Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company
dedicated to transforming the treatment of iron deficiency and
anemia management and improving outcomes for patients around the
world, today reported financial results and a business update for
the three months ended March 31, 2021.
“We continued to drive our business forward in
the first quarter,” said Russell Ellison, M.D., M.Sc., President
and Chief Executive Officer of Rockwell Medical. “We believe our
Home Infusion FPC program remains on track for a pre-IND meeting
with the FDA expected in the third quarter of this year, with
multiple upcoming milestones, including our current expectation
that the subsequent initiation of our Phase 2 clinical trial of FPC
for the treatment of iron deficiency anemia in adult patients in
the home infusion setting will commence in the second half of 2021.
We also received marketing approval of Triferic AVNU in Canada, the
first international regulatory approval for our intravenous
therapy, and continued to generate solid revenue from concentrates,
our base business, ending the quarter in a strong cash
position.”
First Quarter 2021
Operational Highlights
Dialysis Business
- Revenue from hemodialysis concentrates was approximately $15.2
million.
- Revenue from Triferic was approximately $283,000. Rockwell
Medical continues to generate data in clinics showing the benefits
of Triferic in real world protocols.
- The Company announced in April that
Triferic AVNU (ferric pyrophosphate citrate injection) received a
Notice of Compliance (marketing approval) from Health Canada for
the replacement of iron to maintain hemoglobin in adult patients
with hemodialysis-dependent chronic kidney disease. Rockwell
Medical expects Triferic AVNU to become commercially available in
Canada during 2022.
Home Infusion Program
- As previously announced, the U.S.
Food and Drug Administration (FDA) accepted the Company’s proposed
development strategy to pursue an approval via the 505(b)(1)
pathway as a novel new drug application (NDA) for FPC for treatment
of iron deficiency anemia (IDA) in adult patients in the home
infusion setting. Subject to a successful outcome of Rockwell
Medical’s pre-investigational new drug meeting with the FDA, the
Company plans to initiate a Phase 2 clinical trial in the second
half of 2021.
- In April, the Company presented
data from a clinical feasibility study reviewing the practice
patterns of iron deficiency anemia (IDA) in home parenteral
nutrition patients at the National Home Infusion Association’s
(NHIA) 2021 Annual Conference. The study found that although
approximately half of the patients in the home infusion setting
suffer from IDA, and oral iron is indicated as a first-line
therapy, many patients may not tolerate it, or may have
unsatisfactory results with this option. The study results support
the Company’s initial assumptions that management of IDA in the
home infusion population is suboptimal and remains an unmet
clinical need.
Pipeline Development
- 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 second half of 2021.
First Quarter 2021 Selected Financial
Highlights
The following discussion and analysis should be
read in conjunction with our audited condensed consolidated
financial statements and related notes on Form 10-K for the year
ended December 31, 2020, and Form 10-Q for the quarter ended March
31, 2021.
Revenues were $15.5 million for the three months
ended March 31, 2021, compared to $15.9 million for the three
months ended March 31, 2020. Triferic revenue was $0.3 million for
the three months ended March 31, 2021.
Cost of sales was $15.1 million for the three
months ended March 31, 2021, resulting in gross profit of $0.4
million, compared to $14.7 million for the three months ended March
31, 2020, resulting in gross profit of $1.1 million.
Research and product development expenses were
$1.8 million for each of the three months ended March 31, 2021 and
2020. The Company is continuing to invest in its medical and
scientific programs to support the continued data and phase 4
clinical programs for Triferic in dialysis and the advancement of
our FPC technology platform.
Selling and marketing expenses were $1.9 million
during the three months ended March 31, 2021, compared with $2.1
million during the three months ended March 31, 2020. The decrease
of $0.2 million is primarily due to a decrease in marketing costs
related to Triferic (dialysate) partially offset by a slight
increase in costs associated with the launch of Triferic AVNU.
General and administrative expenses were $3.9
million during the three months ended March 31, 2021, compared
with $5.3 million during the three months ended March 31, 2020. The
decrease of $1.4 million is due primarily to a decrease in stock
compensation of $1.2 million, relating to a decrease in incentive
compensation from forfeited equity awards and the change in
probability relating to performance award achievement; a decrease
in legal costs of $0.2 million, relating to previous litigation
that has since been resolved; and a decrease in insurance costs of
$0.1 million, relating to reduced premiums; partially offset by an
increase of $0.1 million for increased headcount and severance pay
related to our former President and Chief Executive Officer.
Net loss was $7.8 million, or $(0.08) basic and
diluted net loss per share for the three months ended March 31,
2021, compared to net loss of $8.0 million, or $(0.12) basic and
diluted net loss per share for the three months ended March 31,
2020.
Cash, cash equivalents, and investments
available-for-sale totaled $46.1 million as of March 31, 2021,
compared to $58.7 million on December 31, 2020. Working capital was
$48.0 million as of March 31, 2021, compared to $56.7 million as of
December 31, 2020.
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 March 31, 2021, there were 93,599,519
shares of common stock outstanding.
First Quarter 2021 Business Update
Conference Call and Webcast
Rockwell Medical's management team will host a
conference call and audio webcast today, May 17, 2021, at 4:30 p.m.
ET to discuss Q1 2021 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 7870946.
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 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
INDICATION
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.
Adverse Reactions
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.
To report an Adverse Events (AE) or Product
Quality Control (PQC) please call the Medical Information
Department at (855) 333-4315 or e-mail at
rockwell.pharmacovigilance@propharmagroup.com.
For full Safety and Prescribing Information
please visit www.Triferic.com and www.Trifericavnu.com.
About Rockwell Medical
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 to
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. Rockwell Medical is also advancing its FPC
platform by developing FPC for the treatment of iron deficiency
anemia in patients outside of dialysis, who are receiving
intravenous medications in the home infusion setting. In addition,
Rockwell Medical is one of two major suppliers of life-saving
hemodialysis concentrate products to kidney dialysis clinics in the
United States. For more information, visit www.RockwellMed.com.
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
development plans and timing for Rockwell Medical’s FPC pipeline
candidates, the timing and outcome of meetings with the FDA, the
timing and outcome of foreign clinical trials and regulatory
approval, the timing for the commencement of our clinical trial of
FPC for treatment of IDA in adult patients in the home infusion
setting, the benefits of Triferic and the timing for a commercial
launch of Triferic AVNU in Canada. 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 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 continuance of the COVID-19 pandemic (including,
applicable federal state or local orders) on business, labor
availability and operating results, including our supply chain,
dialysis concentrates business and the Company’s commercialization
of both pharmaceutical and medical device products; the challenges
inherent in new product development, other new indications and
therapeutics areas for our products; the success 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 international regulatory and
reimbursement approval for Triferic (dialysate) and Triferic AVNU;
the success 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 data results may not demonstrate efficacy or 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 Annual Report on Form 10-K for the
year ended December 31, 2020, 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
SUBSIDIARIESCondensed Consolidated Balance
Sheets(Dollars in
Thousands)(Unaudited)
|
March
31, |
|
December
31, |
|
2021 |
|
|
2020 |
|
|
|
(Unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
Cash and Cash Equivalents |
$ |
35,675 |
|
|
$ |
48,682 |
|
Investments
Available-for -Sale |
|
10,464 |
|
|
|
9,997 |
|
Accounts
Receivable, net of a reserve |
|
6,597 |
|
|
|
4,171 |
|
Inventory |
|
4,117 |
|
|
|
3,913 |
|
Prepaid and
Other Current Assets |
|
2,389 |
|
|
|
2,706 |
|
Total Current Assets |
|
59,242 |
|
|
|
69,469 |
|
Property and
Equipment, net |
|
2,472 |
|
|
|
2,642 |
|
Inventory,
Non-Current |
|
1,325 |
|
|
|
1,176 |
|
Right of Use
Assets, net |
|
4,860 |
|
|
|
2,911 |
|
Goodwill |
|
921 |
|
|
|
921 |
|
Other
Non-current Assets |
|
629 |
|
|
|
629 |
|
Total Assets |
$ |
69,449 |
|
|
$ |
77,748 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Accounts
Payable |
$ |
3,307 |
|
|
$ |
4,155 |
|
Accrued
Liabilities |
|
4,032 |
|
|
|
5,013 |
|
Lease
Liability - Current |
|
1,417 |
|
|
|
1,167 |
|
Deferred
License Revenue |
|
2,170 |
|
|
|
2,175 |
|
Customer
Deposits |
|
135 |
|
|
|
152 |
|
Other
Current Liability - Related Party |
|
171 |
|
|
|
131 |
|
Total Current Liabilities |
|
11,232 |
|
|
|
12,793 |
|
|
|
|
|
|
|
Lease
Liability - Long Term |
|
3,522 |
|
|
|
1,821 |
|
Term Loan,
Net of Issuance Costs |
|
21,041 |
|
|
|
20,949 |
|
Deferred
License Revenue |
|
7,476 |
|
|
|
8,015 |
|
Total Liabilities |
|
43,271 |
|
|
|
43,578 |
|
|
|
|
|
|
|
Stockholders’ Equity: |
|
|
|
|
|
Preferred
Shares, $0.0001 par value, 2,000,000 shares authorized, no shares
issued and outstanding at March 31, 2021 and December 31, 2020 |
|
— |
|
|
|
— |
|
Common
Stock, $0.0001 par value,170,000,000 shares authorized, 93,599,519
and 93,573,165 shares issued and outstanding at March 31, 2021 and
December 31,2020, respectively |
|
9 |
|
|
|
9 |
|
Additional
Paid-in Capital |
|
371,274 |
|
|
|
371,510 |
|
Accumulated
Deficit |
|
(345,158 |
) |
|
|
(337,406 |
) |
Accumulated
Other Comprehensive Income |
|
53 |
|
|
|
57 |
|
Total Stockholders’ Equity |
|
26,178 |
|
|
|
34,170 |
|
Total Liabilities And Stockholders’ Equity |
$ |
69,449 |
|
|
$ |
77,748 |
|
|
|
|
|
|
|
ROCKWELL MEDICAL, INC. AND
SUBSIDIARIESCondensed Consolidated Statements of
Operations(Dollars in Thousands, except per share
amounts)(Unaudited)
|
|
Three Months Ended March 31, 2021 |
|
Three Months Ended March 31, 2020 |
|
|
|
|
|
|
|
Net Sales |
|
$ |
15,473 |
|
|
$ |
15,857 |
|
Cost of
Sales |
|
|
15,072 |
|
|
|
14,744 |
|
Gross Profit |
|
|
401 |
|
|
|
1,113 |
|
Research and
Product Development |
|
|
1,809 |
|
|
|
1,822 |
|
Selling and
Marketing |
|
|
1,851 |
|
|
|
2,073 |
|
General and
Administrative |
|
|
3,923 |
|
|
|
5,273 |
|
Operating Loss |
|
|
(7,182 |
) |
|
|
(8,055 |
) |
|
|
|
|
|
|
|
Other (Expense) Income |
|
|
|
|
|
|
Realized
Gain on Investments |
|
|
— |
|
|
|
2 |
|
Interest
Expense |
|
|
(581 |
) |
|
|
(102 |
) |
Interest
Income |
|
|
11 |
|
|
|
171 |
|
Total Other (Expense) Income |
|
|
(570 |
) |
|
|
71 |
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(7,752 |
) |
|
$ |
(7,984 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Net Loss per Share |
|
$ |
(0.08 |
) |
|
$ |
(0.12 |
) |
|
|
|
|
|
|
|
Basic and Diluted Weighted Average Shares
Outstanding |
|
|
93,591,053 |
|
|
|
67,518,240 |
|
|
|
|
|
|
|
|
CONTACTS
Investors:Argot
Partners212.600.1902Rockwell@argotpartners.com
Media:David RosenArgot
Partners212.600.1902david.rosen@argotpartners.com
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