10-Q quarterly report · filed Aug 3, 2016

Corcept Therapeutics Inc (CORT) Q2 2016 10-Q Quarterly Report

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Corcept Therapeutics Inc (CORT) filed its Q2 2016 10-Q quarterly report on Aug 3, 2016 for the quarter ended Jun 30, 2016.

Corcept Therapeutics Inc Q2 2016 10-Q analysis

AI summary of MD&A and risk factor updates

Management Discussion & Analysis

  • Quarterly net product revenue $19.7M, up from $12.0M YoY
  • Quarterly GAAP net income $977,000, versus $1.9M net loss YoY
  • Best performer: Korlym sales volume and price increases drove revenue growth
  • Cash $41.8M vs $40.4M at year-end; six-month operating cash flow $4.9M
  • Biopharma payments $6.3M in six months; full repayment expected in 2017
  • 2016 R&D expected to increase, with CORT125134 trials and additional compounds advancing toward clinical development

Risk Factors

  • Regulatory risk: February 1, 2016 CMS final rule changed Korlym government-program price reporting, with rebate and chargeback effects unclear
  • Regulatory compliance risk: Off-label promotion findings could trigger FDA enforcement, civil fines, criminal penalties, or false-claims liability
  • Operational risk: Single suppliers produce all Korlym API and tablets, creating interruption risk if either fails FDA requirements
  • Market risk: Novartis Signifor and osilodrostat programs intensify competition for Cushing’s syndrome treatment
  • Financial risk: Biopharma receives 20% of covered-product sales until $45.0 million, with payments rising to 50% after specified defaults

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

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