Harmony Biosciences (NASDAQ:HRMY) reported fourth-quarter and full-year 2025 results highlighting continued growth for WAKIX and an expanding late-stage central nervous system (CNS) pipeline. Management said sustained demand for WAKIX, recent pediatric label expansion, and ongoing lifecycle initiatives position the company to reach “blockbuster” revenue in 2026, while cash generation is funding a broad set of Phase 3 programs and business development efforts.
WAKIX revenue growth and 2026 outlook
CEO Dr. Jeffrey Dayno said Harmony delivered $243.8 million in fourth-quarter net product revenue, up from $201.3 million in the prior-year period, driven by “continued strong demand” for WAKIX. Management noted the quarter marked the third consecutive quarter with approximately 400-plus average patient adds, bringing the franchise to about 8,500 average patients on WAKIX.
Looking ahead, the company reiterated guidance for 2026 WAKIX net revenue of $1.0 billion to $1.04 billion, which management characterized as achieving blockbuster status for the first time in franchise history. CFO Sandeep Kapadia cautioned that first-quarter 2026 revenue is expected to show typical industry seasonality, including higher gross-to-net deductions tied to insurance resets and higher copay obligations, along with potential trade inventory drawdowns.
Commercial execution and pediatric cataplexy approval
Chief Commercial Officer Adam Zaeske attributed the sustained momentum to WAKIX’s “highly differentiated” profile as the only non-scheduled treatment option, along with strong brand awareness, perceived efficacy and tolerability, and stable payer coverage. He said the company has refined field deployment and call planning, improved messaging and targeted promotion, secured “new payer wins,” and implemented patient support processes intended to shorten time-to-dispense and improve conversion.
Zaeske also said Harmony is expanding field-based teams by nearly 20% across field sales, field reimbursement, and remote sales, describing the investment as aimed at “continuing to grow WAKIX today.” He added that field reimbursement headcount is planned to increase by more than 50%, while field sales and remote sales teams are expected to grow by more than 10% each, with hiring targeted to be in place by the end of the quarter.
On the label front, management highlighted the FDA approval (February 13) of WAKIX for cataplexy in pediatric patients six years of age and older with narcolepsy. Kumar Budur, Chief Medical and Scientific Officer, said WAKIX is now approved for both excessive daytime sleepiness and cataplexy in adults and children six and older. Zaeske said pediatric narcolepsy represents about 5% of the total narcolepsy population, and characterized the approval as an important addition that provides greater flexibility for prescribers. He said commercial teams began executing prepared promotional plans on the day of approval.
Intellectual property and generic litigation update
Dayno said Harmony recently settled with three generic filers, bringing the total to six of seven abbreviated new drug application (ANDA) filers. Based on those settlements, management said generic entry would occur no sooner than March 2030 if pediatric exclusivity is granted, which the company said it is on track to obtain. In Q&A, management confirmed that without pediatric exclusivity, market entry would be September 2029.
Management also referenced an ongoing trial involving the remaining filer, saying the company remains confident in the strength of its intellectual property and will continue to defend it. Executives noted a stay is in place extending to February 2027, and that both sides would have access to an appeals process following an outcome, though they said the timing of a ruling is difficult to predict.
Lifecycle strategy: pitolisant GR, pitolisant HD, and a new fatigue-focused formulation
Harmony outlined multiple efforts to extend and expand the pitolisant franchise. Budur said pitolisant GR demonstrated bioequivalence to WAKIX and is intended to allow initiation at a therapeutic dose range of 17.8 mg without titration. The company said it remains on track to submit an NDA in Q2 2026 with a target PDUFA date in Q1 2027. Zaeske said the company views GR as a fast-to-market line extension and described a strategy focused on new patients as well as recontacting prior WAKIX patients where consent was obtained.
Pitolisant HD, an enhanced formulation with a higher dose and optimized pharmacokinetics, is being evaluated in two Phase 3 registrational trials: ONSTRIDE 1 in narcolepsy and ONSTRIDE 2 in idiopathic hypersomnia (IH). Budur said each study targets approximately 200 patients and is designed to pursue differentiated labels, including fatigue in narcolepsy and sleep inertia in IH. Management said it is confident in timelines for top-line data in 2027 and a potential PDUFA in 2028, acknowledging competition for patients but citing the company’s experience with sites and investigators.
Separately, management said it has a newly licensed, issued patent through 2042 supporting exploration of a new pitolisant formulation aimed at broader CNS indications where fatigue is prominent. Budur said the company plans to evaluate fatigue in multiple sclerosis as a lead indication and may explore post-stroke fatigue and fatigue in Parkinson’s disease. He cited prior clinical signals for pitolisant on fatigue, including in a myotonic dystrophy study (with reported clinically meaningful improvement and dose response) and in patients with residual excessive daytime sleepiness in obstructive sleep apnea. Current efforts are focused on formulation optimization, potential modes of delivery, and preparation for a Phase 1 pharmacokinetic study.
On intellectual property for lifecycle products, management said pitolisant GR and pitolisant HD have utility patents filed “out to 2044,” while the new formulation is supported by an issued patent licensed through 2042.
Pipeline progress: orexin agonist and epilepsy programs
Beyond pitolisant, management provided updates on two key programs:
- BP1.15205 (orexin 2 receptor agonist): Budur said the compound is enrolling in a Phase 1 study, with Phase 1 pharmacokinetic data expected in mid-2026. He added the company plans to begin a sleep-deprived healthy volunteer study in the second half of the year and is considering indications beyond central disorders of hypersomnia, including neuropsychiatric opportunities related to cognition and mood.
- EPX-100 (epilepsy): Budur said EPX-100 is advancing in two global Phase 3 registrational programs: Dravet syndrome (ORCHEST) and Lennox-Gastaut syndrome (LIGHTHOUSE), with top-line data expected in the first half of 2027 and potential PDUFA in 2028. He also discussed open-label extension data presented at the AES meeting in December 2025, stating patients with at least six months of exposure showed approximately 50% median reduction in seizures (CMS-28), with at least 50% reduction in about half of patients, and that EPX-100 was generally well tolerated without additional laboratory or special monitoring requirements.
Management also briefly discussed EPX-200 (liquid lorcaserin), saying pre-IND work is underway and that the company aims to leverage existing safety and efficacy datasets to pursue an accelerated development approach in developmental and epileptic encephalopathies.
Financially, Kapadia said fourth-quarter operating expenses rose to $136.7 million from $91.1 million a year earlier, driven by R&D investments, commercialization spending, and ANDA litigation and settlement expenses. He reported non-GAAP adjusted net income of $33.4 million, or $0.57 per diluted share, compared with $64.2 million, or $1.10 per diluted share, in the prior-year quarter. Harmony ended the quarter with $882.5 million in cash, cash equivalents, and investments, reflecting $348.2 million in cash from operations in 2025. Management said it expects increased R&D investment as it advances five ongoing registrational Phase 3 programs and plans for a sixth Phase 3 study anticipated to start later in the year, while continuing to prioritize business development alongside existing share repurchase capacity.
About Harmony Biosciences (NASDAQ:HRMY)
Harmony Biosciences Holdings, Inc is a commercial‐stage biopharmaceutical company focused on developing and delivering therapies for people with rare neurological and endocrine diseases. Founded in 2017 and headquartered in Plymouth Meeting, Pennsylvania, Harmony Biosciences went public in 2020 and trades on the Nasdaq under the ticker HRMY. The company’s mission centers on identifying and advancing medicines that address critical unmet needs in patient populations underserved by existing treatments.
The company’s flagship product is WAKIX (pitolisant), the first and only histamine H3 receptor antagonist/inverse agonist approved by the U.S.
