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
Rhea-AI Summary
Harmony Biosciences (Nasdaq: HRMY) reported Q2 2026 WAKIX net product revenue of $261.3 million, up 30% year over year, with approximately 8,950 average patients, and reiterated 2026 WAKIX net revenue guidance of $1.0 billion to $1.04 billion, according to the company.
Q2 2026 net income was $75.4 million, or $1.28 diluted EPS, versus $39.8 million, or $0.68, in Q2 2025. Cost of product sold rose to $63.2 million (24.2% of revenue), mainly from new Novitium-related royalties. Harmony ended June 30, 2026 with $962.5 million in cash, cash equivalents and investments.
The company shared Phase 1 single ascending dose data for BP-205 showing favorable pharmacokinetics, dose-proportional exposure and general tolerability, with no serious or severe treatment-emergent adverse events. The BP-205 IND is open in the US, with Phase 1b and Phase 2 studies planned from 2026–2027, and multiple pitolisant lifecycle and epilepsy programs progressing toward key 2027–2028 readouts and potential PDUFA decisions.
Positive
- WAKIX Q2 2026 revenue $261.3M, up 30% vs Q2 2025
- Average WAKIX patients increased by 450 to approximately 8,950 in Q2 2026
- 2026 WAKIX revenue guidance reiterated at $1.0B–$1.04B
- Q2 2026 net income $75.4M vs $39.8M in Q2 2025
- Diluted EPS rose to $1.28 from $0.68 year over year
- Total operating expenses decreased 5% to $108.8M vs Q2 2025
- Cash, cash equivalents and investments $962.5M as of June 30, 2026
- BP-205 Phase 1 SAD showed ~25h half-life and no serious or severe TEAEs
- Pitolisant GR NDA accepted with April 1, 2027 target PDUFA date
- Multiple late-stage programs (pitolisant HD, WAKIX in PWS, EPX-100) with topline data expected 2027
Negative
- Cost of product sold increased 66% to $63.2M vs Q2 2025
- Cost of product sold percentage rose to 24.2% of revenue from 19.0%
- Sales and marketing expenses grew 13% to $34.1M year over year
- Interest expense was $3.1M in Q2 2026
- Ongoing ANDA litigation with AET on polymorph and method-of-use pitolisant patents
News Explained
The release adds an accepted pitolisant filing and a pending patent case to the company’s 2027 regulatory and legal milestones.
On
The company says the GR NDA was accepted by the FDA, with a target PDUFA date of
The release also identifies Phase 3 trials for EPX-100 in two rare epilepsies as actively enrolling, with topline data expected in the first half of 2027 and anticipated PDUFA dates in 2028.
News Market Reaction – HRMY
In the Aug 4 session, HRMY gained 8.93%, reflecting a notable positive market reaction. Argus tracked a peak move of +7.3% during that session. Our momentum scanner triggered 29 alerts that day, indicating elevated trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 16 | Phase 3 data presentation | Positive | +0.7% | Open-label extension data presentation from the Phase 3 ARGUS trial. |
| Dec 02 | Phase 3 data presentation | Positive | +1.4% | New open-label extension data from the Phase 3 ARGUS trial. |
| Sep 24 | Phase 3 trial failure | Negative | -16.6% | RECONNECT study failed to meet its primary social-avoidance endpoint. |
| Jun 11 | Preclinical data presentation | Positive | -2.0% | Preclinical BP1.15205 data showed wake-promoting and cataplexy-suppressing effects. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical-trial news produced mixed reactions: the tag-specific average move was -4.11%, with one divergence and three aligned events.
Key Terms
pharmacokinetic medical
single ascending dose medical
pdufa regulatory
nda regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
WAKIX® Net Revenue Grew
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., Aug. 04, 2026 (GLOBE NEWSWIRE) -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today reported Q2 2026 net revenue for WAKIX® (pitolisant) of
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
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 , representing30% growth vs 2Q25- Estimated average number of patients grew 450 to 8,950 in Q2, which is the 2nd highest average patient growth ever
- Executed expansion of field sales, remote sales, field reimbursement and patient outreach teams with all roles hired, trained and fully deployed in 2Q
- 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
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
- A short time to maximum plasma concentration (Tmax) in the range of 30 to 75 minutes
- Potential for rapid onset of efficacy
- 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
- Dose proportional exposure in maximum observed plasma concentration (Cmax) and area under the curve (AUC)
- Predictable systemic exposure across the doses tested
- No age or gender differences in PK parameters
- Supports no dose adjustment for elderly or female patients
- 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% , and3% of the participants, respectively
- A short time to maximum plasma concentration (Tmax) in the range of 30 to 75 minutes
- Next steps in BP-205 development
- Multiple ascending dose (MAD) data in healthy volunteers expected in Q4
- 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
- Initiating Phase 2 studies to evaluate multiple potential CNS indications in mid-2027
- 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
- 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 - Enables patients to initiate treatment at a therapeutic dose without titration, an important clinical differentiation
- Designed with enteric coating meant to reduce the potential for GI side effects in patients with narcolepsy, 80 –
- 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)
- Topline data expected in 2027; anticipated PDUFA date in 2028
- Enhanced formulation with optimized PK profile, enteric coating and higher dose to drive greater efficacy
- 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:
- Lennox-Gastaut syndrome (LGS) – the LIGHTHOUSE Study
- 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:
- 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
- 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
Cost of product sold was
Net income for the second quarter was
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 a7% 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 a13% 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 a17% 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 a5% decrease
As of June 30, 2026, Harmony had cash, cash equivalents and investments of
2026 Net Product Revenue Guidance
Reiterated 2026 WAKIX net revenue guidance of
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.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our full year 2026 net product revenue, expectations for the growth and value of WAKIX, our planned and ongoing clinical trials and expected timing of data readouts, anticipated regulatory milestones, our future results of operations and financial position, business strategy, products, prospective products, product approvals, and the plans and objectives of management for future operations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved, including EPX-100, Pitolisant GR and BP-205; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreements with Bioprojet Société Civile de Recherche (“Bioprojet”); the availability of favorable insurance coverage and reimbursement for WAKIX; the timing of, and our ability to obtain, regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and additional financing needs; our ability to identify, acquire and integrate additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; the significant costs and required management time as a result of operating as a public company; the fact that the price of Harmony's common stock may be volatile and fluctuate substantially; statements related to our intended share repurchases and repurchase timeframe; and macroeconomic effects and changes in market conditions, including the impact of tariffs, inflation and the risk of recession. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 24, 2026 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
| HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (In thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||
| Net product revenue | $ | 261,280 | $ | 200,489 | $ | 476,667 | $ | 385,222 | ||||||||
| Cost of product sold | 63,198 | 38,153 | 107,710 | 70,147 | ||||||||||||
| Gross profit | 198,082 | 162,336 | 368,957 | 315,075 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 46,596 | 50,159 | 115,979 | 84,699 | ||||||||||||
| Sales and marketing | 34,120 | 30,073 | 65,814 | 60,784 | ||||||||||||
| General and administrative | 28,050 | 33,924 | 60,557 | 65,167 | ||||||||||||
| Total operating expenses | 108,766 | 114,156 | 242,350 | 210,650 | ||||||||||||
| Operating income | 89,316 | 48,180 | 126,607 | 104,425 | ||||||||||||
| Other expense, net | (53 | ) | (193 | ) | (180 | ) | (469 | ) | ||||||||
| Interest expense | (3,070 | ) | (3,646 | ) | (6,304 | ) | (7,482 | ) | ||||||||
| Interest income | 7,072 | 5,296 | 12,829 | 10,340 | ||||||||||||
| Income before income taxes | 93,265 | 49,637 | 132,952 | 106,814 | ||||||||||||
| Income tax expense | (17,834 | ) | (9,861 | ) | (25,033 | ) | (21,478 | ) | ||||||||
| Net income | $ | 75,431 | $ | 39,776 | $ | 107,919 | $ | 85,336 | ||||||||
| Unrealized (loss) income on investments | (314 | ) | (6 | ) | (1,073 | ) | 173 | |||||||||
| Comprehensive income | $ | 75,117 | $ | 39,770 | $ | 106,846 | $ | 85,509 | ||||||||
| EARNINGS PER SHARE: | ||||||||||||||||
| Basic | $ | 1.30 | $ | 0.69 | $ | 1.86 | $ | 1.49 | ||||||||
| Diluted | $ | 1.28 | $ | 0.68 | $ | 1.84 | $ | 1.46 | ||||||||
| Weighted average number of shares of common stock - basic | 57,933,818 | 57,469,775 | 57,876,756 | 57,390,298 | ||||||||||||
| Weighted average number of shares of common stock - diluted | 58,755,359 | 58,427,134 | 58,769,504 | 58,468,717 | ||||||||||||
| HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share data) | |||||||
| June 30, | December 31, | ||||||
| 2026 | 2025 | ||||||
| ASSETS | |||||||
| CURRENT ASSETS: | |||||||
| Cash and cash equivalents | $ | 549,769 | $ | 752,502 | |||
| Investments, short-term | 118,022 | 22,838 | |||||
| Trade receivables, net | 110,995 | 96,787 | |||||
| Inventory, net | 6,360 | 5,357 | |||||
| Prepaid expenses | 19,311 | 16,014 | |||||
| Other current assets | 9,877 | 13,516 | |||||
| Total current assets | 814,334 | 907,014 | |||||
| NONCURRENT ASSETS: | |||||||
| Investments, long-term | 294,668 | 107,127 | |||||
| Intangible assets, net | 77,496 | 89,418 | |||||
| Deferred tax asset | 156,765 | 149,699 | |||||
| Other noncurrent assets | 29,821 | 18,373 | |||||
| Total noncurrent assets | 558,750 | 364,617 | |||||
| TOTAL ASSETS | $ | 1,373,084 | $ | 1,271,631 | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
| CURRENT LIABILITIES: | |||||||
| Trade payables | $ | 21,684 | $ | 17,693 | |||
| Accrued compensation | 12,091 | 18,443 | |||||
| Accrued expenses | 169,128 | 191,039 | |||||
| Current portion of long-term debt | 20,000 | 20,000 | |||||
| Other current liabilities | 11,167 | 4,957 | |||||
| Total current liabilities | 234,070 | 252,132 | |||||
| NONCURRENT LIABILITIES: | |||||||
| Long-term debt, net | 133,961 | 143,663 | |||||
| Other noncurrent liabilities | 5,810 | 5,618 | |||||
| Total noncurrent liabilities | 139,771 | 149,281 | |||||
| TOTAL LIABILITIES | 373,841 | 401,413 | |||||
| COMMITMENTS AND CONTINGENCIES (Note 13) | |||||||
| STOCKHOLDERS’ EQUITY: | |||||||
| Common stock— | 1 | 1 | |||||
| Additional paid in capital | 731,147 | 708,968 | |||||
| Accumulated other comprehensive (loss) income | (727 | ) | 346 | ||||
| Retained earnings | 268,822 | 160,903 | |||||
| TOTAL STOCKHOLDERS’ EQUITY | 999,243 | 870,218 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | 1,373,084 | $ | 1,271,631 | |||
Harmony Biosciences Investor Contact:
Brennan Doyle
484-566-3685
bdoyle@harmonybiosciences.com
Harmony Biosciences Media Contact:
Cate McCanless
202-641-6086
cmccanless@harmonybiosciences.com
