Rockwell Medical, Inc. (NASDAQ:RMTI) (“Rockwell Medical” or the
"Company"), a biopharmaceutical company dedicated to improving
outcomes for patients with anemia, with an initial focus on
end-stage renal disease (ESRD), today provided a business update
and information related to the launch of Dialysate Triferic®
(ferric pyrophosphate citrate), and reported preliminary third
quarter 2019 financial results. The Company will host a conference
call on Friday, October 25, 2019 at 8:30 am ET to review these
updates.
“Our mission is to transform anemia management in a wide variety
of disease states across the globe while improving patients’ lives.
We believe Triferic is one of the most innovative advancements in
patient iron management over the last two decades. Accordingly, we
are building the foundation to become a leading medical and
commercial organization in the field of dialysis, which we believe
will enable Triferic to become the standard of care for ESRD
patients. To that end, we are pleased with the early progress we
are making with the commercialization of our Triferic portfolio,”
stated Stuart Paul, President and Chief Executive Officer of
Rockwell Medical.
Dialysate Triferic U.S. Market Introduction
Highlights
Key highlights and early learnings include:
- Most clinics require a three month product trial before
committing to commercial purchase. As a result, the Company
launched an Evaluation Program to enable clinics to utilize
Dialysate Triferic at no cost for up to three months.
- The sales cycle to convert a new account has been approximately
5-6 months on average, which includes initial contact, the
Evaluation Program, and on-boarding.
- Key metrics for Dialysate Triferic adoption include:
- Entered into contracts with 13 clinics for the purchase of
Dialysate Triferic as of September 30, 2019, representing more than
1,000 patients. This translates to more than 150,000 annualized
treatments with Dialysate Triferic;
- More than 15 additional clinics, representing over 1,300
patients, are at various stages of an Evaluation Program; and
- To date, more than 75% of clinics that initiated and completed
an Evaluation Program since launch have entered into contracts to
purchase Dialysate Triferic.
Building a Leading Medical Platform
Rockwell Medical is committed to and focused on enhancing its
medical capabilities. Key highlights and progress to date
include:
- The Company entered into its first contract with a Center of
Excellence for the purchase of Dialysate Triferic during the third
quarter of 2019. The Company defines Centers of Excellence as
leading independent academic institutions that operate their own
clinics or leading nephrology practices that are recognized as
thought leaders in dialysis.
- Rockwell Medical is working with early adopters of Dialysate
Triferic, including Centers of Excellence, to collect and analyze
real-world data. The Company expects to generate an ongoing stream
of data publications, case studies and white papers to enhance the
value proposition for Triferic.
- The Company is collecting real-world data from seven dialysis
clinics totaling more than 500 patients, including five clinics
associated with a medium dialysis organization and two clinics
affiliated with a Center of Excellence, as of September 30,
2019.
- The Company expects the first meaningful data readouts from
these relationships to occur during the first quarter of 2020.
- Rockwell Medical expects to announce updates to its Medical
Advisory Board during the fourth quarter of 2019, including the
addition of world-renowned experts in anemia and ESRD.
Other Business Updates
- The Company submitted comments to the Centers for Medicare
& Medicaid Services (CMS) on the 2020 Proposed Rule for the
End-Stage Renal Disease (ESRD) Prospective Payment System (PPS),
highlighting the innovative nature of I.V. Triferic, as well as the
importance of the Transitional Drug Add-On Payment Adjustment
(TDAPA) to incentivize innovation and competition. A final ruling
from CMS is expected in early November 2019.
- Rockwell Medical is engaged with the U.S. Food and Drug
Administration (FDA) on normal course review activities regarding
the I.V. Triferic New Drug Application. The Company remains on
track for a PDUFA date of March 28, 2020.
Preliminary Financial Results
The Company estimates net sales for the three months ended
September 30, 2019 will be in the range of $15.0 million to $15.4
million. Net sales of Dialysate Triferic are estimated to be in the
range of $90,000 to $100,000 for the third quarter of 2019. Ending
cash, cash equivalents and investments as of September 30, 2019
were approximately $29.0 million. The change in cash, cash
equivalents and investments for the three months ending September
30, 2019 was approximately ($6.2) million.
These current preliminary, estimated results of operations are
based on management’s initial review of operations for the three
months ended September 30, 2019, and remain subject to completion
of the Company’s customary closing and review procedures, final
adjustments and other developments that may arise between now and
the time the financial results for the three months ended September
30, 2019 are finalized. It is possible that the final reported
results for the three months ended September 30, 2019 may differ
materially from the estimates provided in this release.
“Our efforts to drive adoption of our Triferic portfolio
include: the U.S. market introduction of Dialysate Triferic,
building a leading medical platform in the field of dialysis, the
potential approval of I.V. Triferic in the U.S. in 2020, and
continued progress in international market development. We are
especially encouraged that more than 75% of the dialysis centers
that have initiated and completed our Evaluation Program since
launch have now converted to commercial customers who purchase
Triferic,” concluded Mr. Paul.
Conference Call
Rockwell Medical management will host a conference call to
discuss the business update and preliminary third quarter 2019
financial results with dial-in details as follows:
Date |
|
Friday, October 25, 2019 |
Time |
|
8:30 AM EDT |
Telephone U.S: |
|
(877) 383-7438 |
International: |
|
(678) 894-3975 |
Webcast (live and
archive) |
|
https://edge.media-server.com/mmc/p/5myjode4 |
About Triferic Triferic is the only
FDA-approved therapy indicated to replace iron and maintain
hemoglobin in hemodialysis patients via dialysate during each
dialysis treatment. Triferic delivers approximately 5-7 mg iron
with every hemodialysis treatment to the bone marrow and maintains
hemoglobin without increasing iron stores (ferritin). Unlike
traditional IV iron products, 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. 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 with a PDUFA date of March 28, 2020. Please visit
www.triferic.com to view the Triferic mode-of-action (MOA) video
and for more information.
Important Safety InformationSerious
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%).
For more information, including full prescribing information,
visit: http://www.triferic.com.
About Rockwell Medical Rockwell Medical is a
biopharmaceutical company dedicated to improving outcomes for
patients with anemia, with an initial focus on end-stage renal
disease (ESRD) and chronic kidney disease (CKD). Rockwell Medical's
exclusive renal drug therapy, Triferic, supports disease management
initiatives to improve the quality of life and care of dialysis
patients and is intended to deliver safe and effective therapy,
while decreasing drug administration costs and improving patient
convenience. The Company has developed multiple formulations of
Triferic: (1) Dialysate Triferic; and (2) I.V. Triferic. Dialysate
Triferic is the only FDA-approved therapeutic indicated for iron
replacement and maintenance of hemoglobin in hemodialysis patients.
The Company’s strategy is to bring its therapeutics to market in
the United States and to utilize partners to develop and
commercialize such therapeutics in international markets. 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. Please
visit www.rockwellmed.com for more information.
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 intention to bring to market
Triferic, and I.V. Triferic. Words such as "may," "might," "will,"
"should," "believe," "expect," "anticipate," "estimate,"
"continue," "could," "plan," "potential," "predict," "forecast,"
"project," "plan", "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 timing of
data readouts; the timing for the ruling from CMS; potential
market opportunity for I.V. Triferic, as well as other Rockwell
Medical products; pricing and reimbursement status for I.V.
Triferic and other Rockwell Medical products, including the
eligibility of I.V. Triferic for add-on reimbursement under TDAPA,
pursuant to CMS’ preliminary proposed rules as announced by CMS on
July 29, 2019; liquidity and capital resources; expected duration
of Rockwell Medical's existing working capital; success of our
recently announced commercialization of Dialysate Triferic; and
timing and success of our efforts to maintain, grow and improve the
profit margin of the Company’s concentrate business. 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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