via dialysate, can maintain hemoglobin levels by effectively providing iron to the bone marrow, replacing the iron loss patients experienced during each dialysis treatment. Prior to the CRUISE studies, there has never been a controlled 12-month study done in the CKD-HD population to demonstrate iron delivery and hemoglobin maintenance. Because SFP is a maintenance therapy, the trial was designed to control the factors which influence hemoglobin levels in dialysis patients, primarily, erythropoiesis-stimulating agents or ESAs and IV iron. The study did not permit any adjustment to ESA dose once the patients entered an initial run-in period, nor was any IV or oral iron permitted. As a result, this study, designed with FDA input, incorporated 3 stages: a run-in stage, a randomization stage and an open-label stage. Patients who were able to advance from one stage to the next, based upon changes in their hemoglobin levels. 300 patients received study drug at enrollment, and the study population was well balanced at baseline, with 149 patients receiving SFP and 151 placebo. A total of 206 patients, or about 70% were advanced to the open-label study after completion of the -- after the randomized treatment phase. The remaining patients left the study for standard reasons seen in this patient population, including adverse events, changes in dialysis center, transplants, deaths or withdrawal of consent. There were no differences between SFP or placebo in the patients who left the study. The CRUISE-1 study met its predefined primary statistical endpoint and all key secondary endpoint. The primary endpoint was the difference in the change from baseline in hemoglobin values between the SFP and placebo groups during the last 1/6 of the patient's time in the study. At the end of treatment in the SFP group, the mean change from baseline in hemoglobin was a positive 0.6 grams per liter. In the placebo group, the change from baseline was a significant minus 3.0 gram per liter drop in hemoglobin. Thus, the mean difference between SFP and placebo at the end of treatment was 3.6 grams per liter in favor of SFP, with a p-value of 0.011. The p-value calculation on the primary endpoint included every patient who advanced through the study and who received at least one dose of the study drug and who had at least one post baseline hemoglobin value. Let me briefly summarize the other important findings of the trial. The first one is very important, and that is that SFP maintain hemoglobin in the absence of IV iron administration. SFP has clearly shown that it can provide iron to the bone marrow and maintain hemoglobin without any other iron supplementation. SFP maintained reticulocyte hemoglobin. This is also an important result, because reticulocyte hemoglobin concentration is the most important index of iron delivery to erythrocyte precursors and is the earliest indicator of the development of iron deficiency. SFP maintained iron storage relative to placebo, as reflected by the difference in ferritin values between the SFP and placebo groups by the end of treatment. SFP did not increase ferretin above baseline. SFP also did not induce iron overload. This is a very important result, as it indicates that patients receiving SFP-iron use the dialysate delivered iron for red blood cell production rather than storing it. No patients discontinued SFP because of evidence of iron overload. Overall, SFP demonstrated an excellent safety profile. Adverse events and serious adverse events in the SFP group were similar to patients receiving placebo. There was no increase in intradialytic hypotension, infections, anaphylaxis or hypersensitivity reactions compared to the placebo-treated patients in over 10,000 individual administrations of SFP. Compared to other iron studies in this population, this is a tremendous number of individual doses. The benefit risk profile for SFP to maintain hemoglobin levels was very favorable. The population receiving SFP had a statistically significant difference from placebo and hemoglobin levels, with absence of adverse events commonly attributable to iron administration. The strong CRUISE-1 study results support and strengthen the results of the PRIME study reported at the ERA, EDTA meeting earlier this year. Together, the 2 studies demonstrate that SFP can effectively deliver iron to patients, maintain hemoglobin without increasing iron stores and significantly reduce ESA use by 35%. As a longtime clinical mythologist and drug developer, I believe these results will enable clinicians to better manage dialysis patients, ESA and iron requirements. New information about the adverse consequences of IV iron and iron overload in dialysis patients are emerging. And SFP-iron, administered via dialysate, provides a thoughtful, physiologically relevant means of delivering iron, maintaining hemoglobin levels and reducing the hemoglobin swing as commonly observed in this patient population. I'll turn the call back over to Rob at this time for further comments.

We'd like to go to the operator now for Q&A.

[Operator Instructions] Our first question comes from Annabel from Stifel. Annabel Samimy - Stifel, Nicolaus & Co., Inc., Research Division: Just a few practical questions and marketplace questions. First, from a practical perspective for -- I'm getting this question a lot. For dialysis factors, who have central mixing, how practical is this -- is SFP going to be used in those situations? That's the first practical question. And the second one is, going forward, in a couple of years, in terms of CMS reimbursement, how the -- how CMS reimbursement changes? How does SFP fit into this whole calculation?

This is Rob, Annabel, and I'll start with the reimbursement. The reimbursement doesn't affect us, because it's not an oral drug. The only thing that's going to change in the next few years is your old drugs get added to the bundle. SFP will be part of the bundle, just like IV iron is today. The first question was SFP and central feed -- central mixing systems or central feed systems in dialysis clinics. So the first thing that -- or, I guess, the first point I want to make is -- this is an important one, because when people first hear SFP iron in dialysate, they get that, but they don't really understand how it works. And the way it works is the drug -- it's a drug, it's exclusive to the dialysator to concentrate prior to getting into the clinic. So much like IV iron is packaged, SFP is packaged in the same way. It will be in a vial. Several of those in a box will go to the clinic. And then whether the clinic has a central feed system for bicarbonate or not, the SFP will be poured as a liquid into the liquid bicarbonate. The way it works in most clinics today, most clinics have a central feed system for the acid component. Most do not have a central feed system for the bicarbonate component. Almost all chronic units have mixers in the clinic that they fill with reverse osmosis water and then dump bicarb powder into and mix into liquid bicarbonate. SFP will be poured into that mixer. And then from that mixer, if the clinic has essential feed, it will deliver liquid bicarbonate with iron in it out to the dialysis machine. If it does not have a central feed, the clinic fills 2.5-gallon containers and places them next to the machines. So either way, it works with a central feed or without, and it gets introduced into the dialysate via the bicarbonate. Annabel Samimy - Stifel, Nicolaus & Co., Inc., Research Division: Okay, great. And then from a safety perspective you, obviously, have -- the FDA's got certain requirements for safety. What is it that you need? And what is it that you have to date? And how much more do you need?

Are you talking about in the clinical study? Annabel Samimy - Stifel, Nicolaus & Co., Inc., Research Division: On the clinical side, patient numbers, et cetera.

Sure. Ray can handle that.

Sure. I mean, we've had, to date, the entire SFP program encompasses approximately 1,400 patients who have received SFP at various clinical studies, including our large-scale safety study, the SFP 6 [ph] study, which had both a short-term-as well as a long-term component to it. Overall, we have a substantial number of patients who have received long-term therapy with SFP for over -- for a year or greater. And we will be -- we adhere to the ICH guidelines for the total number of exposures, as well as the number of exposures for 6 months and 12-month period of time. So we feel we have a very adequate safety database going into the NDA submission. Annabel Samimy - Stifel, Nicolaus & Co., Inc., Research Division: If I could ask another practical question. I guess, there's a lot of confusion around the blinded part of the trial, which we all know is not real world and was designed -- that was by design. And can you help us understand from a practical perspective, which trial -- or which part of the trial best approximates real world? Is it the PRIME study? Is it the extension study that we're going to be seeing data on in the future? And just can you help us understand to what extent SFP has been used in real world settings -- or the real-world setting they will be applied to?

Well, okay. The first part of the question is real-world settings don't necessarily apply to registrational studies for drug approvals, because, again, as we pointed out, we've designed this study with FDA input to demonstrate substantial evidence that SFP does what we expect it to in the population that it's intended for its use. Now having said that, the FDA also only accepts changes in hemoglobin concentration as a suitable and clinically relevant endpoint for registrational studies. Changes in ESA dosing or IV iron administration are considered non-validated surrogates and are not acceptable for registrational purposes. Having said that, the PRIME study was designed to be closer to a real-world setting, where the hemoglobin levels were allowed to be -- to range within a certain limited goal, and the ESA dose and IV iron dose was carefully tracked in those studies. And the result of that study, as we presented at ERA, demonstrated that over a 9-month period of time, by the end of treatment, there was a 35% reduction in the ESA dose in the SFP group compared to the placebo group. The other factor is that of the patients who actually were with -- were advanced from the study from the randomized phase to the open label phase, 2/3 of the patients in this study actually enrolled in the open-label phase, which is still ongoing, and will be collecting patient -- data for patients up to an additional 12 to 16 months after the patients left the randomized treatment phase of the study. We were hoping to have the result to that study sometime early next year, when we complete collection of data. And in that part of the study, patients will -- are allowed to use intravenous -- ESAs according to the site's protocol. And iron can be administered according to an algorithm, which incorporates the indications for IV iron per patient. Annabel Samimy - Stifel, Nicolaus & Co., Inc., Research Division: And just one last quick question. What is your average share count for the quarter?

At the end of the quarter, Annabel, we had 39.9 million shares outstanding. And I'll come back to you in a second on the average. Annabel, I'll email that to you. I don't have it handy.

[Operator Instructions] Our next question comes from Natasha Eaton [ph] with Cefiro [ph].

I have a question on SFP, and then one on the Calcitriol. How many patients moved from the second trial to the open-extension label?

Randomization.

From randomization to the open label?

Yes.

I don't have data for the second -- for the CRUISE-2 study at this point. The CRUISE-1 study, 206 patients out of the 300 moved from the randomized treatment phase to the open label phase.

Okay, but in general line, is it similar?

We believe it's similar. I guess, that I don't have the exact numbers right here.

Okay. And in terms of your vitamin D. Could you give us a timeline, say, in terms of where -- how long will it take for the FDA to approve your manufacturing? And when you say a considerable increase -- considerably your sales or revenue? It's a generic product, so what does considerable mean?

So first off, with the time line, the best I can give you is that we expect it shortly. We've submitted it to the FDA on April 1. We have since been notified that it's under expedited review, and we're told that it should be within a few months. So we expect it shortly. But again, it's the FDA, so there's no way to put a hard number on that. As far as considerable sales to us, right now, our current operating business is doing a little bit over $50 million a year. And the margins are about 12% to 15% gross margin. Considerable for us would be an additional $50 million a year, but at a much greater margin in the 60% to 70% range. And if we can get half of our current customer base to purchase the Calcitriol product from us, that would generate an additional $50 million in that 60% to 70% range. We feel very confident that we can get that. We actually feel confident that we can do much better than that.

Given that it's a generic product?

Yes, given that it's a generic product. Couple of reasons for that. It's the lowest cost vitamin D available, and what makes it the lowest cost vitamin D available is that it's the original vitamin D that Abbott manufactured under the name Calcijex. It's the most potent, it's the most physiologic. And it only needs 1 microgram per dose for a dialysis patient. So during their treatment, they get 1 microgram. The 2 branded drugs, Hectorol and Zemplar, require a greater amount of micrograms per treatment. Hectorol requires 2 to 4, and Zemplar requires 4 to 6. And as you can imagine in the reimbursement landscape today, everybody is trying to gain an edge on lowering their cost. As a matter of fact, the recent CMS proposal to cut the reimbursement going into 2014 by 9.4% has caused a lot of commotion in the industry. And that's a $20 cost per treatment per patient. That's a hit to the provider of $20 per treatment. So even if they get 4.5% of that, 50%, they get the -- they negotiate it down to half, it's a $10 cost per treatment that now comes out of the current profit structure of a dialysis provider. And I can tell you since that news went out, and I don't think it's that amazing, we fielded several phone calls from our customers across the board asking us how quickly we could have Calcitriol available to the market. And it's -- they're always looking for an edge to reduce cost. It's a high-volume business, and they can reduce cost a little bit if significant.

Okay. If I could ask one more question about -- you mentioned that you have thoughts regarding licensing of SFP. Could you give us some more color on that as to territories and under what structures? I mean, will you sell the product? Will you receive royalties? How would that work? What will be most efficient for you?

Right. I can't really give you any more detail than I did on the call right now. I can tell you it's numerous -- different territories, different geographies, different structures. Some include just SFP, some include all 3 of our products and in between. And all I can tell you is we're working through that. And we're going to make the decision that we feel is best for the company and the shareholders.

Okay. Maybe just then some timelines? When do you expect some progress or when will you be able to make an announcement?

Well, I certainly can't tell you when I think we'll make an announcement. But I can tell you we're making a lot of progress. And it's impossible to give you a timeline.

I'm not showing any further questions at this time. I'd like to turn the conference back over to Rob Chioini for your closing comments.

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