RMTI Rockwell Medical Inc.

1.37
+0.09  (+7%)
Previous Close 1.28
Open 1.31
52 Week Low 0.83
52 Week High 3.85
Market Cap $128,195,236
Shares 93,573,165
Float 81,020,124
Enterprise Value $75,507,651
Volume 2,831,465
Av. Daily Volume 1,316,848
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Drug Pipeline

Drug Stage Notes
IV Triferic
Anemia
Approved
Approved
FDA approval announced date March 27, 2020.
Soluble Ferric Pyrophosphate
Anemia
Approved
Approved
Approved January 26, 2015.

Latest News

  1. WIXOM, Mich., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced that its partner in China, Wanbang Biopharmaceuticals, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., enrolled the first patient in a pivotal Phase 3 trial for Triferic Dialysate to support a new drug application for regulatory approval in that country.

    "The initiation of this pivotal trial is an important milestone in our strategic plan to expand global access to Triferic," said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer…

    WIXOM, Mich., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced that its partner in China, Wanbang Biopharmaceuticals, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., enrolled the first patient in a pivotal Phase 3 trial for Triferic Dialysate to support a new drug application for regulatory approval in that country.

    "The initiation of this pivotal trial is an important milestone in our strategic plan to expand global access to Triferic," said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. "In China, hemodialysis has continued to increase at a rapid rate in recent years, with more than 600,000 patients receiving hemodialysis every year, making it the largest single market in the world. Wanbang Biopharmaceuticals is a leading pharmaceutical company and an outstanding partner to bring our therapy to patients in China."

    "We believe Triferic has the potential to greatly improve the lives of patients on dialysis in China, and we are pleased to have dosed the first patient in our pivotal trial," said Mr. Shibin Wu, Chief Executive Officer of Wanbang Biopharmaceuticals. "Wanbang Biopharmaceuticals is committed to addressing the needs of CKD patients and healthcare providers with a comprehensive range of therapeutic options across home, in-center and hospital dialysis settings. We value our partnership with Rockwell Medical, and our collaboration enhances Wanbang Biopharmaceuticals' pipeline of innovative product candidates."

    The Phase 3 trial [RMFPC-13] is a prospective, randomized, single-blind (patient), parallel two-arm, placebo-controlled, multicenter, study of the efficacy and safety of Triferic® administered via hemodialysate in maintaining iron delivery and hemoglobin concentration in anemic adult patients with chronic kidney disease requiring hemodialysis. The objective of the study is to confirm the efficacy and safety of Triferic administered at each hemodialysis treatment via hemodialysate in maintaining iron delivery for erythropoiesis in anemic iron-replete Chinese CKD-5HD patients.

    Rockwell Medical signed exclusive licensing and manufacturing supply agreements in 2016 with Wanbang Biopharmaceuticals for the rights to commercialize Triferic in China. Under the terms of the agreement, Wanbang Biopharmaceuticals became the exclusive distributor for Triferic in China for an initial commercial term of 10 years, with an extended term of 10 or more years based on achievement of annual minimum purchase requirements. Wanbang Biopharmaceuticals is required to achieve annual minimum purchase requirements to retain exclusive commercialization rights. In consideration for the exclusive rights, Rockwell received an upfront fee and is entitled to a regulatory approval milestone, revenue milestone payments, and Rockwell is entitled to receive ongoing earnings from product sales of Triferic and other additional Triferic therapeutic indications that Wanbang Biopharmaceuticals may develop. In addition to the hemodialysis indication, Wanbang Biopharmaceuticals has the exclusive right to develop and commercialize Triferic for new therapeutic indications for the Chinese market. Wanbang Biopharmaceuticals is responsible for all clinical, regulatory and marketing expenses for Triferic in China as well as development and regulatory costs for new Triferic indications. Rockwell retains manufacturing responsibility of all products.

    About Rockwell Medical

    Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and anemia management in a wide variety of therapeutic areas and across the globe, improving the lives of very sick patients. The Company's initial focus is the treatment of anemia in end-stage kidney disease. Rockwell Medical's exclusive renal drug therapies, Triferic (ferric pyrophosphate citrate) Dialysate and Triferic AVNU, are the only FDA-approved therapeutics indicated for maintenance of hemoglobin in hemodialysis patients. Rockwell Medical is also an established manufacturer, supplier and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad.

    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

    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. Importantly, there have been no reports of anaphylaxis in over 1.2 million patient administrations.

    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%).

    Forward-Looking Statements

    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, patient enrollment in a clinical trial and regulatory filings in China, the success of Triferic Dialysate and Triferic AVNU within clinical trials, the commercialization of Triferic Dialysate and Triferic AVNU in China, the potential approval of Triferic and Triferic AVNU in China, potential future sales within China and anticipated market sizes and future growth, future milestone payments and reliance upon approval and sales, and the development plans and timing for Rockwell Medical's FPC pipeline candidates in new indications. Words such as, "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "can," "would," "develop," "plan," "potential," "predict," "forecast," "project," "intend" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical's SEC filings), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include, but are not limited to: the impact of the COVID-19 pandemic (including, applicable federal state or local orders) on business and operating results, including our supply chain, and the ability to enroll patients in clinical trials, the ability to have governmental agencies review submissions in a timely manner, and the ability to commercialize Triferic and Triferic AVNU; the potential for modifications of regulatory requirements in both internationally and domestically; the challenges inherent in new product development and other indications and therapeutics areas for our products; the success of our commercialization strategy; the success and timing of our commercialization of Triferic Dialysate and Triferic AVNU; the success and timing of international clinical trials for Triferic Dialysate; the success and timing of the development of our FPC pipeline candidates, the risk that topline clinical data and real world results may not be predictive of future results; expected financial performance, including cash flows, revenues, growth, margins, funding, liquidity and capital resources; and those risks more fully discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the period ended September 30, 2020 and of our Annual Report on Form 10-K for the year ended December 31, 2019, as such description may be amended or updated in any future reports we file with the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, except as may be required by law.

    Triferic® is a registered trademark of Rockwell Medical, Inc. Triferic AVNU is pending with the U.S. Patent and Trademark Office. All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902



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  2. WIXOM, Mich., Jan. 05, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced the Rockwell Medical executive management team will record a presentation at H.C. Wainwright BioConnect 2021 Conference. This presentation will become publicly available on January 11, 2021, at 6:00 a.m. ET and will be archived for 30 days thereafter, via the Company's website at www.rockwellmed.com, under the "Investors" section.

    About Rockwell Medical

    Rockwell Medical is a biopharmaceutical company dedicated to transforming…

    WIXOM, Mich., Jan. 05, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced the Rockwell Medical executive management team will record a presentation at H.C. Wainwright BioConnect 2021 Conference. This presentation will become publicly available on January 11, 2021, at 6:00 a.m. ET and will be archived for 30 days thereafter, via the Company's website at www.rockwellmed.com, under the "Investors" section.

    About Rockwell Medical

    Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and anemia management in a wide variety of therapeutic areas and across the globe, improving the lives of very sick patients. The Company's initial focus is the treatment of anemia in end-stage kidney disease (ESKD). Rockwell Medical's exclusive renal drug therapies, Triferic (ferric pyrophosphate citrate) Dialysate and Triferic AVNU, are the only FDA-approved therapeutics indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Rockwell Medical is also an established manufacturer, supplier and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad.

    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 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%).

    Triferic® is a registered trademark of Rockwell Medical, Inc. Triferic AVNU is pending with the U.S. Patent and Trademark Office. All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902

     



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  3. WIXOM, Mich., Dec. 16, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced the appointment of industry leader and renowned life science industry executive, Ms. Andrea Heslin Smiley, to its Board of Directors, effective December 11, 2020. Ms. Smiley currently serves as President and Chief Executive Officer of VMS BioMarketing and is a member of the Board of Directors of life science company, Assertio (formerly Zyla Life Sciences).

    "We are pleased to welcome Andrea to the Board of Directors," said John…

    WIXOM, Mich., Dec. 16, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced the appointment of industry leader and renowned life science industry executive, Ms. Andrea Heslin Smiley, to its Board of Directors, effective December 11, 2020. Ms. Smiley currently serves as President and Chief Executive Officer of VMS BioMarketing and is a member of the Board of Directors of life science company, Assertio (formerly Zyla Life Sciences).

    "We are pleased to welcome Andrea to the Board of Directors," said John P. McLaughlin, Chairman of the Board of Directors of Rockwell Medical. "Andrea brings a wealth of experience in patient adherence and outcomes, clinical educator solutions, nursing networks, and pharmaceutical product launches and marketing. She will be a valuable advisor in maximizing the value of Triferic® in kidney disease and our FPC technology in home infusion and heart failure."

    "I am delighted to join Rockwell Medical's Board of Directors at this exciting time for the Company, especially as we plan to move into the rapidly growing home infusion market," said Ms. Smiley.

    Ms. Smiley brings approximately three decades of commercialization and general management experience in the biopharmaceutical industry in both public and private companies. She joined VMS BioMarketing, a leading provider of patient and healthcare provider support, in 2008, and has served as its President and Chief Executive Officer since 2011. Within her first year as CEO, she spun-off commoditized business units and focused the company on impacting patient adherence and outcomes, all the while establishing VMS BioMarketing as the leading provider and growth leader of clinical nurse educator patient support solutions. Prior to joining VMS BioMarketing, Ms. Smiley spent 18 years at Eli Lilly and Company in various positions of increasing responsibility in finance, business development, corporate affairs, brand management and business unit leadership roles. She was the marketing leader for the launch of Humalog® Mix75/25™, she led sales and marketing for Humatrope®, she was responsible for the development and launch of Forteo® and she was the business unit leader of Lilly's women's health business, among other programs. Earlier in her career, Ms. Smiley worked as a management consultant for Putnam Associates, where she led consulting teams and advised brands in the biotechnology, pharmaceutical and managed healthcare fields on product launches and access strategies. She is a regular speaker and panel member on patient adherence, patient services and women's leadership topics at biopharmaceutical industry conferences. Ms. Smiley serves on the board of numerous nonprofit organizations including the Indiana Alzheimer's Association, Summer Stock, Indiana Salvation Army and the Lung Force Women's Cabinet. She received a gubernatorial appointment to the Indiana Commission for Women. Ms. Smiley earned her Bachelor of Arts degree in economics from DePauw University, where she was an Honors Management Fellow.

    About Rockwell Medical

    Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and anemia management in a wide variety of therapeutic areas and across the globe, improving the lives of very sick patients. The Company's initial focus is the treatment of anemia in end-stage kidney disease (ESKD). Rockwell Medical's exclusive renal drug therapies, Triferic (ferric pyrophosphate citrate) Dialysate and Triferic AVNU, are the only FDA-approved therapeutics indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Rockwell Medical is also an established manufacturer, supplier and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad.

    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 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%).

    Forward-Looking Statements

    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 commercialization of Triferic Dialysate, the launch of Triferic AVNU, the development plans and timing for Rockwell Medical's FPC pipeline candidates including but not limited to the potential application of FPC within the home infusion market, and the commercialization of future FPC pipeline candidates in other therapeutic areas. Words such as, "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "can," "would," "develop," "plan," "potential," "predict," "forecast," "project," "intend" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical's SEC filings), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include, but are not limited to: the impact of the COVID-19 pandemic (including, applicable federal state or local orders) on business and operating results and those risks more fully discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the period ended September 30, 2020 and of our Annual Report on Form 10-K for the year ended December 31, 2019, as such description may be amended or updated in any future reports we file with the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, except as may be required by law.

    Triferic® is a registered trademark of Rockwell Medical, Inc. Triferic AVNU is pending with the U.S. Patent and Trademark Office. All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902



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  4. -Ended the quarter with $67.3 million in cash, cash equivalents and investments-

    -Q3 2020 revenue of $15.3 million-

    -U.S. commercial launch of Triferic® AVNU expected in Q1 2021-

    -Poised to enroll first patient in Phase 3 clinical trial of Triferic in China-

    -Unveiled plans to develop FPC platform in new indications-

    WIXOM, Mich., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today reported financial results and a business update for the three months ended September 30, 2020.

    "Rockwell Medical is…

    -Ended the quarter with $67.3 million in cash, cash equivalents and investments-

    -Q3 2020 revenue of $15.3 million-

    -U.S. commercial launch of Triferic® AVNU expected in Q1 2021-

    -Poised to enroll first patient in Phase 3 clinical trial of Triferic in China-

    -Unveiled plans to develop FPC platform in new indications-

    WIXOM, Mich., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today reported financial results and a business update for the three months ended September 30, 2020.

    "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 U.S. sales of Triferic and soon-to-be-launched Triferic AVNU; expanding the global commercial reach of Triferic through our key partners; and strategically developing new indications for our FPC platform," said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. "I am pleased to report that we have made important progress across all three tracks in the third quarter of 2020."

    Third Quarter 2020 Operational Highlights

    U.S. Sales - Triferic Dialysate and Concentrates

    • Net sales for the concentrates business were $15.0 million and net sales for Triferic were $0.3 million in 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 Medical expects to commercially launch Triferic AVNU in the United States in Q1 2021. Triferic AVNU will be reimbursed within the End Stage Renal Disease ("ESRD") bundle payment that has been established for Medicare patients.

    Triferic – Global Development and Commercialization

    • Wanbang Biopharmaceutical, Rockwell's partner in China, is poised to enroll the first patient in a pivotal Phase 3 trial for Triferic in China to support a filing for regulatory approval. Hemodialysis in China has 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 Pharma is navigating next steps due to the country's temporary suspension of regulatory review due to COVID-19. India is a potentially attractive market for Triferic, with over 120,000 hemodialysis patients.



    • In September 2020, Rockwell Medical entered 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 Medical received an upfront fee of $200,000 and will be eligible for milestone payments and royalties on net sales. South Korea represents a sizable and growing market opportunity, with over 78,000 patients receiving hemodialysis annually.

    New Indications for Ferric Pyrophosphate Citrate ("FPC") Platform:

    • In September 2020, the Rockwell Medical management 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 Medical believes 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 Medical intends 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

    • In September 2020, Rockwell Medical appointed Russell L. Skibsted, M.B.A., as Executive Vice President, Chief Financial Officer and Chief Business Officer. Mr. Skibsted is 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 $15.3 million, a decrease of 0.8% compared to net sales of $15.4 million for the third quarter of 2019. The decrease was primarily due to a decrease in international sales of our dialysis concentrates products. Triferic net sales for the three months ended September 30, 2020, were approximately $0.3 million. Triferic was launched in Q2 2019 via the sample evaluation program and there were nominal revenues during the three months ended September 30, 2019.

    Cost of sales for the third quarter of 2020 was $14.9 million, resulting in gross profit of $0.3 million, compared to cost of sales of $15.4 million and a nominal gross loss during the third quarter of 2019. Gross profits are primarily related to our concentrates business at this time.

    Selling and marketing expenses were $1.7 million for the third quarter of 2020 compared to $1.8 million for the third quarter of 2019.

    General and administrative expenses were $3.6 million for the third quarter of 2020 compared to $4.6 million for the third quarter of 2019. The decrease of $1.0 million was primarily due to a decrease in incentive compensation from forfeited equity awards associated with the departure of our former Chief Financial Officer in July 2020, a decrease in consulting expense relating to strategic development, a decrease in accounting costs relating to a decrease in internal audit fees; partially offset by severance pay related to our former President and Chief Executive Officer.

    Research and product development expenses were $1.7 million for the third quarter of 2020 compared to $1.5 million for the third quarter of 2019. The increase in costs relate to our scientific programs. The Company is continuing to invest in its medical and scientific programs to support the global launch of Triferic and the advancement of our FPC technology platform.

    Net loss for the third quarter of 2020 was $7.4 million, or $0.10 per basic and diluted share, compared to a net loss for third quarter of 2019 of $7.9 million, or $0.12 per basic and diluted share.

    Cash, cash equivalents, and investments available-for-sale totaled $67.3 million as of September 30, 2020, compared to $40.0 million on June 30, 2020. Working capital was $65.2 million as of September 30, 2020, compared to $40.0 million as of June 30, 2020.

    On September 25, 2020, Rockwell Medical closed a registered direct offering of 23,178,809 of its shares of common stock (or common stock equivalents in lieu thereof) and short-term warrants to purchase up purchase up to an aggregate of 23,178,809 shares of common stock to several healthcare-focused and other institutional investors. The gross proceeds from the registered direct offering were $35.0 million before deducting placement agent fees and other offering expenses. The Company intends to use the net proceeds to advance the development of FPC, currently indicated for the maintenance of hemoglobin in dialysis, in new indications, including for the treatment of anemia in the home infusion setting, as well as for working capital and general corporate purposes.

    Additionally, the Company has a debt facility of $35.0 million of which the first tranche of $22.5 million was funded in March 2020 and is classified as long-term debt on the balance sheet. The Company may be eligible to draw on a third tranche of $7.5 million upon the achievement of certain additional milestones, including the achievement of certain Triferic sales thresholds.

    As of September 30, 2020, there were 93,573,165 shares of common stock outstanding versus 70,156,922 shares outstanding as of June 30, 2020.

    Third Quarter 2020 and Business Update Conference Call and Webcast

    Rockwell Medical's management team will host a conference call and audio webcast today at 4:30 p.m. ET to discuss Q3 2020 financial results and provide a business update.

    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 Rockwell Medical

    Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and anemia management in a wide variety of therapeutic areas and across the globe, improving the lives of very sick patients. The Company's initial focus is the treatment of anemia in end-stage kidney disease (ESKD). Rockwell Medical's exclusive renal drug therapies, Triferic (ferric pyrophosphate citrate) Dialysate and Triferic AVNU, are the only FDA-approved therapeutics indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Rockwell Medical is also an established manufacturer, supplier and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad.

    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 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%).

    Forward-Looking Statements

    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 China, regulatory approval in India and estimated market sizes. Words such as, "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "can," "would," "develop," "plan," "potential," "predict," "forecast," "project," "intend" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical's SEC filings), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include, but are not limited to: the impact of the COVID-19 pandemic (including, applicable federal state or local orders) on business and operating results, including our supply chain, dialysis concentrates business and the commercial launch of Triferic AVNU; the challenges inherent in new product development and other indications and therapeutics areas for our products; the success of our commercialization strategy; the success and timing of our commercialization of Triferic Dialysate; the success and timing of international clinical trials for Triferic Dialysate; the success and timing of our commercial launch of Triferic AVNU in the United States; the success and timing of the development of our FPC pipeline candidates, the risk that topline clinical data and real world results may not be predictive of future results; expected financial performance, including cash flows, revenues, growth, margins, funding, liquidity and capital resources; and those risks more fully discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the period ended September 30, 2020 and of our Annual Report on Form 10-K for the year ended December 31, 2019, as such description may be amended or updated in any future reports we file with the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, except as may be required by law.

    Triferic® is a registered trademark of Rockwell Medical, Inc. Triferic AVNU is pending with the U.S. Patent and Trademark Office. All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.

    Financial Tables Follow

     
    ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
    Condensed Consolidated Balance Sheets
    (Dollars in Thousands)
        
     September 30, 2020 December 31, 2019
     (Unaudited)  
    ASSETS   
    Cash and Cash Equivalents$56,614  $11,794 
    Investments Available-for-Sale 10,702   14,250 
    Accounts Receivable, net 4,129   4,203 
    Inventory, net 3,877   3,647 
    Prepaid and Other Current Assets 2,621   2,980 
    Total Current Assets 77,943   36,874 
    Property and Equipment, net 2,785   2,433 
    Inventory, Non-Current 859   441 
    Right of Use Assets, net 2,099   3,213 
    Goodwill 921   921 
    Other Non-Current Assets 629   435 
    Total Assets$ 85,236  $ 44,317 
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Accounts Payable$4,190  $3,018 
    Accrued Liabilities 4,968   4,518 
    Settlement Payable -   104 
    Lease Liability - Current 1,155   1,493 
    Deferred License Revenue - Current 2,180   2,234 
    Insurance Financing Note Payable -   763 
    Customer Deposits 73   55 
    Other Current Liability - Related Party 142   188 
    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 
    Total Liabilities 43,161   23,997 
        
        
    Stockholders' Equity:   
    Preferred Stock, $0.0001 par value, 2,000,000 shares authorized; no shares issued and outstanding at September 30, 2020 and December 31, 2019 -   - 
    Common Stock, $0.0001 par value; 170,000,000 shares authorized; 93,573,165 and 65,378,890 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively 9   7 
    Additional Paid-in Capital 370,760   326,777 
    Accumulated Deficit (328,743)  (306,516)
    Accumulated Other Comprehensive Income 49   52 
    Total Stockholders' Equity 42,075   20,320 
    Total Liabilities and Stockholders' Equity$ 85,236  $ 44,317 
        



     
    ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
    Condensed Consolidated Statements of Operations
    (Unaudited)
            
    In thousands of US dollars ($) except per share amountsThree Months Ended September 30, 2020 Three Months Ended September 30, 2019 Nine Months Ended September 30, 2020 Nine Months Ended September 30, 2019
            
    Net Sales$15,280  $15,407  $47,033  $45,812 
    Cost of Sales 14,934   15,424   44,693   44,085 
    Gross Profit 346   (17)  2,340   1,727 
    Selling and Marketing 1,669   1,827   5,738   7,149 
    General and Administrative 3,622   4,623   11,767   16,341 
    Settlement Expense -   -   -   430 
    Research and Product Development 1,745   1,475   5,183   4,930 
    Operating Loss (6,690)  (7,942)  (20,348)  (27,123)
            
    Other Income (Expense)       
    Realized Gain on Investments 4   6   8   24 
    Warrant Modification Expense -   -   (837)  - 
    Interest Expense (666)  (16)  (1,289)  (16)
    Interest Income 2   97   239   289 
    Total Other Income (660)  87   (1,879)  297 
            
    Net Loss$(7,350) $(7,855) $(22,227) $(26,826)
            
    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 
            

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902

    Primary Logo

    View Full Article Hide Full Article
  5. WIXOM, Mich., Oct. 27, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced that it will host a conference call on Monday, November 9, 2020, at 4:30 p.m. ET to discuss its financial results for the three months ended September 30, 2020, and recent operational highlights.

    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…

    WIXOM, Mich., Oct. 27, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced that it will host a conference call on Monday, November 9, 2020, at 4:30 p.m. ET to discuss its financial results for the three months ended September 30, 2020, and recent operational highlights.

    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.

    To submit questions in advance, please email your questions to .

    About Rockwell Medical

    Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and anemia management in a wide variety of therapeutic areas and across the globe, improving the lives of very sick patients. The Company's initial focus is the treatment of anemia in end-stage kidney disease (ESKD). Rockwell Medical's exclusive renal drug therapies, Triferic® (ferric pyrophosphate citrate) Dialysate and Triferic AVNU, are the only FDA-approved therapeutics indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Rockwell Medical is also an established manufacturer, supplier and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad.

    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 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 1,200,000 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%).

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902

    Primary Logo

    View Full Article Hide Full Article
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