Earnings summaries and quarterly performance for Harmony Biosciences Holdings.
Executive leadership at Harmony Biosciences Holdings.
Board of directors at Harmony Biosciences Holdings.
Research analysts who have asked questions during Harmony Biosciences Holdings earnings calls.
Ami Fadia
Needham & Company, LLC
4 questions for HRMY
Also covers: ACAD, ALKS, AVDL +10 more
AV
Ashwani Verma
UBS Group AG
4 questions for HRMY
Also covers: ACAD, ALKS, ALVO +12 more
David Amsellem
Piper Sandler Companies
4 questions for HRMY
Also covers: ABBV, ALKS, AMGN +27 more
Graig Suvannavejh
Mizuho Securities
4 questions for HRMY
Also covers: ADAP, ADVM, ALEC +11 more
CD
Charles Duncan
Cantor Fitzgerald & Co.
3 questions for HRMY
Also covers: ACAD, ALKS, ATAI +12 more
DH
David Hoang
Citigroup
3 questions for HRMY
Also covers: ACAD, ALKS, AVDL +8 more
Jason Gerberry
Bank of America Merrill Lynch
3 questions for HRMY
Also covers: ALKS, AMPH, ARWR +21 more
DB
Danielle Brill
Truist Securities
2 questions for HRMY
Also covers: ACAD, ARGX, BBIO +5 more
Patrick Trucchio
H.C. Wainwright & Co.
2 questions for HRMY
Also covers: ALT, ARWR, ATAI +13 more
Corinne Jenkins
Goldman Sachs
1 question for HRMY
Also covers: ACRS, ALEC, ATHA +5 more
CJ
Corinne Johnson
Goldman Sachs
1 question for HRMY
Also covers: ALT, AMLX, GERN +5 more
FB
François Brisebois
Oppenheimer & Co. Inc.
1 question for HRMY
Also covers: ACHV, AQST, AVDL +11 more
Jay Olson
Oppenheimer & Co. Inc.
1 question for HRMY
Also covers: ACAD, AMGN, BIIB +22 more
JG
John Gregory Dean
Oppenheimer & Co. Inc.
1 question for HRMY
LS
Luis Santos
H.C. Wainwright & Co.
1 question for HRMY
Also covers: CMPS, MNMD, ONCY +1 more
PP
Pavan Patel
Bank of America
1 question for HRMY
Also covers: AMPH, CPRX, TARS
PS
Pete Stavropoulos
Cantor Fitzgerald
1 question for HRMY
Also covers: ABOS, ALEC, ARCT +7 more
Recent press releases and 8-K filings for HRMY.
Harmony Biosciences Provides 2026 WAKIX Revenue Guidance and Pipeline Updates
HRMY
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
- Harmony Biosciences projects WAKIX net revenue of $1 billion to $1.04 billion for 2026, aiming for blockbuster status, building on $868 million achieved in 2025.
- The company is progressing its late-stage pipeline with key milestones including the NDA submission for Pitolisant GR in Q2 2026 (anticipated PDUFA in Q1 2027) and Phase 3 trials initiated in Q4 2025 for Pitolisant HD, with top-line data expected in 2027.
- Additional catalysts include top-line data in 2026 for the Pitolisant program in Prader-Willi syndrome and mid-2026 for the RxEN2 receptor agonist Phase 1 clinical PK data.
- Harmony maintains a strong financial profile, reporting over $770 million on the balance sheet at the end of Q3 2025, which supports pipeline development, commercial expansion, and business development initiatives.
- WAKIX is on track to secure pediatric exclusivity, extending its Loss of Exclusivity (LOE) to Q3 2030.
1 day ago
Harmony Biosciences Provides 2026 Outlook and Pipeline Updates at JPM Healthcare Conference
HRMY
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
- Harmony Biosciences anticipates WAKIX net revenue to reach $1 billion to $1.04 billion in 2026, achieving blockbuster status, building on $868 million in 2025.
- The company reported a strong financial profile with $770 million on the balance sheet as of Q3 2025, enabling self-funding of its pipeline and commercial expansion.
- Harmony is advancing a robust late-stage pipeline with several upcoming catalysts, including the NDA submission for Pitolisant GR in Q2 2026 (PDUFA Q1 2027), top-line data for Pitolisant HD in 2027 (PDUFA 2028), and top-line data for EPX100 in H1 2027 (PDUFA 2028).
- Pediatric exclusivity for WAKIX is expected to extend its Loss of Exclusivity (LOE) from Q1 2030 to Q3 2030, with the Prader-Willi syndrome study fulfilling the final requirement for this extension.
1 day ago
Harmony Biosciences Presents Pipeline and Franchise Strategy at J.P. Morgan Healthcare Conference
HRMY
Product Launch
New Projects/Investments
Guidance Update
- Harmony Biosciences presented at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026.
- The company plans an NDA submission for Pitolisant GR in Q2 2026 with an anticipated PDUFA date in Q1 2027, aiming to extend the Pitolisant franchise into the 2040s.
- For Pitolisant HD, Phase 3 trials began in Q4 2025, with topline data expected in 2027 for narcolepsy and idiopathic hypersomnia, and PDUFA dates anticipated in 2028.
- Key pipeline catalysts for 2026-2028 include BP1.15205 Phase 1 clinical PK data in mid-2026 and EPX-100 Phase 3 topline data in 1H 2027.
- WAKIX reported 600 average patients in Q3'25 and Q4'25, with 100 net patient additions in Q3'25.
1 day ago
Harmony Biosciences Provides 2026 Outlook and Pipeline Updates
HRMY
Guidance Update
New Projects/Investments
Revenue Acceleration/Inflection
- Harmony Biosciences projects WAKIX net revenue for 2026 to be between $1 billion and $1.04 billion, putting it on track to achieve blockbuster status this year, following $868 million in net revenue for 2025.
- The company is advancing a robust late-stage pipeline, with pitolisant GR NDA submission planned for Q2 2026 (anticipated PDUFA Q1 2027) and pitolisant HD Phase III trials initiated in Q4 2025 (anticipated PDUFA 2028).
- Key pipeline catalysts for 2026 include top-line Phase III data for pitolisant in Prader-Willi syndrome and Phase I clinical PK data for the Orexin-2 receptor agonist.
- Harmony reported strong WAKIX momentum with 400+ new patient adds for three consecutive quarters in 2025 and holds over $770 million in cash as of Q3 2025, prioritizing business development for pipeline and commercial expansion.
1 day ago
Harmony Biosciences Reports Preliminary Q4 and Full Year 2025 Revenue and Issues 2026 WAKIX Guidance
HRMY
Earnings
Guidance Update
New Projects/Investments
- Harmony Biosciences reported preliminary, unaudited net product revenue of approximately $243 million for the fourth quarter ended December 31, 2025, and approximately $868 million for the full year ended December 31, 2025, representing approximately 21% year-over-year growth.
- The company provided 2026 WAKIX net revenue guidance of $1.0 billion to $1.04 billion, indicating it is on track to achieve blockbuster status in narcolepsy.
- Harmony Biosciences is advancing its late-stage pitolisant franchise, with an NDA submission for Pitolisant GR anticipated in Q2 2026 and Phase 3 trials ongoing for Pitolisant HD, with topline data expected in 2027.
- The company's pipeline also includes an Orexin-2 Agonist (BP1.15205) in Phase 1 with clinical data expected in mid-2026, and EPX-100 in Phase 3 trials for Dravet and Lennox-Gastaut syndromes with topline data anticipated in 1H 2027. The ZYN002 program in Fragile X syndrome is being phased out.
3 days ago
Harmony Biosciences Reports Preliminary 2025 Revenue and Provides 2026 WAKIX Guidance
HRMY
Earnings
Guidance Update
New Projects/Investments
- Harmony Biosciences reported preliminary, unaudited net product revenue of approximately $243 million for Q4 2025 and $868 million for the full year 2025, representing approximately 21% growth year-on-year compared to 2024.
- The company projects WAKIX net revenue to be between $1.0 billion to $1.04 billion for the full year ending December 31, 2026, aiming for blockbuster status in narcolepsy.
- Harmony is advancing its late-stage pipeline, with Phase 3 topline data for pitolisant in Prader-Willi syndrome expected in 2H 2026, and an NDA submission for pitolisant GR planned for Q2 2026.
- The ZYN002 program in Fragile X syndrome is being phased out, and the company is no longer pursuing a 22q deletion syndrome indication.
3 days ago
Harmony Biosciences Provides Updates on WAKIX Growth and Pipeline Development
HRMY
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Harmony Biosciences reported record patient additions for WAKIX in Q3, with a 500-patient increase, bringing the total to 8,100 patients on therapy, and anticipates WAKIX to be a $1 billion-plus opportunity.
- The company is advancing its Pitolisant franchise with Pitolisant GR (gastro-resistant) expected to have its NDA submitted early next year for a target PDUFA in Q1 2027, and Pitolisant HD (high-dose) initiating two Phase 3 trials for narcolepsy and idiopathic hypersomnia, targeting a PDUFA in 2028.
- Harmony's orexin agonist is in Phase 1 clinical trials, with initial clinical data expected in 2026, aiming for a potentially best-in-class profile with high potency and selectivity.
- In pediatric epilepsies, Harmony's EPX-100 (clemizole) is in Phase 3 trials for Dravet and Lennox-Gastaut syndromes, with top-line data expected in late 2026.
Dec 3, 2025, 3:30 PM
Harmony Biosciences Reports Record WAKIX Patient Adds and Pipeline Advancements
HRMY
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Harmony Biosciences reported record patient additions for WAKIX in Q3, with a 500-patient increase, the highest since launch, following a 400-patient increase in Q2.
- The company is progressing its pipeline, with Pitolisant GR (gastro-resistant) targeting NDA submission early next year for a Q1 2027 PDUFA and Pitolisant HD (high-dose) initiating Phase 3 trials for narcolepsy and idiopathic hypersomnia with a target PDUFA in 2028.
- Harmony has started a Phase 1 PK/PD program for its orexin-2 agonist, with clinical data expected in 2026, aiming for a best-in-class profile.
- EPX-100 (clemizole hydrochloride) is in Phase 3 for Dravet and Lennox-Gastaut syndromes, with top-line data expected in late 2026 and initial open-label efficacy data to be presented soon.
- Management anticipates minimal short-term impact on WAKIX from Takeda's orexin launch in late 2026/early 2027 and expects Xyrem generics to primarily affect the oxybate market.
Dec 3, 2025, 3:30 PM
Harmony Biosciences Discusses WAKIX Growth, Pipeline Progress, and Market Dynamics
HRMY
Product Launch
Revenue Acceleration/Inflection
New Projects/Investments
- WAKIX continues its strong performance, with Q3 patient adds reaching a record 500, driven by its differentiated profile as the only non-scheduled treatment option and improved patient access.
- Harmony Biosciences expects minimal short-term impact on WAKIX from upcoming Xyrem generics and Takeda's NT1-only orexin agonist, oveporexton, which is anticipated to launch in late 2026/2027.
- The company is progressing its pipeline with an orexin-2 agonist in Phase I (clinical data expected in 2026) , pitolisant GR (NDA submission early 2026, targeting Q1 2027 launch) , and pitolisant HD (initiating two Phase III trials for narcolepsy and IH with a target PDUFA in 2028).
- Harmony's clemizole (EPX-100) is in Phase III for Dravet and Lennox-Gastaut, with top-line data expected in late 2026 and initial efficacy data from the open-label extension to be presented next week.
Dec 3, 2025, 3:30 PM
Harmony Biosciences Provides Business Update at Evercore Conference
HRMY
Guidance Update
Product Launch
New Projects/Investments
- Harmony Biosciences reported strong performance for Wakix, increasing its full-year guidance to $845 million-$865 million for the year, driven by significant patient increases in Q2 and Q3.
- The company is expanding its pitolisant franchise with two new formulations: pitolisant GR, targeting a PDUFA in Q1 2027, and pitolisant HD, targeting a PDUFA in 2028, both designed to extend the franchise into the mid-2040s.
- Harmony's pipeline includes an orexin-2 agonist currently in Phase I studies and EPX-100 in Phase III for Dravet syndrome and Lennox-Gastaut.
- The company is profitable and self-funding its pipeline, with plans for six programs in registrational trials next year, and is actively pursuing business development for commercial-stage assets.
- The ZYN002 program for Fragile X is currently on hold, with an assessment of the path forward expected by year-end or early next year.
Dec 2, 2025, 7:35 PM
Quarterly earnings call transcripts for Harmony Biosciences Holdings.
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