Rockwell Medical, Inc. Provides Third Quarter 2021 Financial and Operational Update
- Third quarter net sales of
- Company recently submitted Investigational New Drug application with FDA for its proposed clinical trial of FPC as a treatment for iron deficiency anemia in patients receiving home infusion -
- Company recently presented Triferic® real world evidence update at ASN Kidney Week 2021; results from pilot observational analysis demonstrate maintenance of hemoglobin and reduction of total IV iron requirement in adult patients on Triferic receiving chronic hemodialysis -
- Q3 2021 conference call and webcast scheduled for today at
“Driven by accelerating growth in dialysis concentrates products,
Third Quarter 2021 Operational Highlights
- Third quarter revenue from hemodialysis concentrates was approximately $15.7 million. The Company is in the process of analyzing its supply chain to identify efficiencies, while actively exploring
U.S.and international expansion of this business with its customers.
- Revenue from Triferic was approximately $280,000 in the third quarter. Rockwell Medical continues to generate data in clinics showing the benefits of Triferic when integrated into anemia management protocols. As part of this initiative and due to the current economic environment, the Company has adjusted its sales and marketing efforts for Triferic and Triferic AVNU and is seeking a commercial partner within
the United States. This decision was based on the dynamics of the hemodialysis market, including provider consolidation, the effects of the CMS bundled payment system and competitive product bundling tactics.
Home Infusion Program
- The Company submitted an IND application with the U.S. Food and Drug Administration (FDA) in support of its proposed Phase 2 clinical trial of FPC, designed for the treatment of iron deficiency anemia and maintenance of hemoglobin in patients receiving infusion therapy in the home setting. Following IND submittal, a sponsor must wait 30 calendar days before initiating any clinical trials. During this time, the FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.
- Home infusion represents a large and rapidly growing segment of healthcare. According to the
National Home Infusion Association, the number of patients served by home infusion therapy has grown from approximately 800,000 in 2010 to over 3,000,000 in 2019. The home infusion setting is expected to continue to expand, which has been further accelerated by the COVID-19 pandemic and the desire to reduce or eliminate hospital and or clinic exposure. Many patient groups requiring home infusion therapies suffer from diseases that are associated with an incidence of iron deficiency and anemia. For example, it is estimated that 40% to 55% of all home parenteral nutrition patients are iron deficient. Management believes, based on the Company’s data with hemodialysis patients, that FPC as a home infusion therapy for iron deficiency anemia may have distinct advantages over currently available iron replacement therapy options.
- Rockwell Medical continues 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 first half of 2022 to discuss the pathway for a potential clinical development program.
Third Quarter 2021 Selected Financial Highlights
The following discussion and analysis should be read in conjunction with our condensed consolidated financial statements and related notes on Form 10-Q for the third quarter ended
Net sales for the third quarter were
Net sales of hemodialysis concentrates were approximately
Cost of sales for the third quarter of 2021 was
Research and product development expenses were
Selling and marketing expenses were
General and administrative expenses were
Net loss for the third quarter of 2021 was
Cash, cash equivalents and investments totaled approximately
Third Quarter 2021 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 7697945. 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.
Rockwell Medical is a commercial-stage biopharmaceutical company developing and commercializing its next-generation parenteral iron technology platform, Ferric Pyrophosphate Citrate (FPC), which has the potential to lead transformative treatments for iron deficiency in multiple disease states, reduce healthcare costs and improve patients’ lives. The Company has two FDA-approved therapies indicated for patients undergoing hemodialysis, which are the first two products developed from the FPC platform. The Company is developing FPC for the treatment of iron deficiency in patients outside of dialysis, who are receiving intravenous medications in the home infusion setting, a large and rapidly growing segment of healthcare, and where these patients suffer from chronic diseases associated with high incidence of iron deficiency and anemia. In addition, Rockwell Medical is one of two major suppliers of life-saving hemodialysis concentrate products to kidney dialysis clinics in the
About Triferic Dialysate and Triferic AVNU
Triferic Dialysate and Triferic AVNU are the only FDA-approved therapies in the U.S. indicated to replace iron and maintain hemoglobin in hemodialysis patients during each dialysis treatment. Triferic Dialysate and Triferic AVNU have a unique and differentiated mechanism of action, which has the potential to benefit patients and health care economics. Triferic Dialysate and Triferic AVNU represent a potential innovative medical advancement in hemodialysis patient iron management – with the potential to become the future standard of care.
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.
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, including meetings regarding use of our FPC platform for the treatment of hospitalized patients with acute heart failure, the potential expansion of our hemodialysis concentrates business, the potential market for home infusion, and the benefit of FPC for the treatment of hospitalized patients with acute heart failure. 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
|Cash and Cash Equivalents||$||23,390||$||48,682|
|Accounts Receivable, net of a reserve||6,036||4,171|
|Prepaid and Other Current Assets||2,815||2,706|
|Total Current Assets||46,082||69,469|
|Property and Equipment, net||2,507||2,642|
|Right of Use Assets, net||6,934||2,911|
|Other Non-current Assets||729||629|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Lease Liability - Current||1,832||1,167|
|Deferred License Revenue||2,176||2,175|
|Insurance Financing Note Payable||1,312||—|
|Term Loan, Net of Issuance Costs||7,131||—|
|Other Current Liability -
|Total Current Liabilities||21,756||12,793|
|Lease Liability - Long Term||5,226||1,821|
|Term Loan, Net of Issuance Costs||14,094||20,949|
|Deferred License Revenue||6,529||8,015|
|Accumulated Other Comprehensive Income||56||57|
|Total Stockholders’ Equity||11,094||34,170|
|Total Liabilities And Stockholders’ Equity||$||58,699||$||77,748|
Condensed Consolidated Statements of Operations
|Three Months Ended
||Three Months Ended
||Nine Months Ended
||Nine Months Ended
|Cost of Sales||16,317||14,934||46,788||44,693|
|Gross (Loss) Profit||(329||)||346||(189||)||2,340|
|Research and Product Development||1,221||1,745||5,445||5,183|
|Selling and Marketing||1,541||1,669||4,860||5,738|
|General and Administrative||3,881||3,622||11,483||11,767|
|Other (Expense) Income|
|Realized Gain on Investments||—||4||(1||)||8|
|Warrant Modification Expense||—||—||—||(837||)|
|Total Other Expense||(609||)||(660||)||(1,756||)||(1,879||)|
|Basic and Diluted Net Loss per Share||$||(0.08||)||$||(0.10||)||$||(0.26||)||$||(0.32||)|
|Basic and Diluted Weighted Average Shares Outstanding||93,882,142||71,811,322||93,726,629||69,594,167|
Source: Rockwell Medical, Inc.