WIXOM, Mich., Nov. 4, 2009 (GLOBE NEWSWIRE) -- Rockwell Medical (Nasdaq:RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD) and iron deficiency anemia, reported today third quarter 2009 sales of $14.2 million, up 4.6% from $13.5 million in the third quarter of 2008. Loss for the third quarter 2009 was ($1.5) million or ($.11) per share compared to ($2.5) million or ($.18) per share for the third quarter of 2008.
Third Quarter Financial Highlights
* Sales of $14.2 million increased 4.6% compared to the third quarter of 2008. * Sales increased 8.8% sequentially or $1.1 million over the second quarter of 2009. * Third quarter gross profit margins increased to 17.0% compared to 4.7% in the third quarter of 2008. * Gross profit increased 276% to $2.4 million compared to $.6 million in the third quarter of 2008. * Gross profit margins increased 2.7% sequentially over the second quarter 2009. * Gross profit increased $.5 million over the second quarter of 2009. * R&D expense was $2.0 million compared to $1.0 million in the third quarter 2008. * Loss of ($1.5) million compared to a loss of ($2.5) million in the third quarter 2008.
First Nine Months Financial Highlights
* Sales of $40.0 million increased $1.8 million or 4.8% compared to the first nine months of 2008. * Gross profit margins increased to 13.7% from 6.1% in the first nine months of 2008. * Gross profit increased 134% to $5.5 million compared to $2.3 million in the first nine months of last year. * R&D expense was $5.3 million compared to $2.6 million in the first nine months of 2008. * Loss of ($4.9) million compared to a loss of ($4.8) million in the nine months of 2008.
Drug Development and Corporate Progress
* Successfully raised $20.5 million in net proceeds from a registered direct offering that closed October 5, 2009. * Completed SFP Phase IIb clinical study in late October 2009. * Rebranded Company with new name and introduced a new website to reflect strategic focus towards bio-pharma. * Inclusion into the Russell 2000, 3000 and Global Indices. * Strengthened regulatory expertise with the addition of Dr. Jur Strobos M.D. to our Scientific Advisory Board.
Mr. Robert L. Chioini, Chairman and CEO stated, "We have made great progress in 2009 showing improvements in both our operating business and our drug development business. Our operating margins have increased significantly due in part to our continued effort to improve efficiencies, thereby contributing cash flow to our drug development efforts, while our recent financing, strengthened regulatory team and completed Phase IIb study should enable us to make considerable progress in our late-stage SFP clinical development."
Rockwell Medical will be hosting a conference call to review its 2009 third quarter results on Wednesday, November 4, 2009 at 4:15 pm EST. Investors are encouraged to call a few minutes in advance at (877) 419-6603 to listen to the call or on the web at:
The call will be available for replay for one week at the same link above.
About SFP:
SFP is a novel, investigational, continuous iron therapy designed to treat iron deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of iron that travels directly to the bloodstream and transfers iron at a cellular level, similar to normal, physiologic dietary iron intake. SFP is designed as a continuous replacement treatment delivering small doses of iron during every dialysis session in order to replenish iron lost during the dialysis procedure, thereby maintaining hemoglobin in the target range as per Kidney Disease Quality Outcomes Initiative (KDQOI) recommendations. Clinical trials to date suggest that SFP, delivered during each dialysis treatment via dialysate, maintains optimal iron balance and avoids liver toxicity, while decreasing associated drug administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response to erythropoiesis-stimulating agents (ESA), thereby decreasing the ESA doses needed to maintain hemoglobin in the target range. Rockwell Medical has licensed exclusive world-wide rights to manufacture and sell SFP and patents have issued for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan, and the European Union. Based on current market data, the U.S. dialysis market for IV iron is approximately $560 million annually while global market potential is approximately $850 million.
About Rockwell Medical:
Rockwell Medical is a fully-integrated biopharmaceutical company offering innovative products and services initially targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia. An established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad, Rockwell provides products that are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Dialysis is a process that duplicates kidney function for patients who suffer from ESRD. There are approximately 400,000 ESRD patients in the United States, a prevalence growing at an annual rate of 4 percent, and approximately 2 million ESRD patients world-wide.
The Company is currently developing unique, proprietary renal drug therapies for iron treatment. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed 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 SFP for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information.
The Rockwell Medical Technologies, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6773
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company 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 the 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.
ROCKWELL MEDICAL TECHNOLOGIES, INC.
CONSOLIDATED INCOME STATEMENTS
For the three and nine months ended September 30, 2009 and
September 30, 2008
(Unaudited)
Three Months Three Months Nine Months Nine Months
Ended Ended Ended Ended
Sept. 30, Sept. 30, Sept. 30, Sept. 30,
2009 2008 2009 2008
----------- ----------- ----------- -----------
Sales $14,158,234 $13,533,986 $39,968,018 $38,128,359
Cost of Sales 11,751,499 12,893,377 34,508,410 35,798,671
----------- ----------- ----------- -----------
Gross Profit 2,406,735 640,609 5,459,608 2,329,688
Selling, General
and
Administrative 1,946,570 2,176,188 5,078,073 4,785,675
Research and
Product
Development 1,977,618 993,262 5,312,499 2,557,718
----------- ----------- ----------- -----------
Operating (Loss) (1,517,453) (2,528,841) (4,930,964) (5,013,705)
Interest Expense
(Income), Net 3,990 (17,795) 20,493 (182,482)
----------- ----------- ----------- -----------
Net (Loss) $(1,521,443) $(2,511,046) $(4,951,457) $(4,831,223)
=========== =========== =========== ===========
Basic Earnings
(Loss) per Share ($0.11) ($0.18) ($0.35) ($0.35)
Diluted Earnings
(Loss) per Share ($0.11) ($0.18) ($0.35) ($0.35)
Note:
The Company reclassified specific quality assurance and operations management expenses totaling $138,000 to "cost of sales" from "selling, general and administrative expense" for the third quarter of 2008 and $398,000 for the first nine months of 2008 to maintain comparability of prior year results with the current year presentation.
ROCKWELL MEDICAL TECHNOLOGIES, INC.
CONSOLIDATED BALANCE SHEETS
As of September 30, 2009 and December 31, 2008
September 30, December 31,
ASSETS 2009 2008
(Unaudited)
------------ ------------
Cash and Cash Equivalents $ 2,767,950 $ 5,596,645
Accounts Receivable, net of a reserve of
$55,000 in 2009 and $97,000 in 2008 5,086,207 5,229,656
Inventory 2,674,569 3,161,625
Other Current Assets 520,583 440,765
------------ ------------
Total Current Assets 11,049,309 14,428,691
Property and Equipment, net 3,491,495 3,249,003
Intangible Assets 229,991 240,656
Goodwill 920,745 920,745
Other Non-current Assets 147,820 120,887
------------ ------------
Total Assets $ 15,839,360 $ 18,959,982
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LIABILITIES AND SHAREHOLDERS' EQUITY
Notes Payable & Capitalized Lease
Obligations $ 68,594 $ 176,850
Accounts Payable 4,219,095 5,210,972
Accrued Liabilities 1,804,868 1,464,828
Customer Deposits 923,086 245,186
------------ ------------
Total Current Liabilities 7,015,643 7,097,836
Long Term Notes Payable & Capitalized
Lease Obligations 26,464 41,203
Shareholders' Equity:
Common Shares, no par value,
14,220,410 and 14,104,690 shares issued
and outstanding 36,378,500 34,799,093
Common Share Purchase Warrants,
2,154,169 and 2,114,169 warrants
issued and outstanding 3,726,758 3,378,398
Accumulated Deficit (31,308,005) (26,356,548)
------------ ------------
Total Shareholders' Equity 8,797,253 11,820,943
------------ ------------
Total Liabilities And Shareholders'
Equity $ 15,839,360 $ 18,959,982
============ ============