Rockwell Medical reported that gross profit for the fourth quarter of 2015 fell 3.3% to $2.1 million, compared to the same quarter last year. Sales for the quarter reached $14.1 million, compared to $14.4 million in the fourth quarter of 2014. Total sales in 2015 were $55.4 million, a $1.2 million or 2.1% increase over 2014.
Triferic, which was commercially launched in September 2015, brought in $200,000 in revenue, and didn’t reach analyst expectations. Shares fell more than 27% in after-hours trading following an investor call Feb. 29. The company has a one-year high of $18.90 and a one-year low of $5.47.
Research and development expenses for the quarter were $2 million, compared to $1.7 million in the fourth quarter of 2014. Net loss was $5.8 million, or $0.12 per share, compared to $6.4 million or $0.14 per share in Q4 2014.
During an investor call, CEO Robert Chioini said the company has filed a new drug application with the U.S. Food and Drug Administration to package Triferic as a powder in a packet instead of having the active pharmaceutical ingredient packaged into a liquid solution in an ampoule.
Chioini also said they are in discussion with the Centers for Medicare & Medicaid Services to be granted a transitional add-on payment, which would place Triferic reimbursement outside of the bundle for a period of time. The drug is currently being reimbursed as part of the ESRD bundled payment.
In February, Rockwell signed exclusive licensing and manufacturing supply agreements with Wanbang Biopharmaceutical Co. Ltd for the rights to commercialize Rockwell’s Triferic and Calcitriol. Wanbang also has the exclusive right to develop and commercialize Triferic for new therapeutic indications for the Chinese market. Rockwell also filed an investigational new drug application to investigate Triferic as a potential treatment for patients with a rare anemia condition called iron-refractory, iron-deficiency anemia.