Short answer
Corcept Therapeutics Inc (CORT) filed its fiscal 2016 10-K annual report with the SEC on Mar 6, 2017. It reported revenue of $81M and net income of $8M.
- Top risk flagged: FDA and CMS compliance: Korlym faces ongoing cGMP, post-marketing, pricing-reporting and promotional oversight, with penalties including approval withdrawal
FY2016 key financial metrics · XBRL
- Revenue
- $81M
- Net income
- $8M
- Operating margin
- 12.5%
- Gross margin
- 28.6%
- EPS (diluted)
- $0.07
- ROE
- 19.7%
- Operating cash flow
- $18M
Source: XBRL data from the Corcept Therapeutics Inc (CORT) FY2016 10-K on SEC EDGAR. USD.
Corcept Therapeutics Inc FY2016 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Pharmaceutical model centered on discovering, developing and commercializing cortisol-modulating drugs, with Korlym as the commercial product
- CORT125134 advanced into two enrolling Phase 2 programs: Cushing syndrome and solid tumors with Abraxane
- Planned 2017 clinical starts for selective modulators CORT118335 and CORT125281, expanding into fatty-liver disease, metabolic disorders and prostate cancer
- Oncology positioning strengthened through Korlym combination data: median PFS 11.1 weeks versus 7.2 weeks with Halaven monotherapy
- R&D spending rose to $23.8 million from $15.4 million, while employee count reached 103 as of December 31, 2016
Management Discussion & Analysis
- Revenue $81.3M, up from $50.3M, driven by higher sales volume and price increases
- GAAP net income $8.1M, versus $6.4M loss; cost-of-sales margin 2.5% vs 2.7%
- Korlym, sole commercial product: $81.3M sales; oncology R&D $4.6M versus Cushing syndrome $3.7M
- Operating cash flow $18.4M; Biopharma repayments $14.8M; cash $51.5M
- 2017 outlook: higher R&D and SG&A; trials and regulatory risks could increase development costs; final financing payment expected in 2017
Risk Factors
- FDA and CMS compliance: Korlym faces ongoing cGMP, post-marketing, pricing-reporting and promotional oversight, with penalties including approval withdrawal
- Third-party concentration: PCAS supplies all Korlym API, Alcami produces all tablets and Dohmen dispenses the product
- Competitive pressure: Novartis’s FDA-approved Signifor and investigational osilodrostat target Cushing disease
- Financing obligation: Biopharma receives 20% of covered-product sales until $45.0 million, rising to 50% after specified breaches
- Key-person dependency: Small management team lacks employment agreements, creating product-development delays if personnel depart
Generated from the filing text; verify against the original. How to read a 10-K
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