Rockwell Medical, Inc. (Nasdaq: RMTI) (“Rockwell Medical” or the
“Company”), 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
September 30, 2021.
“Driven by accelerating growth in dialysis
concentrates products, Rockwell Medical delivered a strong third
quarter, which saw an increase in net sales versus both the second
quarter of 2021 and third quarter of last year,” said Russell
Ellison, M.D., M.Sc., President and Chief Executive Officer
of Rockwell Medical. “We continue to make steady progress to
develop and deliver innovative treatment to patients with iron
deficiency anemia (IDA). We recently submitted an Investigational
New Drug application (IND) for our proposed clinical trial of
Ferric Pyrophosphate Citrate (FPC) as a treatment for IDA in
patients receiving home infusion, which is the first potential
study of its kind in this patient population. At ASN Kidney Week
2021 in early November, we presented a real-world evidence update
reflecting results from a pilot observational analysis, which
demonstrated maintenance of hemoglobin and reduction of total IV
iron requirement in adult patients on Triferic receiving chronic
hemodialysis,” concluded Dr. Ellison.
Third Quarter 2021
Operational Highlights
Dialysis Business
- Third quarter revenue from
hemodialysis concentrates was approximately $15.7 million. The
Company is in the process of analyzing its supply chain to identify
efficiencies, while actively exploring U.S. and international
expansion of this business with its customers.
- Revenue from Triferic was
approximately $280,000 in the third quarter. Rockwell
Medical continues to generate data in clinics showing the
benefits of Triferic when integrated into anemia management
protocols. As part of this initiative and due to the current
economic environment, the Company has adjusted its sales and
marketing efforts for Triferic and Triferic AVNU and is seeking a
commercial partner within the United States. This decision was
based on the dynamics of the hemodialysis market, including
provider consolidation, the effects of the CMS bundled payment
system and competitive product bundling tactics.
Home Infusion Program
- The Company submitted an IND
application with the U.S. Food and Drug
Administration (FDA) in support of its proposed Phase 2
clinical trial of FPC, designed for the treatment of iron
deficiency anemia and maintenance of hemoglobin in patients
receiving infusion therapy in the home setting. Following IND
submittal, a sponsor must wait 30 calendar days before initiating
any clinical trials. During this time, the FDA has an
opportunity to review the IND for safety to assure that research
subjects will not be subjected to unreasonable risk.
- Home infusion represents a large
and rapidly growing segment of healthcare. According to the
National Home Infusion Association, the number of patients served
by home infusion therapy has grown from approximately 800,000 in
2010 to over 3,000,000 in 2019. The home infusion setting is
expected to continue to expand, which has been further accelerated
by the COVID-19 pandemic and the desire to reduce or eliminate
hospital and or clinic exposure. Many patient groups requiring home
infusion therapies suffer from diseases that are associated with an
incidence of iron deficiency and anemia. For example, it is
estimated that 40% to 55% of all home parenteral nutrition patients
are iron deficient. Management believes, based on the Company’s
data with hemodialysis patients, that FPC as a home infusion
therapy for iron deficiency anemia may have distinct advantages
over currently available iron replacement therapy options.
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 first half of 2022 to discuss the pathway for a
potential clinical development program.
Third Quarter 2021 Selected Financial
Highlights
The following discussion and analysis should be
read in conjunction with our condensed consolidated financial
statements and related notes on Form 10-Q for the third quarter
ended September 30, 2021.
Net sales for the third quarter were $16.0
million compared to net sales of $15.3 million for the same period
last year and $15.1 million in the second quarter of this year. The
increase was primarily due to an increase in sales of dialysis
concentrates products.
Net sales of hemodialysis concentrates were
approximately $15.7 million in the third quarter of 2021, which was
approximately $713,000 higher compared to the third quarter of 2020
and approximately $845,000 higher than the second quarter 2021.
Total sales of Triferic were approximately $280,000, roughly flat
versus the third quarter of 2020 and second quarter 2021.
Cost of sales for the third quarter of 2021 was
$16.3 million, resulting in gross loss of $0.3 million, compared to
cost of sales of $14.9 million and a gross profit of $0.3 million
for the third quarter of 2020. Gross profit decreased by $0.6
million, primarily due to an increase in costs related to protocols
implemented because of the ongoing COVID-19 pandemic and an
increase in shipping, fuel, and labor costs.
Research and product development expenses were
$1.2 million for the third quarter of 2021 compared to $1.7 million
for the third quarter of 2020. The decrease of $0.5 million was
primarily due to the timing of investments the Company is
continuing to make in its medical and scientific programs to
support the continued advancement of its FPC technology
platform.
Selling and marketing expenses were $1.5 million
for the third quarter of 2021 compared to $1.7 million for the
third quarter of 2020. The decrease of $0.2 million is primarily
due to a decrease in marketing costs related to Triferic
(dialysate).
General and administrative expenses were $3.8
million for the third quarter of 2021 compared to $3.6 million for
the third quarter of 2020. The increase of $0.2 million is due
primarily to an increase in premiums for the Company’s director and
officer insurance policy.
Net loss for the third quarter of 2021 was $7.5
million, or $0.08 per basic and diluted share, compared to a net
loss of $7.4 million during the third quarter of 2020, or $0.10 per
basic and diluted share.
Cash, cash equivalents and investments totaled
approximately $33.2 million at the end of the third quarter 2021.
Net cash used in operating activities was $7.1 million for the
three months ended September 30, 2021, compared to net cash used in
operating activities of $2.1 million for the three months ended
September 30, 2020. Net cash used in operating activities was $24.5
million for the nine months ended September 30, 2021, compared to
net cash used in operating activities of $21.1 million for the nine
months ended September 30, 2020. The increase in cash used in
operating activities in the first nine months of 2021 was primarily
due to changes in current balance sheet accounts in the ordinary
course of business of approximately $3.2 million, including an
increase in net accounts receivable of $1.9 million and an increase
in accounts payable and accrued expense of approximately $0.2
million.
As of September 30, 2021, there were
93,882,142 shares of common stock outstanding compared to
93,811,381 shares outstanding as of June 30, 2021.
Third Quarter 2021 and Business Update
Conference Call and Webcast
Rockwell Medical's management team will host a
conference call and audio webcast today at 4:00 p.m. ET to discuss
Q3 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 7697945.
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 commercial-stage
biopharmaceutical company developing and commercializing its
next-generation parenteral iron technology platform, Ferric
Pyrophosphate Citrate (FPC), which has the potential to lead
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. The Company is developing FPC for the
treatment of iron deficiency in patients outside of dialysis, who
are receiving intravenous medications in the home infusion setting,
a large and rapidly growing segment of healthcare, and where these
patients suffer from chronic diseases associated with high
incidence of iron deficiency and anemia. 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.
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 ReactionsMost 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.
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,
including meetings regarding use of our FPC platform for the
treatment of hospitalized patients with acute heart failure, the
potential expansion of our hemodialysis concentrates business, the
potential market for home infusion, and the benefit of FPC for the
treatment of hospitalized patients with acute heart failure. 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 continuation 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 regulatory
approval for Triferic (dialysate) and Triferic AVNU; 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;
macroeconomic conditions; 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(unaudited)
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
2021 |
|
2020 |
|
|
|
|
(Unaudited) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
Cash and Cash Equivalents |
$ |
23,390 |
|
|
$ |
48,682 |
|
|
|
Investments Available-for-Sale |
|
9,813 |
|
|
|
9,997 |
|
|
|
Accounts Receivable, net of a reserve |
|
6,036 |
|
|
|
4,171 |
|
|
|
Inventory |
|
4,028 |
|
|
|
3,913 |
|
|
|
Prepaid and Other Current Assets |
|
2,815 |
|
|
|
2,706 |
|
|
|
Total Current Assets |
|
46,082 |
|
|
|
69,469 |
|
|
|
Property and Equipment, net |
|
2,507 |
|
|
|
2,642 |
|
|
|
Inventory, Non-Current |
|
1,526 |
|
|
|
1,176 |
|
|
|
Right of Use Assets, net |
|
6,934 |
|
|
|
2,911 |
|
|
|
Goodwill |
|
921 |
|
|
|
921 |
|
|
|
Other Non-current Assets |
|
729 |
|
|
|
629 |
|
|
|
Total Assets |
$ |
58,699 |
|
|
$ |
77,748 |
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Accounts Payable |
$ |
4,834 |
|
|
$ |
4,155 |
|
|
|
Accrued Liabilities |
|
4,371 |
|
|
|
5,013 |
|
|
|
Lease Liability - Current |
|
1,832 |
|
|
|
1,167 |
|
|
|
Deferred License Revenue |
|
2,176 |
|
|
|
2,175 |
|
|
|
Insurance Financing Note Payable |
|
1,312 |
|
|
|
— |
|
|
|
Term Loan, Net of Issuance Costs |
|
7,131 |
|
|
|
— |
|
|
|
Customer Deposits |
|
100 |
|
|
|
152 |
|
|
|
Other Current Liability - Related Party |
|
— |
|
|
|
131 |
|
|
|
Total Current Liabilities |
|
21,756 |
|
|
|
12,793 |
|
|
|
|
|
|
|
|
|
|
|
Lease Liability - Long Term |
|
5,226 |
|
|
|
1,821 |
|
|
|
Term Loan, Net of Issuance Costs |
|
14,094 |
|
|
|
20,949 |
|
|
|
Deferred License Revenue |
|
6,529 |
|
|
|
8,015 |
|
|
|
Total Liabilities |
|
47,605 |
|
|
|
43,578 |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ Equity: |
|
|
|
|
|
|
|
Preferred Shares, $0.0001 par value, 2,000,000 shares authorized,
no shares issued and outstanding at September 30, 2021 and December
31, 2020 |
|
— |
|
|
|
— |
|
|
|
Common Stock, $0.0001 par value, 170,000,000 shares authorized,
93,966,381 and 93,573,165 shares issued and outstanding at
September 30, 2021 and December 31, 2020, respectively |
|
9 |
|
|
|
9 |
|
|
|
Additional Paid-in Capital |
|
372,168 |
|
|
|
371,510 |
|
|
|
Accumulated Deficit |
|
(361,139 |
) |
|
|
(337,406 |
) |
|
|
Accumulated Other Comprehensive Income |
|
56 |
|
|
|
57 |
|
|
|
Total Stockholders’ Equity |
|
11,094 |
|
|
|
34,170 |
|
|
|
Total Liabilities And Stockholders’ Equity |
$ |
58,699 |
|
|
$ |
77,748 |
|
|
ROCKWELL MEDICAL, INC. AND
SUBSIDIARIESCondensed Consolidated Statements of
Operations(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months EndedSeptember 30, 2021 |
|
Three Months Ended September 30, 2020 |
|
Nine Months Ended September 30, 2021 |
|
Nine Months Ended September 30, 2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Sales |
|
$ |
15,988 |
|
|
$ |
15,280 |
|
|
$ |
46,599 |
|
|
$ |
47,033 |
|
|
|
Cost of Sales |
|
|
16,317 |
|
|
|
14,934 |
|
|
|
46,788 |
|
|
|
44,693 |
|
|
|
Gross (Loss) Profit |
|
|
(329 |
) |
|
|
346 |
|
|
|
(189 |
) |
|
|
2,340 |
|
|
|
Research and Product Development |
|
|
1,221 |
|
|
|
1,745 |
|
|
|
5,445 |
|
|
|
5,183 |
|
|
|
Selling and Marketing |
|
|
1,541 |
|
|
|
1,669 |
|
|
|
4,860 |
|
|
|
5,738 |
|
|
|
General and Administrative |
|
|
3,881 |
|
|
|
3,622 |
|
|
|
11,483 |
|
|
|
11,767 |
|
|
|
Operating Loss |
|
|
(6,972 |
) |
|
|
(6,690 |
) |
|
|
(21,977 |
) |
|
|
(20,348 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (Expense) Income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Realized Gain on Investments |
|
|
— |
|
|
|
4 |
|
|
|
(1 |
) |
|
|
8 |
|
|
|
Warrant Modification Expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(837 |
) |
|
|
Interest Expense |
|
|
(609 |
) |
|
|
(666 |
) |
|
|
(1,772 |
) |
|
|
(1,289 |
) |
|
|
Interest Income |
|
|
— |
|
|
|
2 |
|
|
|
17 |
|
|
|
239 |
|
|
|
Total Other Expense |
|
|
(609 |
) |
|
|
(660 |
) |
|
|
(1,756 |
) |
|
|
(1,879 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(7,581 |
) |
|
$ |
(7,350 |
) |
|
$ |
(23,733 |
) |
|
$ |
(22,227 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Net Loss per Share |
|
$ |
(0.08 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.26 |
) |
|
$ |
(0.32 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Weighted Average Shares
Outstanding |
|
|
93,882,142 |
|
|
|
71,811,322 |
|
|
|
93,726,629 |
|
|
|
69,594,167 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONTACTS
Investors:Argot
Partners212.600.1902Rockwell@argotpartners.com
Media:David RosenArgot
Partners212.600.1902david.rosen@argotpartners.com
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