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Mar 31, 2021
Rockwell Medical Q1 2021 Earnings Report
Reported financial results and business update for the first quarter of 2021.
Key Takeaways
Rockwell Medical reported first quarter 2021 financial results, with revenues of $15.5 million. The company is progressing with its Home Infusion FPC program and received marketing approval in Canada for Triferic AVNU™.
Revenue from hemodialysis concentrates was approximately $15.2 million.
Revenue from Triferic was approximately $0.3 million.
Received marketing approval of Triferic AVNU in Canada.
Planning to initiate Phase 2 clinical trial of FPC for the treatment of iron deficiency anemia in adult patients in the home infusion setting in the second half of 2021.
Rockwell Medical
Rockwell Medical
Forward Guidance
Rockwell Medical is focused on advancing its FPC platform and commercializing Triferic, but faces risks related to clinical trials, regulatory approvals, and market acceptance, as well as the ongoing impact of the COVID-19 pandemic.
Positive Outlook
- Potential effectiveness of FPC in other indications.
- Triferic's ability to generate cost savings.
- Ability to grow dialysis business.
- Advancement of development plans for Rockwell Medical’s FPC pipeline candidates.
- Success and timing of international clinical trials for Triferic Dialysate.
Challenges Ahead
- Challenges inherent in new product development.
- Risk that topline clinical data and real world data results may not demonstrate efficacy.
- The continuance of the COVID-19 pandemic on business.
- Risks related to commercialization of Triferic (dialysate) and Triferic AVNU.
- Uncertainty regarding the timing and outcome of meetings with the FDA.