Harmony Biosciences Holdings, Inc. 10-K

Item 8. Financial Statements and Supplementary Data. ​ Report of Independent Registered Public Accounting Firm (PCAOB ID No. 34 ) 89 Consolidated Balance Sheets 91 Consolidated Statements of Operations and Comprehensive Income (Loss ) 92 Consolidated Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit) 93 Consolidated Statements of Cash Flows 94 Notes to Consolidated Financial Statements 95 ​ ​ 88 Table of Contents 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, 2024 and 2023, 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, 2024, 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, 2024, and 2023, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2024, 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, 2024, 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 25, 2025, 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 acquisition costs, 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. 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 judgments include historical claims experience, payer channel mix, current contract prices, unbilled claims, claims submission time lags, and inventory levels in the distribution channel. 89 Table of Contents 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. /s/ Deloitte & Touche LLP Philadelphia, PA February 25, 2025 ​ We have served as the Company’s auditor since 2017. ​ 90 Table of Contents HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share data) ​ ​ ​ ​ ​ ​ ​ ​ December 31, December 31, ​ 2024 2023 ASSETS ​ ​ CURRENT ASSETS: ​ ​ Cash and cash equivalents ​ $ 453,001 ​ $ 311,660 Investments, short-term ​ ​ 14,185 ​ ​ 41,800 Trade receivables, net ​ 83,033 ​ 74,140 Inventory, net ​ 7,198 ​ 5,363 Prepaid expenses ​ 13,714 ​ 12,570 Other current assets ​ 8,121 ​ 5,537 Total current assets ​ 579,252 ​ 451,070 NONCURRENT ASSETS: ​ ​ Property and equipment, net ​ 1,257 ​ 371 Restricted cash ​ 270 ​ 270 Investments, long-term ​ ​ 108,874 ​ ​ 72,169 Intangible assets, net ​ 113,263 ​ 137,108 Deferred tax asset ​ ​ 190,398 ​ ​ 144,162 Other noncurrent assets ​ 5,886 ​ 6,298 Total noncurrent assets ​ 419,948 ​ 360,378 TOTAL ASSETS ​ $ 999,200 ​ $ 811,448 LIABILITIES AND STOCKHOLDERS’ EQUITY ​ ​ CURRENT LIABILITIES: ​ ​ Trade payables ​ $ 13,744 ​ $ 17,730 Accrued compensation ​ 18,776 ​ 23,747 Accrued expenses ​ 120,640 ​ 99,494 Current portion of long-term debt ​ ​ 16,250 ​ ​ 15,000 Other current liabilities ​ 5,672 ​ 7,810 Total current liabilities ​ 175,082 ​ 163,781 NONCURRENT LIABILITIES: ​ ​ Long-term debt, net ​ 163,016 ​ 178,566 Other noncurrent liabilities ​ 1,947 ​ 2,109 Total noncurrent liabilities ​ 164,963 ​ 180,675 TOTAL LIABILITIES ​ 340,045 ​ 344,456 COMMITMENTS AND CONTINGENCIES (Note 13) ​ ​ STOCKHOLDERS’ EQUITY: ​ ​ Common stock—$ 0.00001 par value; 500,000,000 shares authorized at December 31, 2024 and December 31, 2023, respectively; 57,144,887 and 56,769,081 shares issued and outstanding at December 31, 2024 and December 31, 2023, respectively ​ 1 ​ 1 Additional paid in capital ​ 656,872 ​ 610,266 Accumulated other comprehensive (loss) income ​ ​ 66 ​ ​ 2 Retained earnings (accumulated deficit) ​ 2,216 ​ ( 143,277 ) TOTAL STOCKHOLDERS’ EQUITY ​ 659,155 ​ 466,992 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY ​ $ 999,200 ​ $ 811,448 ​ The accompanying notes are an integral part of the consolidated financial statements ​ 91 Table of Contents 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, ​ 2024 2023 ​ 2022 Net product revenue ​ $ 714,734 ​ $ 582,022 ​ $ 437,855 Cost of product sold ​ 156,815 ​ 121,236 ​ 83,481 Gross profit ​ 557,919 ​ 460,786 ​ 354,374 Operating expenses: ​ ​ ​ Research and development ​ 145,825 ​ 76,063 ​ 70,886 Sales and marketing ​ 110,916 ​ 97,404 ​ 79,285 General and administrative ​ 110,352 ​ 95,289 ​ 84,017 Total operating expenses ​ 367,093 ​ 268,756 ​ 234,188 Operating income ​ 190,826 ​ 192,030 ​ 120,186 Loss on debt extinguishment ​ — ​ ( 9,766 ) ​ — Other (expense) income, net ​ ( 68 ) ​ 159 ​ 169 Interest expense ​ ​ ( 17,496 ) ​ ( 23,757 ) ​ ( 18,795 ) Interest income ​ 18,542 ​ 14,730 ​ 3,126 Income before income taxes ​ 191,804 ​ 173,396 ​ 104,686 Income tax expense ​ ( 46,311 ) ​ ( 44,543 ) ​ 76,782 Net income ​ $ 145,493 ​ $ 128,853 ​ $ 181,468 Unrealized (loss) income on investments ​ 64 ​ 153 ​ ( 151 ) Comprehensive income ​ $ 145,557 ​ $ 129,006 ​ $ 181,317 EARNINGS PER SHARE: ​ ​ ​ Basic ​ $ 2.56 ​ $ 2.17 ​ $ 3.07 Diluted ​ $ 2.51 ​ $ 2.13 ​ $ 2.97 Weighted average number of shares of common stock - basic ​ 56,885,455 ​ 59,469,648 ​ 59,173,121 Weighted average number of shares of common stock - diluted ​ 57,869,915 ​ 60,372,397 ​ 61,097,045 ​ The accompanying notes are an integral part of the consolidated financial statements ​ ​ 92 Table of Contents 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, 2021 ​ 58,825,769 ​ ​ 1 ​ ​ 640,104 ​ ​ — ​ ​ ( 453,598 ) ​ ​ 186,507 Net income — ​ ​ — ​ ​ — ​ ​ — ​ ​ 181,468 ​ 181,468 Unrealized loss on investments ​ — ​ ​ — ​ ​ — ​ ​ ( 151 ) ​ ​ — ​ ​ ( 151 ) Issuance of common stock 8,050 ​ ​ — ​ ​ 408 ​ ​ — ​ ​ — ​ 408 Exercise of options 781,912 ​ ​ — ​ ​ 8,433 ​ ​ — ​ ​ — ​ 8,433 Stock-based compensation — ​ ​ — ​ ​ 26,173 ​ ​ — ​ ​ — ​ 26,173 Balance as of December 31, 2022 59,615,731 ​ $ 1 ​ $ 675,118 ​ $ ( 151 ) ​ $ ( 272,130 ) ​ $ 402,838 Net income ​ — ​ — ​ — ​ ​ — ​ 128,853 ​ ​ 128,853 Unrealized gain 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 Repurchase of common stock ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ — ​ ​ — 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 ​ (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 ​ ​ 93 Table of Contents HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands, except share and per share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 2023 ​ 2022 CASH FLOWS FROM OPERATING ACTIVITIES ​ ​ ​ ​ Net income ​ $ 145,493 ​ $ 128,853 ​ $ 181,468 Adjustments to reconcile net income to net cash used in operating activities: ​ ​ ​ ​ ​ ​ Depreciation ​ 267 ​ 514 ​ ​ 419 Intangible amortization ​ 23,845 ​ 23,845 ​ ​ 22,966 Acquired in-process research & development (IPR&D) expense ​ ​ 43,595 ​ ​ 2,260 ​ ​ — Stock-based and employee stock purchase compensation expense ​ 42,602 ​ 31,705 ​ ​ 26,173 Stock appreciation rights market adjustment ​ 99 ​ ( 499 ) ​ ​ 732 Debt issuance costs amortization ​ 700 ​ 2,274 ​ ​ 1,663 Deferred taxes ​ ​ ( 29,298 ) ​ ​ ( 13,419 ) ​ ​ ( 85,943 ) Amortization of premiums and accretion of discounts on Investment securities ​ ​ ( 2,261 ) ​ ​ ( 2,715 ) ​ ​ ( 432 ) Loss on debt extinguishment ​ ​ — ​ ​ 9,766 ​ ​ — Other non-cash expenses ​ ​ 2,100 ​ ​ 1,768 ​ ​ 1,526 Change in operating assets and liabilities: ​ ​ ​ ​ ​ ​ Trade receivables ​ ( 8,893 ) ​ ( 19,400 ) ​ ​ ( 19,897 ) Inventory ​ ( 1,835 ) ​ ( 1,066 ) ​ ​ 135 Prepaid expenses and other assets ​ ( 3,008 ) ​ 74 ​ ​ ( 7,548 ) Trade payables ​ ( 5,384 ) ​ 8,949 ​ ​ 2,785 Other liabilities ​ 11,799 ​ 46,478 ​ ​ 20,419 Net cash provided by operating activities ​ 219,821 ​ 219,387 ​ 144,466 CASH FLOWS FROM INVESTING ACTIVITIES: ​ ​ ​ ​ ​ Purchase of investment securities ​ ​ ( 105,289 ) ​ ​ ( 127,469 ) ​ ​ ( 110,729 ) Proceeds from maturities and sales of investment securities ​ ​ 98,527 ​ ​ 118,309 ​ ​ 9,069 Purchase of property and equipment ​ ( 1,153 ) ​ ( 312 ) ​ ​ ( 172 ) Acquisition of Zynerba Pharmaceuticals, Inc., net of cash acquired ​ — ​ ( 36,967 ) ​ ​ — Acquisition of Epygenix Therapeutics, Inc., net of cash acquired ​ ​ ( 33,069 ) ​ ​ — ​ ​ — Payment of license fee and milestone ​ ( 26,500 ) ​ — ​ ​ ( 40,000 ) Net cash used in investing activities ​ ( 67,484 ) ​ ( 46,439 ) ​ ( 141,832 ) 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 ​ ​ ( 15,000 ) ​ ​ ( 4,750 ) ​ ​ ( 2,000 ) Repurchase of common stock ​ ​ — ​ ​ ( 100,000 ) ​ ​ — Payments of employee withholding taxes related to stock-based awards ​ ​ ( 2,497 ) ​ ​ ( 514 ) ​ ​ — Proceeds from exercised options ​ 6,501 ​ 5,055 ​ ​ 8,841 Net cash (used in) provided by financing activities ​ ( 10,996 ) ​ ( 105,552 ) ​ ​ 6,841 NET INCREASE IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH ​ 141,341 ​ 67,396 ​ ​ 9,475 CASH, CASH EQUIVALENTS, AND RESTRICTED CASH—Beginning of period ​ 311,930 ​ 244,534 ​ ​ 235,059 CASH, CASH EQUIVALENTS, AND RESTRICTED CASH—End of period ​ $ 453,271 ​ $ 311,930 ​ ​ 244,534 Supplemental Disclosure of Cash Flow Information: ​ ​ ​ ​ Cash paid during the year for interest ​ $ 17,317 ​ $ 20,051 ​ $ 16,364 Cash paid during the year for taxes ​ ​ 79,635 ​ ​ 48,233 ​ ​ 12,645 ​ The accompanying notes are an integral part of the consolidated financial statements ​ 94 Table of Contents 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 . On October 10, 2023, the Company completed a tender offer to acquire all of the outstanding shares of common stock of Zynerba Pharmaceuticals, Inc. (together with its subsidiary, Zynerba Pharmaceutical Pty, Ltd., “Zynerba”). Zynerba was a clinical-stage pharmaceutical company focused on innovative pharmaceutically produced transdermal cannabidiol therapies for orphan neurobehavioral disorders, including Fragile X Syndrome. As of July 1, 2024, Zynerba was renamed and is known as Harmony Biosciences Management, Inc. On April 30, 2024, the Company acquired all of the issued and outstanding capital stock of Epygenix Therapeutics, Inc., a Wyoming corporation (“Epygenix”). 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. 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 Company had retained earnings and an accumulated deficit of $ 2,216 and $ 143,277 , as of December 31, 2024, and 2023, respectively. As of December 31, 2024, the Company had cash, cash equivalents and investments of $ 576,060 . The Company believes that its existing cash, cash equivalents and investments on hand as of December 31, 2024, as well as additional cash generated from operating and financing activities will meet its operational liquidity needs and fund potential investing activities for 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. 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. 95 Table of Contents 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. Fair Value of Financial Instruments The Company’s consolidated financial statements include cash, cash equivalents, accounts payable, and accrued liabilities, all of which are short term in nature and, accordingly, approximate fair value. Additionally, prior to the initial public offering (the “IPO”), the Company’s consolidated financial statements included a warrant liability that was carried at fair value and was re-measured at each balance sheet date until it would be exercised or expired. In connection with the IPO, the Warrants were re-evaluated under the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity, and reclassified to equity. See Note 16 for a further discussion of the warrants. 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, 2024, or December 31, 2023. 96 Table of Contents 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, ​ ​ 2024 ​ 2023 Cash and cash equivalents ​ $ 453,001 ​ $ 311,660 Restricted cash ​ 270 ​ 270 Total cash, cash equivalents, and restricted cash shown in the statements of cash flows ​ $ 453,271 ​ $ 311,930 ​ 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. 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, 2024, three customers accounted for 100 % of gross accounts receivable, Caremark LLC (“CVS Caremark”), which accounted for 39 % of gross accounts receivable; PANTHERx Specialty Pharmacy LLC (“PANTHERx”), which accounted for 31 % of gross accounts receivable; and Accredo Health Group, Inc. (“Accredo), which accounted for 30 % of gross accounts receivable. As of December 31, 2023, three customers accounted for 100 % of gross accounts receivable; Accredo, which accounted for 39 % of gross accounts receivable, CVS Caremark, which accounted for 32 % of gross accounts receivable and PANTHERx, which accounted for 29 % of gross accounts receivable. 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. For the year ended December 31, 2022, three customers accounted for 100 % of gross product revenue; CVS Caremark accounted for 97 Table of Contents 42 % of gross product revenue; PANTHERx accounted for 29 % of gross products revenue; and Accredo accounted for 29 % of gross product revenue. The Company depends on a single supplier 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 sales 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. 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, 2024. 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), or 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 98 Table of Contents 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 it transfers 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 customer obtains control of the product which occurs at a point in time, typically upon delivery. Product revenue is recorded at the product’s list price, net of applicable reserves 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. 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. 99 Table of Contents Advertising Expenses We expense the costs of advertising, including promotional expenses, as incurred. Advertising expenses were $ 27,556 , $ 21,544 and $ 22,428 for the years ended December 31, 2024, 2023 and 2022, 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. 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, 2024 and 2023, 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. ​ 100 Table of Contents 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. ​ Recently Issued Accounting Pronouncements 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 is permitted. The Company is currently evaluating the impact that ASU 2023-09 will have on its consolidated financial statements. ​ 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 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. ​ 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. 101 Table of Contents 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. ZYN002 is the first and only pharmaceutically manufactured, synthetic cannabidiol, devoid of THC, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system and is currently in Phase III clinical trial for the potential treatment of Fragile X Syndrome. 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. 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 ​ 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, 102 Table of Contents 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. 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, 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 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2023 ​ ​ Amortized ​ Unrealized ​ Unrealized ​ ​ Fair ​ ​ Cost ​ Gains ​ Losses ​ ​ Value Short-term: ​ ​ ​ ​ ​ ​ ​ ​ ​ Commercial paper $ 23,832 ​ 36 ​ ( 3 ) ​ $ 23,865 Corporate debt securities ​ 15,968 ​ 28 ​ — ​ ​ 15,996 U.S. government securities ​ 1,940 ​ — ​ ( 1 ) ​ ​ 1,939 Total short-term investments $ 41,740 ​ 64 ​ ( 4 ) ​ $ 41,800 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Long-term: ​ ​ ​ ​ ​ ​ ​ ​ ​ Commercial paper $ 744 ​ — ​ — ​ $ 744 Corporate debt securities ​ 42,688 ​ 81 ​ ( 28 ) ​ ​ 42,741 U.S. government securities ​ 28,795 ​ 7 ​ ( 118 ) ​ ​ 28,684 Total long-term investments $ 72,227 ​ 88 ​ ( 146 ) ​ $ 72,169 103 Table of Contents ​ 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, 2024, and December 31, 2023, respectively. 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, 2024, or December 31, 2023. The Company’s assets measured at fair value consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2024 ​ December 31, 2023 ​ ​ Total ​ Level 1 ​ Level 2 ​ ​ Total ​ Level 1 ​ Level 2 Assets ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Cash equivalents $ 303,545 ​ 303,545 ​ — ​ $ 244,569 ​ 243,685 ​ 884 Commercial paper ​ 7,678 ​ — ​ 7,678 ​ ​ 24,609 ​ — ​ 24,609 Corporate debt securities ​ 93,257 ​ — ​ 93,257 ​ ​ 58,737 ​ — ​ 58,737 U.S. government securities ​ 22,124 ​ — ​ 22,124 ​ ​ 30,623 ​ — ​ 30,623 Total $ 426,604 ​ 303,545 ​ 123,059 ​ $ 358,538 ​ 243,685 ​ 114,853 ​ ​ ​ 7. INVENTORY Inventory, net consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ As of ​ December 31, December 31, ​ ​ 2024 ​ 2023 Raw materials ​ $ 944 ​ $ 1,060 Work in process ​ 3,489 ​ 2,020 Finished goods ​ 2,765 ​ 2,283 Total inventory, net ​ $ 7,198 ​ $ 5,363 ​ ​ ​ 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, 2024, the remaining useful life was 4.8 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, 2024, the remaining useful life was 4.8 years. 104 Table of Contents 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, 2024, the remaining useful life was 4.8 years. Amortization expense was $ 23,845 , $ 23,845 and $ 22,966 for the years ended December 31, 2024, 2023 and 2022, 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, ​ ​ 2025 ​ $ 23,845 2026 ​ 23,845 2027 ​ 23,845 2028 ​ 23,845 2029 ​ 17,883 Thereafter ​ ​ — Total ​ $ 113,263 ​ The gross carrying amount and net book value of the intangible asset is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ As of ​ December 31, December 31, ​ ​ 2024 ​ 2023 Gross Carrying Amount ​ $ 215,000 ​ $ 215,000 Accumulated Amortization ​ ( 101,737 ) ​ ( 77,892 ) Net Book Value ​ $ 113,263 ​ $ 137,108 ​ ​ ​ 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 $ 146,978 , $ 111,685 and $ 77,107 for the years ended December 31, 2024, 2023 and 2022, respectively, for sales-based, trademark and tiered royalties recognized as cost of product sold. As of December 31, 2024, and 2023, the Company had accrued $ 51,746 and $ 40,419 , respectively, for sales-based, trademark and tiered royalties. In July 2022, Harmony entered into a License and Commercialization Agreement (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 105 Table of Contents 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. The $ 30,000 licensing fee was recorded in research and development within the consolidated statement of operations and comprehensive income (loss) for the year ended December 31, 2022. In April 2024, the Company announced that it entered into a 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, and will also be obligated to pay up to $ 127,500 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 . 10. ACCRUED EXPENSES Accrued expenses included the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ As of ​ December 31, December 31, ​ ​ 2024 ​ 2023 Royalties due to Bioprojet ​ $ 51,746 ​ $ 40,419 Rebates and other sales deductions ​ 50,542 ​ 38,842 Interest ​ ​ 2,834 ​ ​ 3,354 Sales and marketing ​ 2,166 ​ 2,354 Research and development ​ 9,014 ​ 9,835 Professional fees, consulting, and other services ​ 3,047 ​ 2,195 Other expenses ​ 1,291 ​ 2,495 ​ ​ $ 120,640 ​ $ 99,494 ​ ​ ​ 106 Table of Contents 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, 2024, was $ 180,569 . 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, for which the Company will pay a ticking fee at a rate of 1 % per annum on the undrawn portion of the DDTL, which commenced on August 10, 2022. 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. 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. 107 Table of Contents Long-term debt, net consists of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, December 31, ​ ​ 2024 ​ 2023 Principal amount ​ $ 181,250 ​ $ 196,250 Unamortized debt discount associated with debt financing costs ​ ( 1,984 ) ​ ( 2,684 ) Total debt, net ​ ​ 179,266 ​ ​ 193,566 Less current portion ​ ​ ( 16,250 ) ​ ​ ( 15,000 ) Long-term debt, net ​ $ 163,016 ​ $ 178,566 ​ Future minimum payments relating to long-term debt, net as of December 31, 2024, for the periods indicated below consists of the following: ​ ​ ​ ​ ​ Years ending December 31, ​ ​ ​ 2025 ​ $ 16,250 2026 ​ 20,000 2027 ​ 20,000 2028 ​ 125,000 2029 ​ — Thereafter ​ — Total ​ $ 181,250 ​ 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, ​ ​ 2024 2023 ​ 2022 Interest on principal balance ​ $ 16,796 ​ $ 20,511 ​ $ 17,132 Amortization of deferred financing costs ​ 700 ​ 3,246 ​ 1,663 Total term loan interest expense ​ $ 17,496 ​ $ 23,757 ​ $ 18,795 ​ ​ ​ 12. LEASES In June 2018, the Company entered into an operating lease for approximately fifteen thousand square feet of office space in Plymouth Meeting, PA, which was set to expire in May 2024. The Company subsequently entered into two separate operating leases for additional office space in Plymouth Meeting, PA, which include approximately thirteen thousand square feet and seven thousand square feet of additional office space, respectively, and were extended through June 2025. The terms of the lease payments provide for rental payments on a monthly basis and on a graduated scale. The Company also leases a fleet of automobiles that are used by its sales representatives and are classified as operating leases. Operating lease right-of-use assets and operating lease liabilities are recognized based on the present value of the future lease payments using our incremental borrowing rate. Leases with an initial term of 12 months or less are not recorded on the balance sheet. Our leases have remaining lease terms of less than 1 year to 3 years , some of which may include the option to extend or terminate the leases. The company recorded operating lease costs of $ 2,099 , $ 1,811 and $ 1,526 for the years ended December 31, 2024, 2023 and 2022, respectively. As of December 31, 2024, the weighted-average remaining lease term for operating leases was 1.7 years and the weighted-average discount rate for operating leases was 7.71 %. ​ 108 Table of Contents ​ Supplemental balance sheet information related to operating leases was as follows: ​ ​ ​ ​ ​ ​ ​ ​ Leases Classification ​ December 31, 2024 ​ December 31, 2023 Assets ​ ​ ​ ​ ​ ​ Operating lease right-of-use assets Other noncurrent assets $ 2,122 ​ $ 2,344 Liabilities ​ ​ ​ ​ ​ ​ Operating lease liability, current portion Other current liabilities $ 1,318 ​ $ 1,437 Operating lease liability, long-term Other long-term liabilities ​ 822 ​ ​ 1,082 Total operating lease liabilities ​ $ 2,140 ​ $ 2,519 ​ Supplemental cash flow information related to operating leases was as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ December 31, 2024 ​ ​ December 31, 2023 ​ ​ December 31, 2022 Operating cash flows from operating leases $ 2,156 ​ $ 2,016 ​ $ 1,716 Right of use assets obtained in exchange for operating lease obligations $ 1,877 ​ $ 2,163 ​ $ 485 ​ Future payments under non-cancelable operating leases with initial terms of one year or more as of December 31, 2024, consisted of the following: ​ ​ ​ ​ ​ Years ending December 31, ​ ​ 2025 ​ $ 1,420 2026 ​ 689 2027 ​ 169 2028 ​ — 2029 ​ — Thereafter ​ — Total lease payments ​ ​ 2,278 Less: imputed interest ​ ​ ( 138 ) Total lease liabilities ​ $ 2,140 ​ ​ ​ 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 proceedings could have a material adverse effect on the Company’s results of operations and financial condition. As of December 31, 2024, there were no material claims or lawsuits outstanding other than the ANDA litigation discussed below . ​ Abbreviated New Drug Application (“ANDA”) Litigation ​ On September 27, 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”). On September 27, 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 has submitted ANDA No. 218834 109 Table of Contents (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 ’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 and the Novugen Notice Letter assert 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. On November 9, 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, 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. ​ On October 12, 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, ’947 patent, and ’197 patent. On October 12, 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. On October 14, 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. On October 16, 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. 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. 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. 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. 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. On November 21, 2023, the Company, Bioprojet and Bioprojet Pharma filed a complaint for patent infringement of the ’947 patent and the ‘197 patent against AET, Annora, Novitium and Zenara and certain of their affiliates and agents and for patent infringement of the ’430 patent against Annora, Novitium and 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 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 ® . On December 8, 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. On December 11, 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. On January 12, 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. On April 15, 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 four-day bench trial beginning on February 17, 2026. On August 7, 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. On August 13, 2024, we, Bioprojet and 110 Table of Contents 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. ​ On October 31, 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 January 2030, or earlier under certain circumstances. ​ On December 12, 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. On January 24, 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. ​ The resolution of one or more of these 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 year ended December 31, 2024, the Company repurchased and retired 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, 2024, 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 111 Table of Contents 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 31, 2024, there were 6,888,336 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, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted- ​ ​ ​ ​ ​ ​ Weighted- ​ ​ Average ​ ​ ​ ​ ​ ​ ​ Average ​ ​ Remaining ​ ​ Aggregate ​ ​ Number of ​ Exercise ​ ​ Contractual ​ ​ Intrinsic ​ Awards Price ​ Term ​ Value ($000's) Awards outstanding—December 31, 2023 6,316,422 ​ $ 32.47 ​ ​ 7.17 ​ ​ ​ Awards issued 1,309,046 ​ $ 30.71 ​ ​ ​ ​ ​ Awards exercised ( 281,393 ) ​ $ 21.02 ​ ​ ​ ​ ​ Awards forfeited ( 186,840 ) ​ $ 37.11 ​ ​ ​ ​ ​ Awards outstanding—December 31, 2024 7,157,235 ​ $ 32.48 ​ ​ 6.72 ​ $ 43,754 Awards exercisable—December 31, 2024 ​ 4,420,457 ​ $ 31.52 ​ ​ 5.92 ​ $ 32,958 Awards unvested—December 31, 2024 ​ 2,736,778 ​ $ 34.02 ​ ​ 8.01 ​ $ 10,797 ​ The weighted-average grant-date fair value of stock options granted during the year ended December 31, 2024, was $ 20.68 . The total intrinsic value of stock options exercised for the year ended December 31, 2024, was $ 4,328 . Stock Appreciation Rights The following table summarizes SARs activity for the year ended December 31, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted- ​ ​ ​ ​ ​ ​ Weighted- ​ ​ Average ​ ​ ​ ​ ​ ​ ​ Average ​ ​ Remaining ​ ​ Aggregate ​ ​ Number of ​ Exercise ​ ​ Contractual ​ ​ Intrinsic ​ Awards Price ​ Term ​ Value ($000's) Awards outstanding—December 31, 2023 43,208 ​ $ 9.38 ​ ​ 5.32 ​ ​ ​ Awards issued — ​ $ — ​ ​ ​ ​ ​ Awards exercised — ​ $ — ​ ​ ​ ​ ​ Awards forfeited — ​ $ — ​ ​ ​ ​ Awards outstanding—December 31, 2024 43,208 ​ $ 9.38 ​ ​ 4.32 ​ $ 741,809 Awards exercisable—December 31, 2024 ​ 41,382 ​ $ 9.19 ​ ​ 4.27 ​ $ 722,722 ​ 112 Table of Contents Restricted Stock Units The following table summarizes RSU activity for the year ended December 31, 2024: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted- ​ ​ ​ ​ Average ​ ​ Number of ​ Grant Date ​ Awards Fair Value Awards outstanding—December 31, 2023 330,000 ​ $ 31.53 Awards issued 464,600 ​ $ 30.62 Awards vested ( 135,000 ) ​ $ 31.47 Awards forfeited ( 20,700 ) ​ $ 30.69 Awards outstanding—December 31, 2024 638,900 ​ $ 30.90 ​ 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, ​ 2024 2023 ​ 2022 ​ Dividend yield 0.00 % 0.00 % 0.00 % Expected volatility 69.84 - 72.98 % 74.87 - 80.78 % 72.57 - 77.08 % Risk-free interest rate 3.51 - 4.65 % 3.42 - 4.62 % 1.99 - 4.05 % Lack of marketability discount 0.00 % 0.00 % 0.00 % Expected term (years) 1.81 - 6.11 2.26 - 10.77 ​ 3.1 - 6.3 ​ ​ 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 $ 21.28 , $ 20.64 and $ 18.88 in 2024, 2023 and 2022, respectively. Stock-Based Compensation Expense Stock-based compensation expense was $ 42,701 , $ 31,206 and $ 26,905 for the years ended December 31, 2024, 2023 and 2022, respectively, and is recorded in the consolidated statements of operations and comprehensive income (loss) in the following line items: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 2023 ​ 2022 Research and development expense ​ $ 6,682 ​ $ 3,962 ​ $ 2,614 Sales and marketing expense ​ 7,435 ​ 5,148 ​ 3,886 General and administrative expense ​ 28,584 ​ 22,096 ​ 20,405 ​ ​ $ 42,701 ​ $ 31,206 ​ $ 26,905 113 Table of Contents ​ 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, 2024, the total unrecognized stock-based compensation expense was $ 49,247 and $ 15,658 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 2.1 years and 2.7 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, 2024, 2023 and 2022, there were 23,121 , 21,313 and 21,943 shares issued under the ESPP, respectively. The discount on the ESPP was $ 298 , $ 393 and $ 363 for the years ended December 31, 2024, 2023 and 2022, 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, 2024, 2023 and 2022: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Rare Neurological Diseases Segment ​ ​ Year Ended December 31, ​ 2024 ​ 2023 ​ 2022 Net product revenue $ 714,734 ​ $ 582,022 ​ $ 437,855 Less: ​ ​ ​ ​ ​ ​ ​ ​ ​ Cost of product sold ​ ​ 156,788 ​ ​ 121,232 ​ ​ 83,446 Research and development (excluding stock compensation and IPR&D) ​ ​ 95,548 ​ ​ 69,091 ​ ​ 38,282 Sales and marketing (excluding stock compensation) ​ ​ 103,481 ​ ​ 92,256 ​ ​ 75,354 General and administrative (excluding stock compensation, amortization and depreciation) ​ ​ 57,683 ​ ​ 48,838 ​ ​ 40,297 Depreciation and amortization ​ ​ 24,112 ​ ​ 24,359 ​ ​ 23,385 Stock-based compensation ​ ​ 42,701 ​ ​ 31,206 ​ ​ 26,905 Interest expense ​ ​ 17,496 ​ ​ 23,757 ​ ​ 18,795 Interest income ​ ​ ( 18,542 ) ​ ​ ( 14,730 ) ​ ​ ( 3,126 ) Income tax expense (benefit) ​ ​ 46,311 ​ ​ 44,543 ​ ​ ( 76,782 ) Other segment items (a) 43,663 ​ 12,617 ​ 29,831 Consolidated net income $ 145,493 ​ $ 128,853 ​ $ 181,468 114 Table of Contents ​ (a) 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, 2024, 2023 and 2022, 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, ​ 2024 2023 ​ 2022 Numerator ​ ​ ​ ​ ​ Net income ​ $ 145,493 ​ $ 128,853 ​ $ 181,468 Denominator ​ ​ ​ Net income per share of common stock - basic ​ $ 2.56 ​ $ 2.17 ​ $ 3.07 Net income per share of common stock- diluted ​ $ 2.51 ​ $ 2.13 ​ $ 2.97 Weighted average number of shares of common stock - basic ​ 56,885,455 ​ 59,469,648 ​ 59,173,121 Weighted average number of shares of common stock - diluted ​ 57,869,915 ​ 60,372,397 ​ 61,097,045 ​ Securities outstanding that were included in the computation above, utilizing the treasury stock method are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ ​ 2024 2023 ​ 2022 Stock options, SARs, and RSUs to purchase common stock ​ ​ 984,460 ​ ​ 902,749 ​ ​ 1,923,924 ​ 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, ​ 2024 2023 ​ 2022 Stock options, SARs, and RSUs to purchase common stock ​ ​ 6,854,883 ​ 5,786,881 ​ ​ 4,640,231 ​ ​ ​ 18. INCOME TAXES Details of the provision for income taxes consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 2023 ​ 2022 Federal ​ $ 29,523 ​ $ 31,084 ​ $ 10,011 State ​ 15,430 ​ 11,884 ​ 9,573 Foreign ​ ​ 60 ​ ​ — ​ ​ — Valuation allowance ​ 1,298 ​ 1,575 ​ ( 96,366 ) ​ ​ $ 46,311 ​ $ 44,543 ​ $ ( 76,782 ) Current ​ $ 74,311 ​ $ 57,962 ​ $ 9,161 Deferred ​ ( 29,298 ) ​ ( 14,994 ) ​ 10,423 Valuation allowance ​ 1,298 ​ 1,575 ​ ( 96,366 ) Total ​ $ 46,311 ​ $ 44,543 ​ $ ( 76,782 ) ​ 115 Table of Contents The reasons for the difference between the statutory federal income tax rate and the Company’s effective income tax rate as of December 31, 2024, 2023 and 2022 are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 2023 ​ 2022 ​ Federal income tax rate 21.0 % 21.0 % 21.0 % Stock-based compensation 0.5 ​ ( 0.4 ) ​ ( 4.9 ) ​ State taxes 6.4 ​ 5.7 ​ ( 14.1 ) ​ Credits ( 4.7 ) ​ ( 2.1 ) ​ ( 4.8 ) ​ Nondeductible IPR&D 1.8 ​ 0.3 ​ — ​ Valuation allowance — ​ 0.6 ​ ( 70.2 ) ​ Other ( 0.9 ) ​ 0.6 ​ ( 0.3 ) ​ Total 24.1 % 25.7 % ( 73.3 ) % ​ Significant components of the Company’s deferred tax assets and liabilities as of December 31, 2024, and 2023, are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ As of December 31, ​ ​ 2024 2023 ​ ​ Assets Liabilities ​ Assets Liabilities Acquired in-process research and development ​ $ 42,312 ​ $ — ​ $ 35,337 ​ $ — Net operating loss carryforward ​ 52,458 ​ — ​ 45,917 ​ — Accrued compensation ​ 29,116 ​ — ​ 19,915 ​ — Credits ​ 3,902 ​ — ​ — ​ — Lease obligations, net ​ 5 ​ — ​ — ​ 6 Fixed assets ​ 209 ​ — ​ 173 ​ — Inventory ​ 7,169 ​ — ​ 5,344 ​ — Accrued rebates ​ ​ 5,100 ​ ​ — ​ ​ 3,791 ​ ​ — Research and development ​ ​ 57,583 ​ ​ — ​ ​ 38,799 ​ ​ — Other ​ 25 ​ 733 ​ 1,132 ​ 790 Total ​ $ 197,879 ​ 733 ​ $ 150,408 ​ 796 Net deferred tax asset ​ $ 197,146 ​ $ — ​ $ 149,612 ​ $ — Valuation allowance ​ $ ( 6,748 ) ​ $ — ​ $ ( 5,450 ) ​ $ — Total ​ $ 190,398 ​ $ — ​ $ 144,162 ​ $ — ​ As of December 31, 2024, and December 31, 2023, our deferred tax assets were primarily the result of acquired in-process research and development costs, operating loss carryforwards, capitalized research and development costs, inventory, and accrued rebates. During the years ended December 31, 2024 and 2023, the Company recorded a valuation allowance on federal net operating losses of the Company’s subsidiary, Zynerba Pharmaceuticals Pty Ltd., and the state net operating losses of Zynerba. The Company previously recorded a valuation allowance against Harmony’s historical deferred tax assets. The Company recorded $ 96,336 as a benefit to the income tax provision upon release of this valuation allowance during year ended December 31, 2022, in part because in the year ended December 31, 2022, we achieved three years of cumulative pretax income, which was a positive indication of the Company’s ability to generate sufficient future taxable income, the Company determined that there was sufficient positive evidence to conclude that it was more likely than not that additional deferred taxes are realizable and, therefore, released the valuation allowance accordingly. Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2024, 2023 and 2022 were as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 2023 ​ 2022 Valuation allowance at the beginning of the year ​ $ ( 5,450 ) ​ $ — ​ $ ( 96,366 ) Decreases recorded as a benefit to income tax provision ​ — ​ — ​ 96,366 Increases recorded to income tax provision ​ ​ ( 1,298 ) ​ ​ ( 1,575 ) ​ ​ — Increases recorded in opening balance sheet ​ ​ — ​ ​ ( 3,875 ) ​ ​ — Valuation allowance at the end of the year ​ $ ( 6,748 ) ​ $ ( 5,450 ) ​ $ — ​ 116 Table of Contents As of December 31, 2024, and 2023, the Company has approximately $ 220,243 and $ 179,390 , respectively, of federal net operating loss ("NOL") carryforward available to offset future federal taxable income. The Company also has approximately $ 111,079 and $ 137,331 of state NOL carryforwards as of December 31, 2024, and 2023, respectively, available to offset future state taxable income. All of the Company’s tax years remain open to examination by federal and state taxing authorities. The Company’s state NOLs begin to expire in 2037. Utilization of the net operating loss carryforwards may be subject to a substantial limitation due to state provisions. 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. As of December 31, 2024, and 2023, the Company has federal tax credits of $ 3,902 and $ 0 , respectively. ​ ​ 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 $ 2,457 , $ 2,128 , and $ 1,705 for the years ended December 31, 2024, 2023 and 2022, 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. For the years ended December 31, 2024, 2023 and 2022, the Company incurred $ 290 , $ 290 and $ 284 , respectively, in 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, 2024, and 2023, there were no amounts due to or due from related parties included within the consolidated balance sheet. 21. VALUATION AND QUALIFYING ACCOUNTS – ACCOUNTS RECEIVABLE, NET Changes in the valuation allowance for accounts receivable, net during the years ended December 31, 2024, 2023, and 2022, were as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Year Ended December 31, ​ 2024 2023 ​ 2022 Allowance for distribution fees, discounts and chargebacks at the beginning of the year ​ $ 2,644 ​ $ 1,830 ​ $ 1,885 Additions due to current period provision ​ 28,782 ​ 21,821 ​ 14,806 Deductions due to payment of distribution fees, discount and chargebacks ​ ​ ( 27,422 ) ​ ​ ( 21,007 ) ​ ​ ( 14,861 ) Allowance for distribution fees, discounts and chargebacks at the end of the year ​ $ 4,004 ​ $ 2,644 ​ $ 1,830 ​ ​ Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. None.