Harmony Biosciences Holdings Inc.

08/04/2026 | Press release | Distributed by Public on 08/04/2026 06:05

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 (Form 8-K)

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

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.

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.

"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."

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."

Key Drivers of Value Creation

Continued WAKIX Growth in an Evolving Market

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
o Estimated average number of patients grew 450 to 8,950 in Q2, which is the 2nd highest average patient growth ever
o Executed expansion of field sales, remote sales, field reimbursement and patient outreach teams with all roles hired, trained and fully deployed in 2Q
o Launched online portal and changes to reimbursement support process to enable patients to secure WAKIX faster and with higher success rate

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

Advance a Robust, Self-Funded Pipeline

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

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.

● Phase 1 SAD topline data in healthy volunteers support Best-in-Class potential
o A short time to maximum plasma concentration (Tmax) in the range of 30 to 75 minutes
▪ Potential for rapid onset of efficacy
o Mean half-life (T1/2) of approximately 25h across dose groups
▪ Supports once-a-day dosing and potential for durable efficacy throughout the day and into the early evening
o Dose proportional exposure in maximum observed plasma concentration (Cmax) and area under the curve (AUC)
▪ Predictable systemic exposure across the doses tested
o No age or gender differences in PK parameters
▪ Supports no dose adjustment for elderly or female patients
o Generally safe and well tolerated with no serious or severe TEAEs
▪ No cardiovascular, hepatic or visual abnormalities
▪ The most common AEs were headache, fatigue, and diarrhea in approximately 10%, 4%, and 3% of the participants, respectively
● Next steps in BP-205 development
o Multiple ascending dose (MAD) data in healthy volunteers expected in Q4
o US IND open; initiate Phase 1b study in sleep-deprived healthy volunteers in Q3; data expected in early 2027
● Commitment to investing in robust development program for BP-205
o Initiating Phase 2 studies to evaluate multiple potential CNS indications in mid-2027

Pitolisant GR (Gastro-resistant) Tablets: On track to launch in 1H 2027

● NDA accepted by FDA in July; target PDUFA date of April 1, 2027
o Designed with enteric coating meant to reduce the potential for GI side effects in patients with narcolepsy, 80 - 90% of whom experience GI symptoms as part of their disease
o Enables patients to initiate treatment at a therapeutic dose without titration, an important clinical differentiation
● Utility patents filed to extend pitolisant franchise into the 2040s

Pitolisant HD (high dose): Opportunity to extend the pitolisant franchise with differentiated labeling

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

WAKIX (pitolisant): Phase 3 trial in PWS (TEMPO)

● Topline data expected in mid-2027 and anticipated PDUFA date in 2028
● On track for pediatric exclusivity: completion of TEMPO study fulfills the second and last requirement agreed with FDA for WAKIX pediatric exclusivity, which would provide for an additional six months of regulatory exclusivity for WAKIX

Exploring amorphous form of pitolisant to pursue broader CNS indications

● This opportunity is based on the exclusive license to Novitium's issued amorphous pitolisant patent with protection until 2042
● Current efforts focused on formulation optimization, new modes of delivery, and an ongoing Phase 1 PK study

EPX-100 (clemizole hydrochloride)

● Actively enrolling in two Global Phase 3 registrational trials in rare epilepsies:
o Lennox-Gastaut syndrome (LGS) - the LIGHTHOUSE Study
o Dravet syndrome (DS) - the ARGUS Study
● Topline data expected in 1H 2027 and anticipated PDUFA dates in 2028

Emphasis on Business Development

● Focused on opportunities with revenue potential in 2028-2032
● Prioritizing assets in Phase 3, in-registration, or on-market
● Therapeutic areas of interest include Sleep/Wake, Epilepsy, Rare/Orphan CNS, and broader CNS indications
● Supported by a strong balance sheet and clear conviction to execute on strategic business development opportunities
● Strong liquidity position of $962.5 million in cash, cash equivalents, and investments as of June 30, 2026

Protect the Pitolisant Franchise

● Strong IP Protection/Exclusivity: Harmony's pitolisant IP estate is multi-layered (formulations, methods of use, next-gen applications) and supports WAKIX exclusivity to March 2030 (inclusive of 6-months of pediatric exclusivity), with potential protection of the franchise through other formulations into the 2040s via additional patents/applications
● ANDA Settlements: Settled with 6 of the 7 ANDA filers
● Ongoing Litigation:
o AET ANDA litigation for "polymorph" ('197) and "method of use" ('947) patents: The bench trial concluded, the post-trial briefs are public, and the judge has called for closing arguments from both sides on October 22, 2026
o Harmony Biosciences and Novitium filed a patent infringement lawsuit in April against AET Pharma US and AET's marketing partner Sandoz, alleging infringement of patents covering an amorphous form of pitolisant hydrochloride ('920)

Second Quarter 2026 Financial Results

Harmony Biosciences reported net product revenue of $261.3 million for the quarter ended June 30, 2026, compared to $200.5 million for the same period in 2025, representing 30% year-over-year growth. This performance reflects continued strong demand for WAKIX within the large narcolepsy market opportunity (approximately 80,000 diagnosed patients in the U.S.), disciplined commercial execution across the franchise and the product's broad clinical utility. The continued success of WAKIX has been driven by strong demand and commercial execution. Based on our results for the first half of 2026, WAKIX remains on track to achieve full-year net revenue of $1.0 billion to $1.04 billion.

Cost of product sold was $63.2 million in the second quarter of 2026, or 24.2% as a percentage of net product revenue, as compared to $38.2 million, or 19.0%, for the same quarter in 2025, representing a 66% increase. The increase in cost of product sold as a percentage of net product revenue was primarily driven by new royalties related to the Novitium license agreement.

Net income for the second quarter was $75.4 million, or $1.28 per diluted share, compared to $39.8 million, or $0.68 per diluted share, for the same quarter in 2025.

Harmony's operating expenses include the following:

● Research and Development expenses were $46.6 million in the second quarter of 2026, as compared to $50.2 million for the same quarter in 2025, representing a 7% decrease; this was primarily driven by a $15.0 million up-front payment related to the agreement with CiRC that was entered into during the second quarter of 2025, for which there was no corresponding amount in the current year period;
● Sales and Marketing expenses were $34.1 million in the second quarter of 2026, as compared to $30.1 million for the same quarter in 2025, representing a 13% increase, primarily driven by the expansion of our field-based teams;
● General and Administrative expenses were $28.1 million in the second quarter of 2026, as compared to $33.9 million for the same quarter in 2025, representing a 17% decrease; this was primarily driven by a charge related to an ANDA settlement in the second quarter of 2025, for which there was no corresponding amount in the current year period; and
● Total Operating expenses were $108.8 million in the second quarter of 2026, as compared to $114.2 million for the same quarter in 2025, representing a 5% decrease

As of June 30, 2026, Harmony had cash, cash equivalents and investments of $962.5 million, compared to $882.5 million as of December 31, 2025.

2026 Net Product Revenue Guidance

Reiterated 2026 WAKIX net revenue guidance of $1.0 billion to $1.04 billion.

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

Harmony is hosting its second quarter 2026 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 https://ir.harmonybiosciences.com/.

To participate in the live call by phone, dial: 800-347-6865 (primary) or 203-518-9757 (alternate); conference ID is HRMYQ226.

About Harmony Biosciences
Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa., we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit www.harmonybiosciences.com.

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