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Sep 30, 2021
Rockwell Medical Q3 2021 Earnings Report
Reported a strong third quarter with increased net sales driven by dialysis concentrates products.
Key Takeaways
Rockwell Medical reported a strong third quarter with net sales of $16.0 million, a 6% increase sequentially and a 5% increase year-over-year. The growth was primarily driven by an increase in sales of dialysis concentrates products. The company also submitted an Investigational New Drug application with the FDA for its proposed clinical trial of FPC as a treatment for iron deficiency anemia in patients receiving home infusion.
Net sales for the third quarter were $16.0 million, up 6% sequentially and 5% year-over-year.
Revenue from hemodialysis concentrates was approximately $15.7 million.
Revenue from Triferic was approximately $280,000.
Submitted Investigational New Drug application with the FDA for FPC clinical trial.
Rockwell Medical
Rockwell Medical
Forward Guidance
Rockwell Medical continues to explore the use of its FPC platform for the treatment of hospitalized patients with acute heart failure and expects to have a meeting with the FDA in the first half of 2022 to discuss the pathway for a potential clinical development program.
Positive Outlook
- FPC may deliver rapidly bioavailable iron to the heart and improve cardiac energetics.
- This effect could help patients recover faster, resulting in shorter hospital stays.
- Shorter hospital stays could lead to fewer 30-day re-admissions.
- Company is actively exploring U.S. and international expansion of its hemodialysis concentrates business with its customers.
- Management believes that FPC as a home infusion therapy for iron deficiency anemia may have distinct advantages over currently available iron replacement therapy options.
Challenges Ahead
- Company has adjusted its sales and marketing efforts for Triferic and Triferic AVNU and is seeking a commercial partner within the United States.
- The decision to seek a commercial partner was based on the dynamics of the hemodialysis market, including provider consolidation.
- The decision to seek a commercial partner was based on the effects of the CMS bundled payment system.
- The decision to seek a commercial partner was based on competitive product bundling tactics.
- Gross profit decreased by $0.6 million, primarily due to an increase in costs related to protocols implemented because of the ongoing COVID-19 pandemic and an increase in shipping, fuel, and labor costs.