Harmony Biosciences (NASDAQ:HRMY) reported second-quarter net revenue of $261.3 million, up 30% from the prior-year period and 21% sequentially, as sales of its narcolepsy treatment WAKIX rebounded from seasonal market-access pressures earlier in the year.
The company reiterated its 2026 net revenue guidance of $1 billion to $1.04 billion. Net income for the quarter rose to $75.4 million, or $1.28 per diluted share, from $39.8 million, or $0.68 per diluted share, a year earlier.
WAKIX Growth and Commercial Initiatives
Chief Executive Officer Jeffrey Dayno said WAKIX generated record quarterly net revenue and remained on track to surpass $1 billion in annual revenue. He said the second-quarter performance marked a rebound from elevated insurance-plan changes, plan switching and premium increases that delayed some patient starts during the first quarter.
Chief Commercial Officer Adam Zaeske said WAKIX reached an estimated average of 8,950 patients during the quarter, an increase of about 450 patients from the first quarter. He described the increase as the highest second-quarter patient gain in the brand’s history and its second-largest quarterly gain overall.
Zaeske said WAKIX benefits from its position as the only non-scheduled treatment option for narcolepsy, as well as broad payer coverage representing more than 80% of covered lives. Harmony estimated that approximately 170,000 people have narcolepsy, with diagnosis rates below 50% and WAKIX penetration at roughly 20%.
During the quarter, the company completed the deployment of an expanded commercial organization, increasing its field sales, remote sales and field reimbursement presence by about 20%. Harmony also launched an online prescribing portal and made changes to its reimbursement-support process, which Zaeske said were helping patients secure treatment faster and with higher success rates.
BP-205 Phase I Data and Development Plans
Harmony reported results from the single-ascending-dose portion of a Phase I study of BP-205 in 72 healthy volunteers. The randomized, double-blind, placebo-controlled trial evaluated single doses ranging from 0.2 milligrams to 6 milligrams across nine cohorts.
Chief Medical and Scientific Officer Kumar Budur said BP-205 demonstrated rapid absorption, with time to maximum concentration ranging from 30 to 75 minutes, and a mean half-life of approximately 25 hours across dose groups. He said the profile could support once-daily dosing and sustained effects through the day and into the early evening.
The company reported dose-proportional exposure across maximum concentration and area-under-the-curve measures, with no reported age- or gender-related differences in pharmacokinetic parameters. No serious or severe treatment-emergent adverse events were reported in the single-dose study, according to Harmony, and the company said it observed no cardiovascular, hepatic or visual abnormalities.
The most common adverse events were headache in approximately 10% of participants, fatigue in about 4%, and diarrhea in about 3%, Budur said.
Management characterized BP-205 as a potential best-in-class orexin-2 receptor agonist, citing its potency and selectivity. Budur said the compound showed more than 600-fold selectivity for orexin-2 receptors over orexin-1 receptors and more than 1,000-fold selectivity over more than 100 other receptors studied preclinically.
During the question-and-answer session, Budur said preliminary multiple-ascending-dose findings included transient insomnia and polyuria, which he described as potential mechanism-related effects. He said neither was serious nor sustained, while noting that the company would provide a fuller dataset in the fourth quarter.
Harmony said its U.S. investigational new drug application for BP-205 is open and that it expects to begin a Phase Ib trial in sleep-deprived healthy volunteers in the third quarter. The company expects the study to provide its first efficacy signals for the drug. It plans to initiate Phase II trials in multiple CNS indications in mid-2027.
Pipeline Updates and Patent Strategy
Harmony said the FDA accepted its new drug application for pitolisant GR for full review, assigning a target action date of April 1, 2027. The formulation is designed to allow patients to begin at a therapeutic dose of 17.8 milligrams without titration and to reduce the potential for gastrointestinal adverse events.
The company is also advancing pitolisant HD in two Phase III registrational studies: ONSTRIDE-1 in narcolepsy and ONSTRIDE-2 in idiopathic hypersomnia. Top-line data are expected in 2027, with a potential FDA action in 2028, according to management.
For its other late-stage programs, Harmony said top-line data from its TEMPO study in Prader-Willi syndrome are now expected in mid-2027, delayed because of challenges enrolling patients meeting the study’s sleepiness criteria. The company also expects mid-2027 data from Phase III studies of EPX-100 in Dravet syndrome and Lennox-Gastaut syndrome.
Chief Operating Officer Peter Anastasiou said Harmony had settled with six of seven abbreviated new drug application filers related to WAKIX. The remaining litigation involves AET Pharma US, including disputes over the company’s polymorph and method-of-use patents. Closing arguments in the ANDA litigation are scheduled for Oct. 22, he said.
Harmony and Novitium also filed a separate infringement lawsuit in April against AET Pharma US and Sandoz involving a patent for an amorphous form of pitolisant hydrochloride. Anastasiou said the company believes its intellectual property estate supports WAKIX exclusivity through March 2030, including anticipated pediatric exclusivity.
Financial Position and Business Development
Interim Principal Financial Officer Stephen Mollichella said cost of products sold rose to 24.2% of net revenue from 19% a year earlier, primarily due to new royalties tied to Harmony’s Novitium license agreement. Total operating expenses declined to $108.8 million from $114.2 million, largely because the prior-year quarter included a $15 million upfront payment to CIRC.
Harmony ended the quarter with $962.5 million in cash equivalents and investments and $155 million in debt. Management said it expects continued strong cash generation but intends to use capital for pipeline investment and business development.
Anastasiou said the company is evaluating acquisitions and licensing opportunities, primarily for assets with potential revenue contributions between 2028 and 2032, with a focus on sleep-wake disorders, epilepsy, rare CNS conditions and broader CNS markets.
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.
