Harmony Biosciences Holdings, Inc. 10-Q

Item 1. Financial Statements HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARY UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS ​ (In thousands, except share and per share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, ​ 2022 2021 ASSETS ​ ​ CURRENT ASSETS: ​ ​ Cash and cash equivalents ​ $ 261,343 ​ $ 234,309 Investments, short-term ​ ​ 46,420 ​ ​ — Trade receivables, net ​ 55,065 ​ 34,843 Inventory, net ​ 3,900 ​ 4,432 Prepaid expenses ​ 11,246 ​ 7,637 Other current assets ​ 4,108 ​ 3,218 Total current assets ​ 382,082 ​ 284,439 NONCURRENT ASSETS: ​ ​ Property and equipment, net ​ 680 ​ 820 Restricted cash ​ 750 ​ 750 Investments, long-term ​ ​ 8,280 ​ ​ — Intangible assets, net ​ 166,914 ​ 143,919 Deferred tax asset ​ ​ 81,679 ​ ​ — Other noncurrent assets ​ 3,079 ​ 3,515 Total noncurrent assets ​ 261,382 ​ 149,004 TOTAL ASSETS ​ $ 643,464 ​ $ 433,443 LIABILITIES AND STOCKHOLDERS’ EQUITY ​ ​ CURRENT LIABILITIES: ​ ​ Trade payables ​ $ 10,049 ​ $ 1,001 Accrued compensation ​ 8,331 ​ 9,165 Accrued expenses ​ 85,606 ​ 40,249 Current portion of long-term debt ​ ​ 2,000 ​ ​ 2,000 Other current liabilities ​ 1,371 ​ 1,360 Total current liabilities ​ 107,357 ​ 53,775 NONCURRENT LIABILITIES: ​ ​ Long-term debt, net ​ 189,725 ​ 189,984 Other noncurrent liabilities ​ 2,498 ​ 3,177 Total noncurrent liabilities ​ 192,223 ​ 193,161 TOTAL LIABILITIES ​ 299,580 ​ 246,936 COMMITMENTS AND CONTINGENCIES (Note 12) ​ ​ STOCKHOLDERS’ EQUITY: ​ ​ Common stock— $ 0.00001 par value; 500,000,000 shares authorized at September 30, 2022 and December 31, 2021, respectively; 59,304,408 shares and 58,825,769 issued and outstanding at September 30, 2022 and December 31, 2021, respectively ​ 1 ​ 1 Additional paid in capital ​ 664,700 ​ 640,104 Accumulated other comprehensive income (loss) ​ ​ ( 178 ) ​ ​ — Accumulated deficit ​ ( 320,639 ) ​ ( 453,598 ) TOTAL STOCKHOLDERS’ EQUITY ​ 343,884 ​ 186,507 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY ​ $ 643,464 ​ $ 433,443 ​ The accompanying notes are an integral part of the unaudited condensed consolidated financial statements ​ 3 Table of Contents HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARY UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (In thousands, except share and per share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended September 30, ​ Nine Months Ended September 30, ​ 2022 2021 2022 2021 Net product revenues ​ $ 117,206 ​ $ 80,732 ​ $ 309,547 ​ $ 214,227 Cost of product sold ​ 22,959 ​ 14,604 ​ 56,596 ​ 37,701 Gross profit ​ 94,247 ​ 66,128 ​ 252,951 ​ 176,526 Operating expenses: ​ ​ ​ ​ Research and development ​ 40,548 ​ 11,739 ​ 60,794 ​ 22,916 Sales and marketing ​ 20,467 ​ 16,480 ​ 58,210 ​ 49,009 General and administrative ​ 21,331 ​ 16,856 ​ 61,374 ​ 45,704 Total operating expenses ​ 82,346 ​ 45,075 ​ 180,378 ​ 117,629 Operating income ​ 11,901 ​ 21,053 ​ 72,573 ​ 58,897 Loss on debt extinguishment ​ — ​ ( 26,146 ) ​ — ​ ( 26,146 ) Other expense (income), net ​ 56 ​ — ​ 96 ​ ( 15 ) Interest expense, net ​ ( 3,990 ) ​ ( 5,429 ) ​ ( 12,086 ) ​ ( 19,783 ) Income (loss) before income taxes ​ 7,967 ​ ( 10,522 ) ​ 60,583 ​ 12,953 Income tax benefit (expense) ​ 79,976 ​ 902 ​ 72,376 ​ ( 1,070 ) Net income ​ $ 87,943 ​ $ ( 9,620 ) ​ $ 132,959 ​ $ 11,883 Unrealized loss on investments ​ ( 149 ) ​ — ​ ( 178 ) ​ — Comprehensive income ​ $ 87,794 ​ $ ( 9,620 ) ​ $ 132,781 ​ $ 11,883 EARNINGS PER SHARE: ​ ​ ​ ​ Basic ​ $ 1.48 ​ $ ( 0.17 ) ​ $ 2.25 ​ $ 0.21 Diluted ​ $ 1.44 ​ $ ( 0.17 ) ​ $ 2.18 ​ $ 0.20 Weighted average number of shares of common stock - basic ​ 59,234,720 ​ 57,722,163 ​ 59,070,063 ​ 57,188,101 Weighted average number of shares of common stock - diluted ​ 61,207,625 ​ 57,722,163 ​ 60,921,482 ​ 58,776,158 ​ The accompanying notes are an integral part of the unaudited condensed consolidated financial statements ​ 4 Table of Contents HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARY UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (In thousands, except share and per share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ other ​ ​ ​ ​ Total ​ ​ Common Stock ​ paid-in ​ comprehensive ​ Accumulated ​ stockholders’ ​ Shares Amount capital income (loss) deficit equity Balance as of December 31, 2021 58,825,769 ​ $ 1 ​ $ 640,104 ​ $ — ​ $ ( 453,598 ) ​ $ 186,507 Net income — ​ — ​ — ​ ​ — ​ 132,959 ​ 132,959 Unrealized loss on investments ​ — ​ ​ — ​ ​ — ​ ​ ( 178 ) ​ ​ — ​ ​ ( 178 ) Issuance of common stock ​ 8,050 ​ ​ — ​ ​ 408 ​ ​ — ​ ​ — ​ ​ 408 Exercise of options 470,589 ​ — ​ 5,275 ​ ​ — ​ — ​ 5,275 Stock-based compensation — ​ — ​ 18,913 ​ ​ — ​ — ​ 18,913 Balance as of September 30, 2022 59,304,408 ​ $ 1 ​ $ 664,700 ​ $ ( 178 ) ​ $ ( 320,639 ) ​ $ 343,884 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Accumulated ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ other ​ ​ ​ ​ Total ​ ​ Common Stock ​ paid-in ​ comprehensive ​ Accumulated ​ stockholders’ ​ Shares Amount capital income (loss) deficit equity Balance as of June 30, 2022 ​ 59,117,749 ​ $ 1 ​ $ 655,143 ​ $ ( 29 ) ​ $ ( 408,582 ) ​ $ 246,533 Net income — ​ — ​ — ​ ​ — ​ 87,943 ​ 87,943 Unrealized loss on investments ​ — ​ ​ — ​ ​ — ​ ​ ( 149 ) ​ ​ — ​ ​ ( 149 ) Issuance of common stock ​ 8,050 ​ ​ — ​ ​ 408 ​ ​ — ​ ​ — ​ ​ 408 Exercise of options 178,609 ​ — ​ 2,143 ​ ​ — ​ — ​ 2,143 Stock-based compensation — ​ — ​ 7,006 ​ ​ — ​ — ​ 7,006 Balance as of September 30, 2022 59,304,408 ​ $ 1 ​ $ 664,700 ​ $ ( 178 ) ​ $ ( 320,639 ) ​ $ 343,884 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ ​ ​ Total ​ ​ Common Stock ​ paid-in ​ Accumulated ​ stockholders’ ​ Shares Amount capital deficit equity Balance as of December 31, 2020 56,890,569 ​ $ 1 ​ $ 585,374 ​ $ ( 488,195 ) ​ $ 97,180 Net income — ​ — ​ — ​ 11,883 ​ 11,883 Issuance of common stock ​ 1,270,462 ​ ​ — ​ ​ 29,700 ​ ​ — ​ ​ 29,700 Exercise of stock options 253,515 ​ — ​ 1,794 ​ — ​ 1,794 Stock-based compensation — ​ — ​ 11,461 ​ — ​ 11,461 Balance as of September 30, 2021 58,414,546 ​ $ 1 ​ $ 628,329 ​ $ ( 476,312 ) ​ $ 152,018 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Additional ​ ​ ​ Total ​ ​ Common Stock ​ paid-in ​ Accumulated ​ stockholders’ ​ Shares Amount capital deficit equity Balance as of June 30, 2021 57,000,139 ​ $ 1 ​ $ 593,242 ​ $ ( 466,692 ) ​ $ 126,551 Net income — ​ — ​ — ​ ( 9,620 ) ​ ( 9,620 ) Issuance of common stock ​ 1,270,462 ​ ​ — ​ ​ 29,700 ​ ​ — ​ ​ 29,700 Exercise of options 143,945 ​ — ​ 1,134 ​ — ​ 1,134 Stock-based compensation — ​ — ​ 4,253 ​ — ​ 4,253 Balance as of September 30, 2021 58,414,546 ​ $ 1 ​ $ 628,329 ​ $ ( 476,312 ) ​ $ 152,018 The accompanying notes are an integral part of the unaudited condensed consolidated financial statements ​ 5 Table of Contents HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARY UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (In thousands, except share and per share data) ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Nine Months Ended September 30, ​ 2022 2021 ​ CASH FLOWS FROM OPERATING ACTIVITIES ​ ​ ​ Net income ​ $ 132,959 ​ $ 11,883 ​ Adjustments to reconcile net income to net cash used in operating activities: ​ ​ ​ ​ Depreciation ​ 312 ​ 299 ​ Intangible amortization ​ 17,005 ​ 13,781 ​ Stock-based and employee stock purchase compensation expense ​ 18,913 ​ 11,461 ​ Stock appreciation rights market adjustment ​ 321 ​ 261 ​ Debt issuance costs amortization ​ 1,241 ​ 1,820 ​ Deferred taxes ​ ​ ( 81,679 ) ​ ​ — ​ Investment securities interest income ​ ​ ( 225 ) ​ ​ — ​ Loss on debt extinguishment ​ ​ — ​ ​ 26,146 ​ Other non-cash expenses ​ ​ 1,042 ​ ​ 916 ​ Change in operating assets and liabilities: ​ ​ ​ ​ Trade receivables ​ ( 20,222 ) ​ ( 11,030 ) ​ Inventory ​ 532 ​ ( 982 ) ​ Prepaid expenses and other assets ​ ( 4,479 ) ​ ( 3,715 ) ​ Trade payables ​ 9,048 ​ 1,623 ​ Accrued expenses and other current liabilities ​ 43,171 ​ 8,545 ​ Other non-current liabilities ​ ( 151 ) ​ 16 ​ Net cash provided by operating activities ​ 117,788 ​ 61,024 ​ CASH FLOWS FROM INVESTING ACTIVITIES: ​ ​ ​ Purchase of investment securities ​ ​ ( 55,637 ) ​ ​ — ​ Proceeds from maturities and sales of investment securities ​ ​ 872 ​ ​ — ​ Purchase of property and equipment ​ ( 172 ) ​ ( 298 ) ​ Milestone payments ​ ( 40,000 ) ​ ( 100,000 ) ​ Net cash used in investing activities ​ ( 94,937 ) ​ ( 100,298 ) ​ CASH FLOWS FROM FINANCING ACTIVITIES: ​ ​ ​ Proceeds from issuance of common stock ​ ​ 408 ​ ​ 30,000 ​ Common stock issuance costs ​ ​ — ​ ​ ( 300 ) ​ Proceeds from long term debt ​ — ​ 200,000 ​ Debt issuance costs ​ — ​ ( 9,147 ) ​ Extinguishment of debt ​ — ​ ( 200,000 ) ​ Extinguishment of debt exit fees ​ — ​ ( 22,000 ) ​ Principal repayment of long term debt ​ ​ ( 1,500 ) ​ ​ — ​ Proceeds from exercised options ​ 5,275 ​ 1,794 ​ Net cash provided by financing activities ​ 4,183 ​ 347 ​ NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS, AND RESTRICTED CASH ​ 27,034 ​ ( 38,927 ) ​ CASH, CASH EQUIVALENTS, AND RESTRICTED CASH—Beginning of period ​ 235,059 ​ 229,381 ​ CASH, CASH EQUIVALENTS, AND RESTRICTED CASH—End of period ​ $ 262,093 ​ $ 190,454 ​ Supplemental Disclosure of Cash Flow Information: ​ ​ ​ Cash paid during the year for interest ​ $ 11,334 ​ $ 15,997 ​ ​ The accompanying notes are an integral part of the unaudited condensed consolidated financial statements ​ 6 Table of Contents HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARY NOTES TO UNAUDITED CONDENSED 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 subsidiary (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 subsidiary, Harmony Biosciences, LLC (“Harmony”), which was formed in May 2017. The Company is a commercial-stage pharmaceutical company focused on developing and commercializing innovative therapies for patients living with rare neurological diseases as well as patients living with other neurological diseases who have unmet medical needs. The Company is headquartered in Plymouth Meeting, Pennsylvania. Initial Public Offering In August 2020, the Company completed its initial public offering (“IPO”) of common stock, in which it sold 6,151,162 shares, including 802,325 shares pursuant to the underwriters’ over-allotment option. The shares were sold at a price of $ 24.00 per share for net proceeds of approximately $ 135,435 , after deducting underwriting discounts and commissions and offering expenses of approximately $ 12,193 payable by the Company. Upon the closing of the IPO, all outstanding shares of the Company’s convertible preferred stock were automatically converted into shares of common stock and the accrued dividend payable to holders of the convertible preferred stock was paid out in shares of common stock, resulting in a total of 42,926,630 shares of common stock being issued to former holders of the Company’s convertible preferred stock. Warrants exercisable for convertible preferred stock were automatically converted into warrants exercisable for a total of 410,239 shares of common stock. 2. LIQUIDITY AND CAPITAL RESOURCES The unaudited condensed 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 an accumulated deficit of $ 320,639 and $ 453,598 , as of September 30, 2022 and December 31, 2021, respectively. As of September 30, 2022, the Company had cash, cash equivalents and investments of $ 316,043 . The Company believes that its existing cash and cash equivalents on hand as of September 30, 2022, as well as additional cash generated from operating and financing activities will meet its operational liquidity needs and fund its planned investing activities for the next twelve months from the date of issuance of these unaudited condensed consolidated financial statements. 3. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Basis of Presentation The unaudited condensed 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 in consolidation. The unaudited condensed consolidated balance sheet as of September 30, 2022, the unaudited condensed consolidated statements of cash flows for the nine months ended September 30, 2022, and 2021, and the unaudited condensed 7 Table of Contents consolidated statements of operations and comprehensive income and the unaudited condensed consolidated statements of shareholders’ equity for the three and nine months ended September 30, 2022 and 2021, are unaudited. The balance sheet as of September 30, 2022, was derived from audited financial statements as of and for the year ended December 31, 2021. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual financial statements as of and for the year ended December 31, 2021, and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of September 30, 2022, and the results of its operations and its cash flows for the nine months ended September 30, 2022 and 2021. The unaudited condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and disclosures normally included in the financial statements prepared in accordance with GAAP have been condensed or omitted under the SEC’s rules and regulations. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements and accompanying notes thereto contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. The Company has updated certain prior period disclosures within Note 11 in order to conform with current period presentation. 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 unaudited condensed 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. Uncertainties related to the magnitude and duration of COVID-19, the extent to which it will impact our future financial results, worldwide macroeconomic conditions including interest rates, employment rates, consumer spending and health insurance coverage, the speed of the anticipated recovery and governmental and business reactions to the pandemic have increased the complexity of developing estimates and assumptions used in the preparation of the unaudited condensed consolidated financial statements, including the carrying amounts of long-lived assets, and the intangible asset. Actual results may differ significantly from our estimates as a result of COVID-19. 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 that equal the amount reflected in the statements of cash flows. ​ ​ ​ ​ ​ ​ ​ ​ ​ As of ​ September 30, December 31, ​ ​ 2022 ​ 2021 Cash and cash equivalents ​ $ 261,343 ​ $ 234,309 Restricted cash ​ 750 ​ 750 Total cash, cash equivalents, and restricted cash shown in the statements of cash flows ​ $ 262,093 ​ $ 235,059 ​ 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. 8 Table of Contents Investments The Company’s investments consist of debt securities that are classified as available-for-sale. The 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, net, on the unaudited condensed consolidated statements of operations and comprehensive income. Interest income and realized gains and losses, if any, are also recorded in interest expense, net, on the unaudited condensed 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 two 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. Management believes that the Company 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 also 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 September 30, 2022, three customers accounted for 100 % of gross accounts receivable; Caremark LLC (“CVS Caremark”), which accounted for 47 % of gross accounts receivable; Accredo Health Group, Inc. (“Accredo”), which accounted for 30 % of gross accounts receivable; and, PANTHERx Specialty Pharmacy LLC (“Pantherx”, which accounted for 23 % of gross accounts receivable. As of December 31, 2021, three customers accounted for 100 % of gross accounts receivable; Accredo, which accounted for 40 % of gross accounts receivable; Pantherx, which accounted for 31 % of gross accounts receivable; and CVS Caremark, which accounted for 29 % of gross accounts receivable. For the nine months ended September 30, 2022, three customers accounted for 100 % of gross product revenues; CVS Caremark accounted for 40 % of gross product revenues; Pantherx accounted for 30 % of gross product revenues; and Accredo accounted for 30 % of gross product revenues. For the nine months ended September 30, 2021, three customers accounted for 100 % of gross product revenues; CVS Caremark accounted for 36 % of gross product revenues; Pantherx accounted for 36 % of gross product revenues; and Accredo accounted for 28 % of gross product revenues. The Company depends on a single source supplier for each of its product and active pharmaceutical ingredient. Recently Issued Accounting Pronouncements ASU 2020-04, Reference Rate Reform (Topic 848). In March 2020, the FASB issued ASU No. 2020-04, Reference Rate Reform (Topic 848) , which provides guidance related to reference rate reform. The pronouncement provides temporary optional expedients and exceptions to the current guidance on contract modifications and hedge accounting to ease the financial reporting burden related to the expected market 9 Table of Contents transition from the London Interbank Offered Rate (“LIBOR”) and other interbank offered rates to alternative reference rates. The guidance was effective upon issuance and generally can be applied to applicable contract modifications through December 31, 2022. The Company is currently evaluating the impact of the transition from LIBOR to alternative reference rates but does not expect a significant impact to its condensed consolidated financial statements. 4. 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: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2022 ​ ​ Amortized ​ Unrealized ​ Unrealized ​ ​ Fair ​ ​ Cost ​ Gains ​ Losses ​ ​ Value Short-term: ​ ​ ​ ​ ​ ​ ​ ​ ​ Commercial paper $ 12,089 ​ 1 ​ ( 35 ) ​ $ 12,055 Corporate debt securities ​ 30,077 ​ 4 ​ ( 80 ) ​ ​ 30,001 U.S. government securities ​ 4,382 ​ — ​ ( 18 ) ​ ​ 4,364 Total short-term investments $ 46,548 ​ 5 ​ ( 133 ) ​ $ 46,420 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Long-term: ​ ​ ​ ​ ​ ​ ​ ​ ​ Corporate debt securities $ 8,074 ​ 3 ​ ( 50 ) ​ $ 8,027 U.S. government securities ​ 256 ​ — ​ ( 3 ) ​ ​ 253 Total long-term investments $ 8,330 ​ 3 ​ ( 53 ) ​ $ 8,280 ​ 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 unaudited condensed consolidated balance sheet. The investments classified as noncurrent have maturity dates ranging from 1 - 2 years . 5. FAIR VALUE MEASUREMENTS The Company’s unaudited condensed consolidated financial statements include cash, cash equivalents, restricted cash, accounts payable, and accrued liabilities, all of which are short term in nature and, accordingly, approximate fair value. It is the Company’s policy to measure non-financial assets and liabilities at fair value on a nonrecurring basis. These non-financial assets and liabilities are not measured at fair value on an ongoing basis but are subject to fair value adjustments in certain circumstances (such as evidence of impairment), which, if material, are disclosed in the accompanying footnotes. The Company measures certain assets and liabilities at fair value based on the fair value hierarchy that prioritizes inputs to valuation techniques used to measure fair value into three levels based on the source of inputs as follows: Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities. Level 2—Valuations based on observable inputs and quoted prices in active markets for similar assets and liabilities. 10 Table of Contents 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 September 30, 2022 or December 31, 2021. The Company’s assets measured at fair value consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2022 ​ December 31, 2021 ​ ​ Total ​ Level 1 ​ Level 2 ​ ​ Total ​ Level 1 ​ Level 2 Assets ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Cash equivalents $ 180,513 ​ 180,513 ​ — ​ $ 156,782 ​ 156,782 ​ — Commercial paper ​ 12,055 ​ — ​ 12,055 ​ ​ — ​ — ​ — Corporate debt securities ​ 38,028 ​ — ​ 38,028 ​ ​ — ​ — ​ — U.S. government securities ​ 4,617 ​ — ​ 4,617 ​ ​ — ​ — ​ — Total $ 235,213 ​ 180,513 ​ 54,700 ​ $ 156,782 ​ 156,782 ​ — ​ ​ 6. INVENTORY Inventory, net consisted of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ As of ​ September 30, December 31, ​ ​ 2022 ​ 2021 Raw materials ​ $ 605 ​ $ 986 Work in process ​ 1,802 ​ 1,787 Finished goods ​ 2,137 ​ 2,108 Inventory, gross ​ 4,544 ​ 4,881 Reserve for excess inventory ​ ( 644 ) ​ ( 449 ) Total inventory, net ​ $ 3,900 ​ $ 4,432 ​ ​ 7. 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 such intangible asset, and, as of September 30, 2022, the remaining useful life was 7.0 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 such intangible asset, and, as of September 30, 2022, the remaining useful life was 7.0 years. In February 2022, the Company attained $ 500,000 in life-to-date aggregate net sales of WAKIX in the United States. This event triggered a final $ 40,000 payment under the provisions of the 2017 LCA which the 11 Table of Contents Company capitalized as an intangible asset and paid in March of 2022. The Company determined a useful life of 7.6 years for such intangible asset, and, as of September 30, 2022, the remaining useful life was 7.0 years. Amortization expense was $ 5,962 and $ 4,573 for the three months ended September 30, 2022 and 2021, respectively, and $ 17,005 and $ 13,781 for the nine months ended September 30, 2022 and 2021, respectively, and is recorded in general and administrative expenses on the unaudited condensed consolidated statements of operations and comprehensive income. Future amortization expense relating to unamortized intangible assets as of September 30, 2022 for the periods indicated below consists of the following: ​ ​ ​ ​ ​ Years ending December 31, ​ ​ 2022 (Excluding the nine months ended September 30, 2022) ​ $ 5,961 2023 ​ 23,845 2024 ​ 23,845 2025 ​ 23,845 2026 ​ 23,845 Thereafter ​ ​ 65,573 Total ​ $ 166,914 ​ The gross carrying amount and net book value of the intangible assets is as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ As of ​ September 30, December 31, ​ ​ 2022 ​ 2021 Gross Carrying Amount ​ $ 215,000 ​ $ 175,000 Accumulated Amortization ​ ( 48,086 ) ​ ( 31,081 ) Net Book Value ​ $ 166,914 ​ $ 143,919 ​ ​ 8. LICENSE AND ASSET PURCHASE 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 $ 20,944 and $ 13,202 for the three months ended September 30, 2022 and 2021, respectively, and ­$ 51,741 and $ 34,561 for the nine months ended September 30, 2022 and 2021, respectively, for sales-based, trademark and tiered royalties recognized as cost of product sold. As of September 30, 2022 and December 31, 2021, the Company had accrued $ 20,944 and $ 16,396 , respectively, for sales-based, trademark and tiered royalties. On July 31, 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 12 Table of Contents 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 will pay an initial, non-refundable $ 30,000 licensing fee and additional payments of up to $ 155,000 are potentially due under the 2022 LCA upon the achievement of certain future development and sales-based milestones. In addition, there are certain 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. Upon the closing of the 2022 LCA on September 28, 2022, the $ 30,000 licensing fee was recorded in research and development within the unaudited condensed consolidated statement of operations and comprehensive loss for the three and nine months ended September 30, 2022. Agreement Related to Intellectual Property 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. Additionally, there are payments due under the APA upon the achievement of certain milestones including $ 1,750 for preclinical milestones, $ 19,000 for development milestones, $ 44,000 for regulatory milestones and $ 110,000 for sales milestones. 9. ACCRUED EXPENSES Accrued expenses consist of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ As of ​ September 30, December 31, ​ ​ 2022 ​ 2021 Royalties due to third parties ​ $ 20,944 ​ $ 16,396 Rebates and other sales deductions ​ 25,214 ​ 17,141 Interest ​ ​ 3,041 ​ ​ 2,125 Selling and marketing ​ 2,326 ​ 1,983 Research and development ​ 1,852 ​ 658 Professional fees, consulting, and other services ​ 1,229 ​ 1,645 Licensing fee ​ ​ 30,000 ​ ​ — Other expenses ​ 1,000 ​ 301 ​ ​ $ 85,606 ​ $ 40,249 ​ ​ ​ 10. DEBT 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. The repayment schedule for the Initial Term Loan consists of quarterly $ 500 principal payments, which commenced on December 31, 2021, and increasing to quarterly $ 5,000 principal payments beginning on March 31, 2024, with a $ 145,500 payment due on the maturity date of August 9, 2026 (“Maturity Date”). Interest is 13 Table of Contents payable quarterly, which commenced on November 9, 2021, and continues through the Maturity Date. The Initial Term Loan bears interest at a per annum rate equal to LIBOR, subject to a 1.00 % floor, plus 6.50 %. Net cash received from the Initial Term Loan as a result of the transaction, less debt issuance costs of $ 8,151 , was $ 191,849 . The debt issuance costs related to the Initial Term Loan are being amortized as additional interest expense over the five-year loan term of the Blackstone Credit Agreement. In addition, the Company paid $ 1,000 in debt issuance costs relating the DDTL, which are recorded in other current assets within the unaudited condensed consolidated balance sheet. The fair value of the Initial Term Loan as of September 30, 2022 was $ 149,226 . Long-term debt, net consists of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ September 30, December 31, ​ ​ 2022 ​ 2021 Liability component - principal ​ $ 198,000 ​ $ 199,500 Unamortized debt discount associated with debt financing costs ​ ( 6,275 ) ​ ( 7,516 ) Liability component - net carrying value ​ ​ 191,725 ​ ​ 191,984 Less current portion ​ ​ ( 2,000 ) ​ ​ ( 2,000 ) Long-term debt, net ​ $ 189,725 ​ $ 189,984 ​ Future minimum payments relating to long-term debt, net as of September 30, 2022, for the periods indicated below consists of the following: ​ ​ ​ ​ ​ Years ending December 31, ​ ​ ​ 2022 (Excluding the nine months ended September 30, 2022) ​ $ 500 2023 ​ 2,000 2024 ​ 20,000 2025 ​ 20,000 2026 ​ 155,500 Thereafter ​ ​ — Total ​ $ 198,000 ​ Interest expense related to the Company’s long-term debt, net, is included in interest expense, net in the unaudited condensed consolidated statements of operations and comprehensive income and consists of the following: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended ​ Nine Months Ended ​ ​ ​ September 30, ​ September 30, ​ ​ ​ 2022 2021 ​ 2022 2021 ​ Interest on principal balance ​ $ 4,513 ​ $ 5,030 ​ $ 12,110 ​ $ 18,122 ​ Amortization of deferred financing costs ​ 418 ​ 459 ​ 1,241 ​ 1,820 ​ Total term loan interest expense ​ $ 4,931 ​ $ 5,489 ​ $ 13,351 ​ $ 19,942 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 11. 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 expires in May 2024. In December 2020, the Company entered into an operating lease for approximately thirteen thousand square feet of additional office space in Plymouth Meeting, PA, which expires in May 2024. 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. 14 Table of Contents 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 $ 378 and $ 359 for the three months ended September 30, 2022 and 2021, respectively, and $ 1,155 and $ 916 for the nine months ended September 30, 2022 and 2021, respectively. As of September 30, 2022, the weighted-average remaining lease term for operating leases was 1.9 years and the weighted-average discount rate for operating leases was 3.8 %. Supplemental balance sheet information related to operating leases was as follows: ​ ​ ​ ​ ​ ​ ​ Leases Classification ​ September 30, 2022 ​ ​ December 31, 2021 Assets ​ ​ ​ ​ ​ ​ Operating lease right-of-use assets Other noncurrent assets $ 2,658 ​ $ 3,298 Liabilities ​ ​ ​ ​ ​ ​ Operating lease liability, current portion Other current liabilities $ 1,598 ​ $ 1,527 Operating lease liability, long-term Other long-term liabilities ​ 1,384 ​ ​ 2,233 Total operating lease liabilities ​ $ 2,982 ​ $ 3,760 ​ Supplemental cash flow information related to operating leases was as follows: ​ ​ ​ ​ ​ ​ ​ ​ September 30, 2022 ​ ​ September 30, 2021 Operating cash flows from operating leases $ 1,297 ​ $ 833 Right of use assets obtained in exchange for operating lease obligations (1) $ 485 ​ $ 3,365 (1) Including the balance recognized on January 1, 2021, upon adoption of ASU No. 2016-02. Future payments under noncancelable operating leases with initial terms of one year or more as of September 30, 2022 consisted of the following: ​ ​ ​ ​ Years ending December 31, ​ ​ 2022 (Excluding the nine months ended September 30, 2022) ​ $ 419 2023 ​ 1,679 2024 ​ 958 2025 ​ 34 2026 ​ — Thereafter ​ — Total lease payments ​ ​ 3,090 Less: imputed interest ​ ​ ( 108 ) Total lease liabilities ​ $ 2,982 ​ ​ ​ 12. COMMITMENTS AND CONTINGENCIES Litigation 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. As of September 30, 2022, there were no material claims or suits outstanding. 15 Table of Contents ​ 13. 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. 14. STOCK INCENTIVE PLAN AND STOCK-BASED COMPENSATION 2020 Stock Incentive Plan In connection with the Company’s IPO, the board of directors adopted, and its stockholders approved, the 2020 Incentive Award Plan (the “2020 Plan”), in order to facilitate the grant of cash and equity incentives to directors, employees (including the Company’s named executive officers) and consultants of the Company and its subsidiaries. The 2020 Plan provides for the grant of stock options, including incentive stock options (“ISOs”) and non-qualified stock options (“NSOs”), 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 September 30, 2022, there were 4,932,502 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 On August 7, 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, stock appreciation rights (“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. 16 Table of Contents Stock Options The following table summarizes stock option activity for the nine months ended September 30, 2022: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted- ​ ​ ​ ​ Weighted- ​ Average ​ ​ ​ ​ Average ​ Remaining ​ ​ Number of ​ Exercise ​ Contractual ​ Awards Price Term Awards outstanding—December 31, 2021 5,716,597 ​ $ 22.53 8.09 Awards issued 1,533,961 ​ $ 48.59 Awards exercised ( 457,145 ) ​ $ 10.72 Awards forfeited ( 168,758 ) ​ $ 31.42 Awards outstanding—September 30, 2022 6,624,655 ​ $ 29.15 7.94 ​ Stock Appreciation Rights The following table summarizes SARs activity for the nine months ended September 30, 2022: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted- ​ ​ ​ ​ Weighted- ​ Average ​ ​ ​ ​ Average ​ Remaining ​ ​ Number of ​ Exercise ​ Contractual ​ Awards Price Term Awards outstanding—December 31, 2021 49,294 ​ $ 9.24 7.29 Awards issued — ​ $ — Awards exercised ( 3,651 ) ​ $ 8.22 Awards forfeited ( 2,435 ) ​ $ 8.22 Awards outstanding—September 30, 2022 43,208 ​ $ 9.38 6.58 ​ Restricted Stock Units The following table summarizes RSU activity for the nine months ended September 30, 2022: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Weighted- ​ ​ ​ ​ Weighted- ​ Average ​ ​ ​ ​ Average ​ Remaining ​ ​ Number of ​ Exercise ​ Contractual ​ Awards Price Term Awards outstanding—December 31, 2021 60,000 ​ $ 29.03 9.24 Awards issued — ​ $ — Awards exercised — ​ $ — Awards forfeited — ​ $ — Awards outstanding—September 30, 2022 60,000 ​ $ 29.03 8.49 ​ As of September 30, 2022 and December 31, 2021, stock awards issued under the 2017 and 2020 Plans of 1,753,234 and 1,285,432 common shares, respectively, were vested. 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- 17 Table of Contents 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. ​ ​ ​ ​ ​ ​ ​ ​ ​ As of ​ September 30, December 31, ​ ​ 2022 2021 ​ Dividend yield 0.00 % 0.00 % Expected volatility 72.57 - 76.33 % 60.00 % Risk-free interest rate 1.99 - 4.05 % 0.66 - 1.44 % Expected term (years) 3.4 - 6.3 4.1 - 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 2020 Plan was $ 17.60 and $ 12.82 on September 30, 2022 and December 31, 2021, respectively. Stock-Based Compensation Expense Stock-based compensation expense, net for the three and nine months ended September 30, 2022 and 2021, was recorded in the unaudited condensed consolidated statements of operations and comprehensive income in the following line items: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended September 30, ​ Nine Months Ended September 30, ​ 2022 2021 2022 2021 Research and development expense ​ $ 522 ​ $ 579 ​ $ 1,866 ​ $ 1,548 Sales and marketing expense ​ 1,096 ​ 852 ​ 2,956 ​ 2,248 General and administrative expense ​ 5,349 ​ 3,233 ​ 14,412 ​ 7,926 ​ ​ $ 6,967 ​ $ 4,664 ​ $ 19,234 ​ $ 11,722 ​ Stock-based compensation expense, net related to Options and RSUs issued under the 2017 Plan and 2020 Plan is included in stockholder’s equity, and a liability for SARs is included in other non-current liabilities, in the Company’s unaudited condensed consolidated balance sheet. As of September 30, 2022, the total unrecognized stock-based compensation expense related to Options and RSUs was $ 83,981 . Such amount will be recognized in the Company’s consolidated statement of operations over a weighted average period of 3.1 years. ​ Employee Stock Purchase Plan The 2021 Employee Stock Purchase Plan (“ESPP”) was adopted by the Company’s Board of Directors on April 30, 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 18 Table of Contents intended that the ESPP meet the requirements for an “employee stock purchase plan” under Section 423 of the Internal Revenue Code. For both the three and nine months ended September 30, 2022, there were 14,889 shares issued under the ESPP. There were no shares issued under the ESPP for the three and nine months ended September 30, 2021. The discount on the ESPP was $ 86 and $ 60 for the three months ended September 30, 2022 and 2021, respectively, and $ 271 and $ 80 for the nine months ended September 30, 2022 and 2021, respectively, and is recorded within stock-based compensation expense. 15. EARNINGS PER SHARE Basic earnings per share is calculated by dividing net income by the weighted average number of shares of common stock outstanding. 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, the potential dilutive effects of stock options, stock appreciation rights, restricted stock units and warrants. The following table sets forth the computation of basic and diluted net income per share: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended September 30, ​ Nine Months Ended September 30, ​ ​ 2022 2021 2022 2021 Numerator ​ ​ ​ ​ ​ Net income ​ $ 87,943 ​ $ ( 9,620 ) ​ $ 132,959 ​ $ 11,883 Denominator ​ ​ ​ ​ Net income per common share - basic ​ $ 1.48 ​ $ ( 0.17 ) ​ $ 2.25 ​ $ 0.21 Net income per common share - diluted ​ $ 1.44 ​ $ ( 0.17 ) ​ $ 2.18 ​ $ 0.20 Weighted average number of shares of common stock - basic ​ 59,234,720 ​ 57,722,163 ​ 59,070,063 ​ 57,188,101 Weighted average number of shares of common stock - diluted ​ 61,207,625 ​ 57,722,163 ​ 60,921,482 ​ 58,776,158 ​ Securities outstanding that are included in the computation above, utilizing the treasury stock method are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended September 30, ​ Nine Months Ended September 30, ​ ​ 2022 2021 2022 2021 Stock options, SARs, and RSUs to purchase common stock ​ ​ 1,972,905 ​ ​ — ​ ​ 1,851,419 ​ ​ 1,405,092 Warrants ​ ​ — ​ ​ — ​ ​ — ​ ​ 182,965 Total ​ ​ 1,972,905 ​ ​ — ​ ​ 1,851,419 ​ ​ 1,588,057 ​ Potential common shares issuable that were excluded from the computation of diluted weighted-average shares outstanding excluded from the numerator, are as follows: ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ Three Months Ended September 30, ​ Nine Months Ended September 30, ​ ​ ​ 2022 2021 2022 2021 ​ Stock options, SARs, and RSUs to purchase common stock ​ 4,754,958 ​ 6,085,742 ​ ​ 4,876,444 ​ 4,680,651 ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ ​ 16. INCOME TAXES As of September 30, 2022 and December 31, 2021, our deferred tax assets were primarily the result of acquired in-process research and development costs, operating loss carryforwards, deferred research and development costs, disallowed interest, inventory, and accrued rebates. A valuation allowance of $ 96,366 was recorded against our net deferred tax asset balance as of December 31, 2021. We recorded a tax benefit of $ 74,474 as a discrete item in the three and nine months ended September 30, 2022 related to the release of a 19 Table of Contents valuation allowance on certain deferred tax assets, net, which had accumulated through December 31, 2021. We also recorded a tax benefit of $ 21,892 as a component to our current year effective tax rate in the three and nine months ended September 30, 2022, related to deferred tax assets, net which were utilized in the current period. ​ As of each reporting date, the Company considers new evidence, both positive and negative, that could affect its view of the future realization of deferred tax assets. As of September 30, 2022, in part because in the current quarter we achieved three years of cumulative pretax income, which is 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 is more likely than not that additional deferred taxes are realizable and, therefore, released the valuation allowance accordingly. ​ 17. RELATED-PARTY TRANSACTIONS The Company was party to a management agreement for professional services provided by a related party, Paragon Biosciences, LLC (“Paragon”). The related party 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 terminated the management agreement upon the consummation of its IPO. The Company is also 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. In addition, the Company had participated in certain transactions with separate related parties that also share common ownership with the Company, primarily related to combined employee health plans. The Company incurred $ 71 for each of the three months ended September 30, 2022 and 2021, and $ 213 for each of the nine months ended September 30, 2022 and 2021, in expenses to this related party, which are included in general and administrative expense in the unaudited condensed consolidated statements of operations and comprehensive loss. As of September 30, 2022 and December 31, 2021, there were no amounts due to or due from related parties included in the unaudited condensed consolidated balance sheets. ​ 20 Table of Contents