secwatch.observer — SEC 8-K summary
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Issuer:     Vanda Pharmaceuticals Inc. (VNDA)
CIK:        0001347178
Form:       8-K
Filed at:   2023-11-08T23:59:59+00:00
Accession:  0001628280-23-037827
Event type: earnings
Sentiment:  negative
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Vanda Q3 net product sales $38.8M, down 41% YoY; generic Hetlioz hurts; two PDUFA dates in H1 2024
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- Q3 2023 net product sales $38.8M vs $65.3M YoY; net income $0.1M ($0.00 EPS) vs $3.3M ($0.06) prior year.
- Hetlioz sales fell 58% to $17.5M due to at-risk generic launch; Fanapt sales $21.3M, down 11%.
- FDA accepted sNDAs: Fanapt for bipolar I (PDUFA Apr 2, 2024) and Hetlioz for insomnia (PDUFA Mar 4, 2024).
- Tradipitant NDA for gastroparesis ongoing; Phase III motion sickness study over 20% enrolled.
- Vanda to file Supreme Court petition by Jan 12, 2024 in Hetlioz ANDA litigation vs Teva/Apotex.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1347178/000162828023037827/0001628280-23-037827-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1347178/000162828023037827/vnda-20231108.htm
  HTML page:      https://secwatch.observer/filing/0001628280-23-037827

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