Earnings Labs

Rockwell Medical, Inc. (RMTI)

Q3 2016 Earnings Call· Mon, Nov 7, 2016

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Transcript

Operator

Operator

Good day and welcome to the Rockwell Medical Third Quarter 2016 Earnings Conference Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Michael Wood of LifeSci Advisors. Please go ahead, sir.

Michael Wood

Management

Thank you, Bethany, and good afternoon. Thanks everyone for attending Rockwell Medical’s third quarter financial results conference call. I am Michael Wood at 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, Monday, November 7, 2016, 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 Q&A session. I would now turn the call over to Rob Chioini, Founder, Chairman and CEO of Rockwell Medical. Rob, please go ahead.

Rob Chioini

Management

Thank you, Mike. Good afternoon. Thank you for joining us. Joining me on the call today will be our CFO, Tom Klema. To begin, our sales for the third quarter were $12.8 million, $1.6 million lower than Q3 2015. This was due primarily to lower contract manufacturing sales. Gross profit was $1.6 million, about $900,000 less than Q3 2015. This was due to higher manufacturing and regulatory expenses related to our drug products Triferic and Calcitriol, coupled with the reduction in contract manufacturing sales. Tom will provide greater detail shortly. So, let’s talk about our progress with Triferic and reimbursement. As you know, we are working to obtain transitional add-on reimbursement for Triferic in the U.S. and it is a top priority of ours. Add-on reimbursement means, the customer receives 106% of the sales price of Triferic when they submit for reimbursement to CMS. This reimbursement generally lasts for two years. Transitional add-on reimbursement given the new innovative therapy like Triferic ensures that patients will have access to improved clinical benefits and that drug companies continue to commit the innovative therapies in the renal space. Both are very important issues for the 470,000 ESRD patients in the U.S. living with this chronic disease. On the last call, we informed you that we made considerable progress in our reimbursement initiative. Since that time, we have made even greater headway. Our efforts our multipronged and continue to move us closer to achieving our goal. We are having more and more success, and we believe we are closer to gaining add-on reimbursement for Triferic. Since the last update, we have received additional support and action from members of congress, patient advocacy groups, dialysis providers, nephrologists, nurses and importantly patients themselves on behalf of Triferic receiving add-on reimbursement. As I have stated previously, this…

Tom Klema

Management

Thank you, Rob, and good afternoon. I will be covering the financial results for the third quarter and the first nine months of 2016. Our sales in the third quarter of 2016 were $12.8 million off about $1.6 million from the third quarter of last year. Compared to the third quarter, domestic concentrate revenue decreased $300,000, international concentrate revenue was $200,000 lower and third party contract manufacturing sales decreased $900,000 due to the completion of a manufacturing contract in the second quarter of 2015. All of our product sales were from dialysis concentrates. Our sales for the first nine months of 2016 were $39.9 million off $1.3 million compared to the first nine months of last year. Domestic concentrate revenue increased $800,000 while international concentrate revenue decreased $700,000, and third party contract manufacturing sales decrease $1.5 million. Gross profit in the third quarter of 2016 was $1.6 million or $900,000 less than the third quarter of 2015. Higher manufacturing and regulatory expenses related to manufacturing of our drug products, Triferic and Calcitriol, reduced gross profit by $400,000. The remainder of the decrease was due to lower unit volumes on contract manufacturing sales and on domestic and international business compared to the third quarter last year. Gross profit for the first nine months of 2016 was $4.8 million or $2.1 million less than the first nine months of 2015. Gross profit decreased by $1.5 million due to higher manufacturing and other direct costs related to our drug products, which also included $300,000 in value-add taxes paid on the $4 million on licensing payments, we receive from our international licensing agreement for China. Remainder of the decrease was due to lower unit volumes on contract manufacturing sales and on domestic and international business. Our SG&A expense during the third quarter was $5.1…

Operator

Operator

Thank you. [Operator Instructions] And we will take our first question from Annabel Samimy of Stifel.

Unidentified Analyst

Analyst

This is, [indiscernible] in for Annabel. First, can you discuss the rationale behind not lunching Triferic until this reimbursement, specifically the details on potential scenarios launching under the bundle versus outside the bundle? And then second, as the AP [ph] goes from 6% to 2.5%, is the incentive for dialysis providers gone? Thanks.

Rob Chioini

Management

Sure. So, as you know when we launched the product commercially, the reimbursement we were giving from CMS was in the bundle. Prior to the 2016 year, when CMS came out with guidance, we spoke to them late in 2015 and then going in 2016 and we have been pursuing the add-on reimbursement. And the reason for that is because when they put the bundle in place in 2011, they did so with only products or drugs that were available at the time and they stated that. And they said that they needed to address new innovative therapies. So, our belief is and remains that Triferic is a new innovative therapy and deserves reimbursement on their add-on which is exactly what we continue to pursue. If we ever got to a point in the future which today I can tell you, I don’t see us getting to where we said, okay, let’s sell drug in the bundle, we believe we’ll have the same type of success in relation to the drug becoming standard of care. We believe that whether in the bundle or outside of the bundle, Triferic will become standard of care for iron delivery for hemodialysis patients. With reimbursement add-on, which would be 6%, not 2%, although I understand what you are talking about because there is some language about a 2%, but it wouldn’t apply to this transitional add-on for Triferic, but even with 2%, I think you would see greater incentive. In other words quicker adoption of the drug in the marketplace. So, our view is either away, the drug will become standard of care, a little bit quicker with reimbursement whether it’s 2% or 6%, although we believe it will be 6%. And then go ahead and ask me your second question again.

Unidentified Analyst

Analyst

That was both of the questions.

Rob Chioini

Management

That was both them? Okay.

Unidentified Analyst

Analyst

Yes. Thank you.

Operator

Operator

[Operator Instruction] And ladies and gentlemen, this does conclude today’s Q&A session. I would like to turn the call back over to our presenters for any additional or closing remarks.

Rob Chioini

Management

So, as always, we thank you for your support in Rockwell and we look forward to talking to you on the next call. Thank you.

Operator

Operator

And ladies and gentlemen, this does conclude today’s conference. Thank you for participation. You may now disconnect.