Rockwell Medical Reports Fourth Quarter and Full Year 2010 Results
2010 Gross Profit up
Conference call at
Fourth Quarter Financial Highlights
$14.3 million, a 3% decrease compared to the fourth quarter of 2009.
- Gross profit margin increased to 16.6%, compared to gross profit margin of 16.4% in the fourth quarter of 2009.
R&D expense was
$1.7 million, compared to $1.1 millionin the fourth quarter 2009.
Net loss of
($1.7) million, compared to a net loss of ($0.5) millionin the fourth quarter 2009.
2010 Financial Highlights
$59.6 million, an increase of $4.8 millionor 8.8%, compared to 2009.
- Gross profit margins were 16.6%, an increase of 2.2 percentage points compared to gross profit margin of 14.4% in 2009.
Gross profit increased
$2 millionor 25% to $9.9 millioncompared to $7.9 millionin 2009.
R&D expense was
$3.4 millioncompared to $6.5 millionin 2009.
Net loss of
($2.7) million, compared to a net loss of ($5.5) millionin 2009.
Net loss includes non-cash equity compensation charges of
$ 4.0 million.
Year-end cash position of
- Commenced patient screening for Phase III CRUISE clinical trials.
Submitted Phase III study protocol to
FDAand completed site feasibility study.
Confirmed acceptable Phase III primary efficacy endpoint with
- Commenced patient enrollment for ESA-sparing PRIME study.
- Presented new ESA sparing and iron repletion data at ASN 2010.
- Received U.S. patent for proprietary SFP formula extending intellectual property protection to 2029.
Ajay Singhand Dr. Ian Macdougallto Scientific Advisory Board.
- Hired VP of Business Development/Investor Relations.
Conference Call Information:
About CRUISE Phase III Trials:
Rockwell is conducting two pivotal Phase III clinical trials for SFP. Each study is a prospective, randomized, double-blinded, placebo-controlled, multicenter study to demonstrate efficacy and safety of SFP-iron, delivered via dialysate in adult CKD patients requiring hemodialysis. Each study will comprise 300 patients, randomized equally between SFP and placebo groups over a period of up to 12 months.
SFP is a novel, investigational, continuous iron therapy in late-stage clinical development, designed to treat iron deficiency anemia in ESRD patients. In contrast to intravenous (IV) iron delivery, SFP is a proprietary, water-soluble iron that travels to the bloodstream and binds directly to apo-transferrin and then travels to bone marrow to assist in forming a healthy red blood cell, similar to normal physiologic dietary iron intake. SFP is a continuous iron replacement treatment, delivering small doses of iron during every dialysis session, to replenish the 5-7mg of iron lost during the dialysis procedure, thereby maintaining hemoglobin in the target range as per Kidney Disease Quality Outcomes Initiative (KDQOI) recommendations. Clinical trial data to date suggests that SFP, delivered via dialysate during each dialysis treatment, maintains optimal iron balance and avoids liver
toxicity while decreasing associated drug administration costs. Academic studies have shown that more frequent maintenance doses of iron improve therapeutic response to erythropoiesis-stimulating agents (ESA's), thereby decreasing the ESA doses needed to maintain hemoglobin in the target range. Rockwell has licensed exclusive world-wide rights to manufacture and sell SFP and has obtained patent protection for SFP in multiple countries, including the three largest dialysis markets in the world: the
For a demonstration of SFP's unique mechanism of action, please view the animation video at http://www.rockwellmed.com/collateral/documents/english-us/mode-of-action.html.
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.
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," "project," "plan", "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
|ROCKWELL MEDICAL TECHNOLOGIES, INC.|
|CONSOLIDATED INCOME STATEMENTS|
|For the three and twelve months ended December 31, 2010 and December 31, 2009|
|Three Months||Three Months||Year Ended||Year Ended|
December 31, 2010
December 31, 2009
|Sales||$ 14,322,514||$ 14,761,487||$ 59,554,592||$ 54,729,505|
|Cost of Sales||11,947,062||12,333,924||49,693,753||46,842,334|
|Selling, General and Administrative||2,460,015||1,836,125||9,307,621||6,914,198|
|Research and Product Development||1,735,468||1,141,853||3,422,134||6,454,352|
|Operating Income (Loss)||(1,820,031)||(550,415)||(2,868,916)||(5,481,379)|
|Interest and Dividend Income||157,577||5,320||195,218||5,320|
|Interest (Income) Expense, net||825||4,686||9,701||25,179|
|(Loss) Before Income Taxes||(1,663,279)||(549,781)||(2,683,399)||(5,501,238)|
|Income Tax Expense||--||--||--||--|
|Net Income (Loss)||$ (1,663,279)||$ (549,781)||$ (2,683,399)||$ (5,501,238)|
|Basic Earnings (Loss) per Share||$ (0.10)||$ (0.03)||$ (0.16)||$ (0.37)|
|Diluted Earnings (Loss) per Share||$ (0.10)||$ (0.03)||$ (0.16)||$ (0.37)|
|ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY|
|CONSOLIDATED BALANCE SHEETS|
|As of December 31, 2010 and 2009|
|Cash and Cash Equivalents||$ 12,263,449||$ 23,038,095|
|Investments Available for Sale||11,938,098||--|
|Accounts Receivable, net of a reserve of $23,000 in 2010 and $31,000 in 2009||4,507,296||3,492,622|
|Other Current Assets||1,020,647||329,876|
|Total Current Assets||32,666,368||29,948,945|
|Property and Equipment, net||3,049,513||3,631,549|
|Other Non-current Assets||163,624||163,645|
|Total Assets||$ 36,966,907||$ 34,879,221|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Capitalized Lease Obligations||$ 18,215||$ 42,938|
|Total Current Liabilities||6,420,220||5,536,957|
|Capitalized Lease Obligations||8,750||19,062|
|Common Shares, no par value, 17,513,608 and 17,200,442 shares issued and outstanding||57,017,236||53,545,394|
|Common Share Purchase Warrants, 3,338,569 and 3,318,569 warrants issued and outstanding||8,275,509||7,635,594|
|Accumulated Other Comprehensive Loss||(213,623)||--|
|Total Shareholders' Equity||30,537,937||29,323,202|
|Total Liabilities And Shareholders' Equity||$ 36,966,907||$ 34,879,221|
|ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY|
|CONSOLIDATED STATEMENTS OF CASH FLOWS|
|For the years ended December 31, 2010 and 2009|
|Cash Flows From Operating Activities:|
|Net (Loss)||$ (2,683,399)||$ (5,501,238)|
|Adjustments To Reconcile Net Loss To Net Cash Used In|
|Depreciation and Amortization||1,389,152||1,233,706|
|Share Based Compensation — Non-employee warrants||639,915||403,203|
|Share Based Compensation- Employees||3,381,394||1,949,684|
|Loss on Disposal of Assets||19,816||36,415|
|Changes in Assets and Liabilities:|
|(Increase) Decrease in Accounts Receivable||(1,014,674)||1,737,034|
|(Increase) Decrease in Inventory||151,474||73,273|
|(Increase) Decrease in Other Assets||(690,750)||68,131|
|Increase (Decrease)in Accounts Payable||270,750||(1,822,215)|
|Increase in Other Liabilities||637,236||395,248|
|Changes in Assets and Liabilities||(645,964)||451,471|
|Cash Provided By (Used) In Operating Activities||2,100,914||(1,426,759)|
|Cash Flows From Investing Activities:|
|Purchase of Investments Available for Sale||(12,151,721)||--|
|Purchase of Equipment||(772,364)||(1,595,999)|
|Proceeds on Sale of Assets||1,800||--|
|Purchase of Intangible Assets||--||(4,949)|
|Cash (Used) In Investing Activities||(12,922,285)||(1,600,948)|
|Cash Flows From Financing Activities:|
|Proceeds from Issuance of Common Shares and Purchase Warrants||90,448||20,650,610|
|Payments on Notes Payable and Capital Lease Obligations||(43,723)||(181,453)|
|Cash Provided By Financing Activities||46,725||20,469,157|
|Increase (Decrease) In Cash||(10,774,646)||17,441,450|
|Cash At Beginning Of Period||23,038,095||5,596,645|
|Cash At End Of Period||$ 12,263,449||$ 23,038,095|
Carl Belczynski, VP Investor Relations Rockwell Medical(248) 960-9009 Brian Korb, VP The Trout Group LLC(646) 378-2923
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