Harmony Biosciences Holdings, Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 7 May 2026: press release. Guidance figures: 1 new, 6 kept. The quarter’s numbers.

Read the filing

Key takeaways

• WAKIX revenue grew 17%: Net product revenue reached $215.4 million for the quarter ended March 31, 2026, up from $184.7 million a year earlier, a 17% increase. Source
• Market access headwinds weighed on Q1: Management said the first quarter was offset by market access headwinds seen every first quarter, which were more pronounced this year. Source
• R&D rose on license up-front payments: R&D expense was $69.4 million, up 101%, with $32.0 million of up-front license payments made in Q1, a $0.45 per share after-tax impact. Source
• Net income fell on license charges: Net income was $32.5 million, or $0.55 diluted EPS, against $45.6 million, or $0.78, in Q1 2025; management attributed the decline to Q1 licensing agreements. Source
• Six of seven ANDA filers settled: Three additional ANDA settlements were reached in Q1, bringing the total to six of the seven ANDA filers. Source
• Exclusivity into 2030, possibly 2040s: Management said its multi-layered IP supports WAKIX exclusivity into 2030, including six months of pediatric exclusivity, with potential protection into the 2040s. Source
• BP-205 described as most potent: Management describes BP-205 as the most potent OX2R agonist in clinical development, with Phase 1 SAD data and a U.S. IND both planned for mid-2026. Source
• Business development refocused on 2028-2032: Management is focused on transactions with revenue potential in 2028 to 2032, prioritizing assets in Phase 3, in registration or on the market. Source

“Harmony is well positioned for long - term growth, and we are focused on four key pillars to drive value creation”

Jeffrey M. Dayno, M.D., President and Chief Executive Officer

Guidance

What changed from last quarter

• Guidance kept: Full year 2026 WAKIX net revenue guidance was reiterated at $1.0 billion to $1.04 billion. Source
• New: Harmony acquired an exclusive license to an issued patent, protected to 2042, covering a novel amorphous form of pitolisant. Source
• New: Harmony and Novitium filed a patent infringement suit in April against AET Pharma US and Sandoz. Source
• New: Peter Anastasiou was appointed Chief Operating Officer and Glenn Reicin was appointed Chief Financial Officer. Source
• New: Management stated a renewed focus on business development, aimed at transactions with revenue potential in 2028 to 2032. Source
• New: Management is exploring BP-205 use outside sleep/wake, in cognition, ADHD, mood and fatigue. Source

Revenue and patient growth

• WAKIX revenue grew 17%: Net product revenue reached $215.4 million for the quarter ended March 31, 2026, up from $184.7 million a year earlier, a 17% increase. Source
• Patient count rose to 8,600: Average patients were 8,500 in the first quarter, and the quarter exited with 8,600 average patients. Source
• Market access headwinds weighed on Q1: Management said the first quarter was offset by market access headwinds seen every first quarter, which were more pronounced this year. Source
• Quarter follows three-quarter run: Management said the quarter follows three consecutive quarters that it described as the top three-quarter run in franchise history. Source
• Demand tied to large narcolepsy market: Management attributed demand to a narcolepsy market of about 80,000 diagnosed U.S. patients and to broad payer coverage and patient support over time. Source

Costs, margins and earnings

• Cost of product sold rose to 20.7%: Cost of product sold was $44.5 million, or 20.7% of net product revenue, against 17.3% a year earlier, driven by new royalties under the Novitium license. Source
• R&D rose on license up-front payments: R&D expense was $69.4 million, up 101%, with $32.0 million of up-front license payments made in Q1, a $0.45 per share after-tax impact. Source
• Sales and G&A rose modestly: Sales and marketing was $31.7 million, up 3%; general and administrative expense was $32.5 million, up 4% from a year earlier. Source
• Total operating expenses up 38%: Total operating expenses were $133.6 million, up 38% from $96.5 million in the first quarter of 2025. Source
• Net income fell on license charges: Net income was $32.5 million, or $0.55 diluted EPS, against $45.6 million, or $0.78, in Q1 2025; management attributed the decline to Q1 licensing agreements. Source

“Executing on these four pillars positions us well to deliver innovative treatments for patients and generate long-term value for shareholders”

Jeffrey M. Dayno, M.D., President and Chief Executive Officer

Pitolisant intellectual property and litigation

• Six of seven ANDA filers settled: Three additional ANDA settlements were reached in Q1, bringing the total to six of the seven ANDA filers. Source
• Exclusivity into 2030, possibly 2040s: Management said its multi-layered IP supports WAKIX exclusivity into 2030, including six months of pediatric exclusivity, with potential protection into the 2040s. Source
• Suit filed against AET and Sandoz: Harmony and Novitium sued AET Pharma US and Sandoz in April over an amorphous form of pitolisant hydrochloride patent. Source

Pitolisant lifecycle and pipeline

• Pitolisant GR filing on schedule: Pitolisant GR, with enteric coating, is due for NDA submission in Q2 2026 with a PDUFA date in Q1 2027; management says it allows dosing without titration. Source
• Pitolisant HD data due 2027: Pitolisant HD has Phase 3 trials in narcolepsy and idiopathic hypersomnia, with topline data in 2027 and a PDUFA date in 2028. Source
• Amorphous pitolisant in formulation work: Efforts on the amorphous form focus on formulation optimization and new delivery modes before a Phase 1 PK study. Source
• Prader-Willi readout in second half: A Phase 3 topline readout for pitolisant in Prader-Willi syndrome is expected in 2H 2026, meeting a pediatric exclusivity requirement. Source

“a renewed emphasis on business development with a goal to transact on opportunities with revenue potential in the 2028 - 2032 timeframe”

Jeffrey M. Dayno, M.D., President and Chief Executive Officer

BP-205 and EPX-100 programs

• BP-205 described as most potent: Management describes BP-205 as the most potent OX2R agonist in clinical development, with Phase 1 SAD data and a U.S. IND both planned for mid-2026. Source
• BP-205 Phase 1b planned: A Phase 1b study in sleep-deprived healthy volunteers is planned for the second half of 2026, with uses outside sleep/wake being explored. Source
• EPX-100 Phase 3 trials enrolling: Two global Phase 3 trials in rare epilepsies, LIGHTHOUSE in Lennox-Gastaut and ARGUS in Dravet, are enrolling across four regions. Source
• EPX-100 topline timing set: EPX-100 topline data are anticipated in the first half of 2027, with a potential PDUFA date in 2028. Source

Business development and leadership

• Business development refocused on 2028-2032: Management is focused on transactions with revenue potential in 2028 to 2032, prioritizing assets in Phase 3, in registration or on the market. Source
• Target therapeutic areas named: Areas of interest are sleep/wake, epilepsy, rare or orphan CNS, and CNS adjacencies beyond rare disease. Source
• New COO and CFO named: Peter Anastasiou took the COO role effective April 2, 2026, and Glenn Reicin took the CFO role effective April 14, 2026. Source

Cash and balance sheet

• Cash balance fell to $870.5 million: Cash, equivalents and investments were $870.5 million at March 31, 2026, down from $882.5 million at December 31, 2025, on license and ANDA settlement payments. Source
• Liquidity cited for deal activity: Management cites the liquidity position and balance sheet as support for its business development plans. Source

Coming up, as management said on 7 May 2026

• Pitolisant GR NDA filing: NDA submission for Pitolisant GR is planned for Q2 2026, with an anticipated PDUFA date in Q1 2027. Source
• BP-205 early clinical data: Clinical PK, safety and tolerability data from the BP-205 SAD phase are expected in mid-2026, alongside a planned U.S. IND. Source
• Prader-Willi Phase 3 readout: Phase 3 topline data for pitolisant in Prader-Willi syndrome are expected in the second half of 2026. Source
• BP-205 Phase 1b start: A Phase 1b study of BP-205 in sleep-deprived healthy volunteers is planned to start in the second half of 2026. Source
• EPX-100 Phase 3 topline: Topline data from the EPX-100 Phase 3 program are anticipated in the first half of 2027. Source

Figures management reported

Risks management discussed

• Demand: Management cited market access headwinds in the first quarter, which it said were more pronounced than in prior years. Source
• Regulatory: Management said it will vigorously protect WAKIX intellectual property and filed suit against AET Pharma and Sandoz over a pitolisant patent. Source

Earlier plans management reported on

• On track: Management said it is on track to achieve more than $1 billion in narcolepsy net sales in 2026. Source
• On track: Management said the Pitolisant GR NDA filing is on track for Q2 2026. Source
• On track: Prior quarter materials said Harmony was on track to obtain pediatric exclusivity, which affects generic launch timing.
• On track: Management said clinical PK, safety and tolerability data from the BP-205 SAD phase are on track for mid-2026. Source

Other quarters

• Q2 FY2026 earnings call
• Q4 FY2025 earnings call
• Q3 FY2025 results
• Q2 FY2025 results

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.