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- Compelling PRIME Data, Calcitriol Manufacturing Submission Highlight Q1- - Company to expand business with DaVita via multi-year supply deal -
WIXOM, Mich., May 8, 2013 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (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, reported financial results for the first quarter of 2013.
Q1 2013 Highlights
Sales were $12.3 million, an increase of 2.6% over Q1 2012.
Domestic sales increased 5.5% over Q1 2012.
Gross profit decreased $300,000, primarily due to higher material and operational costs.
Cash and investments aggregated $5.8 million as of March 31, 2013.
Drug Development Highlights
Calcitriol (active vitamin D) injection data was submitted to FDA for manufacturing approval.
PRIME clinical data showing 35% ESA reduction to be presented at upcoming ERA-EDTA, Istanbul, Turkey.
CRUISE-1 top-line data projected Q3 2013; CRUISE-2 top-line data projected Q4 2013.
For the quarter, Rockwell reported a loss of ($15.4) million or ($0.72) per share compared to ($10.6) million or ($0.54) per share in the first quarter of 2012. R&D costs were $12.75 million compared to $9.4 million in the first quarter of 2012. Non-cash charges for equity compensation and warrant revaluation expense were $2.3 million.
"We achieved two very important clinical goals in Q1," stated Rob Chioini, Founder, Chairman and CEO of Rockwell Medical. "First, our SFP clinical data from the PRIME study was excellent, showing an impressive reduction in the need for ESA and supporting our belief that SFP will demonstrate efficacy in the Phase 3 CRUISE clinical studies. Second, we submitted our Calcitriol manufacturing data to the FDA, which was the last major step we needed to complete to be able to launch the drug commercially. Once we get approval confirmation from the FDA, we plan to offer Calcitriol to dialysis providers across the U.S. and we are optimistic that we will have success gaining sales."