Business
Rockwell Medical Provides First Quarter 2022 Financial and Operational Update
- First quarter net sales of $16.1 million, up 4.2% year-over-year - - Submitted Supplemental Data to FDA for IND Application to enable Phase 2 FPC Home
About this update from Rockwell Medical, Inc.
[{"type":"text","content":"- First quarter net sales of $16.1 million, up 4.2% year-over-year - \n- Submitted Supplemental Data to FDA for IND Application to enable Phase 2 FPC Home Infusion Trial -\n- Amended and expanded supply agreement with DaVita, including $7.5M investment, strengthens Rockwell's financial position, laying groundwork for profitable concentrates business -\n- Completion of patient enrollment ahead of schedule in pivotal Phase 3 trial of Triferic® in China -\n- Conference call and webcast scheduled for today at 4:15 p.m. ET -\nWIXOM, Mich., May 16, 2022 /PRNewswire/ -- Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today reported financial results and a business update for the three months ended March 31, 2022.\n\n \n \n \n \n \n \n\n \n\"As a result of our focused development plans for Ferric Pyrophosphate Citrate (\"FPC\"), we are setting Rockwell Medical on course to begin generating data in our Home Infusion program, where we believe FPC has the potential to be the future standard of care in the U.S. for patients receiving home infusion therapy and suffering from iron deficiency anemia. We look forward to beginning our proposed Phase 2 trial of FPC in the home infusion setting soon after the review and clearance of our recent submission by the FDA,\" said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. \"In our dialysis business, we are one of the two largest suppliers of life saving concentrates in the U.S., generating in excess of $60 million in revenues in 2021. We plan to restructure and grow this business to generate acceptable gross margins and cash flow. We believe we took a significant first step with our recently announced amended supply agreement and securities purchase agreement with DaVita, Inc.\" \nFirst Quarter 2022 & Recent Highlights:\nHome Infusion Program:\nOn May 6, Rockwell provided the FDA with requested supplemental data related to its IND application submitted in December 2021 and must wait 30 calendar days from the date of submission before initiating any clinical trials, while the FDA has an opportunity to review the submission.Home health is an area of medicine experiencing significant growth – a trend that will ...