Form 8-K - Current report

0001802665false00018026652024-10-292024-10-29

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

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Date of report (Date of earliest event reported): October 29, 2024

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HARMONY BIOSCIENCES HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

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

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630 W. Germantown Pike, Suite 215

Plymouth Meeting, PA 19462

(Address of principal executive offices) (Zip Code)

[phone]

(Registrant’s telephone number, including area code)

N/A

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

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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)

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

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

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

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

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​		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

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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).

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Emerging growth company ☐

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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. ☐

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Item 2.02.    Results of Operations and Financial Condition.

On October 29, 2024, Harmony Biosciences Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2024. 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 October 29, 2024, 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.

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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.

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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, 2023, which was filed with the Securities and Exchange Commission (“SEC,”) on February 22, 2024, 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.

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Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

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Exhibit		​
No.	​	Description
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99.1*	​	Press release issued by the Company, dated October 29, 2024.
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99.2*	​	Investor Presentation dated October 29, 2024.
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104	​	Cover Page Interactive Data File (embedded within the Inline XBRL document).

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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.

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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.

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​	HARMONY BIOSCIENCES HOLDINGS, INC.
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Date: October 29, 2024	By:	/s/ Sandip Kapadia
​	​	Sandip Kapadia
​	​	Chief Financial Officer and Chief Administrative Officer

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‌Exhibit 99.1

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HARMONY BIOSCIENCES REPORTS STRONG THIRD QUARTER 2024 FINANCIAL RESULTS AND HIGHLIGHTS CATALYST-RICH, LATE-STAGE PIPELINE POISED TO DELIVER ONE OR MORE NEW LAUNCHES EVERY YEAR OVER NEXT FIVE YEARS

 

WAKIX (pitolisant) Net Revenue of $186.0 Million for Third Quarter 2024; Surpassed $2B in Cumulative Net Revenue in Less Than Five Years

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On Track to Submit sNDA for Pitolisant in Idiopathic Hypersomnia (IH) in Q4 2024 Based on Updated Strong and Sustained Efficacy Data from Long-Term Extension Study

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Next-Gen Pitolisant-GR and Pitolisant-HD Programs Advance; IND for Potential Best-In-Class, Novel Orexin-2 Agonist On Track for mid-2025, Extending Leadership in Sleep/Wake Beyond 2040s

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Highlights Most Advanced Development Program and Proven Serotonergic (5-HT₂) Mechanism of Action For EPX-100 in Rare Epilepsies; Pivotal Phase 3 Trial in Dravet Syndrome Ongoing; Phase 3 Registrational Trial in Lennox-Gastaut Syndrome to Initiate Before Year End

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Next Major Clinical Catalyst: Topline Data From ZYN-002 Pivotal Phase 3 RECONNECT Trial in Fragile X Syndrome on Track For mid-2025

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Reiterates 2024 Net Product Revenue Guidance of $700 - $720 Million

 

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

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PLYMOUTH MEETING, PA., October 29, 2024 — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY), today reported a record $186.0 million in net revenue for the quarter ending on September 30, 2024, surpassing $2 billion in cumulative net revenues since

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the launch of WAKIX® in adult narcolepsy in November of 2019. In addition, the company recently hosted an Investor Day on October 1, during which it highlighted its transformation into an innovative, catalyst-rich, self-funding biotech company with a robust late-stage pipeline.

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“Going into Q4, Harmony has great momentum. During our Investor Day, we shared new data in support of our confidence and excitement about the company’s growth trajectory as we advance our robust, catalyst-rich, late-stage pipeline and expand into additional rare CNS therapeutic areas. We are building on our success in sleep/wake with a strategy focused on continuous innovation, patient impact, and long-term value creation for our shareholders, and, if successful, our current pipeline is poised to deliver over $3 billion in net revenue going forward,” said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. “We have been building a leading CNS biotech company and are committed to addressing unmet medical needs for people living with CNS disorders that have few or no treatment options and, when we deliver on this promise to patients, we have the potential to deliver significant value to our shareholders as well.”

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Key Franchise Highlights:

Sleep/Wake: Extending Leadership Position

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WAKIX:

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Net Sales for the quarter were $186.0M; with these quarterly sales, WAKIX surpassed $2B in cumulative net revenue in less than five years on the market

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The average number of patients on WAKIX increased by approximately 250 patients sequentially to approximately 6,800 for the quarter ended September 30, 2024

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Pitolisant in Idiopathic Hypersomnia (IH): 

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New data from the Long-Term Extension study demonstrate robust and sustained efficacy of pitolisant in patients with idiopathic hypersomnia

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Mean improvement in Epworth Sleepiness Scale (ESS) was ~9 points from baseline out beyond one year, with the majority of patients in the normal range as measured by the ESS

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Sustained efficacy was also observed on the Idiopathic Hypersomnia Severity Scale (IHSS) and Sleep Inertia Questionnaire (SIQ) beyond one year

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Data supports strong benefit/risk proposition; on track to submit sNDA in Q4 2024

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Pitolisant-HD (high dose) program: 

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Pitolisant-HD is an enhanced formulation of pitolisant designed with the following attributes:

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A higher dose with an optimized pharmacokinetic profile to drive greater efficacy in EDS and cataplexy

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Targeting a unique indication for fatigue in narcolepsy

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A gastro-resistant coating with no need for a titration dose

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Preliminary safety data up to 5x the current highest labeled dose of WAKIX are consistent with the established safety profile of WAKIX and establish safety margins for the pitolisant-HD development program

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Pitolisant-HD on track for PDUFA in 2028 with the goal to extend the pitolisant franchise to mid-2040s

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Provisional patents filed until 2044 with the opportunity to grow the pitolisant franchise by pursuing additional indications

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Pitolisant-GR (gastro-resistant) program: 

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Pitolisant-GR is a gastro-resistant formulation of pitolisant designed to minimize GI tolerability issues in patients with narcolepsy; approximately 90% of patients with narcolepsy experience GI symptoms partly related to the underlying disease mechanism

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On track to initiate pivotal bioequivalence study and dosing optimization study (to remove the titration dose) in Q1 2025

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PDUFA on track for 2026 with IP to the mid-2040s

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Orexin-2 agonist program: 

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BP1.15205 (formerly TPM-1116) potential to be best-in-class orexin-2 receptor agonist

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Based on a novel chemical scaffold

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Demonstrated greater potency compared to all publicly disclosed data on orexin-2 agonists; allows for dosing flexibility to target all central disorders of hypersomnolence. The potency was consistent across species along with an excellent selectivity of greater than 600x which translates to over 140-fold margin over orexin-1 receptors at the anticipated maximum human dose

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In addition, BP1.15205 demonstrated over 1000-fold selectively over 150 other targets of interest

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Preclinical PK data consistent with once-a-day dosing

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Rare Epilepsy: Most Advanced Development Program in the 5-HT₂ agonist class

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EPX-100 (clemizole hydrochloride):

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MoA: Proven serotonergic (5-HT2) mechanism of action in Developmental Epileptic Encephalopathies (DEEs) confirmed via a validated and highly predictive preclinical model (zebra fish model)

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Most advanced development program for the DEEs:

EPX-100 in Phase 3 registration trial, ARGUS study, in patients with Dravet syndrome (DS); on track for topline data in 2026

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EPX-100 Phase 3 registration trial for Lennox-Gastaut syndrome (LGS) on track to initiate later this year

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Preliminary Safety and Tolerability data suggests favorable profile compared to select approved drugs for rare epilepsies (with no need for routine laboratory or cardiac monitoring)

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Received Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) by the FDA for DS and LGS

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EPX-200 (lorcaserin hydrochloride):

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MoA: Potent, selective 5HT2C agonist with proven mechanism of action in DEEs confirmed via non-clinical and clinical data

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Currently in IND-enabling stage

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Received ODD for DS, and ODD / RPDD for LGS by the FDA; and ODD for DS by the European Medicines Agency

Neurobehavioral: Next Major Clinical Catalyst

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ZYN-002

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Pivotal Phase 3 RECONNECT trial in Fragile X syndrome ongoing; topline data on track for mid-2025

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Anticipate initiation of pivotal Phase 3 trial in 22q11.2 deletion syndrome (22q) in 2025

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Third Quarter 2024 Financial Results

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Net product revenues for the quarter ended September 30, 2024, were $186.0 million, compared to $160.3 million for the same period in 2023. The 16% growth versus the same period in 2023 is primarily attributed to strong commercial sales of WAKIX driven by continued organic demand tapping into a large market opportunity (approximately 80,000 patients diagnosed with narcolepsy in the U.S.) and the broad clinical utility of WAKIX across the approximately 9,000 HCPs that we call on (about 5,000 of whom do not participate in an oxybate REMS program). The average number of patients on WAKIX increased by approximately 250 sequentially to approximately 6,800 for the

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quarter ended September 30, 2024.

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GAAP net income for the quarter ended September 30, 2024, was $46.1 million, or $0.79 earnings per diluted share, compared to GAAP net income of $38.5 million, or $0.63 earnings per diluted share, for the same period in 2023. Non-GAAP adjusted net income was $59.6 million, or $1.03 earnings per diluted share, for the quarter ended September 30, 2024, compared to Non-GAAP adjusted net income of $58.8 million, or $0.97 per diluted share, for the same period in 2023.

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Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included at the end of this press release.

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Harmony’s operating expenses include the following:

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Research and Development expenses were $25.4 million in the third quarter of 2024, as compared to $17.5 million for the same quarter in 2023, representing a 45% increase;

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Sales and Marketing expenses were $27.6 million in the third quarter of 2024, as compared to $23.4 million for the same quarter in 2023, representing a 18% increase;

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General and Administrative expenses were $28.6 million in the third quarter of 2024, as compared to $22.5 million for the same quarter in 2023, representing a 27% increase; and

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Total Operating Expenses were $81.6 million in the third quarter of 2024, as compared to $63.5 million for the same quarter in 2023, representing a 29% increase.

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As of September 30, 2024, Harmony had cash, cash equivalents and investments of $504.7 million, compared to $425.6 million as of December 31, 2023.

Reiterates 2024 Net Product Revenue Guidance

Expect full year 2024 net product revenue of $700 million to $720 million.

Share Repurchase Program

The remaining amount of common stock authorized for repurchases as of September 30, 2024, was $150 million.

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

We are hosting our third quarter 2024 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 at https://ir.harmonybiosciences.com/. To participate in the live call by phone, dial (800)

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245-3047 (domestic) or [phone] (international), and reference passcode HRMYQ324.

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Non-GAAP Financial Measures

In addition to our GAAP results, we present certain Non-GAAP metrics including Non-GAAP adjusted net income and Non-GAAP adjusted net income per share, which we believe provides important supplemental information to management and investors regarding our performance. These measurements are not a substitute for GAAP measurements, and the manner in which we calculate Non-GAAP adjusted net income and Non-GAAP adjusted net income per share may not be identical to the manner in which other companies calculate adjusted net income and adjusted net income per share. We use these Non-GAAP measurements as an aid in monitoring our financial performance from quarter-to-quarter and year-to-year and for benchmarking against comparable companies.

Non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with our consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future there may be other items that we may exclude for purposes of our Non-GAAP financial measures; and we may in the future cease to exclude items that we have historically excluded for purposes of our Non-GAAP financial measures.

About WAKIX^® (pitolisant) Tablets
WAKIX, a first-in-class medication, is approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of EDS in pediatric patients 6 years of age and older with narcolepsy. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H₃) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated through its activity at H₃ receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter. WAKIX was designed and developed by Bioprojet (France). Harmony has an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States.

Indications and Usage
WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy.

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Important Safety Information

Contraindications
WAKIX is contraindicated in patients with known hypersensitivity to pitolisant or any component of the formulation. Anaphylaxis has been reported. WAKIX is also contraindicated in patients with severe hepatic impairment.

Warnings and Precautions
WAKIX prolongs the QT interval; avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval. Avoid use in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval. 

The risk of QT prolongation may be greater in patients with hepatic or renal impairment due to higher concentrations of pitolisant; monitor these patients for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment. WAKIX is contraindicated in patients with severe hepatic impairment and not recommended in patients with end-stage renal disease (ESRD).

Adverse Reactions
In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and at least twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory tract infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash.

In the placebo-controlled phase of the clinical trial conducted in pediatric patients 6 years and older with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and greater than placebo) for WAKIX were headache (19%) and insomnia (7%). The overall adverse reaction profile of WAKIX in the pediatric clinical trial was similar to that seen in the adult clinical trial program.

Drug Interactions
Concomitant administration of WAKIX with strong CYP2D6 inhibitors increases pitolisant exposure by 2.2-fold. Reduce the dose of WAKIX by half. 

Concomitant use of WAKIX with strong CYP3A4 inducers decreases exposure of pitolisant by 50%. Dosage adjustments may be required.

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H1 receptor antagonists that cross the blood-brain barrier may reduce the effectiveness of WAKIX. Patients should avoid centrally acting H1 receptor antagonists. 

WAKIX is a borderline/weak inducer of CYP3A4. WAKIX may reduce the effectiveness of sensitive CYP3A4 substrates, including hormonal contraceptives. Patients using hormonal contraception should be advised to use an alternative non-hormonal contraceptive method during treatment with WAKIX and for at least 21 days after discontinuing treatment.

Use in Specific Populations

There is a pregnancy exposure registry that monitors pregnancy outcomes in women who are exposed to WAKIX during pregnancy. Patients should be encouraged to enroll in the WAKIX pregnancy registry if they become pregnant. To enroll or obtain information from the registry, patients can call 1-800-833-7460.

The safety and effectiveness of WAKIX have not been established for treatment of excessive daytime sleepiness in pediatric patients less than 6 years of age with narcolepsy.

The safety and effectiveness of WAKIX have not been established for treatment of cataplexy in pediatric patients with narcolepsy.

WAKIX is extensively metabolized by the liver. WAKIX is contraindicated in patients with severe hepatic impairment. Dosage adjustment is required in patients with moderate hepatic impairment.

WAKIX is not recommended in patients with end-stage renal disease. Dosage adjustment of WAKIX is recommended in patients with eGFR <60 mL/minute/1.73 m².

Dosage reduction is recommended in patients known to be poor CYP2D6 metabolizers; these patients have higher concentrations of WAKIX than normal CYP2D6 metabolizers.

Please see the Full Prescribing Information for WAKIX for more information.

To report suspected adverse reactions, contact Harmony Biosciences at 1-800-833-7460 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

About Narcolepsy
Narcolepsy is a rare, chronic, debilitating neurological disease of sleep-wake state instability that impacts approximately 170,000 Americans and is primarily characterized by excessive daytime sleepiness (EDS) and cataplexy – its two cardinal symptoms – along with other manifestations of REM sleep dysregulation (hallucinations and sleep paralysis), which intrude into wakefulness. EDS is the inability to stay awake and alert during the day and is the symptom that is present in all people living with narcolepsy. In most patients, narcolepsy is caused by the loss of hypocretin/orexin, a neuropeptide in

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the brain that supports sleep-wake state stability. This disease affects men and women equally, with typical symptom onset in adolescence or young adulthood; however, it can take up to a decade to be properly diagnosed.

About Idiopathic Hypersomnia
Idiopathic Hypersomnia (IH) is a rare and chronic neurological disease that is characterized by excessive daytime sleepiness (EDS) despite sufficient or even long sleep time. EDS in IH cannot be alleviated by naps, longer sleep or more efficient sleep. People living with IH experience significant EDS along with the symptoms of sleep inertia (prolonged difficulty waking up from sleep) and 'brain fog' (impaired cognition, attention, and alertness). The cause of IH is unknown, but it is likely due to alterations in areas of the brain that stabilize states of sleep and wakefulness. IH is one of the central disorders of hypersomnolence and, like narcolepsy, is a debilitating sleep disorder that can result in significant disruption in daily functioning.

About ZYN-002
ZYN-002 is the first-and-only pharmaceutically manufactured synthetic cannabidiol devoid of THC and formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. The product is manufactured through a synthetic process in a cGMP facility and is not extracted from the cannabis plant. ZYN-002 does not contain THC, the compound that causes the euphoric effect of cannabis, and has the potential to be a nonscheduled product if approved. Cannabidiol, the active ingredient in ZYN-002, has been granted orphan drug designation by the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of FXS and for the treatment of 22q. Additionally, ZYN-002 has received FDA Fast Track designation for the treatment of behavioral symptoms in patients with FXS.

About Fragile X Syndrome
Fragile X syndrome (FXS) is a rare genetic disorder that is the leading known cause of both inherited intellectual disability and autism spectrum disorder. The disorder negatively affects synaptic function, plasticity and neuronal connections, and results in a spectrum of intellectual disabilities and behavioral symptoms, such as social avoidance and irritability. While the exact prevalence is unknown, upwards of 80,000 patients in the U.S. and 121,000 patients in the European Union and the UK are believed to have FXS, based on FXS prevalence estimates of approximately 1 in 4,000 to 7,000 in males and approximately 1 in 8,000 to 11,000 in females. There is a significant unmet medical need in patients living with FXS as there are currently no FDA approved treatments for this disorder.

FXS is caused by a mutation in FMR1, a gene which modulates a number of systems, including the endocannabinoid system, and most critically, codes for a protein called FMRP. The FMR1 mutation manifests as multiple repeats of a DNA segment, known as the CGG triplet repeat, resulting in deficiency or lack of FMRP. FMRP helps regulate the

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production of other proteins and plays a role in the development of synapses, which are critical for relaying nerve impulses, and in regulating synaptic plasticity. In people with full mutation of the FMR1 gene, the CGG segment is repeated more than 200 times, and in most cases causes the gene to not function. Methylation of the FMR1 gene also plays a role in determining functionality of the gene. In approximately 60% of patients with FXS, who have complete methylation of the FMR1 gene, no FMRP is produced, resulting in dysregulation of the systems modulated by FMRP.

About 22q11.2 Deletion Syndrome
22q11.2 deletion syndrome (22q) is a disorder caused by a small missing piece of the 22nd chromosome. The deletion occurs near the middle of the chromosome at a location designated q11.2. It is considered a mid-line condition, with physical symptoms including characteristic palate abnormalities, heart defects, immune dysfunction, and esophageal/ GI issues, as well as debilitating neuropsychiatric and behavioral symptoms, including anxiety, social withdrawal, ADHD, cognitive impairment and autism spectrum disorder. It is estimated that 22q occurs in one in 4,000 live births, suggesting that there are approximately 80,000 people living with 22q in the U.S. and 129,000 in the European Union and the UK. Patients with 22q deletion syndrome are managed by multidisciplinary care providers, and there are currently no FDA approved treatments for this disorder.

About Clemizole Hydrochloride (EPX-100)
EPX-100, clemizole hydrochloride, is under development for the treatment of Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). EPX-100 acts by targeting central 5-hydroxytryptamine receptors to modulate serotonin signaling. The drug candidate is administered orally twice a day in a liquid formulation and has been developed based on a proprietary phenotype-based zebrafish drug screening platform. DS is caused by a loss of function mutation in the SCN1A gene, and scn1 mutant zebrafish replicate the genetic etiology and phenotype observed in the majority of DS patients. The scn1Lab mutant zebrafish model that expresses voltage gated sodium channels has been used for high-throughput screening of compounds that modulate Nav1.1 in the central nervous system.

About Lorcaserin (EPX-200)

EPX-200, liquid formulation of lorcaserin is under development for the treatment of DEEs (Developmental Epileptic Encephalopathies). EPX-200 is a selective 5-HT2C receptor agonist. The drug candidate is developed based on a proprietary phenotype-based zebrafish drug screening platform and clinical data in patients with DEEs1,2.

About Dravet Syndrome
Dravet syndrome (DS) is a severe and progressive epileptic encephalopathy that begins in infancy and causes significant impact on patient functioning. DS begins in the first year of life and is characterized by high seizure frequency and severity, intellectual disability, and a risk of sudden unexpected death in epilepsy. Approximately 85% of

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Dravet Syndrome cases are caused by de novo loss-of-function (LOF) mutations in a voltage-gated sodium channel gene, SCN1A1. DS has an estimated incidence rate of 1:15,700.

About Lennox-Gastaut Syndrome
Lennox-Gastaut Syndrome (LGS) is a rare and drug-resistant epileptic encephalopathy characterized by onset in children between 3-5 years of age. The underlying cause of LGS is unknown and can be related to a wide range of factors including genetic differences and structural differences in the brain. As a result, patients experience multiple seizure types, including atonic seizures, and developmental, cognitive, and behavioral issues. LGS affects approximately 48,000 patients in the U.S. 

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 2024 net product revenue, expectations for the growth and value of WAKIX, plans to submit an sNDA for pitolisant in idiopathic hypersomnia; 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; 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

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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 the significant costs and required management time as a result of operating as a public company. 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 22, 2024, 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.

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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,
​		2024			2023			2024			2023
Net product revenue	​	$	186,038	​	$	160,268	​	$	513,467	​	$	413,610
Cost of product sold	​		42,778	​		32,296	​		102,406	​		78,084
Gross profit	​		143,260	​		127,972	​		411,061	​		335,526
Operating expenses:	​			​			​			​
Research and development	​		25,387	​		17,499	​		111,159	​		45,757
Sales and marketing	​		27,576	​		23,418	​		83,316	​		70,518
General and administrative	​		28,587	​		22,546	​		81,487	​		67,417
Total operating expenses	​		81,550	​		63,463	​		275,962	​		183,692
Operating income	​		61,710	​		64,509	​		135,099	​		151,834
Loss on debt extinguishment	​		—	​		(9,766)	​		—	​		(9,766)
Other (expense) income, net	​		(124)	​		(5)	​		(228)	​		(34)
Interest expense	​	​	(4,348)	​	​	(7,012)	​	​	(13,287)	​		(18,961)
Interest income	​		4,932	​		4,106	​		14,065	​		10,634
Income before income taxes	​		62,170	​		51,832	​		135,649	​		133,707
Income tax expense	​		(16,077)	​		(13,371)	​		(39,631)	​		(31,461)
Net income	​	$	46,093	​	$	38,461	​	$	96,018	​	$	102,246
Unrealized (loss) income on investments	​		733	​		6	​		497	​		(365)
Comprehensive income	​	$	46,826	​	$	38,467	​	$	96,515	​	$	101,881
EARNINGS PER SHARE:	​			​			​			​
Basic	​	$	0.81	​	$	0.64	​	$	1.69	​	$	1.71
Diluted	​	$	0.79	​	$	0.63	​	$	1.66	​	$	1.68
Weighted average number of shares of common stock - basic	​		56,870,234	​		59,863,102	​		56,815,167	​		59,856,941
Weighted average number of shares of common stock - diluted	​		58,103,963	​		60,681,676	​		57,754,016	​		60,892,992

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HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

​

(In thousands, except share and per share data)

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​	​	​	​	​	​	​
​		September 30,			December 31,
​		2024			2023
ASSETS		​			​
CURRENT ASSETS:		​			​
Cash and cash equivalents	​	$	387,367	​	$	311,660
Investments, short-term	​	​	23,109	​	​	41,800
Trade receivables, net	​		81,502	​		74,140
Inventory, net	​		6,915	​		5,363
Prepaid expenses	​		16,057	​		12,570
Other current assets	​		7,455	​		5,537
Total current assets	​		522,405	​		451,070
NONCURRENT ASSETS:	​			​
Property and equipment, net	​		750	​		371
Restricted cash	​		270	​		270
Investments, long-term	​	​	94,222	​	​	72,169
Intangible assets, net	​		119,225	​		137,108
Deferred tax asset	​	​	185,016	​	​	144,162
Other noncurrent assets	​		6,247	​		6,298
Total noncurrent assets	​		405,730	​		360,378
TOTAL ASSETS	​	$	928,135	​	$	811,448
LIABILITIES AND STOCKHOLDERS’ EQUITY	​			​
CURRENT LIABILITIES:	​			​
Trade payables	​	$	10,532	​	$	17,730
Accrued compensation	​		14,224	​		23,747
Accrued expenses	​		109,673	​		99,494
Current portion of long-term debt	​	​	15,000	​	​	15,000
Other current liabilities	​		11,850	​		7,810
Total current liabilities	​		161,279	​		163,781
NONCURRENT LIABILITIES:	​			​
Long-term debt, net	​		167,847	​		178,566
Other noncurrent liabilities	​		2,205	​		2,109
Total noncurrent liabilities	​		170,052	​		180,675
TOTAL LIABILITIES	​		331,331	​		344,456
COMMITMENTS AND CONTINGENCIES (Note 13)	​			​
STOCKHOLDERS’ EQUITY:	​			​
Common stock—$0.00001 par value; 500,000,000 shares authorized at September 30, 2024 and December 31, 2023, respectively; 57,030,897 and 56,769,081 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively	​		1	​		1
Additional paid in capital	​		643,563	​		610,266
Accumulated other comprehensive (loss) income	​	​	499	​	​	2
Accumulated deficit	​		(47,259)	​		(143,277)
TOTAL STOCKHOLDERS’ EQUITY	​		596,804	​		466,992
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY	​	$	928,135	​	$	811,448

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HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES

RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS

(In thousands except share and per share data)

​

​

​

Three Months Ended

​

Nine Months Ended

​

​

September 30,

​

September 30,

​

September 30,

​

September 30,

​

​

2024

​

2023

​

2024

​

2023

GAAP net income

​

$

46,093

​

$

38,461

​

$

96,018

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$

102,246

Non-GAAP Adjustments:

​

​

​

​

Non-cash interest expense (1)

​

175

​

2,221

​

531

​

3,061

Depreciation

​

7

​

144

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261

​

350

Amortization (2)

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5,961

​

5,962

​

17,883

​

17,884

Stock-based compensation expense

​

11,448

​

7,957

​

32,845

​

22,311

Licensing fee and milestone payments (3)

​

​

1,000

​

​

-

​

​

26,500

​

​

750

Loss on debt extinguishment (4)

​

​

-

​

​

9,766

​

​

-

​

​

9,766

Transaction related costs (5)

​

​

-

​

​

-

​

​

17,095

​

​

-

Income tax effect related to non-GAAP adjustments (6)

​

(5,096)

​

(5,723)

​

(20,215)

​

(10,987)

Non-GAAP adjusted net income

​

$

59,596

​

$

58,788

​

$

170,926

​

$

145,381

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​

​

GAAP reported net income per diluted share

​

$

0.79

​

$

0.63

​

$

1.66

​

$

1.68

Non-GAAP adjusted net income per diluted share

​

$

1.03

​

$

0.97

​

$

2.96

​

$

2.39

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​

​

​

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​

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​

​

Weighted average number of shares of common stock used in non-GAAP diluted per share

​

58,103,963

​

60,681,676

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57,754,016

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60,892,992

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(1) Includes amortization of deferred finance charges.

(2) Includes amortization of intangible asset related to WAKIX.

(3) Amount represents upfront licensing fee incurred upon closing the 2024 Bioprojet Sublicense Agreement, milestone payment related to HBS-102 in September 2024 and milestone payment related to HBS-102 in March 2023.

(4) Includes loss on extinguishment of the Blackstone Credit Agreement.

(5) Includes IPR&D charge related to the acquisition of Epygenix.

(6) Calculated using the reported effective tax rate for the periods presented less impact of discrete items.

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Harmony Biosciences Investor Contact:

Brennan Doyle

484-539-9700

[e-mail]

​

Harmony Biosciences Media Contact:

Cate McCanless

202-641-6086

[e-mail]

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Exhibit 99.2

Copyright © 2024 Harmony Biosciences. All rights reserved. Q3 2024 Financial Results and Business Updates October 29, 2024

Forward-Looking Statements This presentation includes forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Holdings, Inc.’s (the “Company”) future financial position, business strategy and plans and objectives of management for future operations, should be considered forward-looking statements. Forward-looking statements use words like “believes,” “plans,” “expects,” “intends,” “will,” “would,” “anticipates,” “estimates,” “may,” “could,” “might,” “continue,” “potential,” and similar words or expressions in discussions of the Company’s future operations, financial performance or the Company’s strategies, but the absence of these words does not mean that a statement is not forward-looking. These statements are based on current expectations or objectives that are inherently uncertain. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expressed or implied forwarding-looking statements, including, but not limited to the risk factors discussed under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 22, 2024 and its other filings with the SEC. While the Company may elect to update such forward-looking statements at some point in the future, it disclaims any obligation to do so, even if subsequent events cause its views to change. This presentation includes information related to market opportunity as well as cost and other estimates obtained from internal analyses and external sources. The internal analyses are based upon management’s understanding of market and industry conditions and have not been verified by independent sources. Similarly, the externally sourced information has been obtained from sources the Company believes to be reliable, but the accuracy and completeness of such information cannot be assured. Neither the Company, nor any of its respective officers, directors, managers, employees, agents, or representatives, (i) make any representations or warranties, express or implied, with respect to any of the information contained herein, including the accuracy or completeness of this presentation or any other written or oral information made available to any interested party or its advisor (and any liability therefore is expressly disclaimed), (ii) have any liability from the use of the information, including with respect to any forward-looking statements, or (iii) undertake to update any of the information contained herein or provide additional information as a result of new information or future events or developments. 2

Innovative, Patient Focused, and Catalyst-Rich Portfolio 3 5 Anticipate 1 or more new product or indication launches each year over next 5 years $1B+ Proven commercial product and growing $3B+ Establishing leadership position in CNS 13 Development programs; 4 in Phase 3 by year end Catalyst-rich pipeline poised to deliver both near-term and long-term value creation

Innovation driving growth of the portfolio Extending Our Leadership Position • Compelling new data; conviction in IH - sNDA on track for Q4 2024 • Next-generation formulations of pitolisant to extend franchise beyond 2040 • Potential best-in-class orexin-2 agonist (BP1.15205) Next Major Clinical Catalyst • Pivotal Phase 3 trial in Fragile X syndrome; topline data on track for mid-2025 • Plan to initiate pivotal Phase 3 trial in 22q deletion syndrome in 2025 Most Advanced 5-HT2 Development Program • EPX-100: validated MOA • Pivotal registrational trial in Dravet syndrome; topline data in 2026 • Pivotal Phase 3 trial in Lennox-Gastaut syndrome to initiate Q4 • EPX-200: proven and confirmed MOA SLEEP/ WAKE NEURO BEHAVIORAL EPILEPSY Harmony Biosciences data on file.

$160.2 $186.0 HIGHLIGHTS  Durable double-digit sales growth continuing into year five on the market  Passed $2B in cumulative net revenue since launch  Underlying demand drove continued revenue growth – Strong patient interest – Continue to add new prescribers and grow WAKIX prescriber base Q3 ‘23 Q3 ‘24 Reiterating Full Year Guidance of $700-$720M WAKIX Net Revenue ($M) WAKIX® Net Revenue Performance 5 16% Confident in WAKIX being a potential $1B+ opportunity in narcolepsy alone Confident in WAKIX being a potential $1B+ opportunity in narcolepsy alone

0 1000 2000 3000 4000 5000 6000 7000 Q3 20 Q4 20 Q1 21 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 Average # of Patients Net Patient Additions Meaningfully Differentiated Product Profile Key Driver in Strong Durable Growth in Patients on WAKIX® 6 Q3 24 Highlights More unique prescribers of WAKIX® than sodium oxybate Strong market access coverage (>80%) – even with the availability of generic and new 1 oxybate options ~Average # of Patients on WAKIX ~Approximate Patient Counts 2,200 +300 +300 +400 +400 +300 +300 +300 +300 +350 +350 +350 +200 +100 ~6,800 1. Net Patient Additions based on previously disclosed quarterly average number of patients on WAKIX ~6,800 Average number of patients on WAKIX and growing On our way to a $1B+ opportunity in adult narcolepsy +150 +250 +250

Unique Prescriber Dynamics Support Continued WAKIX® Growth, Opportunity for Next-Gen Pitolisant Assets in Narcolepsy 7 ~4,000 Enrolled in oxybate REMS ~5,000 Not enrolled in oxybate REMS Depth of prescribing Breadth of prescribing WAKIX growth ~9,000 NARCOLEPSY TREATING HCPs WAKIX growth Growing prescriber base for WAKIX with access to full diagnosed patient opportunity 1. Harmony Market Research, May 2024 MORE UNIQUE PRESCRIBERS OF WAKIX THAN SODIUM OXYBATE Unique feature as non-scheduled treatment is the highest performing driver and differentiator for WAKIX¹

The Pitolisant Franchise: Patient-Centric Drug Development Building Our Leadership Position in Sleep/Wake 8 Non-scheduled Gastro-resistant coating EDS and Cataplexy No titration Fatigue indication Higher dose, enhanced efficacy Non-scheduled EDS and Cataplexy Non-scheduled EDS and Cataplexy Gastro-resistant coating No titration Well tolerated; safety profile Well tolerated; safety profile Well tolerated; safety profile WAKIX®* Pitolisant-GR Pitolisant-HD Products require titration NARCOLEPSY UNMET NEEDS FDA-approved treatments are scheduled (CII – CIV) Only 1 FDA-approved treatment indicated for EDS and cataplexy 1. McCullough et al. Novel treatment options in narcolepsy, Chicago Rush Memorial Center - SLEEP 2019 Abstract; 2. Droogleever et al. (2012). Severe fatigue in narcolepsy with cataplexy. Sleep, 21(2), 163-169; 3. Barateau et al., Dauvilliers, 2019; 4. Wang et al., 2023; 4. Zhan et al., 2023; 5. Postmarketing study; 6. Versta Research, Know Narcolepsy Survey (“Know Narcolepsy”), October 2018; * WAKIX attributes based on FDA-approved adult narcolepsy product labelling. Residual symptoms¹ Report fatigue² Report GI disturbances³, ⁴ Cite nausea as a side effect⁵ Cite frustration with side effects⁶ Don’t achieve clinical benefit 60% 75% 100% 88% 56% 100% 1 33% 1 in 5

Pitolisant Franchise Poised to Drive Durable Patient and Revenue Growth to the Mid-2040s • Two meaningfully differentiated product profiles building off WAKIX with PDUFAs prior to LOE • Provisional patents filed out to 2044 to extend durable patient and net revenue growth • Pursuing other indications (IH, DM1) to drive incremental patient, net revenue growth *Based on pediatric exclusivity WAKIX® (LOE SEPT 2030*) $1B+ foundation in narcolepsy alone PITOLISANT-GR (PDUFA DATE 2026) Expands pitolisant patient base Potential $300–$500M Opportunity PITOLISANT-HD (PDUFA DATE 2028) Grows pitolisant patient base and extends pitolisant franchise Potential $1B+ opportunity in narcolepsy alone 2019 2026 2028 2030 2040 • Pitolisant franchise strengthens leadership position in sleep/wake • Poised to deliver durable patient growth and significant revenue to the mid 2040s 9

Harmony Biosciences: R&D Pipeline PRODUCT / INDICATION PRE-IND PHASE 1 PHASE 2 PHASE 3 REGULATORY FILING MARKETED PRODUCT Sleep/Wake WAKIX® EDS in Narcolepsy (Adults) Cataplexy in Narcolepsy (Adults) EDS in Narcolepsy (Pediatric) Pitolisant Idiopathic Hypersomnia (IH) Prader-Willi Syndrome (PWS) Myotonic Dystrophy (DM1) Pitolisant Gastro-Resistant (GR) Pitolisant High-Dose (HD) BP1.15205 (Orexin-2 Receptor Agonist) Sleep/Wake Disorders HBS-102 PWS Neurobehavioral ZYN-002 (Cannabidiol Gel) Fragile X Syndrome (FXS) 22q11.2 Deletion Syndrome (22q) Rare Epilepsy EPX-100 (Clemizole Hydrochloride) Dravet Syndrome (DS) Lenox-Gastaut Syndrome (LGS) EPX-200 (Lorcaserin) Developmental and Epileptic Encephalopathies (DEE) 3 CNS FRANCHISES 13 DEVELOPMENT 8 PROGRAMS ASSETS 4PHASE 3 PROGRAMS BY YEAR END 10

Idiopathic Hypersomnia: Strong Benefit/Risk Proposition IH: DISORDER WITH HIGH UNMET NEED ESTABLISHED SAFETY Non-scheduled and simple dosing regimen FAVORABLE BENEFIT/RISK PROFILE COMPELLING TOTALITY OF DATA FROM INTUNE STUDY a Phase 3 pivotal study in IH REAL WORLD DATA Experience from a large clinic & Compassionate Use program On-track for sNDA submission in 4Q 2024 11

OX2R Agonist BP1.15205: Potential Best-in-Class Asset High potency with potential efficacy in various sleep disorders and other indications Potent on-target effects Potentially better AE profile Highly desirable QD dosing 24h Potential approval in early 2030s Potential for combination drug development: pitolisant-HD and BP1.15205 Potential best-in-class OX2R agonist with possibility for broad clinical utility; on track for IND submission mid-2025 12

Epilepsy Franchise: Deliver Meaningful Treatment Options to Patients with Serious Unmet Medical Needs ACQUISITION OF EPYGENIX EPX-100 AND EPX-200 EPX-100 and EPX-200: Established serotonergic (5HT2) MoA POTENTIAL FOR FAVORABLE risk/benefit proposition EPX-100: LEAD INDICATION IN DRAVET SYNDROME (DS) Pivotal registrational study on track for topline data in 2026 ON TRACK to initiate EPX-100 Phase 3 study in Lennox-Gastaut syndrome (LGS) in Q4 2024 13

Epilepsy Franchise: Most Advanced and Promising Development Programs in DEEs • EPX-100 (clemizole hydrochloride) • Established serotonergic (5-HT2) mechanism of action • Pre-clinical evidence for efficacy supporting broad utility in DEEs • BID dosing and liquid formulation: Clinically relevant for patients with DEEs and their caregivers • Two decades on market in 1960’s/70’s with no safety signals; Promising preliminary safety and tolerability profile from ongoing Phase 3 registrational trial in DS • On-track for DS Topline data in 2026 • On-track to initiate Phase 3 registrational trial in LGS by end of 2024 • Granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) for both DS & LGS • EPX-200 (liquid formulation of lorcaserin) • Established serotonergic (5-HT2) mechanism of action; selective 5-HT2C agonist • Pre-clinical and clinical evidence for efficacy • Safety and tolerability from short- and long-term studies • Pre-IND stage of development • Granted ODD for DS in US and EU; ODD and RPDD for LGS in US 14

EPX-100 (Clemizole HCl): Overview and Clinical Development Programs • Established MoA; potential for favorable risk/benefit profile in DEEs • On track for topline data in DS and LGS in 2026 • EPX-100 granted ODD and RPDD for both DS and LGS EPX-100 or Clemizole HCl once marketed as a 1st generation antihistamine in the 1960s Sunsetted in 1970s with the introduction of newer antihistamines — no significant post-marketing safety signals 1. Harmony data on file; 2. Griffin et al Brain, 2017; 3. Baraban et al Nature Communications, 2019. Development as an NCE, including completion of preclinical studies prior to human clinical trials1 No additional cardiac or lab monitoring necessary Phase 1 study in Healthy Volunteers completed1 Modulation of serotonin signal (5HT2A/2B/2C)2 established MoA for DEE Ongoing Phase 3 study in DS; initiation of Phase 3 study in LGS in Q4 2024, IP to 2038 Supported by published work from Dr. Baraban et al. at UCSF, funded by NIH3 15

EPX-100: Preliminary Safety and Tolerability Data Compared to Select Approved Drugs in DS and LGS 16 Epidiolex1 Fintepla2 EPX-1003 Decreased appetite 16–22% 8% 0% Diarrhea 9–20% 6% 16% Somnolence 23–25% 11% 12% LFT monitoring Required n/a n/a REMS (CVD and PAH) n/a + n/a Echocardiography n/a Prior to initiation and every 6 months thereafter n/a 1. Epidiolex PI: AEs in patients treated with Epidiolex in clinical trials; 2. Fintepla PI: MC AEs in >5% of patients and more than placebo in placebo-controlled trials; 3. Harmony Biosciences data on file. EPX-100: Preliminary safety/tolerability profile suggests no need for additional lab or cardiac monitoring; potential for favorable risk/benefit profile CVD: cardiac valvular disease PAH: pulmonary arterial hypertension Does not represent Head-to-Head comparison

EPX-200 (liquid lorcaserin): Overview • Established MoA; potential for favorable risk/benefit profile in DEEs • Pre-IND stage of development • EPX-200 granted ODD for DS in US and EU; ODD and RPDD for LGS in US EPX-200: Safety and tolerability established in short- and long-term studies 1. Griffin et al Brain Communications, 2019; 2. Baraban et al Nature Communications, 2019.; 3 Tolete, Devinsky et al, Neurology 2018 Liquid formulation and BID dosing Clinical data in DEEs3 Selective 5HT-2C Agonist1 established MoA for DEEs Supported by published work from Pre-IND Dr. Baraban et al. at UCSF, funded by NIH2 17

Financial Highlights Net Product Revenue Non-GAAP Adjusted Net Income(1) Cash, Cash Equivalents & Investments $160.3 $186.0 Q3 2023 Q3 2024 $58.8 $59.6 $413.6 $513.5 2023 YTD 2024 YTD $145.4 $170.9 2023 YTD 2024 YTD $438.4 $425.6 $453.6 $434.1 $504.7 Sep 30 '24 Sep 30 '23 Dec 31 '23 Mar 31 '24 Jun 30 '24 (1) Non-GAAP Adjusted Net Income= GAAP Net Income excluding non-cash interest expense, depreciation, amortization, stock-based compensation, other non-operating items and tax effect of these items 16% 24% 18% (In millions, USD) Three Months Ended September 30, 2024 Q3 2023 Q3 2024 1% Nine Months Ended September 30, 2024 18 18 +$70

Financial Summary NM denotes not meaningful % change (1) Includes upfront licensing fee of $25.5M related to the 2024 Bioprojet Sublicense Agreement and IPR&D charge of $17.1M related to the acquisition of Epygenix for the nine months ended September 30, 2024 (In millions, USD) Totals may not foot due to rounding Three Months Ended September 30, % Change Nine Months Ended September 30, % Change 2024 2023 2024 2023 Net Product Revenue $186.0 $160.3 16% $513.5 $413.6 24% Cost of Product Sold 42.8 32.3 32.5% 102.4 78.1 31% Total Operating Expenses $81.6 $63.5 29% $276.0 $183.7 50% R&D Expense (1) 25.4 17.5 45% 111.2 45.8 143% S&M Expense 27.6 23.4 18% 83.3 70.5 18% G&AExpense 28.6 22.5 27% 81.5 67.4 21% Net Income $46.1 $38.5 20% $96.0 $102.2 (6%) Cash, cash equivalents & investments $504.7 19

GAAP vs NON-GAAP Reconciliation (In millions, USD) Totals may not foot due to rounding Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 GAAP net income $46.1 $38.5 $96.0 $102.2 Non-cash interest expense(1) 0.2 2.2 0.5 3.1 Depreciation 0.0 0.1 0.3 0.4 Amortization(2) 6.0 6.0 17.9 17.9 Stock-based compensation expense 11.5 8.0 32.9 22.3 Licensing fee and milestone payments(3) 1.0 - 26.5 0.8 Loss on debt extinguishment(6) - 9.8 9.8 Transaction related costs(4) - - 17.1 - Income tax effect related to Non-GAAP adjustments(5) (5.1) (5.7) (20.2) (11.0) Non-GAAP adjusted net income $59.6 $58.8 $170.9 $145.4 GAAP net income per diluted share $0.79 $0.63 $1.66 $1.68 Non-GAAP adjusted net income per diluted share $1.03 $0.97 $2.96 $2.39 Weighted average number of shares of common stock used in non-GAAP diluted per share 58,103,963 60,681,676 57,754,016 60,892,992 (1) Includes amortization of deferred finance charges. (2) Includes amortization of intangible asset related to WAKIX. (3) Amount represents upfront licensing fee incurred upon closing the 2024 Bioprojet Sublicense Agreement and milestones related to HBS102 in September 2024 and March 2023. (4) Includes IPR&D charge related to the acquisition of Epygenix. (5) Calculated using the reported effective tax rate for the periods presented less impact of discrete items. (6) ncludes loss on extinguishment of the Blackstone Credit Agreement. 20

21 Commitment to patients Addressing unmet medical needs Delivering meaningful treatment options Helping patients thrive DELIVER ON PROMISE TO PATIENTS Innovative Catalyst-rich pipeline Profitable biotech company Meaningful investment opportunity DELIVER STONG VALUE TO SHAREHOLDERS

company/harmonybiosciences/ @harmonybio harmony_biosciences www.harmonybiosciences.com

Document and Entity Information	Oct. 29, 2024
Document and Entity Information [Abstract]
Amendment Flag	false
Entity Central Index Key	0001802665
Document Type	8-K
Document Period End Date	Oct. 29, 2024
Entity File Number	001-39450
Entity Registrant Name	HARMONY BIOSCIENCES HOLDINGS, INC.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	82-2279923
Entity Address, Address Line One	630 W. Germantown Pike
Entity Address, Adress Line Two	Suite 215
Entity Address, City or Town	Plymouth Meeting
Entity Address, State or Province	PA
Entity Address, Postal Zip Code	19462
City Area Code	484
Local Phone Number	539-9800
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.00001 par value per share
Trading Symbol	HRMY
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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