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Rockwell Medical, Inc. (RMTI)

Q4 2016 Earnings Call· Wed, Mar 15, 2017

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Transcript

Executives

Management

Paul Arndt - Managing Director, LifeSci Advisors LLC. Robert Chioini - Founder, Chairman and Chief Executive Officer Thomas Klema - Vice President, Chief Financial Officer and Secretary

Operator

Operator

Good day and welcome to the Rockwell Medical Fourth Quarter and Full-Year 2016 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, Mellisa, and good afternoon, everyone. Thank you for attending Rockwell Medical’s fourth quarter and year-end 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, Wednesday, March 15, 2017, and the company does not intend to update any of these forward-looking statements to reflect events or circumstances that could 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.

Robert Chioini

Management

Thanks, Paul. Good afternoon. Thank you for joining us. On the call with me today will be our CFO, Tom Klema; and Dr. Ray Pratt, our Chief Medical Officer. So let’s get started. Sales for the fourth quarter were $13.4 million, about $740,000 less than Q4 2015. Gross profit was $2 million versus $2.1 million same time last year. Net loss was $5.1 million versus $5.8 million same time last year. Cash and investments were about $58 million as of December 31, 2016. Tom will provide greater detail on the financial shortly. So let’s talk about our progress with Triferic and transitional add-on reimbursement for the U.S. market. This has been and continues to be a top priority of ours. It’s a very important issue for 470,000 ESRD patients in the U.S. who suffer from serious anemia symptoms of very low and no energy, which occur as a result of their ongoing dialysis treatment. It’s important that these patients have access to new therapies like Triferic that can improve their lives. It’s also important that these patients don’t have their choice of therapies limited. Throughout 2016, we made it a priority to work towards getting add-on reimbursement with Triferic. I can tell you today, we feel we are close to this goal. Along with patient advocacy groups and dialysis providers, Triferic continues to receive additional strong congressional support for add-on reimbursement. We have growing support from several key members of Congress and focus on policy for the Medicare program and to have special interest in the ESRD population and then working to make this a priority. All indications suggest that policymakers in Congress and the new administration are sensitive to the need to ensure that ESRD patients have access to innovative therapies like Triferic, which can improve quality cost and…

Thomas Klema

Management

Okay. Thank you, Rob, and good afternoon. I’ll be covering the financial results for the fourth quarter and for all of 2016, also discuss our capital resources. Our sales in the fourth quarter of 2016 were $13.4 million, which was 5% below the fourth quarter last year, but up sequentially about $600,000 compared to the third quarter. Compared to the fourth quarter 2015, domestic concentrate revenue was $600,000 lower and international concentrate revenue was down slightly. Sales volumes under the Baxter distribution agreement were below expectations. Our sales for all of 2016 were $53.3 million, $2.1 million lower than 2015. $1.6 million of that was attributable to third-party manufacturing contracts that were completed in 2015, which did not recur in 2016. Our international concentrate sales were $600,000 lower, while our overall domestic concentrate revenue increased about a quarter of a point. Drug-related revenue was not significant in 2016. Our gross profit in the fourth quarter of 2016 was $2 million, about the same level as the fourth quarter last year. Gross profit margins were 14.8% compared to 14.3% in the fourth quarter of last year. Our gross profit was reduced by approximately 300,000 in the fourth quarter for costs related to our drug business, the regulatory manufacturing, inventory and other product costs. Gross profit for 2016 was $6.8 million, or $2.1 million less than 2015. Gross profit margins were 12.7% in 2016 compared to 16.1% in 2015. The lower gross profit was due to cost related to our drug business and the completion of contract manufacturing volumes in 2015. For our drug business operations, gross profit decreased by $1.7 million, primarily due to approximately $1.5 million related to direct operating, regulatory, material inventory and finished product expenses. We also expense 200,000 value-add taxes paid on the $4 million we collected…

Operator

Operator

Thank you. [Operator Instructions] All right. That concludes the question-and-answer session. I will turn the call over to – back to Mr. Chioini for any closing remarks.

Robert Chioini

Management

Thank you for joining us today. Thank you for your support, and we look forward to talking to you soon.

Operator

Operator

Thank you. That does conclude today’s conference. Thank you for your participation. You may now disconnect.

Q -

Analyst