Rockwell Medical, Inc. (NASDAQ:RMTI) (“Rockwell Medical” or the
"Company"), a biopharmaceutical company dedicated to improving
outcomes for patients with anemia, with an initial focus on
end-stage renal disease (ESRD) and chronic kidney disease (CKD),
today reported business updates and financial results for the three
months ended March 31, 2019.
Recent Business and Financial Highlights:
- The Company announced the commencement of commercial sales of
the first formulation in its Triferic portfolio, Dialysate
Triferic, on May 6, 2019.
- The Company expects to submit a New Drug Application (“NDA”)
for I.V. Triferic in the U.S. during the second quarter of
2019.
- Received a preliminary recommendation from the Centers for
Medicare and Medicaid Services (“CMS”) on April 26, 2019 that, if
finalized, would result in a unique J-code for the powder packet
formulation of Dialysate Triferic.
- The Company presented positive data from two studies evaluating
intravenous and peritoneal dialysate formulations of Triferic at
the 39th Annual Dialysis Conference in March 2019.
- Sales for the first quarter of 2019 were $15.6 million compared
to $14.9 million for the first quarter of 2018, an increase of
4%.
- As of March 31, 2019, the Company had cash, cash equivalents
and investments available-for-sale of $27.8 million. Cash used in
operating activities for the first quarter of 2019 was $5.4
million.
“The commercial launch of Dialysate Triferic marks an important
milestone for Rockwell Medical. Triferic offers a much-needed
alternative for healthcare providers who treat anemia in their
hemodialysis patients. Our efforts during the first quarter of 2019
were primarily focused on completing our market and pricing
research, enhancing our medical education platform, and building a
strong commercial and medical infrastructure to execute on our
launch plans,” stated Stuart Paul, President and Chief Executive
Officer of Rockwell Medical.
“We are also in the process of advancing I.V. Triferic, and we
anticipate a large global opportunity for that formulation. We
believe I.V. Triferic will potentially be eligible for
separate reimbursement in the U.S., if approved by CMS, for a
period of two years. It also allows for Triferic administration
with dry bicarbonate bags/cartridges, which are commonly used in
Europe, China and other countries around the globe. We are pleased
with our progress and excited about the opportunities that lie
ahead,” continued Mr. Paul.
Selected First Quarter 2019 Financial
Results
Net sales for the first quarter of 2019 were $15.6 million, an
increase of 4% compared to sales of $14.9 million for the first
quarter of 2018. The increase was primarily due to higher domestic
dialysis concentrate sales to Baxter and an increase in
international sales compared to the three months ended March 31,
2018. Revenue recognized from licensing fees was $0.6 million for
both the three months ended March 31, 2019 and 2018.
Cost of sales for the first quarter of 2019 was $14.6 million,
resulting in gross profit of $1.0 million, compared to cost of
sales of a $15.7 million and a gross loss of $0.7 million during
the first quarter of 2018. Gross profit increased by $1.7 million
in the first quarter of 2019 compared to the first quarter of 2018,
due primarily to an inventory reserve for Triferic of $2.2 million
for the first quarter of 2018, partially offset by a gross profit
decrease of $0.7 million in our dialysis concentrates products. The
decrease in gross profit for our dialysis concentrates products was
primarily attributable to increased labor, materials and overhead
costs, partially offset by increased net sales.
Selling and marketing expenses were $3.1 million for the first
quarter of 2019 compared to $0.2 million in the first quarter of
2018. The increase was due primarily to marketing costs incurred to
prepare for the launch of Triferic and increased headcount.
General and administrative expenses were $6.2 million for the
first quarter of 2019 compared with $3.1 million for the first
quarter of 2018. The increase was primarily due to the reversal of
certain compensation-related accruals in the first quarter of 2018
and an increase in annual reporting and consulting fees.
Research and product development expenses were $0.5 million for
the first quarter of 2019 compared to $1.7 million for the first
quarter of 2018. The decrease was due primarily to a reduction in
clinical trial and other product development costs.
Net loss for the first quarter of 2019 was $8.7 million, or
$0.15 per basic and diluted share, compared to a net loss
of $5.5 million, or $0.11 per basic and diluted share, in
the first quarter of 2018.
The Company encourages shareholders to also review its Form 10-Q
for the quarter ended March 31, 2019, as filed by the Company with
the Securities and Exchange Commission ("SEC").
Key Objectives for 2019
- Increase awareness of Triferic in the dialysis community, build
and enhance relationships with key opinion leaders, and support
medical education of nephrologists and other clinicians, while
generating real-world evidence to support the use of Triferic in
adult hemodialysis patients.
- File an NDA with the U.S. Food and Drug Administration (FDA)
for I.V. Triferic during the second quarter of 2019.
- Advance international opportunities for the Triferic portfolio
through strategic partnerships and licensing agreements.
- Expand and improve operating margin for the Company’s
concentrates business.
Conference Call
As previously announced, Rockwell Medical management will host
its first quarter 2019 conference call as follows:
Date |
Thursday, May 9, 2019 |
Time |
4:30 PM EDT |
Telephone |
U.S: |
(877) 383-7438 |
|
International: |
(678) 894-3975 |
Webcast (live and
archive) |
https://edge.media-server.com/m6/p/7ci5to7r |
About Triferic Triferic is the only
FDA-approved therapy indicated to replace iron and maintain
hemoglobin in hemodialysis patients via dialysate during each
dialysis treatment. Triferic delivers approximately 5-7 mg iron
with every hemodialysis treatment to the bone marrow and maintains
hemoglobin without increasing iron stores (ferritin). Unlike
traditional IV iron products, Triferic donates iron immediately and
completely to transferrin (carrier of iron in the body) upon entry
into the blood and 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 675,000 patient administrations, addressing a significant
medical need in overcoming Functional Iron Deficiency (FID) in ESRD
patients. Please visit www.triferic.com to view the Triferic
mode-of-action (MOA) video and for more information.
About Rockwell Medical Rockwell Medical is a
biopharmaceutical company dedicated to improving outcomes for
patients with anemia, with an initial focus on end-stage renal
disease (ESRD) and chronic kidney disease (CKD). Rockwell Medical's
exclusive renal drug therapy, Triferic, supports disease management
initiatives to improve the quality of life and care of dialysis
patients and is intended to deliver safe and effective therapy,
while decreasing drug administration costs and improving patient
convenience. The Company has developed multiple formulations of
Triferic, the only FDA-approved therapeutic indicated for iron
replacement and maintenance of hemoglobin in hemodialysis patients.
The Company’s strategy is to bring its therapeutics to market in
the United States and to utilize partners to develop and
commercialize such therapeutics in international markets. 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. Please
visit www.rockwellmed.com for more information.
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 bring to market
Triferic, and I.V. Triferic. Words such as "may," "might," "will,"
"should," "believe," "expect," "anticipate," "estimate,"
"continue," "could," "plan," "potential," "predict," "forecast,"
"project," "plan", "intend" or 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: statements about the issuance of a
unique J code for our Triferic Powder Packet; timing and success of
our planned NDA submission for I.V. Triferic; the potential market
opportunity for I.V. Triferic and other Rockwell products; pricing
and reimbursement status for I.V. Triferic, Triferic and other
Rockwell products, including eligibility for add-on reimbursement
under TDAPA; liquidity and capital resources; expected duration of
Rockwell Medical's existing working capital; success of our
recently announced commercialization plans for Dialysate Triferic;
and timing and success of our efforts to renegotiate economic terms
of our concentrate business Rockwell Medical expressly disclaims
any obligation to update or alter any statements whether as a
result of new information, future events or otherwise, except as
required by law.
Triferic® is a registered trademark of Rockwell Medical,
Inc.
Contact Investor Relations: Lisa M. Wilson,
In-Site Communications, Inc. T: 212-452-2793 E:
lwilson@insitecony.com
Source: Rockwell Medical, Inc.
Financial Tables Follow
ROCKWELL
MEDICAL, INC. AND SUBSIDIARIES Condensed
Consolidated Balance Sheets |
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
2019 |
|
2018 |
|
|
|
|
(Unaudited) |
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
Cash and Cash Equivalents |
|
$ |
20,919,518 |
|
|
$ |
22,713,980 |
|
|
Investments Available-for -Sale |
|
|
6,876,221 |
|
|
|
10,818,059 |
|
|
Accounts Receivable, net of a reserve of $2,240 in 2019 and $2,104
in 2018 |
|
|
6,711,410 |
|
|
|
6,979,514 |
|
|
Insurance Receivable |
|
|
— |
|
|
|
371,217 |
|
|
Inventory |
|
|
4,001,570 |
|
|
|
4,038,778 |
|
|
Prepaid and Other Current Assets |
|
|
1,680,818 |
|
|
|
1,903,682 |
|
|
Total Current Assets |
|
|
40,189,537 |
|
|
|
46,825,230 |
|
|
Property and Equipment, net |
|
|
2,572,680 |
|
|
|
2,638,293 |
|
|
Inventory, Non-Current |
|
|
1,501,000 |
|
|
|
1,637,000 |
|
|
Right of Use Assets, net |
|
|
3,005,792 |
|
|
|
— |
|
|
Goodwill |
|
|
920,745 |
|
|
|
920,745 |
|
|
Other Non-current Assets |
|
|
555,310 |
|
|
|
536,516 |
|
|
Total Assets |
|
$ |
48,745,064 |
|
|
$ |
52,557,784 |
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
|
Accounts Payable |
|
$ |
4,522,225 |
|
|
$ |
4,492,071 |
|
|
Accrued Liabilities |
|
|
6,272,040 |
|
|
|
5,129,761 |
|
|
Settlement Payable |
|
|
166,669 |
|
|
|
416,668 |
|
|
Lease Liability - Current |
|
|
1,680,475 |
|
|
|
— |
|
|
Deferred License Revenue - Current |
|
|
2,248,062 |
|
|
|
2,252,868 |
|
|
Customer Deposits |
|
|
240,239 |
|
|
|
63,143 |
|
|
Other Current Liability - Related Party |
|
|
600,000 |
|
|
|
850,000 |
|
|
Total Current Liabilities |
|
|
15,729,710 |
|
|
|
13,204,511 |
|
|
|
|
|
|
|
|
|
|
Lease Liability - Long-Term |
|
|
1,336,319 |
|
|
|
— |
|
|
Deferred License Revenue - Long-Term |
|
|
11,517,988 |
|
|
|
12,076,399 |
|
|
Total Liabilities |
|
|
28,584,017 |
|
|
|
25,280,910 |
|
|
|
|
|
|
|
|
|
|
Shareholders’ Equity: |
|
|
|
|
|
|
|
Preferred Shares, no par value, no shares issued and outstanding at
March 31, 2019 andDecember 31, 2018 |
|
|
— |
|
|
|
— |
|
|
Common Shares, no par value, 57,128,327 and 57,034,154 shares
issued and outstanding atMarch 31, 2019 and December 31, 2018,
respectively |
|
|
301,171,733 |
|
|
|
299,601,960 |
|
|
Accumulated Deficit |
|
|
(281,066,581 |
) |
|
|
(272,388,234 |
) |
|
Accumulated Other Comprehensive Income |
|
|
55,895 |
|
|
|
63,148 |
|
|
Total Shareholders’
Equity |
|
|
20,161,047 |
|
|
|
27,276,874 |
|
|
Total Liabilities And Shareholders’ Equity |
|
$ |
48,745,064 |
|
|
$ |
52,557,784 |
|
|
|
|
|
|
|
|
|
ROCKWELL
MEDICAL, INC. AND SUBSIDIARIES Condensed
Consolidated Statements of Operations
(unaudited) |
|
|
|
Three Months EndedMarch 31, 2019 |
|
Three Months EndedMarch 31, 2018 |
|
|
|
|
|
|
|
|
|
Net Sales |
|
$ |
15,559,439 |
|
|
$ |
14,948,579 |
|
|
Cost of Sales |
|
|
14,549,047 |
|
|
|
15,669,072 |
|
|
Gross Profit (Loss) |
|
|
1,010,392 |
|
|
|
(720,493 |
) |
|
Selling and Marketing |
|
|
3,102,378 |
|
|
|
215,083 |
|
|
General and Administrative |
|
|
6,220,499 |
|
|
|
3,116,872 |
|
|
Research and Product Development |
|
|
497,276 |
|
|
|
1,666,356 |
|
|
Operating Loss |
|
|
(8,809,761 |
) |
|
|
(5,718,804 |
) |
|
|
|
|
|
|
|
|
|
Other Income (Expense) |
|
|
|
|
|
|
|
Realized Gain (Loss) on Investments |
|
|
13,888 |
|
|
|
(2,892 |
) |
|
Interest Income |
|
|
117,526 |
|
|
|
175,307 |
|
|
Other Income |
|
|
— |
|
|
|
(3,132 |
) |
|
Total Other Income (Expense) |
|
|
131,414 |
|
|
|
169,283 |
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(8,678,347 |
) |
|
$ |
(5,549,521 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and Diluted Net Loss per Share |
|
$ |
(0.15 |
) |
|
$ |
(0.11 |
) |
|
|
|
|
|
|
|
|
|
Basic and Diluted Weighted Average Shares
Outstanding |
|
|
57,098,947 |
|
|
|
51,288,424 |
|
|
|
|
|
|
|
|
|
|
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