Short answer
Assembly Biosciences Inc (ASMB) filed its fiscal 2018 10-K annual report with the SEC on Feb 28, 2019. It reported revenue of $15M (+64.1% year over year) and net income of −$91M.
- Top risk flagged: FDA approval risk: no NDA or BLA submitted, with candidates still in early clinical or nonclinical development
FY2018 key financial metrics · XBRL
- Revenue
- $15M
- +64.1% YoY
- Net income
- −$91M
- −112.0% YoY
- Operating margin
- -626.4%
- −47.3 pp YoY
- ROE
- -43.1%
- −5.2 pp YoY
- Operating cash flow
- −$65M
- −3592.2% YoY
Source: XBRL data from the Assembly Biosciences Inc (ASMB) FY2018 10-K on SEC EDGAR. USD.
Assembly Biosciences Inc FY2018 10-K analysis
AI summary of each section, grounded in the filing text
Business Overview
- Clinical-stage biotechnology model centered on HBV-cure core inhibitors and oral synthetic live biotherapeutics for microbiome disorders
- New ABI-H2158 Phase 1a/1b trial initiated, while third candidate ABI-H3733 entered IND-enabling studies
- ABI-H0731 received FDA Fast Track designation and advanced into two Phase 2a combination studies across five countries
- Microbiome expansion: ABI-M201 ulcerative-colitis IND filed in December 2018, with Phase 1b launched in February 2019
- Workforce reached 95 employees as of December 31, 2018, supporting expanded clinical development across both platforms
Management Discussion & Analysis
- Collaboration revenue $14.8M in 2018, versus $50.0M upfront payment received in 2017
- Net loss $90.8M, driven by R&D expense $72.7M, up from $44.2M
- HBV program largest R&D segment at $41.5M, versus Microbiome $19.4M
- Operating cash use $65.0M, investing cash use $135.4M, financing cash inflow $159.8M
- July 2018 equity offering generated $155.4M; continued funding needs and clinical-development risks ahead
Risk Factors
- FDA approval risk: no NDA or BLA submitted, with candidates still in early clinical or nonclinical development
- China exposure: planned international expansion faces tariffs, trade barriers, currency controls and geopolitical disruptions
- Manufacturing vulnerability: third parties supply ABI-H0731, ABI-H2158 and ABI-H3733 for clinical and nonclinical studies
- Competitive disruption: emerging HBV, microbiome and biologic competitors could render candidates noncompetitive
- Financing risk: accumulated deficit $341.8 million and 2018 net loss $90.8 million require substantial additional capital
Generated from the filing text; verify against the original. How to read a 10-K
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