HRMY
Harmony Biosciences Holdings, Inc.38.83
-0.09-0.23%
Dec 16, 4:00:01 PM EST
Earnings Call Transcripts
This Quarter (Q1 '26)
No earnings call transcript available yet
Last Quarter (Q4 '25)
FY Q4 '25
Pipeline details boost confidence
Q&A drilled into pipeline grit without tweaking WAKIX's $1B-$1.04B guide or IP settlements locking generics past 2030. EPX-100 shone in Dravet OLE with 50% median seizure reductions, clean safety, and liquid BID ease trumping rivals' TID regimens. Orexin agonist eyes cognition, mood beyond hypersomnolence post mid-2026 Phase I. Enrollment faces rivals but sites activate confidently for pitolisant HD. Sales force swells 20% purely for WAKIX momentum. Cash at $882M backs BD or $150M buybacks. Pipeline catalysts accelerate.
Key Stats
Market Cap
2.24BP/E (TTM)
12.25Basic EPS (TTM)
3.17Dividend Yield
0%Recent Filings
10-K
FY2025 results
Harmony Biosciences drove FY2025 net product revenue to $868.5 million from WAKIX sales, up 21.5% y/y on 18.3% unit growth and a 7.0% price hike, though Q4 specifics remain undisclosed in the 10-K. Q4 saw average patients on therapy hold steady at ~8,500 while unique prescribers climbed, signaling steady demand amid pediatric label expansions for EDS (Q2 2024) and cataplexy (Q1 2026). Gross margins slipped to 77.2% from higher royalties, yet operating income rose 9.2% to $208.5 million on controlled spend; R&D jumped 30% to $189.6 million fueling EPX-100 Phase 3 data and next-gen pitolisant advances. Cash swelled to $882.5 million with $165 million debt; $150 million remains for buybacks. Pipeline momentum accelerated—Pitolisant GR NDA eyes Q1 2027 PDUFA—but Lupin generic challenges risk eroding exclusivity.
8-K
WAKIX revenue hits $869M
Harmony Biosciences posted Q4 2025 WAKIX net revenue of $243.8M, up 21% year-over-year, driving full-year 2025 revenue to $868.5M, a 22% jump. Cash swelled to $882.5M amid pipeline advances like pitolisant GR NDA in Q2 2026. WAKIX rockets toward $1.0–$1.04B in 2026. Six generic settlements lock protection to 2030.
8-K
WAKIX hits $868M, guides $1B+
Harmony Biosciences reported preliminary unaudited 2025 WAKIX net revenue of ~$868M, up ~21% from $714.7M in 2024, with Q4 at ~$243M versus $201.3M last year. The company guided 2026 WAKIX revenue to $1.0–$1.04B while advancing pitolisant extensions and five Phase 3 trials. ZYN002 phased out. Pipeline fuels self-funded growth.
8-K
Q3 revenue surges 29% to $239.5M
Harmony Biosciences posted Q3 2025 WAKIX net revenue of $239.5M, up 29% YoY from $186M, fueled by a record ~500 patient adds to hit 8,100 average patients. Cash swelled to $778M amid raised 2025 guidance of $845-$865M, yet R&D jumped 117% on a $15M ZYN002 milestone—while ZYN002's Phase 3 missed primary endpoint. Pipeline powers on: pitolisant HD Phase 3 trials start Q4 2025. Cash fuels growth.
10-Q
Q3 FY2025 results
Harmony Biosciences posted Q3 net product revenue of $239.5M, up 28.7% y/y from $186.0M, with gross margin dipping to 75.1% from 77.0% on higher royalties. Operating income climbed to $65.5M (27.4% y/y), diluted EPS $0.87 (10.1% y/y) on 58.7M shares. Cash from operations hit $222.0M YTD, cash swelled to $647.0M, debt down to $170.0M (maturing 2028). R&D jumped on $15M ZYN002 milestone and CiRC upfront. Generic WAKIX threats loom via ANDA suits.
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