Item 8. Financial Statements and Supplementary Data
Item 8. Financial Statements and Supplementary Data.
Report of Independent Registered Public Accounting Firm (PCAOB ID No. 34 )
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Consolidated Balance Sheets
93
Consolidated Statements of Operations and Comprehensive Income (Loss )
94
Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)
95
Consolidated Statements of Cash Flows
96
Notes to Consolidated Financial Statements
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the shareholders and the Board of Directors of Harmony Biosciences Holdings, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Harmony Biosciences Holdings, Inc. and subsidiaries (the “Company”) as of December 31, 2025 and 2024, the related consolidated statements of operations and comprehensive income (loss), stockholders’ equity (deficit), and cash flows for each of the three years in the period ended December 31, 2025, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025, and 2024, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control — Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated February 24, 2026, expressed an unqualified opinion on the Company’s internal control over financial reporting.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current-period audit of the financial statements that was communicated or required to be communicated to the audit committee and that (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Rebate Accrual for Medicaid – Refer to “Note 3- Net Product Revenue” to the financial statements
Critical Audit Matter Description
As more fully disclosed in Note 3 to the financial statements, the Company recognizes revenue on sales of WAKIX when the customer obtains control of the product, which occurs at a point in time, typically upon delivery. Product revenue is recorded at the product’s wholesale list price, net of applicable reserves for variable consideration that are offered within contracts between the Company and its customers, payors, and other indirect customers relating to the sale of WAKIX. Components of variable consideration include government and commercial contracts, product returns, commercial co-payment assistance program transactions, and distribution service fees. These deductions are based on the amounts earned, or to be claimed on the related sales, and are classified as a current liability or reduction of receivables on the Company’s consolidated balance sheet.
The rebate provision and related liability related to the Medicaid Drug Rebate Program (the “Medicaid rebate accrual”) involves the use of significant assumptions and judgments in the Company’s calculation. These significant assumptions and
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judgments include historical claims experience, payer channel mix, current contract prices, unbilled claims, claims submission time lags, and inventory levels in the distribution channel.
Given the complexity involved in determining the significant assumptions used in calculating the Medicaid rebate accrual, auditing these estimates involved especially subjective judgment.
How the Critical Audit Matter was Addressed in the Audit
Our audit procedures related to the Medicaid rebate accrual included the following, among others:
● We evaluated the appropriateness and consistency of the Company’s methods and assumptions used to calculate the Medicaid rebate accrual.
● We tested the effectiveness of internal controls over the review of the Company’s estimation model, including underlying assumptions and key inputs into the Company’s process to calculate the Medicaid rebate accrual.
● We tested the mathematical accuracy of the Medicaid rebate accrual.
● We tested significant assumptions and key inputs used to calculate the Medicaid rebate accrual.
● We evaluated the Company’s ability to estimate the Medicaid rebate accrual accurately by comparing the actual amounts incurred for the Medicaid rebate accrual to historical estimates.
● We tested the overall reasonableness of the Medicaid rebate accrual recorded at period end by developing an expectation for comparison to actual recorded balances.
● We involved audit professionals with industry and quantitative analytics experience to assist us in performing our auditing procedures.
/s/ Deloitte & Touche LLP
Philadelphia, PA
February 24, 2026
We have served as the Company’s auditor since 2017.
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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
The accompanying notes are an integral part of the consolidated financial statements
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HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(In thousands, except share and per share data)
Year Ended December 31,
2025
2024
2023
Net product revenue
$
868,453
$
714,734
$
582,022
Cost of product sold
198,342
156,815
121,236
Gross profit
670,111
557,919
460,786
Operating expenses:
Research and development (1)
189,594
145,825
76,063
Sales and marketing
119,512
110,916
97,404
General and administrative
152,536
110,352
95,289
Total operating expenses
461,642
367,093
268,756
Operating income
208,469
190,826
192,030
Loss on debt extinguishment
—
—
( 9,766 )
Other (expense) income, net
( 680 )
( 68 )
159
Interest expense
( 14,649 )
( 17,496 )
( 23,757 )
Interest income
21,924
18,542
14,730
Income before income taxes
215,064
191,804
173,396
Income tax expense
( 56,377 )
( 46,311 )
( 44,543 )
Net income
$
158,687
$
145,493
$
128,853
Unrealized income on investments
280
64
153
Comprehensive income
$
158,967
$
145,557
$
129,006
EARNINGS PER SHARE:
Basic
$
2.76
$
2.56
$
2.17
Diluted
$
2.71
$
2.51
$
2.13
Weighted average number of shares of common stock - basic
57,492,277
56,885,455
59,469,648
Weighted average number of shares of common stock - diluted
58,544,570
57,869,915
60,372,397
(1) Includes $ 15,000 in related party expenses for the year ended December 31, 2025, and no related party expenses for the years ended December 31, 2024, and 2023.
The accompanying notes are an integral part of the consolidated financial statements
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HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
(In thousands, except share and per share data)
Accumulated
Retained
Total
Additional
other
earnings
stockholders’
Common Stock
paid-in
comprehensive
(accumulated
equity
Shares (1)
Amount
capital
income (loss)
deficit)
(deficit)
Balance as of December 31, 2022
59,615,731
1
675,118
( 151 )
( 272,130 )
402,838
Net income
—
—
—
—
128,853
128,853
Unrealized loss on investments
—
—
—
153
—
153
Repurchase of common stock
( 3,254,445 )
—
( 101,097 )
—
—
( 101,097 )
Exercise of options and vesting of restricted stock units (2)
407,795
—
4,540
—
—
4,540
Stock-based compensation
—
—
31,705
—
—
31,705
Balance as of December 31, 2023
56,769,081
$
1
$
610,266
$
2
$
( 143,277 )
$
466,992
Net income
—
—
—
—
145,493
145,493
Unrealized gain on investments
—
—
—
64
—
64
Exercise of options and vesting of restricted stock units (2)
375,806
—
4,004
—
—
4,004
Stock-based compensation
—
—
42,602
—
—
42,602
Balance as of December 31, 2024
57,144,887
$
1
$
656,872
$
66
$
2,216
$
659,155
Net income
—
—
—
—
158,687
158,687
Unrealized gain on investments
—
—
—
280
—
280
Exercise of options and vesting of restricted stock units (2)
581,283
—
7,201
—
—
7,201
Stock-based compensation
—
—
44,895
—
—
44,895
Balance as of December 31, 2025
57,726,170
$
1
$
708,968
$
346
$
160,903
$
870,218
(1) Common stock of Harmony Biosciences Holdings, Inc.
(2) Inclusive of fees and 1 % excise tax on shares repurchased.
The accompanying notes are an integral part of the consolidated financial statements
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HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands, except share and per share data)
Year Ended December 31,
2025
2024
2023
CASH FLOWS FROM OPERATING ACTIVITIES
Net income
$
158,687
$
145,493
$
128,853
Adjustments to reconcile net income to net cash used in operating activities:
Depreciation and impairment of long-lived assets
1,490
267
514
Intangible amortization
23,845
23,845
23,845
Acquired in-process research & development (IPR&D) expense
34,250
43,595
2,260
Stock-based compensation
44,895
42,602
31,705
Stock appreciation rights market adjustment
65
99
( 499 )
Debt issuance costs amortization
647
700
2,274
Deferred taxes
( 7,301 )
( 29,298 )
( 13,419 )
Amortization of premiums and accretion of discounts on Investment securities
( 1,521 )
( 2,261 )
( 2,715 )
Loss on debt extinguishment
—
—
9,766
Other non-cash expenses
1,325
2,100
1,768
Change in operating assets and liabilities:
Trade receivables
( 13,754 )
( 8,893 )
( 19,400 )
Inventory
1,841
( 1,835 )
( 1,066 )
Prepaid expenses and other assets
31,787
( 3,008 )
74
Trade payables
3,949
( 5,384 )
8,949
Other liabilities
67,994
11,799
46,478
Net cash provided by operating activities
348,199
219,821
219,387
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of investment securities
( 86,151 )
( 105,289 )
( 127,469 )
Proceeds from maturities and sales of investment securities
81,062
98,527
118,309
Purchase of property and equipment
( 310 )
( 1,153 )
( 312 )
Acquisition of Zynerba Pharmaceuticals, Inc., net of cash acquired
—
—
( 36,967 )
Acquisition of Epygenix Therapeutics, Inc., net of cash acquired
—
( 33,069 )
—
Payment of milestones
( 19,250 )
( 1,000 )
—
Payment of upfront fee related to license agreements (1)
( 15,000 )
( 25,500 )
—
Net cash used in investing activities
( 39,649 )
( 67,484 )
( 46,439 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from long-term debt
—
—
200,000
Debt issuance costs
—
—
( 2,997 )
Extinguishment of debt
—
—
( 196,500 )
Extinguishment of debt exit fees
—
—
( 5,846 )
Principal repayment of long-term debt
( 16,250 )
( 15,000 )
( 4,750 )
Repurchase of common stock
—
—
( 100,000 )
Payments of employee withholding taxes related to stock-based awards
( 3,004 )
( 2,497 )
( 514 )
Proceeds from exercised options
10,205
6,501
5,055
Net cash used in financing activities
( 9,049 )
( 10,996 )
( 105,552 )
NET INCREASE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH
299,501
141,341
67,396
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH—Beginning of period
453,271
311,930
244,534
CASH, CASH EQUIVALENTS, AND RESTRICTED CASH—End of period
$
752,772
$
453,271
311,930
Supplemental Disclosure of Cash Flow Information:
Cash paid during the year for interest
$
14,685
$
17,317
$
20,051
Cash paid during the year for income taxes net of refunds received
19,820
79,635
48,233
(1) Includes $ 15,000 in cash paid to a related party during the year ended December 31, 2025, and no related party payments during the years ended December 31, 2024, and 2023.
The accompanying notes are an integral part of the consolidated financial statements
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HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share data)
1. ORGANIZATION AND DESCRIPTION OF BUSINESS
The Company
Harmony Biosciences Holdings, Inc., and its consolidated subsidiaries (the “Company”) was founded in July 2017 as Harmony Biosciences II, LLC, a Delaware limited liability company. The Company converted to a Delaware corporation named Harmony Biosciences II, Inc. in September 2017 and, in February 2020, the Company changed its name to Harmony Biosciences Holdings, Inc. The Company’s operations are conducted in its wholly owned subsidiaries, Harmony Biosciences, LLC (“Harmony”), and Harmony Biosciences Management, Inc. The Company is a commercial-stage pharmaceutical company focused on developing and commercializing innovative therapies for patients living with rare neurological disorders as well as patients living with other neurological diseases who have unmet medical needs. The Company is headquartered in Plymouth Meeting, Pennsylvania .
We are cultivating a differentiated neuroscience company, rooted in innovation and driven by a commitment to addressing the unmet needs of patients living with neurological diseases. To date, we have focused on rare neurological diseases with a growing portfolio now spanning sleep/wake, neurobehavioral, and rare epilepsy, and we are harnessing scientific insights and pioneering approaches to advance meaningful treatments that help patients thrive.
In July 2017, the Company entered into a License Agreement (the “2017 LCA”) with Bioprojet Société Civile de Recherche (“Bioprojet”) whereby the Company acquired the exclusive right to commercialize the pharmaceutical compound pitolisant. Our lead product, WAKIX® (pitolisant) (“WAKIX”), is a first-in-class therapy with a novel mechanism of action designed to enhance histamine signaling in the brain by binding to H 3 receptors. Since its initial FDA approval in 2019 for excessive daytime sleepiness (“EDS”) in adult patients with narcolepsy, WAKIX has subsequently been approved for cataplexy in adult patients in 2020 and EDS in pediatric patients six years and older in 2024. Beyond narcolepsy, we are also advancing late-stage clinical programs exploring pitolisant in Prader-Willi syndrome (“PWS”) and continue to grow our impact in other rare neurological diseases. In July 2022, the Company entered into a License and Commercialization Agreement (the “2022 LCA”) with Bioprojet whereby we obtained exclusive rights to manufacture, develop and commercialize one or more next generation pitolisant based products in the United States and Latin America. Two of the next generations formulations, Pitolisant Gastro-Resistant (“Pitolisant GR”) and Pitolisant High-Dose (“Pitolisant HD”) are currently in clinical development.
Along with nurturing the growth of our original pipeline, our innovation strategy includes targeted business development that strengthens our foundation and strategically extends our patient reach as we look to expand our portfolio to new diseases beyond histaminergic science. In June 2025, we entered into a research collaboration, option and license agreement (the “CiRC Agreement”) with CiRC Biosciences, Inc. (“CiRC”), a related party. Under this agreement, Harmony and CiRC will collaborate on the research and development of two discovery-stage candidates, CBS105 for treatment-resistant narcolepsy and CBS104 for refractory epilepsy (together, the “Candidates”), using cell replacement therapy for the treatment of refractory epilepsies and treatment-resistant narcolepsy.
In April 2024, we expanded into orexin science through a sublicense agreement with Bioprojet for an orexin 2 receptor agonist (“BP1.15205”) in preclinical development for narcolepsy and other potential indications. Under the sublicense agreement the Company obtained the exclusive right to develop, manufacture and commercialize BP1.15205 in the United States and Latin American territories, which are rights originally licensed from Teijin Pharma, the innovator of BP1.15205. We further broadened our portfolio into rare epilepsy when the Company acquired Epygenix Therapeutics, Inc. (“Epygenix”) in April 2024. As a result, the Company now has an exclusive license relating to the use of clemizole hydrochloride, initially for the treatment of Dravet Syndrome (“DS”) and Lennox-Gastaut Syndrome (“LGS”), and a liquid formulation of lorcaserin for the treatment of developmental and epileptic encephalopathies .
2. LIQUIDITY AND CAPITAL RESOURCES
The consolidated financial statements have been prepared as though the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The
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Company had retained earnings of $ 160,903 and $ 2,216 , as of December 31, 2025, and 2024, respectively. As of December 31, 2025, the Company had cash, cash equivalents and investments of $ 882,467 .
The Company believes that its existing cash, cash equivalents and investments on hand as of December 31, 2025, as well as additional cash generated from operating and financing activities will meet its operational liquidity needs and fund potential investing activities for at least the next twelve months from the date of issuance of these consolidated financial statements.
3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and include all adjustments necessary for the fair presentation of the Company’s financial position for the periods presented. All intercompany accounts and transactions have been eliminated.
Reclassifications
Certain prior period amounts within the consolidated balance sheets have been reclassified to conform to current period presentation. In particular, restricted cash and property, plant and equipment were previously classified as separate captions and are now included within other noncurrent assets. The reclassification of these items had no impact on net income, earnings per share or accumulated deficit in current or prior periods.
Significant Risks and Uncertainties
The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors include, but are not limited to, the results of clinical testing and trial activities of the Company’s product candidates; the Company’s ability to obtain regulatory approval to market its products; competition from products manufactured and sold or being developed by other companies; the price of, and demand for, the Company’s products, if approved; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its product candidates; and the Company’s ability to raise capital.
The Company currently has one commercially approved product, WAKIX, and there can be no assurance that the Company’s research and development efforts will result in successfully commercialized products in addition to WAKIX. Developing and commercializing a product requires significant time and capital and is subject to regulatory review and approval as well as competition from other biotechnology and pharmaceutical companies. The Company operates in an environment of rapid change and is dependent upon the continued services of its employees and consultants and obtaining and protecting intellectual property.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts and disclosures in the consolidated financial statements, including the notes thereto, and elsewhere in this report. Actual results may differ significantly from estimates, which include rebates due pursuant to commercial and government contracts, accrued research and development expenses, stock-based compensation expense and income taxes.
Operating Segments
The Company holds all its tangible assets, conducts its operations, and generates its revenue in the U.S. Operating segments which are defined as components of an entity for which separate financial information is available and that is regularly reviewed by the Chief Operating Decision Maker (“CODM”) in deciding how to allocate resources to an individual segment and in assessing performance. The Company has determined it operates in a single operating segment and, therefore, has one reportable segment.
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Fair Value of Financial Instruments
The Company’s consolidated financial statements include cash, cash equivalents, accounts receivable, other current assets, accounts payable, and accrued liabilities, all of which are short term in nature and, accordingly, approximate fair value.
It is the Company’s policy to measure non-financial assets and liabilities at fair value on a nonrecurring basis. These non-financial assets and liabilities are not measured at fair value on an ongoing basis but are subject to fair value adjustments in certain circumstances (such as evidence of impairment), which, if material, are disclosed in the accompanying footnotes.
The Company measures certain assets and liabilities at fair value based on the fair value hierarchy that prioritizes inputs to valuation techniques used to measure fair value into three levels based on the source of inputs as follows:
Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities.
Level 2—Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities.
Level 3—Valuations based on unobservable inputs and models that are supported by little or no market activity.
Money market funds are classified as Level 1 fair value instruments. Investments in available-for-sale debt securities are classified as Level 2 and carried at fair value, which we estimate utilizing a third-party pricing service. The pricing service utilizes industry standard valuation models whereby all significant inputs, including benchmark yields, reported trades, broker/dealer quotes, issuer spreads, bids, offers, or other market-related data, are observable. We validate valuations obtained from third-party services by obtaining market values from other pricing sources. The Company did not classify any assets or liabilities as Level 3 as of December 31, 2025, or December 31, 2024.
Cash, Cash Equivalents and Restricted Cash
Cash and cash equivalents and restricted cash consist of cash and, if applicable, highly liquid investments with an original maturity of three months or less when purchased, including investments in money market funds and debt securities that approximate fair value. The following table provides a reconciliation of cash, cash equivalents, and restricted cash reported within the balance sheet and in the statements of cash flows.
As of
December 31,
December 31,
2025
2024
Cash and cash equivalents
$
752,502
$
453,001
Restricted cash included in other noncurrent assets
270
270
Total cash, cash equivalents, and restricted cash shown in the statements of cash flows
$
752,772
$
453,271
Restricted cash includes amounts required to be held as a security deposit in the form of letters of credit for the Company’s credit card program and the fleet program.
Investments
The Company’s investments consist of debt securities that are classified as available-for-sale. Short-term and long-term investments are carried at fair value and unrealized gains and losses are recorded as a component of accumulated comprehensive income in stockholders’ equity. The amortization of premiums and accretion of discounts adjust the carrying value of investments and are recorded in interest expense on the consolidated statements of operations and comprehensive income. Interest income and realized gains and losses, if any, are also recorded in interest income on the consolidated statement of operations and comprehensive income. Realized gains and losses that result from the sale of investments are determined on a specific identification basis.
At each reporting period, the Company reviews any unrealized losses position to determine if the decline in the fair value of the underlying investments is a result of credit losses or other factors. If the assessment indicates that a credit loss exists, any impairment is recognized as an allowance for credit losses in our consolidated statement of operations.
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Concentrations of Risk
Substantially all of the Company’s cash and money market funds are held in five financial institutions. Due to their size, the Company believes these financial institutions represent minimal credit risk. Deposits may exceed the amount of insurance provided on such deposits by the Federal Deposit Insurance Corporation for U.S. institutions. The Company has not experienced any losses on its deposits of cash and cash equivalents. The Company believes that it is not exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held.
The Company is subject to credit risk from its trade receivables related to its product sales. The Company extends credit to specialty pharmaceutical distribution companies within the United States. Customer creditworthiness is monitored and collateral is not required. Historically, the Company has not experienced credit losses on its accounts receivable. The Company monitors its exposure within accounts receivable and would record a reserve against uncollectible accounts receivable if necessary. As of December 31, 2025, three customers accounted for 100 % of gross accounts receivable, Accredo Health Group, Inc. (“Accredo”), which accounted for 45 % of gross accounts receivable; Caremark LLC (“CVS Caremark”), which accounted for 36 % of gross accounts receivable; and PANTHERx Specialty Pharmacy LLC (“PANTHERx”), which accounted for 19 % of gross accounts receivable. As of December 31, 2024, three customers accounted for 100 % of gross accounts receivable; CVS Caremark, which accounted for 39 % of gross accounts receivable, PANTHERx, which accounted for 31 % of gross accounts receivable and Accredo, which accounted for 30 % of gross accounts receivable.
For the year ended December 31, 2025, three customers accounted for 100 % of gross product revenue; CVS Caremark accounted for 38 % of gross product revenue; Accredo accounted for 36 % of gross product revenue; and PANTHERx accounted for 26 % of gross product revenue. For the year ended December 31, 2024, three customers accounted for 100 % of gross product revenue; CVS Caremark accounted for 39 % of gross product revenue; Accredo accounted for 34 % of gross product revenue; and PANTHERx accounted for 27 % of gross product revenue. For the year ended December 31, 2023, three customers accounted for 100 % of gross product revenue; CVS Caremark accounted for 37 % of gross product revenue; Accredo accounted for 32 % of gross product revenue; and PANTHERx accounted for 31 % of gross product revenue.
The Company depends on two suppliers of the active pharmaceutical ingredient (“API”) for its commercial product, WAKIX, and single API suppliers for each of its potential product candidates.
Share Repurchases
The Company accounts for share repurchases as constructive retirements, whereby it reduces common stock and additional paid-in capital by the amount of the original issuance, with any excess purchase price recorded as a reduction to retained earnings. Under this method, issued and outstanding shares of common stock are reduced by the amount of shares of common stock repurchased, and no treasury stock is recognized on the condensed consolidated financial statements.
Inventory
Inventory is valued at the lower of cost or net realizable value. Cost is determined using the specific identification method for all inventory. Our policy is to write down inventory that has become obsolete, that has a cost basis in excess of its expected net realizable value and/or that we have quantities in excess of expected future demand. The estimate of excess quantities is subjective and primarily dependent on our estimates of future demand. If our estimate of future demand changes, we consider the impact on the reserve for excess inventory and adjust the reserve as required. Inventory reserves are recorded as a component of cost of product sold in our consolidated statement of operations.
We may capitalize inventory costs associated with products prior to regulatory approval when future commercialization is probable. Otherwise, such costs are expensed as research and development. The determination to capitalize inventory costs is based on various factors, including status and expectations of the regulatory approval process, any known safety or efficacy concerns, potential labeling restrictions, and any other impediments to obtaining regulatory approval.
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Property and Equipment
Property and equipment are stated at cost less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three and ten years . Leasehold improvements are depreciated using the straight-line method over the shorter of the estimated useful life of the asset or the term of the lease. The Company’s leasehold improvements primarily relate to its corporate headquarters in Plymouth Meeting, PA, and have been fully depreciated as of December 31, 2025. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in the consolidated statement of operations and comprehensive income (loss) in the period realized.
Intangible Assets
Intangible assets with finite useful lives consist primarily of purchased developed technology and are amortized on a straight-line basis over their estimated useful lives. The estimated useful lives associated with finite-lived intangible assets are consistent with the estimated lives of the associated products and may be modified when circumstances warrant. Such assets are reviewed for impairment when events or circumstances indicate that the carrying value of an asset may not be recoverable. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset and its eventual disposition are less than its carrying amount. The amount of any impairment is measured as the difference between the carrying amount and the fair value of the impaired asset.
Revenue Recognition
We account for contracts with our customers in accordance with ASC 606, Revenue from Contracts with Customers (ASC 606). Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. The amount of variable consideration which is included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under contracts will not occur in a future period. Our analyses contemplate the application of the constraint in accordance with ASC 606. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.
We have determined that the delivery of our product to our customer constitutes a single performance obligation as there are no other promises to deliver goods or services in contracts with our customers. Shipping and handling activities are considered to be fulfilment activities and are not considered to be a separate performance obligation. The payment terms with our customers do not exceed one year and therefore, no amount of consideration has been allocated as a financing component. Taxes collected related to product sales are remitted to governmental authorities and are excluded from revenue.
Net Product Revenue
We recognize revenue from sales of WAKIX when the customers, specialty pharmacies, obtain control of the product which occurs at a point in time, typically upon delivery. Product revenue is recorded at the product’s list price, and is reduced from the product’s list price at the time of recognition for variable consideration that are offered within contracts between us and our customers, payors, and other indirect customers relating to the sale of WAKIX. Components of variable consideration include government (as detailed below) and commercial contracts, commercial co-payment assistance program, and distribution service fees. These deductions are based on the amounts earned, or to be claimed on the related sales, and are classified as a current liability or reduction of receivables in our consolidated balance sheet.
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Government Contracts
We have entered into contracts (i) to participate in the Medicaid Drug Rebate Program and the Medicare Part D program, and (ii) to sell to the U.S. Department of Veterans Affairs, 340b entities and other government agencies, or government payors, so that WAKIX will be eligible for purchase by, in partial or full reimbursement from, such government payors. We record reserves for rebates due pursuant to these contracts as a reduction of revenue in the same period in which the revenue is recognized. The liability for government rebates is included in accrued expenses in our consolidated balance sheet.
We estimate rebates due pursuant to government contracts based upon our historical payment trends, information obtained from third parties estimating current payment trends, the government-mandated discounts applicable to government-funded programs, as well as information obtained from our customers. The liability for these government rebates consists of estimates of claims for WAKIX dispensed in the current period, plus an estimate for product which has shipped and has been recognized as revenue but remains in the distribution channel at the end of a reporting period.
Cost of Product Sold
Cost of product sold includes manufacturing and distribution costs, the cost of drug substance, FDA program fees, royalties due to third parties on net product sales, freight, shipping, handling, storage costs, and salaries of employees involved with production.
Research and Development Expenses
Research and development costs are expensed as incurred. Liabilities due to third parties in connection with research and development collaborations prior to regulatory approval are expensed as incurred.
Upfront payments and pre-FDA approval milestone payments made for licensing of technology are expensed as research and development in the period in which they are incurred. Advance payments for goods and services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed.
Advertising Expenses
We expense the costs of advertising, including promotional expenses, as incurred. Advertising expenses were $ 29,526 , $ 27,556 and $ 21,544 for the years ended December 31, 2025, 2024 and 2023, respectively.
Stock-Based Compensation
The Company recognizes stock-based compensation expense in operating results using a fair value measurement method, in accordance with FASB ASC 718, Compensation-Stock Compensation. ASC 718 requires all stock-based payments to employees to be recognized in operating results as compensation expense based on fair value over the requisite service period of the awards. The vesting periods have a time-based provision consisting of one to five years and expire no more than 10 years after the date of grant. Upon a change of control, certain unvested awards will immediately vest. The Company determines the fair value of stock-based awards on their grant date using the Black-Scholes option-pricing model, which uses both historical and current market data to estimate fair value. The method incorporates various assumptions, such as the risk-free interest rate, expected volatility, expected dividend yield, and expected life of the options. The Company recognizes forfeitures as they occur.
Basic and Diluted Net Income per Share
Basic net income per share is determined using the weighted average number of shares of common stock outstanding during each period. Diluted net income per share includes the effect, if any, from the potential exercise or conversion of securities, such as stock options, and warrants which would result in the issuance of incremental shares of common stock.
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Income Taxes
Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.
Deferred tax assets may be reduced by a valuation allowance if, based on all available evidence, it is more likely than not that some portion or all of the deferred income tax assets will not be realized. Management judgment is required in determining the period in which a reversal of a valuation allowance should occur. The Company is required to consider all available evidence, both positive and negative, such as historical levels of income and future forecasts of taxable income among other items, in determining whether a full or partial release of its valuation allowance is required. Our accounting for deferred tax consequences represents the best estimate of those future events. The Company presents deferred income taxes on the Consolidated Balance Sheet on a jurisdictional basis as either a net noncurrent asset or liability.
The Company recognizes the effect of income tax positions only if those positions are more likely than not sustainable, based solely on its technical merits and consideration of the relevant taxing authority’s widely understood administrative practices and precedents. Recognized income tax positions are measured at the largest amount that is greater than 50% likely of being realized. Changes in recognition or measurement are reflected in the period in which a change in judgment occurs. At December 31, 2025, and 2024, the Company did not have any unrecognized uncertain tax positions. The Company’s policy is to include any interest and penalties as a component of income tax expense.
Business Combinations
Business combinations and asset acquisitions are accounted for in accordance with FASB ASC 805 Business Combinations. Refer to Note 4, Acquisitions , for a more detailed discussion of the Company’s acquisition of Zynerba and Epygenix.
Recently Adopted Accounting Pronouncements
In November 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-07, Improvements to Reportable Segment Disclosures (“ASU 2023-07”). ASU 2023-07 is intended to improve reportable segment disclosures primarily through enhanced disclosure of reportable segment expenses and requires that a public entity that has a single reportable segment provide all the disclosures required by ASU 2023-07 and all existing segment disclosures in Topic 280. This ASU was effective for annual reporting periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption was permitted. ASU 2023-07 was required to be applied retrospectively to all prior periods presented in the financial statements. The Company adopted this guidance in the fourth quarter of 2024. This pronouncement addresses disclosures only and had no impact on its consolidated financial results.
In December 2023, the FASB issued Accounting Standards Update (“ASU”) No 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures” (“ASU 2023-09”). ASU 2023-09 expands disclosures in the rate reconciliation and requires disclosure of income taxes paid by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024. Early adoption was permitted. The Company adopted this guidance in the fourth quarter of 2025 on a prospective basis. This pronouncement addresses disclosures only and had no impact on its consolidated financial results.
Recently Issued Accounting Pronouncements
In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40) . ASU 2024-03 requires disclosure, in the notes to the financial statements, of specified information about certain costs and expenses, including amounts of purchases of inventory, employee compensation, depreciation, and intangible asset amortization included in each relevant expense caption, as well as a qualitative description of amounts remaining in relevant expense captions that are not separately disaggregated quantitatively. ASU 2024-03 also requires disclosure of the total amount of selling expenses and, in annual periods, an entity’s definition of selling expenses. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and
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interim periods within fiscal years beginning after December 15, 2027. The guidance may be applied prospectively or retrospectively. Early adoption is permitted. The Company is currently evaluating the impact that ASU 2024-03 will have on its consolidated financial statements.
In September 2025, the FASB issued ASU 2025-06, Targeted Improvements to the Accounting for Internal-Use Software . ASU 2025-06 makes targeted improvements to accounting for and disclosure of software costs under ASC 350-40. This ASU is effective for all entities for annual reporting periods beginning after December 15, 2027, and interim reporting periods within those annual reporting periods. The guidance may be adopted prospectively, retrospectively, or via a modified prospective transition method. Early adoption is permitted. The Company is currently evaluating the impact that ASU 2025-06 will have on its consolidated financial statements.
4. ACQUISITION
Acquisition of Zynerba
In October 2023, the Company completed a tender offer to purchase the outstanding common stock of Zynerba (“Zynerba Common Stock”) for (i) $ 1.1059 per share of Zynerba Common Stock (the “Common Cash Amount”), plus (ii) one contingent value right (each, a “CVR”) per share of Zynerba Common Stock (the “Common CVR Amount”), which represents the right to receive up to approximately $ 2.5444 per share of Zynerba Common Stock, subject to the achievement of certain clinical, regulatory and sales-based milestones. The Common CVR Amounts are to be paid in cash, subject to any applicable withholding of taxes and without interest. The aggregate amount of consideration to acquire Zynerba Common Stock was $ 60,000 , excluding transaction-related fees of $ 2,645 and was paid by the Company using cash on hand.
The total purchase consideration for Zynerba was as follows:
Cash consideration paid to selling shareholders (i)
$
55,960
Cash consideration paid to settle Zynerba restricted stock awards ("RSAs") as stock options (ii)
4,040
Transaction costs
2,645
Total purchase consideration
$
62,645
(i) The cash consideration paid to selling shareholders was determined based on the total number of Zynerba shares tendered at closing of 50,602,656 at a per share price of $ 1.1059 .
(ii) The cash consideration paid to settle Zynerba restricted stock awards (“RSAs”) and stock options under Zynerba equity incentive plans was determined based on the total number of underlying shares of 4,000,169 at a per share price of $ 1.1059 , less exercise price for the stock options.
All consideration was paid during the year ended December 31, 2023.
The Zynerba Acquisition was accounted for as an asset acquisition under ASC Topic 805, Business Combinations, because substantially all of the fair value of the gross assets acquired was concentrated in a single identifiable IPR&D asset, ZYN002, Zynerba’s lead asset. The Company recognized the acquired assets and assumed liabilities based on the consideration paid, including transaction costs, on a relative fair value basis, and after first allocating the preliminary excess of the fair value of net assets acquired over the purchase price consideration to certain qualifying assets, principally, the IPR&D asset. The guidance in ASC Topic 730 Research and Development requires that both tangible and intangible identifiable research and development assets with no alternative future use be allocated a portion of the consideration transferred and recorded as research and development expense at the acquisition date. As a result, the Company recorded a charge of $ 2,260 related to acquired in-process research and development expense related to the ZYN002 IPR&D asset during the year ended December 31, 2023.
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The following table shows the allocation of the purchase consideration based on the relative fair value of assets acquired and liabilities assumed by the Company, after reducing the excess fair value of the IPR&D asset as described above:
Assets acquired
Cash and cash equivalents
$
25,658
Prepaid expenses and other current assets
3,540
Deferred tax asset
44,800
Restricted cash
20
Acquired in-process research and development
2,260
Total assets acquired
$
76,278
Liabilities assumed
Accounts payable
4,995
Accrued expenses and accrued compensation
8,479
Other current liabilities
159
Total liabilities assumed
$
13,633
Net assets acquired
$
62,645
In September 2025, the Company achieved a clinical milestone for ZYN002 that triggered a $ 15,000 payment, which was paid in the fourth quarter of 2025.
Acquisition of Epygenix
On April 30, 2024, the Company acquired all of the issued and outstanding capital stock of Epygenix pursuant to the terms of a stock purchase agreement. The Company paid the former stockholders of Epygenix up front consideration of $ 35,000 less a working capital adjustment. In addition, the Company will be obligated to pay up to $ 130,000 upon the achievement of development and regulatory milestones and up to $ 515,000 upon the achievement of certain sales-based milestones, in each case to Epygenix’s former stockholders. As a result, the Company now has an exclusive license relating to the use of clemizole, initially for the treatment of Dravet Syndrome and Lennox-Gastaut Syndrome.
The total purchase consideration for Epygenix was as follows:
Cash consideration paid to selling shareholders and to settle restricted stock units ("RSUs")
$
32,686
Transaction costs
450
Total purchase consideration
$
33,136
The acquisition of Epygenix was accounted for as an asset acquisition under ASC Topic 805, Business Combinations. The Company did not acquire any outputs and there was not an acquired substantive process in place to create outputs. The Company recognized the acquired assets and assumed liabilities based on the consideration paid, including transaction costs, on a relative fair value basis, and after first allocating the preliminary excess of the fair value of net assets acquired over the purchase price consideration to certain qualifying assets, principally, the IPR&D asset. In accordance with the accounting for asset acquisitions, an entity that acquires IPR&D assets in an asset acquisition follows the guidance in ASC Topic 730, Research and Development, which requires that both tangible and intangible identifiable research and development assets with no alternative future use be allocated a portion of the consideration transferred and recorded as research and development expense at the acquisition date. As a result, the Company recorded a charge of $ 17,095 related to acquired in-process research and development expense during the year ended December 31, 2024.
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The following table shows the allocation of the purchase consideration based on the relative fair value of assets acquired and liabilities assumed by the Company, after reducing the excess fair value of the IPR&D asset as described above:
Assets acquired
Acquired in-process research and development
$
17,095
Deferred tax asset
18,268
Other assets
590
Total assets acquired
$
35,953
Total liabilities assumed
$
2,817
Net assets acquired
$
33,136
5. INVESTMENTS
The carrying value and amortized cost of the Company’s available-for-sale debt securities, summarized by type of security, consisted of the following:
December 31, 2025
Amortized
Unrealized
Unrealized
Fair
Cost
Gains
Losses
Value
Short-term:
Commercial paper
$
7,558
7
—
$
7,565
Corporate debt securities
15,261
12
—
15,273
Total short-term investments
$
22,819
19
—
$
22,838
Long-term:
Commercial paper
$
805
1
—
$
806
Corporate debt securities
88,626
248
—
88,874
U.S. government securities
17,369
78
—
17,447
Total long-term investments
$
106,800
327
—
$
107,127
December 31, 2024
Amortized
Unrealized
Unrealized
Fair
Cost
Gains
Losses
Value
Short-term:
Commercial paper
$
7,670
9
( 1 )
$
7,678
Corporate debt securities
6,495
12
—
6,507
Total short-term investments
$
14,165
21
( 1 )
$
14,185
Long-term:
Corporate debt securities
86,700
192
( 142 )
86,750
U.S. government securities
22,128
11
( 15 )
22,124
Total long-term investments
$
108,828
203
( 157 )
$
108,874
The Company classifies investments with an original maturity of less than one year as current and investments with an original maturity date of greater than one year as noncurrent on its consolidated balance sheet. The investments classified as noncurrent have original maturity dates ranging from 1 - 2 years . The Company did not have any available-for-sale debt security investments in a continuous unrealized loss position of greater than 12 months as of December 31, 2025, and December 31, 2024, respectively.
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6. FAIR VALUE MEASUREMENTS
Money market funds are classified as Level 1 fair value instruments. Investments in available-for-sale debt securities are classified as Level 2 and carried at fair value, which we estimate utilizing a third-party pricing service. The pricing service utilizes industry standard valuation models whereby all significant inputs, including benchmark yields, reported trades, broker/dealer quotes, issuer spreads, bids, offers, or other market-related data, are observable. We validate valuations obtained from third-party services by obtaining market values from other pricing sources. The Company did not classify any assets or liabilities as Level 3 as of December 31, 2025, or December 31, 2024.
The Company’s assets measured at fair value consisted of the following:
December 31, 2025
December 31, 2024
Total
Level 1
Level 2
Total
Level 1
Level 2
Assets
Cash equivalents
$
225,605
225,605
—
$
303,545
303,545
—
Commercial paper
8,371
—
8,371
7,678
—
7,678
Corporate debt securities
104,147
—
104,147
93,257
—
93,257
U.S. government securities
17,447
—
17,447
22,124
—
22,124
Total
$
355,570
225,605
129,965
$
426,604
303,545
123,059
7. INVENTORY
Inventory, net consisted of the following:
As of
December 31,
December 31,
2025
2024
Raw materials
$
—
$
944
Work in process
2,885
3,489
Finished goods
2,636
2,765
Inventory, gross
5,521
7,198
Reserve for excess inventory
( 164 )
—
Total inventory, net
$
5,357
$
7,198
8. INTANGIBLE ASSETS
In August 2019, the Company received FDA approval of WAKIX ® (pitolisant) for the treatment of excessive daytime sleepiness (“EDS”) in adult patients with narcolepsy. This event triggered a milestone payment of $ 75,000 under the provisions of the 2017 LCA (defined below) which the Company capitalized as an intangible asset. The Company determined a useful life of 10 years for the intangible asset, and, as of December 31, 2025, the remaining useful life was 3.8 years.
In October 2020, the Company received FDA approval for the New Drug Application (“NDA”) for WAKIX ® for the treatment of cataplexy in adult patients with narcolepsy. This event triggered a milestone payment of $ 100,000 under the provisions of the 2017 LCA which the Company capitalized as an intangible asset and paid in January of 2021. The Company determined a useful life of 9 years for the intangible asset, and, as of December 31, 2025, the remaining useful life was 3.8 years.
In February 2022, the Company attained $ 500,000 in life-to-date aggregate net sales of WAKIX in the United States. This event triggered a final $ 40,000 payment under the provisions of the 2017 LCA which the Company capitalized as an intangible asset and paid in March of 2022. The Company determined a useful life of 7.6 years for the intangible asset, and, as of December 31, 2025, the remaining useful life was 3.8 years.
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Amortization expense was $ 23,845 for each of the years ended December 31, 2025, 2024 and 2023, respectively, and is recorded in general and administrative expenses in the consolidated statements of operations and comprehensive income (loss).
Future annual amortization expense for the unamortized intangible assets is as follows:
Years ending December 31,
2026
$
23,845
2027
23,845
2028
23,845
2029
17,883
2030
—
Thereafter
—
Total
$
89,418
The gross carrying amount and net book value of the intangible asset is as follows:
As of
December 31,
December 31,
2025
2024
Gross Carrying Amount
$
215,000
$
215,000
Accumulated Amortization
( 125,582 )
( 101,737 )
Net Book Value
$
89,418
$
113,263
9. LICENSE AGREEMENTS AND ASSET PURCHASE AGREEMENTS
Bioprojet Agreements
In July 2017, Harmony entered into a License Agreement (the “2017 LCA”) with Bioprojet Société Civile de Recherche (“Bioprojet”) whereby Harmony acquired the exclusive right to commercialize the pharmaceutical compound pitolisant for the treatment, and/or prevention, of narcolepsy, obstructive sleep apnea, idiopathic hypersomnia, and Parkinson’s disease as well as any other indications unanimously agreed by the parties in the United States and its territories. A milestone payment of $ 50,000 was due upon acceptance by the FDA of pitolisant’s NDA, which was achieved in February 2019 and was expensed within research and development for the year ended December 31, 2019. A milestone payment of $ 77,000 , which included a $ 2,000 fee that is described below, was due upon FDA approval of WAKIX (pitolisant) for treatment of EDS in adult patients with narcolepsy, which was achieved in August 2019. The $ 2,000 payment and $ 75,000 milestone payment were paid in August and November 2019, respectively. In addition, a milestone payment of $ 102,000 , which included a $ 2,000 fee was due upon the FDA approval of the NDA for WAKIX for the treatment of cataplexy in adult patients with narcolepsy. The $ 2,000 payment was paid in October 2020, and a $ 100,000 milestone payment was paid in January 2021. A final $ 40,000 milestone payment was paid to Bioprojet in March 2022 upon WAKIX attaining $ 500,000 in aggregate net sales in the United States. The 2017 LCA also requires a fixed trademark royalty and a tiered royalty based on net sales, which is payable to Bioprojet on a quarterly basis. The Company incurred $ 188,482 , $ 146,978 and $ 111,685 for the years ended December 31, 2025, 2024 and 2023, respectively, for sales-based, trademark and tiered royalties recognized as cost of product sold. As of December 31, 2025, and 2024, the Company had accrued $ 65,819 and $ 51,746 , respectively, for sales-based, trademark and tiered royalties.
In July 2022, Harmony entered into the 2022 LCA with Bioprojet whereby Harmony obtained exclusive rights to manufacture, use and commercialize one or more new products based on pitolisant in the United States and Latin America, with the potential to add additional indications and formulations upon agreement of both parties. Harmony paid an initial, non-refundable $ 30,000 licensing fee in October 2022 and additional payments of up to $ 155,000 are potentially due under the 2022 LCA upon the achievement of certain future development and sales-based milestones. In addition, there are other payments due upon achievement of development milestones for new indications and formulations as agreed upon by both parties. The 2022 LCA also requires a fixed trademark royalty and a tiered royalty based on net sales upon commercialization, which will be payable to Bioprojet on a quarterly basis.
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In April 2024, the Company announced that it entered into the Sublicense agreement with Bioprojet for an orexin-2 receptor agonist (OX2R), BP1.15205, to be evaluated for the treatment of narcolepsy and other potential indications (the “Sublicense”). Under the Sublicense, the Company obtained the exclusive right to develop, manufacture and commercialize BP1.15205 in the United States and Latin American territories (the “Licensed Territories”), which are rights that Bioprojet originally licensed from Teijin Pharma, the innovator of BP1.15205. BP1.15205 is currently in pre-clinical development with a Clinical Trial Application currently anticipated in mid-2025. Under the Sublicense, the Company paid Bioprojet an upfront license fee of $ 25,500 , which the Company recognized as an IPR&D charge recorded in research and development within the consolidated statements of operations and comprehensive income for the year ended December 31, 2024. In November 2025, the Company achieved a clinical milestone for BP1.15205 that triggered a $ 4,250 payment to Bioprojet under the Sublicense, which was paid in December 2025. The Company will also be obligated to pay up to $ 123,250 upon achievement of development and regulatory milestones and up to $ 240,000 upon achievement of sales-based milestones, as well as royalty rates in the mid-teens on any sales of product using the Licensed Compound in the Licensed Territories.
ConSynance Agreement
In August 2021, the Company entered into an asset purchase agreement with ConSynance Therapeutics, Inc. (the “APA”) to acquire HBS-102 (formerly referred to as “CSTI-100”), a potential first-in-class molecule with a novel mechanism of action. Under the terms of the APA, the Company acquired full development and commercialization rights globally, with the exception of Greater China, for $ 3,500 . The Company accounted for the transaction as an asset acquisition as substantially all of the fair value of the assets acquired was concentrated in a single identified asset. In March 2023, the Company achieved a preclinical milestone, which triggered a $ 750 payment under the provisions of the APA, which the Company recognized as an IPR&D charge recorded in research and development within the consolidated statement of operations and comprehensive income for the year ended December 31, 2023. In September 2024, the Company achieved a milestone for preclinical proof-of-concept, which triggered a $ 1,000 payment under the provisions of the APA, which the Company recognized as an IPR&D charge recorded in research and development within the consolidated statement of operations and comprehensive income for the year ended December 31, 2024. There are additional payments due under the APA upon the achievement of certain milestones including $ 19,000 for development milestones, $ 44,000 for regulatory milestones and $ 110,000 for sales milestones .
CiRC Agreement
In June 2025, the Company entered into a research collaboration, option and license agreement (the “CiRC Agreement”) with a related party, CiRC Biosciences, Inc. (“CiRC”). Under this agreement, the Company and CiRC will collaborate on the research and development of two discovery-stage candidates (together the “Candidates”) using cell replacement therapy for treatment of refractory epilepsies and treatment-resistant narcolepsy. In connection with the CiRC Agreement, the Company paid CiRC an upfront fee of $ 15,000 , which was recognized as an IPR&D charge recorded in research and development within the condensed consolidated statements of operations and comprehensive income for the year ended December 31, 2025. The Company will also be obligated to pay $ 2,000 to CiRC upon the achievement of certain research milestones for each of the Candidates. In addition, the Company has an option to obtain an exclusive license for each of the Candidates that would grant the Company global rights to develop, manufacture and commercialize each Candidate. Upon exercise of each option, the Company would be obligated to pay an option exercise fee of $ 8,000 , or $ 16,000 in the aggregate if the options related to both Candidates were to be exercised, and the Company would be obligated upon achievement to pay future development, regulatory and sales-based milestones, as well as royalties on sales of any product derived from the Candidates. Refer to Note 20, Related-Party Transactions , for further discussion of related party considerations for the CiRC Agreement.
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10. ACCRUED EXPENSES
Accrued expenses included the following:
As of
December 31,
December 31,
2025
2024
Royalties due to Bioprojet
$
65,819
$
51,746
Rebates and other sales deductions
76,304
50,542
Interest
2,151
2,834
Sales and marketing
3,153
2,166
Research and development
12,193
9,014
Accrued legal and professional fees
29,999
3,047
Other expenses
1,420
1,291
$
191,039
$
120,640
11. DEBT
Credit Agreements
Term Loan A Credit Agreement
On July 26, 2023, the Company entered into a Credit Agreement (the “TLA Credit Agreement”) with JPMorgan Chase Bank, N.A., as “Administrative Agent”, and certain lenders. The TLA Credit Agreement provides for a five-year senior secured term loan (the “TLA Term Loan”) in an aggregate principal amount of $ 185,000 .
On September 21, 2023, the Company entered into the First Incremental Amendment (the “First Incremental Amendment”) with the Administrative Agent and Bank of America, N.A., as incremental lender. The First Incremental Amendment provides for an incremental senior secured term loan (the “Incremental Term Loan”) in an aggregate principal amount of $ 15,000 . The First Incremental Amendment amends the TLA Credit Agreement and provides that the Incremental Term Loan will have identical terms as the TLA Term Loan.
The repayment schedule for both the TLA Term Loan and the Incremental Term Loan (together, the “Term Loans”) consists of quarterly $ 3,750 principal payments, which commence on December 31, 2023, increasing to quarterly $ 5,000 principal payments beginning on December 31, 2025, with a $ 115,000 payment due on the maturity date of July 26, 2028. The Term Loans bear interest at a per annum rate equal to, at the Company’s option, (i) a base rate plus a specified margin ranging from 2.50 % to 3.00 %, based on the Company’s senior secured net leverage ratio (as defined in the TLA Credit Agreement) or (ii) Term SOFR plus a credit spread adjustment of 0.10 % plus a specified margin ranging from 3.50 % to 4.00 %, based on the Company’s senior secured net leverage ratio.
The net cash received related to the Term Loans as a result of the transactions, less debt issuance costs of $ 2,997 , was $ 197,003 . The debt issuance costs related to the Term Loans will be amortized as additional interest expense over the loan term of the TLA Credit Agreement. The fair value of the Term Loans as of December 31, 2025, was $ 163,393 .
Blackstone Credit Agreement
In August 2021, the Company entered into the Blackstone Credit Agreement that provides for (i) a senior secured term loan facility in an aggregate original principal amount of $ 200,000 (the “Initial Term Loan”) and (ii) a senior secured delayed draw term loan facility in an aggregate principal amount up to $ 100,000 (the “DDTL” and, together with the Initial Term Loan, the “Loans”). The DDTL was initially available to draw down through August 9, 2022. In August 2022, the Company entered into an agreement to extend the expiration date of the DDTL to August 9, 2023.
Net cash received from the Initial Term Loan was $ 191,849 , net of debt issuance costs of $ 8,151 . In addition, the Company paid $ 1,000 in debt issuance costs relating to the DDTL, which was initially recorded in other current assets within the consolidated balance sheet for the year ended December 31, 2021.
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In connection with the TLA Credit Agreement, the Company extinguished the Blackstone Credit Agreement, which required a payoff amount of $ 207,308 consisting of principal repayment, interest, exit fees, Ticking Fee and a prepayment premium. The Company recognized a loss on extinguishment of debt of $ 9,766 relating to the Blackstone Credit Agreement within the Company’s consolidated statements of operation and comprehensive income for the year ended December 31, 2023. In addition, the Company recognized $ 1,972 relating to unamortized debt issuance costs relating to the DDTL and the Ticking Fee, which was recorded in interest expense, net within the consolidated statement of operations and comprehensive income for the year ended December 31, 2023.
Long-term debt, net consists of the following:
December 31,
December 31,
2025
2024
Principal amount
$
165,000
$
181,250
Unamortized debt discount associated with debt financing costs
( 1,337 )
( 1,984 )
Total debt, net
163,663
179,266
Less current portion
( 20,000 )
( 16,250 )
Long-term debt, net
$
143,663
$
163,016
Future minimum payments relating to long-term debt, net as of December 31, 2025, for the periods indicated below consists of the following:
Years ending December 31,
2026
$
20,000
2027
20,000
2028
125,000
2029
—
2030
—
Thereafter
—
Total
$
165,000
Interest expense related to the Company’s long-term debt, net, is included in interest expense in the consolidated statements of operations and comprehensive income (loss) and consists of the following:
Year Ended
December 31,
2025
2024
2023
Interest on principal balance
$
14,002
$
16,796
$
20,511
Amortization of deferred financing costs
647
700
3,246
Total term loan interest expense
$
14,649
$
17,496
$
23,757
12. LEASES
Beginning in June 2018, the Company was party to an operating lease and subsequent amendments for three office suites of approximately fifteen thousand square feet, seven thousand square feet and thirteen thousand square feet in Plymouth Meeting, PA, which was set to expire in November 2025. In November 2025, t he Company entered into a new operating lease amendment (the “PM Lease Amendment”) extending the lease through March 31, 2031. The terms of the PM Lease Amendment provide for fixed rental payments on a monthly basis and on a graduated scale. Additionally, the terms of the PM Lease Amendment also provide the Company with an option to extend the lease for two additional five-year periods and an option to early terminate the lease effective on the forty-first month, which were not considered in the determination of the operating lease right-of-use asset (“ROU asset”) or operating lease liability as neither option is reasonably certain to be exercised by the Company.
The Company also leases a fleet of automobiles that are used by its sales representatives and are classified as operating leases.
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As the rate implicit in the lease is not readily determinable, the Company’s operating lease right-of-use assets and operating lease liabilities are recognized based on the present value of the future lease payments using the Company’s incremental borrowing rate, defined as the rate of interest that it would have to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. As a policy election, leases with an initial term of 12 months or less are not recorded on the balance sheet. The Company’s leases have remaining lease terms of less than 1 year to approximately 5 years , some of which may include the option to extend or terminate the leases.
The Company recorded operating lease costs of $ 1,971 , $ 2,099 and $ 1,811 for the years ended December 31, 2025, 2024 and 2023, respectively.
As of December 31, 2025, the weighted-average remaining lease term for operating leases was 4.6 years and the weighted-average discount rate for operating leases was 7.6 %.
Supplemental balance sheet information related to operating leases was as follows:
Leases
Classification
December 31, 2025
December 31, 2024
Assets
Operating lease right-of-use assets
Other noncurrent assets
$
5,344
$
2,122
Liabilities
Operating lease liability, current portion
Other current liabilities
$
1,073
$
1,318
Operating lease liability, long-term
Other long-term liabilities
4,512
822
Total operating lease liabilities
$
5,585
$
2,140
Supplemental cash flow information related to operating leases was as follows:
December 31, 2025
December 31, 2024
December 31, 2023
Operating cash flows from operating leases
$
1,995
$
2,156
$
2,016
Right of use assets obtained in exchange for operating lease obligations
$
4,795
$
1,877
$
2,163
Future payments under non-cancelable operating leases with initial terms of one year or more as of December 31, 2025, consisted of the following:
Years ending December 31,
2026
$
1,447
2027
1,307
2028
1,229
2029
1,180
2030
1,215
Thereafter
311
Total lease payments
6,689
Less: imputed interest
( 1,104 )
Total lease liabilities
$
5,585
13. COMMITMENTS AND CONTINGENCIES
Legal Proceedings
From time to time, the Company is subject to claims and suits arising in the ordinary course of business. The Company accrues such liabilities when they are known, if they are deemed probable and can be reasonably estimated. Accruals may be adjusted from time to time, as appropriate, in light of new information. The amount of loss incurred in relation to matters for which an accrual has been established may be higher or lower than the amounts accrued. Any expenses, fines, fees, penalties, judgments or settlements that might be incurred by the Company in connection with
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proceedings could have a material adverse effect on the Company’s results of operations and financial condition. As of December 31, 2025, there were no material claims or lawsuits outstanding other than the Abbreviated New Drug Application (“ANDA”) litigation discussed below .
ANDA Litigation
In September 2023, the Company and its licensor, Bioprojet, received notice from Lupin Limited (“Lupin”) pursuant to 21 U.S.C. § 355(j) et seq. and 21 C.F.R. § 314.95 et seq. (the “Lupin Notice Letter”) that Lupin has submitted ANDA No. 218846 (the “Lupin ANDA”) to the FDA and is seeking regulatory approval to market a generic version of WAKIX ® before the expiration of U.S. Patent Nos. 8,486,947 (“’947 patent”) and 8,207,197 (“’197 patent”). The ’947 patent and the ‘197 patent are listed with respect to WAKIX ® in the FDA’s Orange Book and will expire in September 2029 and March 2030, respectively. The Lupin Notice Letter asserts that their generic product will not infringe the ’947 patent and the ‘197 patent and/or that the ’947 patent and the ‘197 patent are invalid or unenforceable. In November 2023, we, Bioprojet and Bioprojet’s wholly owned subsidiary, Bioprojet Pharma SAS (“Bioprojet Pharma”), filed a complaint for patent infringement of the ’947 patent and the ‘197 patent against Lupin and certain of their affiliates and agents in the United States District Court for the District of Delaware in response to the filing of their respective ANDAs with the FDA. In December 2024, the Company and Bioprojet received further notice from Lupin pursuant to 21 U.S.C. § 355(j) et seq. and 21 C.F.R. § 314.95 et seq . (the “Second Lupin Notice Letter”) that Lupin has submitted the Lupin ANDA to the FDA and is seeking regulatory approval to market a generic version of WAKIX ® before the expiration of the ‘947 patent and the ‘197 patent. The Second Lupin Notice Letter asserts that its generic product will not infringe the ’947 patent and the ‘197 patent and/or that the ’947 patent and the ‘197 patent are invalid or unenforceable. In January 2025, we, Bioprojet and Bioprojet Pharma filed a complaint in the United States District Court for the District of Delaware for patent infringement of the ’947 patent and the ‘197 patent against Lupin. I n June 2025, the Company reached an agreement with Lupin to resolve the dispute over Lupin’s ANDA to market a generic version of WAKIX. Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of Delaware will be dismissed, and Lupin will have a license to sell its generic product beginning July 2030 if WAKIX receives pediatric exclusivity, or earlier under certain circumstances
In September 2023, the Company and Bioprojet received notice from Novugen Pharma Sdn. Bhd. (“Novugen”) pursuant to 21 U.S.C. § 355(j) et seq. and 21 C.F.R. § 314.95 et seq. (the “Novugen Notice Letter”) that Novugen had submitted ANDA No. 218834 (the “Novugen ANDA”) to the FDA and is seeking regulatory approval to market a generic version of WAKIX ® before the expiration of the ’947 patent and ’197 patent. The Novugen Notice Letter asserts that their generic product will not infringe the ’947 patent and the ‘197 patent and/or that the ’947 patent and the ‘197 patent are invalid or unenforceable. In November 2023, we, Bioprojet and Bioprojet’s wholly owned subsidiary, Bioprojet Pharma SAS (“Bioprojet Pharma”), filed a complaint for patent infringement of the ’947 patent and the ‘197 patent against Novugen and certain of their affiliates and agents in the United States District Court for the District of Delaware in response to the filing of their respective ANDAs with the FDA. In October 2024, the Company reached an agreement with Novugen Pharma to resolve the dispute over Novugen’s ANDA for a generic pitolisant hydrochloride product. Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of Delaware was ended on November 4, 2024, and Novugen will have a license to sell its generic product beginning July 2030 if WAKIX receives pediatric exclusivity, or earlier under certain circumstances.
In October 2023, the Company and Bioprojet received notice from Novitium Pharma LLC (“Novitium”), pursuant to 21 U.S.C. § 355(j) et seq. and 21 C.F.R. § 314.95 et seq. (the “Novitium Notice Letter”), that Novitium has submitted ANDA No. 218495 (the “Novitium ANDA”) to the FDA and is seeking regulatory approval to market a generic version of WAKIX ® before the expiration of U.S. Patent No. 8,354,430 (the “’430 patent”), which is also listed with respect to WAKIX ® in the FDA’s Orange Book and will expire in February 2026. The Novitium Notice Letter asserts that its generic product will not infringe the ‘430 patent, ’947 patent and the ‘197 patent and/or that the ‘430 patent, ’947 patent and the ‘197 patent are invalid or unenforceable. In November 2023, the Company, Bioprojet and Bioprojet Pharma filed a complaint for patent infringement of the ’947 patent and the ‘197 patent against Novitium and certain of their affiliates and agents and for patent infringement of the ’430 patent against Novitium and certain of their affiliates and agents in the United States District Court for the District of Delaware in response to their filing of their respective ANDAs with the FDA. In January 2026, the Company reached an agreement with Novitium to resolve the dispute over Novitium’s ANDA to market a generic version of WAKIX. Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of Delaware will be dismissed, and Novitium will have a license to sell its generic product beginning July 2030 if WAKIX receives pediatric exclusivity, or earlier under certain circumstances .
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In October 2023, the Company and Bioprojet received notice from Zenara Pharma Pvt. Ltd. (“Zenara”), pursuant to 21 U.S.C. § 355(j) et seq. and 21 C.F.R. § 314.95 et seq. (the “Zenara Notice Letter”), that Zenara has submitted ANDA No. 218796 (the “Zenara ANDA”) to the FDA and is seeking regulatory approval to market a generic version of WAKIX ® before the expiration of the ’430 patent, ’947 patent and the ’197 patent. The Zenara Notice Letter asserts that its generic product will not infringe the ‘430 patent, ’947 patent and the ‘197 patent and/or that the ‘430 patent, ’947 patent and the ‘197 patent are invalid or unenforceable. In November 2023, the Company, Bioprojet and Bioprojet Pharma filed a complaint for patent infringement of the ’947 patent and the ‘197 patent against Zenara and certain of their affiliates and agents and for patent infringement of the ’430 patent against Zenara and certain of their affiliates and agents in the United States District Court for the District of Delaware in response to their filing of their respective ANDAs with the FDA. In January 2026, the Company reached an agreement with Hikma (to whom Zenara transferred its ANDA) to resolve the dispute over Hikma’s ANDA to market a generic version of WAKIX. Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of Delaware will be dismissed, and Hikma will have a license to sell its generic product beginning March 2030 if WAKIX receives pediatric exclusivity, or earlier under certain circumstances.
In October 2023, the Company and Bioprojet received notice from AET Pharma US, Inc. (“AET”), pursuant to 21 U.S.C. § 355(j) et seq. and 21 C.F.R. § 314.95 et seq. (the “AET Notice Letter”), that AET has submitted ANDA No. 218892 (the “AET ANDA”) to the FDA and is seeking regulatory approval to market a generic version of WAKIX ® before the expiration of the ’947 patent and the ’197 patent. AET’s Notice Letter asserts that AET’s generic product will not infringe the ’947 patent and the ‘197 patent and/or that ’947 patent and the ‘197 patent are invalid or unenforceable. In November 2023, the Company, Bioprojet and Bioprojet Pharma filed a complaint for patent infringement of the ’947 patent and the ‘197 patent against AET and certain of their affiliates and agents in the United States District Court for the District of Delaware in response to their filing of their respective ANDAs with the FDA. In August 2024, the Company and Bioprojet received further notice from AET pursuant to 21 U.S.C. § 355(j) et seq. and 21 C.F.R. § 314.95 et seq . (the “Second AET Notice Letter”) that AET has submitted the AET ANDA to the FDA and is seeking regulatory approval to market a generic version of WAKIX ® before the expiration of the ‘947 patent and the ‘197 patent. The Second AET Notice Letter asserts that its generic product will not infringe the ’947 patent and the ‘197 patent and/or that the ’947 patent and the ‘197 patent are invalid or unenforceable. In August 2024, we, Bioprojet and Bioprojet Pharma filed a complaint in the United States District Court for the District of Delaware for patent infringement of the ’947 patent and the ‘197 patent against AET.
In October 2023, the Company and Bioprojet received notice from Annora Pharma Private Limited (“Annora”), pursuant to 21 U.S.C. § 355(j) et seq. and 21 C.F.R. § 314.95 et seq. (the “Annora Notice Letter”), that Annora has submitted ANDA No. 218832 (the “Annora ANDA”) to the FDA and is seeking regulatory approval to market a generic version of WAKIX ® before the expiration of the ’430 patent, the ’947 patent and the ’197 patent. The Annora Notice Letter asserts that its generic product will not infringe the ‘430 patent, ’947 patent and the ‘197 patent and/or that the ‘430 patent, ’947 patent and the ‘197 patent are invalid or unenforceable. In November 2023, the Company, Bioprojet and Bioprojet Pharma filed a complaint for patent infringement of the ’947 patent and the ‘197 patent against Annora and certain of their affiliates and agents and for patent infringement of the ’430 patent against Annora and certain of their affiliates and agents in the United States District Court for the District of Delaware in response to their filing of their respective ANDAs with the FDA. In March 2025, the Company reached an agreement with Annora to resolve the dispute over Annora’s ANDA for a generic pitolisant hydrochloride product. Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of Delaware was ended on March 31, 2025, and Annora will have a license to sell its generic product beginning July 2030 if WAKIX receives pediatric exclusivity, or earlier under certain circumstances.
In October 2023, MSN Pharmaceuticals Inc. (“MSN Pharma”) sent correspondence to the Company and Bioprojet stating that MSN Pharma has submitted ANDA No. 218873 (the “MSN ANDA”) to the FDA and is seeking regulatory approval to market a generic version of WAKIX ® . In December 2023, MSN Laboratories Private Limited (“MSN”) filed a declaratory judgment action in the United States District Court for the Eastern District of Virginia against Bioprojet claiming that the ‘430 patent, the ’947 patent and the ‘197 patent will not be infringed by MSN’s generic version of WAKIX ® and that the ‘947 patent is invalid. In December 2023, we, Bioprojet and Bioprojet Pharma filed a complaint in the United States District Court for the District of Delaware for patent infringement of the ‘430 patent, the ’947 patent and the ‘197 patent against MSN and MSN Pharma. In January 2024, the declaratory judgment action was transferred from the United States District Court for the Eastern District of Virginia to the United States District Court for the District of Delaware. In January 2026, the Company reached an agreement with MSN to resolve the dispute over MSN’s ANDA to market a generic version of WAKIX. Under the terms of the settlement agreement, the litigation between the parties in the United States District Court for the District of Delaware will be dismissed. The remaining terms of the settlement agreement remain confidential.
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In April 2024, the United States District Court for the District of Delaware issued a scheduling order consolidating the cases described above for all purposes up to and including trial (the “Scheduling Order”). The Scheduling Order set March 27, 2025, as the date for the hearing on claim construction and scheduled a bench trial that began on February 17, 2026, and concluded on February 19, 2026. A post-trial briefing schedule and closing arguments are to be scheduled at a later date.
Settlement amounts associated with ANDA litigation have been recognized in general and administrative expenses on the Company’s consolidated statements of operation and comprehensive income for the year ended December 31, 2025. Unpaid settlements as of December 31, 2025, have been recognized in accrued expenses on the Company’s consolidated balance sheets as of December 31, 2025.
The resolution of any ANDA litigation matters against the Company could have a significant negative effect on the Company’s results of operations.
14. STOCKHOLDERS’ EQUITY
Common Stock
The holders of common stock are entitled to one vote for each share held on all matters submitted to a vote of the Company’s stockholders. The holders of common stock do not have any cumulative voting rights. Holders of common stock are entitled to receive ratably any dividends declared by the Company’s board of directors out of funds legally available for that purpose, subject to any preferential dividend rights of any outstanding preferred stock. The Company’s common stock has no preemptive rights, conversion rights or other subscription rights or redemption or sinking fund provisions.
Share Repurchase Program
In August 2023, the Company’s Board of Directors approved a program providing for the repurchase of shares of common stock in an aggregate amount of up to $ 125,000 , excluding commissions and transaction fees (the “August 2023 Repurchase Program”). During the year ended December 31, 2023, the Company repurchased and retired 1,439,792 shares of common stock at an aggregate cost of $ 50,000 under the August 2023 Repurchase Program, excluding commissions and transaction fees.
In October 2023, the Company’s Board of Directors terminated the August 2023 Repurchase Program and any remaining amount authorized for the repurchase of shares and simultaneously approved a new share repurchase program (the “October 2023 Repurchase Program”) providing for the repurchase of shares of common stock in an aggregate amount of up to $ 200,000 , excluding commissions and transaction fees. The October 2023 Repurchase Program may be suspended, terminated, or modified at any time for any reason. During the years ended December 31, 2025, and 2024, the Company repurchased no shares of common stock. During the year ended December 31, 2023, the Company repurchases and retired 1,814,653 shares of common stock at an aggregate cost of $ 50,000 under the October 2023 Repurchase Program, excluding commissions and transaction fees. As of December 31, 2025, the remaining amount of common stock authorized for repurchase was $ 150,000 .
15. STOCK INCENTIVE PLAN AND STOCK-BASED COMPENSATION
2020 Stock Incentive Plan
In August 2020, the Company adopted, and its stockholders approved, the 2020 Incentive Award Plan (the “2020 Plan”), in order to facilitate the grant of cash and equity incentives to directors, employees (including the Company’s named executive officers) and consultants of the Company and its subsidiaries. The 2020 Plan provides for the grant of stock options, including incentive stock options (“ISOs”) and non-qualified stock options (“NSOs”), stock appreciation rights (“SARs”), restricted stock, dividend equivalents, restricted stock units (“RSUs”) and other stock or cash-based awards.
Stock options and stock appreciation rights under the 2020 Plan have a 10-year contractual term and vest over the vesting period specified in the applicable award agreement, at achievement of a performance requirement, or upon change of control (as defined in the applicable plan). RSUs vest over the vesting period specified in the applicable award agreement, at achievement of a performance requirement, or upon change of control (as defined in the applicable plan). As of December
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31, 2025, there were 8,704,203 shares of common stock available for issuance under the 2020 Plan. The number of shares that may be issued under the 2020 Plan will automatically increase on January 1 of each year in an amount equal to the lesser of (i) 4.0 % of the shares of the Company’s common stock outstanding on December 31 of the preceding year or (ii) an amount determined by the Company’s board of directors.
2017 Stock Incentive Plan
In August 2017, the Company adopted an equity incentive plan (the “2017 Plan”). Under the 2017 Plan, directors, officers, employees, consultants, and advisors of the Company can be paid incentive compensation measured by the value of the Company’s common shares through grants of stock options, SARs, or restricted stock. Following the adoption of the 2020 Plan, no further grants have been, or will be, made under the 2017 Plan. However, the 2017 Plan will continue to govern the terms and conditions of outstanding awards granted under it.
Stock Options
The following table summarizes stock option activity for the year ended December 31, 2025:
Weighted-
Weighted-
Average
Average
Remaining
Aggregate
Number of
Exercise
Contractual
Intrinsic
Awards
Price
Term
Value ($000's)
Awards outstanding—December 31, 2024
7,157,235
$
32.48
6.7
Awards issued
1,427,931
$
36.13
Awards exercised
( 439,606 )
$
22.01
Awards forfeited
( 283,635 )
$
36.95
Awards outstanding—December 31, 2025
7,861,925
$
33.56
6.3
$
51,952
Awards exercisable—December 31, 2025
5,624,889
$
32.86
5.4
$
44,826
Awards unvested—December 31, 2025
2,237,036
$
35.34
8.6
$
7,126
The weighted-average grant-date fair values of stock options granted during the years ended December 31, 2025, and 2024, were $ 24.08 and $ 20.68 , respectively. The total intrinsic value of stock options exercised for the years ended December 31, 2025, and 2024, were $ 6,439 and $ 4,328 , respectively.
Stock Appreciation Rights
The following table summarizes SARs activity for the year ended December 31, 2025:
Weighted-
Weighted-
Average
Average
Remaining
Aggregate
Number of
Exercise
Contractual
Intrinsic
Awards
Price
Term
Value ($000's)
Awards outstanding—December 31, 2024
43,208
$
9.38
4.3
Awards issued
—
$
—
Awards exercised
( 9,737 )
$
11.66
Awards forfeited
—
$
—
Awards outstanding—December 31, 2025
33,471
$
8.72
3.2
$
692
Awards exercisable—December 31, 2025
33,471
$
8.72
3.2
$
692
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Restricted Stock Units
The following table summarizes RSU activity for the year ended December 31, 2025:
Weighted-
Average
Number of
Grant Date
Awards
Fair Value
Awards outstanding—December 31, 2024
638,900
$
30.90
Awards issued
458,650
$
37.61
Awards vested
( 215,795 )
$
30.99
Awards forfeited
( 85,257 )
$
33.39
Awards outstanding—December 31, 2025
796,498
$
34.47
Value of Stock Options and SARs
The Company values options and SARs using the Black-Scholes option-pricing model. The Company lacks sufficient historical company-specific volatility information. Therefore, the Company estimates expected stock volatility based on historical volatility of peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. For options with service-based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. For SARs, the expected term is based upon the weighting of certain future events. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for the time periods approximately equal to the expected term of the award. An expected dividend yield of 0 % is based on the fact that the Company has never paid cash dividends and does not expect to do so in the foreseeable future.
The assumptions used to value the awards are summarized in the following table.
Year Ended December 31
2025
2024
2023
Dividend yield
0.00
%
0.00
%
0.00
%
Expected volatility
69.03 - 71.43
%
69.84 - 72.98
%
74.87 - 80.78
%
Risk-free interest rate
3.72 - 4.44
%
3.51 - 4.65
%
3.42 - 4.62
%
Lack of marketability discount
0.00
%
0.00
%
0.00
%
Expected term (years)
1.4 - 6.1
1.8 - 6.1
2.3 - 10.8
Value of RSUs
The fair value of RSUs is equal to the value of the Company’s common stock on the grant date.
The weighted average per share fair value of awards issued under the 2017 Plan and the 2020 Plan was $ 37.61 , $ 30.62 and $ 31.78 in 2025, 2024 and 2023, respectively.
Stock-Based Compensation Expense
Stock-based compensation expense was $ 44,960 , $ 42,701 and $ 31,206 for the years ended December 31, 2025, 2024 and 2023, respectively, and is recorded in the consolidated statements of operations and comprehensive income (loss) in the following line items:
Year Ended December 31,
2025
2024
2023
Research and development expense
$
8,958
$
6,682
$
3,962
Sales and marketing expense
7,376
7,435
5,148
General and administrative expense
28,626
28,584
22,096
$
44,960
$
42,701
$
31,206
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Stock-based compensation expense, net related to options and RSUs issued under the 2017 Plan and 2020 Plan and the employee stock purchase plan is included in stockholder’s equity, and a liability for S AR s is included in other non-current liabilities, in the Company’s consolidated balance sheet. As of December 31, 2025, the total unrecognized stock-based compensation expense was $ 43,697 and $ 20,446 for stock options and RSUs, respectively. These amounts will be recognized in the Company’s consolidated statement of operations over a weighted average period of 2.4 years and 2.6 years for stock options and RSU’s, respectively.
Employee Stock Purchase Plan
The 2021 Employee Stock Purchase Plan (“ESPP”) was adopted by the Company’s Board of Directors in April 2021. The ESPP permits eligible employees to purchase shares of the Company’s common stock at a 15 % discount from the lesser of the fair market value per share of the Company’s common stock on the first day of the offering period or the fair market value of the Company’s common stock on the purchase date. Funds are collected from employees through after-tax payroll deductions. The total number of shares reserved for issuance under the ESPP was initially 629,805 , which will automatically increase on January 1 of each year in an amount equal to the lesser of (i) 1.0 % of the shares of the Company’s common stock outstanding on December 31 of the preceding year or (ii) an amount determined by the Company’s board of directors. It is intended that the ESPP meet the requirements for an “employee stock purchase plan” under Section 423 of the Internal Revenue Code. For the years ended December 31, 2025, 2024 and 2023, there were 25,856 , 23,121 and 21,313 shares issued under the ESPP, respectively. The discount on the ESPP was $ 281 , $ 298 and $ 393 for the years ended December 31, 2025, 2024 and 2023, respectively, and is recorded within stock-based compensation expense.
16. SEGMENT INFORMATION
The Company has one reportable segment: rare neurological diseases. The rare neurological diseases segment consists of the Company’s commercial product, WAKIX, and its potential product candidates, that focus on patients living with rare neurological diseases who have unmet needs. The Company currently derives all of its revenue from sales of WAKIX, which is used in the treatment of EDS and cataplexy in adult patients with narcolepsy and the treatment of EDS in pediatric patients six years and older with narcolepsy and manages its business activities on a consolidated basis.
The accounting policies of the rare neurological diseases segment are consistent with those described in Note 3, Summary of Significant Accounting Policies , and the measure of segment assets is reported on the consolidated balance sheets as total assets. The Company’s CODM is the chief executive officer. The CODM assesses performance of the rare neurological diseases segment using net income as reported in the consolidated statements of operations and comprehensive income. Net income is assessed by the CODM to make decisions on how to allocate resources, such as reinvesting profits into the rare neurological diseases segment or pursuing potential investing activities.
The following table summarizes segment revenue and significant segment expenses for the years ended December 31, 2025, 2024 and 2023:
Year Ended December 31,
2025
2024
2023
Net product revenue
$
868,453
$
714,734
$
582,022
Less:
Cost of product sold (a)
198,315
156,788
121,232
Research and development (b)
144,923
95,548
69,091
Sales and marketing (c)
112,136
103,481
92,256
General and administrative (d)
100,065
57,683
48,838
Depreciation and amortization
25,335
24,112
24,359
Stock-based compensation
44,960
42,701
31,206
Interest expense
14,649
17,496
23,757
Interest income
( 21,924 )
( 18,542 )
( 14,730 )
Income tax expense
56,377
46,311
44,543
Other segment items (e)
34,930
43,663
12,617
Consolidated net income
$
158,687
$
145,493
$
128,853
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(a) Cost of product sold excluding depreciation.
(b) Research and development excluding stock-based compensation, IPR&D and impairment of long-lived assets.
(c) Sales and marketing excluding stock-based compensation.
(d) General and administrative excluding stock-based compensation and amortization.
(e) Other segment items include other expense (income), net, IPR&D charges and charges related to the extinguishment of debt.
17. EARNINGS PER SHARE
Basic earnings per share is calculated by diving net income by the weighted average number of shares of common stock outstanding. For the years ended December 31, 2025, 2024 and 2023, respectively, the Company calculated Diluted net income per common share is computed under the treasury stock method by using the weighted average number of shares of common stock outstanding, plus, for periods with net income attributable to common stockholders, the potential dilutive effects of stock options, stock appreciation rights and restricted stock units.
The following table sets forth the computation of basic and diluted net income (loss) per share:
Year Ended December 31,
2025
2024
2023
Numerator
Net income
$
158,687
$
145,493
$
128,853
Denominator
Net income per share of common stock - basic
$
2.76
$
2.56
$
2.17
Net income per share of common stock- diluted
$
2.71
$
2.51
$
2.13
Weighted average number of shares of common stock - basic
57,492,277
56,885,455
59,469,648
Weighted average number of shares of common stock - diluted
58,544,570
57,869,915
60,372,397
Securities outstanding that were included in the computation above, utilizing the treasury stock method are as follows:
Year Ended December 31,
2025
2024
2023
Stock options, SARs, and RSUs to purchase common stock
1,052,293
984,460
902,749
Potential common shares issuable upon conversion of preferred stock and exercise of stock options that were excluded from the computation of diluted weighted-average shares outstanding excluded from the numerator are as follows:
Year Ended December 31,
2025
2024
2023
Stock options, SARs, and RSUs to purchase common stock
7,639,601
6,854,883
5,786,881
18. INCOME TAXES
Details of the provision for income taxes consist of the following:
Year Ended December 31,
2025
2024
2023
Federal
$
41,749
$
29,465
$
32,136
State
14,628
16,846
12,407
$
56,377
$
46,311
$
44,543
Current
$
15,678
$
74,311
$
57,962
Deferred
40,699
( 28,000 )
( 13,419 )
Total
$
56,377
$
46,311
$
44,543
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A reconciliation of the differences between the U.S. statutory federal income tax rate of 21.0 % and the Company’s effective income tax rate as of December 31, 2025, after the adoption of ASU 2023-09, is as follows:
Year Ended December 31,
2025
Amount
Percent
Federal statutory rate
$
45,163
21.0 %
State income taxes, net of federal tax effect*
13,601
6.3 %
Tax credits
Orphan drug credit
( 7,999 )
( 3.7 )%
Research and development credit
( 610 )
( 0.3 )%
Nontaxable or nondeductible Items
In-process research and development
3,150
1.5 %
Other
1,967
0.9 %
Other adjustments
1,105
0.5 %
Effective tax rate
$
56,377
26.2 %
* State taxes include the impact of the remeasurement of state deferred tax assets. There was no individual state that made up the majority (greater than 50%) of the tax effect in this category.
A reconciliation of the differences between the U.S. statutory federal income tax rate of 21.0 % and the Company’s effective income tax rate as of December 31, 2024, and 2023, prior to the adoption of ASU 2023-09, is as follows:
Year Ended December 31,
2024
2023
Federal income tax rate
21.0
%
21.0
%
Stock-based compensation
0.5
( 0.4 )
State taxes
6.4
5.7
Credits
( 4.7 )
( 2.1 )
Nondeductible IPR&D
1.8
0.3
Valuation allowance
—
0.6
Other
( 0.9 )
0.6
Total
24.1
%
25.7
%
The Company made cash payments for income taxes, net of refunds, during the year ended December 31, 2025, as follows:
Year Ended December 31,
2025
Federal
$
12,254
State
Pennsylvania
4,006
Tennessee
2,715
Other
845
Total State
$
7,566
Total Income tax paid, net of refunds
$
19,820
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Significant components of the Company’s deferred tax assets and liabilities as of December 31, 2025, and 2024, are as follows:
As of December 31,
2025
2024
Assets
Liabilities
Assets
Liabilities
Acquired in-process research and development
$
36,992
$
—
$
42,312
$
—
Net operating loss carryforward
49,242
—
52,458
—
Accrued compensation
36,459
—
29,116
—
Credits
3,499
—
3,902
—
Lease obligations, net
52
—
5
—
Fixed assets
—
41
209
—
Inventory
4,713
—
7,169
—
Accrued rebates
6,320
—
5,100
—
Research and development
10,794
—
57,583
—
Other
6,068
542
25
733
Total
$
154,139
583
$
197,879
733
Net deferred tax asset
$
153,556
197,146
Valuation allowance
$
( 3,857 )
$
—
$
( 6,748 )
$
—
Total
$
149,699
$
—
$
190,398
$
—
As of December 31, 2025, and December 31, 2024, our deferred tax assets primarily related to acquired in-process research and development costs, operating loss carryforwards, capitalized research and development costs, inventory, and accrued rebates. On July 4, 2025, the "One Big Beautiful Bill Act" (the "OBBBA") was enacted. The OBBBA contains several changes to corporate taxation, including the allowance of immediate expensing of domestic research and development expenses. As a result, the Company recorded a $ 48,000 reduction to deferred tax assets related to domestic research and development expenses which is reflected in its consolidated balance sheet as of December 31, 2025. As of December 31, 2024, the Company had a valuation allowance on net operating loss carryforwards of the Company’s subsidiary, Zynerba Pharmaceuticals Pty Ltd., and net operating loss carryforwards and other deferred tax assets of the Company’s subsidiary, Harmony Biosciences Management, Inc. During the year ended December 31, 2025, it was determined that the net operating loss carryforward and other deferred tax assets related to the Company’s subsidiaries were not utilizable, accordingly the Company removed the related deferred tax asset and the corresponding valuation allowance, which reduced the valuation allowance by $ 2,891 .
As of December 31, 2025, and 2024, the Company has approximately $ 203,788 and $ 220,243 , respectively, of federal net operating loss ("NOL") carryforward available to offset future federal taxable income. The Company also has approximately $ 110,579 and $ 111,079 of state NOL carryforwards as of December 31, 2025, and 2024, respectively, available to offset future state taxable income. The Company’s state NOLs begin to expire in 2037. As of December 31, 2025, and 2024, the Company had federal tax credits of $ 3,499 and $ 3,902 , respectively.
Utilization of the net operating loss carryforwards and federal tax credits may be subject to a substantial limitation under Section 382 of the Internal Revenue Code due to ownership changes that could occur in the future. These changes may limit the amount of net operating loss and tax credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. In general, an “ownership change” as defined by Section 382 of the Code results from a transaction or series of transactions over a three-year period resulting in an ownership change of more than 50 percentage points of the outstanding stock of a company by certain stockholders or public groups. The majority of the Company’s carryforwards and federal tax credits were acquired in conjunction with the Zynerba and Epygenix acquisitions and are subject to annual limitations under Section 382 of the Internal Revenue Code.
The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending income tax examinations. The Company’s tax years are still open under statute from 2022 to present. All open years may be examined to the extent that tax credits or NOLs are used in future periods. The Company’s policy is to record interest and penalties related to income taxes as part of its income tax provision. The Company has not recorded any amounts for unrecognized tax benefits as of December 31, 2025, and 2024.
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19. RETIREMENT PLAN
The Company formed a 401(k) defined contribution savings plan (the “401(k) Plan”) in January 2021. The 401(k) Plan is for the benefit of all qualifying employees and permits voluntary contributions by employees limited by the IRS-imposed maximum. Employer contributions were $ 4,034 , $ 2,457 , and $ 2,128 for the years ended December 31, 2025, 2024 and 2023, respectively.
20. RELATED-PARTY TRANSACTIONS
The Company’s related party, Paragon, is an entity that shares common ownership with the Company. In addition, the Chairman of the Company’s board of directors was the President and owner of the entity. The Company is party to a right of use agreement with the related party whereby it has access to and the right to use certain office space leased by the related party in Chicago, Illinois. Additionally, the Company received consulting services from Paragon during the twelve months ended December 31, 2025. For the years ended December 31, 2025, 2024 and 2023, the Company incurred $ 474 , $ 290 and $ 290 , respectively, of expenses pursuant to the right of use agreement with this related party, which are included in general and administrative expense in the consolidated statements of operations and comprehensive income (loss). As of December 31, 2 0 25, and 2024, there were no amounts due to or due from related parties included within the consolidated balance sheet.
In June 2025, the Company entered into the CiRC Agreement with CiRC, an entity controlled by Paragon. The Company paid a $ 15,000 upfront payment to CiRC pursuant to the CiRC Agreement which was recorded as an IPR&D charge in research and development in the consolidated statements of operations and comprehensive income. As of December 31, 2 0 25, there were no amounts due to or due from CiRC under the CiRC agreement. Refer to Note 9, License Agreements , for further discussion regarding the CiRC Agreement.
21. VALUATION AND QUALIFYING ACCOUNTS – ACCOUNTS RECEIVABLE, NET
Changes in the valuation allowance for accounts receivable, net during the years ended December 31, 2025, 2024, and 2023, were as follows:
Year Ended December 31,
2025
2024
2023
Allowance for distribution fees, discounts and chargebacks at the beginning of the year
$
4,004
$
2,644
$
1,830
Additions due to current period provision
38,921
28,782
21,821
Deductions due to payment of distribution fees, discount and chargebacks
( 37,806 )
( 27,422 )
( 21,007 )
Allowance for distribution fees, discounts and chargebacks at the end of the year
$
5,119
$
4,004
$
2,644
22. SUBSEQUENT EVENTS
On January 11, 2026, the Company entered into a license agreement with a third party, which includes an exclusive license to additional intellectual property that will expand the patent estate of the Company, as well as a co-exclusive license, with which the Company intends to develop a new formulation of pitolisant in broad CNS indications outside of sleep/wake. Under the license agreement, the Company paid an upfront license fee of $ 15,000 and will also be obligated to pay up to $ 10,000 upon achievement of certain development milestones, as well as low single-digit royalties on net sales of pitolisant based products.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
None.
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