Rockwell Medical, Inc. Provides First Quarter 2021 Financial and Operational Update
-Home Infusion FPC Program expected to initiate Phase 2 trial in second half of 2021-
-Company received marketing approval in
-Conference call and webcast on
“We continued to drive our business forward in the first quarter,” said
First Quarter 2021 Operational Highlights
- Revenue from hemodialysis concentrates was approximately
- Revenue from Triferic was approximately
$283,000. Rockwell Medicalcontinues to generate data in clinics showing the benefits of Triferic in real world protocols.
- The Company announced in April that Triferic AVNU (ferric pyrophosphate citrate injection) received a Notice of Compliance (marketing approval) from
Health Canadafor the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. Rockwell Medicalexpects Triferic AVNU to become commercially available in Canadaduring 2022.
Home Infusion Program
- As previously announced, the
U.S. Food and Drug Administration(FDA) accepted the Company’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. Subject to a successful outcome of Rockwell Medical’s pre-investigational new drug meeting with the FDA, the Company plans to initiate a Phase 2 clinical trial in the second half of 2021.
- In April, the Company presented data from a clinical feasibility study reviewing the practice patterns of iron deficiency anemia (IDA) in home parenteral nutrition patients at the National Home Infusion Association’s (NHIA) 2021 Annual Conference. The study found that although approximately half of the patients in the home infusion setting suffer from IDA, and oral iron is indicated as a first-line therapy, many patients may not tolerate it, or may have unsatisfactory results with this option. The study results support the Company’s initial assumptions that management of IDA in the home infusion population is suboptimal and remains an unmet clinical need.
Rockwell Medicalcontinues to explore the use of its FPC platform for the treatment of hospitalized patients with acute heart failure. Management currently believes that 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 and fewer 30-day re-admissions. The Company expects to have a meeting with the FDA in the second half of 2021.
First Quarter 2021 Selected Financial Highlights
The following discussion and analysis should be read in conjunction with our audited condensed consolidated financial statements and related notes on Form 10-K for the year ended
Cost of sales was
Research and product development expenses were
Selling and marketing expenses were
General and administrative expenses were
Net loss was
Cash, cash equivalents, and investments available-for-sale totaled
The Company has a debt facility of
First Quarter 2021 Business Update Conference Call and Webcast
To access the conference call, please dial (877) 383-7438 (local) or (678) 894-3975 (international) at least 10 minutes prior to the start time and refer to conference ID 7870946. A live webcast of the call will be available under "Events & Presentations" in the Investor section of the Company's website, https://ir.rockwellmed.com/. An archived webcast will be available on the Company's website approximately two hours after the event and will be available for 30 days.
About Triferic Dialysate and Triferic AVNU
Triferic Dialysate and Triferic AVNU are the only FDA-approved therapies in the
Triferic Dialysate and Triferic AVNU both deliver approximately 5-7 mg iron with every hemodialysis treatment to replace the ongoing losses to maintain hemoglobin without increasing iron stores. Both formulations donate iron immediately and completely to transferrin (carrier of iron in the body), which is then transported to the bone marrow to be incorporated into hemoglobin. Because of this unique mechanism of action, there is no increase in ferritin (a measure of stored iron). Triferic and Triferic AVNU address a significant medical need in treating functional iron deficiency in end-stage kidney disease patients.
The safety profile of Triferic is similar to placebo in controlled clinical trials in patients with end-stage kidney disease. Since approval, there have been no safety related changes to the product labeling.
IMPORTANT SAFETY INFORMATION FOR TRIFERIC AND TRIFERIC AVNU
TRIFERIC and TRIFERIC AVNU are indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).
Limitations of Use
TRIFERIC and TRIFERIC AVNU are not intended for use in patients receiving peritoneal dialysis. TRIFERIC and TRIFERIC AVNU have not been studied in patients receiving home hemodialysis.
Warnings and Precautions
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving parenteral iron products. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions. Hypersensitivity reactions have been reported in 1 (0.3%) of 292 patients receiving TRIFERIC in two randomized clinical trials.
Iron status should be determined on pre-dialysis blood samples. Post-dialysis serum iron parameters may overestimate serum iron and transferrin saturation.
Most common adverse reactions (incidence ≥3% and at least 1% greater than placebo) in controlled clinical studies include: headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, procedural hypotension, muscle spasms, pain in extremity, back pain, and dyspnea.
To report an Adverse Events (AE) or Product Quality Control (PQC) please call the
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, the development plans and timing for Rockwell Medical’s FPC pipeline candidates, the timing and outcome of meetings with the FDA, the timing and outcome of foreign clinical trials and regulatory approval, the timing for the commencement of our clinical trial of FPC for treatment of IDA in adult patients in the home infusion setting, the benefits of Triferic and the timing for a commercial launch of Triferic AVNU in
Triferic® is a registered trademark of
Financial Tables Follow
Condensed Consolidated Balance Sheets
(Dollars in Thousands)
|Cash and Cash Equivalents||$||35,675||$||48,682|
|Investments Available-for -Sale||10,464||9,997|
|Accounts Receivable, net of a reserve||6,597||4,171|
|Prepaid and Other Current Assets||2,389||2,706|
|Total Current Assets||59,242||69,469|
|Property and Equipment, net||2,472||2,642|
|Right of Use Assets, net||4,860||2,911|
|Other Non-current Assets||629||629|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Lease Liability - Current||1,417||1,167|
|Deferred License Revenue||2,170||2,175|
|Other Current Liability -
|Total Current Liabilities||11,232||12,793|
|Lease Liability - Long Term||3,522||1,821|
|Term Loan, Net of Issuance Costs||21,041||20,949|
|Deferred License Revenue||7,476||8,015|
|Accumulated Other Comprehensive Income||53||57|
|Total Stockholders’ Equity||26,178||34,170|
|Total Liabilities And Stockholders’ Equity||$||69,449||$||77,748|
Condensed Consolidated Statements of Operations
(Dollars in Thousands, except per share amounts)
|Cost of Sales||15,072||14,744|
|Research and Product Development||1,809||1,822|
|Selling and Marketing||1,851||2,073|
|General and Administrative||3,923||5,273|
|Other (Expense) Income|
|Realized Gain on Investments||—||2|
|Total Other (Expense) Income||(570||)||71|
|Basic and Diluted Net Loss per Share||$||(0.08||)||$||(0.12||)|
|Basic and Diluted Weighted Average Shares Outstanding||93,591,053||67,518,240|
Source: Rockwell Medical, Inc.