-PRIME ESA-sparing Study Completed Enrollment-
-Sales Up 1.1% and Gross Profit Up 5.3% QoQ-
Report is Available for Download at: www.lifesciadvisors.com/clients/rockwell
Last Thursday, Rockwell Medical (NASDAQ: RMTI) issued a press release and held a conference call announcing first quarter earnings for 2012. During the second quarter, Rockwell completed patient enrollment (n=100) for the PRIME ESA-sparing study and also successfully completed an equity capital raise, which netted the Company $16.2MM, resulting in a current cash balance of $25.6MM.
PRIME ESA-sparing Study Completed Enrollment. One of the largest pieces of news released recently by Rockwell was that full enrollment (n=100) for the PRIME ESA-sparing trial was met. This news was announced on April 30, 2012. The primary objective of the study is to measure the ability for SFP-iron treatment via dialysate to reduce the requirement for ESA agents. The PRIME study is a nine month study with data expected in the first quarter of 2013. If an ESA-sparing benefit is observed with SFP, upon FDA approval this would deliver an additional important benefit to SFP adoption over other iron replacement drugs on the market in a cost-bundled dialysis environment,
CRUISE Studies to Complete Enrollment in 6-8 Weeks. Regarding the CRUISE-1/2 ongoing Phase 3 studies, the Company reported that they should complete enrollment over the next 6-8 weeks. During the second quarter, the CRUISE DSMB met for the second time and again recommended continuation with no modifications to protocol, which we view as very positive.
Calcitriol on Track for Launch by the End of the Year. The Company also reported that preparation for the newly acquired Calcitriol is on track and commercial launch is expected to occur by the end of the year. Calcitriol is expected to be materially accretive, with a potential $50MM in sales within the first two years of launch, while requiring minimal SG&A expense, thereby increasing Rockwell’s top line.