Rockwell Medical, Inc. Provides Fourth Quarter and Full Year 2020 Financial and Operational Update
- 2020 revenue of
- Ended the year with
- Conference call and webcast on
“2020 was an important year for us as we evolved our strategy to become a more medically-, scientifically- and data-driven company. There has been an evolution of both our management and Board of Directors, providing us with greater relevant experience,” said
Recent Operational Highlights
- Revenue from hemodialysis concentrates were
$61.1 millionin 2020.
- Revenue from Triferic were approximately
$1.1 millionin 2020.
- Results from a study, conducted by
New York Universityand reported in Critical Care Medicine, showed $296,000in cost savings from Triferic.
The study, which was independent of Rockwell, reviewed the effects of long-term use of Triferic in a large outpatient dialysis clinic. The results showed substantial cost savings due to reductions in
ESAand macromolecular IV iron use without impacting patient safety or hemoglobin targets. In a retrospective data review of 100 patients that were followed before and after implementation of Triferic dialysate, there was a relative reduction in average weekly ESAdose of 26.4%, total use of IV iron replacement therapy decreased with a relative reduction in the use of all iron products (iron sucrose 65.7%, sodium ferric gluconate 98.2%) while anemia targets were met. This clinic determined that the reduction of these agents resulted in a net savings of more than $296,000in one fiscal year.
- Triferic AVNU (ferric pyrophosphate citrate injection), the IV formulation of Triferic, was made commercially available to patients in
the United States. Korea: In September 2020, Rockwell Medicalpartnered with Jeil Pharmaceutical Co., Ltd. for exclusive rights. In February 2021, Jeil filed a New Drug Application for Triferic (dialysate) and Triferic AVNU in Korea. China: In January 2021, Wanbang Biopharmaceuticals enrolled the first patient in a pivotal Phase 3 trial. India: In January 2020, Rockwell Medicaland Sun Pharma entered into a licensing agreement, and Sun Pharma is in the regulatory process in India. Canada: In May 2020, Rockwell Medicalannounced the filing of a New Drug Submission with Health Canadafor Triferic AVNU.
Home Infusion Program
U.S. Food and Drug Administration(FDA) has accepted our 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. Pending a successful outcome of our pre-investigational new drug meeting with the FDA, the Company plans to initiate a clinical study during the second half of 2021. Rockwell Medicalis exploring the use of its FPC platform for the treatment of hospitalized patients with acute heart failure. Management 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 plans to hold a Type C meeting with the FDA in the second half of 2021.
2020 Corporate Updates
December 2020, Rockwell Medicalappointed industry leader and life science industry executive, Ms. Andrea Heslin Smiley, to its Board of Directors. Ms. Smileybrings commercial experience and a deep expertise in clinical nurse educators.
September 2020, the Company appointed Russell L. Skibsted, M.B.A., as Executive Vice President, Chief Financial Officer and Chief Business Officer. Mr. Skibstedbrings more than 25 years of experience in finance, global business development, capital raising, investor relations and operations.
June 2020, Rockwell Medicalappointed industry leader and renowned authority on kidney disease, Allen R. Nissenson, M.D., F.A.C.P., to its Board of Directors. Dr. Nissensonbrings clinical, regulatory and public policy expertise, combined with his senior executive experience at a large dialysis organization.
April 2020, the Company appointed Russell H. Ellison, M.D., M.Sc., as President and Chief Executive Officer. Dr. Ellison, who continues to serve as a member of the Board of Directors, brings broad medical, clinical development and corporate leadership experience to the role.
March 2020, Rockwell Medicalappointed Robert S. Radieto its Board of Directors. Mr. Radiebrings more than three decades of industry experience, working in senior executive roles with both public and private pharmaceutical and biotech companies.
Fourth Quarter and Full Year 2020 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 were
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
Fourth Quarter and Full Year 2020 and 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 6154055. 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 effectiveness of FPC in other indications, Triferic’s ability to generate cost savings, our ability to grow our dialysis business, 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 and future trends related to our sales and marketing costs. Words such as, “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,” “can,” “would,” “develop,” “plan,” “potential,” “predict,” “forecast,” “project,” “intend” and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While
Triferic® is a registered trademark of
Financial Tables Follow
Condensed Consolidated Balance Sheets
(Dollars in Thousands)
|Cash and Cash Equivalents||$||48,682||$||11,795|
|Accounts Receivable, net of a reserve of
|Prepaid and Other Current Assets||2,706||2,979|
|Total Current Assets||69,469||36,874|
|Property and Equipment, net||2,642||2,433|
|Right of Use Assets, net||2,911||3,213|
|Other Non-current Assets||629||435|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Lease Liability - Current||1,167||1,493|
|Deferred License Revenue||2,175||2,234|
|Insurance Financing Note Payable||—||763|
|Other Current Liability -
|Total Current Liabilities||12,793||12,374|
|Lease Liability - Long Term||1,821||1,781|
|Term Loan, Net of Issuance Costs||20,949||—|
|Deferred License Revenue||8,015||9,842|
|Accumulated Other Comprehensive Income||57||52|
|Total Stockholders’ Equity||34,170||20,320|
|Total Liabilities And Stockholders’ Equity||$||77,748||$||44,317|
Condensed Consolidated Statements of Operations
(Dollars in Thousands, except per share amounts)
|Three Months Ended
||Three Months Ended
|Cost of Sales||14,780||14,379||59,472||58,464|
|Gross Profit (Loss)||384||1,111||2,725||2,839|
|Research and Product Development||1,909||1,956||7,092||6,886|
|Selling and Marketing||2,133||1,901||7,871||9,050|
|General and Administrative||4,416||4,657||16,182||20,998|
|Settlement Expense, net of Reimbursement||—||—||—||430|
|Other Income (Expense)|
|Realized Gain (Loss) on Investments||—||6||8||30|
|Warrant Modification Expense||—||—||(837||)||—|
|Total Other Income||(590||)||101||(2,470||)||397|
|Basic and Diluted Net Loss per Share||$||(0.09||)||$||(0.11||)||$||(0.41||)||$||(0.56||)|
|Basic and Diluted Weighted Average Shares Outstanding||93,573,165||64,450,030||75,621,674||60,918,544|
Source: Rockwell Medical, Inc.