Rockwell Medical Reports Third Quarter Results
Third Quarter Financial Highlights
- Sales increased to
$14.7 million, up 4.1% compared to the third quarter of 2009. - Gross profit was
$2.4 million; unchanged from the third quarter of 2009. - R&D expense was
$0.7 million, compared to $2.0 million in the third quarter of 2009. - Net loss was
($0.7) million, compared to a net loss of ($1.5) million in the third quarter of 2009. - Net loss was
($.04) per share, compared to a net loss of ($.11) per share in the third quarter of 2009.
First Nine Months 2010 Financial Highlights
- Sales increased to
$45.2 million, up 13.2% or $5.3 million compared to the first nine months of 2009. - Gross profit increased to
$7.5 million, up 37% or $2.0 million compared to the first nine months of 2009. - Gross profit margins increased to 16.5%, compared to 13.7% in the first nine months of 2009.
- R&D expense was
$1.7 million, compared to $5.3 million in the first nine months of 2009. - Net loss was
($.06) per share, compared to a loss of ($.35) per share in the first nine months of 2009. - Net loss was
($1.0) million, compared to a loss of ($5.0) million in the first nine months of 2009. - Cash and cash equivalents were
$23.7 million at September 30, 2010, an increase of $0.6 million from December 31, 2009.
Third Quarter SFP Drug Development and Corporate Progress
- Confirmed approvable Phase III primary efficacy endpoint with the
FDA. - Finalized Phase III trial design with
FDA. - Received U.S. patent for SFP proprietary GMP formula.
- Appointed Dr.
Ian Macdougall to the Scientific Advisory Board.
Mr.
Conference Call Information:
About SFP:
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.
About
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
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. AND SUBSIDIARY | ||||
| CONSOLIDATED INCOME STATEMENTS | ||||
| For the three and nine months ended September 30, 2010 and September 30, 2009 | ||||
| (Unaudited) | ||||
| Three Months Ended | Three Months Ended | Nine Months Ended | Nine Months Ended | |
| Sept. 30, 2010 | Sept. 30, 2009 | Sept. 30, 2010 | Sept. 30, 2009 | |
| Sales | $ 14,745,414 | $ 14,158,234 | $ 45,232,078 | $ 39,968,018 |
| Cost of Sales | 12,345,221 | 11,751,499 | 37,746,691 | 34,508,410 |
| Gross Profit | 2,400,193 | 2,406,735 | 7,485,387 | 5,459,608 |
| Selling, General and Administrative | 2,431,367 | 1,946,570 | 6,847,606 | 5,078,073 |
| Research and Product Development | 727,978 | 1,977,618 | 1,686,666 | 5,312,499 |
| Operating Income (Loss) | (759,152) | (1,517,453) | (1,048,885) | (4,930,964) |
| Interest Expense (Income), Net | (15,795) | 3,990 | (28,765) | 20,493 |
| Net Income (Loss) | $ (743,357) | $ (1,521,443) | $ (1,020,120) | $ (4,951,457) |
| Basic Earnings (Loss) per Share | ($ 0.04) | ($ 0.11) | ($ 0.06) | ($ 0.35) |
| Diluted Earnings (Loss) per Share | ($ 0.04) | ($ 0.11) | ($ 0.06) | ($ 0.35) |
| ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY | ||
| CONSOLIDATED BALANCE SHEETS | ||
| As of September 30, 2010 and December 31, 2009 | ||
| ASSETS |
September 30, 2010 |
December 31, 2009 |
| (unaudited) | ||
| Cash and Cash Equivalents | $ 23,657,128 | $ 23,038,095 |
| Accounts Receivable, net of a reserve of $25,700 in 2010 and $31,000 in 2009 | 4,636,534 | 3,492,622 |
| Inventory | 2,534,644 | 3,088,352 |
| Other Current Assets | 844,141 | 329,876 |
| Total Current Assets | 31,672,447 | 29,948,945 |
| Property and Equipment, net | 3,272,869 | 3,631,549 |
| Intangible Assets | 190,613 | 214,337 |
| Goodwill | 920,745 | 920,745 |
| Other Non-current Assets | 163,624 | 163,645 |
| Total Assets | $ 36,220,298 | $ 34,879,221 |
| LIABILITIES AND SHAREHOLDERS' EQUITY |
||
| Capitalized Lease Obligations | $ 23,220 | $ 42,938 |
| Accounts Payable | 2,843,219 | 3,388,757 |
| Accrued Liabilities | 1,900,016 | 1,854,347 |
| Customer Deposits | 103,184 | 250,915 |
| Total Current Liabilities | 4,869,639 | 5,536,957 |
| Capitalized Lease Obligations | 11,740 | 19,062 |
| Shareholders' Equity: | ||
| Common Shares, no par value, 17,463,108 and 17,200,442 shares issued and outstanding | 55,993,030 | 53,545,394 |
| Common Share Purchase Warrants, 3,338,569 and 3,318,569 warrants issued and outstanding | 8,223,795 | 7,635,594 |
| Accumulated Deficit | (32,877,906) | (31,857,786) |
| Total Shareholders' Equity | 31,338,919 | 29,323,202 |
| Total Liabilities and Shareholders' Equity | $ 36,220,298 | $ 34,879,221 |
| ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY | ||
| CONSOLIDATED STATEMENTS OF CASH FLOWS | ||
| For the nine months ended September 30, 2010 and September 30, 2009 | ||
| (Unaudited) | ||
| For the nine months ended September 30, | ||
| 2010 | 2009 | |
| Cash Flows From Operating Activities: | ||
| Net (Loss) | $ (1,020,120) | $ (4,951,457) |
| Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities: | ||
| Depreciation and Amortization | 1,047,077 | 836,020 |
| Loss (Gain) on Disposal of Assets | 16,822 | 20,403 |
| Share Based Compensation — Non-employee Warrants | 588,201 | 348,360 |
| Share Based Compensation — Employees | 2,392,688 | 1,394,410 |
| Changes in Assets and Liabilities: | ||
| (Increase) Decrease in Accounts Receivable | (1,143,912) | 143,449 |
| Decrease in Inventory | 553,708 | 487,056 |
| (Increase) in Other Assets | (514,244) | (106,751) |
| (Decrease) in Accounts Payable | (545,538) | (991,877) |
| Increase (Decrease) in Other Liabilities | (102,062) | 1,017,940 |
| Changes in Assets and Liabilities | (1,752,048) | 549,817 |
| Cash Provided by (Used) In Operating Activities | 1,272,620 | (1,802,447) |
| Cash Flows From Investing Activities: | ||
| Purchase of Equipment | (682,295) | (1,080,495) |
| Proceeds on Sale of Assets | 800 | 5,120 |
| Purchase of Intangible Assets | (12,875) | |
| Cash (Used ) In Investing Activities | (681,495) | (1,088,250) |
| Cash Flows From Financing Activities: | ||
| Issuance of Common Shares and Purchase Warrants | 54,948 | 184,997 |
| Payments on Notes Payable | (27,040) | (122,995) |
| Cash Provided By Financing Activities | 27,908 | 62,002 |
| Increase (Decrease) In Cash and Cash Equivalents | 619,033 | (2,828,695) |
| Cash and Cash Equivalents at Beginning of Period | 23,038,095 | 5,596,645 |
| Cash and Cash Equivalents at End of Period | $ 23,657,128 | $ 2,767,950 |
CONTACT:Rockwell Medical Carl Belczynski, VP Investor Relations (248) 960-9009 The Trout Group LLC Brian Korb, VP (646) 378-2923 LaVoie Group Media Contact: Lisa Rivero, Director, Media Relations (978) 745-4200 ext. 106
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