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 and full year ended December 31, 2020.
“2020 was an important year for us as we evolved
our strategy to become a more medically-, scientifically- and
data-driven company. There has been an evolution of both our
management and Board of Directors, providing us with greater
relevant experience,” said Russell Ellison, M.D., M.Sc., President
and Chief Executive Officer of Rockwell Medical. “We believe these
changes support an improved execution of our strategy to accelerate
Rockwell Medical’s growth by creating and developing pharmaceutical
products based on our Ferric Pyrophosphate Citrate ("FPC")
technology for disease states where patients can benefit the most
from an effective treatment for iron deficiency, while concurrently
strengthening our dialysis business to drive incremental growth and
efficiencies.”
Dr. Ellison added: “We’ve identified two areas
beyond dialysis where we believe FPC will have the biggest impact:
iron deficiency anemia in the home infusion setting and acute heart
failure in hospitalized patients.”
Recent Operational
Highlights
Dialysis Business
- Revenue from hemodialysis concentrates were $61.1 million in
2020.
- Revenue from Triferic were approximately $1.1 million in
2020.
- Results from a study, conducted by
New York University and reported in Critical Care Medicine, showed
$296,000 in cost savings from Triferic.The study, which was
independent of Rockwell, reviewed the effects of long-term use of
Triferic in a large outpatient dialysis clinic. The results showed
substantial cost savings due to reductions in ESA and
macromolecular IV iron use without impacting patient safety or
hemoglobin targets. In a retrospective data review of 100
patients that were followed before and after implementation of
Triferic dialysate, there was a relative reduction in average
weekly ESA dose of 26.4%, total use of IV iron replacement therapy
decreased with a relative reduction in the use of all iron products
(iron sucrose 65.7%, sodium ferric gluconate 98.2%) while anemia
targets were met. This clinic determined that the reduction of
these agents resulted in a net savings of more than $296,000 in one
fiscal year.
- Triferic AVNU (ferric pyrophosphate
citrate injection), the IV formulation of Triferic, was made
commercially available to patients in the United States.
- Korea: In September 2020, Rockwell
Medical partnered with Jeil Pharmaceutical Co., Ltd. for exclusive
rights. In February 2021, Jeil filed a New Drug Application for
Triferic (dialysate) and Triferic AVNU in Korea.
- China: In January 2021, Wanbang
Biopharmaceuticals enrolled the first patient in a pivotal Phase 3
trial.
- India: In January 2020, Rockwell Medical and Sun Pharma entered
into a licensing agreement, and Sun Pharma is in the regulatory
process in India.
- Canada: In May 2020, Rockwell Medical announced the filing of a
New Drug Submission with Health Canada for Triferic AVNU.
Home Infusion Program
- The U.S. Food and Drug
Administration (FDA) has accepted our 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. Pending a
successful outcome of our pre-investigational new drug meeting with
the FDA, the Company plans to initiate a clinical study during the
second half of 2021.
Pipeline Development
- Rockwell Medical is exploring the
use of its FPC platform for the treatment of hospitalized patients
with acute heart failure. Management 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 plans to hold a Type C meeting with the FDA in the
second half of 2021.
2020 Corporate Updates
- In December 2020, Rockwell Medical
appointed industry leader and life science industry executive, Ms.
Andrea Heslin Smiley, to its Board of Directors. Ms. Smiley brings
commercial experience and a deep expertise in clinical nurse
educators.
- In September 2020, the Company
appointed Russell L. Skibsted, M.B.A., as Executive Vice President,
Chief Financial Officer and Chief Business Officer. Mr. Skibsted
brings more than 25 years of experience in finance, global business
development, capital raising, investor relations and
operations.
- In June 2020, Rockwell Medical
appointed industry leader and renowned authority on kidney disease,
Allen R. Nissenson, M.D., F.A.C.P., to its Board of Directors. Dr.
Nissenson brings clinical, regulatory and public policy expertise,
combined with his senior executive experience at a large dialysis
organization.
- In April 2020, the Company
appointed Russell H. Ellison, M.D., M.Sc., as President and Chief
Executive Officer. Dr. Ellison, who continues to serve as a member
of the Board of Directors, brings broad medical, clinical
development and corporate leadership experience to the role.
- In March 2020, Rockwell Medical
appointed Robert S. Radie to its Board of Directors. Mr. Radie
brings more than three decades of industry experience, working in
senior executive roles with both public and private pharmaceutical
and biotech companies.
Fourth Quarter and Full Year 2020
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.
Revenues were $15.2 million and $62.2 million
for the three months and year ended December 31, 2020,
respectively, compared to $15.5 million and $61.3 million for the
three months and year ended December 31, 2019, respectively.
Triferic revenue was $0.5 million and $1.1 million for the three
months and year ended December 31, 2020, respectively. Triferic was
launched in Q2 2019 via the sample evaluation program.
Cost of sales were $14.8 million and $59.5
million for the three months and year ended December 31, 2020,
respectively, compared to $14.4 million and $58.5 million for the
three months and year ended December 31, 2019, respectively. Cost
of sales for the year ended December 31, 2020 resulted in gross
profit of $2.7 million, compared to a gross profit of $2.8 million
for the year ended December 31, 2019.
Research and product development expenses were
$1.9 million and $7.1 million for the three months and year ended
December 31, 2020, respectively, compared to $2.0 million and $6.9
million for the three months and year ended December 31, 2019,
respectively. The increase of $0.2 million year over year is
related to clinical trials and other product development expenses
for Triferic. 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 $2.1 million
and $7.9 million for the three months and year ended December 31,
2020, respectively, compared to $1.9 million and $9.1 million for
the three months and year ended December 31, 2019, respectively.
The decrease of $1.2 million year over year is due primarily to the
decrease in marketing costs of $2.3 million, partially offset by an
increase in costs associated with hiring, training and educating
new employees of $1.1 million. The fluctuation in these costs is
mainly due to the timing of the Triferic (dialysate) launch in the
third quarter of 2019. We expect lower quarter-to-quarter
fluctuations in sales and marketing costs going forward.
General and administrative expenses were $4.4
million and $16.2 million for the three months and year ended
December 31, 2020, respectively, compared to $4.7 million and $21.0
for the three months and year ended December 31, 2019,
respectively. The $4.8 million decrease year over year was driven
primarily by decreases to stock compensation, legal, recruiting and
consulting fees, partially offset by an increase in labor costs.
The decrease in stock compensation primarily relate to the
resignation of our former President and Chief Executive Officer,
Stuart Paul, in April 2020 and former Chief Financial Officer
effective July 2020.
Net loss was $8.7 million, or $(0.09) basic and
diluted net loss per share, and $30.9 million, or $(0.41) basic and
diluted net loss per share, for the three months and year ended
December 31, 2020, respectively, compared to net loss of $7.3
million, or $(0.11) basic and diluted net loss per share, and $34.1
million, or $(0.56) basic and diluted net loss per share, for the
three months and year ended December 31, 2019, respectively.
Cash, cash equivalents, and investments
available-for-sale totaled $58.7 million as of December 31, 2020,
compared to $67.3 million on September 30, 2020. Working capital
was $56.7 million as of December 31, 2020, compared to $65.2
million as of September 30, 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 December 31, 2020, there were 93,573,165
shares of common stock outstanding.
Fourth Quarter and Full Year 2020 and
Business Update Conference Call and Webcast
Rockwell Medical's management team will host a
conference call and audio webcast today, March 31, 2021, at 4:30
p.m. ET to discuss Q4 and Full Year 2020 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 6154055.
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 biopharmaceutical company
dedicated to transforming iron deficiency and 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 kidney disease. Rockwell Medical's
exclusive renal drug therapies, Triferic (ferric pyrophosphate
citrate) Dialysate and Triferic AVNU, are the only FDA-approved
therapeutics indicated for maintenance of hemoglobin in
hemodialysis patients. 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.
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
effectiveness of FPC in other indications, Triferic’s ability to
generate cost savings, our ability to grow our dialysis business,
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 and future trends related to our sales and
marketing costs. 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 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)
|
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
Cash and Cash Equivalents |
$ |
48,682 |
|
|
$ |
11,795 |
|
|
|
Investments Available-for-Sale |
|
9,997 |
|
|
|
14,250 |
|
|
|
Accounts Receivable, net of a reserve of $9 for both 2020 and
2019 |
|
4,171 |
|
|
|
4,203 |
|
|
|
Inventory |
|
3,913 |
|
|
|
3,647 |
|
|
|
Prepaid and Other Current Assets |
|
2,706 |
|
|
|
2,979 |
|
|
|
Total Current Assets |
|
69,469 |
|
|
|
36,874 |
|
|
|
Property and Equipment, net |
|
2,642 |
|
|
|
2,433 |
|
|
|
Inventory, Non-Current |
|
1,176 |
|
|
|
441 |
|
|
|
Right of Use Assets, net |
|
2,911 |
|
|
|
3,213 |
|
|
|
Goodwill |
|
921 |
|
|
|
921 |
|
|
|
Other Non-current Assets |
|
629 |
|
|
|
435 |
|
|
|
Total Assets |
$ |
77,748 |
|
|
$ |
44,317 |
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Accounts Payable |
$ |
4,155 |
|
|
$ |
3,018 |
|
|
|
Accrued Liabilities |
|
5,013 |
|
|
|
4,518 |
|
|
|
Settlement Payable |
|
— |
|
|
|
104 |
|
|
|
Lease Liability - Current |
|
1,167 |
|
|
|
1,493 |
|
|
|
Deferred License Revenue |
|
2,175 |
|
|
|
2,234 |
|
|
|
Insurance Financing Note Payable |
|
— |
|
|
|
763 |
|
|
|
Customer Deposits |
|
152 |
|
|
|
55 |
|
|
|
Other Current Liability - Related Party |
|
131 |
|
|
|
189 |
|
|
|
Total Current Liabilities |
|
12,793 |
|
|
|
12,374 |
|
|
|
|
|
|
|
|
|
|
|
Lease Liability - Long Term |
|
1,821 |
|
|
|
1,781 |
|
|
|
Term Loan, Net of Issuance Costs |
|
20,949 |
|
|
|
— |
|
|
|
Deferred License Revenue |
|
8,015 |
|
|
|
9,842 |
|
|
|
Total Liabilities |
|
43,578 |
|
|
|
23,997 |
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ Equity: |
|
|
|
|
|
|
|
Preferred Shares, $0.0001 par value, 2,000,000 shares authorized,
no shares issued and outstanding at December 31, 2020 and 2019 |
|
— |
|
|
|
— |
|
|
|
Common Stock, $0.0001 par value,170,000,000 shares authorized,
93,573,165 and 65,378,890 shares issued and outstanding at December
31, 2020 and 2019, respectively |
|
9 |
|
|
|
7 |
|
|
|
Additional Paid-in Capital |
|
371,510 |
|
|
|
326,777 |
|
|
|
Accumulated Deficit |
|
(337,406 |
) |
|
|
(306,516 |
) |
|
|
Accumulated Other Comprehensive Income |
|
57 |
|
|
|
52 |
|
|
|
Total Stockholders’ Equity |
|
34,170 |
|
|
|
20,320 |
|
|
|
Total Liabilities And Stockholders’ Equity |
$ |
77,748 |
|
|
$ |
44,317 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ROCKWELL MEDICAL, INC. AND
SUBSIDIARIESCondensed Consolidated Statements of
Operations(Dollars in Thousands, except per share
amounts)(Unaudited)
|
|
|
|
|
|
|
Three Months Ended
December 31, 2020 |
|
Three Months Ended
December 31, 2019 |
|
Year Ended December 31, 2020 |
|
Year Ended December 31, 2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Sales |
|
$ |
15,164 |
|
|
$ |
15,490 |
|
|
$ |
62,197 |
|
|
$ |
61,303 |
|
|
|
Cost of Sales |
|
|
14,780 |
|
|
|
14,379 |
|
|
|
59,472 |
|
|
|
58,464 |
|
|
|
Gross Profit (Loss) |
|
|
384 |
|
|
|
1,111 |
|
|
|
2,725 |
|
|
|
2,839 |
|
|
|
Research and Product Development |
|
|
1,909 |
|
|
|
1,956 |
|
|
|
7,092 |
|
|
|
6,886 |
|
|
|
Selling and Marketing |
|
|
2,133 |
|
|
|
1,901 |
|
|
|
7,871 |
|
|
|
9,050 |
|
|
|
General and Administrative |
|
|
4,416 |
|
|
|
4,657 |
|
|
|
16,182 |
|
|
|
20,998 |
|
|
|
Settlement Expense, net of Reimbursement |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
430 |
|
|
|
Operating Loss |
|
|
(8,074 |
) |
|
|
(7,403 |
) |
|
|
(28,420 |
) |
|
|
(34,525 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income (Expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Realized Gain (Loss) on Investments |
|
|
— |
|
|
|
6 |
|
|
|
8 |
|
|
|
30 |
|
|
|
Warrant Modification Expense |
|
|
— |
|
|
|
— |
|
|
|
(837 |
) |
|
|
— |
|
|
|
Interest Expense |
|
|
(588 |
) |
|
|
(8 |
) |
|
|
(1,879 |
) |
|
|
(25 |
) |
|
|
Interest Income |
|
|
(2 |
) |
|
|
103 |
|
|
|
238 |
|
|
|
392 |
|
|
|
Total Other Income |
|
|
(590 |
) |
|
|
101 |
|
|
|
(2,470 |
) |
|
|
397 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(8,664 |
) |
|
$ |
(7,302 |
) |
|
$ |
(30,890 |
) |
|
$ |
(34,128 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Net Loss per Share |
|
$ |
(0.09 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.41 |
) |
|
$ |
(0.56 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Weighted Average Shares
Outstanding |
|
|
93,573,165 |
|
|
|
64,450,030 |
|
|
|
75,621,674 |
|
|
|
60,918,544 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CONTACTS
Investors:Argot
Partners212.600.1902Rockwell@argotpartners.com
Media:David RosenArgot
Partners212.600.1902david.rosen@argotpartners.com
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