updated 11/4/2010 7:45:53 AM ET 2010-11-04T11:45:53

YTD Gross Profit Increases 37%

Conference Call at 8:30am ET to Discuss Results and Review Clinical Development

WIXOM, Mich., Nov. 4, 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 third quarter 2010 results today.

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. Robert L. Chioini, Chairman and CEO stated, "We are pleased with our operating business which continues to perform well ahead of last year. The positive results we have realized through nine months give us solid momentum heading into 2011. Regarding our clinical progress, we have achieved notable milestones this past quarter and we are pleased to be proceeding forward into our Phase III program. We have concurred with the FDA on our protocol design and primary efficacy endpoint, and we are in the final stages of preparation to commence the CRUISE studies. We have great confidence in our Phase III program being successful."

Conference Call Information:

Rockwell Medical will be hosting a conference call to review its 2010 third quarter results on Thursday, November 4, 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 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 http://www.rockwellmed.com/collateral/documents/english-us/mode-of-action.html.

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 5-6 percent, while there are 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 new information, future events or otherwise, except as required by law.

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