secwatch.observer — SEC 8-K summary
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Issuer:     Eton Pharmaceuticals, Inc. (ETON)
CIK:        0001710340
Form:       8-K
Filed at:   2024-03-14T23:59:59+00:00
Accession:  0001437749-24-007850
Event type: earnings
Sentiment:  neutral
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Eton Pharma Q4 revenue up 109% to $7.3M; ET-400 NDA submission planned Q2 2024
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- Q4 2023 product sales & royalty revenue $7.3M, up 109% YoY; full-year revenue $26.1M (+132%).
- Net loss of $2.3M ($0.09/share) in Q4 vs net income of $0.9M in Q4 2022; operating cash flow positive $0.4M.
- ET-400 (oral hydrocortisone) passed pivotal bioequivalence study; NDA submission expected Q2 2024.
- ET-600 passed pilot bioequivalence study; pivotal study planned H2 2024, NDA in early 2025.
- Launched Nitisinone capsules in Feb 2024; sampling program for ALKINDI SPRINKLE went live.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1710340/000143774924007850/0001437749-24-007850-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1710340/000143774924007850/eton20231213_8k.htm
  HTML page:      https://secwatch.observer/filing/0001437749-24-007850

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer