secwatch.observer — SEC 8-K summary
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Issuer:     Harmony Biosciences Holdings, Inc. (HRMY)
CIK:        0001802665
Form:       8-K
Filed at:   2024-10-29T23:59:59+00:00
Accession:  0001558370-24-013802
Event type: earnings
Sentiment:  positive
Materiality: 0.70
Item codes: 2.02, 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Harmony Biosciences Q3 net revenue $186M (+16% YoY); reiterates FY2024 guidance $700-720M
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- GAAP net income $46.1M ($0.79 diluted EPS) vs $38.5M ($0.63) in Q3 2023; non-GAAP adjusted EPS $1.03.
- Average WAKIX patients ~6,800 (+250 sequentially); cumulative net revenue surpasses $2B since 2019 launch.
- On track to submit sNDA for pitolisant in idiopathic hypersomnia in Q4 2024; LTS data show sustained efficacy.
- Pipeline: EPX-100 Phase 3 for Dravet syndrome (data 2026); Phase 3 for LGS to start by year-end; ZYN-002 topline mid-2025.
- Reiterates FY2024 net product revenue guidance of $700-$720 million.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1802665/000155837024013802/0001558370-24-013802-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1802665/000155837024013802/hrmy-20241029x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-24-013802

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