Rockwell Medical, Inc. Provides Third Quarter 2020 Financial and Operational Update
-Ended the quarter with
-Q3 2020 revenue of $15.3 million-
-Poised to enroll first patient in Phase 3 clinical trial of Triferic in
-Unveiled plans to develop FPC platform in new indications-
“Rockwell Medical is sufficiently capitalized to drive value creation now, in the near-term and into the future, and we are working across three tracks concurrently: maximizing
Third Quarter 2020 Operational Highlights
- Net sales for the concentrates business were
$15.0 millionand net sales for Triferic were $0.3 millionin the third quarter of 2020.
- There were approximately 3,400 contracted patients on therapy in the third quarter, representing approximately 500,000 annualized treatments.
- Rockwell continues to implement appropriate COVID-19 precautions to reduce the risk of possible exposure to employees. The Company has experienced no material impact on its supply chain to date. The Company continued to experience an impact on its sales and marketing efforts for Triferic Dialysate due to the restrictions put in place because of COVID-19.
Triferic AVNU – United States
Rockwell Medicalexpects to commercially launch Triferic AVNU in the United Statesin Q1 2021. Triferic AVNU will be reimbursed within the End Stage Renal Disease (“ESRD”) bundle payment that has been established for Medicare patients.
- Wanbang Biopharmaceutical, Rockwell’s partner in
China, is poised to enroll the first patient in a pivotal Phase 3 trial for Triferic in Chinato support a filing for regulatory approval. Hemodialysis in Chinahas continued to increase at a rapid rate in recent years, with over 600,000 hemodialysis patients in China, making it the largest single market in the world.
- Sun Pharma, Rockwell’s partner in
India, submitted all regulatory appeal process documents to the Indian Central Drugs Standard Control Organization’s Technical Committee. Sun Pharmais navigating next steps due to the country’s temporary suspension of regulatory review due to COVID-19. Indiais a potentially attractive market for Triferic, with over 120,000 hemodialysis patients.
September 2020, Rockwell Medicalentered into an exclusive license agreement with Jeil Pharmaceutical Co., Ltd. (“Jeil”), for the rights to commercialize Triferic in South Korea. Under the terms of the license agreement, Jeil will be the exclusive development and commercialization partner for Triferic in South Korea. In consideration for the license, Rockwell Medicalreceived an upfront fee of $200,000and will be eligible for milestone payments and royalties on net sales. South Korearepresents a sizable and growing market opportunity, with over 78,000 patients receiving hemodialysis annually.
New Indications for Ferric Pyrophosphate Citrate (“FPC”) Platform:
September 2020, the Rockwell Medicalmanagement team, in conjunction with leading key opinion leaders (“KOLs”), announced the Company’s growth plan and new therapeutic opportunities for its FPC platform:
○ The Company’s priority new indication to pursue is FPC for the treatment of iron deficiency in patients requiring home infusion therapy, a rapidly growing area of medicine, with more than 3.2 million patients served in 2019. Iron deficiency anemia (“IDA”) is a common co-morbidity in many sub-groups of patients receiving home infusion therapy, particularly in those receiving long-term home parenteral nutrition (“HPN”).
Rockwell Medicalbelieves that FPC is uniquely suited for the treatment of IDA in the home infusion population based upon its kinetic profile and outstanding safety profile in both clinical trials and post-marketing use, and may fill an unmet clinical need as a uniquely suitable home infusion therapy for treatment of IDA. Rockwell Medicalintends to hold a Type C meeting with the FDA in Q1 2021 to discuss the pathway for clinical development and anticipates conducting a Phase II observational study and a dose scheduling study to achieve proof-of-concept, with data expected to report around the end of 2021.
○ The Company is evaluating the potential of FPC to improve cardiac function in hospitalized acute heart failure patients. Heart failure in the
U.S.has a large and growing patient population, with more than one million patients hospitalized each year with acute decompensated heart failure; iron deficiency (“ID”) is a common co-morbidity.
Third Quarter 2020 Corporate Updates
September 2020, Rockwell Medicalappointed Russell L. Skibsted, M.B.A., as Executive Vice President, Chief Financial Officer and Chief Business Officer. Mr. Skibstedis a seasoned executive with more than 25 years of experience in finance, global business development, capital raising, investor relations, and operations. He has worked with a variety of both public and private life sciences companies, from commercial stage, development stage and start up.
Third Quarter 2020 Selected Financial Highlights
The following discussion and analysis should be read in conjunction with our unaudited condensed consolidated financial statements and related notes on Form 10-Q for the third quarter ended September 30, 2020.
Net sales for the third quarter of 2020 were
Cost of sales for the third quarter of 2020 was
Selling and marketing expenses were
General and administrative expenses were
Research and product development expenses were
Net loss for the third quarter of 2020 was
Cash, cash equivalents, and investments available-for-sale totaled
Additionally, the Company has a debt facility of
Third Quarter 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 7679074. 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 the bone marrow and maintain hemoglobin without increasing iron stores (ferritin). Both formulations donate iron immediately and completely to transferrin (carrier of iron in the body) upon entry into the blood which is then transported directly to the bone marrow to be incorporated into hemoglobin, with no increase in ferritin (stored iron and inflammation) and no reports of anaphylaxis in over 1,000,000 patient administrations, addressing a significant medical need in overcoming Functional Iron Deficiency (FID) in ESKD patients.
Important Safety Information
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.
The most common adverse reactions (≥3% and at least 1% greater than placebo) in controlled clinical studies include: procedural hypotension (21.6%), muscle spasms (9.6%), headache (9.2%), pain in extremity (6.8%), peripheral edema (6.8%), dyspnea (5.8%), back pain (4.5%), pyrexia (4.5%), urinary tract infection (4.5%), asthenia (4.1%), fatigue (3.8%), arteriovenous (AV) fistula thrombosis (3.4%), and AV fistula site hemorrhage (3.4%).
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 impact of COVID-19 on Rockwell Medical’s business and operations, the commercialization of Triferic Dialysate, the launch of Triferic AVNU, expected reimbursement for Triferic AVNU, the development plans and timing for Rockwell Medical’s FPC pipeline candidates, the patient enrollment in a clinical trial and regulatory filings in
Triferic® is a registered trademark of
Financial Tables Follow
|Condensed Consolidated Balance Sheets|
|(Dollars in Thousands)|
|Cash and Cash Equivalents||$||56,614||$||11,794|
|Accounts Receivable, net||4,129||4,203|
|Prepaid and Other Current Assets||2,621||2,980|
|Total Current Assets||77,943||36,874|
|Property and Equipment, net||2,785||2,433|
|Right of Use Assets, net||2,099||3,213|
|Other Non-Current Assets||629||435|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Lease Liability - Current||1,155||1,493|
|Deferred License Revenue - Current||2,180||2,234|
|Insurance Financing Note Payable||-||763|
|Other Current Liability -
|Total Current Liabilities||12,708||12,373|
|Lease Liability - Long-Term||1,039||1,781|
|Term Loan, Net of Issuance Costs||20,856||-|
|Deferred License Revenue - Long-Term||8,558||9,843|
|Accumulated Other Comprehensive Income||49||52|
|Total Stockholders’ Equity||42,075||20,320|
|Total Liabilities and Stockholders’ Equity||$||85,236||$||44,317|
|ROCKWELL MEDICAL, INC. AND SUBSIDIARIES|
|Condensed Consolidated Statements of Operations|
|In thousands of US dollars ($) except per share amounts||Three Months Ended
||Three Months Ended
||Nine Months Ended
||Nine Months Ended
|Cost of Sales||14,934||15,424||44,693||44,085|
|Selling and Marketing||1,669||1,827||5,738||7,149|
|General and Administrative||3,622||4,623||11,767||16,341|
|Research and Product Development||1,745||1,475||5,183||4,930|
|Other Income (Expense)|
|Realized Gain on Investments||4||6||8||24|
|Warrant Modification Expense||-||-||(837||)||-|
|Total Other Income||(660||)||87||(1,879||)||297|
|Basic and Diluted Net Loss per Share||$||(0.10||)||$||(0.12||)||$||(0.32||)||$||(0.45||)|
|Basic and Diluted Weighted Average Shares Outstanding||71,811,322||63,796,723||69,594,167||59,728,446|
Source: Rockwell Medical, Inc.