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Hyperion Therapeutics Announces Fourth Quarter And Full Year 2013 Financial Results

BRISBANE, Calif., Feb. 27, 2014 (GLOBE NEWSWIRE) -- Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today reported net revenue of $18.6 million and $42.2 million for the fourth quarter and full year 2013, respectively. Hyperion's revenues are for sales of its two products for the treatment of urea cycle disorders, RAVICTI ® (glycerol phenylbutyrate) Oral Liquid, launched on March 1, 2013 and BUPHENYL ® (sodium phenylbutyrate) Tablets and Powder acquired on May 31, 2013. Adjusted net income for the fourth quarter 2013 was $4.1 million compared to an adjusted net loss of $7.9 million in the fourth quarter of 2012, an increase in net income of $12.0 million. The company ended 2013 with cash, cash equivalents and investments of $118.1 million, an increase of $9.5 million from the prior quarter.

"2013 was a year with significant achievements on many fronts - clinical, regulatory and commercial - which resulted in our successful launch of RAVICTI, the acquisition and effective integration of BUPHENYL into our commercial operation, and the advancement of another program expected to enter Phase 3 clinical testing in late 2014 or by early 2015," said Donald J. Santel, president and chief executive officer of Hyperion. "The commercialization of RAVICTI and BUPHENYL are going well and it is our privilege and pleasure to help the historically underserved urea cycle disorder community."

2013 Accomplishments

  • Received FDA approval and launched RAVICTI, the first therapeutic alternative in 18 years for the chronic management of adult and pediatric patients with urea cycle disorders, or UCD, in patients two years and older.
  • Received orphan drug exclusivity for RAVICTI offering protection against generic drug approval for the UCD indication until 2020.
  • Obtained method of use patents that support claims in UCD until 2032.
  • Acquired worldwide rights to BUPHENYL, enabling the company to offer another treatment option to the UCD patient community.
  • Submitted to the FDA a package that outlined Hyperion's planned approach for measuring hepatic encephalopathy events in its planned pivotal clinical trial of glycerol phenylbutyrate.

Fourth Quarter 2013 Financial Results

Net income as measured under U.S. generally accepted accounting principles ("GAAP") was $0.5 million, or $0.02 per diluted share for the three months ended December 31, 2013 compared with a net loss of $8.3 million, or $(0.50) per diluted share for the same period of 2012. Adjusted net income was $4.1 million, or $0.19 per diluted share for the three months ended December 31, 2013 compared with an adjusted net loss of $7.9 million, or $(0.48) per diluted share for the same period in 2012. A reconciliation of adjusted net income (loss) to GAAP net income (loss) is provided in the accompanying table below entitled "Reconciliation of GAAP Net Income (Loss) to Adjusted Net Income (Loss)."

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