10-Q quarterly report · filed Nov 4, 2019

Neurocrine Biosciences Inc (NBIX) Q3 2019 10-Q Quarterly Report

Short answer

Neurocrine Biosciences Inc (NBIX) filed its Q3 2019 10-Q quarterly report on Nov 4, 2019 for the quarter ended Sep 30, 2019.

Neurocrine Biosciences Inc Q3 2019 10-Q analysis

AI summary of MD&A and risk factor updates

Management Discussion & Analysis

  • Q3 revenue $222.1M, up $70.3M from $151.8M YoY, driven by INGREZZA sales
  • INGREZZA product sales $198.1M vs $111.3M YoY, strongest revenue contributor
  • Q3 net income $53.8M vs $50.8M YoY, diluted EPS $0.56 vs $0.52
  • Cash and investments $875.0M vs $866.9M at December 31, 2018; nine-month operating cash flow $49.5M vs $50.9M
  • Near-term catalysts: KINECT-HD enrollment expected in Q4 2019; opicapone PDUFA date April 26, 2020

Risk Factors

  • New Voyager collaboration risk: four-program agreement effective March 2019, with Voyager operational responsibility before specified transition events
  • Opicapone regulatory risk: FDA NDA submitted June 2019, with PDUFA target date April 26, 2020
  • Manufacturing concentration risk: limited suppliers for INGREZZA and active pharmaceutical ingredients, making replacement qualification time-consuming
  • Competitive risk: INGREZZA competes with AUSTEDO, approved by FDA in August 2017, plus off-label medicines
  • Debt and liquidity risk: $517.5 million of 2.25% convertible senior notes due May 15, 2024

Generated from the filing text; verify against the original. 10-K vs 10-Q vs 8-K

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