Rockwell Medical, Inc. (RMTI) Q4 2012 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen, and welcome to the Rockwell Medical Technologies Fourth Quarter Earnings Call. [Operator Instructions] And as a reminder, today's conference is being recorded. And now, I would like to introduce your host for today, Rob Chioini.

Good afternoon, thank you for joining us. I will cover 4 areas today: our fourth quarter numbers, our SFP clinical progress, our Calcitriol progress and our financial resources. Let's start with the fourth quarter. Our operating business performed very well. Fourth quarter 2012 sales were $13 million, an increase of 9.3% over the fourth quarter of 2011. Sequentially, sales increased 2.4% from the previous quarter. Fourth quarter gross profit was up 10.2% over the third quarter 2011. Gross profit margins were 13.1%. We expect continued sales and margin growth in our operating business going forward. R&D for the fourth quarter was $11.8 million, in line with our expectations. Net loss for the quarter was $13.7 million compared to net loss of $9 million in the fourth quarter of 2011. The fourth quarter loss was due primarily to our clinical work for investigational drug SFP. Cash and cash equivalents at the end of the year were $4.7 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 SFP. As most of you know, we achieved a major milestone on February 4 this year, when we announced positive data from our PRIME study, which was designed to measure the ESA-sparing effect of SFP. The PRIME study managed primary endpoint and achieved statistical significance and demonstrated 2 very important data points. One is that SFP is able to reduce ESA use significantly, 37% compared to placebo. This is important because $2 billion was spent on ESA use in 2012 in dialysis, and that 37% reduction equates to a $740 million cost savings across the industry. This reduction in ESA also potentially lowers the serious risks associated with the dosing of ESA. Altogether, we expect SFP will command a premium price once launched into the commercial market. The second important data point is that the PRIME data supports our belief that the Phase III CRUISE clinical studies will meet their primary efficacy endpoint. In the PRIME study, the objective was to keep hemoglobin levels between 9.5 and 11.5. And to do so, both groups were allowed to have ESA dose adjusted. The study worked perfectly, and both groups completed the study with a 10.5 hemoglobin. The placebo group, however, needed 37% more ESA to maintain their hemoglobin level. Now had the ESA dose not been allowed to be adjusted, that 37% increase in ESA would be equivalent to a 1 to 1.5 gram decrease in hemoglobin. In the Phase III CRUISE studies, the ESA dose is not allowed to be adjusted. And in the Phase III CRUISE studies, we need just a 0.5 gram change in hemoglobin to meet efficacy. So based upon the PRIME data, we expect the Phase III primary efficacy endpoint should be met. Regarding our Phase III efficacy studies. As you know, they are on track to finish in May and August of this year, and we expect topline efficacy data for CRUISE-1 to read out in July, and CRUISE-2 to read out in October. Moving to Calcitriol, our FDA-approved generic Vitamin D injection. Our manufacturing batch was required to be a 90-day stability and that has now been completed. We intend to submit that data under expedited review to the FDA this month. We expect to launch into commercial market immediately after FDA approval. Calcitriol is complementary to our existing operating business. And we expect to sell it to our existing customer base, as well as the entire $350 million U.S. market, while requiring minimal SG&A expenses in the process. We expect Calcitriol will enable us to increase our sales and profit margins considerably while strengthening our existing business and providing further leverage to our planned offering of SFP once FDA market-approved. Regarding our financial resources. As I mentioned earlier, cash and cash equivalents at the yearend were $4.7 million. We expect our operating business, excluding R&D, to continue to generate cash and to gain momentum throughout 2013. We anticipate Calcitriol will generate additional cash upon market launch. And we continue to be active in potential business partnerships, which should generate further capital. In the meantime, we are evaluating several financing alternatives and addressing our cash requirements. In closing, we had a strong execution in 2012, making significant progress across clinical development and commercial operations. We executed well with our existing operating business. And we expect to see sales and margins continue to increase going forward. And we are progressing well towards our commercial launch of Calcitriol. Lastly, we are very pleased with our recent positive PRIME data. And we are excited about the upcoming CRUISE Phase III data which, if successful, should transform the company. I will now turn the call over to Tom for his comments on the financial results.

Good afternoon. I'll provide you with a review of our fourth quarter and 2012 results. We'll also cover liquidity and financing activities. Let's start with the fourth quarter. Sales in the fourth quarter increased to $13 million compared to $11.9 million in the fourth quarter of last year. Sales increased $1.1 million or up 9.3% as a result of both domestic and international sales increasing over 2011. Domestic sales were up by a healthy 10.9% compared to last year's fourth quarter. Sequentially our sales increased 2.4% or $310,000 over the third quarter, and 2012 sales overall increased to $49.8 million, up $900,000 or 1.8% over 2011. Domestic business increased up about 4% in 2012. And excluding our Venezuela business in 2011, international sales were up 12.2%. And gross profit, our gross profit margins in the fourth quarter of 2012 increased to 13.1% and gross profit dollars increased 10.2% to $1.7 million. Margin improvements were a result of higher margin product sales, led by our CitraPure concentrate, along with continued conversion to our Dry Acid Concentrate product line. Our gross profit in 2012 surged 18.6% to $6.7 million, an increase of $1.1 million compared to 2011. Gross profit margins rose to 13.4%, an improvement of 1.9 percentage points over 2011. The margin improvements reflects increased volumes of high-margin products and improved production efficiencies, offsetting inflationary, transportation and raw material costs. On SG&A. The costs from Q4 were $3.6 million compared to $2.6 million last year. Noncash equity compensation increased $1 million, while the rest of SG&A was flat. In 2012, SG&A expenses were $12.7 million compared to $9.5 million in 2011. The increase of $3.2 million was primarily due to noncash charges for equity compensation of $2.9 million. Consistent with our clinical guidance, our R&D expense costs in Q4 were $11.8 million compared to $7.9 million in Q4 last year. For 2012, in total, we incurred R&D costs aggregating $48.3 million. Costs incurred were almost entirely for conducting clinical trials for SFP and related testing and development activities. On net income, the net loss for the quarter was $13.7 million compared to a loss of $9 million in Q4 last year. R&D expense for the quarter totaled $11.8 million, while in 2011, R&D was $7.9 million. The loss from 2012 was $54 million compared to $21.4 million last year. The investment in SFP Phase III program was the primary driver for the loss in 2012. As we noted, our gross profit in the core business was up $1 million, and our SG&A was essentially flat after excluding non-cash equity compensation. On funding and capital resources, our business operations are expected to improve throughout 2013. We anticipate a successful launch of Calcitriol later this year, which we believe will increase our operating income and cash flows from operations. We expect our operating income to improve significantly in 2014. And we project that we will be profitable before SFP is approved. We also anticipate potential cash flows from one or more sources, including non-diluted business development or other potential partnerships we are discussing both inside and outside of the U.S. We are evaluating financing to fund our development efforts and expect to address our cash requirements shortly. With that, I will now turn the call back to the operator for some Q&A.

[Operator Instructions] And I'm showing we'll take our first question from Carol Werther from Summer Street.

So when the CRUISE trials have wound down, how much improvement do you expect in your R&D line?

R&D expense will drop off, Carol, as we progress throughout the year and -- but we will be spending some money on the NDA preparation, which we expect to have done by the end of the year.

And we'll take our next question from Ritu Baral from Canaccord.

I wanted to round back to the NxStage deal that you guys announced recently. What could that mean for the franchise, for the dialysate franchise? What do you think that they would preferentially order, given their particular needs and those patient needs? And also, a follow-up question is on Calcitriol. What is the FDA -- or is the FDA waiting on any additional data or is it just a question of you guys getting the submission together?

Right. So on Calcitriol, first, they're not waiting on any additional data and they're just waiting on our submission which will happen this month. The NxStage supply agreement really should just be looked at as, as you know, NxStage is a home dialysis company. They need a dialysate for their machine. And Rockwell is -- and the agreement that we have with NxStage provides for us to manufacture dialysate for them so they can package it with their machine.

Is there one particular line or one particular product that you guys offer that would be most impacted by the NxStage deal or would they sort of -- would they order sort of across the board?

They have, I think, 3, maybe 4 different formulas. And we manufacture each one of those 4.

[Operator Instructions] And we'll take our next question from Dan Bailey from Rochester Wealth Management.

Two questions. One, you touched upon the NxStage answer. If I could follow up a little bit though with the Vitamin D, you mentioned that once you submit your data, that would be under an expedited review. Is there any typical timeframe you would expect from the FDA to get back to you with the approval? Or is that completely up to their discretion and kind of no idea how long it may take?

The guidance we have been given on that is 4 to 6 months.

And I'm showing another question coming from Carol Werther from Summer Street.

I was just wondering what you think the rate-limiting step will be for the filing for SFP? Is it clinical data that will be out, I guess in October? And along with that, do you think CRUISE-1 results might be at ASN this year, but it sounds like CRUISE-2 won't be because it's a month before [indiscernible]

So as far as the rate-limiting step, Carol, as you know, there's a handful of things that need to be done and completed to file the NDA. At this time, we've got everything internally on schedule. So the best answer I can give you now is the rate-limiting step would be the data. As far as the data being shared at the ASN, I would say you may be correct, we may see data at the ASN. I can't really confirm that at this time though on the call.

[Operator Instructions] And our next question is from Jeff Briggs from Rochester Wealth Management.

Rob, I had a question on the financing. On the third quarter call, you mentioned that you were going to try to do it through licensing development agreements. Now it looks like you went to $13 million in the quarter and we ended with $4.7 million. We're a few weeks away from being done with the first quarter. And given the effect of stocks bouncing off 52-week lows, I would think that would be a priority to get it done. Can you give us any color at all on the timing that we're going to look for in getting some direction on this?

Well, I mean, I agree with you that it is a priority. You can imagine it's a priority. We're evaluating several options. And we're going to choose the best one. And we're going to move as fast as possible.

[Operator Instructions] Okay. So at this time, this does conclude our Q&A session. I would like to turn the conference back to your host for any concluding remarks.

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