EXHIBIT 99.1
Rockwell Medical Reports Record Second Quarter Results
- Revenues Increase 19.2 %; Gross Profit Increases 49% -
- Conference Call at 8:30am ET to Discuss Results and Review Clinical Development -
WIXOM, Mich., Aug. 5, 2010 (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 second quarter 2010 results today.
Second Quarter Financial Highlights
- Sales increased to $15.5 million, up 19.2% compared to the second quarter of 2009.
- Gross profit increased to $2.8 million, up 49% or $0.9 million compared to the second quarter of 2009.
- Gross profit margins increased to 17.9%, compared to 14.3% in the second quarter of 2009.
- R&D expense was $0.4 million, compared to $2.0 million in the second quarter of 2009.
- Net income was $.01 per share, compared to a loss of ($.12) per share in the second quarter of 2009.
- Net income was $0.1 million, compared to a loss of ($1.7) million in the second quarter of 2009.
First Half 2010 Financial Highlights
- Sales increased to $30.5 million, up 18.1% compared to the first half of 2009.
- Gross profit increased to $5.1 million, up 67% or $2 million compared to the first half of 2009.
- Gross profit margins increased to 16.7%, compared to 11.8% in the first half of 2009.
- R&D expense was $1.0 million, compared to $3.3 million in the first half of 2009.
- Net loss was ($.02) per share, compared to a loss of ($.25) per share in the first half of 2009.
- Net loss was ($0.3) million, compared to a loss of ($3.4) million in the first half of 2009.
- Cash and cash equivalents were $24.2 million at June 30, 2010, an increase of $1.2 million from December 31, 2009.
Second Quarter Drug Development and Corporate Progress
- Successfully completed End of Phase II meeting with the FDA; confirmed approvable Phase III primary endpoint.
- Presented SFP Phase IIb study data at European Dialysis Conference.
- Appointed Dr. Ajay Singh to Scientific Advisory Board.
"We are pleased with our strong second quarter earnings, reflecting our best quarterly results to date. Our performance was in line with our expectations and we expect that our operating business will continue to generate cash to support the funding of our Phase III clinical development," stated Mr. Robert L. Chioini, Chairman and CEO of Rockwell. "From our recent End of Phase II meeting with the FDA, we confirmed a change in hemoglobin as an approvable primary efficacy endpoint for our Phase III study design. We intend to use a primary efficacy endpoint in the Phase III study that is identical to a secondary efficacy endpoint we had in our Phase IIb study, which achieved a statistically significant p-value, demonstrating an excess of 0.5 g/dL difference in hemoglobin between placebo and the SFP 10 ug/dl dose group." Mr. Chioini further stated, "Our regulatory path for SFP is now clear and we expect to submit our Phase III protocol design to the FDA shortly. We remain on track to st art the pivotal Phase III program later this year."
Conference Call Information:
Rockwell Medical will be hosting a conference call to review its 2010 second quarter results on Thursday, August 5, 2010 at 8:30am ET. Investors are encouraged to call in a few minutes in advance at (877) 383-7438. International participants can call in at (678) 894-3975. To listen to the call on the web or to the call replay, investors can visit: http://ir.rockwellmed.com/.
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 need ed 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 $1 billion.
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," "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'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 ne w information, future events or otherwise, except as required by law.
ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED INCOME STATEMENTS
For the three and six months ended June 30, 2010 and June 30, 2009
(Unaudited)
|
| | Three Months
Ended | Three Months
Ended | Six Months
Ended | Six Months
Ended |
| | June 30, 2010 | June 30, 2009 | June 30, 2010 | June 30, 2009 |
| Sales | $ 15,506,712 | $ 13,013,012 | $ 30,486,664 | $ 25,809,784 |
| Cost of Sales | 12,735,047 | 11,153,086 | 25,401,470 | 22,756,911 |
| Gross Profit | 2,771,665 | 1,859,926 | 5,085,194 | 3,052,873 |
| Selling, General and Administrative | 2,221,336 | 1,570,688 | 4,416,239 | 3,131,503 |
| Research and Product Development | 441,273 | 1,996,571 | 958,688 | 3,334,881 |
| Operating Income (Loss) | 109,056 | (1,707,333) | (289,733) | (3,413,511) |
| Interest Expense (Income), Net | (7,861) | 7,238 | (12,970) | 16,503 |
| Net Income (Loss) | $ 116,917 | $(1,714,571) | $(276,763) | $(3,430,014) |
| | | | | |
| Basic Earnings (Loss) per Share | $ 0.01 | ($ 0.12) | ($ 0.02) | ($ 0.25) |
| | | | | |
| Diluted Earnings (Loss) per Share | $ 0.01 | ($ 0.12) | ($ 0.02) | ($ 0.25) |
| | | |
ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED BALANCE SHEETS
As of June 30, 2010 and December 31, 2009
| | |
ASSETS | June 30,
2010 | December 31,
2009 |
| | (unaudited) | |
| Cash and Cash Equivalents | $ 24,199,534 | $ 23,038,095 |
| Accounts Receivable, net of a reserve of $30,000 in 2010 and $31,000 in 2009 | 4,598,332 | 3,492,622 |
| Inventory | 2,863,461 | 3,088,352 |
| Other Current Assets | 451,158 | 329,876 |
| Total Current Assets | 32,112,485 | 29,948,945 |
| | | |
| Property and Equipment, net | 3,431,426 | 3,631,549 |
| Intangible Assets | 198,521 | 214,337 |
| Goodwill | 920,745 | 920,745 |
| Other Non-current Assets | 163,706 | 163,645 |
| Total Assets | $ 36,826,883 | $ 34,879,221 |
| | | |
LIABILITIES AND SHAREHOLDERS' EQUITY
| | |
| Capitalized Lease Obligations | $ 27,280 | $ 42,938 |
| Accounts Payable | 3,441,891 | 3,388,757 |
| Accrued Liabilities | 1,831,253 | 1,854,347 |
| Customer Deposits | 630,448 | 250,915 |
| Total Current Liabilities | 5,930,872 | 5,536,957 |
| | | |
| Capitalized Lease Obligations | 9,365 | 19,062 |
| | | |
| Shareholders' Equity: | | |
| Common Shares, no par value, 17,202,108 and 17,200,442 shares issued and outstanding |
55,062,172 |
53,545,394 |
| Common Share Purchase Warrants, 3,328,569 and 3,318,569 warrants issued and outstanding |
7,959,023 |
7,635,594 |
| Accumulated Deficit | (32,134,549) | (31,857,786) |
| Total Shareholders' Equity | 30,886,646 | 29,323,202 |
| | | |
| Total Liabilities and Shareholders' Equity | $ 36,826,883 | $ 34,879,221 |
| | | |
ROCKWELL MEDICAL TECHNOLOGIES, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the six months ended June 30, 2010 and June 30, 2009
(Unaudited)
| | |
| | 2010 | 2009 |
| | | |
| Cash Flows From Operating Activities: | | |
| Net (Loss) | $ (276,763) | $ (3,430,014) |
| Adjustments To Reconcile Net Loss To Net Cash Used In | | |
| Operating Activities: | | |
| Depreciation and Amortization | 707,749 | 527,292 |
| Loss (Gain) on Disposal of Assets | 16,822 | (5,120) |
| Share Based Compensation – Non-employee Warrant | 323,429 | 256,362 |
| Share Based Compensation – Employees | 1,511,630 | 773,833 |
| | | |
| Changes in Assets and Liabilities: | | |
| (Increase)Decrease in Accounts Receivable | (1,105,710) | 484,707 |
| Decrease in Inventory | 224,891 | 348,313 |
| (Increase) Decrease in Other Assets | (121,343) | 4,898 |
| Increase (Decrease) in Accounts Payable | 53,134 | (191,036) |
| Increase (Decrease) in Other Liabilities | 356,439 | (492,749) |
| Changes in Assets and Liabilities | (592,589) | 154,133 |
| Cash Provided by (Used) In Operating Activities | 1,690,278 | (1,723,514) |
| | | |
| Cash Flows From Investing Activities: | | |
| Purchase of Equipment | (509,432) | (589,008) |
| Proceeds on Sale of Assets | 800 | 5,120 |
| Purchase of Intangible Assets | -- | (10,257) |
| Cash (Used ) In Investing Activities | (508,632) | (594,145) |
| | | |
| Cash Flows From Financing Activities: | | |
| Issuance of Common Shares and Purchase Warrants | 5,148 | 140,502 |
| Payments on Notes Payable | (25,355) | (84,030) |
| Cash Provided (Used) By Financing Activities | (20,207) | 56,472 |
| | | |
| Increase (Decrease) In Cash and Cash Equivalents | 1,161,439 | (2,261,187) |
| Cash and Cash Equivalents at Beginning of Period | 23,038,095 | 5,596,645 |
| Cash and Cash Equivalents at End of Period | $ 24,199,534 | $ 3,335,458 |
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