Rockwell Medical Reports Second Quarter 2012 Results
Clinical Development Accelerates; Gross Margins Improve
(firmenpresse) - WIXOM, MI -- (Marketwire) -- 08/07/12 -- Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, announced today its results for the second quarter ended June 30, 2012.
Sales were $12.1 million compared to $11.8 million in the second quarter 2011.
Gross profit increased $0.6 million or a 60% increase over the second quarter of 2011.
Gross profit margins increased 5.1 percentage points to 14.2% compared to 9.1% in the second quarter of 2011.
SG&A increased $0.5 million.
R&D expense increased to $10.9 million compared to $3.3 million in second quarter of 2011, due to accelerated Phase III clinical development.
Net loss was ($11.9) million compared to a net loss of ($4.5) million in second quarter of 2011, due to higher R&D expense.
Sales were $24.2 million compared to $25.1 million in the first half of 2011, due to lower sales to a single international distributor when comparing first quarter 2012 to first quarter 2011.
Gross profit margins improved 3.1 percentage points to 13.9% compared to 10.8% in the first half of 2011.
Gross profit dollars increased 23% or $0.6 million compared to the first half of 2011.
SG&A increased $1.1 million due mainly to higher non-cash charges for equity compensation.
R&D expense increased to $20.3 million compared to $5.7 million in the first half of 2011, due to the cost of Phase III clinical trial development of SFP.
Net loss was ($22.5) million compared to a net loss of ($7.5) million in first half of 2011, due to higher R&D expense.
Cash and cash equivalents aggregated $20.4 million as of June 30, 2012.
Phase III CRUISE efficacy studies have completed enrollment.
PRIME study designed to capture ESA-sparing data completed enrollment.
Data Safety Monitoring Board recommended continuation of CRUISE studies with no modifications after 3rd review.
Preparation for Calcitriol (vitamin-D) launch on track.
Raymond D. Pratt, MD, hired as Chief Medical Officer.
Mr. Robert L. Chioini, Chairman and CEO, stated, "We are pleased to report solid progress this past quarter, highlighted by the completion of enrollment in our Phase III CRUISE studies. We are approximately six months from seeing data on ESA sparing from the PRIME study, our Calcitriol product launch is expected to occur first quarter 2013, and we anticipate completion of the Phase III CRUISE studies mid-year 2013. In our operating business, second quarter operating performance was solid with sales, gross profit and gross profit margins increasing significantly over last year."
Rockwell Medical will be hosting a conference call to review its second quarter 2012 results on Tuesday, August 7, 2012 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:
Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis.
Rockwell's lead, late-stage investigational drug for iron therapy treatment is called Soluble Ferric Pyrophosphate (SFP). SFP delivers iron in a non-invasive, physiologic manner to dialysis patients via dialysate during their regular dialysis treatment. SFP is currently in ongoing Phase III clinical trials (CRUISE-1 and CRUISE-2) and addresses a $600M U.S. and $1B global market. Rockwell's Calcitriol (generic Active Vitamin D) injection for treating secondary hyperparathyroidism is expected to launch in Q1 2013 and addresses a $350M U.S. market.
Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. These products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Rockwell's operating infrastructure is a ready-made sales and distribution channel to provide seamless integration into the commercial market for its drug products, Calcitriol and SFP, upon FDA market approval.
Rockwell's exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended 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. For a demonstration of SFP's unique mechanism of action in delivering iron via dialysate, please view the animation video at .
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell's intention to launch Calcitriol and SFP following FDA approval. 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 Rockwell Medical 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:
Michael Rice
Investor Relations
(646) 597-6979
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Datum: 07.08.2012 - 11:30 Uhr
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