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
June 30, 2021.
“We made significant progress in the second
quarter on a number of fronts to develop and deliver innovative
treatment to patients with iron deficiency anemia (IDA),”
said Russell Ellison, M.D., M.Sc., President and Chief
Executive Officer of Rockwell Medical. “Ferric pyrophosphate
citrate (FPC) for the treatment of IDA in home infusion patients
remains our top development priority. We have received a written
response to our pre-IND submission and intend to engage with the
FDA to clarify and refine study design elements for our planned
Phase II study, the first potential study of its kind in this
patient population. In the meantime, we continue to work on the
logistics and preparatory aspects of the trial. Assuming positive
FDA feedback, we expect a potential commencement date in 2H
2021.”
“In the second quarter, we also extended our
multi-year distribution with Nipro Medical for the distribution of
dialysis concentrates in Latin America and the Caribbean, and we
entered into an exclusive license agreement for the right to
commercialize Triferic in Turkey, with new partner Drogsan
Pharmaceuticals,” concluded Dr. Ellison.
Second Quarter 2021
Operational Highlights
Dialysis Business
- Revenue from hemodialysis
concentrates was approximately $14.9 million. The
Company is in the process of analysis of its supply chain to
identify efficiencies while actively exploring U.S. expansion of
this business with our two largest customers.
- Revenue from Triferic was
approximately $273,000. 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.
- The Company announced in June an
exclusive license agreement with Drogsan Pharmaceuticals, a leading
pharmaceutical company in Turkey with an established
presence in the nephrology space, for the rights to commercialize
Triferic AVNU (ferric pyrophosphate citrate injection)
in Turkey. With approximately 65,000 patients receiving
hemodialysis annually, Turkey represents a potentially significant
and expanding market opportunity.
- The Company also announced in June
that it extended its distribution agreement with its long-term
distribution partner, Nipro Medical Corporation (NMC),
for a period of three years through May 2024. The agreement
was originally initiated in 2008. With the extension of the
agreement, NMC will continue to distribute dialysis concentrates
manufactured by Rockwell Medical to numerous countries
in Latin America and the Caribbean. NMC is a leading
renal, medical, surgical, and interventional radiology products
manufacturer and a major distributor of renal products in these
regions.
Home Infusion Program
- The Company received a written
response to its pre-IND submission and intends to work with FDA to
clarify and refine study design elements for our planned Phase II
study of FPC in patients with IDA receiving long-term home infusion
therapy.
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 to discuss the pathway for
a potential clinical development program.
Second 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 second quarter
ended June 30, 2021.
Net sales were $15.1 million compared to net
sales of $15.9 million during the same second quarter period last
year and $15.5 million in the first quarter of this year. The
decrease was primarily due to a decrease in sales of dialysis
concentrates products related to the impact of COVID on the
dialysis patient populations of our partners.
Net sales of hemodialysis concentrates were
approximately $14.9 million in the second quarter of 2021, which
was about $800,000 lower compared to the second quarter of 2020,
and about $320,000 lower than in first quarter 2021. Total sales of
Triferic were approximately $273,000, roughly an 15% increase
versus the sales of Triferic in the second quarter of 2020, but
essentially flat versus the first quarter 2021.
Cost of sales for the second quarter of 2021 was
$15.4 million, resulting in gross loss of $0.3 million, compared to
cost of sales of $15.0 million and a gross profit of $0.9 million
during the second quarter of 2020. Gross profit decreased by $1.2
million mainly due to a decrease in concentrate sales and an
increase in costs related to protocols implemented because of the
ongoing COVID-19 pandemic, shipping, fuel and labor. Gross profits
are primarily related to our Dialysis concentrates products at this
time. The Company anticipates that potential future sales of
Triferic will impact the mix on our future gross profits.
Research and product development expenses were
$2.4 million for the second quarter of 2021 compared to $1.6
million for the second quarter of 2020. The increase of $0.8
million was primarily due to the Company continuing to invest in
its medical and scientific programs to support the continued
advancement of our FPC technology platform.
Selling and marketing expenses were $1.5 million
for the second quarter of 2021 compared to $2.0 million for the
second quarter of 2020. The decrease of $0.5 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 $3.7
million for the second quarter of 2021 compared to $2.9 million for
the second quarter of 2020. The increase of $0.8 million was
primarily due to an increase in stock compensation of $1.9 million,
which was a decrease in incentive compensation in second quarter
2020 of $1.5 million from forfeited equity awards of the former
President and Chief Executive Officer, partially offset by a
decrease of $0.8 million for the reduction of severance costs
related to our former President and Chief Executive Officer.
Net loss for the second quarter of 2021 was $8.4
million, or $0.09 per basic and diluted share, compared to a net
loss of $6.9 million during the second quarter of 2020, or $0.10
per basic and diluted share.
Cash, cash equivalents and investments totaled
approximately $41 million at the end of the second quarter 2021,
which we believe keeps the Company in a strong position to drive
our strategic initiatives. Net cash used in operating activities
was $4.9 million for the three months ended June 30, 2021, compared
to net cash used in operating activities of $9.6 million for the
three months ended June 30, 2020. Net cash used in operating
activities was $17.4 million for the six months ended June 30,
2021, compared to net cash used in operating activities of $16.2
million for the six months ended June 30, 2020. The increase in
cash used from operating activities during the first half of 2021
was primarily due to changes in current balance sheet accounts in
the ordinary course of business of approximately $3.0 million,
including an increase in net accounts receivable of $1.2 million
and a reduction in accounts payable and accrued expense of
approximately $0.4 million. Overall, our cash burn for the six
months ended June 30, 2021 was in line with our expectations, and
we continue to expect, in aggregate, 2021 cash burn to be lower
than 2020 cash burn.
As of June 30, 2021, there were
93,811,381 shares of common stock outstanding versus
93,599,519 shares outstanding as of March 31, 2021.
Second Quarter 2021 and Business Update
Conference Call and Webcast
Rockwell Medical's management team will host a
conference call and audio webcast today at 4:30 p.m. ET to discuss
Q2 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 1254179.
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
AVNUTriferic 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
StatementsCertain 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 to clarify and refine requirements for our
planned Phase II study of FPC in patients with IDA, 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(unaudited) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
2021 |
|
2020 |
|
|
(Unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
Cash and Cash Equivalents |
$ |
32,378 |
|
|
$ |
48,682 |
|
Investments
Available-for -Sale |
|
8,574 |
|
|
|
9,997 |
|
Accounts
Receivable, net of a reserve |
|
5,357 |
|
|
|
4,171 |
|
Inventory |
|
4,677 |
|
|
|
3,913 |
|
Prepaid and
Other Current Assets |
|
1,413 |
|
|
|
2,706 |
|
Total Current Assets |
|
52,399 |
|
|
|
69,469 |
|
Property and
Equipment, net |
|
2,529 |
|
|
|
2,642 |
|
Inventory,
Non-Current |
|
1,122 |
|
|
|
1,176 |
|
Right of Use
Assets, net |
|
6,085 |
|
|
|
2,911 |
|
Goodwill |
|
921 |
|
|
|
921 |
|
Other
Non-current Assets |
|
628 |
|
|
|
629 |
|
Total Assets |
$ |
63,684 |
|
|
$ |
77,748 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Accounts
Payable |
$ |
4,932 |
|
|
$ |
4,155 |
|
Accrued
Liabilities |
|
3,993 |
|
|
|
5,013 |
|
Lease
Liability - Current |
|
1,674 |
|
|
|
1,167 |
|
Deferred
License Revenue |
|
2,166 |
|
|
|
2,175 |
|
Term Loan,
Net of Issuance Costs |
|
21,133 |
|
|
|
— |
|
Customer
Deposits |
|
140 |
|
|
|
152 |
|
Other
Current Liability - Related Party |
|
— |
|
|
|
131 |
|
Total Current Liabilities |
|
34,038 |
|
|
|
12,793 |
|
|
|
|
|
|
|
Lease
Liability - Long Term |
|
4,506 |
|
|
|
1,821 |
|
Term Loan,
Net of Issuance Costs |
|
— |
|
|
|
20,949 |
|
Deferred
License Revenue |
|
6,937 |
|
|
|
8,015 |
|
Total Liabilities |
|
45,481 |
|
|
|
43,578 |
|
|
|
|
|
|
|
Stockholders’ Equity: |
|
|
|
|
|
Preferred
Shares, $0.0001 par value, 2,000,000 shares authorized, no shares
issued and outstanding at June 30, 2021 and December 31, 2020 |
|
— |
|
|
|
— |
|
Common
Stock, $0.0001 par value,170,000,000 shares authorized, 93,811,381
and 93,573,165 shares issued and outstanding at June 30, 2021 and
December 31,2020, respectively |
|
9 |
|
|
|
9 |
|
Additional
Paid-in Capital |
|
371,700 |
|
|
|
371,510 |
|
Accumulated
Deficit |
|
(353,558 |
) |
|
|
(337,406 |
) |
Accumulated
Other Comprehensive Income |
|
52 |
|
|
|
57 |
|
Total Stockholders’ Equity |
|
18,203 |
|
|
|
34,170 |
|
Total Liabilities And Stockholders’ Equity |
$ |
63,684 |
|
|
$ |
77,748 |
|
|
|
|
|
|
|
|
ROCKWELL
MEDICAL, INC. AND SUBSIDIARIESCondensed
Consolidated Statements of
Operations(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2021 |
|
Three Months Ended June 30, 2020 |
|
Six Months Ended June 30, 2021 |
|
Six Months Ended June 30, 2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Sales |
|
$ |
15,137 |
|
|
$ |
15,896 |
|
|
$ |
30,611 |
|
|
$ |
31,753 |
|
Cost of
Sales |
|
|
15,399 |
|
|
|
15,015 |
|
|
|
30,471 |
|
|
|
29,759 |
|
Gross Profit |
|
|
(262 |
) |
|
|
881 |
|
|
|
140 |
|
|
|
1,994 |
|
Research and
Product Development |
|
|
2,416 |
|
|
|
1,616 |
|
|
|
4,224 |
|
|
|
3,438 |
|
Selling and
Marketing |
|
|
1,468 |
|
|
|
1,997 |
|
|
|
3,319 |
|
|
|
4,069 |
|
General and
Administrative |
|
|
3,677 |
|
|
|
2,871 |
|
|
|
7,602 |
|
|
|
8,145 |
|
Operating Loss |
|
|
(7,823 |
) |
|
|
(5,603 |
) |
|
|
(15,005 |
) |
|
|
(13,658 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (Expense) Income |
|
|
|
|
|
|
|
|
|
|
|
|
Realized
Gain on Investments |
|
|
(1 |
) |
|
|
2 |
|
|
|
(1 |
) |
|
|
4 |
|
Warrant
Modification Expense |
|
|
— |
|
|
|
(837 |
) |
|
|
— |
|
|
|
(837 |
) |
Interest
Expense |
|
|
(583 |
) |
|
|
(521 |
) |
|
|
(1,164 |
) |
|
|
(623 |
) |
Interest
Income |
|
|
7 |
|
|
|
67 |
|
|
|
18 |
|
|
|
238 |
|
Total Other Expense |
|
|
(577 |
) |
|
|
(1,289 |
) |
|
|
(1,147 |
) |
|
|
(1,218 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(8,400 |
) |
|
$ |
(6,892 |
) |
|
$ |
(16,152 |
) |
|
$ |
(14,876 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Net Loss per Share |
|
$ |
(0.09 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.17 |
) |
|
$ |
(0.22 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Weighted Average Shares
Outstanding |
|
|
93,703,492 |
|
|
|
69,428,574 |
|
|
|
93,647,583 |
|
|
|
68,473,407 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONTACTS
Investors:Argot
Partners212.600.1902Rockwell@argotpartners.com
Media:David RosenArgot
Partners212.600.1902david.rosen@argotpartners.com
Rockwell Medical (NASDAQ:RMTI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Rockwell Medical (NASDAQ:RMTI)
Historical Stock Chart
From Apr 2023 to Apr 2024