Harmony Biosciences Holdings, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 4 November 2026: press release. Guidance figures: 7 kept. The quarter’s numbers.

Key takeaways

WAKIX revenue rose 12% year on year: WAKIX net revenue was $268.9 million for the quarter, up from $239.5 million a year earlier, according to the company. Source
Patient count rose by 400: Estimated average patients grew by 400 to 9,350. Management said five of the last six quarters had more than 400 patient additions. Source
Cost of sales rose on Novitium royalties: Cost of product sold was $80.7 million, or 30% of WAKIX net revenue, versus $59.7 million or 25% a year earlier. The company attributed the change mainly to new Novitium royalties. Source
Net income fell to $48.2 million: Net income was $48.2 million, or $0.81 per diluted share, versus $50.9 million, or $0.87, a year earlier. Source
MAD study design and population: A 14-day placebo-controlled study gave once-daily BP-205 at 0.1, 0.6, 1 and 3 mg across six cohorts, with 94 healthy volunteers in total. Source
Half-life of about 29 hours: Mean effective half-life after 14 days of repeat dosing was about 29 hours, with no clinically meaningful change from the single-dose study, supporting once-daily dosing. Source
Settlements cover six of seven filers: Harmony has settled with six of the seven ANDA filers, and the company says these actions reinforce its confidence in WAKIX exclusivity. Source
Injunction hearing set for January: The judge set a preliminary injunction hearing for January 26, 2027, with a decision expected by February 14, 2027, when the 30-month stay expires. Source

“I believe Harmony is operating from a position of strength, with a durable and growing WAKIX franchise, the financial flexibility to invest in innovation”
Jeffrey Dayno, MD, President and Chief Executive Officer of Harmony Biosciences

Guidance

Area	Period	Figure	Against last quarter
WAKIX full-year net revenue Source	full year 2026	$1.0 billion to $1.04 billion	Kept
BP-205 Phase 1b data (sleep-deprived healthy volunteers) Source	first quarter 2027	Q1 2027
BP-205 Phase 2 studies Source	by mid-2027	by mid-2027	Kept
Pitolisant GR launch Source	first half 2027	1H 2027	Kept
Pitolisant GR FDA action date Source	PDUFA date	April 1, 2027	Kept
Pitolisant HD Phase 3 topline and FDA action date Source	2027 topline; 2028 PDUFA	Topline data in 2027; PDUFA date in 2028	Kept
WAKIX Prader-Willi (TEMPO) Phase 3 topline and FDA action date Source	mid-2027 topline; 2028 PDUFA	Topline data in mid-2027; PDUFA date in 2028	Kept
EPX-100 Phase 3 topline and FDA action date Source	mid-2027 topline; 2028 PDUFA	Topline data in mid-2027; PDUFA date in 2028
WAKIX exclusivity Source	through March 2030	March 2030 (inclusive of 6 months of pediatric exclusivity)	Kept

What changed from last quarter

New: Peter Anastasiou, Senior Executive Vice President and Chief Operating Officer, is named to succeed Jeffrey Dayno, MD, as President and CEO effective January 1, 2027. Source
New: BP-205 multiple-ascending dose preliminary results are reported in this release. The prior release had expected MAD data in Q4 2026. Source
New: A patent covering methods of making amorphous pitolisant hydrochloride was issued by the PTO in Q3, according to the company. Source
Ended: The second-quarter release said business development would prioritize assets in Phase 3, in-registration or on-market. That prioritization sentence does not appear in the third-quarter release.

Revenue and patient growth

WAKIX revenue rose 12% year on year: WAKIX net revenue was $268.9 million for the quarter, up from $239.5 million a year earlier, according to the company. Source
Patient count rose by 400: Estimated average patients grew by 400 to 9,350. Management said five of the last six quarters had more than 400 patient additions. Source
Field teams fully deployed in Q2: Field sales, remote sales, field reimbursement and patient outreach teams were expanded, with all roles hired, trained and fully deployed in Q2. Source
Untreated narcolepsy population cited: Management cited about 170,000 U.S. people with narcolepsy, fewer than half diagnosed, and brand penetration of about 20%. Source

Costs and earnings

Cost of sales rose on Novitium royalties: Cost of product sold was $80.7 million, or 30% of WAKIX net revenue, versus $59.7 million or 25% a year earlier. The company attributed the change mainly to new Novitium royalties. Source
R&D rose on MSN milestone charge: R&D expenses were $71.7 million, up 30%, mainly on a $25.0 million milestone charge under the MSN license, partly offset by a prior-year $15.0 million ZYN002 charge. Source
Sales and marketing up on field teams: Sales and marketing expenses were $34.7 million, up 18%, primarily from expansion of field-based teams. Source
G&A fell on lower stock compensation: General and administrative expenses were $27.7 million, down 7%, primarily driven by lower stock-based compensation expense. Source
Total operating expenses up 17%: Total operating expenses were $134.0 million, up 17% from $114.3 million a year earlier, reflecting the R&D and sales and marketing increases. Source
Net income fell to $48.2 million: Net income was $48.2 million, or $0.81 per diluted share, versus $50.9 million, or $0.87, a year earlier. Source

“I am proud of the talented team and passionate organization we have built, which position Harmony for continued success in delivering innovative treatments to patients”
Jeffrey Dayno, MD, President and Chief Executive Officer of Harmony Biosciences

Cash, capital and business development

Cash and investments reached $1,051.6M: Cash, cash equivalents and investments were $1,051.6 million at September 30, 2026, up from $882.5 million at December 31, 2025. Source
Capital priorities: pipeline and deals: Stated priorities are investment in the R&D pipeline, especially the BP-205 plan, success-based milestone payments, and strategic business development. Source
Deals sought for 2028 to 2032 revenue: Business development targets two categories: assets adding near-term revenue in 2028 to 2032, and innovative pipeline assets such as BP-205. Source

BP-205 orexin program

MAD study design and population: A 14-day placebo-controlled study gave once-daily BP-205 at 0.1, 0.6, 1 and 3 mg across six cohorts, with 94 healthy volunteers in total. Source
Half-life of about 29 hours: Mean effective half-life after 14 days of repeat dosing was about 29 hours, with no clinically meaningful change from the single-dose study, supporting once-daily dosing. Source
Headache most common adverse event: Headache occurred in about 25% of participants. Insomnia and urinary events were under 20%, mild, and led to no discontinuations. No serious or severe events were reported. Source
Phase 1b started; data and Phase 2 timing: The Phase 1b study in sleep-deprived volunteers started in Q3 in the US. Phase 2 studies are expected to start by mid-2027. Source
Bioprojet poster on orexin and pitolisant: A Bioprojet poster at SLEEP EU 2026 showed a synergistic effect of orexin and histamine on wakefulness in a narcoleptic mouse model. Source

Other pipeline programs

Pitolisant GR avoids titration: The company said the gastro-resistant formulation lets patients start at a therapeutic dose without titration. The NDA is under FDA review. Source
Pitolisant HD Phase 3 formulation: Two Phase 3 trials, ONSTRIDE 1 in narcolepsy and ONSTRIDE 2 in idiopathic hypersomnia, test an enhanced formulation with differentiated labeling sought for fatigue and sleep inertia. Source
EPX-100 Phase 3 trials enrolling: Two Phase 3 registrational trials in Lennox-Gastaut syndrome (LIGHTHOUSE) and Dravet syndrome (ARGUS) are enrolling. Source
Amorphous form explored for CNS uses: Work on amorphous pitolisant for broader CNS indications continues, including formulation optimization and new modes of delivery. Source

Patent protection and litigation

Settlements cover six of seven filers: Harmony has settled with six of the seven ANDA filers, and the company says these actions reinforce its confidence in WAKIX exclusivity. Source
Polymorph trial closing arguments held: Closing arguments in the AET ANDA bench trial on the '197 and '947 patents were held October 22, 2026. A ruling is expected around the 30-month stay. Source
Injunction hearing set for January: The judge set a preliminary injunction hearing for January 26, 2027, with a decision expected by February 14, 2027, when the 30-month stay expires. Source
Amorphous suit trial not yet scheduled: The '920 amorphous patent trial against AET and Sandoz has not been scheduled. It would be expected sometime in 2029. Source
Methods patent issued in Q3: A patent covering methods of making amorphous pitolisant hydrochloride, licensed from MSN Labs, was issued in Q3. Source

Leadership transition

Dayno retires at year-end 2026: Jeffrey Dayno, MD, is retiring as President and CEO on December 31, 2026, succeeded by Peter Anastasiou. Source
Anastasiou to become CEO in January: Peter Anastasiou, currently Senior Executive Vice President and Chief Operating Officer, becomes President and CEO effective January 1, 2027, as announced October 12, 2026. Source
Priorities and milestone timing unchanged: Management said the transition does not change previously communicated strategic priorities or the expected timing of key commercial and pipeline milestones. Source

Coming up, as management said on 4 November 2026

ARGUS 18-month data at AES: Updated 18-month open-label extension data from the ARGUS study are to be presented at the AES Annual Meeting in December 2026. Source
Full BP-205 MAD results at a meeting: Complete MAD study results will be presented at an upcoming medical meeting. No date was given. Source

Figures management reported

Figure	Reported
WAKIX net product revenue, Q3 2026 Source	$268.9 million
R&D expense, Q3 2026 Source	$71.7 million
Estimated average WAKIX patients, Q3 2026 Source	9,350
BP-205 MAD study volunteers Source	94 healthy volunteers
Pitolisant GR PDUFA date Source	April 1, 2027
Amorphous pitolisant patent protection Source	to 2042

Risks management discussed

Regulatory: Pitolisant patent enforcement is in active litigation, and outcomes in the ANDA and amorphous-form cases are pending. Source
Financial: Milestone charges and new MSN royalty charges reduced earnings compared with the year-earlier quarter, according to the company. Source

Earlier plans management reported on

On track: Management said it remains on track for full-year 2026 WAKIX net revenue guidance. Source
On track: Completion of the TEMPO study is described as fulfilling the second and last FDA requirement for WAKIX pediatric exclusivity. Source
Met: The company says the Phase 1b study in sleep-deprived volunteers was initiated in Q3, as planned in the prior release. Source
On track: Management said it remains on track to report Phase 1b data in the first quarter of 2027. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

‌Exhibit 99.1

Harmony Biosciences Reports Q3 Financial Results

On Track to Achieve More Than $1 Billion WAKIX Net

Revenue and Announces Strong Multiple-Ascending Dose Data for Its Orexin Agonist BP-205, Supporting Potential Best-in-Class Profile

WAKIX ® Net Revenue in Q3 of $269 Million; Driven by Strong Demand with 400 Net Patient Adds in the Quarter; Reiterates Full Year Guidance of $1.0B to $1.04B

Repeated Once-Daily Dosing with BP-205 in Multiple-Ascending Dose Study Reinforces Favorable Safety, Tolerability and Pharmacokinetic Profile Observed in Single-Ascending Dose Study

Results from Phase 1b Study in Sleep-Deprived Healthy Volunteers for BP-205 Remain on Track for Q1 2027; Phase 2 Studies in Multiple CNS Indications Expected to Initiate by Mid-2027

Pitolisant GR NDA Under FDA Review, PDUFA Date April 1, 2027; Pitolisant HD Phase 3 Topline Data in 2027, Target PDUFA Date in 2028

Multi-Layered IP Strategy Across Active Legal Proceedings Reinforces Confidence in WAKIX Exclusivity to March 2030

Peter Anastasiou to Succeed Jeffrey Dayno, MD, as President and Chief Executive Officer Effective January 1, 2027

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

PLYMOUTH MEETING, Pa., November 4, 2026 /Globe Newswire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today reported third quarter 2026 financial results and preliminary data from its multiple-ascending dose (MAD) clinical study for its potential best-in-class orexin agonist BP-205. WAKIX® (pitolisant) delivered third quarter net revenue of $269 million, driven by strong demand of 400 net patient adds, and the Company remains on track to achieve full-year WAKIX net revenue guidance of $1.0 billion to $1.04 billion.

The encouraging preliminary results from the MAD study with BP-205, following 14 days of repeated once-daily dosing, reinforce the favorable safety, tolerability and pharmacokinetic profile observed in the single-ascending dose (SAD) portion of the study. No liver or visual adverse events were reported, and no clinically significant cardiovascular events or EKG abnormalities were recorded. Harmony remains on track to report Phase 1b data in sleep-deprived healthy volunteers in the first quarter of 2027, followed by the initiation of Phase 2 studies across multiple CNS indications by mid-2027.

Additionally, as announced on October 12, 2026, Peter Anastasiou, Senior Executive Vice President and Chief Operating Officer, will become President and Chief Executive Officer effective January 1, 2027, succeeding Jeffrey Dayno, MD, who will retire on December 31, 2026. This planned leadership transition does not change Harmony's previously communicated strategic priorities or the expected timing of key commercial and pipeline milestones.

“As I prepare to transition the President and CEO role to Peter on January 1, I believe Harmony is operating from a position of strength, with a durable and growing WAKIX franchise, the financial flexibility to invest in innovation, conviction to pursue strategic business development opportunities, and a pipeline led by BP-205 that has the potential to generate significant long-term value,” said Jeffrey Dayno, MD, President and Chief Executive Officer of Harmony Biosciences. “I am proud of the talented team and passionate organization we have built, which position Harmony for continued success in delivering innovative treatments to patients and sustained value for our shareholders.”

Key Drivers of Value Creation

Continued WAKIX Growth in an Evolving Market

Third Quarter 2026 Net Product Revenue for WAKIX

WAKIX net revenue for the quarter ended September 30, 2026, was $268.9 million, driven by strong patient demand:
Estimated average number of patients grew by 400 to 9,350 in Q3, continuing strong recent performance with 5 of the last 6 quarters achieving more than 400 patient additions
Executed expansion of field sales, remote sales, field reimbursement and patient outreach teams with all roles hired, trained and fully deployed in Q2
Growth continues to be demand driven: WAKIX is the only non-scheduled treatment option for excessive daytime sleepiness and cataplexy in adult and pediatric patients

with narcolepsy type 1 and 2, supported by more than seven years of clinical experience and coverage for more than 80% of covered lives

Significant market opportunity remains: approximately 170,000 people in the U.S. are living with narcolepsy, fewer than 50% are diagnosed, and brand penetration is approximately 20%

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

Advance Robust, Self-Funded Pipeline

BP-205 (Orexin-2 receptor agonist)

BP-205 MAD Study Design and Preliminary Results

14-day double-blind, randomized, placebo-controlled study that evaluated once-daily doses of BP-205 at 0.1 mg, 0.6 mg, 1 mg, and 3 mg across six cohorts (4 male and 2 female); a total of 94 healthy volunteers participated in this study
BP-205 was rapidly absorbed, with a mean T(max) of approximately 60 minutes (range 30 to 90 minutes) supportive of the potential for rapid onset of efficacy
The mean effective half-life (T1/2) after 14-day repeat dosing was observed to be approximately 29 hours; no clinically meaningful change compared to the half-life in the SAD study and supportive of once-daily dosing
BP-205 was generally well tolerated across all doses evaluated: headache was the most common adverse event occurring in approximately 25% of participants
On-target adverse events of insomnia were reported in less than 20% of participants at all doses evaluated, were mild in severity and did not lead to discontinuation
On-target adverse events of urinary frequency and urgency were reported in less than 20% of participants at the 1mg and 3mg doses only; these events were mild in severity and did not lead to discontinuation
No liver or visual adverse events were reported, and no clinically significant cardiovascular events or EKG abnormalities were recorded
There were no serious or severe adverse events
The complete MAD study results will be presented at an upcoming medical meeting
Next steps in BP-205 development:
Phase 1b study in sleep-deprived healthy volunteers initiated in Q3 in the US; data expected in Q1 2027
Expect to initiate Phase 2 studies to evaluate multiple CNS indications by mid-2027
Poster presented by Bioprojet at the SLEEP EU 2026 meeting showed an in-vivo synergistic effect of orexin and histamine on wakefulness in a narcoleptic mouse model; this suggests concomitant use of an orexin-2 agonist and pitolisant as a potential therapeutic approach for patients with central disorders of hypersomnolence
BP-205, Harmony’s investigational OX2R agonist, was discovered by Teijin Pharma and is being developed in partnership with Bioprojet

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

NDA accepted by the FDA with PDUFA date of April 1, 2027
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):
Topline data expected in 2027 and anticipated PDUFA date in 2028
Enhanced formulation with optimized PK profile, enteric coating and higher dose to drive greater efficacy
Pursuing 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 Prader-Willi syndrome (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 our exclusive license to Novitium’s issued amorphous pitolisant patent with protection until 2042
Continued efforts to optimize formulation and new modes of delivery

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 mid-2027 and anticipated PDUFA date in 2028
Updated 18-month data from the open-label extension part of the ARGUS study to be presented at the American Epilepsy Society (AES) Annual Meeting in December 2026

Emphasis on Business Development

Two categories of opportunity:
Assets that can add near-term revenue in 2028 to 2032 to support our self-funded model
Innovative pipeline assets that drive long-term value creation (e.g., BP-205)
Therapeutic areas of interest include Sleep Disorders, Epilepsy, Rare/Orphan CNS, and broader CNS indications
Supported by a strong balance sheet and clear conviction to execute on strategic business development opportunities

Protect the Pitolisant Franchise

Multi-layered strategy: Harmony is asserting its pitolisant IP in active legal proceedings, with each case covering different components of our multi-layered IP strategy:
Polymorph and method of use ('197 and '947): The bench trial in the AET ANDA litigation closing arguments were held on October 22, 2026; ruling is expected around the time of the 30-month stay (February 2027)
Amorphous form ('920): Harmony Biosciences and Novitium filed a lawsuit alleging patent infringement in April against AET Pharma US and its marketing partner Sandoz; the licensed Novitium patent provides protection to 2042. A scheduling conference was held on October 21. The amorphous '920 patent trial has not yet been scheduled, but would be expected to be scheduled for some time in 2029.
Yesterday, November 3, the judge scheduled a preliminary injunction hearing on January 26, 2027, with an expected decision by February 14, 2027 when the 30-month stay expires. This schedule is identical to the preliminary injunction schedule Harmony proposed to the judge on October 26
In Q1 this year, we obtained the exclusive rights to a patent covering methods of making amorphous pitolisant hydrochloride from our licensee MSN Labs. That patent was issued by the PTO in Q3. The patent strengthens our patent portfolio and protects our development efforts for a new amorphous pitolisant hydrochloride product
Together with settlements with 6 of the 7 ANDA filers, these actions reinforce Harmony's confidence in WAKIX exclusivity to March 2030 (inclusive of 6 months of pediatric exclusivity)

Third Quarter 2026 Financial Results

Harmony Biosciences reported WAKIX net revenue of $268.9 million for the quarter ended September 30, 2026, compared to $239.5 million for the quarter ended September 30, 2025, representing a 12% increase over the same period. 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. Based on our results for the first nine months 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 $80.7 million in the third quarter of 2026, or 30% as a percentage of WAKIX net revenue, as compared to $59.7 million, or 25%, for the same quarter in 2025, representing a 35% 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 third quarter was $48.2 million, or $0.81 per diluted share, compared to $50.9 million, or $0.87 per diluted share, for the same quarter in 2025. The decline in earnings was primarily driven by an increase in milestone charges and the new MSN royalty charges during the third quarter of 2026 as compared to the same quarter in 2025.

Harmony’s operating expenses include the following:

Research and Development expenses were $71.7 million in the third quarter of 2026, as compared to $55.0 million for the same quarter in 2025, representing a 30% increase; this was primarily driven by a $25.0 million charge related to a milestone achieved for the MSN license agreement, partially offset by a $15.0 million charge related to a clinical milestone achieved for ZYN002 in the prior year period;
Sales and Marketing expenses were $34.7 million in the third quarter of 2026, as compared to $29.5 million for the same quarter in 2025, representing an 18% increase, primarily driven by the expansion of our field-based teams;
General and Administrative expenses were $27.7 million in the third quarter of 2026, as compared to $29.8 million for the same quarter in 2025, representing a 7% decrease; primarily driven by a decline in stock-based compensation expense; and
Total Operating expenses were $134.0 million in the third quarter of 2026, as compared to $114.3 million for the same quarter in 2025, representing a 17% increase.

As of September 30, 2026, Harmony had cash, cash equivalents and investments of $1,051.6 million, compared to $882.5 million as of December 31, 2025.

Capital Allocation Priorities

Invest in R&D pipeline, especially BP-205 development plan
Success-based R&D milestone payments
Strategic business development to expand pipeline and diversify commercial portfolio

2026 WAKIX Net Revenue Guidance

Reiterated full year guidance of $1.0 billion to $1.04 billion.

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

Harmony is hosting its third 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 call, please dial 800-347-6865 (domestic) or 203-518-9757 (international or alternate), and reference passcode HRMYQ326.

About Harmony Biosciences Harmony Biosciences is developing and commercializing innovative medicines for both rare and broad CNS disorders, and we are becoming an enduring leader in neuroscience. Our first medicine, WAKIX® (pitolisant), is the first and only FDA-approved non-scheduled treatment for excessive daytime sleepiness or cataplexy in patients 6 years of age and older with narcolepsy. Its launch ranks among the most successful in the history of orphan drugs. Building on our success and profitability, we are continuing to advance our novel clinical-stage pipeline, led by BP-205, an investigational orexin-2 receptor agonist with best-in-class potential across a broad range of CNS disorders. With a strong balance sheet, we have the capacity and conviction to pursue strategic business development opportunities. Harmony is guided by an unwavering commitment to patients and driven to create long-term value for shareholders. For more information, visit: www.harmonybiosciences.com.

Forward-looking statements notice

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, the potential profile of our product candidates, our planned and ongoing clinical trials and expected timing of data readouts, anticipated regulatory milestones and product launches, our future results of operations and financial position, our intellectual property, pending litigation and regulatory exclusivity, our planned leadership transition, market opportunity, business strategy, business development, 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 September 30,		Nine Months Ended September 30,
	2026	2025	2026	2025
Net product revenue	$268,917	$239,455	$745,584	$624,677
Cost of product sold	80,686	59,650	188,396	129,797
Gross profit	188,231	179,805	557,188	494,880
Operating expenses:
Research and development	71,663	54,962	187,642	139,661
Sales and marketing	34,721	29,549	100,535	90,333
General and administrative	27,650	29,807	88,207	94,974
Total operating expenses	134,034	114,318	376,384	324,968
Operating income	54,197	65,487	180,804	169,912
Other expense, net	(316)	(106)	(496)	(575)
Interest expense	(3,060)	(3,621)	(9,364)	(11,103)
Interest income	8,428	5,730	21,257	16,070
Income before income taxes	59,249	67,490	192,201	174,304
Income tax expense	(11,053)	(16,625)	(36,086)	(38,103)
Net income	$48,196	$50,865	$156,115	$136,201
Unrealized (loss) income on investments	(1,213)	118	(2,286)	291
Comprehensive income	$46,983	$50,983	$153,829	$136,492
EARNINGS PER SHARE:
Basic	$0.83	$0.88	$2.68	$2.36
Diluted	$0.81	$0.87	$2.63	$2.32
Weighted average number of shares of common stock - basic	58,409,880	57,550,902	58,271,509	57,655,272
Weighted average number of shares of common stock - diluted	59,679,319	58,717,910	59,272,602	58,738,361

HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

	September 30,	December 31,
	2026	2025
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$647,099	$752,502
Investments, short-term	124,039	22,838
Trade receivables, net	127,739	96,787
Inventory, net	5,871	5,357
Prepaid expenses	18,101	16,014
Other current assets	11,981	13,516
Total current assets	934,830	907,014
NONCURRENT ASSETS:
Investments, long-term	280,467	107,127
Intangible assets, net	71,535	89,418
Deferred tax asset	161,365	149,699
Other noncurrent assets	30,048	18,373
Total noncurrent assets	543,415	364,617
TOTAL ASSETS	$1,478,245	$1,271,631
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables	$26,919	$17,693
Accrued compensation	14,886	18,443
Accrued expenses	208,062	191,039
Current portion of long-term debt	20,000	20,000
Other current liabilities	1,675	4,957
Total current liabilities	271,542	252,132
NONCURRENT LIABILITIES:
Long-term debt, net	129,104	143,663
Other noncurrent liabilities	5,367	5,618
Total noncurrent liabilities	134,471	149,281
TOTAL LIABILITIES	406,013	401,413
COMMITMENTS AND CONTINGENCIES (Note 13)
STOCKHOLDERS’ EQUITY:
Common stock - $0.00001 par value; 500,000,000 shares authorized at September 30, 2026 and December 31, 2025, respectively; 58,720,081 and 57,726,170 shares issued and outstanding at September 30, 2026, and December 31, 2025, respectively	1	1
Additional paid in capital	757,153	708,968
Accumulated other comprehensive (loss) income	(1,940)	346
Retained earnings	317,018	160,903
TOTAL STOCKHOLDERS’ EQUITY	1,072,232	870,218
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	$1,478,245	$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