Harmony Biosciences Holdings, Inc. (Form: 8-K, Received: 05/07/2026 09:25:11)

0001802665false00018026652026-05-072026-05-07

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): May 7, 2026

HARMONY BIOSCIENCES HOLDINGS, INC.

(Exact name of registrant as specified in its charter)


Delaware	001-39450	82-2279923
(State or other jurisdiction	(Commission	(IRS Employer
of incorporation)	File Number)	Identification No.)

630 W. Germantown Pike, Suite 215

Plymouth Meeting, PA 19462

(Address of principal executive offices) (Zip Code)

(484) 539-9800

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


		Trading		Name of each exchange
Title of each class		Symbol(s)		on which registered
Common Stock, $0.00001 par value per share		HRMY		The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02. Results of Operations and Financial Condition.

On May 7, 2026, Harmony Biosciences Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2026. A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 7.01. Regulation FD Disclosure.

On May 7, 2026, the Company posted an investor presentation to its website at ttps://ir.harmonybiosciences.com (the “Investor Presentation”). A copy of the Investor Presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. The Company expects to use the Investor Presentation, in whole or in part, and possibly with modifications, in connection with presentations to investors, analysts and others.

The information contained in the Investor Presentation is summary information that is intended to be considered in the context of the Company’s Securities and Exchange Commission (“SEC”) filings and other public announcements that the Company may make, by press release or otherwise, from time to time. The Investor Presentation speaks only as of the date of this Current Report on Form 8-K. The Company undertakes no duty or obligation to publicly update or revise the information contained in the Investor Presentation, although it may do so from time to time. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure. In addition, the exhibit furnished herewith contains statements intended as “forward-looking statements” that are subject to the cautionary statements about forward-looking statements set forth in such exhibit. By furnishing the information contained in the Investor Presentation, the Company makes no admission as to the materiality of any information in the Investor Presentation that is required to be disclosed solely by reason of Regulation FD.

This Current Report on Form 8-K and its contents (including Exhibits 99.1 and 99.2) are furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

Note Regarding Forward-Looking Statements

Certain statements in this Current Report on Form 8-K constitute “forward-looking statements” within the meaning of the federal securities laws. These statements are based on management’s current opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results. These forward looking statements are only predictions, not historical fact, and involve certain risks and uncertainties, as well as assumptions. Actual results, levels of activity, performance, achievements and events could differ materially from those stated, anticipated or implied by such forward-looking statements. While the Company believes that its assumptions are reasonable, it is very difficult to predict the impact of known factors, and, of course, it is impossible to anticipate all factors that could affect actual results. There are many risks and uncertainties that could cause actual results to differ materially from the forward-looking statements made herein including the risks discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the Securities and Exchange Commission (“SEC,”) on February 24, 2026, as well as other factors described from time to time in the Company’s filings with the SEC. Such forward-looking statements are made only as of the date of this Current Report on Form 8-K. The Company undertakes no obligation to publicly update or revise any forward-looking statement because of new information, future events or otherwise, except as otherwise required by law. If it does update one or more forward-looking statements, no inference should be made that the Company will make additional updates with respect to those or other forward-looking statements.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.


Exhibit
No.		Description

99.1*		Press release issued by the Company, dated May 7, 2026.

99.2*		Investor Presentation, dated May 7, 2026.

104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

This Exhibit is furnished herewith and will not be deemed “filed” for purposes of Section 18 of the Exchange Act or deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act except to the extent that Harmony Biosciences Holdings, Inc. specifically incorporates it by reference.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


	HARMONY BIOSCIENCES HOLDINGS, INC.

Date: May 7, 2026	By:	/s/ Glenn Reicin
		Glenn Reicin
		Chief Financial Officer

Exhibit 99.1

HARMONY BIOSCIENCES REPORTS Q1 FINANCIAL RESULTS AND CONFIRMS 2026 NET REVENUE GUIDANCE OF OVER $1 BILLION; REINFORCES 2026 STRATEGIC PRIORITIES

WAKIX® Net Revenue Grew 17% to $215.4 Million for First Quarter 2026; On Track for Full Year 2026 Net Revenues over $1 Billion

Continue to Vigorously Protect WAKIX IP into 2030; Filed Suit Against AET Pharma/Sandoz Regarding Infringement of Amorphous Pitolisant Patent

Lifecycle Management Advancing with Pitolisant GR on Track for NDA Filing 2Q26, Pitolisant HD Phase 3 Data in 2027, and Recently Acquired Novel Amorphous Form of Pitolisant to Pursue Broader CNS Indications

Potential Best-in-Class Orexin-2 Agonist with BP-205; Phase 1 Clinical PK Data On Track for Mid-2026

Renewed Focus on Business Development Opportunities with Emphasis on Revenue Potential in the 2028 to 2032 Timeframe

Expansion of the Leadership Team with the Addition of New COO and CFO to Support Scale and Next Phase of Growth

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

PLYMOUTH MEETING, Pa., May 7, 2026 /Business Wire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today reported Q1 2026 revenue of $215.4 million, delivering 17% year-over-year growth for WAKIX®. Performance during the quarter reflected continued strong demand, offset by market access headwinds observed every Q1, which were more pronounced this year. This follows the strongest three consecutive quarters in franchise history, and the Company reinforced 2026 full year revenue guidance. The Company also outlined progress across four strategic priorities that it believes underpin long-term shareholder value.

“Harmony is well positioned for long-term growth, and we are focused on four key pillars to drive value creation. First, protect the pitolisant franchise to ensure durability into the 2030s, supported by multi-layered intellectual property. Second, continued growth of the pitolisant franchise in an evolving market by advancing new formulations and differentiated approaches to solidify our leadership in the sleep/wake market. Third, drive value from our pipeline, led by BP-205, which has the potential to be a highly differentiated and best-in-class orexin-2 agonist across multiple indications. And fourth, a renewed emphasis on business development with a goal to transact on opportunities with revenue potential in the 2028–2032 timeframe,” said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. “Executing on these four pillars positions us well to deliver innovative treatments for patients and generate long-term value for shareholders.”

Key Pillars of Value Creation:

Protect the Pitolisant Franchise

●

ANDA Settlements: 3 additional ANDA settlements were reached in Q1, bringing the total settlements to 6 of the 7 ANDA filers

●

Acquired New IP: Acquired exclusive license to an issued patent out to 2042 for a novel amorphous form of pitolisant, providing Harmony with new development opportunities in broader CNS patient populations

●

Strong IP protection/exclusivity: Harmony’s pitolisant IP estate is multi-layered (formulations, methods of use, next-gen applications) and supports WAKIX exclusivity into 2030 (inclusive of 6-months of pediatric exclusivity), with potential protection of the franchise into the 2040’s via additional patents/applications

●

Filed Lawsuit: Harmony Biosciences and Novitium filed a patent infringement lawsuit in April against AET Pharma US and Sandoz, alleging infringement of patents covering an amorphous form of pitolisant hydrochloride

Continued Pitolisant Franchise Growth in an Evolving Market

First Quarter 2026 Net Product Revenue for WAKIX

●

Net product revenue for the quarter ended March 31, 2026, was $215.4 million, compared to $184.7 million for the same period in 2025

o

Average number of patients in Q1 was 8,500; exited the quarter with 8,600 average patients

On track to achieve >$1 Billion in narcolepsy net sales in 2026

●

Net revenue projected between $1.0 billion to $1.04 billion for the full year ending December 31, 2026

●

Received FDA approval of pediatric cataplexy indication on February 13^th

o

Commercial team initiated full promotional efforts immediately upon approval

●

Pitolisant in Prader-Willi syndrome (PWS)

o

Phase 3 topline data readout expected in 2H 2026

o

Supports Pediatric Exclusivity for WAKIX: Fulfills a key regulatory requirement for six months of additional regulatory exclusivity, extending exclusivity to March 2030

Pitolisant GR (gastro-resistant): On track to extend pitolisant franchise into the 2040s

●

NDA submission on track for Q2 2026; anticipated PDUFA date in Q1 2027

o

Approximately 80-90% of patients with narcolepsy experience GI symptoms as part of their disease

o

Pitolisant GR is designed with enteric coating meant to reduce the potential for GI side effects in patients prone to GI symptoms

o

Enables patients to initiate treatment at a therapeutic dose without titration, an important clinical differentiation

●

Utility patents filed to extend franchise into the 2040s

Pitolisant HD (high dose): Opportunity to expand 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 expand franchise into the 2040s

Exploring novel 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 and new modes of delivery in preparation for Phase 1 PK study

Drive Value from our Robust Pipeline

Orexin-2 receptor agonist BP-205 (BP1.15205)

●

BP-205 is Harmony’s lead OX2R agonist, built upon a novel chemical scaffold, with the potential for best-in-class therapy:

o

The most potent OX2R agonist currently in clinical development

o

The high potency enables the potential for significantly lower dosing than current OX2R assets under development

▪

Potential for once-daily dosing across NT1, NT2 and IH (supported by favorable preclinical PK profile)

o

High selectivity for OX2R over OX1R and across 150 other receptors of interest

▪

Potential for favorable safety/tolerability profile (supported by preclinical safety pharmacology and toxicology data)

●

Phase 1 SAD/MAD clinical study ongoing in Europe; on track for clinical PK, safety, and tolerability data from SAD phase in mid-2026

●

U.S. IND submission planned for mid-2026

●

Plan to initiate Phase 1b study in sleep-deprived healthy volunteers in 2H 2026

●

Exploring use outside of sleep/wake, including cognition, ADHD, mood, and fatigue

EPX-100 (clemizole hydrochloride)

●

One of the most advanced development programs in the 5HT2 (serotonin) agonist class

●

Actively enrolling in two Global Phase 3 registrational trials in rare epilepsies:

o

Lennox-Gastaut syndrome – the LIGHTHOUSE Study

o

Dravet syndrome (DS) – the ARGUS Study

◾

Encore safety and effectiveness data from the open-label extension study in DS that showed clinically meaningful reduction in seizures and a favorable safety and tolerability profile was presented at AAN meeting in April 2026

◾

Both trials are currently enrolling in North America, Europe, China and India

●

Topline data anticipated in 1H 2027 and potential PDUFA date in 2028

Renewed 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 CNS adjacencies beyond rare disease

●

Supported by a strong balance sheet and clear conviction to execute on strategic business development opportunities

●

Strong liquidity position of $870.5 million in cash, cash equivalents, and investments as of March 31, 2026

Personnel Updates

●

Appointed Peter Anastasiou as Chief Operating Officer (effective April 2, 2026) and Glenn Reicin as Chief Financial Officer (effective April 14, 2026), supporting continued focus on strategic growth

First Quarter 2026 Financial Results

Harmony Biosciences reported net product revenue of $215.4 million for the quarter ended March 31, 2026, compared to $184.7 million for the same period in 2025, representing 17% year-over-year growth. This performance reflects both continued demand for WAKIX within the large narcolepsy market opportunity (approximately 80,000 diagnosed patients in the U.S.) and the product's broad clinical utility. The continued success has been driven by strong execution across the organization from sales effectiveness to marketing and promotion and supported by broad payer coverage and how the company supports patients over time.

Cost of product sold was $44.5 million in the first quarter of 2026, or 20.7% as a percentage of net product revenue, as compared to $32.0 million, or 17.3%, for the same quarter in 2025, representing a 39% increase. The increase in cost of product sold as a percentage of net product revenue was driven by new royalties related to the Novitium license agreement.

Net income for the quarter was $32.5 million, or $0.55 per diluted share, compared to $45.6 million, or $0.78 per diluted share, in Q1 2025. The decline in earnings was entirely driven by the licensing agreements entered into during Q1 2026.

Harmony’s operating expenses include the following:

●

Research and Development expenses were $69.4 million in the first quarter of 2026, as compared to $34.5 million for the same quarter in 2025, representing a 101% increase; the increase was primarily driven by $32.0 million in expenses related to up-front payments for license agreements that were entered into during Q1 2026, providing new development opportunities, which had an after-tax impact to earnings of $0.45 per share

●

Sales and Marketing expenses were $31.7 million in the first quarter of 2026, as compared to $30.7 million for the same quarter in 2025, representing a 3% increase

●

General and Administrative expenses were $32.5 million in the first quarter of 2026, as compared to $31.2 million for the same quarter in 2025, representing a 4% increase

●

Total Operating Expenses were $133.6 million in the first quarter of 2026, as compared to $96.5 million for the same quarter in 2025, representing a 38% increase

As of March 31, 2026, Harmony had cash, cash equivalents and investments of $870.5 million, compared to $882.5 million as of December 31, 2025. The reduction was primarily due to up-front payments for license agreements and payment of ANDA settlements during Q1 2026.

2026 Net Product Revenue Guidance

Reiterated 2026 WAKIX Net Revenue Guidance of $1.0 Billion – $1.04 Billion

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

Harmony is hosting its first 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: (888) 596-4144 (domestic) or (646) 968-2525 (international, alternate); reference passcode 6626692

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, plans to submit an sNDA for pitolisant in idiopathic hypersomnia; plans to submit an NDA for Pitolisant GR; plans to submit an IND for BP-205; our future results of operations and financial position, business strategy, products, prospective products, product approvals, the plans and objectives of management for future operations and future results of anticipated products. 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 GT 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 March 31,
		2026			2025
Net product revenue		$	215,387		$	184,733
Cost of product sold			44,512			31,994
Gross profit			170,875			152,739
Operating expenses:
Research and development			69,383			34,540
Sales and marketing			31,694			30,711
General and administrative			32,507			31,243
Total operating expenses			133,584			96,494
Operating income			37,291			56,245
Other (expense) income, net			(127)			(276)
Interest expense			(3,234)			(3,836)
Interest income			5,757			5,044
Income before income taxes			39,687			57,177
Income tax expense			(7,199)			(11,617)
Net income		$	32,488		$	45,560
Unrealized (loss) income on investments			(759)			179
Comprehensive income		$	31,729		$	45,739
EARNINGS PER SHARE:
Basic		$	0.56		$	0.79
Diluted		$	0.55		$	0.78
Weighted average number of shares of common stock - basic			57,819,060			57,309,938
Weighted average number of shares of common stock - diluted			58,776,297			58,524,566

HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)


		March 31,			December 31,
		2026			2025
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	589,398		$	752,502
Investments, short-term			51,520			22,838
Trade receivables, net			108,222			96,787
Inventory, net			5,281			5,357
Prepaid expenses			16,801			16,014
Other current assets			7,595			13,516
Total current assets			778,817			907,014
NONCURRENT ASSETS:
Investments, long-term			229,555			107,127
Intangible assets, net			83,457			89,418
Deferred tax asset			153,562			149,699
Other noncurrent assets			26,433			18,373
Total noncurrent assets			493,007			364,617
TOTAL ASSETS		$	1,271,824		$	1,271,631
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables		$	28,600		$	17,693
Accrued compensation			6,726			18,443
Accrued expenses			150,107			191,039
Current portion of long-term debt			20,000			20,000
Other current liabilities			11,907			4,957
Total current liabilities			217,340			252,132
NONCURRENT LIABILITIES:
Long-term debt, net			138,814			143,663
Other noncurrent liabilities			5,321			5,618
Total noncurrent liabilities			144,135			149,281
TOTAL LIABILITIES			361,475			401,413
COMMITMENTS AND CONTINGENCIES (Note 13)
STOCKHOLDERS’ EQUITY:
Common stock—$0.00001 par value; 500,000,000 shares authorized at March 31, 2026, and December 31, 2025, respectively; 57,867,389 and 57,726,170 shares issued and outstanding at March 31, 2026, and December 31, 2025, respectively			1			1
Additional paid in capital			717,370			708,968
Accumulated other comprehensive (loss) income			(413)			346
Retained earnings			193,391			160,903
TOTAL STOCKHOLDERS’ EQUITY			910,349			870,218
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY		$	1,271,824		$	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

Forward-Looking Statements This presentation 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, plans to submit an NDA for Pitolisant GR; plans to submit an IND for BP-205; our future results of operations and financial position, business strategy, products, prospective products, product approvals, the plans and objectives of management for future operations and future results of anticipated products. 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 Pitolisant GR, Pitolisant HD, BP-205, and EPX-100; 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. 2 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved.

PROFITABLE SELF-FUNDING BIOTECH PROVEN COMMERCIAL ENGINE STRONG BALANCE SHEET ROBUST PIPELINE

Moving with Urgency on BD to Generate the Next Wave of Growth RENEWED EMPHASIS ON BUSINESS DEVELOPMENT Led by our OX2R in the clinic, BP 205, potentially best-in-class 5 Phase 3 registrational trials in 5 distinct rare CNS indications ADVANCING ROBUST PIPELINE BEYOND PITOLISANT LIFECYCLE MANAGEMENT Advancing new formulations and differentiated approaches CONTINUED PITOLISANT FRANCHISE GROWTH IN AN EVOLVING MARKET GROWING ADVANCING TRANSACTING PILLARS OF VALUE CREATION PROTECTING PROTECT THE PITOLISANT FRANCHISE Exclusivity into 2030s, supported by multi-layered intellectual property

Moving with Urgency on BD to Generate the Next Wave of Growth RENEWED EMPHASIS ON BUSINESS DEVELOPMENT Led by our OX2R in the clinic, BP 205, potentially best-in-class 5 Phase 3 registrational trials in 5 distinct rare CNS indications ADVANCING ROBUST PIPELINE BEYOND PITOLISANT LIFECYCLE MANAGEMENT Advancing new formulations and differentiated approaches CONTINUED PITOLISANT FRANCHISE GROWTH IN AN EVOLVING MARKET Exclusivity into 2030s, supported by multi-layered intellectual property PROTECT THE PITOLISANT FRANCHISE PROTECTING GROWING ADVANCING TRANSACTING PILLARS OF VALUE CREATION

Protect the Pitolisant Franchise 6 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. WAKIX LOE INTO 2030 WITH PEDIATRIC EXCLUSIVITY PROTECTING GROWING ADVANCING TRANSACTING STRONG IP PROTECTION Multi-layered IP estate – formulation, methods of use, next-gen applications 6-MONTH PEDIATRIC EXCLUSIVITY On track with PWS Phase 3 data 2H 2026 UTILITY PATENTS FILED FOR NEXT GEN PITOLISANT FORMULATIONS Potential protection into the 2040s LICENSE TO NOVEL AMORPHOUS FORM OF PITOLISANT New development opportunity in broader CNS patient populations SETTLEMENTS WITH 6 OF 7 ANDA FILERS Maintaining LOE until March of 2030, inclusive of 6-months of pediatric exclusivity NEW LAWSUIT FILED Harmony and Novitium filed patent infringement lawsuit against AET US and Sandoz alleging infringement of a patent covering amorphous form of pitolisant hydrochloride ®

Moving with Urgency on BD to Generate the Next Wave of Growth RENEWED EMPHASIS ON BUSINESS DEVELOPMENT Led by our OX2R in the clinic, BP 205, potentially best-in-class 5 Phase 3 registrational trials in 5 distinct rare CNS indications ADVANCING ROBUST PIPELINE BEYOND PITOLISANT LIFECYCLE MANAGEMENT Advancing new formulations and differentiated approaches CONTINUED PITOLISANT FRANCHISE GROWTH IN AN EVOLVING MARKET Exclusivity into 2030s, supported by multi-layered intellectual property PROTECT THE PITOLISANT FRANCHISE PROTECTING GROWING ADVANCING TRANSACTING PILLARS OF VALUE CREATION

Continued Pitolisant Franchise Growth in an Evolving Market 8 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. PROTECTING GROWING TRANSACTING CONTINUE TO LEAD WITH WAKIX: ON TRACK FOR >$1B NET REVENUE IN 2026 PITOLISANT GR – NDA SUBMISSION 2Q26, PDUFA DATE ANTICIPATED IN Q1 2027 Positioned to extend the WAKIX franchise with broad clinical utility PITOLISANT HD – 2 ONGOING PHASE 3 REGISTRATIONAL STUDIES WITH TLD EXPECTED IN 2027 To grow pitolisant franchise and extend leadership position in Sleep/Wake NOVEL AMORPHOUS FORM OF PITOLISANT – BROADER CNS INDICATIONS AND PATENT PROTECTION TO 2042 Current efforts focused on formulation optimization and new modes of delivery in preparation for phase 1 PK study ADVANCING GROW EXTEND EXPAND

Moving with Urgency on BD to Generate the Next Wave of Growth RENEWED EMPHASIS ON BUSINESS DEVELOPMENT Led by our OX2R in the clinic, BP 205, potentially best-in-class 5 Phase 3 registrational trials in 5 distinct rare CNS indications ADVANCING ROBUST PIPELINE BEYOND PITOLISANT LIFECYCLE MANAGEMENT Advancing new formulations and differentiated approaches CONTINUED PITOLISANT FRANCHISE GROWTH IN AN EVOLVING MARKET Exclusivity into 2030s, supported by multi-layered intellectual property PROTECT THE PITOLISANT FRANCHISE PROTECTING GROWING ADVANCING TRANSACTING PILLARS OF VALUE CREATION

Robust Pipeline Beyond Pitolisant Lifecycle Management 10 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. PRODUCT INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 REGULATORY FILING MARKETED PRODUCT EDS in Narcolepsy (Adult/Pediatric*) WAKIX® Cataplexy in Narcolepsy (Adult/Pediatric*) Pitolisant Gastro-Resistant (GR) in Narcolepsy Pitolisant Prader-Willi Syndrome (PWS) Pitolisant High-Dose (HD) in Narcolepsy Pitolisant High-Dose (HD) in Idiopathic Hypersomnia Pitolisant High-Dose (HD) in Myotonic Dystrophy (DM1) Pitolisant Amorphous Form CBS105 Treatment-Resistant Narcolepsy HBS-102 PWS Dravet Syndrome (DS) EPX-100 (Clemizole Hydrochloride Lennox-Gastaut Syndrome (LGS) EPX-200 (Lorcaserin) Developmental and Epileptic Encephalopathies CBS104 Refractory Epilepsy *Ages 6 years and older Research collaboration with CiRC Biosciences.. Innovative Late-Stage Pipeline With Multiple Catalysts 2026–2028 PROTECTING GROWING ADVANCING TRANSACTING BP-205 (Orexin-2 Receptor Agonist) Sleep/Wake Disorders

Moving with Urgency on BD to Generate the Next Wave of Growth RENEWED EMPHASIS ON BUSINESS DEVELOPMENT Led by our OX2R in the clinic, BP 205, potentially best-in-class 5 Phase 3 registrational trials in 5 distinct rare CNS indications ADVANCING ROBUST PIPELINE BEYOND PITOLISANT LIFECYCLE MANAGEMENT Advancing new formulations and differentiated approaches CONTINUED PITOLISANT FRANCHISE GROWTH IN AN EVOLVING MARKET Exclusivity into 2030s, supported by multi-layered intellectual property PROTECT THE PITOLISANT FRANCHISE PROTECTING GROWING ADVANCING TRANSACTING PILLARS OF VALUE CREATION

Renewed Emphasis on Business Development 12 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. PROTECTING GROWING TRANSACTING SIGNIFICANT CAPACITY TO TRANSACT RENEWED FOCUS ON BD OPPORTUNITIES WITH EMPHASIS ON: • Revenues in 2028-2032 • Assets in Phase 3, In-Registration, or On-Market THERAPEUTIC AREAS OF INTEREST • Sleep/Wake • Epilepsy • Rare/Orphan CNS • CNS adjacencies beyond Rare/Orphan STRONG BALANCE SHEET WITH ~ $870M IN CASH, EQUIVALENTS URGENCY & CONVICTION TO EXECUTE ON STRATEGIC BD OPPORTUNITIES ADVANCING

Reiterating 2026 Net Revenue Guidance 14 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. $1.00B-$1.04B 2026 NET REVENUE GUIDANCE WAKIX Net Revenue Growth 2020–2025 $160 $305 $438 $582 $715 $869 $1B+ $0 $200 $400 $600 $800 $1,000 2020 2021 2022 2023 2024 2025 2026 Guidance Net Revenue ($M) PROTECTING GROWING TRANSACTING On Track to Achieve $1B+ in Narcolepsy ADVANCING

WAKIX® Differentiation and Strong Execution Drive Performance 15 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. 1. https://narcolepsynetwork.org/accessed Feb 2024 • 17% Quarter over Quarter revenue growth: on track to achieve $1B+ in 2026 net sales • After 3 consecutive quarters of record growth: adding ~400+ patients for the first time • Strong demand despite seasonal headwinds • March demand higher than nearly all months in 2025 • 8,600 exit patients in Q1: momentum into Q2 Average Patients on WAKIX 8,500 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 9,000 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 Q1'24 Q2'24 Q3'24 Q4'24 Q1'25 Q2'25 Q3'25 Q4'25 Q1'26 KEY TAKEAWAY On Track To Achieve $1B+ in Net Sales PROTECTING GROWING ADVANCING TRANSACTING

WAKIX Differentiation and Strong Execution Drive Performance 16 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. 80,000 90,000 ~170,000 Diagnosed Narcolepsy Patients Undiagnosed Narcolepsy Population People Living With Narcolepsy in the U.S.1 90K+ Undiagnosed = 2× Today's Market LARGE MARKET OPPORTUNITY • ~170K total Narcolepsy patients • ~90K+ undiagnosed: 2X opportunity remains • ~20% brand penetration: in polypharmacy market DIFFERENTIATED PRODUCT • Only non-scheduled treatment option • 7+ years clinical experience EXPANDED TEAM • ~20% expansion complete as of Apr 1 • Largest expansion in brand history BROAD PAYER ACCESS • 80% lives covered • Expanded access in 2025 GR & HD LCM PROGRAMS • Differentiated products meet unmet patient needs to fuel continued growth PROTECTING GROWING ADVANCING TRANSACTING KEY TAKEAWAY Significant Growth Potential Remains

Robust Pipeline Beyond Pitolisant Lifecycle Management 17 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. PRODUCT INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 REGULATORY FILING MARKETED PRODUCT EDS in Narcolepsy (Adult/Pediatric*) WAKIX® Cataplexy in Narcolepsy (Adult/Pediatric*) Pitolisant Gastro-Resistant (GR) in Narcolepsy Pitolisant Prader-Willi Syndrome (PWS) Pitolisant High-Dose (HD) in Narcolepsy Pitolisant High-Dose (HD) in Idiopathic Hypersomnia Pitolisant High-Dose (HD) in Myotonic Dystrophy (DM1) Pitolisant Amorphous Form Sleep/Wake Disorders BP-205 (Orexin-2 Receptor Agonist) CBS105 Treatment-Resistant Narcolepsy HBS-102 PWS Dravet Syndrome (DS) EPX-100 (Clemizole Hydrochloride Lennox-Gastaut Syndrome (LGS) EPX-200 (Lorcaserin) Developmental and Epileptic Encephalopathies CBS104 Refractory Epilepsy *Ages 6 years and older Research collaboration with CiRC Biosciences.. Innovative Late-Stage Pipeline With Multiple Catalysts 2026–2028 PROTECTING GROWING ADVANCING TRANSACTING

BP-205: Potential for Best-in-Class OX2R Agonist 18 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. BUILT ON NOVEL CHEMICAL SCAFFOLD Leads to differentiated product profile HIGH POTENCY Enables the potential for significantly lower dosing and target all 3 central disorders of hypersomnolence, NT1, NT2 and IH HIGH SELECTIVITY For OX2R over OX1R and 150 other receptors of interest FAVORABLE SAFETY/TOLERABILITY PROFILE Supported by preclinical safety pharmacology and toxicology data PHASE 1 SAD/MAD CLINICAL STUDY ONGOING IN EUROPE SAD clinical PK, safety, and tolerability data in mid-2026 U.S. IND SUBMISSION PLANNED FOR MID-2026 PLAN TO INITIATE PH 1B IN STUDY IN SLEEP-DEPRIVED HEALTHY VOLUNTEERS IN 2H26 EXPLORING USE OUTSIDE OF SLEEP/WAKE Preclinical experiments in broader neuropsych indications targeting mood, ADHD, cognition, and fatigue. PROTECTING GROWING TRANSACTING MOST POTENT OX2R IN CLINIC ADVANCING

Pitolisant GR (Gastro-Resistant): On Track To Extend Pitolisant Franchise Into 2040’s 19 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. PROTECTING TRANSACTING Q1 2027 ANTICIPATED PDUFA DATE NDA SUBMISSION ON TRACK FOR Q2 2026 Anticipated PDUFA date in Q1 2027 APPROXIMATELY 80-90% OF PATIENTS WITH NARCOLEPSY EXPERIENCE GI SYMPTOMS AS PART OF THEIR DISEASE PITOLISANT GR IS DESIGNED WITH ENTERIC COATING Meant to reduce the potential for GI side effects in patients prone to GI symptoms ALLOWS PATIENTS TO INITIATE TREATMENT AT A THERAPEUTIC DOSE WITHOUT TITRATION An important clinical differentiation UTILITY PATENTS FILED TO EXTEND FRANCHISE INTO THE 2040s GROWING ADVANCING VALUE

Pitolisant HD: Opportunity To Expand Pitolisant Franchise With Differentiated Labeling 20 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. PROTECTING TRANSACTING 2027 ANTICIPATED PHASE 3 TOPLINE DATA PHASE 3 REGISTRATIONAL CLINICAL TRIALS ONGOING TOPLINE DATA ANTICIPATED IN 2027 Target 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 FRANCHISE INTO THE 2040s GROWING ADVANCING

Robust Pipeline Beyond Pitolisant Lifecycle Management 21 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. PRODUCT INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 REGULATORY FILING MARKETED PRODUCT EDS in Narcolepsy (Adult/Pediatric*) WAKIX® Cataplexy in Narcolepsy (Adult/Pediatric*) Pitolisant Gastro-Resistant (GR) in Narcolepsy Pitolisant Pitolisant High-Dose (HD) in Narcolepsy Pitolisant High-Dose (HD) in Idiopathic Hypersomnia Pitolisant High-Dose (HD) in Myotonic Dystrophy (DM1) Sleep/Wake Disorders BP205 (Orexin-2 Receptor Agonist) CBS105 Treatment-Resistant Narcolepsy HBS-102 PWS Dravet Syndrome (DS) EPX-100 (Clemizole Hydrochloride Lennox-Gastaut Syndrome (LGS) EPX-200 (Lorcaserin) Developmental and Epileptic Encephalopathies CBS104 Refractory Epilepsy *Ages 6 years and older Research collaboration with CiRC Biosciences.. Innovative Late-Stage Pipeline With Multiple Catalysts 2026–2028 PROTECTING GROWING ADVANCING TRANSACTING Prader-Willi Syndrome (PWS) Pitolisant Amorphous Form ADVANCING

EPX-100: One of Most Advanced 5-HT2 (Serotonin) Agonist Programs in DEEs 22 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. ESTABLISHED 5-HT2 (SEROTONIN) AGONIST MECHANISM OF ACTION ONGOING PHASE 3 TRIALS IN LENNOX-GASTAUT SYNDROME (LIGHTHOUSE) & DRAVET SYNDROME (ARGUS) Topline data anticipated 1H 2027 SAFETY: POTENTIAL TO OFFER A UNIQUE RISK/BENEFIT PROPOSITION No additional laboratory or special safety monitoring BID DOSING REGIMEN Convenient for patients and caregivers PROTECTING GROWING DRIVING VALUE TRANSACTING Median reduction of ~50% in countable motor seizure frequency per 28 days (CMS-28) in participants who had at least 6- month exposure to EPX-100; at least 50% reduction in CMS-28 in 50% of these participants ADVANCING 2027 ANTICIPATED PHASE 3 TOPLINE DATA

Financial Summary Q1 2026 23 Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved. • $32 million in expenses related to up-front payments for amorphous license agreements impacted diluted EPS by $0.45 a share after taxes. • Cash generation was muted in the quarter due to up-front license fee payments, payments for ANDA settlements announced last quarter and a seasonal reduction in accrued expenses. $184.7 $215.4 Q1 2025 Q1 2026 $610.2 $672.3 $778.4 $882.5 $870.5 Q1 2025 Q2 2025 Q3 2025 Q4 2025 Q1 2026 Three Months Ended March 31, 2026 (In millions, USD) Net Product Revenue Diluted Earnings per Share Cash, Cash Equivalents & Investments -29% 17% -$12M Three Months Ended March 31, 2026 $0.78 $0.55 Q1 2025 Q1 2026 Inclusive of -$0.45 per share related to new license agreements PROTECTING GROWING ADVANCING TRANSACTING

Financial Summary Q1 2026 24 •Cost of Product Sold as a percentage of Net Product Revenue increased due to new royalties related to Novitium License Agreement. •R&D Expense includes $32 million in IPR&D charges related to amorphous license agreements entered in Q1 2026 •Operating Expenses would have increased a modest 5% without IPR&D charges. % Change Three Months Ended March 31, Totals may not foot due to rounding 2026 2025 Net Product Revenue $215.4 $184.7 17% Cost of Product Sold 44.5 32.0 39% Total Operating Expenses $133.6 $96.5 38% R&D Expense 69.4 34.5 101% S&M Expense 31.7 30.7 3% G&A Expense 32.5 31.2 4% Net Income $32.5 $45.6 -29% Cash, cash equivalents & investments $870.5 $610.2 43% (In millions, USD) PROTECTING GROWING ADVANCING TRANSACTING Harmony Biosciences | Q1 2026 Financial Results & Business Update | All rights reserved.

EMPHASIS ON BUSINESS DEVELOPMENT ADVANCING ROBUST PIPELINE BEYOND PITOLISANT LIFECYCLE MANAGEMENT CONTINUED PITOLISANT FRANCHISE GROWTH IN AN EVOLVING MARKET PROTECT THE PITOLISANT FRANCHISE PROTECTING GROWING ADVANCING TRANSACTING Well-positioned to deliver innovative treatments to patients while driving sustained long-term value for shareholders PILLARS OF VALUE CREATION

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