Rockwell Medical, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Rockwell Medical Third Quarter 2021 Results Conference Call. As a reminder, this conference is being recorded. At this time, I would like to introduce Jason Finkelstein, Investor Relations. Please go ahead.

Good afternoon. This is Jason Finkelstein of Argo Partners, the Investor Relations Representative for Rockwell Medical. Joining me from Rockwell Medical on today's call are Dr. Russell Ellison, President and Chief Executive Officer, and Russell Skipstead, Executive Vice President, Chief Financial Officer, and Chief Business Officer. Dr. Mark Hoffman, Chief Medical Officer, and Tim Cole, Senior Vice President of Sales and Marketing, will be available for Q&A. Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements about the company. Within the meeting on the federal securities laws, including but not limited to, the types of statements identified as forward-looking in our quarterly report on Form 10Q that was filed today, our annual report on Form 10K that was filed on March 31st, 2021, and our subsequent periodic reports filed with the SEC, which will be available on our website in the investor relations section. These statements are subject to risks and uncertainties that can cause actual results to differ. Please note that these forward-looking statements reflect our opinions and expectations only as of today. Except as required by law, we specifically disclaim any obligation to update or revise these forward-looking statements in light of new information or future events. Factors that could cause actual results or outcomes to differ materially from those expressed in or implied by such forward-looking statements are discussed in greater detail in our periodic reports filed with the SEC. This conference call can be accessed on Rockwell Medical's Investor Relations webpage. This call is being recorded for audio rebroadcast and can also be accessed on the same webpage. At this time, I would like to turn the conference call over to Rockwell Medical's Chief Executive Officer, Dr. Russell Ellison.

Russell? Thank you, Jason. Good afternoon, and thank you for joining us. In the third quarter of 2021, we continued to progress our strategy with improvements on the solid foundation and reputation of our dialysis business, combined with advancement in the development of the RFPC platform outside of dialysis. Driven by returning growth in dialysis concentrates products, Rockwell delivered a strong third quarter, which saw an increase in net sales versus both the second quarter of 2021 and the third quarter of last year. Our concentrates business continues to perform to our expectations both domestically and internationally. We're in the process of exploring expanding this business geographically in the U.S. We're very pleased to have achieved an important development milestone with the submission of an IND for FPC for patients receiving infusion therapy at home. As you may recall in June, we submitted a pre-IND meeting request to FDA to gain feedback on our Phase II clinical trial proposal. The proposed randomized placebo-controlled study is expected to evaluate two dosing regimens of FPC versus placebo, one for the treatment of iron deficiency anemia and the other for the maintenance of hemoglobin. We have initiated preliminary study activities in anticipation of the clearance of our IND on or about December 9. Home infusion therapy is a service model that allows patients requiring regular infusions of medications to be treated in the comfort of their own homes. For clarity, when we refer to home infusion, we are not referring to home hemodialysis. This is a large, rapidly growing segment of healthcare with more than 3.2 million patients as of 2019. Many patient groups requiring home infusion therapies suffer from chronic diseases that are associated with a high incidence of iron deficiency and anemia. For example, it's estimated that 40 to 55% of all home parenteral nutrition patients are iron deficient. Current treatment patterns can be inadequate for patients on home infusion therapy with iron deficiency anemia, causing them to suffer extreme fatigue and can result in serious health risks, such as poor immune function and heart failure. While it's premature to estimate the market for FPC in these patient populations, we believe that up to 700,000 patients receiving home infusion therapy in the U.S. may benefit from a safe and effective way to treat iron deficiency, which may suggest an addressable market opportunity of up to $600 million. We'll have more to say about the market opportunity in home infusion after our IND clears and we begin our clinical trials. I'll now turn to our recent business development and accomplishments as they pertain to our existing dialysis business, which is comprised of revenue from both Triferic and our concentrates. Our partners continue to progress in their efforts to gain regulatory approval and begin commercialization in FPC in their respective countries. We believe international sales in Triferic will be a strong source of revenue and value in the coming years. as dialysis payer models in many countries outside of the U.S. are more accommodating for innovative products. We recently presented new real-world evidence from an observational analysis program at multiple clinics, which are part of a mid-sized dialysis organization, or MDO, at the American Society of Nephrology Kidney Week 2021 in San Diego, California. Results confirm findings from our prior real-world evidence publication, foremost that the integration of TRIFERIC into anemia management protocols results in the reduction of IV iron utilization and total iron usage. The results are relevant not only for patients and caregivers, but for dialysis clinics and the medical community. And we believe that the results can further strengthen TRIFERIC's position as an important part of the treatment arsenal for patients on hemodialysis. Triceric revenue in the third quarter was essentially flat versus the second quarter. One of our customers was acquired and allowed their contract with us to expire. But we were able to largely offset these losses by securing Triceric agreements with new clinics at an improved average selling price, or ASP, which stabilized revenue for the quarter. Triceric continues to experience headwinds in our efforts to accelerate adoption in the U.S. dialysis market. Changes in medical practice and dialysis are slow to occur and are evidence-based. And, as previously disclosed, Triferic is sold into a heavily competitive space with capitated reimbursement and bundled offerings from our competitors. In the face of these continued headwinds, we have decided to shift our commercial strategy for Triferic and Triferic Avenue in the United States. As part of this initiative, we've adjusted our sales and marketing efforts, and are working to find a sales partner to expand our commercial efforts within the United States. We expect that alignment with a partner will bring commercial strength needed to more effectively compete in the environment of consolidated for-profit dialysis provider organizations and large, vertically integrated competitive suppliers. We continue to believe Triferic is a safe, efficacious, important, and innovative therapeutic for the maintenance of hemoglobin in patients on hemodialysis. While we are committed to the continued commercialization of Triferic in the U.S., we will be intentional about future commercial spending as we acknowledge the challenges we are facing in the present environment. With that, I'll turn the call to Russell Skifstead for a brief financial overview. Russell?