Short answer
Corcept Therapeutics Inc (CORT) filed its fiscal 2015 10-K annual report with the SEC on Mar 10, 2016.
- Top risk flagged: FDA and CMS reimbursement compliance: February 2016 CMS rule may alter Korlym’s reported prices, rebates and chargebacks
Corcept Therapeutics Inc FY2015 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Core model: U.S. commercialization of Korlym for Cushing’s syndrome funding cortisol-modulator discovery and development
- New pipeline emphasis: CORT125134 advancing toward two Phase 2 trials in Cushing’s syndrome and solid-tumor cancers
- Strategic shift: broader oncology positioning through cortisol modulation, including Korlym plus eribulin for metastatic TNBC
- R&D spending $15.4 million, down from $18.4 million in 2014 and representing 29% of operating expenses
- Workforce: 78 full-time, five part-time employees and 13 long-term contract staff as of December 31, 2015
Management Discussion & Analysis
- Net product sales $50.3M, up from $26.6M in 2014, driven by higher Korlym sales volume
- Cost of sales margin 2.7% vs 3.3%, with R&D expenses $15.4M vs $18.4M
- Selling, general and administrative expenses $36.9M, up from $34.9M
- Operating cash flow $3.1M, cash $40.4M, Biopharma payments $9.2M
- 2016 R&D and commercial expenses expected higher, with clinical-trial execution and regulatory risks ahead
Risk Factors
- FDA and CMS reimbursement compliance: February 2016 CMS rule may alter Korlym’s reported prices, rebates and chargebacks
- Mifepristone political controversy: Korlym’s active ingredient also approved for early-pregnancy termination, limiting physician and patient acceptance
- Manufacturing concentration: PCAS supplies all API and AAI produces all tablets, with no internal manufacturing capability
- Competitive pressure: Novartis’s Signifor targets Cushing’s disease, affecting approximately 70% of Cushing’s syndrome patients
- Biopharma financing burden: 20% of covered-product sales payable until $45.0 million, increasing to 50% after specified defaults
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