Short answer
Neurocrine Biosciences Inc (NBIX) filed its fiscal 2018 10-K annual report with the SEC on Feb 8, 2019. It reported revenue of $451M (+179.2% year over year) and net income of $21M.
- Top risk flagged: FDA post-marketing requirements for INGREZZA: noncompliance could trigger approval withdrawal, recalls, fines or labeling restrictions
FY2018 key financial metrics · XBRL
- Revenue
- $451M
- +179.2% YoY
- Net income
- $21M
- +114.8% YoY
- Operating margin
- 8.2%
- +89.5 pp YoY
- EPS (diluted)
- $0.22
- +113.6% YoY
- ROE
- 4.4%
- +42.7 pp YoY
- Operating cash flow
- $101M
- +207.5% YoY
Source: XBRL data from the Neurocrine Biosciences Inc (NBIX) FY2018 10-K on SEC EDGAR. USD.
Neurocrine Biosciences Inc FY2018 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Biopharmaceutical model: internally discovered neurological and endocrine medicines, supplemented by selective licensing and pharmaceutical collaborations
- New 2018 programs: Phase I studies for an internally discovered VMAT2 inhibitor and first-in-class CNS compound
- Commercial expansion: ORILISSA launched by AbbVie for endometriosis, while INGREZZA U.S. sales force expanded 50% to approximately 250 professionals
- Pipeline advancement: positive Phase III elagolix uterine-fibroid data, anticipated FDA NDA in 2019, while valbenazine Tourette study failed its primary endpoint
- Workforce approximately 585 employees as of December 31, 2018, alongside first INGREZZA API order from an Italian manufacturer
Management Discussion & Analysis
- Revenue $451.2M, up $289.6M YoY, driven by INGREZZA sales of $409.6M vs $116.6M
- Net income $21.1M vs $142.5M net loss; operating margin not disclosed
- INGREZZA, best-performing product, $409.6M sales; collaboration revenue, $41.6M vs $45.0M
- Operating cash flow $101.4M; investing outflow $242.9M, primarily investments and facility improvements
- Cash and investments $866.9M; no buybacks or dividends disclosed; outlook, resources sufficient for at least 12 months, with clinical and commercialization risks
Risk Factors
- FDA post-marketing requirements for INGREZZA: noncompliance could trigger approval withdrawal, recalls, fines or labeling restrictions
- Healthcare pricing pressure: ACA mandates 70% Medicare Part D coverage-gap discounts on branded drugs
- INGREZZA supply concentration: single-source suppliers create shortage risk and lengthy FDA qualification requirements for replacements
- TD competition from Teva’s AUSTEDO, FDA-approved in August 2017
- $517.5 million 2.25% convertible notes due May 15, 2024, creating liquidity and dilution exposure
Generated from the filing text; verify against the original. How to read a 10-K
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