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- 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 start the pivotal Phase III program later this year."