WIXOM, Mich., Feb. 26, 2014 (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 results for the fourth quarter and year ended December 31, 2013.
Q4 2013 Highlights
- Sales were $14.0 million, a 7.4% increase over Q4 2012.
- Gross profit was $2.1 million, a 21% increase over Q4 2012.
- R&D expense was $5.8 million, a 51% decrease compared to $11.8 million in Q4 2012
- Cash was $23.9 million as of December 31, 2013.
- Sales were $52.4 million, a 5.1% increase over 2012.
- Gross profit was $6.7 million, about the same as 2012.
- R&D expense was $39.4 million, an 18.4% decrease compared to $48.3 million in 2012.
- Three, large-scale, long-term clinical studies for investigational iron replacement drug Triferic ® successfully met primary and key secondary endpoints.
- PRIME clinical marketing study results demonstrated significant 35% ESA reduction overall and 74.4% in hypo-responsive patients.
- CRUISE-1 and CRUISE-2 Phase 3 efficacy studies met primary and key secondary endpoints, achieved statistical significance, and delivered excellent safety results showing no acute safety signal or anaphylactic reaction in over 100,000 doses.
- Triferic ® accepted as brand name for marketing upon FDA approval.
- Multiple Triferic ® clinical study abstracts were presented at numerous kidney conferences, including the American Society of Nephrology (ASN) Annual Meeting, November 7-9, 2013.
- Calcitriol (active vitamin D injection) chemistry data submitted to FDA for manufacturing approval.