Harmony Biosciences posts 22% 2025 revenue growth
Harmony Biosciences Holdings, Inc. reported strong 2025 results driven by its narcolepsy drug WAKIX.
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Rhea-AI Filing Summary
Harmony Biosciences Holdings, Inc. reported strong 2025 results driven by its narcolepsy drug WAKIX. Net product revenue reached $868.5 million for 2025, up from $714.7 million, while Q4 2025 revenue was $243.8 million, a 21% year-over-year increase.
GAAP net income was $158.7 million for 2025, or $2.71 per diluted share, compared with $145.5 million, or $2.51 per share, in 2024. Non-GAAP adjusted net income rose to $211.0 million, or $3.60 per diluted share. The company ended 2025 with $882.5 million in cash, cash equivalents and investments, up from $576.1 million.
Harmony reiterated 2026 WAKIX net revenue guidance of $1.0–$1.04 billion, highlighting expectations for blockbuster status in narcolepsy. Management also emphasized a late-stage pipeline, including five Phase 3 trials, a planned pitolisant GR NDA submission targeted for Q2 2026, and an ongoing Phase 1 trial of an orexin-2 agonist.
Positive
- Robust 2025 growth and profitability: Net product revenue rose to $868.5 million from $714.7 million, while GAAP net income increased to $158.7 million and non-GAAP adjusted net income to $211.0 million, indicating a growing and profitable commercial franchise.
- Strong 2026 outlook and balance sheet: Reiterated 2026 WAKIX net revenue guidance of $1.0–$1.04 billion and year-end 2025 liquidity of $882.5 million in cash, cash equivalents and investments support continued investment in the late-stage CNS pipeline.
Negative
- None.
Insights
Harmony delivers 22% revenue growth, higher profits, and targets $1B WAKIX sales in 2026.
Harmony Biosciences grew 2025 net product revenue to $868.5M, up from $714.7M, driven by WAKIX demand in narcolepsy. GAAP net income increased to $158.7M, while non-GAAP adjusted net income reached $211.0M, showing the core business remains profitable after higher R&D and SG&A spending.
The company reaffirmed 2026 WAKIX net revenue guidance of $1.0–$1.04B, positioning the product for blockbuster status. It reported $882.5M in cash, cash equivalents and investments as of December 31, 2025, providing substantial funding capacity for clinical programs and potential business development.
Strategically, Harmony is extending the pitolisant franchise with next-generation formulations, including a pitolisant GR NDA submission targeted for Q2 2026, and is running five Phase 3 trials across CNS indications. An orexin-2 agonist (BP1.15205) is in a Phase 1 trial with clinical data expected in mid-2026, creating multiple potential value-inflection points.
8-K Event Classification
FAQ
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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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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Item 2.02. Results of Operations and Financial Condition.
On February 24, 2026, Harmony Biosciences Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 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 February 24, 2026, the Company posted an investor presentation to its website at ttps://ir.harmonybiosciences.com (the “Investor Presentation”). A copy of the Investor Presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. The Company expects to use the Investor Presentation, in whole or in part, and possibly with modifications, in connection with presentations to investors, analysts and others.
The information contained in the Investor Presentation is summary information that is intended to be considered in the context of the Company’s Securities and Exchange Commission (“SEC”) filings and other public announcements that the Company may make, by press release or otherwise, from time to time. The Investor Presentation speaks only as of the date of this Current Report on Form 8-K. The Company undertakes no duty or obligation to publicly update or revise the information contained in the Investor Presentation, although it may do so from time to time. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure. In addition, the exhibit furnished herewith contains statements intended as “forward-looking statements” that are subject to the cautionary statements about forward-looking statements set forth in such exhibit. By furnishing the information contained in the Investor Presentation, the Company makes no admission as to the materiality of any information in the Investor Presentation that is required to be disclosed solely by reason of Regulation FD.
This Current Report on Form 8-K and its contents (including Exhibits 99.1 and 99.2) are furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.
Note Regarding Forward-Looking Statements
Certain statements in this Current Report on Form 8-K constitute “forward-looking statements” within the meaning of the federal securities laws. These statements are based on management’s current opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results. These forward looking statements are only predictions, not historical fact, and involve certain risks and uncertainties, as well as assumptions. Actual results, levels of activity, performance, achievements and events could differ materially from those stated, anticipated or implied by such forward-looking statements. While the Company believes that its assumptions are reasonable, it is very difficult to predict the impact of known factors, and, of course, it is impossible to anticipate all factors that could affect actual results. There are many risks and uncertainties that could cause actual results to differ materially from the forward-looking statements made herein including the risks discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 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 | | |
No. | Description | |
99.1* | Press release issued by the Company, dated February 24, 2026. | |
99.2* | Investor Presentation, dated February 24, 2026. | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
* | This Exhibit is furnished herewith and will not be deemed “filed” for purposes of Section 18 of the Exchange Act or deemed to be incorporated by reference into any filing under the Exchange Act or the Securities Act except to the extent that Harmony Biosciences Holdings, Inc. specifically incorporates it by reference. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
HARMONY BIOSCIENCES HOLDINGS, INC. | ||
Date: February 24, 2026 | By: | /s/ Sandip Kapadia |
Sandip Kapadia | ||
Chief Financial Officer and Chief Administrative Officer | ||
HARMONY BIOSCIENCES REPORTS STRONG 2025 FINANCIAL RESULTS AND REITERATES 2026 NET REVENUE GUIDANCE OF OVER $1 BILLION
WAKIX 2025 Net Revenue of $868.5 Million; 2026 WAKIX Net Revenue Guidance of $1.0 – $1.04 Billion on Track for Blockbuster Status in Narcolepsy
Recently Completed Settlements with 3 Additional Generic Filers Toward Goal of Securing WAKIX Franchise
Pitolisant GR NDA Submission on Track for Q2 2026; Extends the Pitolisant Franchise into the 2040s
Exploring New Opportunities to Broaden the Pitolisant Franchise Beyond Orphan/Rare into Larger CNS Indications
Potential Best-In-Class Orexin-2 Agonist (BP1.15205) Phase 1 Trial Ongoing; Clinical Data Expected in Mid-2026
Conference Call and Webcast Today at 8:30 a.m. ET
PLYMOUTH MEETING, Pa., February 24, 2026 /Business Wire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced earnings with reported revenue of $243.8 million for Q4 2025, representing 21% year-over-year revenue growth for WAKIX®. For the full year 2025, the company generated $868.5 million in net product revenue, reflecting continued commercial strength as evidenced by six consecutive years of revenue growth and profitability. The company enters the year with significant momentum, reinforcing its profile as a profitable, self-funding biotech company with a robust, late-stage pipeline and strong long-term growth potential.
“WAKIX is on track to exceed $1 billion in revenue and achieve blockbuster status in 2026, reflecting the strength and durability of the pitolisant franchise. Based on this commercial success and our strong momentum, we see even greater opportunity for
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pitolisant going forward,” said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. “The next-generation formulations of pitolisant are designed to grow our leadership in sleep-wake, extend the lifecycle of pitolisant into the 2040’s, expand into additional orphan/rare indications, and now broaden our reach beyond orphan/rare into larger CNS patient populations. Our robust late-stage pipeline, including five ongoing Phase 3 registrational trials across five distinct CNS indications, positions Harmony for multiple near-term catalysts and meaningful long-term value creation.”
Fourth Quarter and Full Year 2025 Net Product Revenue for WAKIX
| ● | Net product revenue for the quarter ended December 31, 2025, was $243.8 million, compared to $201.3 million for the same period in 2024 |
| ● | Average number of patients on WAKIX increased by ~400 patients to ~8,500 patients in Q4 2025; representing the third consecutive quarter of ~400+ patient adds |
| ● | Net product revenue for the full year ended December 31, 2025, was $868.5 million, compared to $714.7 million for the full year ended December 31, 2024, representing ~22% growth year on year |
Pitolisant Franchise Strategy
WAKIX: On track to achieve blockbuster status in narcolepsy
| ● | Net revenue projected between $1.0 billion to $1.04 billion for the full year ending December 31, 2026 |
| ● | Received FDA approval of pediatric cataplexy indication on February 13th |
| o | Commercial team triggered full promotional efforts immediately upon approval |
| ● | Pitolisant in Prader-Willi syndrome (PWS) |
| o | Phase 3 topline data readout in 2H 2026 |
| o | Supports Pediatric Exclusivity for WAKIX: Fulfills the last regulatory requirement for six months of additional regulatory exclusivity on top of the longest patent for WAKIX |
ANDA Litigation Update
| ● | Recently completed settlements with 3 additional generic filers bringing the total to six of the seven ANDA filers |
| ● | The settling parties will receive licenses to launch their generic products no earlier than March 2030 if Harmony is granted pediatric exclusivity, which it is on track to obtain |
Pitolisant GR (gastro-resistant): On track to extend pitolisant franchise into the 2040s
| ● | NDA submission in Q2 2026; anticipated PDUFA date in Q1 2027 |
| o | Approximately 80-90% of patients with narcolepsy experience GI symptoms; pitolisant GR is designed to minimize the worsening of these symptoms |
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| o | Ability to initiate treatment at therapeutic dose with no titration |
| ● | Utility patents filed to extend franchise into the 2040s |
Pitolisant HD (high dose): Opportunity to expand pitolisant franchise with differentiated rare indications
| ● | Phase 3 registrational clinical trials ongoing in narcolepsy (ONSTRIDE 1) and idiopathic hypersomnia (ONSTRIDE 2) |
| o | Topline data in 2027; anticipated PDUFA date in 2028 |
| o | Enhanced formulation with optimized PK profile, GR coating and higher dose to drive greater efficacy |
| o | Differentiated indications: fatigue in narcolepsy and sleep inertia in IH |
| ● | Utility patents filed to expand franchise into the 2040s |
Exploring new pitolisant formulation to pursue broader indications in CNS patient populations in which fatigue is a prominent symptom
| ● | Mechanism-based approach supported by clinical data for pitolisant in fatigue |
| ● | Currently planning MS fatigue as the lead indication; follow on indications under consideration include fatigue in Parkinson's disease and post-stroke fatigue |
| ● | Current efforts focused on formulation optimization and new modes of delivery towards a phase 1 PK study |
| ● | Licensed IP with patent protection until 2042 |
Robust Pipeline
Orexin-2 receptor agonist (BP1.15205)
| ● | Phase 1 clinical study ongoing; anticipates clinical PK data in mid-2026 |
| ● | Potential best-in-class orexin-2 receptor agonist based on a novel chemical scaffold, preclinical potency, selectivity, safety and efficacy data, and potential for once-a-day dosing |
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 1H 2027 |
| o | Safety and effectiveness data from the open-label extension study in DS was presented at AES meeting in December 2025 |
| ● | Enrollment ongoing for Phase 3 registrational trial in patients with Lennox-Gastaut syndrome (LIGHTHOUSE Study) with topline data anticipated in 1H 2027 |
Fourth Quarter 2025 Financial Results
Harmony Biosciences reported net product revenue of $243.8 million for the quarter ended December 31, 2025, compared to $201.3 million for the same period in 2024, representing 21% year-over-year growth. This performance reflects both continued demand for WAKIX within the large narcolepsy market opportunity (approximately
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80,000 diagnosed patients in the U.S.) and the product's broad clinical utility. The continued success has been driven by strong execution across the organization from sales effectiveness to marketing and promotion and supported by broad payer coverage and how the company supports patients over time.
On a GAAP basis, net income for the quarter was $22.5 million, or $0.38 per diluted share, compared to $49.5 million, or $0.85 per diluted share, in Q4 2024. Non-GAAP adjusted net income, which we believe better reflects our core business performance, was $33.4 million ($0.57 per diluted share) for the fourth quarter of 2025 versus $64.2 million ($1.10 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 $49.9 million in the fourth quarter of 2025, as compared to $34.7 million for the same quarter in 2024, representing a 44% increase; |
| ● | Sales and Marketing expenses were $29.2 million in the fourth quarter of 2025, as compared to $27.6 million for the same quarter in 2024, representing a 6% increase; |
| ● | General and Administrative expenses were $57.6 million in the fourth quarter of 2025, as compared to $28.9 million for the same quarter in 2024, representing a 99% increase; and |
| ● | Total Operating Expenses were $136.7 million in the fourth quarter of 2025, as compared to $91.1 million for the same quarter in 2024, representing a 50% increase. |
Full Year 2025 Financial Results
Net product revenues for the year ended December 31, 2025, were $868.5 million, compared to $714.7 million for the same period in 2024. The 22% growth versus the same period in 2024 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).
GAAP net income for the year ended December 31, 2025, was $158.7 million, or $2.71 earnings per diluted share, compared to GAAP net income of $145.6 million, or $2.51 earnings per diluted share, for the same period in 2024. Non-GAAP adjusted net income was $211.0 million, or $3.60 earnings per diluted share, for the year ended December 31, 2025, compared to Non-GAAP adjusted net income of $196.7 million, or $3.40 per diluted share, for the same period in 2024.
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Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included at the end of this press release.
Harmony’s operating expenses included the following:
| ● | Research and Development expenses were $189.6 million for the year ended December 31, 2025, as compared to $145.8 million for the prior year, representing a 30% increase. |
| ● | Sales and Marketing expenses were $119.5 million for the year ended December 31, 2025, as compared to $110.9 million for the prior year, representing a 8% increase; |
| ● | General and Administrative expenses were $152.5 million for the year ended December 31, 2025, as compared to $110.4 million for the prior year, representing a 38% increase; and |
| ● | Total Operating Expenses were $461.6 million for the year ended December 31, 2025, as compared to $367.1 million for the prior year, representing a 26% increase. |
As of December 31, 2025, Harmony had cash, cash equivalents and investments of $882.5 million, compared to $576.1 million as of December 31, 2024.
2026 Net Product Revenue Guidance
Reiterated 2026 WAKIX Net Revenue Guidance of $1.0 – $1.04B
Conference Call Today at 8:30 a.m. ET
We are hosting our fourth 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 HRMYQ425.
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 comparable companies. Non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP measures; should be read in
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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 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 patients 6 years of age and older with narcolepsy.
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 higher concentrations of pitolisant (e.g., patients with hepatic or renal impairment). Monitor patients with hepatic or renal impairment 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
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.
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 the treatment of excessive daytime sleepiness or cataplexy in pediatric patients less than 6 years of age 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
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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. The maximum recommended dosage is lower in patients who are CYP2D6 poor metabolizers because these patients have higher pitolisant concentrations CYP2D6 normal metabolizers and may have increased risk of adverse events.
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 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 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
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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
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 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
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results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved, including EPX-100; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreements with Bioprojet Société Civile de Recherche (“Bioprojet”); the availability of favorable insurance coverage and reimbursement for WAKIX; the timing of, and our ability to obtain, regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and additional financing needs; our ability to identify, acquire and integrate additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; the significant costs and required management time as a result of operating as a public company; the fact that the price of Harmony's common stock may be volatile and fluctuate substantially; statements related to our intended share repurchases and repurchase timeframe; and macroeconomic effects and changes in market conditions, including the impact of tariffs, inflation and the risk of recession. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on February 24, 2026, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
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HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARY CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(In thousands, except share and per share data)
| | | | | | | | | | | | |
| | Three Months Ended December 31, | | Year Ended December 31, | ||||||||
| | 2025 | | 2024 | | 2025 | | 2024 | ||||
Net product revenue | | $ | 243,776 | | $ | 201,267 | | $ | 868,453 | | $ | 714,734 |
Cost of product sold | | | 68,545 | | | 54,409 | | | 198,342 | | | 156,815 |
Gross profit | | | 175,231 | | | 146,858 | | | 670,111 | | | 557,919 |
Operating expenses: | | | | | | | | | | | | |
Research and development | | | 49,933 | | | 34,666 | | | 189,594 | | | 145,825 |
Sales and marketing | | | 29,179 | | | 27,600 | | | 119,512 | | | 110,916 |
General and administrative | | | 57,562 | | | 28,865 | | | 152,536 | | | 110,352 |
Total operating expenses | | | 136,674 | | | 91,131 | | | 461,642 | | | 367,093 |
Operating income | | | 38,557 | | | 55,727 | | | 208,469 | | | 190,826 |
Other expense, net | | | (105) | | | 160 | | | (680) | | | (68) |
Interest expense | | | (3,546) | | | (4,209) | | | (14,649) | | | (17,496) |
Interest income | | | 5,854 | | | 4,477 | | | 21,924 | | | 18,542 |
Income before income taxes | | | 40,760 | | | 56,155 | | | 215,064 | | | 191,804 |
Income tax expense | | | (18,274) | | | (6,680) | | | (56,377) | | | (46,311) |
Net income | | $ | 22,486 | | $ | 49,475 | | $ | 158,687 | | $ | 145,493 |
Unrealized income on investments | | | (11) | | | (433) | | | 280 | | | 64 |
Comprehensive income | | $ | 22,475 | | $ | 49,042 | | $ | 159,967 | | $ | 145,557 |
EARNINGS PER SHARE: | | | | | | | | | | | | |
Basic | | $ | 0.39 | | $ | 0.87 | | $ | 2.76 | | $ | 2.56 |
Diluted | | $ | 0.38 | | $ | 0.85 | | $ | 2.71 | | $ | 2.51 |
Weighted average number of shares of common stock - basic | | | 57,634,656 | | | 57,097,092 | | | 57,492,277 | | | 56,885,455 |
Weighted average number of shares of common stock - diluted | | | 58,696,342 | | | 58,218,052 | | | 58,544,570 | | | 57,869,915 |
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| | |
HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
| | December 31, | | December 31, | |||
| | 2025 | | 2024 | |||
ASSETS |
| | |
| | | |
CURRENT ASSETS: |
| | |
| | | |
Cash and cash equivalents | | $ | 752,502 | | $ | 453,001 | |
Investments, short-term | | | 22,838 | | | 14,185 | |
Trade receivables, net | |
| 96,787 | |
| 83,033 | |
Inventory, net | |
| 5,357 | |
| 7,198 | |
Prepaid expenses | |
| 16,014 | |
| 13,714 | |
Other current assets | |
| 13,516 | |
| 8,121 | |
Total current assets | |
| 907,014 | |
| 579,252 | |
NONCURRENT ASSETS: | |
| | |
| | |
Investments, long-term | | | 107,127 | | | 108,874 | |
Intangible assets, net | |
| 89,418 | |
| 113,263 | |
Deferred tax asset | | | 149,699 | | | 190,398 | |
Other noncurrent assets | |
| 18,373 | |
| 7,413 | |
Total noncurrent assets | |
| 364,617 | |
| 419,948 | |
TOTAL ASSETS | | $ | 1,271,631 | | $ | 999,200 | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | |
| | |
CURRENT LIABILITIES: | |
| | |
| | |
Trade payables | | $ | 17,693 | | $ | 13,744 | |
Accrued compensation | |
| 18,443 | |
| 18,776 | |
Accrued expenses | |
| 191,039 | |
| 120,640 | |
Current portion of long-term debt | | | 20,000 | | | 16,250 | |
Other current liabilities | |
| 4,957 | |
| 5,672 | |
Total current liabilities | |
| 252,132 | |
| 175,082 | |
NONCURRENT LIABILITIES: | |
| | |
| | |
Long-term debt, net | |
| 143,663 | |
| 163,016 | |
Other noncurrent liabilities | |
| 5,618 | |
| 1,947 | |
Total noncurrent liabilities | |
| 149,281 | |
| 164,963 | |
TOTAL LIABILITIES | |
| 401,413 | |
| 340,045 | |
COMMITMENTS AND CONTINGENCIES (Note 13) | |
| | |
| | |
STOCKHOLDERS’ EQUITY: | |
| | |
| | |
Common stock—$0.00001 par value; 500,000,000 shares authorized at December 31, 2025 and December 31, 2024, respectively; 57,726,170 and 57,144,887 shares issued and outstanding at December 31, 2025 and December 31, 2024, respectively | |
| 1 | |
| 1 | |
Additional paid in capital | |
| 708,968 | |
| 656,872 | |
Accumulated other comprehensive income | | | 346 | | | 66 | |
Retained earnings | |
| 160,903 | |
| 2,216 | |
TOTAL STOCKHOLDERS’ EQUITY | |
| 870,218 | |
| 659,155 | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | | $ | 1,271,631 | | $ | 999,200 | |
| | |
| | |
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 | | Year Ended | ||||||||
| | December 31, | | December 31, | | December 31, | | December 31, | ||||
| | 2025 | | 2024 | | 2025 | | 2024 | ||||
GAAP net income (1) | | $ | 22,486 | | $ | 49,475 | | $ | 158,687 | | $ | 145,493 |
Non-GAAP Adjustments: | | | | | | | | | | | | |
Non-cash interest expense (2) | | | 157 | | | 169 | | | 647 | | | 700 |
Depreciation | | | 1,470 | | | 6 | | | 1,490 | | | 267 |
Amortization (3) | | | 5,962 | | | 5,962 | | | 23,845 | | | 23,845 |
Stock-based compensation expense | | | 10,292 | | | 9,856 | | | 44,960 | | | 42,701 |
Income tax effect related to non-GAAP adjustments (4) | | | (6,988) | | | (1,227) | | | (18,587) | | | (16,271) |
Non-GAAP adjusted net income (1) | | $ | 33,379 | | $ | 64,241 | | $ | 211,042 | | $ | 196,735 |
| | | | | | | | | | | | |
GAAP reported net income per diluted share | | $ | 0.38 | | $ | 0.85 | | $ | 2.71 | | $ | 2.51 |
Non-GAAP adjusted net income per diluted share | | $ | 0.57 | | $ | 1.10 | | $ | 3.60 | | $ | 3.40 |
| | | | | | | | | | | | |
Weighted average number of shares of common stock used in non-GAAP diluted per share | | | 58,696,342 | | | 58,218,052 | | | 58,544,570 | | | 57,869,915 |
(1) Includes a $4,250 IPR&D charge related to a clinical milestone achieved for BP1.15205 during the three months and year ended December 31, 2025. Includes a $15,000 IPR&D charge related to a clinical milestone achieved for ZYN002 and a $15,000 IPR&D charge related to an upfront fee incurred upon closing the CiRC research collaboration agreement during the year ended December 31, 2025. Includes a Includes a $25,500 charge related to an upfront license fee incurred upon closing the 2024 Bioprojet Sublicense Agreement, a $17,095 IPR&D charge related to the acquisition of Epygenix, and a $1,000 IPR&D charge related to a preclinical milestone achieved for HBS-102 during the year ended December 31, 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
| | |
| Copyright © 2026 Harmony Biosciences. All rights reserved. Q4 & FY 2025 Financial Results & Business Update February 24, 2026 |
| 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 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; 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 24, 2026, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. 2 Harmony Biosciences | Q4 2025 Financial Results & Business Update | All rights reserved. |
| 2026 Net Revenue Guidance $1.00B-$1.04B 2026 NET REVENUE GUIDANCE WAKIX Net Revenue Growth 2020–2025 $160 $305 $438 $582 $715 $869 $1B+ $0 $200 $400 $600 $800 $1,000 2020 2021 2022 2023 2024 2025 2026 Guidance Net Revenue ($M) On Track to Achieve $1B+ in Narcolepsy Alone 3 February 24, 2026 Harmony Biosciences | Q4 2025 Financial Results & Business Update | All rights reserved. |
| WAKIX® Is One of the Most Successful Orphan/Rare Launches KEY TAKEAWAY After Six Years of Growth, Large Market Opportunity Remains 1. https://narcolepsynetwork.org/accessed Feb 2024 80,000 90,000 ~170,000 Diagnosed Narcolepsy Patients Undiagnosed Narcolepsy Population People Living With Narcolepsy in the U.S.1 > 50% of Patients Undiagnosed 4 Average Patients on WAKIX 400 300 300 100 400 300 300 200 350 350 350 150 250 250 300 100 400 500 400 0 1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 9,000 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Q3'23 Q4'23 Q1'24 Q2'24 Q3'24 Q4'24 Q1'25 Q2'25 Q3'25 Q4'25 Average # of Patients Net Patient Additions February 24, 2026 Harmony Biosciences | Q4 2025 Financial Results & Business Update | All rights reserved. |
| Strong Commercial Engine Driving Continued Growth 5 Strong Foundation Recent Developments Implication Only non-scheduled treatment, unique MOA 6+ years clinical experience Unique & Familiar Many team members joined at launch Refined call plan, promo mix, messaging Trusted & Credible >80% lives covered, often advantaged New wins further expanding coverage Accessible Commercial model supports patients, enables broad data capture Added staff, proactive triage, recontact team Supportive DIFFERENTIATED PRODUCT EXPERIENCED TEAM BROAD PAYER ACCESS PATIENT SUPPORT INVESTMENT AND EXPANSION • In 2026, expanding field sales, field reimbursement and remote sales teams • Launching online portal and more Building Momentum February 24, 2026 Harmony Biosciences | Q4 2025 Financial Results & Business Update | All rights reserved. |
| LINE EXTENSION ORPHAN/RARE EXPANSION BROADER CNS INDICATIONS Pitolisant Franchise: Securing CNS Leadership by Addressing Unmet Patient Needs 6 Harmony Biosciences | Q4 2025 Financial Results & Business Update | All rights reserved. EXTEND EXPAND Pitolisant GR Pitolisant HD EXPLORE New Pitolisant Formulation • NDA Filing 2Q26 • Target PDUFA 1Q27 • Remains the only non-scheduled treatment • Designed to address disease related GI symptoms • Ability to start at therapeutic dose with no need for titration PATIENT REACH • Mechanism-based approach supported by clinical data for pitolisant in fatigue • Lead indication planned in MS fatigue; potential additional opportunities include fatigue in Parkinson's disease and post-stroke fatigue • Focused on formulation optimization towards a phase 1 PK study • Licensed IP with patent protection until 2042 • Enhanced formulation with optimized PK profile, higher dose, and GR coating • Designed to provide greater efficacy • Pursuing novel indications • Potential first drug approved for fatigue in narcolepsy and sleep inertia in idiopathic hypersomnia (IH) |
| Pitolisant GR: Fast-To-Market Strategy to Extend WAKIX® Franchise and Harmony’s Leadership in Narcolepsy Q1 2027 Anticipated PDUFA Date POSITIVE PIVOTAL BIOEQUIVALENCE STUDY DOSING OPTIMIZATION STUDY COMPLETED 100% of the patients (46/46) able to initiate pitolisant GR at the therapeutic dose,17.8mg, without titration; No new safety or tolerability issues reported NDA SUBMISSION Q2 2026 ANTICIPATED PDUFA DATE Q1 2027 UTILITY PATENTS FILED TO EXTEND PITOLISANT FRANCHISE INTO 2040s 7 February 24, 2026 Harmony Biosciences | Q4 2025 Financial Results & Business Update | All rights reserved. |
| Pitolisant HD: Expand the Pitolisant Franchise with Enhanced Formulation and Differentiated Product Profile 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 PHASE 3 REGISTRATIONAL TRIALS INITIATED IN Q4 2025 Topline data readouts anticipated in 2027; PDUFA dates anticipated in 2028 UTILITY PATENTS FILED TO EXPAND PITOLISANT FRANCHISE INTO 2040s 2027 Phase 3 Topline Data • Narcolepsy (ONSTRIDE 1) • IH (ONSTRIDE 2) 8 February 24, 2026 Harmony Biosciences | Q4 2025 Financial Results & Business Update | All rights reserved. |
| Exploring Fatigue in Broader CNS Indications Based on Unique Histaminergic MoA of Pitolisant 9 CLINICAL EVIDENCE WITH PITOLISANT Phase 2 PoC study in Myotonic Dystrophy Type 1 (DM1): Statistically significant and clinically meaningful improvements on Fatigue Severity Scale Dose-response Phase 3 study in patients with Obstructive Sleep Apnea and Residual Sleepiness: Improvements in Pichot Fatigue Severity Scale (included in EU label) Physical, Cognitive, and Emotional Components of Fatigue Mediated through Histaminergic Circuits in the Brain Promotes wakefulness (H3 antagonist and inverse agonism) PHYSICAL COGNITIVE EMOTIONAL Stabilizes mood and emotions (modulation of serotonin and norepinephrine) Improvement in attention, concentration and memory (Modulation of histamine and norepinephrine) Fatigue is a multi-dimensional construct Harmony Biosciences | Q4 2025 Financial Results & Business Update | All rights reserved. |
| Innovative Late-Stage Pipeline With Multiple Catalysts 2026–2028 PRODUCT INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 REGULATORY FILING MARKETED PRODUCT WAKIX® EDS in Narcolepsy (Adult/Pediatric*) Cataplexy in Narcolepsy (Adult/Pediatric*) Pitolisant Pitolisant Gastro-Resistant (GR) in Narcolepsy Prader-Willi Syndrome (PWS) Pitolisant High-Dose (HD) in Narcolepsy Pitolisant High-Dose (HD) in Idiopathic Hypersomnia Pitolisant High-Dose (HD) in Myotonic Dystrophy (DM1) Pitolisant in Multiple Sclerosis (MS) Fatigue BP1.15205 (Orexin-2 Receptor Agonist) Sleep/Wake Disorders CBS105 Treatment-Resistant Narcolepsy HBS-102 PWS EPX-100 (Clemizole Hydrochloride Dravet Syndrome (DS) Lennox-Gastaut Syndrome (LGS) EPX-200 (Lorcaserin) Developmental and Epileptic Encephalopathies CBS104 Refractory Epilepsy Research collaboration with CiRC Biosciences. 10 February 24, 2026 Harmony Biosciences | Q4 2025 Financial Results & Business Update | All rights reserved. *Ages 6 years and older. |
| BP1.15205: Potential Best-In-Class Orexin 2 Receptor (OX2R) Agonist PRECLINICAL DATA PRESENTATION AT SLEEP AND WSC Single-oral dose administration of BP1.15205 in transgenic mice produced significant and dose-dependent increases in total wakefulness time and sleep latency at every dose tested beginning at 0.03 mg/kg and 0.1 mg/kg, respectfully, consistent with high potency FIH STUDY INITIATED IN 4Q 2025 Clinical data anticipated in mid-2026 UNIQUE STRUCTURE/CHEMICAL SCAFFOLD Differentiated from other known OX2R agonist chemical structures CLINICAL POTENTIAL • Potency and selectivity • Potent on-target effects • Potentially better AE profile • Once-daily dosing 11 2026 Phase 1 Clinical PK Data Anticipated Mid-2026 February 24, 2026 Harmony Biosciences | Q4 2025 Financial Results & Business Update | All rights reserved. |
| EPX-100: Safety and effectiveness data from ongoing OLE of the Phase 3 Dravet Syndrome (DS) study presented at AES 2025 CLINICALLY MEANINGFUL REDUCTION IN SEIZURES Median reduction of ~50% in countable motor seizure frequency per 28 days (CMS-28) in participants who had at least 6-month exposure to EPX-100; at least 50% reduction in CMS-28 in 50% of these participants PRODUCT PROFILE: POTENTIAL TO OFFER A UNIQUE RISK/BENEFIT PROPOSITION No additional laboratory or special safety monitoring BID DOSING REGIMEN Convenient for patients and caregivers ONGOING PHASE 3 REGISTRATIONAL TRIAL IN PATIENTS WITH DRAVET SYNDROME (Argus Study) Topline data anticipated in 2027 1H 2027 Anticipate Topline Data from Ongoing Global Phase 3 Trial 12 February 24, 2026 Harmony Biosciences | Q4 2025 Financial Results & Business Update | All rights reserved. |
| EPX-100: One of Most Advanced 5-HT2 (Serotonin) Agonist Programs in DEEs 13 ESTABLISHED 5-HT2 (SEROTONIN) AGONIST MECHANISM OF ACTION MoA validated via the zebrafish model ONGOING PHASE 3 TRIAL IN LENNOX-GASTAUT SYNDROME (LGS) (LIGHTHOUSE Study) Topline data anticipated 1H 2027 SAFETY: POTENTIAL TO OFFER A UNIQUE RISK/BENEFIT PROPOSITION No additional laboratory or special safety monitoring BID DOSING REGIMEN Convenient for patients and caregivers February 24, 2026 Harmony Biosciences | Q4 2025 Financial Results & Business Update | All rights reserved. 1H 2027 Anticipate Topline Data from Ongoing Global Phase 3 Trial |
| Path to Long-Term Value Creation Beyond 2026 Pipeline Poised to Deliver Value Through Extension and Expansion of Pitolisant Franchise and Innovative Epilepsy Assets 2027 Pitolisant GR PDUFA Pitolisant HD Phase 3 TLD in narcolepsy and idiopathic hypersomnia (IH) EPX-100 Phase 3 TLD in DS and LGS 2028 Pitolisant HD PDUFA Narcolepsy and IH EPX-100 PDUFA DS and LGS Pitolisant PWS PDUFA 2026 WAKIX Pediatric cataplexy approval Pitolisant PWS Phase 3 TLD OX2R Phase 1 clinical PK data 14 KEY TAKEAWAY 5 February 2026 Harmony Biosciences | Q4 2025 Financial Results & Business Update | All rights reserved. |
| $201.3 $243.8 Q4 2024 Q4 2025 $576.1 $610.2 $672.3 $778.4 $882.5 Q4 2024 Q1 2025 Q2 2025 Q3 2025 Q4 2025 $64.2 $33.4 Q4 2024 Q4 2025 Financial Highlights Q4 2025 15 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 December 31, 2025 (In millions, USD) Net Product Revenue Non-GAAP Adjusted Net Income1 Cash, Cash Equivalents & Investments - 48% 21% +$104 Harmony Biosciences | Q4 2025 Financial Results & Business Update | All rights reserved. $714.7 $868.5 FY 2024 FY 2025 22% Twelve Months Ended December 31, 2025 $196.7 $211.1 FY 2024 FY 2025 7% Three Months Ended December 31, 2025 Twelve Months Ended December 31, 2025 CONSISTENT REVENUE GROWTH AND PROFITABILITY ON TRACK TO BLOCKBUSTER STATUS IN NARCOLEPSY SELF FUNDING ACROSS THE ENTERPRISE POISED FOR VALUE CREATION |
| Financial Summary Q4 2025 16 Harmony Biosciences | Q4 2025 Financial Results & Business Update | All rights reserved. Totals may not foot due to rounding Three Months Ended December 31, % Change Twelve Months Ended December 31, 2025 2024 2025 2024 % Change Net Product Revenue $243.8 $201.3 21% $868.5 $714.7 22% Cost of Product Sold 68.5 54.4 26% 198.3 156.8 27% Total Operating Expenses $136.6 $91.1 50% $461.6 $367.1 26% R&D Expense 49.9 34.6 44% 189.6 145.8 30% S&M Expense 29.2 27.6 6% 119.5 110.9 8% G&AExpense 57.5 28.9 99% 152.5 110.4 38% Net Income $22.5 $49.5 -55% $158.7 $145.5 9% Cash, cash equivalents & investments $882.5 $576.1 53% (In millions, USD) |
| GAAP vs NON-GAAP Reconciliation Q4 2025 17 Harmony Biosciences | Q4 2025 Financial Results & Business Update | All rights reserved. (In millions, USD) Totals may not foot due to rounding Three Months Ended December 31, Nine Months Ended December 31, 2025 2024 2025 2024 GAAP net income1 $22.5 $49.5 $158.7 $145.5 Non-cash interest expense2 0.2 0.2 0.6 0.7 Depreciation 1.5 0.0 1.5 0.3 Amortization3 6.0 6.0 23.8 23.8 Stock-based compensation expense 10.3 9.9 45.0 42.7 Income tax effect related to Non-GAAP adjustments4 (7.0) (1.2) (18.6) (16.3) Non-GAAP adjusted net income1 $33.4 $64.2 $211.0 $196.7 GAAP net income per diluted share $0.38 $0.85 $2.71 $2.51 Non-GAAP adjusted net income per diluted share $0.57 $1.10 $3.60 $3.40 Weighted average number of shares of common stock used in non-GAAP diluted per share 58.7 58.2 58.5 57.9 (1) Includes a $4,250 IPR&D charge related to a clinical milestone achieved for BP1.15205 during the three months and year ended December 31, 2025. Includes a $15,000 IPR&D charge related to a clinical milestone achieved for ZYN002 and a $15,000 IPR&D charge related to an upfront fee incurred upon closing the CiRC research collaboration agreement during the year ended December 31, 2025. Includes a Includes a $25,500 charge related to an upfront license fee incurred upon closing the 2024 Bioprojet Sublicense Agreement, a $17,095 IPR&D charge related to the acquisition of Epygenix, and a $1,000 IPR&D charge related to a preclinical milestone achieved for HBS-102 during the year ended December 31, 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. |
| company/harmonybiosciences/ @harmonybio harmony_biosciences www.harmonybiosciences.com |
