- First quarter net sales of $16.1 million, up 4.2% year-over-year
-
- Submitted Supplemental Data to FDA for IND
Application to enable Phase 2 FPC Home Infusion Trial -
- Amended and expanded supply agreement with
DaVita, including $7.5M investment,
strengthens Rockwell's financial position, laying groundwork for
profitable concentrates business -
- Completion of patient enrollment ahead of
schedule in pivotal Phase 3 trial of Triferic® in China -
- Conference call and webcast scheduled for
today at 4:15 p.m. ET -
WIXOM,
Mich., May 16, 2022 /PRNewswire/
-- 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,
2022.
"As a result of our focused development plans for Ferric
Pyrophosphate Citrate ("FPC"), we are setting Rockwell Medical on
course to begin generating data in our Home Infusion program, where
we believe FPC has the potential to be the future standard of care
in the U.S. for patients receiving home infusion therapy and
suffering from iron deficiency anemia. We look forward to beginning
our proposed Phase 2 trial of FPC in the home infusion setting soon
after the review and clearance of our recent submission by the
FDA," said Russell Ellison,
M.D., M.Sc., President and Chief Executive Officer of Rockwell
Medical. "In our dialysis business, we are one of the two largest
suppliers of life saving concentrates in the U.S., generating in
excess of $60 million in revenues in
2021. We plan to restructure and grow this business to generate
acceptable gross margins and cash flow. We believe we took a
significant first step with our recently announced amended supply
agreement and securities purchase agreement with DaVita, Inc."
First Quarter 2022 & Recent Highlights:
Home Infusion Program:
- On May 6, Rockwell provided the
FDA with requested supplemental data related to its IND application
submitted in December 2021 and must
wait 30 calendar days from the date of submission before initiating
any clinical trials, while the FDA has an opportunity to review the
submission.
- Home health is an area of medicine experiencing significant
growth – a trend that will likely continue over the next decade due
to an aging US population, the need to control costs, the desire to
improve patient outcomes, and the convenience of home healthcare.
The global home healthcare market is expected to grow by nearly 8%
annually to $545 billion by 2028,
according to a new report by Grand View Research.
- Home infusion therapy represents a large and rapidly growing
segment of home health. According to the National Home Infusion
Association (NHIA), the number of US 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. We believe, based on the Company's data related to
hemodialysis patients, that FPC as a home infusion therapy for iron
deficiency anemia may have distinct advantages over currently
available iron replacement therapy options.
Dialysis Business:
- In January 2022, Rockwell's
partner in South Korea, Jeil
Pharmaceutical Co., Ltd., received regulatory approval by the
Ministry of Food and Drug Safety of the Republic of Korea for
Triferic Dialysate (ferric pyrophosphate citrate sodium sulfate
co-precipitate hydrate) for maintaining hemoglobin in adult
patients with HDD-CKD and regulatory approval for Triferic
Injection, marketed in the United
States as Triferic AVNU (ferric pyrophosphate citrate
injection) for iron supplementation therapy and maintaining
hemoglobin in adult patients with hemodialysis-dependent chronic
kidney disease.
- In April 2022, Rockwell's partner
in China, Wanbang
Biopharmaceuticals, completed enrollment of its pivotal Phase 3
clinical trial for Triferic Dialysate (ferric pyrophosphate citrate
sodium sulfate co-precipitate hydrate) ahead of schedule, to
support a new drug application for regulatory approval in
China, which is targeted for
submission in the third quarter of 2023.
- First quarter revenue from hemodialysis concentrates was
approximately $16.0 million, which is
an increase of 4.7% year-over-year. 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.
- In April 2022, Rockwell announced
an amended supply agreement with DaVita, Inc. ("DaVita") for
the supply of our concentrate products that included price
increases as well as the pass-through of certain costs. This
amendment will provide Rockwell's concentrates business the
potential to operate profitably in the future.
- In April 2022, Rockwell entered
into a securities purchase agreement with DaVita for a $7.5 million investment in Rockwell's
convertible preferred stock. An additional $7.5 million may be funded at a later date
subject to certain conditions.
First Quarter 2022 Selected Financial Highlights
The following discussion and analysis should be read in
conjunction with our unaudited condensed consolidated financial
statements and related notes on Form 10-Q for the first
quarter ended March 31, 2022.
Revenues were $16.1 million for
the three months ended March 31,
2022, compared to $15.5
million for the three months ended March 31, 2021. The increase of $0.7 million was primarily due to an increase in
sales of dialysis concentrates products from Baxter Healthcare
Corporation and our international customers. We expect our
concentrate sales to continue to grow due to the restructuring of
our supply contract with DaVita.
Cost of sales was $16.9 million
for the three months ended March 31,
2022, resulting in gross loss of $0.8
million, compared to $15.1
million for the three months ended March 31, 2021, resulting in gross profit of
$0.4 million. Gross profit
decreased by $1.2 million due to
significant inflationary pressures related to national supply chain
issues that impacted our concentrates business. Rockwell
renegotiated certain terms of its supply contract with
DaVita that included price increases as well as the
pass-through of certain costs. As a result of these changes,
Rockwell expects an improvement in margins for the remainder of
2022.
Net loss was $7.2 million, or
$(0.84) split adjusted basic and
diluted net loss per share for the three months ended March 31, 2022, compared to net loss of
$7.8 million, or $(0.91) split adjusted basic and diluted net loss
per share for the three months ended March
31, 2021.
As of March 31, 2022, cash and
cash equivalents and working capital totaled $9.9 million and $5.2
million, respectively. In April
2022, Rockwell entered into a securities purchase agreement
with DaVita, for a $7.5 million
investment in Rockwell's convertible preferred stock. An additional
$7.5 million may be funded at a later
date subject to certain conditions.
First Quarter 2022 and Operating Results Conference Call and
Webcast
Rockwell Medical's management team will host a conference call
and audio webcast today at 4:15 p.m.
ET to discuss Q1 2022 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 2599375. 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 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. 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.
About Triferic Dialysate and Triferic AVNU
Triferic Dialysate (ferric pyrophosphate citrate) and Triferic
AVNU (ferric pyrophosphate citrate injection) 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 AVNU is not intended for use in patients receiving
peritoneal dialysis. TRIFERIC AVNU has 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.
Forward-Looking Statements
Certain statements in this press release may constitute
"forward-looking statements" within the meaning of the federal
securities laws. Words such as, "may," "might," "will," "should,"
"believe," "expect," "anticipate," "estimate," "continue," "could,"
"can," "would," "develop," "plan," "potential," "predict,"
"forecast," "project," "intend," "look forward to," "remain
confident" or the negative of these terms, and similar expressions,
or statements regarding intent, belief, or current expectations,
are forward looking statements. There can be no assurance that
Rockwell Medical will be able to maintain timing for planned
clinical trials and regulatory filings, achieve planned cost
savings to operate its concentrates business profitability, or that
Rockwell Medical will be able to satisfy the funding conditions for
the second tranche of the DaVita investment. 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
those risks more fully discussed in the "Risk Factors" section of
our Annual Report on Form 10-K for the year ended December 31,
2021, 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.
Financial Tables Follow
ROCKWELL MEDICAL,
INC. AND SUBSIDIARIES
|
Condensed
Consolidated Balance Sheets
|
(unaudited)
|
|
|
March
31,
|
|
December
31,
|
|
2022
|
|
2021
|
|
|
(Unaudited)
|
|
|
|
ASSETS
|
|
|
|
|
|
Cash and Cash
Equivalents
|
$
|
9,914
|
|
$
|
13,280
|
Investments
Available-for -Sale
|
|
—
|
|
|
9,158
|
Accounts Receivable,
net of a reserve
|
|
7,121
|
|
|
5,913
|
Inventory
|
|
5,531
|
|
|
4,076
|
Prepaid and Other
Current Assets
|
|
2,231
|
|
|
2,861
|
Total Current
Assets
|
|
24,797
|
|
|
35,288
|
Property and Equipment,
net
|
|
2,377
|
|
|
2,486
|
Inventory,
Non-Current
|
|
1,523
|
|
|
1,523
|
Right of Use Assets,
net
|
|
7,200
|
|
|
7,737
|
Goodwill
|
|
921
|
|
|
921
|
Other Non-current
Assets
|
|
618
|
|
|
619
|
Total
Assets
|
$
|
37,436
|
|
$
|
48,574
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
Accounts
Payable
|
$
|
4,224
|
|
$
|
3,739
|
Accrued
Liabilities
|
|
4,373
|
|
|
5,090
|
Lease Liability -
Current
|
|
1,983
|
|
|
2,004
|
Deferred License
Revenue
|
|
2,163
|
|
|
2,171
|
Term Loan, Net of
Issuance Costs
|
|
6,631
|
|
|
7,381
|
Insurance Financing
Note Payable
|
|
—
|
|
|
437
|
Customer
Deposits
|
|
221
|
|
|
144
|
Total Current
Liabilities
|
|
19,595
|
|
|
20,966
|
|
|
|
|
|
|
Lease Liability - Long
Term
|
|
5,400
|
|
|
5,887
|
Term Loan, Net of
Issuance Costs
|
|
11,778
|
|
|
13,186
|
Deferred License
Revenue
|
|
5,456
|
|
|
5,986
|
Long Term Liability -
Other
|
|
14
|
|
|
14
|
Total
Liabilities
|
|
42,243
|
|
|
46,039
|
|
|
|
|
|
|
Stockholders'
Equity:
|
|
|
|
|
|
Preferred Shares,
$0.0001 par value, 2,000,000 shares authorized, no shares issued
and outstanding at March 31, 2022 and December 31, 2021
|
|
—
|
|
|
—
|
Common Stock, $0.0001
par value,170,000,000 shares authorized, 8,544,225 and 8,544,225
shares issued and outstanding at March 31, 2022 and December
31,2021, respectively
|
|
1
|
|
|
1
|
Additional Paid-in
Capital
|
|
372,383
|
|
|
372,562
|
Accumulated
Deficit
|
|
(377,242)
|
|
|
(370,080)
|
Accumulated Other
Comprehensive Income
|
|
51
|
|
|
52
|
Total Stockholders'
Equity
|
|
(4,807)
|
|
|
2535
|
Total Liabilities
And Stockholders' Equity
|
$
|
37,436
|
|
$
|
48,574
|
ROCKWELL MEDICAL,
INC. AND SUBSIDIARIES
|
Condensed
Consolidated Statements of Operations
|
(unaudited)
|
(In Thousands,
Except Shares and Per Share Amounts)
|
|
|
|
Three Months
Ended March
31, 2022
|
|
Three Months
Ended March
31, 2021
|
|
|
|
|
|
|
|
Net
Sales
|
|
$
|
16,124
|
|
$
|
15,473
|
Cost of
Sales
|
|
|
16,910
|
|
|
15,072
|
Gross (Loss)
Profit
|
|
|
(786)
|
|
|
401
|
Research and Product
Development
|
|
|
1,567
|
|
|
1,809
|
Selling and
Marketing
|
|
|
455
|
|
|
1,851
|
General and
Administrative
|
|
|
3,818
|
|
|
3,923
|
Operating
Loss
|
|
|
(6,626)
|
|
|
(7,182)
|
|
|
|
|
|
|
|
Other (Expense)
Income
|
|
|
|
|
|
|
Realized Gain on
Investments
|
|
|
4
|
|
|
—
|
Interest
Expense
|
|
|
(540)
|
|
|
(581)
|
Interest
Income
|
|
|
—
|
|
|
11
|
Total Other
Expense
|
|
|
(536)
|
|
|
(570)
|
|
|
|
|
|
|
|
Net
Loss
|
|
$
|
(7,162)
|
|
$
|
(7,752)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted
Net Loss per Share
|
|
$
|
(0.84)
|
|
$
|
(0.91)
|
|
|
|
|
|
|
|
Basic and Diluted
Weighted Average Shares Outstanding
|
|
|
8,544,225
|
|
|
8,508,278
|
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SOURCE Rockwell Medical Technologies, Inc.