Rockwell Medical Reports Third Quarter Results

WIXOM, Mich., Nov. 07, 2016 (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 third quarter of 2016.

Q3 2016 Financial Highlights
  • Sales were $12.8 million, or $1.6 million lower than Q3 2015, primarily due to lower contract manufacturing sales.
  • Gross profit was $1.6 million compared to $2.5 million in Q3 2015, due to lower contract manufacturing revenue and due to an increase in manufacturing and costs related to our drug products.   
  • SG&A expense was $5.1 million compared $3.8 million in Q3 2015.
  • R&D expense was $1.3 million and at the same level as in Q3 2015.
  • Net loss was $4.5 million or ($0.09) per share compared to a $2.4 million loss or ($0.05) per share in Q3 2015.
  • Net loss in Q3 was lower sequentially by $0.8 million compared to Q2 2016 due to lower R&D expenses.
  • Cash and investments were $57.7 million as of September 30, 2016.
  • Net working capital was $72.5 million as of September 30, 2016.

YTD 2016 Financial Highlights
  • Sales were $39.9 million, compared to $41.2 million in the first nine months of 2015.
  • Gross profit was $4.8 million compared to $6.9 million in the first nine months of 2015.
  • Gross profit was impacted by higher drug manufacturing costs, a value add tax paid on the $4.0 million payment received from Wanbang Biopharma and lower third party contract manufacturing revenue.
  • SG&A expense was $15.1 million compared $13.0 million in the first nine months of 2015.
  • R&D expense was $4.6 million compared to $2.9 million in the first nine months of 2015.
  • Net loss was $14.7 million or ($0.29) per share versus $8.7 million or ($0.17) per share in 2015.

YTD Corporate Highlights
  • Triferic Phase-1 Healthy Volunteer Intravenous (IV) Pharmacokinetic Study published in the September 2016 edition of the Journal of Clinical Pharmacology.
  • Entered into license agreement with ARAM Medical to market Triferic in Saudi Arabia and other middle eastern countries.
  • Received FDA approval to market Triferic powder packet.
  • Partnered with Wanbang Biopharma to commercialize Triferic and Calcitriol in the People's Republic of China, receiving up to $39 million in milestone payments and ongoing profit on commercial product sales in China.

Mr. Robert L. Chioini, Chairman and Chief Executive Officer of Rockwell stated, "We continue to make solid progress in our efforts to obtain transitional add-on reimbursement for Triferic. We believe we are moving closer to our goal of securing it. Multiple stakeholders have aided us and support add-on reimbursement for Triferic. Concurrently, we have been educating our customers and patients about Triferic and its unique benefits. We also have advanced Triferic clinical development work for the renal application outside the U.S. as well as additional therapeutic indications. Overall, we are pleased with our progress, which includes ensuring we have redundancy in our manufacturing and supply capability."

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