Harmony Biosciences NASDAQ: HRMY reported third-quarter net revenue of $269 million, up from $239 million a year earlier, as demand for its narcolepsy treatment WAKIX continued to grow. The company reiterated its full-year WAKIX net revenue guidance of $1 billion to $1.04 billion and said it expects to exceed $1 billion in annual WAKIX revenue for the first time.
The company also reported preliminary multiple ascending dose data for BP-205, its orexin-2 receptor agonist in development, and discussed plans to advance the program into additional studies in 2027. Separately, Harmony outlined its approach to business development, ongoing efforts to defend WAKIX intellectual property, and a planned executive transition at the end of the year.
WAKIX Demand Supports Revenue Growth
WAKIX generated $269 million in third-quarter net product revenue, with approximately 9,350 average patients receiving the treatment during the quarter. The company added 400 net patients, which Chief Commercial Officer Adam Zaeske said marked the fifth quarter out of the last six in which WAKIX added at least 400 patients.
Zaeske said WAKIX remains the only non-scheduled treatment option for excessive daytime sleepiness and cataplexy in adult and pediatric narcolepsy patients. He cited more than 80% payer coverage and the product's use across narcolepsy type 1 and type 2 patients as drivers of continued demand.
Harmony expanded its field sales, remote sales, reimbursement and patient outreach teams during the second quarter. Zaeske said the company is seeing higher healthcare-provider engagement and that changes to reimbursement and patient-support programs have shortened the time needed for patients to fill prescriptions.
In response to an analyst question about Takeda's anticipated ORZEYFUL launch, Zaeske said Harmony expects WAKIX's performance drivers to remain in place. He noted that ORZEYFUL is expected to be indicated only for narcolepsy type 1, while WAKIX is used across both narcolepsy types and in adults and pediatric patients.
BP-205 Data and Pipeline Plans
Harmony released preliminary results from the multiple ascending dose portion of its Phase I study of BP-205. The 14-day randomized, double-blind, placebo-controlled study evaluated once-daily doses ranging from 0.1 milligrams to 3 milligrams in 94 healthy volunteers.
Chief Medical and Scientific Officer Kumar Budur said the preliminary data showed a pharmacokinetic profile consistent with the earlier single ascending dose study. The mean time to maximum concentration was about 60 minutes, while the mean effective half-life was about 29 hours, which the company said supports the potential for once-daily dosing.
The most common adverse event was headache, reported in about 25% of participants. Insomnia occurred in fewer than 20% of participants at all doses studied, while urinary frequency and urgency were reported in fewer than 20% of participants and only at the 1-milligram and 3-milligram doses. Budur said these events were mild and did not result in discontinuations. The company reported no serious or severe treatment-emergent adverse events, no liver or visual adverse events, and no clinically significant cardiovascular events or EKG abnormalities.
Harmony initiated a Phase Ib study in sleep-deprived healthy volunteers during the third quarter, with top-line data expected in the first quarter of 2027. The company said that study is expected to provide the first efficacy signals for BP-205 and help inform dose selection for planned Phase II studies across multiple central nervous system indications beginning in mid-2027.
- Pitolisant GR has an FDA PDUFA date of April 1, 2027, with a planned first-half 2027 launch if approved.
- Pitolisant HD Phase III studies in narcolepsy and idiopathic hypersomnia are ongoing, with top-line data expected in 2027 and a targeted PDUFA date in 2028.
- The Phase III TEMPO study of WAKIX in Prader-Willi syndrome is recruiting, with top-line data expected in mid-2027.
- EPX-100 is enrolling patients in Phase III studies in Lennox-Gastaut syndrome and Dravet syndrome, with top-line data expected in mid-2027.
Profitability, Cash Position and Business Development
Harmony reported third-quarter net income of $48 million, or $0.81 per diluted share, compared with $51 million, or $0.87 per diluted share, in the prior-year period. Cost of products sold rose to 30% of net revenue from 25% a year earlier, primarily due to a royalty associated with the Novitium license agreement signed in the first quarter.
Total operating expenses increased to $134 million from $114 million. Interim Principal Financial Officer Steve Mollichella attributed the increase primarily to a $25 million milestone charge related to MSN Labs, continued research and development investment, and expansion of the field-based team. Harmony ended the quarter with more than $1 billion in cash equivalents and investments and $150 million in debt.
Incoming President and CEO Peter Anastasiou said Harmony is pursuing business-development opportunities that could provide near-term revenue between 2028 and 2032, including Phase III, registration-stage or marketed assets. The company is also evaluating earlier innovative pipeline assets for long-term growth, with areas of interest including sleep disorders, epilepsy, rare orphan CNS conditions and broader CNS indications.
Patent Defense and CEO Transition
Harmony said it has settled with six of seven abbreviated new drug application filers and continues to defend its pitolisant intellectual property in litigation involving AET Pharma US and Sandoz. The company said it expects a ruling in the AET ANDA litigation around the expiration of the 30-month stay in February 2027.
A preliminary injunction hearing related to Harmony's amorphous pitolisant patent is scheduled for Jan. 26, 2027, with an expected decision by Feb. 14, 2027. Anastasiou said the company remains confident that its intellectual-property strategy supports WAKIX exclusivity through March 2030, including six months of potential pediatric exclusivity.
President and CEO Jeffrey Dayno will step down at the end of 2026, with Anastasiou succeeding him as president and chief executive officer on Jan. 1, 2027. Dayno will remain an advisor to the company through 2027.
About Harmony Biosciences (NASDAQ:HRMY)
Harmony Biosciences Holdings, Inc is a commercial-stage biopharmaceutical company focused on developing and providing therapies for patients with rare neurological disorders. The company's activities center on conditions involving sleep-wake regulation and other central nervous system disorders where treatment options may be limited.
Harmony's principal product is WAKIX (pitolisant), an oral, non-scheduled treatment that acts as a histamine-3 receptor antagonist/inverse agonist. In the United States, WAKIX is approved for the treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy and for excessive daytime sleepiness in pediatric patients aged 6 and older with narcolepsy.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.
Before you consider Harmony Biosciences, you'll want to hear this.
MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Harmony Biosciences wasn't on the list.
While Harmony Biosciences currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys.
View The Five Stocks Here
Nuclear energy is entering a new growth cycle as rising power demand, expanding data centers, and renewed policy support bring the sector back into focus. After strong gains in recent years, the most impactful phase of nuclear investment may still be ahead. This report highlights seven nuclear energy stocks positioned across the value chain—combining near-term revenue with long-term upside as next-generation technologies scale. Click the link below to unlock the full list.
Get This Free Report
Continue following MarketBeat
Add MarketBeat as your preferred source on Google to see our latest stories in your feed.
