Short answer
Penumbra Inc (PEN) filed its fiscal 2016 10-K annual report with the SEC on Feb 28, 2017. It reported revenue of $263M and net income of $15M.
- Top risk flagged: FDA Form 483s in 2015: unresolved CAPA and clinical-site monitoring deficiencies could trigger enforcement actions
FY2016 key financial metrics · XBRL
- Revenue
- $263M
- Net income
- $15M
- Operating margin
- -0.5%
- Gross margin
- 64.9%
- EPS (diluted)
- $0.44
- ROE
- 5.6%
- Operating cash flow
- −$13M
Source: XBRL data from the Penumbra Inc (PEN) FY2016 10-K on SEC EDGAR. USD.
Penumbra Inc FY2016 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Global interventional-device model spanning neuro and peripheral vascular thrombectomy and embolization markets
- 2016 emphasis on investigational 3D revascularization device, with successful clinical study and U.S. 510(k) clearance pursuit
- Peripheral expansion through Indigo System, offering four catheter sizes for arterial and venous thrombectomy
- Revenue $263.3 million, up 41.5%; direct sales represented 82.1% of revenue
- Approximately 1,500 employees worldwide and 295,000 square feet of Alameda facilities, including 15,882 square feet added in 2016
Management Discussion & Analysis
- Revenue $263.3M, up $77.2M or 41.5% YoY, with international sales at 33.1%
- Operating margin (0.5%) vs 2.2%; gross margin 64.9% vs 66.7%
- Best segment Peripheral Vascular, $77.8M, up 74.1%; Neuro $185.5M, up 31.2%
- Operating cash flow $(12.8)M; capex $13.6M; marketable investments $115.5M
- Outlook: higher R&D and SG&A spending, expansion investments, competition and supply concentration risks
Risk Factors
- FDA Form 483s in 2015: unresolved CAPA and clinical-site monitoring deficiencies could trigger enforcement actions
- International sales 33.1% of revenue, with Brexit-driven euro and pound volatility pressuring reported results
- Alameda campus produces substantially all products without redundant facilities, creating earthquake-related production interruption risk
- Boston Scientific, Medtronic and Stryker possess substantially greater resources for competing neurovascular technologies
- Japanese distributor Medico’s Hirata represented approximately 11.5% of 2016 revenue, creating customer concentration risk
Generated from the filing text; verify against the original. How to read a 10-K
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