HRMY

EX-99.1

2 hrmy-20260804xex99d1.htm

EX-99.1

‌Exhibit 99.1

Harmony Biosciences Announces Record Q2 2026 Revenue and Shares Initial Clinical Data for Its Orexin-2 Agonist BP-205 Reinforcing Potential Best-in-Class Profile

WAKIX® Net Revenue Grew 30% Year over Year to $261.3 Million for Second Quarter 2026; Estimated Average Patients Increased 450 to 8,950; Reiterates 2026 WAKIX Net Revenue Guidance of $1.0 Billion to $1.04 Billion

Phase 1 SAD Data for BP-205 Demonstrate Favorable PK and Safety/Tolerability Profiles; Phase 1 MAD Data Expected in Q4 2026

BP-205 IND Open in US; Initiating Phase 1b Study in Sleep-Deprived Healthy Volunteers in Q3; Data Expected Early 2027

Initiating Phase 2 Trials for BP-205 in Mid-2027 to Evaluate Multiple CNS Indications

Pitolisant GR NDA Accepted in July; Target PDUFA Date April 1, 2027

Pitolisant HD On Track for Phase 3 Topline Data in 2027 and Target PDUFA Date in 2028

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

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PLYMOUTH MEETING, Pa., August 4, 2026 /Business Wire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today reported Q2 2026 net revenue for WAKIX® (pitolisant) of $261.3 million, delivering 30% year-over-year growth in its seventh year on the market. These results underscore continued strong demand for WAKIX, disciplined commercial execution across the franchise and sustained momentum through the first half of 2026. Average patients for the quarter were approximately 8,950, an increase in average patients of 450. WAKIX remains on track to achieve full-year net revenue guidance of $1.0 billion to $1.04 billion.

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The Company also announced encouraging single ascending dose (SAD) data from its Phase 1 study of BP-205, demonstrating favorable pharmacokinetic (PK) and safety/tolerability profiles that reinforce Harmony’s conviction in BP-205 as a potential best-in-class orexin-2 receptor (OX2R) agonist. These data support Harmony’s robust orexin development strategy, including initiating Phase 2 studies beginning in mid-2027 to evaluate multiple CNS indications.

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“Our record second-quarter revenue reflects sustained demand for WAKIX and keeps us firmly on track to deliver over $1 billion in revenue this year. With this strong foundation, we are aggressively advancing our pipeline, with our orexin-2 agonist BP-205 as the centerpiece, that we believe can create significant long-term value for both patients and shareholders,” said Jeffrey M. Dayno, MD, President and Chief Executive Officer of Harmony Biosciences. “The Phase 1 clinical PK and safety/tolerability data for BP-205 that we shared today, together with pre-clinical data demonstrating the highest potency of any orexin-2 agonist currently in the clinic, reinforce our conviction that BP-205 has the potential to be the best-in-class orexin-2 agonist with broad clinical utility across multiple CNS indications.”

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Bruce C. Corser, MD, Medical Director of the Sleep Management Institute, said, “The Phase 1 single ascending dose pharmacokinetic and safety/tolerability data for BP-205 are compelling. The potential for rapid onset of action and once-daily dosing, along with a favorable safety/tolerability profile, exceptional potency and high selectivity, suggests that BP-205 may have potential clinical utility in indications beyond orexin deficiency. I look forward to following the continued clinical development of this program.”

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Key Drivers of Value Creation

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Continued WAKIX Growth in an Evolving Market

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Second Quarter 2026 Net Product Revenue for WAKIX

●Net product revenue for the quarter ended June 30, 2026, was $261.3 million, representing 30% growth vs 2Q25

oEstimated average number of patients grew 450 to 8,950 in Q2, which is the 2nd highest average patient growth ever

oExecuted expansion of field sales, remote sales, field reimbursement and patient outreach teams with all roles hired, trained and fully deployed in 2Q

oLaunched online portal and changes to reimbursement support process to enable patients to secure WAKIX faster and with higher success rate

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On Track to Achieve 2026 WAKIX Net Revenue Guidance of $1.0 Billion to $1.04 Billion

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Advance a Robust, Self-Funded Pipeline

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Orexin-2 receptor agonist BP-205 (BP1.15205) is Harmony’s OX2R agonist discovered by Teijin Pharma and developed in partnership with Bioprojet. It is designed to deliver a differentiated

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profile through its high potency, excellent selectivity, favorable safety/tolerability, and a predictable PK profile with the potential for once-a-day dosing. It is the most potent OX2R agonist currently in clinical development.

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●Phase 1 SAD topline data in healthy volunteers support Best-in-Class potential

oA short time to maximum plasma concentration (Tmax) in the range of 30 to 75 minutes

▪Potential for rapid onset of efficacy

oMean half-life (T1/2) of approximately 25h across dose groups

▪Supports once-a-day dosing and potential for durable efficacy through

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