Short answer
Penumbra Inc (PEN) filed its fiscal 2018 10-K annual report with the SEC on Feb 26, 2019. It reported revenue of $445M (+33.3% year over year) and net income of $7M.
- Top risk flagged: FDA clearance risk: EU Medical Device Regulation becomes effective May 2020, increasing clinical-data and Unique Device Identification obligations
FY2018 key financial metrics · XBRL
- Revenue
- $445M
- +33.3% YoY
- Net income
- $7M
- +41.7% YoY
- Operating margin
- -0.2%
- −0.5 pp YoY
- Gross margin
- 65.7%
- +0.7 pp YoY
- EPS (diluted)
- $0.18
- +38.5% YoY
- ROE
- 1.6%
- +0.4 pp YoY
- Operating cash flow
- $29M
- +127.0% YoY
Source: XBRL data from the Penumbra Inc (PEN) FY2018 10-K on SEC EDGAR. USD.
Penumbra Inc FY2018 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Global medical-device model: in-house innovation, manufacturing and specialist-physician sales across neuro and vascular markets
- 2018 emphasis on Indigo continuous-aspiration thrombectomy, including expanded peripheral and coronary catheter sizes
- Manufacturing expansion: 160,000-square-foot Roseville facility lease, alongside 295,000 square feet in Alameda
- Revenue $444.9 million, up 33.3% from 2017, with neuro revenue $294.3 million and vascular revenue $150.6 million
- ISO 13485:2016 recertification and first MDSAP certification achieved in 2018, broadening multi-country compliance coverage
Management Discussion & Analysis
- Revenue $444.9M, up $111.2M or 33.3% YoY, driven by neuro $294.3M and vascular $150.6M
- Gross margin 65.7% vs 65.1%; operating margin (0.2)% vs 0.3%, including $30.8M MVI IPR&D charge
- Best segment vascular, revenue up 48.6% to $150.6M; worst segment neuro, up 26.6% to $294.3M
- Operating cash flow $28.8M; capex $9.6M; MVI acquisition payments $20.4M; no buybacks or dividends disclosed
- Outlook: 2019 R&D expected to significantly increase; risks include competition, foreign exchange and medical device excise tax reinstatement in 2020
Risk Factors
- FDA clearance risk: EU Medical Device Regulation becomes effective May 2020, increasing clinical-data and Unique Device Identification obligations
- International exposure: non-U.S. sales 34.7% of revenue, with Brexit and U.S.-China tariffs threatening trade and pricing
- Manufacturing concentration: substantially all products made at nonredundant Alameda campus on earthquake-prone filled land
- Competitive disruption: Boston Scientific, Johnson & Johnson, Medtronic, Stryker and Terumo possess greater resources
- Ownership concentration: executives, directors and 5% holders control 38.9% of voting stock, enabling significant influence over corporate actions
Generated from the filing text; verify against the original. How to read a 10-K
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