Short answer
Assembly Biosciences Inc (ASMB) filed its fiscal 2017 10-K annual report with the SEC on Mar 8, 2018. It reported revenue of $9M and net income of −$43M.
- Top risk flagged: FDA approval risk: no NDA or BLA submitted, leaving HBV and microbiome candidates without a regulatory path to commercialization
FY2017 key financial metrics · XBRL
- Revenue
- $9M
- Net income
- −$43M
- +3.3% YoY
- Operating margin
- -579.1%
- ROE
- -37.8%
- +17.6 pp YoY
- Operating cash flow
- $2M
- +105.3% YoY
Source: XBRL data from the Assembly Biosciences Inc (ASMB) FY2017 10-K on SEC EDGAR. USD.
Assembly Biosciences Inc FY2017 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Clinical-stage biotech focused on oral HBV-cure therapies and synthetic live biotherapeutics targeting microbiome disorders
- New lead CpAM ABI-H2158 selected in Q4 2017, with enhanced preclinical potency and IND-enabling studies underway
- Strategic validation through Allergan collaboration: $50M upfront, up to $630M development milestones and $2.15B commercial milestones
- R&D expense rose to $38.8M from $30.1M, with HBV spending $23.2M and microbiome spending $15.6M
- Microbiome strategy narrowed toward ABI-M201 for ulcerative colitis and ABI-M301 for Crohn’s disease after deferring ABI-M101 development
Management Discussion & Analysis
- Collaboration revenue approximately $9.0M in 2017, versus no product sales revenue
- Net loss approximately $42.8M, with R&D expense $44.2M versus $33.1M in 2016
- HBV R&D $23.2M, strongest program, versus Microbiome $15.6M
- Operating cash flow $1.9M, capex $0.9M, no buybacks or dividends disclosed
- $64.8M equity proceeds and $50.0M Allergan upfront payment, with additional funding required beyond twelve months
Risk Factors
- FDA approval risk: no NDA or BLA submitted, leaving HBV and microbiome candidates without a regulatory path to commercialization
- Financing dependence: approximately $251.0 million accumulated deficit and no product revenues, requiring additional capital to fund operations
- Manufacturing vulnerability: no internal manufacturing for ABI-H0731 or ABI-H2158, with clinical supply dependent on third-party manufacturers
- Competitive disruption: emerging HBV treatments could render the company’s CpAM technology noncompetitive
- Collaboration concentration: Allergan may terminate the microbiome agreement on 90 or 120 days’ notice, jeopardizing funding and milestones
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