Rockwell Medical, Inc. (Nasdaq: RMTI) (“Rockwell Medical” or the
“Company”), a biopharmaceutical company dedicated to transforming
anemia management and improving outcomes for patients around the
world, today reported financial results and a business update for
quarter ended March 31, 2020.
“In my new role, my charge is to maximize the
commercial potential of our two FDA-approved products, Triferic
Dialysate and Triferic AVNU, while developing Rockwell Medical into
a more medically- and scientifically-driven company, which includes
leading the strategic identification and pursuit of new therapeutic
areas for our ferric pyrophosphate citrate platform,” said Russell
Ellison, M.D., M.Sc., President and Chief Executive Officer of
Rockwell Medical. “I am pleased to report continued progress in our
commercialization of Triferic Dialysate in the first quarter,
including an acceleration of Triferic Dialysate Evaluation Programs
and a continued increase in contracted clinics. Importantly, we
secured FDA approval of Triferic AVNU at the end of March and are
working diligently to prepare for a successful launch of this
intravenous (“IV”) formulation later this year.”
Dr. Ellison added: “In addition, we are
encouraged by the top-line data announced today from a
retrospective real-world analysis of Triferic Dialysate within a
dialysis clinic. Following adoption of Triferic within the studied
clinic, we observed the reduction of the use of erythropoietin
stimulating agents (“ESAs”) and traditional IV iron, improvement in
hemoglobin levels, fewer missed appointments among patients, and an
improvement in patients’ quality of life. These measures are
important factors in patient care and speak to the value that
Triferic can confer to providers, patients and the overall
healthcare system.”
First Quarter 2020
Operational Highlights
Triferic Dialysate
- The Company currently has active or committed Evaluation
Programs with independent dialysis clinics and small dialysis
chains representing more than 2,250 patients and 36 clinics, a 260%
increase from December 31, 2019.
- Signed contracts with four additional clinics during the first
quarter of 2020, and an additional eight clinics that are
affiliated with MDO were trained and approved for adoption as of
March 31, 2020.
- Nearly 2,000 contracted patients on therapy as of March 31,
2020, representing over 300,000 annualized treatments.
- Triferic net sales were $0.3 million in the first quarter of
2020.
- Entered into exclusive license and supply agreements with Sun
Pharma for the rights to commercialize Triferic Dialysate in India.
Rockwell Medical received an upfront fee and will be eligible for
milestone payments and royalties on net sales.
- With respect to the COVID-19 pandemic, the Company has
implemented precautions to reduce the risk of possible exposure by
restricting employee travel, adopting new preventative safety
measures within our manufacturing facilities, instituting a
work-from-home policy for substantially all employees, excluding
our essential manufacturing and distribution employees, and
leveraging virtual technology for the sales force to use in its
communications with customers. The Company has experienced no
material impact on its supply chain to date, and has experienced a
small increase in demand for its dialysis concentrates products,
believed to be attributed to customers building safety stock and
turning to Rockwell Medical in instances where other suppliers have
not been able to meet demand.
Triferic AVNU (IV
Formulation)
- On March 27, 2020, Rockwell Medical announced that the FDA
approved its New Drug Application for Triferic AVNU, its
intravenous formulation of Triferic.
- With this approval, Triferic AVNU joins Triferic Dialysate as
the only FDA-approved products indicated to replace iron and
maintain hemoglobin in adult patients with hemodialysis-dependent
chronic kidney disease.
- The Company has initiated a commercial strategy to leverage the
experience gained from the 2019 launch of Triferic Dialysate and
lay the groundwork for the commercial introduction of Triferic
AVNU. The Company expects to launch evaluation programs during the
third quarter of 2020 to allow clinics to gain direct experience
with Triferic AVNU, and expects Triferic AVNU to be available
commercially during the fourth quarter of 2020, following the
completion of the initial evaluation programs.
Triferic Real-World Data
Today, the Company announced the top-line
results from a retrospective analysis of Triferic Dialysate
clinical use. The analysis included patient outcomes from an
independent dialysis clinic with approximately 65 patients, from a
baseline period of 3 months prior to the adoption of Triferic
Dialysate through 18 months post-adoption.
“Today’s results, while a snapshot from a single
clinic, demonstrate meaningful clinical and real-world trends
observed following the adoption of Triferic Dialysate,” said Marc
Hoffman, M.D., Chief Medical Officer of Rockwell Medical. “The
potential clinical and financial implications from this analysis
are compelling and we believe they support Triferic’s important
place in the physician’s arsenal for treating adult patients with
hemodialysis-dependent chronic kidney disease.”
Findings from the analysis include:
- A more than 23% reduction in ESAs utilized per patient, per
week during the sixth quarter after Triferic Dialysate
administration vs. baseline.
- A 74% reduction in traditional IV iron (ferric gluconate)
utilization per patient, per week, beginning at month 3 and
continuing through the observation period vs. baseline.
- Stable to increasing hemoglobin levels, with consistent
hemoglobin control throughout the observation period.
- A meaningful reduction in missed treatments of nearly one-fifth
and one-half for the 5th and 6th quarters, respectively.
- Improvements in key quality of life indicators as measured by
KDQOLTM-36.
The Company is evaluating potential publication
and/or presentation of the full results of the findings at a future
medical meeting.
First Quarter 2020
Corporate Updates
- The Company announced the appointment of Russell H. Ellison,
M.D., M.Sc., as President and Chief Executive Officer, effective
April 20, 2020. Dr. Ellison, who will continue to serve as a member
of the Board of Directors for Rockwell Medical, brings broad
medical, clinical development and leadership experience to the
role.
- The Company announced the appointment of Robert S. Radie to its
Board of Directors, effective March 31, 2020. Mr. Radie brings more
than three decades of industry experience, working in senior
executive roles with both public and private pharmaceutical and
biotech companies across a range of therapeutic areas.
- On March 17, 2020, the Company entered into a debt financing
agreement with an affiliate of Innovatus Capital Partners, LLC
("Innovatus") to provide the Company with up to $35.0 million in
term loans. The first $22.5 million tranche was funded on March 16,
2020. The Company will be eligible to draw on a second tranche of
$5.0 million following the completion of certain milestones, which
includes the FDA approval of Triferic AVNU, and a third tranche of
$7.5 million upon the achievement of certain additional milestones,
including the achievement of certain Triferic sales
thresholds.
- The Company completed the pricing of an underwritten public
offering of the Company’s common stock in February 2020 for gross
proceeds of approximately $8.1 million, before deducting issuance
costs.
First Quarter 2020 Financial
Results
Net sales for the first quarter of 2020 were
$15.9 million, an increase of 2% compared to net sales of $15.6
million for the first quarter of 2019. The increase was primarily
due to an increase in U.S. product sales of Triferic Dialysate as a
result of the commercial launch in May 2019.
Cost of sales for the first quarter of 2020 was
$14.7 million, resulting in gross profit of $1.1 million, compared
to cost of sales of $14.5 million and a gross profit of $1.0
million during the first quarter of 2019. Gross profit increased by
$0.1 million in the first quarter of 2020 compared to the first
quarter of 2019 due primarily to an increase in U.S. product sales
of Triferic Dialysate as a result of the commercial launch in May
2019, partially offset by a decrease in gross profit for our
dialysis concentrate products.
Selling and marketing expenses were $2.1 million
for the first quarter of 2020 compared to $3.1 million for the
first quarter of 2019. The decrease was due primarily to various
marketing investments made during the first quarter of 2019 to
support the commercial launch of Triferic Dialysate that did not
recur in the first quarter of 2020, partially offset by investments
in selling and marketing headcount to support the ongoing launch of
Triferic Dialysate and the upcoming launch of Triferic AVNU.
General and administrative expenses were $5.3
million for the first quarter of 2020 compared to $6.2 million for
the first quarter of 2019. The decrease was primarily due to a
reduction in legal expenses, stock-based compensation and
consulting costs, partially offset by an increase in headcount and
insurance expenses.
Research and product development expenses were
$1.8 million for the first quarter of 2020 compared to $0.5 million
for the first quarter of 2019. The increase was due primarily to
investments the Company is making in its medical platform to
support the development and the global launch of Triferic,
including medical, scientific and technical staffing costs,
clinical trial costs and consulting expenses. We expect our
research and product development expenses to increase in the future
due to additional clinical development of our ferric pyrophosphate
citrate technology platform, innovations in administration of
Triferic, the continuation of the pediatric clinical trial for
Triferic, and an increase in headcount to support medical education
efforts for Triferic.
Net loss for the first quarter of 2020 was $8.0
million, or $0.12 per basic and diluted share, compared to a net
loss for first quarter of 2019 of $8.7 million, or $0.15 per basic
and diluted share.
Cash, cash equivalents, and investments
available-for-sale totaled $48.9 million as of March 31, 2020,
compared to approximately $26.0 million on December 31, 2019. Cash
used in operating activities was $6.5 million during the first
quarter of 2020. The balance sheet was strengthened by a $35
million debt financing agreement with Innovatus, announced in March
2020, from which the Company drew $22.5 million at closing, as well
as the underwritten public offering of the Company’s common stock
in February 2020 for gross proceeds of approximately $8.1 million,
before deducting issuance costs. Additionally, the Company has
approximately $35 million remaining for issuance under its
at-the-market equity offering facility, pursuant to which the
Company may sell, at such times and amounts as it deems
appropriate, shares of common stock to support its business plan,
subject to certain restrictions on use.
First Quarter 2020 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
Q1 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 9391556.
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 biopharmaceutical company
dedicated to transforming 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 renal disease (ESRD). Rockwell Medical's
exclusive renal drug therapies, Triferic (ferric pyrophosphate
citrate) Dialysate and Triferic AVNU, are the only FDA-approved
therapeutics indicated for iron replacement and 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.
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 the bone marrow and maintain hemoglobin without increasing iron
stores (ferritin). Both formulations donate iron immediately and
completely to transferrin (carrier of iron in the body) upon entry
into the blood which is then transported directly to the bone
marrow to be incorporated into hemoglobin, with no increase in
ferritin (stored iron and inflammation) and no reports of
anaphylaxis in over 1,000,000 patient administrations, addressing a
significant medical need in overcoming Functional Iron Deficiency
(FID) in ESRD patients.
Important Safety Information
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.
The most common adverse reactions (≥3% and at
least 1% greater than placebo) in controlled clinical studies
include: procedural hypotension (21.6%), muscle spasms (9.6%),
headache (9.2%), pain in extremity (6.8%), peripheral edema (6.8%),
dyspnea (5.8%), back pain (4.5%), pyrexia (4.5%), urinary tract
infection (4.5%), asthenia (4.1%), fatigue (3.8%), arteriovenous
(AV) fistula thrombosis (3.4%), and AV fistula site hemorrhage
(3.4%).
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, Rockwell
Medical’s intention to commercialize Triferic Dialysate, and
Triferic AVNU. Words such as, “may,” “might,” “will,” “should,”
“believe,” “expect,” “anticipate,” “estimate,” “continue,” “could,”
“can,” “would,” “develop,” “plan,” “potential,” “predict,”
“forecast,” “project,” “intend” or the negative of these terms, 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: statements about the
challenges inherent in new product development and other
indications and therapeutics areas for our products; the success of
our commercialization strategy; the success and timing of our
commercialization of Triferic Dialysate, which was launched in May
2019; the success and timing of our evaluation program for
Triferic AVNU and for a commercial launch of Triferic AVNU in the
United States; the risk that topline clinical data and real world
results may not be predictive of future results; the anticipated
number of future clinics with which we may contract for use of
Triferic Dialysate; the expected number of annualized treatments
for Triferic Dialysate; the potential impact 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 commercial launch of
Triferic AVNU; the timing and availability of future publications
and presentations; potential future milestone payments and
royalties under our license agreements; 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 Quarterly
Report on Form 10-Q for the period ended March 31, 2020 and of our
Annual Report on Form 10-K for the year ended December 31, 2019, 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)
|
March
31, |
|
December 31, |
|
2020 |
|
2019 |
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
Cash and Cash Equivalents |
$ |
37,399,801 |
|
|
$ |
11,794,526 |
|
Investments
Available-for -Sale |
|
11,456,285 |
|
|
|
14,250,176 |
|
Accounts
Receivable, net |
|
4,586,748 |
|
|
|
4,202,725 |
|
Inventory |
|
4,292,768 |
|
|
|
3,646,906 |
|
Prepaid and
Other Current Assets |
|
1,758,002 |
|
|
|
2,979,504 |
|
Total Current Assets |
|
59,493,604 |
|
|
|
36,873,837 |
|
Property and
Equipment, net |
|
2,430,113 |
|
|
|
2,433,405 |
|
Inventory,
Non-Current |
|
623,000 |
|
|
|
441,000 |
|
Right of Use
Assets, net |
|
2,797,759 |
|
|
|
3,212,530 |
|
Goodwill |
|
920,745 |
|
|
|
920,745 |
|
Other
Non-current Assets |
|
560,588 |
|
|
|
434,935 |
|
Total Assets |
$ |
66,825,809 |
|
|
$ |
44,316,452 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Accounts
Payable |
$ |
3,123,181 |
|
|
$ |
3,018,424 |
|
Accrued
Liabilities |
|
6,160,047 |
|
|
|
4,517,732 |
|
Settlement
Payable |
|
57,000 |
|
|
|
104,000 |
|
Lease
Liability - Current |
|
1,351,348 |
|
|
|
1,493,394 |
|
Deferred
License Revenue - Current |
|
2,179,383 |
|
|
|
2,233,640 |
|
Insurance
Financing Note Payable |
|
190,855 |
|
|
|
763,422 |
|
Customer
Deposits |
|
146,831 |
|
|
|
55,100 |
|
Other
Current Liability - Related Party |
|
148,523 |
|
|
|
187,849 |
|
Total Current Liabilities |
|
13,357,168 |
|
|
|
12,373,561 |
|
|
|
|
|
|
|
Lease
Liability - Long-Term |
|
1,559,749 |
|
|
|
1,780,626 |
|
Term Loan,
Net of Issuance Costs |
|
20,683,704 |
|
|
|
— |
|
Deferred
License Revenue - Long-Term |
|
9,450,983 |
|
|
|
9,842,762 |
|
Total Liabilities |
|
45,051,604 |
|
|
|
23,996,949 |
|
|
|
|
|
|
|
Stockholders’ Equity: |
|
|
|
|
|
Preferred
Stock, $0.0001 par value, no shares issued and outstanding at March
31, 2020 and December 31, 2019 |
|
— |
|
|
|
— |
|
Common
Stock, $0.0001 par value; 170,000,000 shares authorized; 69,049,102
and 65,378,890 shares issued and outstanding at March 31, 2020 and
December 31, 2019, respectively |
|
6,905 |
|
|
|
6,538 |
|
Additional
paid-in capital |
|
336,216,422 |
|
|
|
326,777,250 |
|
Accumulated
Deficit |
|
(314,500,003 |
) |
|
|
(306,516,265 |
) |
Accumulated
Other Comprehensive Income |
|
50,881 |
|
|
|
51,980 |
|
Total Stockholders’ Equity |
|
21,774,205 |
|
|
|
20,319,503 |
|
Total Liabilities And Stockholders’ Equity |
$ |
66,825,809 |
|
|
$ |
44,316,452 |
|
|
|
|
|
|
|
ROCKWELL MEDICAL, INC. AND
SUBSIDIARIESCondensed Consolidated Statements of
Operations(unaudited)
|
Three Months Ended March 31, 2020 |
|
Three Months Ended March 31, 2019 |
|
|
|
|
|
|
Net Sales |
$ |
15,856,539 |
|
|
$ |
15,559,439 |
|
Cost of
Sales |
|
14,743,613 |
|
|
|
14,549,047 |
|
Gross Profit |
|
1,112,926 |
|
|
|
1,010,392 |
|
Selling and
Marketing |
|
2,072,798 |
|
|
|
3,102,378 |
|
General and
Administrative |
|
5,273,433 |
|
|
|
6,220,499 |
|
Research and
Product Development |
|
1,821,488 |
|
|
|
497,276 |
|
Operating Loss |
|
(8,054,793 |
) |
|
|
(8,809,761 |
) |
|
|
|
|
|
|
Other Income (Expense) |
|
|
|
|
|
Realized
Gain on Investments |
|
1,929 |
|
|
|
13,888 |
|
Interest
Expense |
|
(101,951 |
) |
|
|
— |
|
Interest
Income |
|
171,077 |
|
|
|
117,526 |
|
Total Other Income |
|
71,055 |
|
|
|
131,414 |
|
|
|
|
|
|
|
Net Loss |
$ |
(7,983,738 |
) |
|
$ |
(8,678,347 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Net Loss per Share |
$ |
(0.12 |
) |
|
$ |
(0.15 |
) |
|
|
|
|
|
|
Basic and Diluted Weighted Average Shares
Outstanding |
|
67,518,240 |
|
|
|
57,098,947 |
|
|
|
|
|
|
|
CONTACTS
Investors:Argot
Partners212.600.1902Rockwell@argotpartners.com
Media:David RosenArgot
Partners212.600.1902david.rosen@argotpartners.com
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