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 first quarter of 2016.

Q1 2016 Financial Highlights

  • Sales were $13.6 million, compared to $13.9 million in Q1 2015, or 1.9% less than Q1 2015.
  • Dialysis concentrate sales increased $0.2 million while contract manufacturing sales decreased $0.5 million.
  • Gross profit was $1.7 million compared to $2.3 million in Q1 2015.
    • Gross profit was impacted by a one-time $0.3 million value add tax related to the Wanbang Triferic license agreement payment of $4 million.
  • SG&A expense was $5.0 million compared $5.3 million in Q1 2015.
  • R&D expense was $1.3 million compared to $0.8 million in Q1 2015.
  • Income tax expense was $0.4 million, related to the $4 million Wanbang license payment.
  • Net loss was ($4.8) million or ($0.10) per share compared to ($3.7) million or ($0.07) per share in Q1 2015.
    • Net loss was impacted by a one-time $0.7 million charge related to the Wanbang Triferic license agreement payment of $4 million.
  • Cash and investments were $69.4 million as of March 31, 2016.

2016 YTD Corporate Highlights

  • Received FDA approval to market Triferic® powder packet presentation, which is a more convenient package for customers that reduces storage space and requires fewer reorders to maintain inventory.
  • Signed exclusive license and manufacturing supply agreement with Wanbang Biopharma for the rights to commercialize Triferic and Calcitriol in the People’s Republic of China. The agreement calls for up to $39 million in milestone payments and ongoing profit on commercial product sales following drug approval in China.

Mr. Robert L. Chioini, Chairman and Chief Executive Officer of Rockwell, stated, “We completed two key objectives in our growth strategy during the first few months of 2016. We secured our first major international partnership, signing a license and supply agreement for the rights to commercialize Triferic and Calcitriol in the People’s Republic of China. We expect China will become the largest dialysis market in the world over the next several years. Also, we received our second FDA approval for Triferic, with the April approval of the Triferic powder packet. Gaining this approval is a significant advancement, and it will provide both production and distribution efficiencies for Triferic.”  Mr. Chioini further stated, “We continue to make solid progress on our marketing and reimbursement initiatives with Triferic. This spring we have exhibited at several conferences and as expected there has been high interest in Triferic across the spectrum of stakeholders. We also continue to make progress to obtain transitional add-on reimbursement for Triferic, which we believe will provide a positive catalyst for providers in adopting Triferic as it will offset their cost of conversion to an innovative therapy that benefits their patients.” (Original Source)

Shares of Rockwell Medical closed today at $7.32, up $0.26 or 3.68%. RMTI has a 1-year high of $18.90 and a 1-year low of $5.47. The stock’s 50-day moving average is $7.91 and its 200-day moving average is $8.67.

On the ratings front, Rockwell has been the subject of a number of recent research reports. In a report issued on April 6, Morgan Stanley analyst Andrew Berens reiterated a Sell rating on RMTI, with a price target of $3, which reflects a potential downside of -57.2% from last closing price. Separately, on March 1, Stifel Nicolaus’ Annabel Samimy downgraded the stock to Hold .

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Andrew Berens and Annabel Samimy have a total average return of 16.0% and 11.6% respectively. Berens has a success rate of 67.6% and is ranked #308 out of 3828 analysts, while Samimy has a success rate of 56.3% and is ranked #322.

Rockwell Medical, Inc. is a biopharmaceutical company, which engages in the targeting of end-stage renal disease and chronic kidney disease and manufactures innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis. Its dialysis products include Triferic, Calcitriol Vitamin D Injection, Hemodialysis Concentrates, CitraPure, Dri-Sate, and ancillary products. The company was founded by Robert L. Chioini in January 1995 and is headquartered in Wixom, MI.