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- Successful Top Line Data from Phase 3 SFP Study Highlight Quarter -
- Conference Call at 4:15pm Eastern Time -
WIXOM, Mich., Aug. 1, 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 replacement, secondary hyperparathyroidism and hemodialysis, reported financial results for the second quarter of 2013.
Q2 2013 Highlights
Sales were $13.0 million, a 7.1% increase over Q2 2012.
Sales increased 5.3% sequentially from Q1 2013.
CitraPure ® product line highlighted increased sales growth.
Gross profit was equivalent to Q2 2012.
Multi-year contract with DaVita calls for increased business.
R&D cost was $10.2 million vs. $10.9 million in Q2 2012; down $2.5 million from Q1 2013.
Completed $57.7 million combined debt and equity financing.
Cash and investments of $41 million as of June 30, 2013.
Drug Development Highlights
SFP Phase 3 CRUISE-1 efficacy trial met primary and key secondary endpoints, achieved statistical significance and delivered excellent safety results.
CRUISE-2 trial results expected in September.
PRIME clinical data, demonstrating SFP significantly reduced ESA 35%, was presented at the ERA-EDTA in Istanbul, Turkey.
FDA-approved Calcitriol (active vitamin D) injection under FDA review for manufacturing approval.
For the quarter, Rockwell reported a loss of ($11.9) million or ($0.38) per share compared to ($11.9) million or ($0.58) per share in the second quarter of 2012. The lower loss per share was due to additional shares outstanding in 2013. Non-cash charges for equity compensation were $1.6 million.
For the six months ending June 30, 2013, Rockwell's loss was ($27.2) million or ($1.04) per share compared to ($22.5) million or ($1.12) per share in the first half of 2012. The lower loss per share was due additional shares outstanding in 2013. Non-cash charges for equity compensation and warrant revaluation expense were $3.9 million.