Horizon Pharma (HZNP) Tops Q4 EPS by 1c

Horizon Pharma (NASDAQ: HZNP) reported Q4 EPS of $0.63, $0.01 better than the analyst estimate of $0.62. Revenue for the quarter came in at $244.5 million versus the consensus estimate of $240.92 million.

• Orphan Business Unit: ACTIMMUNE sales of $28.1 million increased 25 percent compared to the fourth quarter of 2014. RAVICTI and BUPHENYL sales in the fourth quarter were $34.5 million and $5.6 million, respectively. The orphan commercial organization continues to drive awareness of ACTIMMUNE and RAVICTI among both patients and physicians, leading to consistent patient additions throughout the quarter. The Company continued to make significant progress with clinical development programs for its orphan medicines:
  • The STEADFAST phase 3 trial for ACTIMMUNE in Friedreich's ataxia is 70 percent enrolled and is on track for enrollment completion in the second quarter of 2016. Initial trial results are expected by the end of 2016.
  • The Company also initiated a phase 1 clinical study and began patient enrollment, in collaboration with Fox Chase Cancer Center, to evaluate ACTIMMUNE in combination with nivolumab (OPDIVO�, Bristol-Myers Squibb) in kidney and bladder cancers.
  • In November, RAVICTI was approved in Europe for use as an adjunctive therapy for chronic management of adult and pediatric patients two months of age and older with six subtypes of Urea Cycle Disorders (UCDs); commercial launch is expected in 2017.
  • In the U.S., the Company is pursuing an expanded RAVICTI indication for children with UCDs who are two months to two years of age and expects to submit a supplemental new drug application to the FDA in the second quarter of 2016. Importantly, this expanded indication, if approved, would allow physicians to start patients in this age group on RAVICTI instead of starting them on BUPHENYL as they do today.
  • On February 22, 2016, the Company announced RAVICTI is eligible for data protection in Canada. The regulatory review process will be reinitiated to obtain approval in Canada for the approximately 100 patients with UCDs.

For earnings history and earnings-related data on Horizon Pharma (HZNP) click here.

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