Rockwell Medical Reports Fourth Quarter 2014 Results
February 26 2015 - 4:01PM
Rockwell Medical, Inc. (Nasdaq:RMTI), 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, reported results for the
fourth quarter and year ended December 31, 2014.
Q4 2014 Financial Highlights
- Sales were $14.4 million, a 3.5% increase over Q4 2013.
- Gross profit was $2.6 million, a 25% increase over Q4
2013.
- R&D expense was $1.7 million, a 71% decrease compared to
$5.8 million in Q4 2013.
- Cash and investments were $85.7 million at December 31,
2014.
Q4 2014 Corporate Highlights
- Received $20 million in cash from Baxter Healthcare Corporation
upon executing exclusive concentrate product commercialization
agreement; additionally cash potential of $17.5 million for meeting
milestones.
- Received $15 million in cash from Baxter for equity investment
for RMTI common stock at $11.39 per share.
- Received $8.4 million in cash from warrant conversion.
- Raised $55 million in cash from equity financing with Bank of
America Merrill Lynch.
- Paid off long-term debt of $20 million.
- Received FDA Advisory Committee majority vote to approve
Triferic for iron replacement and maintenance of hemoglobin in
hemodialysis patients.
2014 Financial Highlights
- Sales were $54.2 million, a 3.5% increase over 2013.
- Gross profit was $8.5 million, an increase of 28.3% over
2013.
- R&D expense was $7.8 million, an 80% decrease compared to
$39.4 million in 2013.
- Loss for the year was $21.3 million, a 56% decrease compared to
$48.8 million loss in 2013.
Recent Corporate Highlights
- Received U.S. FDA market approval for Triferic for iron
replacement and maintenance of hemoglobin in hemodialysis
patients.
- Presented two Triferic posters at Annual Dialysis Conference in
New Orleans, Louisiana.
"We had a very eventful active year," stated Mr. Robert L.
Chioini, Chairman and Chief Executive Officer of Rockwell. "Our
fourth quarter was exceptional and included three major milestone
accomplishments. First, we monetized and de-risked our operating
business and positioned it for future growth through our new
partnership with Baxter. Then, we conducted a successful FDA
advisory committee meeting, achieving a majority vote to approve
Triferic as the only iron replacement and hemoglobin maintenance
drug for hemodialysis patients. Additionally, we completed a
successful financing, strengthening our cash and liquidity position
resulting in a strong balance sheet with no debt."
Mr. Chioini further commented, "Recently, we received FDA
approval to commercially market Triferic in the U.S., where we are
confident that this new drug will improve the lives of hemodialysis
patients and create value for the dialysis providers in the renal
community. We are now working diligently towards the commercial
launch of both Triferic and Calcitriol, as well as expanding our
operating business. Overall, we accomplished significant, strategic
milestones and as we continue to execute we are focused and well
prepared to offer patients and physicians clinically beneficial
products while building Rockwell into a leading biotech
company."
Conference Call Information
Rockwell Medical will be hosting a conference call to review its
fourth quarter and 2014 year end results on Thursday, February 26,
2015 at 4:30 pm ET. Investors are encouraged to call a few minutes
in advance at (877) 383-7438, or for international callers (678)
894-3975, passcode #89813322 or to listen to the call via webcast
at the Rockwell Medical IR web page: http://ir.rockwellmed.com/
About Triferic
Triferic is a unique iron compound that is delivered to
hemodialysis patients via dialysate, replacing the ongoing iron
loss that occurs during their dialysis treatment. Triferic is
introduced into bicarbonate concentrate, on-site at the dialysis
clinic, and subsequently mixed into dialysate. Once in dialysate,
Triferic crosses the dialyzer membrane and enters the blood where
it immediately binds to transferrin and is transported to the
erythroid precursor cells to be incorporated into hemoglobin. In
completed clinical trials, Triferic has demonstrated that it can
effectively deliver sufficient iron to the bone marrow and maintain
hemoglobin, without increasing iron stores (ferritin). Please visit
www.triferic.com for more information.
About Rockwell Medical
Rockwell 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. In
completed clinical trials, 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.
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 manufacturing/distribution facilities located in the
U.S.
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 launch Calcitriol and Triferic following FDA approval.
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. Trifericâ„¢ is a
trademark of Rockwell Medical, Inc.
ROCKWELL MEDICAL, INC.
AND SUBSIDIARY |
|
CONSOLIDATED INCOME
STATEMENTS |
|
For the three and
twelve months ended December 31, 2014 and December 31,
2013 |
|
|
Three Months Ended |
Three Months Ended |
Twelve Months Ended |
Twelve Months Ended |
|
December 31,
2014 |
December 31,
2013 |
December 31,
2014 |
December 31, 2013 |
Sales |
$14,447,653 |
$13,964,624 |
$54,188,444 |
$52,379,543 |
Cost of Sales |
11,871,106 |
11,904,730 |
45,643,231 |
45,720,323 |
Gross Profit |
2,576,547 |
2,059,894 |
8,545,213 |
6,659,220 |
Selling, General and
Administrative |
5,917,480 |
3,795,325 |
18,320,720 |
14,336,449 |
Research and Product Development |
1,679,878 |
5,793,579 |
7,783,594 |
39,382,037 |
Operating Income
(Loss) |
(5,020,811) |
(7,529,010) |
(17,559,101) |
(47,059,266) |
Interest and Investment Income,
net |
187,144 |
69,317 |
386,257 |
98,101 |
Interest Expense |
1,549,980 |
872,412 |
4,154,313 |
1,822,147 |
Income (Loss) Before Income
Taxes |
(6,383,647) |
(8,332,105) |
(21,327,157) |
(48,783,312) |
Income Tax Expense |
-- |
-- |
-- |
-- |
Net Income
(Loss) |
$ (6,383,647) |
$ (8,332,105) |
$ (21,327,157) |
$ (48,783,312) |
|
|
|
|
|
Basic Earnings (Loss) per
Share |
($0.14) |
($0.21) |
($0.52) |
($1.48) |
|
|
|
|
|
Diluted Earnings (Loss) per
Share |
($0.14) |
($0.21) |
($0.52) |
($1.48) |
|
|
|
|
|
|
|
|
|
|
ROCKWELL MEDICAL, INC.
AND SUBSIDIARY |
|
CONSOLIDATED BALANCE
SHEETS |
|
As of December 31, 2014
and 2013 |
|
|
December 31, |
December 31, |
ASSETS |
2014 |
2013 |
Cash and Cash Equivalents |
$65,800,451 |
$11,881,451 |
Investments Available for Sale |
19,927,310 |
12,034,622 |
Accounts Receivable, net of a reserve of
$52,000 in 2014 and $37,000 in 2013 |
4,472,002 |
4,578,319 |
Inventory |
3,920,185 |
2,799,648 |
Other Current Assets |
587,201 |
623,734 |
Total Current Assets |
94,707,149 |
31,917,774 |
|
|
|
Property and Equipment, net |
1,496,912 |
1,648,949 |
Intangible Assets |
332,686 |
499,715 |
Goodwill |
920,745 |
920,745 |
Other Non-current Assets |
542,224 |
1,374,941 |
Total Assets |
$97,999,716 |
$36,362,124 |
|
|
|
LIABILITIES AND SHAREHOLDERS'
EQUITY |
|
|
|
|
|
Note Payable Capitalized Lease
Obligations |
$ -- |
$2,308,145 |
Accounts Payable |
5,294,515 |
8,686,153 |
Accrued Liabilities |
4,325,997 |
6,647,828 |
Customer Deposits |
183,890 |
207,545 |
Total Current
Liabilities |
9,804,402 |
17,849,671 |
|
|
|
Deferred License Revenue |
19,492,520 |
-- |
Long Term Debt |
-- |
17,916,914 |
|
|
|
Shareholders' Equity: |
|
|
Common Shares, no par value, 50,284,007 and
40,110,661 shares issued and outstanding |
249,018,189 |
154,457,878 |
Common Share Purchase Warrants, none and
983,071 warrants issued and outstanding |
-- |
4,895,811 |
Accumulated Deficit |
(180,117,726) |
(158,790,569) |
Accumulated Other Comprehensive
Income |
(197,669) |
32,419 |
Total Shareholders' Equity |
68,702,794 |
595,539 |
|
|
|
Total Liabilities And Shareholders'
Equity |
$97,999,716 |
$36,362,124 |
|
|
|
ROCKWELL MEDICAL, INC.
AND SUBSIDIARY |
|
CONSOLIDATED STATEMENTS
OF CASH FLOWS |
|
For the years ended
December 31, 2014 and 2013 |
|
|
2014 |
2013 |
Cash Flows From Operating Activities: |
|
|
Net (Loss) |
$ (21,327,157) |
$ (48,783,312) |
Adjustments To Reconcile Net Loss To Net
Cash Used In |
|
|
Operating Activities: |
|
|
Depreciation and
Amortization |
996,321 |
1,007,411 |
Share Based Compensation –
Non-employee |
-- |
1,862,874 |
Share Based Compensation-
Employees |
10,094,685 |
5,849,196 |
Loss (Gain) on Disposal of
Assets |
7,338 |
16,410 |
Loss on Sale of Investments
Available for Sale |
1,223 |
-- |
Amortization of Debt Issuance
Costs |
882,716 |
227,059 |
Non-Cash Interest Expense |
874,942 |
225,059 |
|
|
|
Changes in Assets and
Liabilities: |
|
|
(Increase) Decrease in Accounts
Receivable |
106,317 |
(146,387) |
(Increase) in Inventory |
(1,120,537) |
(150,009) |
(Increase) Decrease in Other
Assets |
(13,466) |
669,896 |
Increase (Decrease) in Accounts
Payable |
(3,391,638) |
(6,147,412) |
Increase (Decrease) in Other
Liabilities |
(2,345,486) |
(5,295,738) |
Deferred Distribution Agreement
Income |
20,000,000 |
-- |
Recognized Distribution Agreement
Income |
(507,480) |
-- |
Changes in Assets and
Liabilities |
12,727,710 |
(11,069,650) |
Cash Provided By (Used In) Operating
Activities |
4,257,778 |
(50,664,953) |
|
|
|
Cash Flows From Investing Activities: |
|
|
Purchase of Investments Available for
Sale |
(13,100,000) |
(12,002,203) |
Sale of Investments Available for
Sale |
4,976,000 |
-- |
Purchase of Equipment |
(684,593) |
(654,197) |
Proceeds on Sale of Assets |
-- |
6,898 |
Cash Provided By (Used In) Investing
Activities |
(8,808,593) |
(12,649,502) |
|
|
|
Cash Flows From Financing Activities: |
|
|
Proceeds from Issuance of Common Shares
and Purchase Warrants |
79,569,815 |
51,596,232 |
Proceeds from the Issuance of Notes
Payable |
-- |
20,000,000 |
Debt Issuance Costs |
-- |
(1,109,776) |
Payments on Notes Payable and Capital
Lease Obligations |
(21,100,000) |
(2,280) |
Cash Provided By Financing
Activities |
58,469,815 |
70,484,176 |
|
|
|
Increase (Decrease) In Cash |
53,919,000 |
7,169,721 |
Cash At Beginning Of Period |
11,881,451 |
4,711,730 |
Cash At End Of Period |
$65,800,451 |
$11,881,451 |
CONTACT: Michael Rice, Investor Relations; 646-597-6979
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