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Rockwell Medical Reports Third Quarter 2013 Results

– Successful Triferic Phase 3 Clinical Results Highlight Quarter –

- Conference Call 4:15pm Eastern Time -

WIXOM, Mich., Nov. 5, 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 third quarter of 2013.

Q3 2013 Highlights

  • Sales were $13.1 million, a 3.2% increase over Q3 2012.
  • Gross profit was $1.6 million, equivalent to Q3 2012.
  • R&D expense was $10.6 million, a reduction of 35% compared to $16.2 million in Q3 2012.
  • Cash and investments of $31.2 million as of September 30, 2013.

Drug Development Highlights

  • Phase 3 CRUISE-2 clinical study for investigational iron replacement drug Triferic met primary and key secondary endpoints, achieved statistical significance and delivered excellent safety results.
  • Phase 3 CRUISE-1 and CRUISE-2 clinical studies achieved identical positive efficacy results, demonstrating effective iron delivery to the bone marrow while maintaining hemoglobin.
  • Phase 3 CRUISE-1 and CRUISE-2 clinical studies demonstrated clean safety profile with over 100,000 accumulated administrations to date without a single acute safety signal or anaphylactic reaction.
  • Triferic accepted as brand name for marketing upon FDA approval.
  • (4) Triferic poster presentations and (1) oral presentation demonstrating clinical study results are accepted for presentation at the American Society of Nephrology (ASN) Annual Meeting, November 7-9, 2013.
  • Triferic selected to be showcased at the ASN Kidney Week "Innovators Place" which highlights innovative investigational drugs and devices to the nephrology community.

For the quarter, Rockwell reported a loss of ($13.2) million or ($0.34) per share compared to ($17.9) million or ($0.86) per share in the third quarter of 2012. Non-cash charges for equity compensation were $1.9 million.

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