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Dec 31, 2020
Rockwell Medical Q4 2020 Earnings Report
Reported financial results and a business update.
Key Takeaways
Rockwell Medical reported Q4 2020 revenues of $15.2 million compared to $15.5 million for the same quarter of the previous year. Net loss was $8.7 million, or $(0.09) basic and diluted net loss per share, compared to a net loss of $7.3 million, or $(0.11) basic and diluted net loss per share, for the same period in 2019. The company ended the year with $58.7 million in cash, cash equivalents and investments.
Revenues were $15.2 million for the quarter ended December 31, 2020, compared to $15.5 million for the same period in 2019.
Triferic revenue was $0.5 million for the quarter ended December 31, 2020.
Net loss was $8.7 million, or $(0.09) basic and diluted net loss per share for the quarter ended December 31, 2020, compared to a net loss of $7.3 million, or $(0.11) basic and diluted net loss per share, for the same period in 2019.
Cash, cash equivalents, and investments available-for-sale totaled $58.7 million as of December 31, 2020.
Rockwell Medical
Rockwell Medical
Forward Guidance
Rockwell Medical is focused on the treatment of anemia in end-stage kidney disease and is working to expand the use of its FPC platform for the treatment of hospitalized patients with acute heart failure.
Positive Outlook
- The FDA has accepted Rockwell Medical's proposed development strategy to pursue an approval via the 505(b)(1) pathway as a novel new drug application (NDA) for FPC for treatment of iron deficiency anemia (IDA) in adult patients in the home infusion setting.
- Rockwell Medical plans to initiate a clinical study during the second half of 2021 for FPC for treatment of IDA in adult patients in the home infusion setting.
- Rockwell Medical is exploring the use of its FPC platform for the treatment of hospitalized patients with acute heart failure.
- Jeil filed a New Drug Application for Triferic (dialysate) and Triferic AVNU in Korea.
- Wanbang Biopharmaceuticals enrolled the first patient in a pivotal Phase 3 trial in China.
Challenges Ahead
- The company is facing challenges related to the COVID-19 pandemic, which is impacting its business and operating results.
- The company is subject to various risks and uncertainties, including those set forth in Rockwell Medical’s SEC filings.
- The company's actual results could be materially different from its forward-looking statements.
- The company's success is dependent on the commercialization of Triferic (dialysate) and Triferic AVNU.
- The company's success is dependent on the success and timing of international clinical trials for Triferic Dialysate.