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Rockwell Medical, Inc. (RMTI)

Q1 2017 Earnings Call· Tue, May 9, 2017

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Transcript

Operator

Operator

Good day, everyone, and welcome to the Rockwell Medical First Quarter 2017 Earnings Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Paul Arndt with LifeSci Advisors. Please go ahead.

Paul Arndt

Management

Thank you, Tillari, and good afternoon, everyone. Thank you for attending Rockwell Medical’s first quarter financial results conference call. I’m Paul Arndt with LifeSci Advisors. On the call this afternoon are Rob Chioini, Founder, Chairman and CEO of the company; 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 the 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 actual results to differ materially from those indicated. Among the factors that could cause actual results to differ materially include risks and uncertainties related to Triferic, including the Company’s ability to successfully commercialize Triferic, manufacturing capabilities and other risk factors identified from time-to-time in reports filed with the SEC. Any forward-looking statements made on this conference call speak only as of today’s date, Tuesday, May 9, 2017, and the company does 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 at www.rockwellmed.com. All participants on this call will be listen-only. The call will be followed by a brief question-and-answer session. I’d now like to turn the call over to Rob Chioini, Founder, Chairman and CEO of Rockwell Medical. Rob, please go ahead.

Rob Chioini

Management

Thanks, Paul. Good afternoon. Thank you for joining us. On the call with me today will be our CFO, Tom Klema. So let’s get started. Sales for the quarter increased 7% or $14.6 million, $1 million higher than last year, sequentially sales increased approximately 9% over the fourth quarter last year. Gross profit increased to $2.4 million compared to $1.7 million in Q1 2016. Net loss was $4.7 million versus $4.8 million. Cash and investments were about $53 million as of March 31, 2016. Tom will provide greater detail on the financial shortly. I think it’s important to provide some background information and perspective. Especially as it pertains to how Rockwell has grown, evolved and executed on a strategy to become a major drug company. In 2002, we recognized the value and potential opportunity of an innovative iron delivery technology, at the time it was called SFP. We felt it had great promise, we evaluated it and we licensed it. We then determined it was best to take what is now Triferic to clinical development and get FDA approval and sell it into the commercial market ourselves, allowing us to keep full ownership of Triferic. We determined it was best to maximize the full value of Triferic for the company and its shareholders. We raised $150 million in the capital markets over several years, to fund our clinical development program. And we did so carefully, keeping shares low. So when it was all set and done, we had just 51 million shares outstanding. We built the top level clinical team from scratch in Michigan. We designed the clinical program and we successfully met the endpoints of the studies. We then went in front of the FDA Advisory Committee and successfully achieved a favorable outcome for Triferic to be approved. Then…

Tom Klema

Management

Thank you, Rob, and good afternoon. I’ll be covering the financial results for the first quarter and also discuss our capital resources. Our concentrate sales in the first quarter of 2017 were $14.6 million, an increase of $1 million or 7.1% in the first quarter last year. We realized increased sales in our domestic concentrate business of $1 million due to higher unit volumes including $600,000 in orders from Baxter in the first quarter which we do not expect to be reoccurring. Our international sales were $100,000 lower than the first quarter of last year and sequentially first quarter sales were $1.2 million or 9% higher than the fourth quarter. Gross profit in the first quarter was $2.4 million, which was $700,000 higher than in the first quarter of 2016. The increase was due to higher sales in the first quarter compared to the first quarter last year coupled with lower direct cost in our drug business. The lower cost in 2017 were primarily a result of the payment of $300,000 value-add taxes paid in 2016 related to the licensing payments received following execution of our license agreement Wanbang Pharmaceutical. Comparison with the fourth quarter gross profit was up 18.6% or $360,000 and gross profit margins moved up to 16.2% from 14.8% in the fourth quarter. Selling, general and administrative expenses during the first quarter of 2017 were $6.1 million compared to $5 million in the first quarter last year, $1.1 million increase in expense was primarily due to $900,000 in higher legal costs and higher cost for the 2017 Annual Meeting. The increase was also due to increased marketing costs for Triferic of $200,000, compared to the first quarter last year. It was a reduction in equity compensation cost of $400,000, which was partially offset by higher compensation in…

Rob Chioini

Management

So before turning to Q&A, I’d like to briefly touch our upcoming Annual Meeting on June 1. We have been speaking and will continue to speak directly with many of Rockwell’s shareholders your firsthand, what they think about the direction of the company. The Rockwell Board is actively engaged and committed to ensuring that Rockwell remains well governed and shareholder focused. The Board has the leadership and pharmaceutical and financial experience necessary to continue executing our proven strategy. The Board also continues in its commitment to evolve with the changing needs of the business by adding relevant experience and strengthening its corporate governance practices. The purpose of today’s call is to discuss our earnings results. So we ask that you keep questions focused on that topic and thank you for your cooperation in that regard. And the operator can go ahead and field questions.

Operator

Operator

Thank you so much. [Operator Instructions] We’ll take our first question from Charles Haff with Craig-Hallum.

Charles Haff

Analyst

Hi guys, thanks for taking my questions. Can you hear me okay?

Rob Chioini

Management

Yes. We can hear you.

Charles Haff

Analyst

So for the revenue from Baxter the $600,000 that Tom you referenced was non-recurring. Is there anything unique about that revenue would you expect? Then next quarter to maybe have $600,000 less how should we think about this bolus of revenues impacting your business going forward?

Tom Klema

Management

Charles, I would expect that there was nothing really unusual about that would not expected to repeat. We are continuing to pick up business all the times. So it’s hard to predict, if we might get some additional business.

Charles Haff

Analyst

Okay. So there’s not going to be a drop off, you’re not expecting a drop off next quarter beyond where your original expectations were because of this big order than, is that you’re saying?

Tom Klema

Management

That’s right, yes.

Charles Haff

Analyst

Okay, okay. And then in terms of operating cash flow for 2017, so you had a negative $5.2 million this quarter. Is that kind of the right run rate to think about for the remaining quarters of the year? Or are you thinking something different than that?

Tom Klema

Management

I think it’ll be a little bit less we paid down some accounts payable. So I would anticipate it’s going to be closer to $2.5 million to $3 million per quarter.

Charles Haff

Analyst

Okay.

Tom Klema

Management

And we build inventory and I don’t expect us to continue to build that level of inventory.

Charles Haff

Analyst

Okay. I thought your previous comments you said that you expect to maybe build up inventory a little bit more. You were just talking about the rate of change wouldn’t be is…

Tom Klema

Management

I don’t think…

Charles Haff

Analyst

…dramatic as it was this quarter?

Tom Klema

Management

Right, yes.

Charles Haff

Analyst

Okay, okay. And then Rob, you talked about the 470,000 dialysis patients in the U.S. And I’m wondering when you think about your packet form of Triferic and then hemodialysis and peritoneal dialysis and so forth and all the different permutations. What do you think the size of the target market is out of that 470,000 that you think is kind of your sweet spot for the current formulation of Triferic that you’re pursuing? Thanks.

Rob Chioini

Management

So the 400 – so when you look at PD in the U.S., I believe and I don’t have these percentages right in front of me, but I’m probably pretty close. I believe the PD market in the U.S. is somewhere around 8% maybe as high as 10%, but maybe not, but probably in that 8%, 9% range. Other than that we look at the entire market. Anybody who’s on hemodialysis is a potential market for Triferic.

Charles Haff

Analyst

Okay. But would you say that maybe there’s a sweet spot is it younger, healthier or is it older, more acute? Is there kind of a sweet spot that you would pursue in the early days presuming that you get new add-on reimbursement?

Rob Chioini

Management

So that’s a good question. And actually the best way to answer that is kind of refresh the mode of action of the drug and what it does right, so when we look at Triferic and we look at IV iron. What we know is that there’s been nothing in the market for the last 30 years except IV iron. And IV iron was approved by the FDA with a clinical indication that says treat iron deficiency anemia, which the FDA defines as a ferritin of less than 200. And when IV iron first came into the market, the average ferritin back then was about 200 to 300. But over the last 30 years that ferritin level and ferritin by the way just to remind you is the store – it’s the stored iron in the body and it’s also a marker of inflammation.

Charles Haff

Analyst

Sure.

Rob Chioini

Management

So the average iron stored in the body of dialysis patients over 30 years has increased from 200 on average to 800.

Charles Haff

Analyst

Yes.

Rob Chioini

Management

And because there’s been nothing available to treat ongoing or the iron loss that occurs every single treatment three times a week to these patients. So no fault of IV iron, IV iron has been used off label for 30 years to try to do something it’s incapable of doing. IV irons are rescue or repletion therapy, you give it to a patient ideally, when they have excessive blood loss and lose a lot of blood and they need like a bolus or rescue dose. Triferic on the other hand was approved by the FDA, specifically to treat the constant iron loss every treatment and the FDA approved indication is actually very important and it says to replace iron and maintain hemoglobin. There’s no other drug with that indication approved. And so we’ve got two drugs in the anemia space. One that’s designed to be given every single treatment to the patient because they’re losing that 5 to 7 milligrams of iron every treatment. And Triferic has been approved to replace it. And then another IV iron, which can now be used as it was intended as a rescue therapy sparingly when patients have excessive blood loss and they need some quick iron boost, some iron stores. And so the answer is, when you understand Triferic is approved indication and what it’s for and that every single patient in the U.S. on dialysis loses iron, whether they come on today for the first time or been on for 10 years, every one of them needs that that dose of Triferic. So when we look at the sweet spot for the market, it’s anybody who’s on dialysis.

Charles Haff

Analyst

Okay. I appreciate the comprehensive answer there. Thanks sir.

Rob Chioini

Management

Thanks.

Operator

Operator

That does conclude our question-and-answer session. At this time everyone, I’ll turn the call back over to Rob Chioini for any final or additional comments.

Rob Chioini

Management

So we want to thank the shareholders for their support and we look forward to giving you an update on the next earnings call. Thank you.

Operator

Operator

Everyone, that does conclude our conference call for today. We do thank you all for your participation. You may now disconnect.