Rockwell Medical, Inc. to Discuss Fourth Quarter and Full Year 2019 Financial Results on March 12, 2020
March 04 2020 - 4:30PM
Rockwell Medical, Inc. ("Rockwell Medical" or the “Company”)
(Nasdaq: RMTI) today announced that the Company will release its
2019 fourth quarter and full year financial results on Thursday,
March 12, 2020, after the close of the U.S. financial markets.
Stuart Paul, Chief Executive Officer, and Angus Smith, Chief
Financial Officer, will host a conference call to discuss the
results as follows:
DateTimeToll
free (U.S.)InternationalWebcast (live and replay) |
Thursday,
March 12, 20204:30 p.m. ET(877) 383-7438(678)
894-3975www.rockwellmed.com under the “Investor” section |
The webcast will be archived for 30 days at the aforementioned
URL.
About Rockwell Medical
Rockwell Medical is a biopharmaceutical company dedicated to
transforming 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 renal disease (ESRD). Rockwell Medical's exclusive renal
drug therapy, Triferic (ferric pyrophosphate citrate), is the only
FDA-approved therapeutic indicated for iron replacement and
maintenance of hemoglobin in hemodialysis patients. The Company has
developed multiple formulations of Triferic (1) FDA-approved
Dialysate Triferic, and (2) I.V. Triferic, for which the Company
filed a New Drug Application in May 2019. 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
Triferic is the only FDA-approved therapy in the U.S. indicated
to replace iron and maintain hemoglobin in hemodialysis patients
via dialysate during each dialysis treatment. Triferic has a unique
and differentiated mechanism of action which has the potential to
benefit patients and health care economics. Triferic represents a
potential innovative medical advancement in hemodialysis patient
iron management– with the potential to become the future standard
of care.
Triferic delivers approximately 5-7 mg iron with every
hemodialysis treatment to the bone marrow and maintains hemoglobin
without increasing iron stores (ferritin). Triferic donates iron
immediately and completely to transferrin (carrier of iron in the
body) upon entry into the blood and 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 ESRD 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, Rockwell Medical’s
expectations regarding the consummation of the offering, the terms
of the offering, and the satisfaction of customary closing
conditions with respect to the offering and the anticipated use of
the net proceeds of the offering. Words such as “may,” “might,”
“will,” “should,” “believe,” “expect,” “anticipate,” “estimate,”
“continue,” “could,” “plan,” “potential,” “predict,” “forecast,”
“project,” “intend” or 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: statements about the issuance of a unique J code for our
Triferic powder packet; timing and regulatory approval process for
Dialysate Triferic in China; the potential market opportunity and
commercialization of Dialysate Triferic in China upon regulatory
approval; the timing and regulatory approval process for our NDA
filing for I.V. Triferic as filed with the FDA: the potential
market opportunity for I.V. Triferic, as well as other Rockwell
Medical products; CMS’ announced final rule relating to the
eligibility criteria for TDAPA; liquidity and capital resources;
expected duration of Rockwell medical’s existing working capital;
our ability to successfully commercialize Dialysate Triferic, which
commenced in May 2019; and the timing and success of our efforts to
maintain, grow and improve the profit margin of the Company’s
concentrate business; and the impact of general economic,
industrial or political conditions in the United States or
internationally, as well as those risks more fully discussed in
Rockwell Medical’s SEC filings. Accordingly, you should not place
undue reliance on these forward-looking statements. Rockwell
Medical expressly disclaims any obligation to update or alter any
statements whether as a result of new information, future events or
otherwise, except as required by law.
Triferic® is a registered trademark of Rockwell Medical,
Inc.
Contact Investor Relations: Lisa M. Wilson,
In-Site Communications, Inc. T: 212-452-2793 E:
lwilson@insitecony.com
Source: Rockwell Medical, Inc.
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