WIXOM, Mich.—Rockwell Medical announced its results for the third quarter ended September 30
Third Quarter Financial Highlights
- Sales were $12.7 million, increasing 6 percent compared to third quarter 2011.
- Sales increased 4.7 percent sequentially, $0.6 million above second quarter 2012.
- Gross profit increased 19.6 percent or $0.3 million over third quarter of 2011.
- Gross profit margins increased to 13.0 percent compared to 11.5 percent in third quarter of 2011.
- SG&A increased by $1.0 million.
- R&D expense was $16.2 million due to accelerated Phase III clinical development, compared to $4.2 million in third quarter of 2011.
- Net loss was ($17.9) million compared to ($5.0) million in third quarter of 2011 primarily due to higher R&D expense.
- Cash and investments aggregated $11.3 million as of September 30, 2012.
Nine Month Financial Highlights
- Sales were $36.8 million compared to $37.1 million in the first nine months of 2011.
- Gross profit margins increased 2.5 percentage points to 13.5 percent, compared to 11.1 percent in the first nine months of 2011.
- Gross profit dollars increased 21.8 percent or $0.9 million compared to the first nine months of 2011.
- SG&A was $2.2 million, due mainly to higher non-cash charges for equity compensation.
- R&D expense was $36.5 million compared to $9.9 million in the first nine months of 2011, due to the cost of Phase III clinical trial development for the Company’s lead drug candidate SFP.
- Net loss was ($40.3) million compared to ($12.5) million in first nine months of 2011, due to higher R&D expense.
2012 Drug Development Highlights
- Phase 3 CRUISE efficacy studies completed enrollment mid-year.
- PRIME study designed to capture ESA-sparing data completed enrollment in the first quarter.
- Data Safety Monitoring Board recommended continuation of CRUISE studies with no modifications after 3rd independent review.
- Manufacturing transfer work for Calcitriol (vitamin-D) substantially completed.
- Raymond D. Pratt, MD, hired as Chief Medical Officer.
“In the third quarter we achieved strong operating performance and continued to make progress in areas that are important to our long term strategic plan," Robert L. Chioini, chairman and CEO said. "From an operating perspective, sales and gross profit increased nicely, and we expect that trend to continue. From a clinical development perspective, we continue to move toward completion of our SFP clinical program, including faster than anticipated enrollment in our required long-term safety study. We are a few months from viewing ESA sparing data from our PRIME study and our clinical and regulatory team are diligently working towards our NDA submission for later next year, following what we anticipate to be the successful completion of our Phase 3 efficacy studies. We are also progressing well toward commercial launch of our Calcitriol vitamin-D injection.”