WAKIX® (pitolisant) Net Revenue of $201.3 Million for Fourth Quarter and $714.7 Million for Full Year 2024; Representing Growth of 23% in Year-Five on the Market
2025 WAKIX Net Revenue Guidance Between $820 – $860 Million; On Track Toward a Potential $1 Billion+ Opportunity
Committed to Leadership in Sleep/Wake with Next Generation Pitolisant Formulations and Orexin 2 Receptor Agonist; Phase 3 Registrational Trials with Pitolisant HD in Narcolepsy and IH to Initiate in Q4 2025
Topline Data Readout from Phase 3 Registrational Trial with ZYN002 in Fragile X Syndrome On Track for Q3 2025
Pitolisant Patent Position Strengthened with Favorable Settlement of First Generic Litigation
Conference Call and Webcast to be Held Today at 8:30 a.m. ET
PLYMOUTH MEETING, Pa.–(BUSINESS WIRE)–Feb. 25, 2025– Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced a record $201.3 million in net product revenues for the fourth quarter 2024, and full year 2024 net revenues of $714.7 million, ending the year with $576 million in cash, cash equivalents and investments on the balance sheet. The company has guided 2025 WAKIX® net revenues to $820 – $860 million, targeting a $1B+ opportunity with WAKIX in narcolepsy alone.
“2025 is set up to be a transformational year for Harmony, as our robust, late-stage pipeline comes into focus and we advance our long-term growth strategy,” said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. “This year will bring major milestones for Harmony, with the topline data readout from our Phase 3 registrational trial with ZYN002 in Fragile X syndrome expected in Q3 and the potential, if successful, to bring the first approved treatment to the Fragile X patient community. In Q4, we will be initiating two Phase 3 registrational trials with our next gen Pitolisant HD formulation in both narcolepsy and idiopathic hypersomnia, potentially extending the pitolisant franchise out to the 2040s and further solidifying our leadership in sleep/wake. Taken together, these catalysts underscore the importance of 2025 as a pivotal year in Harmony’s long-term growth strategy. With at least one new product candidate or indication launch each year over the coming years, our pipeline has the potential to deliver over $3 billion in net revenue as the leading CNS company focused on developing and delivering innovative treatments for patients with unmet needs.”
Franchise Highlights
Sleep/Wake Franchise
WAKIX in Narcolepsy
- Net Sales were $201.3M for Q4 2024 and $714.7M for FY 2024
- 2025 Net Revenue projected between $820 to $860 million
- Settlement reached in first Abbreviated New Drug Application (ANDA) litigation, giving Novugen Pharma a license to sell its generic product beginning in January 2030 or earlier under certain circumstances
- This settlement reinforces the strength and durability of Harmony’s intellectual property portfolio and its vigorous defense of its patent estate
- On track to obtain pediatric exclusivity which, if granted, would add an additional 6 months of regulatory exclusivity
Pitolisant HD (high-dose)
- Higher dose and optimized pharmacokinetic profile designed to address the need for greater efficacy in excessive daytime sleepiness (EDS) and other symptoms in patients with central disorders of hypersomnolence
- Phase 3 registrational trial in narcolepsy to include endpoint on narcolepsy-related fatigue in pursuit of differentiated label
- Trial to initiate in Q4 2025; topline data readout anticipated in 2027 with potential PDUFA date in 2028
- Phase 3 registrational trial in IH to include endpoint on sleep inertia in pursuit of differentiated label
- Trial to initiate in Q4 2025; topline data readout anticipated in 2027 with potential PDUFA date in 2028
- Provisional IP filed out to 2044 for narcolepsy and IH
Pitolisant GR (gastro-resistant)
- Pivotal bioequivalence study on track to initiate Q1 2025
- Topline data readout anticipated in Q3 2025 with potential PDUFA in 2026
- Provisional IP filed out to 2044
Orexin-2 receptor agonist (BP1.15205)
- Potential to be best-in-class orexin-2 receptor agonist based on a novel chemical scaffold, preclinical potency, selectivity and safety data, as well as its potential for once-a-day dosing
- Preclinical safety and efficacy data to be presented at SLEEP 2025 (June)
- IMPD submission on track for mid-2025; first-in-human study expected to initiate 2H 2025
Neurobehavioral Franchise
ZYN002
- Innovative product profile: pharmaceutically manufactured synthetic cannabidiol devoid of THC
- The RECONNECT study is designed to confirm the positive findings from the prespecified analysis of the primary outcome in the subgroup of patients with complete methylation from the Phase 2/3 CONNECT study
- Potential to be the first and only approved treatment for patients with Fragile X syndrome (FXS) (80,000 patients in the U.S.), and also possess global rights
- Topline data readout from Phase 3 registrational trial of ZYN002 in FXS (RECONNECT study) in Q3 2025 with potential PDUFA date in 2026
- Phase 3 registrational trial in 22q11.2 deletion syndrome (22q) to initiate in 2025
Rare Epilepsy Franchise
EPX-100 (clemizole hydrochloride}
- Most advanced development program in the 5HT2 (serotonin) agonist class
- Topline data readout from Phase 3 registrational trial in Dravet syndrome (ARGUS Study) anticipated in 2026
- Topline data for Phase 3 registrational trial in patients with Lennox-Gastaut syndrome (LIGHTHOUSE study) anticipated in 2026
EPX-200 (lorcaserin hydrochloride)
- Proven mechanism of action in developmental and epileptic encephalopathies (DEEs) confirmed via non-clinical and clinical data
- Currently in IND enabling stage
Fourth Quarter 2024 Financial Results
Net product revenues for the quarter ended December 31, 2024, were $201.3 million, compared to $168.4 million for the same period in 2023. The 20% growth versus the same period in 2023 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). The average number of patients on WAKIX increased by approximately 300 sequentially to approximately 7,100 for the quarter ended December 31, 2024.
GAAP net income for the quarter ended December 31, 2024, was $49.5 million, or $0.85 earnings per diluted share, compared to GAAP net income of $26.6 million, or $0.45 earnings per diluted share, for the same period in 2023. Non-GAAP adjusted net income was $63.0 million, or $1.08 earnings per diluted share, for the quarter ended December 31, 2024, compared to Non-GAAP adjusted net income of $42.8 million, or $0.73 per diluted share, for the same period in 2023.
Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included at the end of this press release.
Harmony’s operating expenses included the following:
- Research and Development expenses were $34.7 million in the fourth quarter of 2024, as compared to $30.3 million for the same quarter in 2023, representing a 14% increase;
- Sales and Marketing expenses were $27.6 million in the fourth quarter of 2024, as compared to $26.9 million for the same quarter in 2023, representing a 3% increase;
- General and Administrative expenses were $28.9 million in the fourth quarter of 2024, as compared to $27.9 million for the same quarter in 2023, representing a 4% increase; and
- Total Operating Expenses were $91.1 million in the fourth quarter of 2024, as compared to $85.1 million for the same quarter in 2023, representing a 7% increase.
Full Year 2024 Financial Results
Net product revenues for the year ended December 31, 2024, were $714.7 million, compared to $582.0 million for the same period in 2023. The 23% growth versus the same period in 2023 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, 2024, was $145.5 million, or $2.51 earnings per diluted share, compared to GAAP net income of $128.9 million, or $2.13 earnings per diluted share, for the same period in 2023. Non-GAAP adjusted net income was $233.9 million, or $4.04 earnings per diluted share, for the year ended December 31, 2024, compared to Non-GAAP adjusted net income of $188.4 million, or $3.12 per diluted share, for the same period in 2023.
Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included at the end of this press release.
Harmony’s operating expenses included the following:
- Research and Development expenses were $145.8 million for the year ended December 31, 2024, as compared to $76.1 million for the prior year, representing an 92% increase, primarily driven by a $25.5 million upfront licensing fee as part of the 2024 Bioprojet Sublicense Agreement for BP1.15205, an orexin-2 receptor agonist, and a $17.1 million IPR&D charge related to the acquisition of Epygenix
- Sales and Marketing expenses were $110.9 million for the year ended December 31, 2024, as compared to $97.4 million for the prior year, representing a 14% increase;
- General and Administrative expenses were $110.4 million for the year ended December 31, 2024, as compared to $95.3 million for the prior year, representing a 16% increase; and
- Total Operating Expenses were $367.1 million for the year ended December 31, 2024, as compared to $268.8 million for the prior year, representing a 37% increase.
As of December 31, 2024, Harmony had cash, cash equivalents and investments of $576.1 million, compared to $425.6 million as of December 31, 2023.
2025 Net Product Revenue Guidance
Expect full year 2025 net product revenue of $820 million to $860 million.
Share Repurchase Program
The remaining amount of common stock authorized for repurchases as of December 31, 2024, was $150 million.
Conference Call Today at 8:30 a.m. ET
We are hosting our fourth quarter and full year 2024 financial results conference call and webcast today, beginning at 8:30 a.m. Eastern Time. The live and replay webcast of the call will be available on the investor relations page of our website at https://ir.harmonybiosciences.com/. To participate in the live call by phone, dial 800-445-7795 (domestic) or 785-424-1699 (international), and reference passcode HRMYQ424.
