# EDGAR Filing Document

**Accession Number:** 0001802665
**File Stem:** 0001104659-25-105942
**Filing Date:** 2025-11
**Character Count:** 68426
**Document Hash:** 76ed96ba4ca96322a5a99d67dab36256
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001104659-25-105942.hdr.sgml**: 20251104

**ACCESSION NUMBER**: 0001104659-25-105942

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 33

**CONFORMED PERIOD OF REPORT**: 20251104

**ITEM INFORMATION**: Results of Operations and Financial Condition

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251104

**DATE AS OF CHANGE**: 20251104

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Harmony Biosciences Holdings, Inc.
- **CENTRAL INDEX KEY:** 0001802665
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 822279923
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39450
- **FILM NUMBER:** 251446536

**BUSINESS ADDRESS:**
- **STREET 1:** 630 W GERMANTOWN PIKE
- **STREET 2:** SUITE 215
- **CITY:** PLYMOUTH MEETING
- **STATE:** PA
- **ZIP:** 19462
- **BUSINESS PHONE:** (484) 539-9800

**MAIL ADDRESS:**
- **STREET 1:** 630 W GERMANTOWN PIKE
- **STREET 2:** SUITE 215
- **CITY:** PLYMOUTH MEETING
- **STATE:** PA
- **ZIP:** 19462

?xml version='1.0' encoding='ASCII'? HARMONY BIOSCIENCES HOLDINGS, INC._November 4, 2025

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**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

![Graphic](hrmy-20251104x8k001.jpg)

**FORM 8-K**

![Graphic](hrmy-20251104x8k001.jpg)

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d)**

**of the Securities Exchange Act of 1934**

**Date of report (Date of earliest event reported): November 4, 2025**

![Graphic](hrmy-20251104x8k001.jpg)

## HARMONY BIOSCIENCES HOLDINGS, INC .
**(Exact name of registrant as specified in its charter)**

![Graphic](hrmy-20251104x8k001.jpg)

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| | | |
|:---|:---|:---|
| &nbsp;&nbsp;**Delaware** | **001-39450** | **82-2279923** |
| &nbsp;&nbsp;**(State or other jurisdiction** | **(Commission** | **(IRS Employer** |
| &nbsp;&nbsp;**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)**

**(484) 539-9800**

**(Registrant's telephone number, including area code)**

**N/A**

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

![Graphic](hrmy-20251104x8k001.jpg)

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:**

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| | | |
|:---|:---|:---|
| <br>&nbsp;&nbsp;**Title of each class** | &nbsp;&nbsp;**Trading**<br>&nbsp;&nbsp;**Symbol(s)** | &nbsp;&nbsp;**Name of each exchange**<br>&nbsp;&nbsp;**on which registered** |
| &nbsp;&nbsp;**Common Stock, $0.00001 par value per share** | &nbsp;&nbsp;**HRMY** | &nbsp;&nbsp;**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).

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. ☐

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#### Item 2.02.&nbsp;&nbsp;&nbsp;&nbsp; Results of Operations and Financial Condition.
On November 4, 2025, Harmony Biosciences Holdings, Inc. (the "Company") issued a press release announcing its financial results for the quarter ended September 30, 2025. 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 November 4, 2025, 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, 2024, which was filed with the Securities and Exchange Commission ("SEC,") on February 25, 2025, 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 |  |
| &nbsp;&nbsp;No. | Description |
| 99.1\* | [Press release issued by the Company, dated November 4, 2025.](hrmy-20251104xex99d1.htm) |
| 99.2\* | [Investor Presentation dated November 4, 2025.](hrmy-20251104xex99d2.htm) |
| 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.

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| | | |
|:---|:---|:---|
|  | **HARMONY BIOSCIENCES HOLDINGS, INC.** | **HARMONY BIOSCIENCES HOLDINGS, INC.** |
| Date: November 4, 2025 | By: | /s/ Sandip Kapadia |
|  |  | Sandip Kapadia |
|  |  | Chief Financial Officer and Chief Administrative Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![Graphic](hrmy-20251104xex99d1001.jpg)<br>

***HARMONY BIOSCIENCES REPORTS STRONG Q3 2025 FINANCIAL RESULTS; RECENTLY RAISED 2025 REVENUE GUIDANCE TO***

***$845-$865M***

 

*WAKIX® (pitolisant) Franchise Delivers Net Revenue of $239M in Q3 2025 (+29% YoY Growth)*

 

*Record Increase in Average Number of Patients of Approximately 500 to Achieve 8,100 Average Patients in Q3 2025*

 

*Strong Cash Generation of $106M with $778M On Balance Sheet at end of Q3 2025*

*Pitolisant HD IND submitted; On Track to Initiate Phase 3 Trials in Narcolepsy and Idiopathic Hypersomnia in Q4 2025*

*Potential Best-In-Class Orexin 2 Agonist (BP1.15205) On Track to Dose First Subject in Q4 2025; Phase 1 Clinical Data in 2026*

*Late-Stage Catalyst-Rich Pipeline Advances with up to Five Phase 3 Programs by Year End*

 

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

 

**PLYMOUTH MEETING, Pa., November 4, 2025 /Business Wire/** -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced earnings of $239.5M for Q3 2025, representing 29% year-over-year revenue growth for WAKIX®. These results were driven by the highest ever increase in average number of patients of approximately 500 for the quarter, accelerating the trajectory toward blockbuster status for WAKIX in narcolepsy. The company continues to build on four consecutive years of revenue growth and profitability. With over $778 million in cash and investments at quarter end, Harmony has further strengthened its financial position, solidifying its unique profile as a profitable, self-funding biotech company with a robust, late-stage pipeline and strong long-term growth potential.

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"Our exceptional performance this quarter highlights the continued strength of WAKIX and significant market opportunity that remains ahead. I am incredibly proud of our team's focus and executional excellence, as we delivered very strong results today, which positions Harmony for future growth," said Jeffrey M. Dayno, M.D., President and CEO of Harmony Biosciences. "I continue to have firm conviction in our late-stage pipeline to deliver multiple catalysts over the next several years and, given our strong cash position, we intend to strategically pursue value-enhancing assets to add to our pipeline and build a broader product portfolio of innovative treatments that can help even more patients living with unmet medical needs."

**Franchise Highlights**

<u>Sleep/Wake Franchise</u> 

**WAKIX in Narcolepsy**

● Net Revenue was $239.5 million for Q3 2025

● Recently raised 2025 Net Revenue guidance from $820-$860 million to $845-$865 million

● Record increase in average number of patients of approximately 500 to achieve approximately 8,100 average patients in Q3 2025

**Pitolisant HD (high dose)**

● IND submitted to the FDA

● Phase 3 registrational trials in both narcolepsy and IH to initiate in Q4 2025 with target PDUFA dates in 2028

● Higher dose and optimized pharmacokinetic profile designed for greater efficacy without compromising safety and tolerability profile

● Phase 3 registrational trial in narcolepsy designed for greater efficacy in excessive daytime sleepiness and cataplexy; includes endpoint on narcolepsy-related fatigue in pursuit of a differentiated label

● Phase 3 registrational trial in IH to include endpoint on sleep inertia in pursuit of a differentiated label

● Utility patents filed for pitolisant HD with potential exclusivity to 2044

**Pitolisant GR (gastro-resistant)** 

● Designed to minimize the potential for treatment-related GI side effects as patients with narcolepsy commonly experience GI symptoms related to their underlying disease (up to 90%)

● Topline data readout from pivotal bioequivalence study on track for Q4 2025

● Provides patients with the ability to start at therapeutic dose range without the need for titration

● Topline data from dosing optimization study showed 100% (46/46) of patients were able to initiate pitolisant GR at the therapeutic dose of 17.8mg

● Utility patents filed for pitolisant GR with potential exclusivity to 2044

**Orexin-2 receptor agonist (BP1.15205)**

● First-in-human study to commence in Q4 2025 with clinical data anticipated in 2026

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&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

● Comprehensive and compelling preclinical safety and efficacy data presented at SLEEP and World Sleep Congress

● Potential to be best-in-class orexin-2 receptor agonist based on a novel chemical scaffold, preclinical potency, selectivity, safety and efficacy data, as well as its potential for once-a-day dosing

<u>Rare Epilepsy Franchise</u> 

**EPX-100 (clemizole hydrochloride)**

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

● Enrollment ongoing for Phase 3 registrational trial in Dravet syndrome (ARGUS Study) with topline data anticipated in 2026

● Enrollment ongoing for Phase 3 registrational trial in patients with Lennox-Gastaut syndrome (LIGHTHOUSE Study) with topline data anticipated in 2026

● Presenting data from the ARGUS open label extension study at the American Epilepsy Society Meeting in December 2025

**EPX-200 (lorcaserin hydrochloride)** 

● Proven mechanism of action in developmental and epileptic encephalopathies (DEEs) confirmed via non-clinical and clinical data

● Currently in the IND-enabling stage

<u>Neurobehavioral Franchise</u> 

**ZYN002**

● The ZYN002 phase 3 RECONNECT study in Fragile X syndrome did not meet the primary endpoint of improvement in social avoidance primarily due to a higher-than-expected placebo response rate; a review of the full data set is ongoing

● The ZYN002 development program in 22q11.2 deletion syndrome (22q) has been paused pending the full review of the RECONNECT data

**Third Quarter 2025 Financial Results**

Harmony Biosciences reported net product revenue of $239.5 million for the quarter ended September 30, 2025, compared to $186 million for the same period in 2024, representing 29% 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. Our 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 we support patients over time.

On a GAAP basis, net income for the quarter was $50.9 million, or $0.87 per diluted share, compared to $46.1 million, or $0.79 per diluted share, in Q3 2024. Non-GAAP adjusted net income, which we believe better reflects our core business performance,

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was $63.5 million ($1.08 per diluted share) for the third quarter of 2025 versus $57.3 million ($0.99 per diluted share) for the comparable 2024 period.

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

Harmony's operating expenses include the following:

● Research and Development expenses were $55.0 million in the third quarter of 2025, as compared to $25.4 million for the same quarter in 2024, representing a 117% increase; primarily driven by a $15.0 million IPR&D charge related to a clinical milestone achieved for ZYN002;

● Sales and Marketing expenses were $29.5 million in the third quarter of 2025, as compared to $27.6 million for the same quarter in 2024, representing a 7% increase;

● General and Administrative expenses were $29.8 million in the third quarter of 2025, as compared to $28.6 million for the same quarter in 2024, representing a 4% increase; and

● Total Operating Expenses were $114.3 million in the third quarter of 2025, as compared to $81.6 million for the same quarter in 2024, representing a 40% increase.

As of September 30, 2025, Harmony had cash, cash equivalents and investments of $778.4 million, compared to $576.1 million as of December 31, 2024.

**2025 Net Product Revenue Guidance**

Recently raised full year 2025 net product revenue range from $820-$860 million to $845-$865 million.

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

We are hosting our third quarter 2025 financial results conference call and webcast today, beginning at 8:30 a.m. Eastern time. The live and replay webcast of the call will be available on the investor relations page of our website https://ir.harmonybiosciences.com/.

To participate in the live call by phone, dial 800-274-8461 (domestic) or 203-518-9814 (international), and reference passcode HRMYQ325.

**Non-GAAP Financial Measures**

In addition to our GAAP results, we present certain Non-GAAP measures 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 benchmarking against

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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**<br>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**<br>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.

**Important Safety Information**

**Contraindications**<br>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**<br>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).

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**Adverse Reactions**<br>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**<br>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.

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.

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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**<br>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 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**<br>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 ZYN002**<br>ZYN002 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. ZYN002 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 ZYN002, 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, ZYN002 has received FDA Fast Track designation for the treatment of behavioral symptoms in patients with FXS.

**About Fragile X Syndrome**<br>

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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 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 Clemizole Hydrochloride (EPX-100)**<br>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 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 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**<br>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

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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**<br>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**<br>*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 2025 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, including ZYN002 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 25, 2025, 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 SUBSIDIARY CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME** 

**(In thousands, except share and per share data)**

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | &nbsp;&nbsp;&nbsp;**Three Months Ended September 30,**  | &nbsp;&nbsp;&nbsp;**Three Months Ended September 30,**  | &nbsp;&nbsp;&nbsp;**Nine Months Ended September 30,**  | &nbsp;&nbsp;&nbsp;**Nine Months Ended September 30,**  |
|  | &nbsp;&nbsp;&nbsp;**2025** | &nbsp;&nbsp;&nbsp;**2024** | &nbsp;&nbsp;&nbsp;**2025** | &nbsp;&nbsp;&nbsp;**2024** |
| &nbsp;&nbsp;&nbsp;Net product revenue | $&nbsp;&nbsp;&nbsp; 239455 | $&nbsp;&nbsp;&nbsp; 186038 | $&nbsp;&nbsp;&nbsp; 624677 | $&nbsp;&nbsp;&nbsp; 513467 |
| &nbsp;&nbsp;&nbsp;Cost of product sold | &nbsp;&nbsp;&nbsp; 59650 | &nbsp;&nbsp;&nbsp; 42778 | &nbsp;&nbsp;&nbsp; 129797 | &nbsp;&nbsp;&nbsp; 102406 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Gross profit | &nbsp;&nbsp;&nbsp; 179805 | &nbsp;&nbsp;&nbsp; 143260 | &nbsp;&nbsp;&nbsp; 494880 | &nbsp;&nbsp;&nbsp; 411061 |
| &nbsp;&nbsp;&nbsp;Operating expenses: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Research and development | &nbsp;&nbsp;&nbsp; 54962 | &nbsp;&nbsp;&nbsp; 25387 | &nbsp;&nbsp;&nbsp; 139661 | &nbsp;&nbsp;&nbsp; 111159 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Sales and marketing | &nbsp;&nbsp;&nbsp; 29549 | &nbsp;&nbsp;&nbsp; 27576 | &nbsp;&nbsp;&nbsp; 90333 | &nbsp;&nbsp;&nbsp; 83316 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;General and administrative | &nbsp;&nbsp;&nbsp; 29807 | &nbsp;&nbsp;&nbsp; 28587 | &nbsp;&nbsp;&nbsp; 94974 | &nbsp;&nbsp;&nbsp; 81487 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total operating expenses | &nbsp;&nbsp;&nbsp; 114318 | &nbsp;&nbsp;&nbsp; 81550 | &nbsp;&nbsp;&nbsp; 324968 | &nbsp;&nbsp;&nbsp; 275962 |
| &nbsp;&nbsp;&nbsp;Operating income | &nbsp;&nbsp;&nbsp; 65487 | &nbsp;&nbsp;&nbsp; 61710 | &nbsp;&nbsp;&nbsp; 169912 | &nbsp;&nbsp;&nbsp; 135099 |
| &nbsp;&nbsp;&nbsp;Other expense, net | &nbsp;&nbsp; (106) | &nbsp;&nbsp; (124) | &nbsp;&nbsp; (575) | &nbsp;&nbsp; (228) |
| &nbsp;&nbsp;&nbsp;Interest expense | &nbsp;&nbsp;&nbsp; (3621) | &nbsp;&nbsp;&nbsp; (4348) | &nbsp;&nbsp;&nbsp; (11103) | &nbsp;&nbsp;&nbsp; (13287) |
| &nbsp;&nbsp;&nbsp;Interest income | &nbsp;&nbsp;&nbsp; 5730 | &nbsp;&nbsp;&nbsp; 4932 | &nbsp;&nbsp;&nbsp; 16070 | &nbsp;&nbsp;&nbsp; 14065 |
| &nbsp;&nbsp;&nbsp;Income before income taxes | &nbsp;&nbsp;&nbsp; 67490 | &nbsp;&nbsp;&nbsp; 62170 | &nbsp;&nbsp;&nbsp; 174304 | &nbsp;&nbsp;&nbsp; 135649 |
| &nbsp;&nbsp;&nbsp;Income tax expense | &nbsp;&nbsp;&nbsp; (16625) | &nbsp;&nbsp;&nbsp; (16077) | &nbsp;&nbsp;&nbsp; (38103) | &nbsp;&nbsp;&nbsp; (39631) |
| &nbsp;&nbsp;&nbsp;Net income  | $&nbsp;&nbsp;&nbsp; 50865 | $&nbsp;&nbsp;&nbsp; 46093 | $&nbsp;&nbsp;&nbsp; 136201 | $&nbsp;&nbsp;&nbsp; 96018 |
| &nbsp;&nbsp;&nbsp;Unrealized income on investments | &nbsp;&nbsp;&nbsp; 118 | &nbsp;&nbsp;&nbsp; 733 | &nbsp;&nbsp;&nbsp; 291 | &nbsp;&nbsp;&nbsp; 497 |
| &nbsp;&nbsp;&nbsp;Comprehensive income  | $&nbsp;&nbsp;&nbsp; 50983 | $&nbsp;&nbsp;&nbsp; 46826 | $&nbsp;&nbsp;&nbsp; 136492 | $&nbsp;&nbsp;&nbsp; 96515 |
| &nbsp;&nbsp;&nbsp; EARNINGS PER SHARE: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Basic | $&nbsp;&nbsp; 0.88 | $&nbsp;&nbsp; 0.81 | $&nbsp;&nbsp; 2.36 | $&nbsp;&nbsp; 1.69 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Diluted | $&nbsp;&nbsp; 0.87 | $&nbsp;&nbsp; 0.79 | $&nbsp;&nbsp; 2.32 | $&nbsp;&nbsp; 1.66 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Weighted average number of shares of common stock - basic | &nbsp;&nbsp;&nbsp; 57550902 | &nbsp;&nbsp;&nbsp; 56870234 | &nbsp;&nbsp;&nbsp; 57655272 | &nbsp;&nbsp;&nbsp; 56815167 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Weighted average number of shares of common stock - diluted | &nbsp;&nbsp;&nbsp; 58717910 | &nbsp;&nbsp;&nbsp; 58103963 | &nbsp;&nbsp;&nbsp; 58738361 | &nbsp;&nbsp;&nbsp; 57754016 |

---

 

 

 

 

 

 

------

**HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES**

**CONSOLIDATED BALANCE SHEETS**

**(In thousands, except share and per share data)**

---

| | | |
|:---|:---|:---|
|  | &nbsp;&nbsp;&nbsp;**September 30,**  | &nbsp;&nbsp;&nbsp;**December 31,**  |
|  | &nbsp;&nbsp;&nbsp;**2025** | &nbsp;&nbsp;&nbsp;**2024** |
| &nbsp;&nbsp;&nbsp;**ASSETS** |  |  |
| &nbsp;&nbsp;&nbsp;CURRENT ASSETS: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Cash and cash equivalents | $&nbsp;&nbsp;&nbsp; 646999 | $&nbsp;&nbsp;&nbsp; 453001 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Investments, short-term | &nbsp;&nbsp;&nbsp; 25582 | &nbsp;&nbsp;&nbsp; 14185 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Trade receivables, net | &nbsp;&nbsp;&nbsp; 100651 | &nbsp;&nbsp;&nbsp; 83033 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Inventory, net | &nbsp;&nbsp;&nbsp; 6882 | &nbsp;&nbsp;&nbsp; 7198 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Prepaid expenses | &nbsp;&nbsp;&nbsp; 23308 | &nbsp;&nbsp;&nbsp; 13714 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Other current assets | &nbsp;&nbsp;&nbsp; 35378 | &nbsp;&nbsp;&nbsp; 8121 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current assets | &nbsp;&nbsp;&nbsp; 838800 | &nbsp;&nbsp;&nbsp; 579252 |
| &nbsp;&nbsp;&nbsp;NONCURRENT ASSETS: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Property and equipment, net | &nbsp;&nbsp;&nbsp; 1440 | &nbsp;&nbsp;&nbsp; 1257 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Investments, long-term | &nbsp;&nbsp;&nbsp; 105831 | &nbsp;&nbsp;&nbsp; 108874 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Intangible assets, net | &nbsp;&nbsp;&nbsp; 95380 | &nbsp;&nbsp;&nbsp; 113263 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Deferred tax asset | &nbsp;&nbsp;&nbsp; 157075 | &nbsp;&nbsp;&nbsp; 190398 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Other noncurrent assets | &nbsp;&nbsp;&nbsp; 9692 | &nbsp;&nbsp;&nbsp; 6156 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total noncurrent assets | &nbsp;&nbsp;&nbsp; 369418 | &nbsp;&nbsp;&nbsp; 419948 |
| &nbsp;&nbsp;&nbsp;TOTAL ASSETS | &nbsp;&nbsp;&nbsp; 1208218 | $&nbsp;&nbsp;&nbsp; 999200 |
| &nbsp;&nbsp;&nbsp;LIABILITIES AND STOCKHOLDERS' EQUITY |  |  |
| &nbsp;&nbsp;&nbsp;CURRENT LIABILITIES: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Trade payables | $&nbsp;&nbsp;&nbsp; 26341 | $&nbsp;&nbsp;&nbsp; 13744 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accrued compensation | &nbsp;&nbsp;&nbsp; 14935 | &nbsp;&nbsp;&nbsp; 18776 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accrued expenses | &nbsp;&nbsp;&nbsp; 161302 | &nbsp;&nbsp;&nbsp; 120640 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Current portion of long-term debt | &nbsp;&nbsp;&nbsp; 20000 | &nbsp;&nbsp;&nbsp; 16250 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Other current liabilities | &nbsp;&nbsp;&nbsp; 825 | &nbsp;&nbsp;&nbsp; 5672 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total current liabilities | &nbsp;&nbsp;&nbsp; 223403 | &nbsp;&nbsp;&nbsp; 175082 |
| &nbsp;&nbsp;&nbsp;NONCURRENT LIABILITIES: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Long-term debt, net | &nbsp;&nbsp;&nbsp; 148506 | &nbsp;&nbsp;&nbsp; 163016 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Other noncurrent liabilities | &nbsp;&nbsp;&nbsp; 1186 | &nbsp;&nbsp;&nbsp; 1947 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Total noncurrent liabilities | &nbsp;&nbsp;&nbsp; 149692 | &nbsp;&nbsp;&nbsp; 164963 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;TOTAL LIABILITIES | &nbsp;&nbsp;&nbsp; 373095 | &nbsp;&nbsp;&nbsp; 340045 |
| &nbsp;&nbsp;&nbsp;COMMITMENTS AND CONTINGENCIES (Note 13) |  |  |
| &nbsp;&nbsp;&nbsp;STOCKHOLDERS' EQUITY: |  |  |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Common stock—$0.00001 par value; 500,000,000 shares authorized at September 30, 2025 and December 31, 2024, respectively; 57,596,358 and 57,144,887 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively | &nbsp;&nbsp;&nbsp; 1 | &nbsp;&nbsp;&nbsp; 1 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Additional paid in capital | &nbsp;&nbsp;&nbsp; 696348 | &nbsp;&nbsp;&nbsp; 656872 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Accumulated other comprehensive income | &nbsp;&nbsp;&nbsp; 357 | &nbsp;&nbsp;&nbsp; 66 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Retained earnings | &nbsp;&nbsp;&nbsp; 138417 | &nbsp;&nbsp;&nbsp; 2216 |
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;TOTAL STOCKHOLDERS' EQUITY | &nbsp;&nbsp;&nbsp; 835123 | &nbsp;&nbsp;&nbsp; 659155 |
| &nbsp;&nbsp;&nbsp;TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | &nbsp;&nbsp;&nbsp; 1208218 | $&nbsp;&nbsp;&nbsp; 999200 |

---

------

**HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES**

**RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL RESULTS**

**(In thousands except share and per share data)**

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | &nbsp;&nbsp;&nbsp;**Three Months Ended** | &nbsp;&nbsp;&nbsp;**Three Months Ended** | &nbsp;&nbsp;&nbsp;**Nine Months Ended** | &nbsp;&nbsp;&nbsp;**Nine Months Ended** |
|  | &nbsp;&nbsp;&nbsp;**September 30,** | &nbsp;&nbsp;&nbsp;**September 30,** | &nbsp;&nbsp;&nbsp;**September 30,** | &nbsp;&nbsp;&nbsp;**September 30,** |
|  | &nbsp;&nbsp;&nbsp;**2025** | &nbsp;&nbsp;&nbsp;**2024** | &nbsp;&nbsp;&nbsp;**2025** | &nbsp;&nbsp;&nbsp;**2024** |
| &nbsp;&nbsp;&nbsp;**GAAP net income** (1) | $&nbsp;&nbsp;&nbsp;**50865** | $&nbsp;&nbsp;&nbsp;**46093** | $&nbsp;&nbsp;&nbsp;**136201** | $&nbsp;&nbsp;&nbsp;**96018** |
| &nbsp;&nbsp;&nbsp;Non-GAAP Adjustments: |  |  |  |  |
| &nbsp;&nbsp;&nbsp;Non-cash interest expense (2) | &nbsp;&nbsp;&nbsp;161 | &nbsp;&nbsp;&nbsp; 175 | &nbsp;&nbsp;&nbsp;490 | &nbsp;&nbsp;&nbsp;531 |
| &nbsp;&nbsp;&nbsp;Depreciation | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;7 | &nbsp;&nbsp;&nbsp;7 | &nbsp;&nbsp;&nbsp;20 | &nbsp;&nbsp;&nbsp;261 |
| &nbsp;&nbsp;&nbsp;Amortization (3) | &nbsp;&nbsp;&nbsp; 5961 | &nbsp;&nbsp;&nbsp;5961 | &nbsp;&nbsp;&nbsp;17883 | &nbsp;&nbsp;&nbsp;17883 |
| &nbsp;&nbsp;&nbsp;Stock-based compensation expense | &nbsp;&nbsp;&nbsp;10824 | &nbsp;&nbsp;&nbsp;11448 | &nbsp;&nbsp;&nbsp; 34668 | &nbsp;&nbsp;&nbsp;32845 |
| &nbsp;&nbsp;&nbsp;Income tax effect related to non-GAAP adjustments (4) | &nbsp;&nbsp;&nbsp;(4338) | &nbsp;&nbsp;&nbsp;(6412) | &nbsp;&nbsp;&nbsp;(11599) | &nbsp;&nbsp;&nbsp;(15044) |
| &nbsp;&nbsp;&nbsp;Non-GAAP adjusted net income (1) | $&nbsp;&nbsp;&nbsp;63480 | $&nbsp;&nbsp;&nbsp;57272 | $&nbsp;&nbsp;&nbsp;177663 | $&nbsp;&nbsp;&nbsp;132494 |
| &nbsp;&nbsp;&nbsp;**GAAP reported net income per diluted share** | $&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**0.87** | $&nbsp;&nbsp; **0.79** | $&nbsp;&nbsp;**2.32** | $&nbsp;&nbsp;**1.66** |
| &nbsp;&nbsp;&nbsp;Non-GAAP adjusted net income per diluted share | $&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;1.08 | $&nbsp;&nbsp; 0.99 | $&nbsp;&nbsp;3.02 | $&nbsp;&nbsp;2.29 |
| &nbsp;&nbsp;&nbsp;Weighted average number of shares of common stock used in non-GAAP diluted per share  | &nbsp;&nbsp;&nbsp;58717910 | &nbsp;&nbsp;&nbsp;58103963 | &nbsp;&nbsp;&nbsp;58738361 | &nbsp;&nbsp;&nbsp; 57754016 |

---

(1) Includes a $15,000 IPR&D charge related to a clinical milestone achieved for ZYN002 during the three and nine months ended September 30, 2025. Includes a $15,000 IPR&D charge related to an upfront fee incurred upon closing the CiRC research collaboration agreement for the nine months ended September 30, 2025. Includes a $1,000 IPR&D charge related to a preclinical milestone achieved for HBS-102 during the three and nine months ended September 30, 2024. Includes a $25,500 charge related to an upfront license fee incurred upon closing the 2024 Bioprojet Sublicense Agreement and a $17,095 IPR&D charge related to the acquisition of Epygenix for the nine months ended September 30, 2024.

(2) Includes amortization of deferred finance charges.

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

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

**Harmony Biosciences Investor Contact:**

Matthew Beck

917-415-1750

matthew.beck@astrpartners.com

**Harmony Biosciences Media Contact:**

Cate McCanless

202-641-6086

cmccanless@harmonybiosciences.com

------

## Exhibit 99.2

#### Exhibit 99.2

---

| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](hrmy-20251104xex99d2g001.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Copyright© 2024 Harmony Biosciences. All rights reserved. Q3 2025 Financial Results & Business Update November 4 , 2025 Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 |

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| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](hrmy-20251104xex99d2g002.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;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 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 25, 2025, 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 \| Q3 2025 Financial Results & Business Update \| All rights reserved. Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 |

---

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| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](hrmy-20251104xex99d2g003.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;WAKIX® APPROACHING BLOCKBUSTER STATUS UP TO 5 PHASE 3 REGISTRATIONAL TRIALS BY YEAR-END PROFITABLE, SELF-FUNDING BIOTECH POISED TO ACCELERATE GROWTH STRATEGY UNIQUE COMPANY PROFILE Harmony Biosciences \| Q3 2025 Financial Results & Business Update \| All rights reserved. Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 |

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| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](hrmy-20251104xex99d2g004.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;WAKIX®: Q3 2025 Strong Revenue Growth 4 Harmony Biosciences \| Q3 2025 Financial Results & Business Update \| All rights reserved. 29% $186.0 $239.5 Q3 2024 Q3 2025 Year-Over-Year Revenue ($M) DOUBLE-DIGIT REVENUE GROWTH in Year 6 on the Market RECENTLY RAISED 2025 FULL YEAR GUIDANCE TO $845M - $865M WAKIX® Rapidly Approaching Blockbuster Status KEY TAKEAWAY Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 |

---

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| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](hrmy-20251104xex99d2g005.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;5 Harmony Biosciences \| Q3 2025 Financial Results & Business Update \| All rights reserved. Differentiated Product and Strong Execution Drives Growth Q3 2025 HIGHLIGHTS • ~500 average patient adds represents highest quarterly increase since launch • 8,100 average patients on WAKIX • Highly differentiated product – only non-scheduled treatment option • Growing depth & breadth of prescribers • Strong payer coverage of >80% of lives • Sharpened sales execution, messaging and patient support activities 400 300 300 100 400 300 300 200 350 350 350 150 250 250 300 100 400 500 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 Average # of Patients Net Patient Additions Highest Quarterly Increase in Average Patients Since Launch KEY TAKEAWAY Average Patients on WAKIX Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 |

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| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](hrmy-20251104xex99d2g006.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Innovative Late-Stage Pipeline 6 Harmony Biosciences \| Q3 2025 Financial Results & Business Update \| All rights reserved. PRODUCT / INDICATION DISCOVERY PHASE PRECLINICAL 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 Prader-Willi Syndrome (PWS) Myotonic Dystrophy (DM1) Pitolisant Gastro-Resistant (GR) Pitolisant High-Dose (HD) BP1.15205 (Orexin-2 Receptor Agonist) Sleep/Wake Disorders CBS105 Treatment-Resistant Narcolepsy HBS-102 PWS Neurobehavioral ZYN002 (Cannabidiol Gel) Fragile X Syndrome (FXS) 22q11.2 Deletion Syndrome (22q) Rare Epilepsy EPX-100 (Clemizole Hydrochloride) Dravet Syndrome (DS) Lennox-Gastaut Syndrome (LGS) EPX-200 (Lorcaserin) Developmental and Epileptic Encephalopathies CBS104 Refractory Epilepsy 3 CNS FRANCHISES 13 DEVELOPMENT 8 PROGRAMS\* ASSETS 5PHASE 3 PROGRAMS BY YEAR END \*Includes additional ongoing clinical and regulatory programs; Research collaboration with CiRC Biosciences. Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 |

---

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| | |
|:---|:---|
| &nbsp;&nbsp;![GRAPHIC](hrmy-20251104xex99d2g007.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Extending Our Leadership Position • Pitolisant HD: IND submission completed; to initiate Phase 3 registrational trials in narcolepsy and IH Q4 2025; utility patents filed with potential protection until 2044 • Pitolisant GR: Pivotal BE study topline data readout Q4 2025; Dosing optimization study completed with positive topline data; utility patents filed with potential protection until 2044 • BP1.15205: potential best-in-class orexin-2 agonist; FIH study to commence Q4 2025, clinical data anticipated 2026 Ongoing Review of RECONNECT Phase 3 Data • The ZYN002 phase 3 RECONNECT study in Fragile X syndrome did not meet the primary endpoint of improvement in social avoidance primarily due to a higher-than-expected placebo response rate; a review of the full data set is ongoing • The ZYN002 development program in 22q11.2 deletion syndrome (22q) has been paused pending the full review of the RECONNECT data One of the Most Advanced 5-HT2 Development Program • EPX-100: Phase 3 registrational trials ongoing in Dravet syndrome (ARGUS study) & Lennox-Gastaut syndrome (LIGHTHOUSE study) o Presenting efficacy, safety and tolerability data from the ARGUS open label extension study at the American Epilepsy Society Meeting in December o Topline data anticipated in 2026 from the ARGUS and the LIGHTHOUSE studies Advancement of late-stage, catalyst-rich pipeline SLEEP/WAKE NEURO BEHAVIORAL EPILEPSY Harmony Biosciences \| Q3 2025 Financial Results & Business Update \| All rights reserved. Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 |

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| &nbsp;&nbsp;![GRAPHIC](hrmy-20251104xex99d2g008.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pitolisant HD: Phase 3 Registrational Trials in Narcolepsy & IH – Q4 2025 8 Harmony Biosciences \| Q3 2025 Financial Results & Business Update \| All rights reserved. Q4 2025 Initiation of Phase 3 Registrational Trials of Pitolisant HD • Narcolepsy • IH ENHANCED FORMULATION WITH OPTIMIZED PK PROFILE AND HIGHER DOSE Designed to address the need for greater efficacy in excessive daytime sleepiness (EDS) in patients with central disorders of hypersomnolence PROGRAMS TO PURSUE A DIFFERENTIATED LABEL Fatigue in narcolepsy; sleep inertia in IH IND SUBMITTED; NARCOLEPSY AND IH PHASE 3 REGISTRATIONAL TRIALS TO BE INITIATED Q4 2025 Topline data readouts anticipated 2027; PDUFA dates targeted for 2028 UTILITY PATENTS FILED TO EXTEND PITOLISANT FRANCHISE INTO 2040s Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 |

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| &nbsp;&nbsp;![GRAPHIC](hrmy-20251104xex99d2g009.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pitolisant GR: Fast To Market Strategy Designed to Demonstrate Bioequivalence to WAKIX® Formulation 9 Q1 2027 Target PDUFA Date PIVOTAL BIOEQUIVALENCE STUDY COMPLETED Topline Data in Q4 2025 DOSING OPTIMIZATION STUDY COMPLETED 100% of the patients (46/46) able to initiate pitolisant GR at the therapeutic dose,17.8mg, without titration; No safety or tolerability issues reported NDA SUBMISSION EARLY 2026 TARGET PDUFA Q1 2027 Harmony Biosciences \| Q3 2025 Financial Results & Business Update \| All rights reserved. Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 |

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| &nbsp;&nbsp;![GRAPHIC](hrmy-20251104xex99d2g010.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;ZYN002: Pharmaceutically Manufactured Synthetic Cannabinoid Gel in FXS 10 Harmony Biosciences \| Q3 2025 Financial Results & Business Update \| All rights reserved. ZYN002: INNOVATIVE PRODUCT PROFILE 100% synthetic, pharmaceutically manufactured cannabidiol (CBD), devoid of THC, in a patent-protected, permeation-enhanced gel formulation RECENTLY COMPLETED PHASE 3 RECONNECT STUDY RECONNECT phase 3 study in FXS did not meet the primary endpoint of improvement in social avoidance primarily due to a higher-than-expected placebo response rate; a review of the full data set is ongoing • The ZYN002 development program in 22q11.2 deletion syndrome (22q) has been paused pending the full review of the RECONNECT data MARKET OPPORTUNITY ~80,000 patients in the US with FXS; worldwide rights VERY HIGH UNMET NEED No approved products for FXS Data Review ongoing: RECONNECT Phase 3 Trial Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 |

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| &nbsp;&nbsp;![GRAPHIC](hrmy-20251104xex99d2g011.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;EPX-100: One of Most Advanced 5-HT2 (Serotonin) Agonist Programs in DEEs 11 Harmony Biosciences \| Q3 2025 Financial Results & Business Update \| All rights reserved. 2026 Anticipate Topline Data from Ongoing Global Phase 3 Trials • DS • LGS ESTABLISHED 5-HT2 (SEROTONIN) AGONIST MECHANISM OF ACTION MoA validated via the zebrafish model PHASE 3 STUDIES IN DS AND LGS Recruitment ongoing for Phase 3 registrational trials in patients with Dravet syndrome (ARGUS study) and Lennox-Gastaut syndrome (LIGHTHOUSE study) • Anticipate topline data in 2026 SAFETY: POTENTIAL TO OFFER A VERY UNIQUE RISK/BENEFIT PROPOSITION No additional laboratory or special safety monitoring BID DOSING REGIMEN Convenient for patients and caregivers Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 |

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| &nbsp;&nbsp;![GRAPHIC](hrmy-20251104xex99d2g012.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Catalyst-Rich Pipeline Driving Value Beyond 2025 12 Harmony Biosciences \| Q3 2025 Financial Results & Business Update \| All rights reserved.. Pipeline Poised to Deliver Multiple New Product or Indication Launches Over the Next Several Years KEY TAKEAWAY Q4 2025 Pitolisant HD Initiation of Phase 3 registrational trials in narcolepsy and IH Pitolisant GR Pivotal BE topline data 2026 Pitolisant PWS Phase 3 TLD EPX-100 DS/LGS Phase 3 topline data (TLD) OX2R Phase 1 clinical PK data 2027 – 2028 Pitolisant GR PDUFA (2027) Pitolisant-HD Phase 3 TLD in narcolepsy and IH (2027) Pitolisant-HD PDUFA narcolepsy and IH (2028) EPX-100 DS/LGS PDUFA Pitolisant PWS PDUFA Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 |

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| &nbsp;&nbsp;![GRAPHIC](hrmy-20251104xex99d2g013.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Financial Highlights Q3 2025 13 1. Non-GAAP Adjusted Net Income= GAAP Net Income excluding non-cash interest expense, depreciation, amortization, stock-based compensation, and tax effect of these items. Three Months Ended September 30, 2025 (In millions, USD) $186.0 $239.5 Q3 2024 Q3 2025 Net Product Revenue Non-GAAP Adjusted Net Income1 Cash, Cash Equivalents & Investments 11% $57.3 $63.5 Q3 2024 Q3 2025 29% $504.7 $576.1 $610.2 $672.3 $778.4 Q3 2024 Q4 2024 Q1 2025 Q2 2025 Q3 2025 +$106 UNIQUE COMPANY PROFILE 29% REVENUE GROWTH Year 6 on the market 2025 FULL YEAR REVENUE GUIDANCE $845M-$865M STRONG PROFITABILITY 4+ Years SIGNIFICANT CASH GENERATION $778M+ Cash, Cash Equivalents and Investments Harmony Biosciences \| Q3 2025 Financial Results & Business Update \| All rights reserved. Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 |

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| &nbsp;&nbsp;![GRAPHIC](hrmy-20251104xex99d2g014.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Financial Summary Q3 2025 14 Harmony Biosciences \| Q3 2025 Financial Results & Business Update \| All rights reserved. Totals may not foot due to rounding Three Months Ended September 30, % Change Nine Months Ended September 30, 2025 2024 2025 2024 % Change Net Product Revenue $239.5 $186.0 29% $624.7 $513.5 22% Cost of Product Sold 59.7 42.8 39% 129.8 102.4 27% Total Operating Expenses $114.3 $81.6 40% $325.0 $276.0 18% R&D Expense 55.0 25.4 117% 139.7 111.2 26% S&M Expense 29.5 27.6 7% 90.3 83.3 8% G&AExpense 29.8 28.6 4% 95.0 81.5 17% Net Income $50.9 $46.1 10% $136.2 $96.0 42% Cash, cash equivalents & investments $778.4 $504.7 54% (In millions, USD) Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 |

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| &nbsp;&nbsp;![GRAPHIC](hrmy-20251104xex99d2g015.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;GAAP vs NON-GAAP Reconciliation Q3 2025 15 Harmony Biosciences \| Q3 2025 Financial Results & Business Update \| All rights reserved. (In millions, USD) Totals may not foot due to rounding Three Months Ended September 30, Nine Months Ended September 30, 2025 2024 2025 2024 GAAP net income1 $50.9 $46.1 $136.2 $96.0 Non-cash interest expense2 0.2 0.2 0.5 0.5 Depreciation 0.0 0.1 0.0 0.3 Amortization3 6.0 6.0 17.9 17.9 Stock-based compensation expense 10.8 11.4 34.7 32.8 Income tax effect related to Non-GAAP adjustments4 (4.3) (6.4) (11.6) (15.0) Non-GAAP adjusted net income1 $63.5 $57.3 $177.7 $132.5 GAAP net income per diluted share $0.87 $0.79 $2.32 $1.66 Non-GAAP adjusted net income per diluted share $1.08 $0.99 $3.02 $2.29 Weighted average number of shares of common stock used in non-GAAP diluted per share 58.7 58.1 58.7 57.8 (1) Includes a $15.0 million IPR&D charge related to a clinical milestone achieved for ZYN002 during the three and nine months ended September 30, 2025. Includes a $15.0 million IPR&D charge related to an upfront fee incurred upon closing the CiRC research collaboration agreement for the nine months ended September 30, 2025. Includes a $1.0 million IPR&D charge related to a preclinical milestone achieved for HBS-102 during the three and nine months ended September 30, 2024. Includes a $25.5 million charge related to an upfront license fee incurred upon closing the 2024 Bioprojet Sublicense Agreement and a $17.1 million IPR&D charge related to the acquisition of Epygenix for the nine months ended September 30, 2024. (2) Includes amortization of deferred finance charges. (3) Includes amortization of intangible asset related to WAKIX. (4) Calculated using the reported effective tax rate for the periods presented less impact of discrete items. Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 |

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| &nbsp;&nbsp;![GRAPHIC](hrmy-20251104xex99d2g016.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;16 Harmony Biosciences \| Q3 2025 Financial Results & Business Update \| All rights reserved. Commitment to patients Addressing unmet medical needs Delivering meaningful treatment options Helping patients thrive DELIVER ON PROMISE TO PATIENTS Executional excellence Innovative, catalyst-rich pipeline Profitable, self-funding biotech Meaningful investment opportunity DELIVER STONG VALUE TO SHAREHOLDERS Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 |

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| &nbsp;&nbsp;![GRAPHIC](hrmy-20251104xex99d2g017.jpg) | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Docusign Envelope ID: 2D97A8FD-7F63-4CC0-8B0C-4744974F1080 |

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