WIXOM, Mich., May 5, 2011 (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, today announced results for the first quarter ended March 31, 2011:
- Sales of $13.3 million and gross profit margin of 12.4% were down $1.7 million and 3 percentage points respectively from first quarter 2010, due mainly to fluctuations in international orders.
- International sales decreased $1.25 million compared to first quarter 2010, due primarily to lower purchase volumes from an international distributor.
- SG&A increased 2.4% compared to first quarter 2010.
- R&D expense increased to $2.4 million, compared to $0.5 million in first quarter 2010.
- Net loss was ($2.9) million, compared to a net loss of ($0.4) million in first quarter 2010.
- Cash and short term investments aggregated $20 million at March 31, 2011.
Drug Development Highlights
- Phase III CRUISE studies began patient enrollment.
- PRIME study, for ESA-sparing data, began patient enrollment
- Completed GMP manufacture and packaging of SFP drug.
Mr. Robert L. Chioini, Chairman and CEO stated, "Beginning enrollment in our Phase III CRUISE-1 and CRUISE-2 clinical studies is a significant milestone for Rockwell. Our study design and current progress gives us great confidence in a successful outcome. We believe the new bundled reimbursement system now in effect for dialysis providers is an ideal scenario for SFP adoption upon FDA market approval." Mr. Chioini further stated, "Our first quarter operating performance was impacted primarily by volatility in our international sales orders. Our primary focus remains on the development of SFP and its potential to address other unmet medical needs, which has the potential to add further shareholder value."
Conference Call Information:
Rockwell Medical will be hosting a conference call to review its 2011 first quarter results on Thursday, May 5, 2011 at 8:30 am ET. Investors are encouraged to call a few minutes in advance at (877) 383-7438 or to listen to the call on the web at:
About Phase III CRUISE Trials:
Rockwell is conducting two pivotal Phase III clinical trials for SFP. Each study is a prospective, randomized, 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.
Soluble Ferric Pyrophosphate (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 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.
For a demonstration of SFP's unique mechanism of action, please view the animation video at .
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. World-wide there are approximately 2 million ESRD patients, growing at an annual rate of 5-6 percent.
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 for more information.
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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 new information, future events or otherwise, except as required by law.
CONTACT: Carl Belczynski, VP Investor Relations Rockwell Medical (248) 960-9009 Brian Korb, VP The Trout Group LLC (646) 378-2923