WAKIX 2025 Net Revenue of $868.5 Million; 2026 WAKIX Net Revenue Guidance of $1.0 -- $1.04 Billion on Track for Blockbuster Status in Narcolepsy

Recently Completed Settlements with 3 Additional Generic Filers Toward Goal of Securing WAKIX Franchise

Pitolisant GR NDA Submission on Track for Q2 2026; Extends the Pitolisant Franchise into the 2040s

Exploring New Opportunities to Broaden the Pitolisant Franchise Beyond Orphan/Rare into Larger CNS Indications

Potential Best-In-Class Orexin-2 Agonist (BP1.15205) Phase 1 Trial Ongoing; Clinical Data Expected in Mid-2026

Conference Call and Webcast Today at 8:30 a.m. ET

PLYMOUTH MEETING, Pa.--(BUSINESS WIRE)--February 24, 2026-- 

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced earnings with reported revenue of $243.8 million for Q4 2025, representing 21% year-over-year revenue growth for WAKIX$(R)$ . For the full year 2025, the company generated $868.5 million in net product revenue, reflecting continued commercial strength as evidenced by six consecutive years of revenue growth and profitability. The company enters the year with significant momentum, reinforcing its profile as a profitable, self-funding biotech company with a robust, late-stage pipeline and strong long-term growth potential.

"WAKIX is on track to exceed $1 billion in revenue and achieve blockbuster status in 2026, reflecting the strength and durability of the pitolisant franchise. Based on this commercial success and our strong momentum, we see even greater opportunity for pitolisant going forward," said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. "The next-generation formulations of pitolisant are designed to grow our leadership in sleep-wake, extend the lifecycle of pitolisant into the 2040's, expand into additional orphan/rare indications, and now broaden our reach beyond orphan/rare into larger CNS patient populations. Our robust late-stage pipeline, including five ongoing Phase 3 registrational trials across five distinct CNS indications, positions Harmony for multiple near-term catalysts and meaningful long-term value creation."

Fourth Quarter and Full Year 2025 Net Product Revenue for WAKIX

   --  Net product revenue for the quarter ended December 31, 2025, was $243.8 
      million, compared to $201.3 million for the same period in 2024 
 
   --  Average number of patients on WAKIX increased by 400 patients to 
      8,500 patients in Q4 2025; representing the third consecutive quarter of 
      400+ patient adds 
 
   --  Net product revenue for the full year ended December 31, 2025, was 
      $868.5 million, compared to $714.7 million for the full year ended 
      December 31, 2024, representing 22% growth year on year 

Pitolisant Franchise Strategy

WAKIX: On track to achieve blockbuster status in narcolepsy

   --  Net revenue projected between $1.0 billion to $1.04 billion for the 
      full year ending December 31, 2026 
 
   --  Received FDA approval of pediatric cataplexy indication on February 
      13th 
 
          --  Commercial team triggered full promotional efforts immediately 
             upon approval 
 
 
 
   --  Pitolisant in Prader-Willi syndrome $(PWS)$ 
 
          --  Phase 3 topline data readout in 2H 2026 
 
          --  Supports Pediatric Exclusivity for WAKIX: Fulfills the last 
             regulatory requirement for six months of additional regulatory 
             exclusivity on top of the longest patent for WAKIX 
 
 

ANDA Litigation Update

   --  Recently completed settlements with 3 additional generic filers 
      bringing the total to six of the seven ANDA filers 
 
   --  The settling parties will receive licenses to launch their generic 
      products no earlier than March 2030 if Harmony is granted pediatric 
      exclusivity, which it is on track to obtain 

Pitolisant GR (gastro-resistant): On track to extend pitolisant franchise into the 2040s

   --  NDA submission in Q2 2026; anticipated PDUFA date in Q1 2027 
 
          --  Approximately 80-90% of patients with narcolepsy experience GI 
             symptoms; pitolisant GR is designed to minimize the worsening of 
             these symptoms 
 
          --  Ability to initiate treatment at therapeutic dose with no 
             titration 
 
 
 
   --  Utility patents filed to extend franchise into the 2040s 

Pitolisant HD (high dose): Opportunity to expand pitolisant franchise with differentiated rare indications

   --  Phase 3 registrational clinical trials ongoing in narcolepsy (ONSTRIDE 
      1) and idiopathic hypersomnia (ONSTRIDE 2) 
 
          --  Topline data in 2027; anticipated PDUFA date in 2028 
 
          --  Enhanced formulation with optimized PK profile, GR coating and 
             higher dose to drive greater efficacy 
 
          --  Differentiated indications: fatigue in narcolepsy and sleep 
             inertia in IH 
 
 
 
   --  Utility patents filed to expand franchise into the 2040s 

Exploring new pitolisant formulation to pursue broader indications in CNS patient populations in which fatigue is a prominent symptom

   --  Mechanism-based approach supported by clinical data for pitolisant in 
      fatigue 
 
   --  Currently planning MS fatigue as the lead indication; follow on 
      indications under consideration include fatigue in Parkinson's disease 
      and post-stroke fatigue 
 
   --  Current efforts focused on formulation optimization and new modes of 
      delivery towards a phase 1 PK study 
 
   --  Licensed IP with patent protection until 2042 

Robust Pipeline

Orexin-2 receptor agonist (BP1.15205)

   --  Phase 1 clinical study ongoing; anticipates clinical PK data in 
      mid-2026 
 
   --  Potential best-in-class orexin-2 receptor agonist based on a novel 
      chemical scaffold, preclinical potency, selectivity, safety and efficacy 
      data, and potential for once-a-day dosing 

EPX-100 (clemizole hydrochloride)

   --  One of the most advanced development programs in the 5HT2 (serotonin) 
      agonist class 
 
   --  Enrollment ongoing for Phase 3 registrational trial in Dravet syndrome 
      (ARGUS Study) with topline data anticipated in 1H 2027 
 
          --  Safety and effectiveness data from the open-label extension 
             study in DS was presented at AES meeting in December 2025 
 
 
 
   --  Enrollment ongoing for Phase 3 registrational trial in patients with 
      Lennox-Gastaut syndrome (LIGHTHOUSE Study) with topline data anticipated 
      in 1H 2027 

Fourth Quarter 2025 Financial Results

Harmony Biosciences reported net product revenue of $243.8 million for the quarter ended December 31, 2025, compared to $201.3 million for the same period in 2024, representing 22% year-over-year growth. This performance reflects both continued demand for WAKIX within the large narcolepsy market opportunity (approximately 80,000 diagnosed patients in the U.S.) and the product's broad clinical utility. The continued success has been driven by strong execution across the organization from sales effectiveness to marketing and promotion and supported by broad payer coverage and how the company supports patients over time.

On a GAAP basis, net income for the quarter was $22.5 million, or $0.38 per diluted share, compared to $49.5 million, or $0.85 per diluted share, in Q4 2024. Non-GAAP adjusted net income, which we believe better reflects our core business performance, was $33.4 million ($0.57 per diluted share) for the fourth quarter of 2025 versus $64.2 million ($1.10 per diluted share) for the comparable 2024 period.

Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included at the end of this press release.

Harmony's operating expenses include the following:

   --  Research and Development expenses were $49.9 million in the fourth 
      quarter of 2025, as compared to $34.7 million for the same quarter in 
      2024, representing a 44% increase; 
 
   --  Sales and Marketing expenses were $29.2 million in the fourth quarter 
      of 2025, as compared to $27.6 million for the same quarter in 2024, 
      representing a 6% increase; 
 
   --  General and Administrative expenses were $57.6 million in the fourth 
      quarter of 2025, as compared to $28.9 million for the same quarter in 
      2024, representing a 99% increase; and 
 
   --  Total Operating Expenses were $136.7 million in the fourth quarter of 
      2025, as compared to $91.1 million for the same quarter in 2024, 
      representing a 50% increase. 

Full Year 2025 Financial Results

Net product revenues for the year ended December 31, 2025, were $868.5 million, compared to $714.7 million for the same period in 2024. The 22% growth versus the same period in 2024 is primarily attributed to strong commercial sales of WAKIX driven by continued organic demand tapping into a large market opportunity (approximately 80,000 patients diagnosed with narcolepsy in the U.S.) and the broad clinical utility of WAKIX across the approximately 9,000 HCPs that we call on (about 5,000 of whom do not participate in an oxybate REMS program).

GAAP net income for the year ended December 31, 2025, was $158.7 million, or $2.71 earnings per diluted share, compared to GAAP net income of $145.6 million, or $2.51 earnings per diluted share, for the same period in 2024. Non-GAAP adjusted net income was $211.0 million, or $3.60 earnings per diluted share, for the year ended December 31, 2025, compared to Non-GAAP adjusted net income of $196.7 million, or $3.40 per diluted share, for the same period in 2024.

Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included at the end of this press release.

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February 24, 2026 07:30 ET (12:30 GMT)