Full Press Release Details
Rockwell Medical, lnc.
Presentation at the 2019
| Female Speaker: | I would like to introduce Rockwell Biopharmaceutical right now. Paul Stuart is here, the president and CEO. |
| Stuart Paul: | Thank you, good afternoon. Thanks for joining us and thanks for being here for the presentation on Rockwell Medical. |
| We are a biopharmaceutical company focused on the renal space. I ll flip through the forward language here and get straight to the investment highlights. | |
| So, essentially, we re repositioning the company for growth. It s a fully integrated biopharmaceutical company targeting end-stage renal disease and chronic kidney disease, dialysis patients who are on hemodialysis. And we have an expanded focus around anemia management. | |
| I came on board in September. We ve taken the last quarter or so to form a new executive management team. We ve strengthened the board of directors, strengthened our scientific advisory board, and we have a team that s very deep in pharmaceutical and renal experience. | |
| Triferic is an innovative therapeutic that is a first and only FDA approved therapy indicated to maintain hemoglobin and replace iron that is lost in every single hemodialysis treatment, and that occurs in every dialysis treatment. It works very physiologically like dietary iron in the body and avoids iron toxicity, so it has a wonderful safety profile. And we are planning our commercial launch in the first half of 2019 for our, what we would call our dialysate version. It s actually added to the dialysate, which is one of the liquids used in the hemodialysis procedure. | |
| And we re planning on filing our NDA for the I.V. version for Triferic in the first half of 2019, as well, for a potential FDA approval in 2020. And we re really excited about the I.V. version because we believe it also has global market appeal and global market potential. | |
| And then, of course, we also have an orange book listing for our patents with expiry in 2029. So, the IP is quite solid. And, as it turns out, we re already an in-market company. We are the number two supplier of concentrates to the dialysis industry, and we have over $50 million in revenues and relationships with the leading, largest dialysis companies in the United States, which is, essentially for us, a strategic asset and a base from which we can expand and develop our pharmaceutical and market portfolio further. |