Rockwell Medical Reports Second Quarter Results
August 09 2017 - 3:13PM
Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated
biopharmaceutical company targeting end-stage renal disease (ESRD)
and chronic kidney disease (CKD) with innovative products for the
treatment of iron replacement, secondary hyperparathyroidism and
hemodialysis, reported results for the quarter and six months ended
June 30, 2017.
Q2 2017 Financial
Highlights
- Sales were $13.2 million compared to $13.4 in Q2 2016.
- Gross profit was $1.5 million, unchanged compared to Q2
2016.
- SG&A expense was $6.5 million compared $5.0 million in Q2
2016.
- R&D expense was $1.7 million compared to $2.1 million in Q2
2016.
- Net loss was $7.1 million or ($0.14) per share compared to a
$5.4 million loss or ($0.11) per share in Q2 2016.
- Cash and investments were $43.2 million as of June 30,
2017.
- Net working capital was $56.1 million as of June 30, 2017.
Q2 YTD 2017 Financial
Highlights
- Sales were $27.8 million, an increase of $0.8 million or 2.8%
over the first six months of 2016.
- Gross profit was $3.9 million, an increase of $0.7 million or
21.1% over the first six months of 2016.
- SG&A expense was $12.6 million compared to $10.0 million in
the first six months of 2016.
- R&D expense was $2.9 million compared to $3.4 million in
the first six months of 2016.
- Net Loss was $11.8 million or ($0.23) per share compared to
$10.2 million or ($0.20) per share in the first six months of
2016.
“Our immediate priority is to secure add-on
reimbursement for Triferic and we continue to make solid progress
in our efforts,” stated Mr. Robert L. Chioini, chairman and chief
executive officer of Rockwell. “We are working with key leadership
within the new administration including Health and Human Services
and Centers for Medicare and Medicaid Services, and we continue to
receive outstanding congressional support. Feedback reported from
our Triferic drug sample program continues to be very favorable and
there is clearly recognition in the medical community of the value
that Triferic can bring to patient outcomes. Calcitriol manufacture
is progressing well and we remain on track with our FDA
submission.”
Conference Call
InformationRockwell Medical will be hosting a conference
call to review its 2017 second quarter and year to date results on
Wednesday, August 9, 2017 at 4:30 p.m. EDT. Investors are
encouraged to call a few minutes in advance at (888) 487-0354, or
for international callers (719) 325-2301, passcode #3956742 or to
listen to the call via webcast at the Rockwell Medical IR web
page: http://ir.rockwellmed.com/
About TrifericTriferic is the
only FDA approved drug indicated to replace iron and maintain
hemoglobin in hemodialysis patients suffering from anemia. Via
dialysate during each dialysis treatment, Triferic replaces the 5-7
mg iron loss that occurs in all patients, effectively maintaining
their iron balance. Unlike IV iron products, Triferic binds iron
immediately and completely to transferrin (carrier of iron in the
body) upon entering the blood and it is then transported directly
to the bone marrow to be incorporated into hemoglobin, with no
increase in ferritin (stored iron and inflammation) and no
anaphylaxis, addressing a significant unmet 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 MedicalRockwell
Medical is a fully-integrated biopharmaceutical company targeting
end-stage renal disease (ESRD) and chronic kidney disease (CKD)
with innovative products and services for the treatment of iron
replacement, secondary hyperparathyroidism and hemodialysis.
Rockwell’s recent FDA approved drug
Triferic is indicated for iron replacement and maintenance of
hemoglobin in hemodialysis patients. Triferic delivers iron to
patients during their regular dialysis treatment, using dialysate
as the delivery mechanism. Triferic has demonstrated that it safely
and effectively delivers sufficient iron to the bone marrow and
maintains hemoglobin, without increasing iron stores (ferritin).
Rockwell intends to market Triferic to hemodialysis patients in the
U.S. dialysis market and globally.
Rockwell’s FDA approved generic drug Calcitriol
is for treating secondary hyperparathyroidism in dialysis patients.
Calcitriol (active vitamin D) injection is indicated in the
management of hypocalcemia in patients undergoing chronic renal
dialysis. It has been shown to significantly reduce elevated
parathyroid hormone levels. Reduction of PTH has been shown to
result in an improvement in renal osteodystrophy. Rockwell
intends to market Calcitriol to hemodialysis patients in the U.S.
dialysis market.
Rockwell is also an established manufacturer and
leader in delivering high-quality hemodialysis
concentrates/dialysates to dialysis providers and distributors in
the U.S. and abroad. As one of the two major suppliers in the U.S.,
Rockwell’s products are used to maintain human life by removing
toxins and replacing critical nutrients in the dialysis patient’s
bloodstream. Rockwell has three U.S. manufacturing/distribution
facilities.
Rockwell’s exclusive renal drug therapies
support disease management initiatives to improve the quality of
life and care of dialysis patients and are intended to deliver safe
and effective therapy, while decreasing drug administration costs
and improving patient convenience. Rockwell Medical is developing a
pipeline of drug therapies, including extensions of Triferic for
indications outside of hemodialysis. Please visit
www.rockwellmed.com for more information.
Certain statements in this press release
constitute "forward-looking statements" within the meaning of the
federal securities laws, including, but not limited to, Rockwell’s
intention to sell and market Calcitriol and Triferic. Words such as
“may,” “might,” “will,” “should,” “believe,” “expect,”
“anticipate,” “estimate,” “continue,” “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. Thus, actual results could be materially different.
Rockwell Medical expressly disclaims any obligation to update or
alter statements whether as a result of new information, future
events or otherwise, except as required by law.
Michael Rice, Investor Relations;
646-597-6979
Triferic® is a registered trademark of Rockwell
Medical, Inc.
ROCKWELL MEDICAL, INC. AND
SUBSIDIARIES |
|
CONSOLIDATED INCOME STATEMENTS |
|
For the three and six months ended June 30, 2017 and
June 30, 2016 |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
June 30, 2017 |
|
Three Months Ended
June 30, 2016 |
|
Six Months Ended
June 30, 2017 |
|
Six Months Ended
June 30, 2016 |
Sales |
|
$ |
13,243,107 |
|
|
$ |
13,452,517 |
|
|
$ |
27,835,361 |
|
|
$ |
27,079,565 |
|
Cost of Sales |
|
|
11,744,819 |
|
|
|
11,962,989 |
|
|
|
23,979,601 |
|
|
|
23,895,111 |
|
Gross
Profit |
|
|
1,498,288 |
|
|
|
1,489,528 |
|
|
|
3,855,760 |
|
|
|
3,184,454 |
|
Selling, General and
Administrative |
|
|
6,541,179 |
|
|
|
5,014,370 |
|
|
|
12,641,894 |
|
|
|
10,001,111 |
|
Research and Product
Development |
|
|
1,675,494 |
|
|
|
2,063,324 |
|
|
|
2,890,345 |
|
|
|
3,377,754 |
|
Operating
Income (Loss) |
|
|
(6,718,385 |
) |
|
|
(5,588,166 |
) |
|
|
(11,676,479 |
) |
|
|
(10,194,411 |
) |
Interest and Investment
Income |
|
|
(364,599 |
) |
|
|
227,020 |
|
|
|
(148,528 |
) |
|
|
413,582 |
|
Income
(Loss) Before Income Taxes |
|
|
(7,082,984 |
) |
|
|
(5,361,146 |
) |
|
|
(11,825,007 |
) |
|
|
(9,780,829 |
) |
Income Tax Expense |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(404,527 |
) |
Net
Income (Loss) |
|
$ |
(7,082,984 |
) |
|
$ |
(5,361,146 |
) |
|
$ |
(11,825,007 |
) |
|
$ |
(10,185,356 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic Earnings (Loss)
per Share |
|
$ |
(0.14 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.20 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted Earnings (Loss)
per Share |
|
$ |
(0.14 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.20 |
) |
ROCKWELL MEDICAL, INC. AND
SUBSIDIARIES |
|
CONSOLIDATED BALANCE SHEETS |
|
As of June 30, 2017 and December 31, 2016 |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2017 |
|
2016 |
ASSETS |
|
|
|
|
|
|
Cash and Cash
Equivalents |
|
$ |
8,327,695 |
|
|
$ |
17,180,594 |
|
Investments Available
for Sale |
|
|
34,914,331 |
|
|
|
40,759,703 |
|
Accounts Receivable,
net of a reserve of $7,000 in 2017 and $5,000 in 2016 |
|
|
4,880,969 |
|
|
|
6,393,228 |
|
Inventory |
|
|
13,774,065 |
|
|
|
12,141,072 |
|
Other Current
Assets |
|
|
1,907,270 |
|
|
|
2,034,598 |
|
Total
Current Assets |
|
|
63,804,330 |
|
|
|
78,509,195 |
|
Property and Equipment,
net |
|
|
1,529,639 |
|
|
|
1,391,575 |
|
Inventory,
Non-Current |
|
|
2,725,958 |
|
|
|
1,826,554 |
|
Intangible Assets |
|
|
4,205 |
|
|
|
4,382 |
|
Goodwill |
|
|
920,745 |
|
|
|
920,745 |
|
Other Non-current
Assets |
|
|
490,738 |
|
|
|
501,187 |
|
Total
Assets |
|
$ |
69,475,615 |
|
|
$ |
83,153,638 |
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
|
|
Accounts Payable |
|
$ |
3,869,646 |
|
|
$ |
5,858,234 |
|
Accrued
Liabilities |
|
|
3,585,198 |
|
|
|
4,210,151 |
|
Customer Deposits |
|
|
212,320 |
|
|
|
77,217 |
|
Total
Current Liabilities |
|
|
7,667,164 |
|
|
|
10,145,602 |
|
|
|
|
|
|
|
|
Deferred License
Revenue |
|
|
17,962,468 |
|
|
|
20,051,737 |
|
|
|
|
|
|
|
|
Shareholders’ Equity: |
|
|
|
|
|
|
Common Shares, no par
value, 51,740,040 and 51,527,711 shares issued and outstanding |
|
|
270,302,780 |
|
|
|
268,199,939 |
|
Accumulated
Deficit |
|
|
(226,166,099 |
) |
|
|
(214,341,092 |
) |
Accumulated Other
Comprehensive Income |
|
|
(290,698 |
) |
|
|
(902,548 |
) |
Total
Shareholders’ Equity |
|
|
43,845,983 |
|
|
|
52,956,299 |
|
Total
Liabilities And Shareholders’ Equity |
|
$ |
69,475,615 |
|
|
$ |
83,153,638 |
|
ROCKWELL MEDICAL, INC. AND
SUBSIDIARIES |
|
CONSOLIDATED STATEMENTS OF CASH FLOWS |
|
For the six months ended June 30, 2017 and June 30,
2016 |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
2017 |
|
2016 |
Cash Flows From
Operating Activities: |
|
|
|
|
|
|
Net
(Loss) |
|
$ |
(11,825,007 |
) |
|
$ |
(10,185,356 |
) |
Adjustments To Reconcile Net Loss To Net Cash Used In Operating
Activities: |
|
|
|
|
|
|
Depreciation and Amortization |
|
|
259,084 |
|
|
|
395,990 |
|
Share
Based Compensation—Non-employee |
|
|
88,487 |
|
|
|
— |
|
Share
Based Compensation—Employees |
|
|
4,301,585 |
|
|
|
5,222,723 |
|
Loss on
Disposal of Assets |
|
|
3,634 |
|
|
|
258 |
|
Loss
(gain) on Sale of Investments Available for Sale |
|
|
368,519 |
|
|
|
(3,302 |
) |
Changes
in Assets and Liabilities: |
|
|
|
|
|
|
Decrease
(Increase) in Accounts Receivable |
|
|
343,993 |
|
|
|
(2,543,404 |
) |
(Increase) in Inventory |
|
|
(2,532,397 |
) |
|
|
(3,137,896 |
) |
Decrease
(Increase) in Other Assets |
|
|
349,378 |
|
|
|
(54,132 |
) |
Increase
(Decrease) in Accounts Payable |
|
|
(1,988,717 |
) |
|
|
980,981 |
|
Increase
(Decrease) in Other Liabilities |
|
|
(489,857 |
) |
|
|
106,441 |
|
(Decrease) in Deferred License Revenue |
|
|
(996,240 |
) |
|
|
(963,372 |
) |
Increase
(Decrease) in Deferred Drug License Revenue |
|
|
(136,362 |
) |
|
|
3,886,365 |
|
Changes
in Assets and Liabilities |
|
|
(5,450,202 |
) |
|
|
(1,725,017 |
) |
Cash
(Used In) Operating Activities |
|
|
(12,253,900 |
) |
|
|
(6,294,704 |
) |
Cash Flows From
Investing Activities: |
|
|
|
|
|
|
Purchase
of Investments Available for Sale |
|
|
(27,262,362 |
) |
|
|
(9,259,648 |
) |
Sale of
Investments Available for Sale |
|
|
33,351,339 |
|
|
|
8,328,987 |
|
Purchase
of Equipment |
|
|
(401,055 |
) |
|
|
(229,287 |
) |
Proceeds
on Sale of Assets |
|
|
450 |
|
|
|
1,000 |
|
Cash
Provided by (Used In) Investing Activities |
|
|
5,688,372 |
|
|
|
(1,158,948 |
) |
Cash Flows From
Financing Activities: |
|
|
|
|
|
|
Proceeds
from Issuance of Common Shares |
|
|
— |
|
|
|
77,250 |
|
Restricted Stock Retained in Satisfaction of Tax Liabilities |
|
|
(2,287,231 |
) |
|
|
— |
|
Cash
Provided By (Used In) Financing Activities |
|
|
(2,287,231 |
) |
|
|
77,250 |
|
|
|
|
|
|
|
|
Effects of exchange
rate changes |
|
|
(140 |
) |
|
|
— |
|
(Decrease) Increase In
Cash |
|
|
(8,852,899 |
) |
|
|
(7,376,402 |
) |
Cash At Beginning Of
Period |
|
|
17,180,594 |
|
|
|
31,198,182 |
|
Cash At End Of
Period |
|
$ |
8,327,695 |
|
|
$ |
23,821,780 |
|
|
|
|
|
|
|
|
|
|
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