Harmony Biosciences Holdings, Inc. HRMY reported second-quarter 2026 earnings of $1.28 per share, up from 68 cents in the year-ago quarter. The figure surpassed the Zacks Consensus Estimate of 97 cents.
Quarterly revenues rose 30% year over year to $261.28 million and surpassed the Zacks Consensus Estimate of $253 million. Growth was driven by sustained demand for lead drug, Wakix (pitolisant), with the estimated average patient count increasing by 450 sequentially to 8,950.
Shares gained 8.9% following the results. Year to date, shares of HRMY have risen 3.6% compared with the industry’s 0.8% gain.
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HRMY Q2 Cost Analysis
Cost of products sold represented 24.2% of product revenues compared with 19% in the prior-year quarter, primarily due to new royalties tied to the Novitium license agreement.
Research and development expenses declined 7.1% to $46.6 million, reflecting the absence of a $15-million CiRC upfront payment recorded a year ago. Sales and marketing expenses increased 13.5% to $34.1 million due to the expansion of field-based teams.
General and administrative expenses decreased 17.3% to $28.1 million due to a charge related to an ANDA settlement in the second quarter of 2025.
Cash, cash equivalents and investments totaled $962.5 million as of June 30, 2026, up from $882.5 million as of 2025-end.
Harmony Pipeline Updates Highlight BP-205
In April 2024, the company expanded into orexin-based therapies through a sublicense agreement with Bioprojet for BP-205, an investigational orexin-2 receptor agonist being developed for narcolepsy and other central nervous system (CNS) disorders.
The agreement grants exclusive rights to develop, manufacture and commercialize BP-205 in the United States and Latin America.
Harmony reported favorable phase I single-ascending-dose data for BP-205, its orexin-2 receptor agonist. The candidate demonstrated a short time to maximum plasma concentration (30-75 minutes) and a mean half-life of approximately 25 hours, supporting the potential for rapid onset and once-daily dosing.
Exposure increased proportionally across the tested doses. BP-205 was generally safe and well tolerated, with no serious or severe treatment-emergent adverse events.
Multiple-ascending-dose data in healthy volunteers are expected in the fourth quarter of 2026. Harmony also plans to begin a phase Ib study in sleep-deprived healthy volunteers during the third quarter, with data expected in early 2027. Phase II studies across multiple central nervous system indications are scheduled to begin in mid-2027.
HRMY Advances Pitolisant and Epilepsy Assets
The FDA accepted the new drug application for pitolisant GR, assigning a target action date of April 1, 2027. The gastro-resistant formulation is designed to reduce gastrointestinal side effects and allow patients to begin treatment at a therapeutic dose without titration.
Harmony is pursuing label expansion opportunities for pitolisant beyond narcolepsy, targeting rare neurological disorders such as Prader-Willi syndrome (PWS) and myotonic dystrophy type 1 (DM1).
Phase III ONSTRIDE studies of high-dose pitolisant in narcolepsy and idiopathic hypersomnia remain underway, with top-line data expected in 2027. Top-line results are expected in mid-2027.
The company is conducting the phase III TEMPO study in PWS, supported by FDA alignment, which has the potential to serve as the registrational trial and support the company’s efforts to seek pediatric exclusivity for pitolisant.
The FDA granted Orphan Drug designation to pitolisant for the treatment of PWS in 2024.
The company also strengthened its rare epilepsy pipeline by acquiring Epygenix Therapeutics, gaining exclusive rights to develop EPX-100 (clemizole hydrochloride) for Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS).
EPX-100 is being evaluated in the phase III LIGHTHOUSE study for LGS and the ARGUS study for DS. Top-line results from both rare-epilepsy programs are expected in the first half of 2027, with potential regulatory action targeted for 2028.
Harmony Reiterates 2026 Revenue Outlook
Harmony reaffirmed its 2026 Wakix net revenue guidance of $1 billion to $1.04 billion.
Wakix net product revenues rose 21% sequentially in the second quarter, reflecting a rebound from the seasonal market-access headwinds that affected patient starts during the first quarter.
Management expects patient growth to continue steadily through the second half of the year, supported by the expanded commercial infrastructure.
The average patient increase was the second highest in the product’s seven-year commercial history. Four of the past five quarters generated more than 400 patient additions, indicating steady demand within the narcolepsy market.
Management attributed the strong performance to Wakix’s0020position as the only nonscheduled treatment option for narcolepsy. The product has payer coverage for more than 80% of covered lives and is used both as a standalone therapy and in combination with other narcolepsy therapies.
Our Take on HRMY’s Q2 Performance
HRMY delivered a strong second quarter, beating earnings and revenue estimates on robust demand for Wakix, while reaffirming its full-year revenue outlook. The company continues to generate healthy cash flows, providing ample resources to advance its pipeline.
Wakix remains the key growth driver, supported by rising patient additions, broad payer coverage and its differentiated profile as the only non-scheduled treatment for narcolepsy.
While Harmony remains heavily dependent on Wakix, its expanding pipeline, strong balance sheet and multiple near-term regulatory and clinical catalysts strengthen its long-term growth outlook.
HRMY’s Zacks Rank and Other Stocks to Consider
HRMY currently sports a Zacks Rank #1 (Strong Buy). A couple of other top-ranked stocks from the sector are Liquidia Corporation LQDA and Novavax NVAX, each sporting a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share (EPS) have increased from $2.97 to $3.02. Over the same period, EPS estimates for 2027 have increased from $4.81 to $5.31.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Novavax’s 2026 loss per share is unchanged at 20 cents. Over the same period, loss per share estimates for 2027 have narrowed from 26 cents to 25 cents.
Novavax’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 305.24%.
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Liquidia Corporation (LQDA): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).
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