Michael Wood - LifeSci Advisors Rob Chioini - Founder, Chairman & CEO Tom Klema - CFO Ray Pratt - CMO.

Charles Haff - Craig-Hallum Ling Wang - Oppenheimer.

Good day, ladies and gentlemen. And welcome to the Rockwell Medical Third Quarter Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. Following the prepared remarks, we will open the call for your questions. Please be advised, that this call is being recorded at the company's request.

I would now like to turn the call over to Mr. Michael Wood of LifeSci Advisors. Mr. Wood, please go ahead..

Thank you, Brian, and good afternoon, everyone. Thank you for attending the Rockwell Medical third quarter 2015 financial results conference call. I am Michael Wood, LifeSci Advisors, and on the call this afternoon are Rob Chioini, Founder, Chairman and CEO; and Tom Klema, Chief Financial Officer.

Before we begin, I'd like to remind you that various remarks about future expectations, plans and prospects constitute forward-looking statements for purposes of the 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 could 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 Securities and Exchange Commission.

Any forward-looking statements made on this conference call speak only as of today's date, Monday, November 9, 2015, 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 in this call will be in a listen-only, and the call will be followed by a brief Q&A session. I will now turn the call over to Rob Chioini, Founder, Chairman and CEO of Rockwell Medical. Rob, please go ahead..

Thank you, Mike, and good afternoon to everyone joining us on the call today. We made significant progress on a number of fronts during the third quarter. Most importantly, the U.S. commercial launch of Triferic, and we're excited to provide this update.

On the call today, I will review some of our accomplishments and then turn the call over to Tom, who will discuss the financials. After that both, Tom and I, and Dr. Pratt are available to take questions. Beginning with our financial results, our sales for the third quarter of 2015 were $14.4 million, up 4.6% over the comparable period in 2014.

Gross profit was $2.5 million representing a 10.3% increase for the same period last year. We have a strong balance sheet. We ended September with approximately $73 million in cash and investments and we have no debt.

In September, we announced commercial availability of Triferic, and we're very excited that this important new drug is now available to dialysis patients. Just over the first eight weeks, Triferic has received positive feedback from the dialysis community including providers, doctors, nurses, and patient advocacy groups.

And although expected it is very encouraging. Importantly, I'm pleased to announce that we have just signed a supply contract with one of the four largest dialysis providers. We have taken orders from other customers as well. We continue to be very busy promoting Triferic to our customer base.

As you are aware, we know this market very well, having successfully launched a number of renal products over the past 20 years. We have stable long-term relationships with all the providers cultivated by providing them with innovative, high quality products and exceptional customer delivery service consistently overtime.

And we are leveraging these relationships as we roll out Triferic. As you know this is a very concentrated customer market, and after two recently announced acquisitions there are now just seven customers who control about 85% of the market, all of whom we have relationships with.

Due to the concentrated nature of our customer base, we expect Triferic to capture a significant portion of the market. Triferic as we announced previously was granted a unique product reimbursement code by CMS. Last week CMS came out with its final rules detailing how the agency will pay for services provided to Medicare beneficiaries for 2016.

As expected, Triferic is in the bundled reimbursement, therefore as already accounted for in the bundled payment made to healthcare providers. So when the customers convert to Triferic, they will be paid for Triferic from the portion of their payment that was originally allocated to IV iron.

We've talked a lot about Triferic and how it's a true iron maintenance therapy, its exceptional safety profile, it's unique mode of action, its ability to donate its iron directly to transparent and bypass the RE block resulting in efficient iron delivery and stable hemoglobin concentrations without increasing iron stores.

The fact is, Triferic is the most important new treatment option for hemodialysis patients in the last 25 years. Triferic benefits all stakeholders within the healthcare system; patients, nurses, doctors, and healthcare providers.

And we expect Triferic to become the standard of care in treating anemia and dialysis patients in the U.S., and then over the next several years globally. Having just come back from ASN Kidney Week in San Diego, I remain convinced this will be a global first choice therapy for treating anemia and dialysis.

As you would expect, the ASN is always an important event for Rockwell, the specialty stall this year, with Triferic just launching into the market and four abstracts selected for presentation.

Interest level and traffic at our exhibit booth was exceptionally high as it was Friday afternoon for our oral presentation covering the Phase III extension studies, and as well as Saturday for our three individual poster presentations. Lastly, we had two important journal publications occur this quarter.

In July, Kidney International published results from the Triferic ESA-Sparing PRIME Study and Nephrology Dialysis Transplantation published data from the Phase III crew studies. Both publications highlight Triferic's unique mode of action in its patient and provider benefits. We remain active in our business development activity.

Turning tail to Calcitriol, we continue to move closer to commercial availability for our customers. We continue to work with our manufacturer to build the necessary inventory and we are moving closer to launch.

Once commercially available, we expect Calcitriol will have success based on its lowest dose, most cost offering, anticipate giving you an update on the launch in a very near future. I'll now turn the call over to our Chief Financial Officer, Tom Klema..

Thank you, Rob and good afternoon. I'll provide a brief review of our third quarter and nine month results. Starting with sales, our sales in the third quarter were $14.4 million or $600,000 higher than third quarter last year.

Domestic concentrate sales increased $0.5 million or 4.2% compared to the third quarter of 2014, primarily due to higher concentrate unit volume sales aggregating $400,000 coupled with recognition of about $0.5 million in red deferred license revenue, partially offset by the lower wholesale prices paid by Baxter as a distributor.

Our sales for the first nine months of 2015 were $41.2 million, an increase of $1.5 million or 3.7% over the first nine months of 2014. Concentrate sales increased 3.3% with international concentrate sales up 2.4%, and domestic concentrate sales up 3.5% or $1.2 million compared to the first nine months of last year.

Our domestic concentrate sales increase was primarily due to the amortization of $1.5 million of deferred license income related to our distribution agreement with Baxter, and partially offset by lower wholesale prices paid by Baxter.

Our gross profit in the third quarter of 2015 was $2.5 million, an increase of 10.3% or $200,000 over the third quarter last year. Gross profit margins increased to 17.4% from 16.5% in the third quarter of 2014. Gross profit was favorably impacted by the recognition of deferred license revenue under the Baxter distribution agreement.

Gross profit for the first nine months of 2015 was $6.9 million, an increase of 13% compared to $6 million in the first nine months of 2014. Gross profit was favorably impacted by the recognition of deferred license revenue under the Baxter distribution agreement.

Gross profit margin was 16.7% for the first nine months of 2015 compared to 15% in first nine months of last year. So, in general and administrative expenses during the third quarter were $3.8 million compared to $4.1 million in the third quarter of 2014.

A decrease of $300,000 was primarily the result of a $800,000 decrease in non-cash equity compensation to $1.1 million in the third quarter of 2015 compared to the third quarter of 2014.

This decrease was partially offset by an increase in cost of approximately $0.5 million for personnel, marketing and other operating costs in support of the commercial launch of Triferic. SG&A expenses for the first nine months of 2015 were $13 million compared to $12.4 million for the first nine months of last year.

The increase was directly related to the Triferic product launch including increased spending on marketing, advertising, personnel and regulatory compliance. On R&D, our research and product development cost declined to $1.2 million in the third quarter, or $1.3 million in the third quarter last year.

Research and product development cost in the first nine months of 2015 declined to $2.9 million from $6.1 million in the first nine months of last year following FDA approval to market Triferic. Future research and product development spending over the next year will be primarily related to advancing other Triferic indications.

Our net loss for the quarter was $2.4 million or $0.05 per share compared to $4 million or $0.10 per share in last year's third quarter.

The net loss year-to-date was $8.7 million in the first nine months compared to $14.9 million in the first nine months of last year, a $6.2 million reduction, and year-to-date net loss per share was $0.17 compared to $0.37 per share in the first nine months of last year.

On our capital resources and liquidity, we have adequate capital resources and substantial liquidity to execute our business strategy. With penetration of our drug products, we expect our business to become profitable and to generate positive cash flow in the year ahead.

As of September 30, we had $87.9 million in current assets and networking capital of $79.4 million. We had $73 million in cash and investments including $33.2 million in cash as of September 30, and we have no debt.

Major cash expenditures in the first nine months of 2015 included 2.9 million for research and product development and we increased our inventory by 3.5 million in connection with the launch of our drug products.

Capital expenditures on our current facilities are not expected to materially exceed depreciation expense, future R&D work and we'll be spending on Triferic platform and is expected to be minor in relationship to our cash resources, our near term cash requirements are anticipate to be primarily for working capital and support of drug sales including inventory and accounts receivable until the trade cycle related to our drug business begins to generate positive cash flows.

At this point I will now turn the call back to Brian our operator for Q&A..

[Operator Instructions]. Our first question comes from the line of Charles Haff with Craig-Hallum. Your line is open. Please go ahead..

Tom, I wanted to ask you about the inventories, you touched on that towards the end there.

Would you expect inventories and the other working capital asset liability lines to be at a similar level in the fourth quarter as they were in the third quarter? Are there any one offs that we should be aware of?.

Charles, we are continuing to build and adjust inventories and I would anticipate that we will continue to see the inventory values go up a bit. Can't give you an exact number at this point..

Okay.

So operating cash flow at least from the working caps side should be about the same for fourth quarter as it was in the third quarter or?.

We have not provided guidance and at this point I think it would be premature for us to try to project what the working capital is going to be..

And then I had a question on Triferic, is there a shelf life for the product?.

Yes it's three years, 36 months..

And then you mentioned OUS maybe over the next few years I'm wondering it's been a little while since we heard anything about potential distribution partners. I know that you're having some conversations, is there any movement there or is all the focus on the U.S.

right now and you've kind of put that on the back burner for now?.

No that is not definitely on the back burner. There's actually a lot of activity.

I think we're very close to a couple different potential deals and our goal is to make sure that we get every bit of value that we can get before we sign anything with the distributor and that of course is after we've made sure that there is a best partner in that territory. So still very active..

And congratulations on the supply contract with one of the four largest dialysis providers.

I'm wondering if you could share which one that is?.

Well the reason I didn't share that is because right now for competitive reasons we're keeping that quiet and provider is also on board with that. But I think in some point we'll be able to get that news out..

Okay is that something that you're trying to negotiate with them to be able to use their name or is that too premature?.

No, really for competitive reasons at the moment as we're going through this process..

Thank you. Our next question comes from the line of Annabel Samimy with Stifel. Your line is now open. Please go ahead..

This is Aster in for Annabel, congratulations on the launch.

Just a couple of questions so any timeline on when we can expect to hear the name of the supplier?.

No I won't give you a timeline as we're working with some of the other groups, we probably have better clarity on that..

Okay and then anything additional you can tell us about the details on the next steps for broader rollout?.

We're continuing to do what we've done since we've started and you know some groups as I had mentioned in the past have just ordered it and started using it. These are some of the smaller groups.

The larger ones obviously I mean I just think within their own organization they've got to be required to do a pilot and we continue to do that we continue to work with each setting up the pilot.

There's a lot of work involved in that, you've got educate the appropriate keep people, key stockholders, the corporate personnel, the doctors, the nurses, the technicians inside the clinic that actually are working to write protocols to administer the drug ad you get identify centers, they are going to participate and then there's a real effort between us and them to help craft a protocol for the pilot, then of course we negotiate price.

All that work is ongoing and has been and then I will add also falls around some the other things that they have going on that are no priorities for them..

And then just one last question so congratulations on getting Triferic in the bundle payment.

So it looks like they took away a portion that was allocated to IV Iron, can we get more specifics on that so it's iron sucrose that it's taking away from and is it comparable the amount that was allocated for IV Iron that is for Triferic?.

Right. I think the best way to maybe understand this is to go back to 2011 when the bundle was being put together, what CMS did is they took a $1 amount and allocated it to each drug that was being used and then added it to bundle.

Today it's all really just kind of one big payment so those allocations really don't play out anymore, but underneath that one big payment.

The amount that's being spent on IV Iron at least that much is now going to go in so many converts to Triferic are going to stop or discontinue use of the IV product and they're going to move to Triferic, they're going to get whatever they were getting or whatever they have allocated mostly probably internally now as they manage their costs that allocation will go to Triferic..

Our next question comes from the line of [indiscernible] with Bank of America Merrill Lynch. Your line is now open. Please go ahead..

I was just curious if you could share where the sales were for Triferic and Calcitriol?.

We just ended the call or I ended my portion to call, Calcitriol is not selling yet. As far as Triferic goes there were some sales, they were minimal not material to report..

Your next question comes from the line of Ling Wang with Oppenheimer. Your line is open. Please go ahead..

So Rob, I was wondering whether you are at the position to perhaps provide us a little bit more detail on the goal or you know the [indiscernible] the contract that you signed up with the one of largerst providers at this point..

Ling, for competitive reasons I think we're just going to keep that to ourselves right now..

Okay.

And then on Calcitriol, can you share with us what are the remaining things that need to be done before the commercial launch?.

I mean is it strictly just manufacturing of the product at this point..

Okay.

And maybe lastly give us some color on where you stand in terms of the regular [indiscernible] process of Triferic in EU?.

Well actually the regulatory process of Triferic is been moved forward in several countries, the EU is one of them. We have not scheduled a date with the regulatory body as of yet.

That’s mostly because of the discussions that we have with the potential partner, but we are moving all of them pretty quickly, actually there's I don’t know the exact number I think it's maybe 30, 40 countries that you have a FDA approval in the U.S.

that they consider a rubber stamp in these other countries, you don't have to do any more clinical work. We've been doing a lot of work on those countries and I would expect we'll have some approvals coming up in some other countries in the near future..

Also I just want to confirm you did mention that some of the independent clinical ready start [indiscernible] make sure I got them right..

That’s accurate. We have other clinics who have ordered..

Thank you. This concludes our question answer session. I will now like to turn the call back to Rob Chioini, Chief Executive Officer for closing remarks..

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

Ladies and gentlemen this does conclude today's program. You may all disconnect. Everybody have a wonderful day..