Cover Page
Cover Page - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 15, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-35986 | ||
Entity Registrant Name | Esperion Therapeutics, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 26-1870780 | ||
Entity Address, Address Line One | 3891 Ranchero Drive, Suite 150 | ||
Entity Address, City or Town | Ann Arbor | ||
Entity Address, State or Province | MI | ||
Entity Address, Postal Zip Code | 48108 | ||
City Area Code | 734 | ||
Local Phone Number | 887-3903 | ||
Title of 12(b) Security | Common Stock, $0.001 par value | ||
Trading Symbol | ESPR | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 142.5 | ||
Entity Common Stock, Shares Outstanding | 185,052,705 | ||
Documents Incorporated by Reference | Part III of this Annual Report on Form 10-K incorporates by reference information from the definitive Proxy Statement for the registrant’s 2024 Annual Meeting of Shareholders, which is expected to be filed with the Securities and Exchange Commission not later than 120 days after the Registrant’s fiscal year ended December 31, 2023. | ||
Entity Central Index Key | 0001434868 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2023 | |
Audit Information [Abstract] | |
Auditor Name | Ernst & Young LLP |
Auditor Location | Detroit, Michigan |
Auditor Firm ID | 42 |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 82,248 | $ 124,775 |
Short-term investments | 0 | 42,086 |
Accounts receivable | 48,494 | 33,729 |
Inventories, net | 65,623 | 35,201 |
Prepaid clinical development costs | 193 | 1,026 |
Other prepaid and current assets | 4,507 | 9,866 |
Total current assets | 201,065 | 246,683 |
Noncurrent assets: | ||
Property and equipment, net | 0 | 164 |
Right of use operating lease assets | 4,675 | 1,036 |
Intangible assets | 56 | 56 |
Total assets | 205,796 | 247,939 |
Current liabilities: | ||
Accounts payable | 31,718 | 23,040 |
Accrued clinical development costs | 3,441 | 5,426 |
Accrued legal fees | 34,284 | 21,987 |
Other accrued liabilities | 24,998 | 13,204 |
Revenue interest liability | 34,828 | 24,760 |
Deferred revenue from collaborations | 25,402 | 3,507 |
Operating lease liabilities | 1,553 | 384 |
Total current liabilities | 156,224 | 92,308 |
Convertible notes, net of issuance costs | 261,596 | 259,899 |
Revenue interest liability | 239,950 | 218,845 |
Operating lease liabilities | 3,020 | 665 |
Total liabilities | 660,790 | 571,717 |
Commitments and contingencies (Note 5) | ||
Stockholders’ (deficit) equity: | ||
Preferred stock, $0.001 par value; 5,000,000 shares authorized and no shares issued or outstanding as of December 31, 2023 and December 31, 2022 | 0 | 0 |
Common stock, $0.001 par value; 480,000,000 shares authorized as of December 31, 2023 and 240,000,000 shares authorized as of December 31, 2022; 120,204,513 shares issued at December 31, 2023 and 76,564,396 shares issued at December 31, 2022 | 118 | 75 |
Additional paid-in capital | 1,149,170 | 1,071,183 |
Treasury stock, at cost; 1,994,198 shares at December 31, 2023 and December 31, 2022 | (54,998) | (54,998) |
Accumulated other comprehensive loss | 0 | (2) |
Accumulated deficit | (1,549,284) | (1,340,036) |
Total stockholders' deficit | (454,994) | (323,778) |
Total liabilities and stockholders' deficit | $ 205,796 | $ 247,939 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 480,000,000 | 240,000,000 |
Common stock, shares issued (in shares) | 120,204,513 | 76,564,396 |
Treasury stock (in shares) | 1,994,198 | 1,994,198 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Revenues: | ||
Total Revenues | $ 116,334 | $ 75,475 |
Operating expenses: | ||
Cost of goods sold | 43,267 | 26,967 |
Research and development | 86,107 | 118,927 |
Selling, general and administrative | 142,523 | 109,082 |
Total operating expenses | 271,897 | 254,976 |
Loss from operations | (155,563) | (179,501) |
Interest expense | (58,976) | (56,810) |
Other income, net | 5,291 | 2,652 |
Net loss | $ (209,248) | $ (233,659) |
Net loss per common share - basic (in dollars per share) | $ (2.03) | $ (3.52) |
Net loss per common share - diluted (in dollars per share) | $ (2.03) | $ (3.52) |
Weighted-average shares outstanding - basic (in shares) | 103,106,616 | 66,407,242 |
Weighted-average shares outstanding - diluted (in shares) | 103,106,616 | 66,407,242 |
Other comprehensive (loss) gain: | ||
Unrealized gain on investments | $ 2 | $ 29 |
Total comprehensive loss | (209,246) | (233,630) |
Product | ||
Revenues: | ||
Total Revenues | 78,335 | 55,863 |
Collaboration Revenue | ||
Revenues: | ||
Total Revenues | $ 37,999 | $ 19,612 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Treasury Stock | Accumulated Other Comprehensive Loss |
Beginning balance (in shares) at Dec. 31, 2021 | 60,879,496 | |||||
Beginning balance at Dec. 31, 2021 | $ (196,944) | $ 61 | $ 964,401 | $ (1,106,377) | $ (54,998) | $ (31) |
Increase (Decrease) in Stockholders' Equity | ||||||
Issuance of common stock from ATM Program, net of issuance costs (in shares) | 13,043,797 | |||||
Issuance of common stock from ATM Program, net of issuance costs | 90,848 | $ 13 | 90,835 | |||
Vesting of restricted stock units (in shares) | 440,697 | |||||
Vesting of restricted stock units | 1 | $ 1 | ||||
Vesting of ESPP Shares (in shares) | 206,208 | |||||
Vesting of ESPP Shares | 732 | 732 | ||||
Stock-based compensation | 15,215 | 15,215 | ||||
Other comprehensive gain (loss) | 29 | 29 | ||||
Net loss | (233,659) | (233,659) | ||||
Ending balance (in shares) at Dec. 31, 2022 | 74,570,198 | |||||
Ending balance at Dec. 31, 2022 | (323,778) | $ 75 | 1,071,183 | (1,340,036) | (54,998) | (2) |
Increase (Decrease) in Stockholders' Equity | ||||||
Issuance of common stock and warrants from offering, net of issuance costs (in shares) | 12,205,000 | |||||
Issuance of common stock and warrants from offering, net of issuance costs | 52,428 | $ 12 | 52,416 | |||
Issuance of common stock from ATM Program, net of issuance costs (in shares) | 3,312,908 | |||||
Issuance of common stock from ATM Program, net of issuance costs | 4,448 | $ 3 | 4,445 | |||
Vesting of restricted stock units (in shares) | 1,034,631 | |||||
Vesting of restricted stock units | 1 | $ 1 | ||||
Vesting of ESPP Shares (in shares) | 271,084 | |||||
Vesting of ESPP Shares | 740 | 740 | ||||
Stock-based compensation | 11,958 | 11,958 | ||||
Exercise of pre-funded warrants (in shares) | 20,965,747 | |||||
Exercise of pre-funded warrants | 21 | $ 21 | ||||
Exercise of warrants (in shares) | 5,850,747 | |||||
Exercise of warrants | 8,434 | $ 6 | 8,428 | |||
Other comprehensive gain (loss) | 2 | 2 | ||||
Net loss | (209,248) | (209,248) | ||||
Ending balance (in shares) at Dec. 31, 2023 | 118,210,315 | |||||
Ending balance at Dec. 31, 2023 | $ (454,994) | $ 118 | $ 1,149,170 | $ (1,549,284) | $ (54,998) | $ 0 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating activities | ||
Net loss | $ (209,248) | $ (233,659) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation expense | 164 | 500 |
Amortization of premiums and discounts on investments | (412) | 279 |
Amortization of discount and issuance costs on convertible notes | 1,697 | 1,621 |
Non-cash interest expense related to the revenue interest liability | 46,679 | 44,590 |
Stock-based compensation expense | 11,958 | 15,215 |
Changes in assets and liabilities: | ||
Accounts receivable | (14,765) | (10,795) |
Prepaids and other assets | 6,192 | 1,419 |
Deferred revenue | 21,895 | (2,810) |
Inventories | (30,422) | (807) |
Accounts payable | 8,678 | 5,603 |
Other accrued liabilities | 22,097 | 4,017 |
Net cash used in operating activities | (135,487) | (174,827) |
Investing activities | ||
Purchases of investments | 0 | (59,897) |
Proceeds from sales/maturities of investments | 42,500 | 68,001 |
Net cash provided by investing activities | 42,500 | 8,104 |
Financing activities | ||
Proceeds from issuance of common stock and warrants from offering, net of issuance costs | 52,428 | 0 |
Proceeds from issuance of common stock from ATM Program, net of issuance costs | 4,448 | 90,849 |
Proceeds from exercise of warrants | 9,069 | 0 |
Proceeds from exercise of pre-funded warrants | 21 | 0 |
Payments on revenue interest liability | (15,506) | (8,024) |
Repayment of principal on revenue interest liability | 0 | (50,000) |
Payment for other issuance costs | 0 | (219) |
Net cash provided by financing activities | 50,460 | 32,606 |
Net decrease in cash, cash equivalents and restricted cash | (42,527) | (134,117) |
Cash, cash equivalents and restricted cash at beginning of period | 124,775 | 258,892 |
Cash and cash equivalents at end of period | 82,248 | 124,775 |
Supplemental disclosure of cash flow information: | ||
Issuance costs not yet paid | 635 | 1 |
Non-cash right of use asset | $ 115 | $ 5 |
The Company and Basis of Presen
The Company and Basis of Presentation | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
The Company and Basis of Presentation | The Company and Basis of Presentation Esperion Therapeutics, Inc. ("the Company”) is a pharmaceutical company currently focused on developing and commercializing accessible, oral, once-daily, non-statin medicines for patients struggling with elevated low density lipoprotein cholesterol ("LDL-C"). Through commercial execution and completion of the CLEAR Outcomes trial as well as advancing the Company's pre-clinical pipeline, the Company continues to evolve into a differentiated, global biotech. The Esperion team of experts are dedicated to lowering LDL-cholesterol through the discovery, development and commercialization of innovative medicines and their combinations with established medicines. The Company's first two products were approved by the U.S. Food and Drug Administration ("FDA"), European Medicines Agency ("EMA") and Swiss Agency for Therapeutic Products ("Swissmedic") in 2020. NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) tablets are oral, once-daily, non-statin medicines for the treatment of primary hyperlipidemia in adults with heterozygous familial hypercholesterolemia ("HeFH") or atherosclerotic cardiovascular disease ("ASCVD"), who require additional lowering of LDL-C. The Company completed a global cardiovascular outcomes trial ("CVOT"), —known as C holesterol L owering via B E mpedoic Acid, an A CL-inhibiting R egimen ("CLEAR") Outcomes. The trial was designed to evaluate whether treatment with bempedoic acid reduced the risk of cardiovascular events in patients who are statin averse and who have cardiovascular disease ("CVD") or are at high risk for CVD. The Company initiated the CLEAR Outcomes CVOT in December 2016 and fully enrolled the study with nearly 14,000 patients in August 2019. The primary endpoint of the study was the effect of bempedoic acid on four types of major adverse cardiovascular events ("MACE") (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or coronary revascularization; also referred to as "four-component MACE"). CLEAR Outcomes was an event-driven trial and concluded once the predetermined number of MACE endpoints occurred. On December 7, 2022, the Company announced that the study had met its primary endpoint. On March 4, 2023, the Company announced the full results from the CLEAR Outcomes trial. The study showed that bempedoic acid demonstrated significant cardiovascular risk reductions and significantly reduced the risk of heart attack and coronary revascularization as compared to placebo. These results were seen in a broad population of primary and secondary prevention patients who are unable to maximize or tolerate a statin. The proportions of patients experiencing adverse events and serious adverse events were similar between the active and placebo treatment groups. Bempedoic acid, contained in NEXLETOL (bempedoic acid) tablets and NEXLIZET (bempedoic acid and ezetimibe) tablets, became the first LDL-C lowering therapy since statins to demonstrate the ability to lower hard ischemic events, not only in those with ASCVD but also in the large number of primary prevention patients for whom limited therapies exist. On March 19, 2023, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain purchasers named therein (the “Purchasers”), pursuant to which the Company agreed to issue and sell, in a registered direct offering (the “Registered Direct Offering”), 12,205,000 shares of its common stock, par value $0.001 per share (the “Common Stock”), pre-funded warrants to purchase up to an aggregate of 20,965,747 shares of Common Stock (the “Pre-Funded Warrants”) in lieu of shares of Common Stock, and warrants to purchase up to 33,170,747 shares of Common Stock (the “Warrants”). The combined purchase price of each share of Common Stock and accompanying Warrant is $1.675 per share. The purchase price of each Pre-Funded Warrant and the accompanying Warrant is $1.674 (equal to the combined purchase price per share of Common Stock and accompanying Warrant, minus $0.001). The Purchase Agreement contains customary representations, warranties, covenants and indemnification rights and obligations of the Company and the Purchasers. The Registered Direct Offering closed on March 22, 2023. In connection with the Registered Direct Offering, the Company amended, pursuant to Warrant Amendment Agreements (the “Warrant Amendment Agreements”), certain existing warrants to purchase up to an aggregate of 9,024,212 shares of the Company's common stock that were previously issued in December 2021 at an exercise price of $9.00 per share and had an expiration date of December 7, 2023, effective upon the closing of the Registered Direct Offering, such that the amended warrants have a reduced exercise price of $1.55 per share and expire three and one half years following the closing of the Registered Direct Offering, for additional consideration of $0.125 per amended warrant. The Company received gross proceeds of approximately $55.5 million from the Registered Direct Offering, before deducting placement agent fees and related offering expenses. The net proceeds to the Company from the Registered Direct Offering, after deducting the placement agent fees and expenses and the Company’s estimated offering expenses, are approximately $51.3 million. In addition, the Company received approximately $1.2 million as the gross consideration in connection with the Warrant Amendment Agreements. The net proceeds of the Warrant Amendment Agreements after deducting placement fees were approximately $1.1 million. Refer to Note 12 "Stockholders' Deficit" for further information. On June 1, 2023, the Company announced that it submitted Supplemental New Drug Applications ("sNDAs") to the FDA seeking to add the use of both NEXLETOL and NEXLIZET for cardiovascular risk reduction and also seeking to remove the statin limitation in the LDL-C indication. Subsequently, the FDA accepted the sNDAs with an anticipated Prescription Drug User Fee Act date, or target action date, of March 31, 2024. On June 28, 2023, the Company announced that the application was filed for a Type II(a) variation with the EMA for the Company’s oral non-statin products marketed as NILEMDO® (bempedoic acid) tablets and NUSTENDI® (bempedoic acid and ezetimibe) tablets in Europe. The application asks EMA to approve both NILEMDO and NUSTENDI to reduce cardiovascular risk in patients with or at high risk for atherosclerotic cardiovascular disease. The Company anticipates EMA approval in the second quarter of 2024. On January 2, 2024, the Company entered into a settlement agreement with Daiichi Sankyo Europe GmbH ("DSE") to amicably resolve and dismiss the commercial dispute then pending in the Southern District of New York ("Settlement Agreement"). Under the Settlement Agreement, DSE agreed to pay the Company an aggregate of $125 million, including (1) a $100-million payment within 15 business days of the effective date of the Settlement Agreement and (2) a $25-million payment in the calendar quarter immediately following the calendar quarter in which the EMA renders a decision on the application that was filed with the EMA for a Type II(a) variation for the Company's oral non-statin products marketed as NILEMDO® (bempedoic acid) tablets and NUSTENDI® (bempedoic acid and ezetimibe) tablets in Europe. The application asks the EMA to approve both NILEMDO and NUSTENDI to reduce cardiovascular risk in patients with or at high risk for atherosclerotic cardiovascular disease. The legal action pending in the United States District Court for the Southern District of New York has now been dismissed. Refer to Note 3 "Collaborations with Third Parties," Note 5 "Commitments and Contingencies," and Note 18 "Subsequent Events" for further information. On January 18, 2024, the Company entered into an Underwriting Agreement (the “Underwriting Agreement”) with Jefferies LLC (“Jefferies”), as representative of several underwriters (the “Underwriters”), related to an underwritten public offering (the “January 2024 Offering”) of 56,700,000 shares of common stock of the Company, par value $0.001 per share (“Common Stock”), at a purchase price to the public of $1.50 per share. The Underwriters were also granted a 30-day option to purchase up to an additional 8,505,000 shares of Common Stock, at the public offering price. On January 19, 2024, Jefferies gave notice to the Company of its election to exercise the option to purchase additional shares, in full. Giving effect to the exercise of Underwriters' option, the offering proceeds to the Company were approximately $90.8 million, after deducting the underwriting discount and estimated offering expenses. The January 2024 Offering closed on January 23, 2024. The Company's primary activities since incorporation have been conducting research and development activities, including nonclinical, preclinical and clinical testing, performing business and financial planning, recruiting personnel, raising capital, and commercializing its products. The Company received approval by the FDA in February 2020 to commercialize NEXLETOL and NEXLIZET in the U.S., and accordingly commenced principal operations on March 30, 2020 with the commercialization of NEXLETOL. The Company is subject to risks and uncertainties which include the need to successfully commercialize its products, research, develop, and clinically test therapeutic products; obtain regulatory approvals for its products; successfully manage relationships with its collaboration partners; expand its management, commercial and scientific staff; and finance its operations with an ultimate goal of achieving profitable operations. The Company has sustained annual operating losses since inception and expects such losses to continue over the foreseeable future. While management believes current cash resources, including the cash received in January 2024 as disclosed in Note 18 "Subsequent Events," and future cash received from the Company's net product sales and collaboration agreements with DSE, Otsuka Pharmaceutical Co., Ltd ("Otsuka"), and Daiichi Sankyo Co. Ltd ("DS"), entered into on January 2, 2019, April 17, 2020 and April 26, 2021, respectively, will fund operations for the foreseeable future, management may continue to fund operations and advance the development of the Company's products and product candidates through a combination of collaborations with third parties, strategic alliances, licensing arrangements, permitted debt financings, permitted royalty-based financings, and permitted private and public equity offerings or through other sources. If adequate funds are not available, the Company may not be able to continue the development of its current products or future product candidates, or to commercialize its current or future product candidates, if approved. Basis of Presentation The accompanying financial statements have been prepared by the Company in accordance with generally accepted accounting principles in the United States of America (“GAAP”). |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in accordance with generally accepted accounting principles in the United States requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, net revenues, expenses and related disclosures. Actual results could differ from those estimates. Cash and Cash Equivalents The Company invests its excess cash in bank deposits, money market accounts, and short-term investments. The Company considers all highly liquid investments with an original maturity of 90 days or less at the time of purchase to be cash equivalents. Cash equivalents are reported at fair value. Restricted Cash Restricted cash consists of legally restricted amounts held by financial institutions pursuant to contractual arrangements. Pursuant to the Amendment and Waiver (as defined below), in 2021 the Company deposited $50.0 million in a deposit account that was subject to a block account control agreement. Oberland had the sole control over the funds deposited in the account and such funds could be withdrawn only with the consent of Eiger III SA LLC, or Oberland, an affiliate of Oberland Capital LLC. On November 23, 2022, pursuant to the Waiver and Amendment No. 3, the Company agreed to make a one-time partial call payment with regards to the Revenue Interests, as defined in the Revenue Interest Purchase Agreement ("RIPA"), in the amount of $50.0 million, the full amount that was subject to the block account control agreement. Refer to Note 10 "Liability Related to the Revenue Interest Purchase Agreement" for further information on the Amendment and Waiver. Investments Investments are considered to be available-for-sale and are carried at fair value. Unrealized gains and losses, if any, are reported in accumulated other comprehensive income (loss). The cost of investments classified as available-for-sale are adjusted for the amortization of premiums and accretion of discounts to maturity and recorded in other income, net. Realized gains and losses, if any, are determined using the specific identification method and recorded in other income, net. Investments with original maturities beyond 90 days at the date of purchase and which mature at, or less than twelve months from, the balance sheet date are classified as current. Investments with a maturity beyond twelve months from the balance sheet date are classified as long-term. Selling, General and Administrative Expenses Selling, general and administrative expenses primarily consist of salaries and benefits, stock-based compensation, and costs of programs necessary for the general conduct of the Company's business, including costs associated with the commercialization of NEXLETOL and NEXLIZET in the U.S. Selling, general and administrative expenses are expensed as costs are incurred, services are performed, or goods are delivered. The Company incurred advertising costs of $15.6 million and $11.3 million for the years ended December 31, 2023 and December 31, 2022, respectively. Concentration of Credit Risk Cash, cash equivalents, and investments consist of financial instruments that potentially subject the Company to concentrations of credit risk. The Company has established guidelines for investment of its excess cash and believes the guidelines maintain safety and liquidity through diversification of counterparties and maturities. The Company enters into a limited number of distribution agreements with distributors and specialty pharmacies. The Company's net product sales are with these customers. As of December 31, 2023, eleven customers accounted for all of the Company's net trade receivables and as of December 31, 2022 eleven customers accounted for all the Company's net trade receivables. As of December 31, 2023, three customers hold approximately 96% of the Company's trade receivables associated with net product sales and accounted for approximately 95% of gross sales of NEXLETOL and NEXLIZET in 2023. Inventories Inventories are stated at the lower of cost or net realizable value and recognized on a first-in, first-out ("FIFO") method. The Company uses standard cost to determine the cost basis for inventory. Inventory is capitalized based on when future economic benefit is expected to be realized. The Company analyzes its inventory levels on a periodic basis to determine if any inventory is at risk for expiration prior to sale or has a cost basis that is greater than its estimated future net realizable value. Any adjustments are recognized through cost of goods sold in the period in which they are incurred. Segment Information The Company views its operations and manages its business in one operating segment, which is the business of researching, developing and commercializing therapies for the treatment of patients with elevated LDL-C. Fair Value of Financial Instruments The Company’s cash, cash equivalents, and investments are carried at fair value. Financial instruments, including accounts receivable, other prepaid and current assets, accounts payable and accrued liabilities are carried at cost, which approximates fair value. Debt is carried at amortized cost, which approximates fair value. Property and Equipment, Net Property and equipment are recorded at cost, less accumulated depreciation. Depreciation is provided using the straight-line method over the estimated useful lives of the respective assets, generally three Impairment of Long-Lived Assets The Company reviews long-lived assets, including property and equipment and right-of-use operating lease assets, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. The impairment loss, if recognized, would be based on the excess of the carrying value of the impaired asset over its respective fair value. No impairment losses have been recorded through December 31, 2023. Leases The Company reviews all arrangements to determine if the contract contains a lease or an embedded lease using the criteria in Accounting Standards Codification ("ASC") 842 Leases ("ASC 842"). If a lease is identified, the Company reviews the consideration in the contract and separates the lease components from the nonlease components. In addition, the Company reviews the classification of the lease between operating and finance leases. According to ASC 842, lessees should discount lease payments at the lease commencement date using the rate implicit in the lease. If the rate implicit in the lease is not readily determinable, a lessee must use its incremental borrowing rate for purposes of classifying the lease and measuring the right-of-use asset and liability. To the extent the rate is not implicit in the lease, the Company uses the incremental borrowing rate it would have to pay to borrow on a collateralized basis over a similar term in an amount equal to the lease payments in a similar economic environment. Convertible Notes The convertible notes are reported as a single liability at their amortized costs on the balance sheets, net of unamortized issuance costs. Issuance costs are amortized to interest expense over the life of the convertible debt. The Company uses the if-converted method when calculating diluted earnings per share. Revenue Interest Liability The revenue interest liability is presented net of deferred issuance costs on the balance sheets. The Company imputes interest expense associated with this liability using the effective interest rate method. The effective interest rate is calculated based on the rate that would enable the debt to be repaid in full over the anticipated life of the arrangement. The interest rate on the liability may vary during the term of the agreement depending on a number of factors, including the level of forecasted net sales. The Company evaluates the interest rate quarterly based on its current net sales forecasts utilizing the prospective method. Revenue Recognition In accordance with ASC 606, Revenue from Contracts with Customers ("ASC 606"), the Company recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for the goods or services provided. To determine revenue recognition for arrangements within the scope of ASC 606, the Company performs the following five steps: identify the contracts with a customer; identify the performance obligations in the contract; determine the transaction price; allocate the transaction price to the performance obligations in the contract; and recognize revenue when or as the entity satisfies a performance obligation. At contract inception the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when or as the performance obligation is satisfied. The Company derives revenue through two primary sources: collaboration revenue and product sales. Collaboration revenue consists of the collaboration payments to the Company for collaboration arrangements outside of the United States for the development, manufacturing and commercialization of the Company's product candidates by the Company's partners and product sales consists of sales of NEXLETOL and NEXLIZET in the United States. a. Collaboration Revenue The Company has entered into agreements related to its activities to develop, manufacture, and commercialize its product candidates. The Company earns collaboration revenue in connection with a collaboration agreement to develop and/or commercialize product candidates where the Company deems the collaborator to be the customer. In accordance with ASC 606, revenue is measured as the amount of consideration expected to be entitled to in exchange for transferring promised goods or providing services to a customer. Revenue is recognized when (or as) the Company satisfies performance obligations under the terms of a contract. Depending on the terms of the arrangement, the Company may defer the recognition of all or a portion of the consideration received as the performance obligations are satisfied. The collaboration agreements may require the Company to deliver various rights, services, and/or goods across the entire life cycle of a product or product candidate. In an agreement involving multiple goods or services promised to be transferred to a customer, the Company must assess, at the inception of the contract, whether each promise represents a separate performance obligation (i.e., is "distinct"), or whether such promises should be combined as a single performance obligation. The terms of the agreements typically include consideration to be provided to the Company in the form of non-refundable up-front payments, development milestones, sales milestones, and royalties on sales of products within a respective territory. The Company recognizes regulatory and approval milestones consideration when it is probable that a future reversal is unlikely to occur. For sales based milestones and royalties based on sales of product in a territory, the Company applies the sales-based royalty exception in ASC 606 to all of these milestones and royalties. At the inception of a contract, the transaction price reflects the amount of consideration the Company expects to be entitled to in exchange for transferring promised goods or services to its customer. In the arrangement where the Company satisfies performance obligation(s) during the regulatory phase over time, the Company recognizes collaboration revenue typically using an input method on the basis of regulatory costs incurred relative to the total expected cost which determines the extent of progress toward completion. The Company reviews the estimate of the transaction price and the total expected cost each period, and makes revisions to such estimates as necessary. Under contracted supply agreements with collaborators, the Company may manufacture and supply quantities of active pharmaceutical ingredient (“API”) or bulk tablets reasonably required by collaboration partners for the development or sale of licensed products in their respective territory. The Company recognizes revenue when the collaboration partner has obtained control of the API or bulk tablets. The Company records the costs related to the supply agreement in cost of goods sold on the statements of operations and comprehensive income (loss). Under the Company's collaboration agreements, product sales and cost of sales may be recorded by the Company's collaborators as they are deemed to be the principal in the transaction. The Company receives royalties from the commercialization of such products, and records its share of the variable consideration, representing a percentage of net product sales, as collaboration revenue in the period in which such underlying sales occur and costs are incurred by the collaborators. b. Product Sales, Net On March 30, 2020, NEXLETOL was commercially available in the U.S. through prescription and on June 4, 2020, NEXLIZET was commercially available in the U.S. through prescription. Net product sales totaled $78.3 million and $55.9 million for the years ended December 31, 2023 and December 31, 2022, respectively. The Company sells NEXLETOL and NEXLIZET to wholesalers in the U.S and recognizes revenue at the point in time when the customer is deemed to have obtained control of the product. The customer is deemed to have obtained control of the product at the time of physical receipt of the product at the customers’ distribution facilities, or free on board (“FOB”) destination, the terms of which are designated in the contract. Product sales are recorded at the net selling price, which includes estimates of variable consideration for which reserves are established for (a) rebates and chargebacks, (b) co-pay assistance programs, (c) distribution fees, (d) product returns, and (e) other discounts and fees. Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as current contractual and statutory requirements, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company's best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contract. The amount of variable consideration 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 will not occur in a future period. Given the early stage of the Company’s commercial operations it has provided constraint of its variable consideration due to its potential consumption trends. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known. Liabilities for co-pay assistance, expected product returns, rebates, and distributor fees are classified as “Accrued variable consideration" in the balance sheets. Discounts, such as prompt pay discounts, and chargebacks are recorded as a reduction to trade accounts receivable in the balance sheets. Forms of Variable Consideration Rebates and Chargebacks: The Company estimates reductions to product sales for Public Health Service Institutions, such as Medicaid, Medicare and Veterans' Administration ("VA") programs, as well as certain other qualifying federal and state government programs, and other group purchasing organizations. The Company estimates these reductions based upon the Company's contracts with government agencies and other organizations, statutorily defined discounts and estimated payor mix. These organizations purchase directly from the Company's wholesalers at a discount and the wholesalers charge the Company back the difference between the wholesaler price and the discounted price. The Company's liability for Medicare and Medicaid rebates consists of estimates for claims that a state will make for a current quarter. The Company's reserve for this discounted pricing is based on expected sales to qualified healthcare providers and the chargebacks that customers have already claimed. Co-pay assistance: Eligible patients who have commercial insurance may receive assistance from the Company to reduce the patient's out of pocket costs. The Company will buy down the difference between the amount of the eligible patient's co-pay when the drug is purchased at the pharmacy at a determined price. Liabilities for co-pay assistance are calculated by actual program participation from third-party administrators. Distribution Fees: The Company has written contracts with its customers that include terms for distribution fees and costs for inventory management. The Company estimates and records distribution fees due to its customers based on gross sales. Product Returns: The Company generally offers a right of return based on the product’s expiration date and certain spoilage and damaged instances. The Company estimates the amount of product sales that may be returned and records the estimate as a reduction of product sales in the period the related product sales is recognized. The Company’s estimates for expected returns are based primarily on an ongoing analysis of historical returns sales information and visibility into the inventory remaining in the distribution channel. Discounts: The Company provides product discounts, such as prompt pay discounts, to its customers. The Company estimates cash discounts based on terms in negotiated contracts and the Company’s expectations regarding future payment patterns. Cost of Goods Sold Cost of goods sold is related to the Company's net product sales of NEXLETOL and NEXLIZET and the cost of the API and tablets supplied to collaboration partners under supply agreements. Cost of goods sold includes the actual product costs, including inbound freight charges and certain outbound freight charges, purchasing, sourcing, inspection and receiving costs. Research and Development Research and development expenses consist of costs incurred to further the Company’s research and development activities and include salaries and related benefits, costs associated with clinical activities, nonclinical activities, regulatory activities, manufacturing activities to support clinical activities and commercial product manufacturing supply prior to the Company's regulatory approval, research-related overhead expenses, in-licensing agreements and fees paid to external service providers that conduct certain research and development, clinical, and manufacturing activities on behalf of the Company. Research and development costs are expensed as incurred. Accrued Clinical Development Costs Outside research costs are a component of research and development expense. These expenses include fees paid to clinical research organizations and other service providers that conduct certain clinical and product development activities on behalf of the Company. Depending upon the timing of payments to the service providers, the Company recognizes prepaid expenses or accrued expenses related to these costs. These accrued or prepaid expenses are based on management’s estimates of the work performed under service agreements, milestones achieved and experience with similar contracts. The Company monitors each of these factors and adjusts estimates accordingly. Income Taxes Deferred tax assets and liabilities are determined based on differences between financial reporting and the tax basis of assets and liabilities and are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company has incurred annual operating losses since inception. Accordingly, it is not more likely than not that the Company will realize a tax benefit from its deferred tax assets and as such, it has recorded a full valuation allowance. Stock-Based Compensation The Company accounts for stock-based compensation in accordance with the provisions of ASC 718, Compensation—Stock Compensation . Accordingly, compensation costs related to equity instruments granted are recognized over the requisite service periods of the awards on a straight-line basis at the grant-date fair value. The fair value for stock options and performance-based stock options is calculated using a Black-Scholes option-pricing model. If the instruments contain performance conditions, compensation expense is recognized only if achievement of the performance condition is probable. The Company accounts for forfeitures as they occur. Expense is recognized during the period the related services are rendered. Recent Accounting Pronouncements In December 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2023-07, Segment Reporting (Topic 280): Improvements to Segment Reporting Disclosures. This standard requires an entity to provide more detailed information about its reportable segment expenses that are included within management’s measurement of profit and loss and will require certain annual disclosures to be provided on an interim basis. The amendments in this ASU are effective for the Company in 2025 for annual reporting and in 2026 for interim reporting, with early adoption permitted beginning in 2024, and is required to be applied using the full retrospective method of transition. The Company is evaluating the timing and effects of adoption of this ASU on the Company’s segment disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires disaggregated information about a reporting entity's effective tax rate reconciliation, as well as information related to income taxes paid to enhance the transparency and decision usefulness of income tax disclosures. This ASU will be effective for the annual period ending December 31, 2025. The Company is currently evaluating the timing and impacts of adoption of this ASU. The Company does not expect adoption of any remaining recently issued accounting pronouncements to have a material impact on the financial statements. |
Collaborations with Third Parti
Collaborations with Third Parties | 12 Months Ended |
Dec. 31, 2023 | |
Collaborations with Third Parties | |
Collaborations with Third Parties | Collaborations with Third Parties DSE Agreement Terms On January 2, 2019, the Company entered into a license and collaboration agreement with DSE, which was further amended on June 18, 2020. Pursuant to the agreement (as amended), the Company granted DSE exclusive commercialization rights to bempedoic acid and the bempedoic acid / ezetimibe combination tablet in the European Economic Area, Turkey and Switzerland (“DSE Territory”). DSE will be responsible for commercialization in the DSE Territory. DSE's designated affiliate in Turkey will be solely responsible, at its sole cost and expense, for all regulatory matters relating to such products in Turkey, including obtaining regulatory approval for such products in Turkey. The Company remains responsible for clinical development, regulatory and manufacturing activities for the licensed products globally, included in the DSE Territory outside of Turkey. Pursuant to the agreement, the Company received upfront cash of $150.0 million in 2019, and a $150.0 million cash payment to the Company in 2020 following the completion of the NUSTENDI Marketing Authorisation Applications ("MAA"). The Company is responsible for supplying DSE with certain manufacturing supply of the API or bulk tablets. In addition, the Company is eligible to receive additional sales milestone payments related to total net sales achievements for DSE in the DSE Territory. Finally, the Company will receive tiered fifteen percent (15%) to twenty-five percent (25%) royalties on net DSE Territory sales. The agreement calls for both parties to participate in a Joint Collaboration Committee (the “DSE JCC”). The DSE JCC is comprised of executive management from each company and the Company will lead in all aspects related to development and DSE will lead in all aspects related to commercialization in the DSE Territory. On January 2, 2024, the Company entered into a Settlement Agreement with DSE to amicably resolve and dismiss their commercial dispute in the Southern District of New York. Under the Settlement Agreement, DSE has agreed to pay the Company an aggregate of $125 million, including (1) a $100-million payment within 15 business days of the effective date of the Settlement Agreement and (2) a $25-million payment in the calendar quarter immediately following the calendar quarter in which the EMA renders a decision on the application that was filed with the EMA for a Type II(a) variation for the Company’s oral non-statin products marketed as NILEMDO (bempedoic acid) tablets and NUSTENDI (bempedoic acid and ezetimibe) tablets in Europe. The DSE Amendment grants DSE the exclusive rights for clinical development, regulatory activities, manufacture and commercialization of a bempedoic acid/ezetimibe/statin triple combination pill in the DSE Territory. Further, after a transition period, DSE will assume sole responsibility for the manufacture of NILEMDO and NUSTENDI for the DSE Territory. As of January 2, 2024, DSE shall have sole authority and control of regulatory communications with the EMA regarding the pending marketing authorization applications for NILEMDO and NUSTENDI. Pursuant to the DSE Amendment, the Company is entitled to receive one-time cash payments of up to $300 million upon the achievement of certain commercial milestones related to total net sales achievements in the DSE Territory. The Company is also entitled to receive tiered 15% to 25% royalties on net DSE Territory sales. Collaboration Revenue During the years ended December 31, 2023 and December 31, 2022, the Company recognized collaboration revenue of $37.2 million and $18.2 million, respectively, related to royalty revenue from DSE as well as the sales of bulk tablets to DSE pursuant to the supply agreement that was executed with DSE. All remaining future potential milestone amounts were not included in the transaction price, as they were all determined to be fully constrained following the concepts of ASC 606 due to the fact that such amounts hinge on development activities, regulatory approvals and sales-based milestones. Additionally, the Company expects that any consideration related to sales-based milestones will be recognized when the subsequent sales occur. Otsuka Agreement Terms On April 17, 2020, the Company entered into a license and collaboration agreement ("the Otsuka Agreement") with Otsuka. Pursuant to the Otsuka Agreement, the Company granted Otsuka exclusive development and commercialization rights to NEXLETOL and NEXLIZET in Japan. Otsuka will be responsible for all development, regulatory, and commercialization activities in Japan. In addition, Otsuka will fund all clinical development costs associated with the program in Japan. Pursuant to the agreement, the consideration consists of a $60.0 million upfront cash payment and the Company will be eligible to receive additional payments of up to $450.0 million if certain regulatory and commercial milestones are achieved by Otsuka. The potential future milestone payments include up to $20 million upon first JNDA submissions in the Otsuka Territory, up to $70.0 million upon the first NHI Price Listing for NEXLETOL in the Otsuka Territory, and up to $50.0 million upon the achievement of the primary major adverse cardiovascular events (“MACE”) in the CLEAR Outcomes study and inclusion of the CV risk reduction indication in the U.S. label, depending on the range of relative risk reduction in the CLEAR Outcomes study. In addition, the Company is eligible to receive additional sales milestone payments up to $310.0 million related to total net sales achievements for Otsuka in Japan. Finally, the Company will receive tiered fifteen percent (15%) to thirty percent (30%) royalties on net sales in Japan. Collaboration Revenue During the years ended December 31, 2023, and December 31, 2022, the Company recognized collaboration revenue of $0.1 million and $0.6 million, respectively, related to sales of bulk tablets to Otsuka pursuant to the supply agreement that was executed with Otsuka. All future potential milestone amounts were not included in the transaction price, as they were all determined to be fully constrained following the concepts of ASC 606 due to the fact that such amounts hinge on development activities, regulatory approvals and sales-based milestones. Additionally, the Company expects that any consideration related to royalties and sales-based milestones will be recognized when the subsequent sales occur. The Company has not yet recognized any revenue for milestone payments as the related regulatory and commercial milestones have not yet been achieved. DS Agreement Terms Pursuant to the license and collaboration agreement ("DS Agreement"), executed in April 2021, the Company granted DS exclusive rights to develop and commercialize bempedoic acid and the bempedoic acid / ezetimibe combination tablet in the DS Territory. The agreement allows for potential expansion across geographies including Saudi Arabia, Kuwait, Oman, UAE, Qatar, Bahrain, Yemen, Colombia and other Latin American countries. Except for certain development activities in South Korea and Taiwan, DS will be responsible for development and commercialization in these territories. In addition, DS will fund all development costs associated with the program in the DS Territory. Pursuant to the agreement, the consideration consists of a $30.0 million upfront cash payment that is non-refundable, non-reimbursable and non-creditable. The Company will be eligible to receive additional one-time payments of up to $175.0 million if certain commercial milestones are achieved by DS. Also, the Company will receive tiered royalties of five percent (5%) to twenty percent (20%) of net sales in the DS Territory. Pursuant to the Settlement Agreement, on January 2, 2024, the Company entered a 1st Amendment (the “DS Amendment”) to the License and Collaboration Agreement with DS. The DS Amendment grants DS exclusive rights for clinical development, regulatory activities, manufacture and commercialization of a bempedoic acid/ezetimibe/statin triple combination pill in the DS Territory. Further, after a transition period, DS will assume sole responsibility for the manufacture of NILEMDO and NUSTENDI for the DS Territory. Collaboration Revenue The Company considered the guidance under ASC 606 and concluded that the DS Agreement was in the scope of ASC 606. The Company concluded that the upfront payment of $30.0 million should be included in the transaction price and related to the following performance obligations under the DS Agreement: 1) the license to the Company’s intellectual property and 2) the obligation to provide ongoing development activities. The Company used the adjusted market assessment approach in determining the standalone selling price of the Company’s intellectual property and the expected cost plus margin approach in determining the standalone selling price of the Company’s obligation to provide ongoing development activities. During the years ended December 31, 2023 and December 31, 2022, the Company recognized $0.7 million and $0.8 million, respectively, of collaboration revenue related to the ongoing regulatory and development activities. All future potential milestone amounts were not included in the transaction price, as they were all determined to be fully constrained following the concepts of ASC 606 due to the fact that such amounts hinge on development activities, regulatory approvals and sales-based milestones. Additionally, the Company expects that any consideration related to royalties and sales-based milestones will be recognized when the subsequent sales occur. Other Agreements In December 2020, the Company entered into a licensing agreement with Serometrix to in-license a series of early stage compounds known as scaffolds related to its oral, small molecule PCSK9 inhibitor program. The agreement allowed the Company use of the PCSK9 compounds, which were patented by Serometrix prior to the licensing agreement, to perform further research and development with the goal of developing a small molecule oral PCSK9 inhibitor that can be taken as a tablet. On July 6, 2023, the Company provided notice to Serometrix of its intent to terminate the licensing agreement between the Company and Serometrix dated December 3, 2020. The agreement terminated as of August 5, 2023. The Company expects to continue to advance its internal pipeline assets, including next-generation ACLY inhibitors. |
Inventories, net
Inventories, net | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories, net | Inventories, net Inventories, net consist of the following: December 31, 2023 2022 (in thousands) Raw materials $ 61,890 $ 26,558 Work in process 1,728 6,548 Finished goods 2,005 2,095 $ 65,623 $ 35,201 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Legal Proceedings On March 27, 2023, the Company filed a complaint in the United States District Court for the Southern District of New York seeking declaratory judgment against DSE regarding the Company’s right to receive a $300 million milestone payment upon inclusion of cardiovascular risk reduction in the EU label that correlates with a relative risk reduction rate of at least 20%, based on the results of the CLEAR Outcomes CVOT. On May 4, 2023, the Company filed an amended complaint against DSE in the Southern District of New York seeking a judicial declaration, on an expedited basis, that DSE is contractually required to make a $300 million milestone payment to the Company upon applicable regulatory approval. On June 20, 2023, DSE filed a response to the amended complaint. On January 2, 2024, the Company entered into a settlement agreement with DSE to amicably resolve and dismiss the commercial dispute then pending in the Southern District of New York, or the Settlement Agreement. Under the Settlement Agreement, DSE agreed to pay the Company an aggregate of $125 million, including (1) a $100-million payment within 15 business days of the effective date of the Settlement Agreement and (2) a $25-million payment in the calendar quarter immediately following the calendar quarter in which the EMA renders a decision on the application that was filed with the EMA for a Type II(a) variation for the Company's oral non-statin products marketed as NILEMDO® (bempedoic acid) tablets and NUSTENDI® (bempedoic acid and ezetimibe) tablets in Europe. The application asks the EMA to approve both NILEMDO and NUSTENDI to reduce cardiovascular risk in patients with or at high risk for atherosclerotic cardiovascular disease. The legal action pending in the United States District Court for the Southern District of New York has now been dismissed. Pursuant to the Settlement Agreement, also on January 2, 2024, the Company entered into a 3rd Amendment to the License and Collaboration Agreement dated January 2, 2019 with DSE, and a 1 st |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, net | Property and Equipment, net Property and equipment, net, consist of the following: December 31, 2023 2022 (in thousands) Computer equipment $ 249 $ 278 Software 968 968 Furniture, fixtures and other 606 1,170 Leasehold improvements 189 299 Subtotal 2,012 2,715 Less accumulated depreciation and amortization 2,012 2,551 Property and equipment, net $ — $ 164 Depreciation expense was $0.2 million and $0.5 million for the years ended December 31, 2023 and 2022, respectively. |
Other Accrued Liabilities
Other Accrued Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Other Accrued Liabilities | Other Accrued Liabilities Other accrued liabilities consist of the following: December 31, 2023 2022 (in thousands) Accrued compensation $ 10,769 $ 9,053 Accrued legal fees 9,202 186 Accrued professional fees 2,712 2,361 Accrued interest on convertible notes 1,325 1,325 Accrued other 990 279 Total other accrued liabilities $ 24,998 $ 13,204 |
Investments
Investments | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | Investments The following table summarizes the Company’s cash equivalents and investments: December 31, 2023 Gross Gross Estimated Amortized Unrealized Unrealized Fair Cost Gains Losses Value (in thousands) Cash equivalents: Money market funds $ 68,445 $ — $ — $ 68,445 Certificates of deposit 402 — — 402 Total $ 68,847 $ — $ — $ 68,847 December 31, 2022 Gross Gross Estimated Amortized Unrealized Unrealized Fair Cost Gains Losses Value (in thousands) Cash equivalents: Money market funds $ 105,078 $ — $ — $ 105,078 U.S. treasury notes 4,994 1 — 4,995 Certificates of deposit 401 — — 401 Short-term investments: U.S. treasury notes 42,089 2 (5) 42,086 Total $ 152,562 $ 3 $ (5) $ 152,560 During the years ended December 31, 2023 and 2022, other income, net in the statements of operations includes interest income on available-for-sale investments of $4.4 million and $2.4 million, respectively. Other income, net in the statements of operations includes amortization of premiums and discounts on investments of $0.4 million and $0.2 million during the years ended December 31, 2023 and 2022, respectively. There were no unrealized gains or losses on investments reclassified from accumulated other comprehensive loss to other income, net in the statements of operations during the years ended December 31, 2023 and 2022. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company follows accounting guidance that emphasizes that fair value is a market-based measurement, not an entity-specific measurement. Fair value is defined as “the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.” Fair value measurements are defined on a three level hierarchy: Level 1 inputs: Quoted prices for identical assets or liabilities in active markets; Level 2 inputs: Observable inputs other than Level 1 prices, such as quoted market prices for similar assets or liabilities or other inputs that are observable or can be corroborated by market data; and Level 3 inputs: Unobservable inputs that are supported by little or no market activity and require the reporting entity to develop assumptions that market participants would use when pricing the asset or liability. The following table presents the Company’s financial assets that have been measured at fair value on a recurring basis: Description Total Level 1 Level 2 Level 3 December 31, 2023 Assets: Money market funds $ 68,445 $ 68,445 $ — $ — Certificates of deposit 402 402 — — Total assets at fair value $ 68,847 $ 68,847 $ — $ — December 31, 2022 Assets: Money market funds $ 105,078 $ 105,078 $ — $ — Certificates of deposit 401 401 — — U.S. treasury notes 47,081 47,081 — — Total assets at fair value $ 152,560 $ 152,560 $ — $ — There were no transfers between Levels 1, 2 or 3 during the years ended December 31, 2023 or December 31, 2022. |
Liability Related to the Revenu
Liability Related to the Revenue Interest Purchase Agreement | 12 Months Ended |
Dec. 31, 2023 | |
Liability Related to the Revenue Interest Purchase Agreement | |
Liability Related to the Revenue Interest Purchase Agreement | Liability Related to the Revenue Interest Purchase Agreement On June 26, 2019, the Company entered into a RIPA with Oberland, as agent for purchasers party thereto (the “Purchasers”), and the Purchasers named therein, to obtain financing in respect to the commercialization and further development of bempedoic acid and the bempedoic acid / ezetimibe combination tablet and other working capital needs. Pursuant to the RIPA, the Company received $125.0 million at closing, less certain issuance costs. The Company was entitled to receive up to approximately $75.0 million in subsequent installments subject to the terms and conditions set forth in the RIPA: (i) $25.0 million upon certain regulatory approval of its product candidates and (ii) $50.0 million, at the Company’s option, upon reaching $100.0 million trailing worldwide six-month net sales any time prior to December 31, 2021 (the “Third Payment”). In March 2020, the Company received $25.0 million from Oberland upon receiving regulatory approval of NEXLETOL. As consideration for such payments, the Purchasers will have a right to receive certain revenue interests (the “Revenue Interests”) from the Company based upon net sales of the Company’s certain products, once approved, which will be tiered payments initially ranging from 2.5% to 7.5% of the Company’s net sales in the covered territory (the “Covered Territory”); provided that if annual net sales equal or exceed the Sales Threshold and if the Purchasers receive 100% of their invested capital by December 31, 2024, the revenue interest rate will be decreased to a single rate of 0.4% of the Company’s net sales in the Covered Territory beginning on January 1, 2025. If the Third Payment is drawn down by the Company, the applicable royalty rates will increase by one-third. The Covered Territory is the United States, but is subject to expand to include the world-wide net sales if the Company’s annual U.S. net sales are less than $350.0 million for the year ended December 31, 2021. The U.S. net sales milestone thresholds are not to be taken as financial guidance. The Purchasers’ rights to receive the Revenue Interests shall terminate on the date on which the Purchasers have received Revenue Interests payments of 195% of the then aggregate purchase price (the “Cumulative Purchaser Payments”) paid to the Company, unless the RIPA is terminated earlier. Under the RIPA, the Company has an option (the “Call Option”) to terminate the RIPA and repurchase future Revenue Interests at any time upon advance written notice. Additionally, the Purchasers have an option (the “Put Option”) to terminate the RIPA and to require the Company to repurchase future Revenue Interests upon enumerated events such as a bankruptcy event, an uncured material breach, a material adverse effect or a change of control. In addition, the RIPA contains various representations and warranties, information rights, non-financial covenants, indemnification obligations and other provisions that are customary for a transaction of this nature. RIPA Amendments On April 26, 2021, the Company entered into Amendment No. 2 (the “RIPA Amendment 2”) to the RIPA with Oberland, as agent for the purchaser parties thereto. Pursuant to the RIPA Amendment 2, Oberland waived the original trailing six-month world-wide net sales condition to the third installment payment under the RIPA and released the final $50 million payment payable to the Company under the terms of the RIPA. The Company and Oberland also agreed to amend additional terms of the RIPA such that the purchasers will have a right to receive certain revenue interests (the “Revenue Interests”) from the Company based on net sales of the Company’s certain products, once approved, which will be tiered payments ranging from 3.33% to 10% (the “Third Payment Applicable Percentage”) of the Company’s net sales in the covered territory (the “Covered Territory”); provided that (a) prior to December 31, 2024, with respect to each country defined in the Daiichi Territory, if the percentage of net sales that Company receives from Daiichi (the “Receivables Percentage”) is less than the Third Payment Applicable Percentage, then the Revenue Interest for such country payable to the purchasers will be equal to the Receivables Percentages, (b) if annual net sales equal or exceed $350 million and if the Purchasers receive 100% of their invested capital (Cumulative Purchaser Payments") by December 31, 2024, the revenue interest rate will be decreased to a single rate of 3.33% of the Company’s net sales in the Covered Territory for all subsequent calendar quarters and (c) if the Purchasers receive Revenue Interest payments less than 100% of Cumulative Purchaser Payments by December 31, 2024, the Third Payment Applicable Percentage will be increased to a single rate of the Company’s net sales that would have provided 100% of Cumulative Purchaser Payments had such rate applied from the initial funding by the Purchasers. The Covered Territory was originally the United States, but has been expanded to worldwide for all calendar years beginning on or after January 1, 2022. Under the RIPA Amendment 2, the Company has an option (the “Call Option”) to terminate the RIPA and repurchase future Revenue Interests at any time upon advance written notice. Additionally, the Purchasers have an option (the “Put Option”) to terminate the RIPA and to require the Company to repurchase future Revenue Interests upon enumerated events such as a bankruptcy event, an uncured material breach, a material adverse effect or a change of control. If the Put Option or the Call Option are exercised, the required repurchase price will be 200% of the Cumulative Purchaser Payments (minus all payments Company has made to the Purchasers in connection with the Revenue Interests), if such option is exercised prior to the third anniversary of the closing date, and 225% of the Cumulative Purchaser Payments (minus all payments Company has made to the Purchasers in connection with the Revenue Interests), if such option is exercised thereafter. On May 16, 2021, the Company entered into an Amendment to the Security Agreement and Waiver ("Amendment and Waiver") with the same parties to the Security Agreement, by and among the Company, Eiger Partners II LP (the "Purchaser") and Eiger III SA LLC (the "Purchaser Agent"), dated as of June 26, 2019 (the "Security Agreement"). Pursuant to the Amendment and Waiver, if (i) the net revenue from sales of NEXLETOL and NEXLIZET and certain other products in the United States (as reported in the Company’s financial statements as “product sales, net” in accordance with GAAP and excluding, for the avoidance of doubt, upfront or milestone payments and other collaboration revenue) (the “Specified Net Revenue”) for the calendar quarter ended September 30, 2021 does not exceed $15.0 million, or (ii) the Specified Net Revenue for any calendar quarter ending after September 30, 2021 does not exceed $15.0 million, then the Company shall deposit $50.0 million in a deposit account that is subject to a block account control agreement in favor of the Purchase Agent, no later than the earlier of (x) the date the Specified Net Revenue for such calendar quarter has been determined and (y) 45 days after the last day of such calendar quarter. Since the Specified Net Revenue for the calendar quarter ended September 30, 2021 did not exceed $15.0 million, the Company deposited $50.0 million in a deposit account that is subject to a block account control agreement, which is classified as restricted cash on the balance sheets. The Purchaser Agent shall have sole dominion and control over all funds deposited in the deposited account and such funds may be withdrawn therefrom only with the consent of the Purchaser Agent. Upon the occurrence and during the continuance of a Put Option Event, the Purchaser Agent shall have the right to apply amounts held in the deposit account in payment of certain secured obligations in the manner provided for in the Security Agreement. The Amendment and Wavier does not substitute, replace or release the Pledgors from any other obligations under the RIPA or Security Agreement. On November 23, 2022, the Company entered into Waiver and Amendment No. 3 to Revenue Interest Purchase Agreement and Amendment No. 2 to Security Agreement (the “RIPA Amendment 3”), by and among the Company, the Purchasers and the Purchaser Agent, which amends (i) the Revenue Interest Purchase Agreement, by and among the Company, the Purchasers, and the Purchaser Agent, dated effective as of June 26, 2019 (as amended by Amendment No. 1 to Revenue Interest Purchase Agreement dated as of November 9, 2020 and Amendment No. 2 to Revenue Interest Purchase Agreement dated as of April 26, 2021, and as may be further amended, restated, supplemented or modified from time to time, the “RIPA”) and (ii) the Security Agreement, by the Company in favor of the Purchaser Agent, dated as of June 28, 2019 (as amended by the Amendment to Security Agreement and Waiver by and among the Company, the Purchaser and the Purchaser Agent, effective as of May 16, 2021, and as may be further amended, restated, supplemented or modified from time to time, the “Security Agreement”). Pursuant to the RIPA Amendment 3, among other things, (a) the Company agreed to make a one-time partial call payment with regards to the Revenue Interests (as defined in the RIPA) in an amount equal to $50 million from the restricted cash account (the “Partial Call”), (b) the amount of the Cumulative Purchaser Payments (as defined in the RIPA) was reduced to $177,777,778, and (c) the Purchasers and Purchaser Agent waived certain claimed defaults, breaches and Put Option Events under the RIPA and other related documents that may have occurred as a result of the Company’s opening of a new bank account. In accordance with the guidance in ASC 470‑50, “Debt—Modifications and Extinguishments,” the RIPA Amendment 3 was accounted for as a debt modification. The amendment resulted in a less than $0.1 million loss on modification of debt, consisting of third-party fees associated with the transaction, which is included in selling, general, and administrative expenses in the statements of operations for the year ended December 31, 2022. In connection with the arrangement, as of December 31, 2023, the Company has recorded a liability, referred to as the “Revenue interest liability” on the balance sheet, of $274.8 million, net of $0.2 million of capitalized issuance costs in connection with the RIPA, which will be amortized to interest expense over the estimated term of the RIPA. The total redemption amount is equal to 225% of the Cumulative Purchaser Payments, or $400 million. At December 31, 2023, the remaining redemption amount is $372.6 million. The Company imputes interest expense associated with this liability using the effective interest rate method. The effective interest rate is calculated based on the rate that would enable the debt to be repaid in full over the anticipated life of the arrangement. The interest rate on this liability may vary during the term of the agreement depending on a number of factors, including the level of forecasted net sales. The Company evaluates the interest rate quarterly based on its current net sales forecasts utilizing the prospective method. A significant increase or decrease in future net sales will materially impact the revenue interest liability, interest expense and the time period for repayment. The Company recorded approximately $46.7 million and $44.6 million in interest expense related to this arrangement for the years ended December 31, 2023 and 2022, respectively. The repayment of the RIPA to Oberland does not have a fixed repayment schedule, rather it will be completely repaid and extinguished when the Company has repaid 225% of the Cumulative Purchaser Payments. Since there is not a fixed repayment schedule, the Company does not project its future repayments by year. Each period, the Company estimates the future expected sales of its products in the covered territory and determines the effective annual imputed interest rate, which updates and changes the timing of the Company’s payments. Under the terms of the agreement, every $100 million of net sales generated, less than or equal to $250 million in an annual aggregate year, would result in a repayment obligation of approximately $10.0 million or 10.0% at the stated repayment rate in the first year. Annual net sales for a calendar year exceeding $250 million would result in a repayment obligation of approximately $3.3 million or 3.3% for every $100 million of sales above the threshold. In 2025, the percent of net revenue paid to Oberland could reset to a higher amount if certain revenue milestones are not met. This could result in substantially higher payments starting in 2025. As the U.S. net sales were less than $350 million for the year ended December 31, 2021, the Covered Territory was expanded to include worldwide sales beginning in 2022. The Company’s repayments of the RIPA are directly tied to the growth of its net sales, and as the Company’s net sales grow, the Company expects the related repayments of the RIPA to grow as well. The Company currently expects to repay $34.8 million in the next twelve months. The effective annual imputed interest rate is 17.6% as of December 31, 2023. Payments made to Oberland as a result of the Company’s net sales will reduce the revenue interest liability. The following table summarizes the revenue interest liability activity during the years ended December 31, 2023 and 2022: (in thousands) Revenue interest liability at December 31, 2021 $ 257,039 Repayment upon execution of Amendment No. 3 (50,000) Interest expense recognized 44,590 Revenue interest payments (8,024) Revenue interest liability at December 31, 2022 $ 243,605 Interest expense recognized 46,679 Revenue interest payments (15,506) Revenue interest liability at December 31, 2023 $ 274,778 |
Convertible Notes
Convertible Notes | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Convertible Notes | Convertible Notes In November 2020, the Company issued $280.0 million aggregate principal amount of 4.0% senior subordinated convertible notes due November 2025. The net proceeds the Company received from the offering was approximately $271.1 million, after deducting the initial purchasers’ discounts and commissions and offering expenses payable by the Company (the “Convertible Notes”). The Company used approximately $46.0 million of the net proceeds from the offering of the notes to pay the cost of the Capped Call (as defined below) and $55.0 million of the net proceeds from the offering of the initial notes to finance the Prepaid Forward (as defined below). The Convertible Notes are the Company's senior unsecured obligations and mature on November 15, 2025 (the “Maturity Date”), unless earlier repurchased or converted into shares of common stock under certain circumstances described below. The Convertible Notes are convertible into shares of the Company’s common stock, can be repurchased for cash, or a combination thereof, at the Company’s election, at an initial conversion rate of 30.2151 shares of common stock per $1,000 principal amount of the Convertible Notes, which is equivalent to an initial conversion price of approximately $33.096 per share of common stock, subject to adjustment. The Company will pay interest on the Convertible Notes semi-annually in arrears on May 15 and November 15 of each year. The Convertible Notes are general unsecured obligations of the Company that are subordinated in right of payment to indebtedness, obligations and other liabilities under the Company’s RIPA, the revenue interests issued pursuant to such agreement, and any refinancing of the foregoing. Holders may convert their Convertible Notes at their option at any time prior to the close of business on the business day immediately preceding August 15, 2025 in the following circumstances: (1) during any calendar quarter commencing after the calendar quarter ending on March 31, 2021 (and only during such calendar quarter), if the last reported sale price per share of the Company’s common stock, par value $0.001 per share (“common stock”), is greater than or equal to 130% of the conversion price for each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter; (2) during the five business days after any five consecutive trading day period (such five consecutive trading day period, the “measurement period”) in which the trading price per $1,000 principal amount of notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price per share of the Company’s common stock and the conversion rate for the notes on each such trading day; (3) if the Company calls such notes for redemption, any such notes that have been called for redemption may be converted at any time prior to the close of business on the second scheduled trading day immediately preceding the redemption date, but only with respect to the notes called for redemption; and (4) upon the occurrence of specified corporate events, as provided in the Indenture. On or after August 15, 2025, to the close of business on the second scheduled trading day immediately before the maturity date, holders may convert all or any portion of their notes at the applicable conversion rate at any time at the option of the holder regardless of the foregoing conditions. In addition, following certain corporate events or following issuance of a notice of redemption, the Company will, in certain circumstances, increase the conversion rate for a holder who elects to convert its notes in connection with such a corporate event or to convert its notes called (or deemed called) for redemption during the related redemption period, as the case may be. The Convertible Notes will be redeemable, in whole or in part, at the Company’s option at any time, and from time to time, on or after November 20, 2023 and before the 41st scheduled trading day immediately before the maturity date, at a cash redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any, but only if the last reported sale price per share of the Company’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive), including the trading day immediately preceding the date the Company sends the related redemption notice, during any 30 consecutive trading day period ending on, and including, the trading day immediately preceding the date on which the Company sends such redemption notice. No sinking fund is provided for the notes. If the Company redeems less than all the outstanding notes, at least $125.0 million aggregate principal amount of notes must be outstanding and not subject to redemption as of the relevant redemption notice date. If the Company undergoes a “fundamental change” (as defined in the Indenture), holders may require the Company to repurchase their notes for cash all or any portion of their notes at a fundamental change repurchase price equal to 100% of the principal amount of the notes to be repurchased, plus accrued and unpaid interest, to, but excluding, the fundamental change repurchase date. The Indenture includes customary terms and covenants, including certain events of default. On October 22, 2021, the Company entered into a privately negotiated exchange agreement (the “Exchange Agreement”) with two co-managed holders (the “Holders”) of its Convertible Notes. Under the terms of the Exchange Agreement the Holders agreed to exchange (the “Exchange”) with the Company $15.0 million aggregate principal amount of the Convertible Notes held in the aggregate by them (and accrued interest thereon) for shares of the Company’s common stock. Pursuant to the Exchange Agreement, the number of shares of common stock to be issued by the Company to the Holders upon consummation of the Exchange was determined based upon the volume-weighted-average-price per share of common stock, subject to a floor of $5.62 per share, during the five As of December 31, 2023, the principal amount of convertible notes was $265.0 million, and the unamortized debt discount and issuance costs were $3.4 million, for a net carrying amount of $261.6 million. As of December 31, 2022, the principal amount of convertible notes was $265.0 million, and the unamortized debt discount and issuance costs were $5.1 million, for a net carrying amount of $259.9 million. The Company recorded $12.3 million and $12.2 million of interest expense during the years ended December 31, 2023 and 2022, respectively, relating to the cash interest on the convertible notes due semi-annually and amortization of the debt issuance costs. As of December 31, 2023, no Convertible Notes were convertible pursuant to their terms. The estimated fair value of the Convertible Notes was $155.9 million as of December 31, 2023 and $145.9 million as of December 31, 2022. The estimated fair value of the Convertible Notes was determined through consideration of quoted market prices. As of December 31, 2023, the if-converted value of the Convertible Notes did not exceed the principal value of those notes. Capped Call Transactions In connection with the offering of the Convertible Notes, the Company entered into privately-negotiated capped call transactions with one of the initial purchasers of the convertible notes or its affiliate and certain other financial institutions. The Company used approximately $46.0 million of the net proceeds from the offering of the Convertible Notes to pay the cost of the capped call transactions. The capped call transactions are expected generally to reduce potential dilution to the Company’s common stock upon any conversion of the Convertible Notes and/or offset any cash payments the Company is required to make in excess of the principal amount of converted notes, as the case may be, in the event that the market value per share of the Company’s common stock, as measured under the terms of the capped call transactions at the time of exercise, is greater than the strike price of the capped call transactions (which initially corresponds to the initial conversion price of the Convertible Notes, and is subject to certain adjustments), with such reduction and/or offset subject to a cap initially equal to approximately $55.16 (which represents a premium of approximately 100% over the last reported sale price of the Company’s common stock on November 11, 2020), subject to certain adjustments. The capped call transactions are separate transactions, entered into by the Company and are not part of the terms of the Convertible Notes. Given that the transactions meet certain accounting criteria, the convertible note capped call transactions are recorded in stockholders’ equity, and they are not accounted for as derivatives and are not remeasured each reporting period. As of December 31, 2023, the Company had not purchased any shares under the convertible note capped call transactions. Prepaid Forward In connection with the offering of the Convertible Notes, the Company entered into a prepaid forward stock repurchase transaction (“Prepaid Forward”) with a financial institution (“Forward Counterparty”). Pursuant to the Prepaid Forward, the Company used approximately $55.0 million of the net proceeds from the offering of the Convertible Notes to fund the Prepaid Forward. The aggregate number of shares of the Company’s common stock underlying the Prepaid Forward was approximately 1,994,198. The expiration date for the Prepaid Forward is November 15, 2025, although it may be settled earlier in whole or in part. Upon settlement of the Prepaid Forward, at expiration or upon any early settlement, the Forward Counterparty will deliver to the Company the number of shares of common stock underlying the Prepaid Forward or the portion thereof being settled early. The shares purchased under the Prepaid Forward are treated as treasury stock and not outstanding for purposes of the calculation of basic and diluted earnings per share, but will remain outstanding for corporate law purposes, including for purposes of any future stockholders’ votes, until the Forward Counterparty delivers the shares underlying the Prepaid Forward to the Company. As of December 31, 2023, 448,698 shares had been delivered to the Company. The Company’s Prepaid Forward hedge transaction exposes the Company to credit risk to the extent that its counterparty may be unable to meet the terms of the transaction. The Company mitigates this risk by limiting its counterparty to a major financial institution. |
Stockholders' Deficit
Stockholders' Deficit | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Stockholders' Deficit | Stockholders' Deficit ATM Offering On April 15, 2022, the Company filed a new registration statement on Form S-3 to replace its prior automatically effective registration statement on Form S-3ASR filed on August 3, 2021, which registered the offering, issuance and sale of up to $239 million of common stock from time to time in “at-the-market” offerings (the “New ATM Program”). On February 21, 2023, the Company terminated the Open Market Sales Agreement with Jefferies LLC and entered into a Controlled Equity Offering Sales Agreement with Cantor Fitzgerald & Co., as sales agent, to provide for the issuance and sale by the Company of up to $70 million of shares of the Company's common stock from time to time in “at-the-market” offerings (the "2023 ATM Program"), pursuant to its existing Form S-3 and the prospectus supplement to be filed on February 21, 2023. The Company may continue to use the 2023 ATM Program to address potential short-term or long-term funding requirements that may arise. Such program will continue to be subject to the volatility of the price of the Company's common stock and general market conditions. During the year ended December 31, 2022, the Company issued 13,043,797 shares of common stock resulting in net proceeds of approximately $90.8 million after deducting $3.1 million of underwriting discounts and commissions and other expenses, pursuant to the New ATM Program. During the year ended December 31, 2023, the Company issued 3,312,908 shares of common stock resulting in net proceeds of approximately $4.4 million after deducting $0.4 million of underwriting discounts and commissions and other expenses, pursuant to the 2023 ATM Program. Warrants In connection with an underwriting agreement with H.C. Wainwright & Co., LLC ("Wainwright") on December 2, 2021, the Company issued warrants to purchase 36,964,286 shares of common stock at an exercise price of $9.00 and an expiration date of December 7, 2023. The warrants were recorded at fair value of $61.9 million to additional-paid-in-capital in accordance with ASC 815-10 based upon the allocation of the proceeds between the common shares issued with the December 2021 Offering and the warrants. On December 7, 2023, 27,940,074 of these warrants expired. The remaining 9,024,212 warrants were amended as described below. Registered Direct Offering and Warrant Amendment On March 19, 2023, the Company entered into a Purchase Agreement with the Purchasers pursuant to which the Company agreed to issue and sell, in a Registered Direct Offering, 12,205,000 shares of its Common Stock, par value $0.001 per share, Pre-Funded Warrants to purchase up to an aggregate of 20,965,747 shares of Common Stock in lieu of shares of Common Stock, and Warrants to purchase up to 33,170,747 shares of Common Stock. The combined purchase price of each share of Common Stock and accompanying Warrant is $1.675 per share. The Warrants expire on September 22, 2026 and have an exercise price of $1.55. The purchase price of each Pre-Funded Warrant is $1.674 (equal to the combined purchase price per share of Common Stock and accompanying Warrant, minus $0.001). The Purchase Agreement contains customary representations, warranties, covenants and indemnification rights and obligations of the Company and the Purchasers. The Registered Direct Offering closed on March 22, 2023. The warrants and pre-funded warrants were recorded at fair value of $22.8 million to additional-paid-in-capital in accordance with ASC 815-10 based upon the allocation of the proceeds between the common shares issued with the Registered Direct Offering and the warrants and pre-funded warrants. The Company estimated the fair value of the warrants using a Black-Scholes option-pricing model, which is based, in part, upon subjective assumptions including but not limited to stock price volatility, the expected life of the warrant, the risk-free interest rate and the fair value of the common stock underlying the warrant. The Company estimates the volatility based on its historical volatility that is in line with the expected remaining life of the warrants. The risk-free interest rate is based on the U.S. Treasury daily rate for a maturity similar to the expected remaining life of the warrants. The expected remaining life of the warrants is assumed to be equivalent to its remaining contractual term. The Company estimated the fair value of the pre-funded warrants based on the market price of the Company's common stock at issuance. In connection with the Registered Direct Offering, the Company amended, pursuant to Warrant Amendment Agreements certain existing warrants to purchase up to an aggregate of 9,024,212 shares of the Company's common stock that were previously issued in December 2021 at an exercise price of $9.00 per share and had an expiration date of December 7, 2023, effective upon the closing of the Registered Direct Offering, such that the amended warrants have a reduced exercise price of $1.55 per share and expire three and one half years following the closing of the Registered Direct Offering, or September 22, 2026, for additional consideration of $0.125 per amended warrant. Based on the change in the fair value of the amended warrants, the Company recorded issuance costs to additional paid-in capital of $2.9 million. The Company received gross proceeds of approximately $55.5 million from the Registered Direct Offering, before deducting placement agent fees and related offering expenses. The net proceeds to the Company from the Registered Direct Offering, after deducting the placement agent fees and expenses and the Company’s estimated offering expenses of $4.2 million, were approximately $51.3 million. In addition, the Company received approximately $1.2 million as the gross consideration in connection with the Warrant Amendment Agreements. The net proceeds of the Warrant Amendment Agreements after deducting placement fees of $0.1 million were approximately $1.1 million. During the year ended December 31, 2023, 20,965,747 shares of pre-funded warrants were exercised and 5,850,747 shares of warrants were exercised. As of December 31, 2023, no pre-funded warrants were outstanding. The following table summarizes the warrants outstanding for the Company as of December 31, 2023 and 2022: December 31, 2023 December 31, 2022 Weighted average exercise price Warrants outstanding from 2021 agreement, expiring December 7, 2023 — 36,964,286 $ 9.00 Warrants outstanding from Warrant Amendment Agreements, expiring September 22, 2026 9,024,212 — $ 1.55 Warrants outstanding from Purchase Agreement, expiring September 22, 2026 27,320,000 — $ 1.55 Total warrants outstanding 36,344,212 36,964,286 |
Stock Compensation
Stock Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock Compensation | Stock Compensation 2022 Stock Option and Incentive Plan In May 2022, the Company's stockholders approved the 2022 Stock Option and Incentive Plan (the "2022 Plan"). The number of shares of common stock available for awards under the 2022 Plan was set to 4,400,000, with any shares underlying awards that are forfeited, canceled, held back upon exercise of an option or settlement of an award to cover the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied without the issuance or shares, or otherwise terminated (other than by exercise) under the 2022 Plan may be added back to the shares of common stock available for issuance under the 2022 Plan. The 2022 Plan provides for the award of stock options (both incentive and non-qualified options), stock appreciation rights, restricted stock, restricted stock units ("RSUs"), unrestricted stock, cash-based awards, and dividend equivalent rights. Following the approval of the 2022 Plan, no further awards will be issued under the Company’s 2013 Stock Option and Incentive Plan (the “2013 Plan”). In June 2023, the Company's stockholders approved an amendment to the 2022 Plan, which increased the number of shares of common stock reserved for awards under the 2022 Plan to 10,650,000. Employee Stock Purchase Plan In April 2020, the board of directors approved the Esperion Therapeutics, Inc. 2020 Employee Stock Purchase Plan (the "ESPP") which was approved by the Company's shareholders on May 28, 2020. The ESPP allows eligible employees to authorize payroll deductions of up to 10% of their base salary or wages up to $25,000 annually to be applied toward the purchase of shares of the Company's common stock on the last trading day of the offering period. Participating employees will purchase shares of the Company's common stock at a discount of up to 15% on the lesser of the closing price of the Company's common stock on the NASDAQ Global Select Market (i) on the first trading day of the offering period or (ii) the last day of any offering period. Offering periods under the ESPP will generally be in six months increments, commencing on September 1 and March 1 of each calendar year with the administrator having the right to establish different offering periods. During the years ended December 31, 2023 and 2022, the Company recognized $0.3 million and $0.4 million of stock compensation expense related to the ESPP, respectively. As of December 31, 2023, there have been 610,506 shares issued and 214,494 shares reserved for future issuance under the ESPP. The Company paused the ESPP effective as of September 1, 2023, such that the offering period which would otherwise have begun on September 1, 2023 did not commence. The administrator will determine the next offering period, pursuant to the ESPP. 2017 Inducement Equity Plan In May 2017, the Company's board of directors approved the Esperion Therapeutics, Inc. 2017 Inducement Equity Plan (as amended in November 2019 and August 2023, the "2017 Plan"). The number of shares of common stock available for awards under the 2017 Plan is 2,650,000, with any shares of common stock that are forfeited, cancelled, held back upon the exercise or settlement of an award to cover the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied without the issuance of common stock, or otherwise terminated (other than by exercise) under the 2017 Plan added back to the shares of common stock available for issuance under the 2017 Plan. The 2017 Plan provides for the granting of stock options, stock appreciation rights, restricted stock awards, restricted stock units ("RSUs"), unrestricted stock awards and dividend equivalent rights. 2013 Stock Option and Incentive Plan In May 2015, the Company’s stockholders approved the amended and restated 2013 Plan which, among other things, increased the number of shares of common stock reserved for issuance thereunder. The number of shares of common stock available for awards under the 2013 Plan was increased by 923,622 shares from 2,051,378 shares to 2,975,000 shares, plus (i) shares of common stock that are forfeited, cancelled, held back upon the exercise or settlement of an award to cover the exercise price or tax withholding, reacquired by the Company prior to vesting, satisfied without the issuance of common stock or otherwise terminated (other than by exercise) under the 2013 Plan and the Company’s 2008 Incentive Stock Option and Restricted Stock Plan are added back to the shares of common stock available for issuance under the 2013 Plan, and (ii) on January 1, 2016, and each January 1, thereafter, the number of shares of common stock reserved and available for issuance under the 2013 Plan will be cumulatively increased by 2.5% of the number of shares of common stock outstanding on the immediately preceding December 31, or such lesser number of shares of common stock determined by the compensation committee. The 2013 Plan provides for the granting of stock options, stock appreciation rights, restricted stock awards, RSUs, unrestricted stock awards, cash-based awards, performance share awards and dividend equivalent rights. The Company incurs stock-based compensation expense related to stock options, performance-based stock options ("PBSOs"), RSUs and performance-based restricted stock units ("PBRSUs"). The fair value of RSUs and PBRSUs is determined by the closing market price of the Company’s common stock on the date of grant. The fair value of stock options and PBSOs is calculated using a Black-Scholes option-pricing model. Compensation costs related to equity instruments granted are recognized over the requisite service periods of the awards on a straight-line basis at the grant-date fair value. The Company accounts for forfeitures as they occur. Under the 2022 Plan, 2017 Plan, and 2013 Plan the vesting of options granted or restricted awards given will be determined individually with each option grant. Generally, 25% of the granted amount will vest upon the first anniversary of the option grant with the remainder vesting ratably on the first day of each calendar quarter for the following three years. Stock options have a 10-year life and expire if not exercised within that period, or if not exercised within 90 days of cessation of providing service to the Company. Stock Options The following table summarizes the activity relating to the Company’s options to purchase common stock for the year ended December 31, 2023: Weighted-Average Weighted-Average Remaining Number of Exercise Price Contractual Aggregate Options Per Share Term (Years) Intrinsic Value (in thousands) Outstanding at December 31, 2022 3,842,737 $ 27.75 4.86 $ 1,658 Granted 1,550,200 $ 3.53 Forfeited or cancelled (vested and unvested) (1,706,746) $ 35.69 Outstanding at December 31, 2023 3,686,191 $ 13.88 7.47 $ 584 Vested and expected to vest at December 31, 2023 3,686,191 $ 13.88 7.47 $ 584 Exercisable at December 31, 2023 1,706,622 $ 23.99 5.84 $ 20 No stock options were exercised during the years ended December 31, 2023 or December 31, 2022. The following table shows the weighted-average assumptions used to compute the stock-based compensation costs for the stock options granted to employees during each of the two years ending December 31, 2023, using the Black-Scholes option-pricing model: Year ended December 31, 2023 2022 Risk-free interest rate 3.83 % 2.26 % Dividend yield — — Weighted-average expected life of options (years) 6.17 6.16 Volatility 79 % 81 % The risk-free interest rate assumption was based on the United States Treasury’s rates for U.S. Treasury zero-coupon bonds with maturities similar to those of the expected term of the award being valued. The assumed dividend yield was based on the Company’s expectation of not paying dividends in the foreseeable future. The weighted-average expected life of the options was calculated using the simplified method as prescribed by the Securities and Exchange Commission Staff Accounting Bulletin No. 107 (“SAB No. 107”). This decision was based on the lack of relevant historical data due to the Company’s limited historical experience. The Company estimates volatility based on the Company's historical stock prices over the expected life of the stock options. The weighted-average grant-date fair values of stock options granted during the years ended December 31, 2023 and 2022, were $2.51 and $3.38, respectively. During the years ended December 31, 2023 and 2022, the Company recognized stock-based compensation expense related to stock options of $3.8 million and $5.6 million, including $0.2 million and $0.6 million that was capitalized into inventory, respectively. As of December 31, 2023, there was approximately $6.7 million of unrecognized compensation cost related to unvested options, which will be recognized over a weighted-average period of approximately 2.3 years. Restricted Stock Units The following table summarizes the activity relating to the Company’s RSUs for the year ended December 31, 2023: Number of Weighted-Average RSUs Fair Value Per Share Outstanding and unvested at December 31, 2022 1,768,185 $ 8.80 Granted 2,456,485 $ 3.22 Forfeited or expired (342,876) $ 7.14 Vested (833,906) $ 8.07 Outstanding and unvested at December 31, 2023 3,047,888 $ 4.69 During the years ended December 31, 2023 and 2022, the Company recognized stock-based compensation expense related to RSUs of $6.6 million, including $0.4 million that was capitalized into inventory, and $6.6 million, including $0.7 million that was capitalized into inventory, respectively. As of December 31, 2023, there was approximately $13.2 million of unrecognized stock-based compensation expense related to unvested RSUs, which will be recognized over a weighted-average period of approximately 2.5 years. Performance-based Restricted Stock Units ("PBRSUs") In 2021, the Company granted PBRSUs from the 2013 Plan that vest upon various performance-based milestones as set forth in the individual grant agreements, such as achievement of predetermined milestones based on the Company's U.S. net product sales or clinical or regulatory outcomes. The actual number of units (if any) received under these awards will depend on continued employment and actual performance over the performance period. Each quarter, the Company updates their assessment of the probability that the performance milestone will be achieved. The Company amortizes the fair value of the PBRSUs based on the expected performance period to achieve the performance milestone. The fair value of the PBRSUs is based on the quoted market price of the Company's common stock on the date of grant. The Company expects the performance criteria to be met. The following table summarizes the activity relating to the Company's PBRSUs for the year ended December 31, 2023: Numbers of Weighted-Average PBRSU's Fair Value Per Share Outstanding and unvested at December 31, 2022 461,250 $ 9.50 Granted — $ — Forfeited (100,250) $ 11.50 Vested (200,725) $ 8.94 Outstanding and unvested at December 31, 2023 160,275 $ 8.94 Stock-based compensation related to the PBRSUs was approximately $0.4 million, including less than $0.1 million that was capitalized into inventory, for the year ended December 31, 2023. Stock-based compensation related to PBRSUs was approximately $1.8 million, including $0.2 million that was capitalized into inventory, for the year ended December 31, 2022. As of December 31, 2023, there was approximately $0.2 million of unrecognized stock-based compensation expense related to unvested PBRSUs, which will be recognized over a weighted-average period of approximately 0.2 years. Performance-based stock options ("PBSOs") In 2021, 2022, and 2023 the Company granted PBSOs from the 2013 Plan and the 2022 Plan, that vest upon various performance-based milestones as set forth in the individual grant agreements, such as achievement of predetermined clinical or regulatory outcomes. The actual number of units (if any) received under these awards will depend on continued employment and actual performance over the performance period. Each quarter, the Company updates their assessment of the probability that the performance milestone will be achieved. The Company amortizes the fair value of the PBSOs based on the expected performance period to achieve the performance milestone. The fair value of the PBSOs is based on the Black Scholes model as detailed in the stock option section above. The Company expects the performance criteria to be met. The weighted-average grant-date fair value of PBSOs granted during the years ended December 31, 2023 and December 31, 2022 was $1.14 and $4.36, respectively. The following table summarizes the activity relating to the Company’s performance-based stock options for the year ended December 31, 2023: Weighted-Average Weighted-Average Remaining Number of Exercise Price Contractual Aggregate PBSOs Per Share Term (Years) Intrinsic Value (in thousands) Outstanding at December 31, 2022 499,200 $ 6.73 9.32 $ 12 Granted 227,900 $ 1.62 Forfeited (65,250) $ 6.76 Outstanding at December 31, 2023 661,850 $ 4.97 8.63 $ 312 Vested and expected to vest at December 31, 2023 661,850 $ 4.97 8.63 $ 312 Exercisable at December 31, 2023 48,100 $ 8.94 5.87 $ — |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plan | Employee Benefit Plan During 2008, the Company adopted the Esperion Therapeutics, Inc. 401(k) Plan (the “401(k) Plan”), which qualifies as a deferred salary arrangement under Section 401(k) of the Internal Revenue Code. Under the 401(k) Plan, participating employees may defer a portion of their pretax earnings. The Company may, at its sole discretion, contribute for the benefit of eligible employees. Company contributions to the 401(k) Plan during the years ended December 31, 2023 and 2022, were $1.3 million and $0.7 million, respectively. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Leases | Leases The Company has operating leases primarily related to the Company's principal executive office, automobile leases and other IT related equipment. The lease for the principal executive office has a lease term of 5 years from November 1, 2023, and the automobile leases and IT equipment leases primarily have a term of 3 years. During the years ended December 31, 2023 and December 31, 2022, the Company recognized $1.0 million and $1.3 million, respectively, of operating lease costs, recognized on the statements of operations and comprehensive loss, and paid cash for the amounts included in the measurement of lease liabilities of $1.0 million and $1.2 million, respectively, which were included in operating cash flows on the statements of cash flows. At December 31, 2023 and December 31, 2022, the weighted-average remaining lease term of operating leases was 2.9 years and 4.7 years, respectively, and the weighted average discount rate was 7.5% and 7.7%, respectively. There was $4.5 million and $0.6 million in right-of-use assets obtained in exchange for lease obligations for the twelve months ended December 31, 2023 and December 31, 2022, respectively. The Company had 45 additional operating and finance leases that had not yet commenced as of December 31, 2023, mainly associated with increased headcount for the Company's sales force. The following table summarizes the Company's future maturities of operating lease liabilities as of December 31, 2023: (in thousands) 2024 $ 1,838 2025 1,811 2026 1,140 2027 169 2028 144 Total lease payments 5,102 Less imputed interest (529) Total $ 4,573 The following table summarizes supplemental balance sheet information related to leases as of December 31, 2023: Operating Leases (in thousands) Total right of use operating lease assets $ 4,675 Operating lease liabilities (short-term) $ (1,553) Operating lease liabilities (long-term) (3,020) Total lease obligations under operating leases $ (4,573) |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes There was no provision for income taxes for the years ended December 31, 2023 and 2022 because the Company has incurred operating losses since inception. At December 31, 2023, the Company concluded that it is not more likely than not that the Company will realize the benefit of its deferred tax assets due to its history of losses. Accordingly, a full valuation allowance has been applied against the net deferred tax assets. As of December 31, 2023 and 2022, the Company had net deferred tax assets, before valuation allowance, of approximately $395.6 million and $352.1 million, respectively. Realization of the deferred assets is dependent upon future taxable income, if any, the amount and timing of which are uncertain. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance. As of December 31, 2023 and 2022, the Company had federal net operating loss (“NOL”) carryforwards of approximately $1,027.5 million and $950.8 million, respectively. Of the total federal NOL carryforwards, $347.4 million will expire at various dates beginning in 2028, if not utilized; the remaining federal NOLs do not expire. As of December 31, 2023 and 2022, the Company had state NOL carryforwards of approximately $696.1 million and $698.4 million, respectively. In 2022, state NOL carryforwards began to expire as they were not able to be fully utilized. State NOL carryforwards will continue to expire in 2023 onward at various dates, if not utilized. The Company has research and developmental tax credits of $21.0 million. The tax credit carryforwards will expire beginning in 2031, if not utilized. The Company files income tax returns in the U.S. federal jurisdiction, and various states. With few exceptions, the Company is no longer subject to U.S. federal or state and local income tax examinations by tax authorities for years before 2017. A reconciliation of the U.S. statutory income tax rate to the Company’s effective tax rate is as follows: December 31, 2023 2022 Federal income tax (benefit) at statutory rate (21.0) % (21.0) % Change in state tax rate 0.2 % (0.5) % Permanent items 0.2 % 0.1 % Prior period adjustments 0.9 % (3.6) % Change in valuation allowance 19.7 % 25.0 % Effective income tax rate 0.0 % 0.0 % Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, or the Code, if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes, such as research tax credits, to offset its post-change income may be limited. If the Company experiences a greater than 50 percentage point aggregate change in ownership of certain significant stockholders over a three-year period, a Section 382 ownership change could be deemed to have occurred. If a Section 382 change occurs, the Company’s future utilization of the net operating loss carryforwards and credits as of the ownership change will be subject to an annual limitation under Section 382 of the Internal Revenue Code of 1986, as amended, and similar state provisions. Some of the U.S. Federal and State net operating loss and credit carryforwards are subject to annual limitations due to ownership changes. The annual limitation may result in the expiration of net operating losses or credit carryforwards before utilization. The Company experienced an ownership change in 2017, 2021 and 2023. The Company’s reserves related to taxes are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized following resolution of any potential contingencies present related to the tax benefit. The Company recognized no material adjustment for unrecognized income tax benefits. Through December 31, 2023, the Company had accrued $2.1 million for unrecognized income tax benefits and related interest and penalties against credits. A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows. The Company does not expect this amount to change in the next twelve months. At December 31, 2023, all of the amount of unrecognized tax benefits, if recognized, would result in a deferred tax asset and corresponding increase in the entity’s valuation allowance. Such unrecognized tax benefit would not affect the effective rate if recognized. December 31, 2023 2022 (in thousands) Balance at January 1 $ 2,099 $ 2,099 Reductions for tax positions of prior year — — Balance at December 31 2,099 2,099 Significant components of the Company’s deferred tax assets are summarized in the table below: December 31, 2023 2022 (in thousands) Deferred tax assets: Federal and state operating loss carryforwards $ 258,836 $ 242,584 Equity compensation 25,413 26,243 Capitalized research and development 37,998 26,480 R&D tax credits, net of reserves 18,887 18,887 Disallowed interest 43,239 29,979 Temporary differences 12,362 8,340 Total deferred tax assets 396,735 352,513 Deferred tax liabilities: Other (1,154) (400) Total deferred tax liabilities (1,154) (400) Valuation allowance (395,581) (352,113) Net deferred tax assets $ — $ — |
Net Loss Per Common Share
Net Loss Per Common Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Common Share | Net Loss Per Common Share Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period, without consideration for common stock equivalents. Pre-Funded Warrants are included in the weighted-average number of common shares outstanding during the periods. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common stock equivalents outstanding for the period determined using the treasury-stock method. For purposes of this calculation, warrants for common stock, stock options, PBSOs, unvested RSUs and PBRSUs, shares issuable under the ESPP and shares issuable upon conversion of the convertible notes are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. The shares outstanding at the end of the respective periods presented below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: December 31, December 31, Common shares under option 3,686,191 3,842,737 Unvested RSUs 3,047,888 1,768,185 Shares issuable related to the ESPP — 27,558 Unvested PBRSUs 160,275 461,250 Common shares under PBSOs 661,850 499,200 Shares issuable upon conversion of convertible notes 8,007,010 8,007,010 Warrants for common stock 36,344,212 36,964,286 Total potential dilutive shares 51,907,426 51,570,226 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events As discussed in Note 5 "Commitments and Contingencies," on March 27, 2023, the Company filed a complaint in the United States District Court for the Southern District of New York seeking declaratory judgment against DSE regarding the Company’s right to receive a $300 million milestone payment upon inclusion of cardiovascular risk reduction in the EU label that correlates with a relative risk reduction rate of at least 20%, based on the results of the CLEAR Outcomes CVOT. On May 4, 2023, the Company filed an amended complaint against DSE in the Southern District of New York seeking a judicial declaration, on an expedited basis, that DSE is contractually required to make a $300 million milestone payment to the Company upon applicable regulatory approval. On June 20, 2023, DSE filed a response to the amended complaint. On January 2, 2024, the Company entered into a settlement agreement with DSE to amicably resolve and dismiss the commercial dispute then pending in the Southern District of New York, or the Settlement Agreement. Under the Settlement Agreement, DSE agreed to pay the Company an aggregate of $125 million, including (1) a $100-million payment within 15 business days of the effective date of the Settlement Agreement and (2) a $25-million payment in the calendar quarter immediately following the calendar quarter in which the EMA renders a decision on the application that was filed with the EMA for a Type II(a) variation for the Company's oral non-statin products marketed as NILEMDO (bempedoic acid) tablets and NUSTENDI (bempedoic acid and ezetimibe) tablets in Europe. The application asks the EMA to approve both NILEMDO and NUSTENDI to reduce cardiovascular risk in patients with or at high risk for atherosclerotic cardiovascular disease. The legal action pending in the United States District Court for the Southern District of New York has now been dismissed. Pursuant to the Settlement Agreement, also on January 2, 2024, the Company entered into a 3rd Amendment to the License and Collaboration Agreement dated January 2, 2019 with DSE, and a 1 st Amendment to the License and Collaboration Agreement dated April 26, 2021 with DS. Each of these amendments grant each of DSE and DS exclusive rights for clinical development, regulatory activities, manufacture and commercialization of a bempedoic acid/ezetimibe/statin triple combination pill in their existing respective territories of the European Economic Area, UK, Switzerland and Turkey (the “DSE Territory”) and South Korea, Taiwan, Hong Kong, Thailand, Vietnam, Brazil, Macao, Cambodia and Myanmar (the “DS Territory”). Further, after a transition period, DSE and DS will assume sole responsibility for the manufacture of NILEMDO and NUSTENDI for, respectively, the DSE Territory and DS Territory. As of January 2, 2024, DSE shall have sole authority and control of regulatory communications with the EMA regarding the pending marketing authorization applications for NILEMDO and NUSTENDI. On January 18, 2024, the Company entered into an Underwriting Agreement with Jefferies, as representative of several Underwriters, related to an underwritten public offering (the “January 2024 Offering”) of 56,700,000 shares of Common Stock of the Company, par value $0.001 per share, at a purchase price to the public of $1.50 per share. The Underwriters were also granted a 30-day option to purchase up to an additional 8,505,000 shares of Common Stock, at the public offering price. On January 19, 2024, Jefferies gave notice to the Company of its election to exercise the option to purchase additional shares, in full. Giving effect to the exercise of Underwriters' option, the offering proceeds to the Company were approximately $90.8 million, after deducting the underwriting discount and estimated offering expenses. The January 2024 Offering closed on January 23, 2024. |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net loss | $ (209,248) | $ (233,659) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared by the Company in accordance with generally accepted accounting principles in the United States of America (“GAAP”). |
Use of Estimates | Use of Estimates The preparation of financial statements in accordance with generally accepted accounting principles in the United States requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, net revenues, expenses and related disclosures. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company invests its excess cash in bank deposits, money market accounts, and short-term investments. The Company considers all highly liquid investments with an original maturity of 90 days or less at the time of purchase to be cash equivalents. Cash equivalents are reported at fair value. |
Restricted Cash | Restricted Cash Restricted cash consists of legally restricted amounts held by financial institutions pursuant to contractual arrangements. Pursuant to the Amendment and Waiver (as defined below), in 2021 the Company deposited $50.0 million in a deposit account that was subject to a block account control agreement. Oberland had the sole control over the funds deposited in the account and such funds could be withdrawn only with the consent of Eiger III SA LLC, or Oberland, an affiliate of Oberland Capital LLC. On November 23, 2022, pursuant to the Waiver and Amendment No. 3, the Company agreed to make a one-time partial call payment with regards to the Revenue Interests, as defined in the Revenue Interest Purchase Agreement ("RIPA"), in the amount of $50.0 million, the full amount that was subject to the block account control agreement. Refer to Note 10 "Liability Related to the Revenue Interest Purchase Agreement" for further information on the Amendment and Waiver. |
Investments | Investments Investments are considered to be available-for-sale and are carried at fair value. Unrealized gains and losses, if any, are reported in accumulated other comprehensive income (loss). The cost of investments classified as available-for-sale are adjusted for the amortization of premiums and accretion of discounts to maturity and recorded in other income, net. Realized gains and losses, if any, are determined using the specific identification method and recorded in other income, net. Investments with original maturities beyond 90 days at the date of purchase and which mature at, or less than twelve months from, the balance sheet date are classified as current. Investments with a maturity beyond twelve months from the balance sheet date are classified as long-term. |
Selling, General and Administrative Expenses | Selling, General and Administrative Expenses |
Concentration of Credit Risk | Concentration of Credit Risk |
Inventories | Inventories Inventories are stated at the lower of cost or net realizable value and recognized on a first-in, first-out ("FIFO") method. The Company uses standard cost to determine the cost basis for inventory. Inventory is capitalized based on when future economic benefit is expected to be realized. The Company analyzes its inventory levels on a periodic basis to determine if any inventory is at risk for expiration prior to sale or has a cost basis that is greater than its estimated future net realizable value. Any adjustments are recognized through cost of goods sold in the period in which they are incurred. |
Segment Information | Segment Information The Company views its operations and manages its business in one operating segment, which is the business of researching, developing and commercializing therapies for the treatment of patients with elevated LDL-C. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The Company’s cash, cash equivalents, and investments are carried at fair value. Financial instruments, including accounts receivable, other prepaid and current assets, accounts payable and accrued liabilities are carried at cost, which approximates fair value. Debt is carried at amortized cost, which approximates fair value. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are recorded at cost, less accumulated depreciation. Depreciation is provided using the straight-line method over the estimated useful lives of the respective assets, generally three |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company reviews long-lived assets, including property and equipment and right-of-use operating lease assets, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of the asset and its eventual disposition are less than its carrying amount. The impairment loss, if recognized, would be based on the excess of the carrying value of the impaired asset over its respective fair value. No impairment losses have been recorded through December 31, 2023. |
Leases | Leases The Company reviews all arrangements to determine if the contract contains a lease or an embedded lease using the criteria in Accounting Standards Codification ("ASC") 842 Leases ("ASC 842"). If a lease is identified, the Company reviews the consideration in the contract and separates the lease components from the nonlease components. In addition, the Company reviews the classification of the lease between operating and finance leases. According to ASC 842, lessees should discount lease payments at the lease commencement date using the rate implicit in the lease. If the rate implicit in the lease is not readily determinable, a lessee must use its incremental borrowing rate for purposes of classifying the lease and measuring the right-of-use asset and liability. To the extent the rate is not implicit in the lease, the Company uses the incremental borrowing rate it would have to pay to borrow on a collateralized basis over a similar term in an amount equal to the lease payments in a similar economic environment. |
Convertible Notes | Convertible Notes The convertible notes are reported as a single liability at their amortized costs on the balance sheets, net of unamortized issuance costs. Issuance costs are amortized to interest expense over the life of the convertible debt. The Company uses the if-converted method when calculating diluted earnings per share. |
Revenue Interest Liability | Revenue Interest Liability The revenue interest liability is presented net of deferred issuance costs on the balance sheets. The Company imputes interest expense associated with this liability using the effective interest rate method. The effective interest rate is calculated based on the rate that would enable the debt to be repaid in full over the anticipated life of the arrangement. The interest rate on the liability may vary during the term of the agreement depending on a number of factors, including the level of forecasted net sales. The Company evaluates the interest rate quarterly based on its current net sales forecasts utilizing the prospective method. |
Revenue Recognition | Revenue Recognition In accordance with ASC 606, Revenue from Contracts with Customers ("ASC 606"), the Company recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for the goods or services provided. To determine revenue recognition for arrangements within the scope of ASC 606, the Company performs the following five steps: identify the contracts with a customer; identify the performance obligations in the contract; determine the transaction price; allocate the transaction price to the performance obligations in the contract; and recognize revenue when or as the entity satisfies a performance obligation. At contract inception the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when or as the performance obligation is satisfied. The Company derives revenue through two primary sources: collaboration revenue and product sales. Collaboration revenue consists of the collaboration payments to the Company for collaboration arrangements outside of the United States for the development, manufacturing and commercialization of the Company's product candidates by the Company's partners and product sales consists of sales of NEXLETOL and NEXLIZET in the United States. a. Collaboration Revenue The Company has entered into agreements related to its activities to develop, manufacture, and commercialize its product candidates. The Company earns collaboration revenue in connection with a collaboration agreement to develop and/or commercialize product candidates where the Company deems the collaborator to be the customer. In accordance with ASC 606, revenue is measured as the amount of consideration expected to be entitled to in exchange for transferring promised goods or providing services to a customer. Revenue is recognized when (or as) the Company satisfies performance obligations under the terms of a contract. Depending on the terms of the arrangement, the Company may defer the recognition of all or a portion of the consideration received as the performance obligations are satisfied. The collaboration agreements may require the Company to deliver various rights, services, and/or goods across the entire life cycle of a product or product candidate. In an agreement involving multiple goods or services promised to be transferred to a customer, the Company must assess, at the inception of the contract, whether each promise represents a separate performance obligation (i.e., is "distinct"), or whether such promises should be combined as a single performance obligation. The terms of the agreements typically include consideration to be provided to the Company in the form of non-refundable up-front payments, development milestones, sales milestones, and royalties on sales of products within a respective territory. The Company recognizes regulatory and approval milestones consideration when it is probable that a future reversal is unlikely to occur. For sales based milestones and royalties based on sales of product in a territory, the Company applies the sales-based royalty exception in ASC 606 to all of these milestones and royalties. At the inception of a contract, the transaction price reflects the amount of consideration the Company expects to be entitled to in exchange for transferring promised goods or services to its customer. In the arrangement where the Company satisfies performance obligation(s) during the regulatory phase over time, the Company recognizes collaboration revenue typically using an input method on the basis of regulatory costs incurred relative to the total expected cost which determines the extent of progress toward completion. The Company reviews the estimate of the transaction price and the total expected cost each period, and makes revisions to such estimates as necessary. Under contracted supply agreements with collaborators, the Company may manufacture and supply quantities of active pharmaceutical ingredient (“API”) or bulk tablets reasonably required by collaboration partners for the development or sale of licensed products in their respective territory. The Company recognizes revenue when the collaboration partner has obtained control of the API or bulk tablets. The Company records the costs related to the supply agreement in cost of goods sold on the statements of operations and comprehensive income (loss). Under the Company's collaboration agreements, product sales and cost of sales may be recorded by the Company's collaborators as they are deemed to be the principal in the transaction. The Company receives royalties from the commercialization of such products, and records its share of the variable consideration, representing a percentage of net product sales, as collaboration revenue in the period in which such underlying sales occur and costs are incurred by the collaborators. b. Product Sales, Net On March 30, 2020, NEXLETOL was commercially available in the U.S. through prescription and on June 4, 2020, NEXLIZET was commercially available in the U.S. through prescription. Net product sales totaled $78.3 million and $55.9 million for the years ended December 31, 2023 and December 31, 2022, respectively. The Company sells NEXLETOL and NEXLIZET to wholesalers in the U.S and recognizes revenue at the point in time when the customer is deemed to have obtained control of the product. The customer is deemed to have obtained control of the product at the time of physical receipt of the product at the customers’ distribution facilities, or free on board (“FOB”) destination, the terms of which are designated in the contract. Product sales are recorded at the net selling price, which includes estimates of variable consideration for which reserves are established for (a) rebates and chargebacks, (b) co-pay assistance programs, (c) distribution fees, (d) product returns, and (e) other discounts and fees. Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as current contractual and statutory requirements, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company's best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contract. The amount of variable consideration 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 will not occur in a future period. Given the early stage of the Company’s commercial operations it has provided constraint of its variable consideration due to its potential consumption trends. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known. Liabilities for co-pay assistance, expected product returns, rebates, and distributor fees are classified as “Accrued variable consideration" in the balance sheets. Discounts, such as prompt pay discounts, and chargebacks are recorded as a reduction to trade accounts receivable in the balance sheets. Forms of Variable Consideration Rebates and Chargebacks: The Company estimates reductions to product sales for Public Health Service Institutions, such as Medicaid, Medicare and Veterans' Administration ("VA") programs, as well as certain other qualifying federal and state government programs, and other group purchasing organizations. The Company estimates these reductions based upon the Company's contracts with government agencies and other organizations, statutorily defined discounts and estimated payor mix. These organizations purchase directly from the Company's wholesalers at a discount and the wholesalers charge the Company back the difference between the wholesaler price and the discounted price. The Company's liability for Medicare and Medicaid rebates consists of estimates for claims that a state will make for a current quarter. The Company's reserve for this discounted pricing is based on expected sales to qualified healthcare providers and the chargebacks that customers have already claimed. Co-pay assistance: Eligible patients who have commercial insurance may receive assistance from the Company to reduce the patient's out of pocket costs. The Company will buy down the difference between the amount of the eligible patient's co-pay when the drug is purchased at the pharmacy at a determined price. Liabilities for co-pay assistance are calculated by actual program participation from third-party administrators. Distribution Fees: The Company has written contracts with its customers that include terms for distribution fees and costs for inventory management. The Company estimates and records distribution fees due to its customers based on gross sales. Product Returns: The Company generally offers a right of return based on the product’s expiration date and certain spoilage and damaged instances. The Company estimates the amount of product sales that may be returned and records the estimate as a reduction of product sales in the period the related product sales is recognized. The Company’s estimates for expected returns are based primarily on an ongoing analysis of historical returns sales information and visibility into the inventory remaining in the distribution channel. Discounts: The Company provides product discounts, such as prompt pay discounts, to its customers. The Company estimates cash discounts based on terms in negotiated contracts and the Company’s expectations regarding future payment patterns. |
Cost of Goods Sold | Cost of Goods Sold |
Research and Development | Research and Development Research and development expenses consist of costs incurred to further the Company’s research and development activities and include salaries and related benefits, costs associated with clinical activities, nonclinical activities, regulatory activities, manufacturing activities to support clinical activities and commercial product manufacturing supply prior to the Company's regulatory approval, research-related overhead expenses, in-licensing agreements and fees paid to external service providers that conduct certain research and development, clinical, and manufacturing activities on behalf of the Company. Research and development costs are expensed as incurred. |
Accrued Clinical Development Costs | Accrued Clinical Development Costs Outside research costs are a component of research and development expense. These expenses include fees paid to clinical research organizations and other service providers that conduct certain clinical and product development activities on behalf of the Company. Depending upon the timing of payments to the service providers, the Company recognizes prepaid expenses or accrued expenses related to these costs. These accrued or prepaid expenses are based on management’s estimates of the work performed under service agreements, milestones achieved and experience with similar contracts. The Company monitors each of these factors and adjusts estimates accordingly. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are determined based on differences between financial reporting and the tax basis of assets and liabilities and are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company has incurred annual operating losses since inception. Accordingly, it is not more likely than not that the Company will realize a tax benefit from its deferred tax assets and as such, it has recorded a full valuation allowance. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation in accordance with the provisions of ASC 718, Compensation—Stock Compensation . Accordingly, compensation costs related to equity instruments granted are recognized over the requisite service periods of the awards on a straight-line basis at the grant-date fair value. The fair value for stock options and performance-based stock options is calculated using a Black-Scholes option-pricing model. If the instruments contain performance conditions, compensation expense is recognized only if achievement of the performance condition is probable. The Company accounts for forfeitures as they occur. Expense is recognized during the period the related services are rendered. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In December 2023, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") 2023-07, Segment Reporting (Topic 280): Improvements to Segment Reporting Disclosures. This standard requires an entity to provide more detailed information about its reportable segment expenses that are included within management’s measurement of profit and loss and will require certain annual disclosures to be provided on an interim basis. The amendments in this ASU are effective for the Company in 2025 for annual reporting and in 2026 for interim reporting, with early adoption permitted beginning in 2024, and is required to be applied using the full retrospective method of transition. The Company is evaluating the timing and effects of adoption of this ASU on the Company’s segment disclosures. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires disaggregated information about a reporting entity's effective tax rate reconciliation, as well as information related to income taxes paid to enhance the transparency and decision usefulness of income tax disclosures. This ASU will be effective for the annual period ending December 31, 2025. The Company is currently evaluating the timing and impacts of adoption of this ASU. The Company does not expect adoption of any remaining recently issued accounting pronouncements to have a material impact on the financial statements. |
Inventories, net (Tables)
Inventories, net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventories, net consist of the following: December 31, 2023 2022 (in thousands) Raw materials $ 61,890 $ 26,558 Work in process 1,728 6,548 Finished goods 2,005 2,095 $ 65,623 $ 35,201 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment, net, consist of the following: December 31, 2023 2022 (in thousands) Computer equipment $ 249 $ 278 Software 968 968 Furniture, fixtures and other 606 1,170 Leasehold improvements 189 299 Subtotal 2,012 2,715 Less accumulated depreciation and amortization 2,012 2,551 Property and equipment, net $ — $ 164 |
Other Accrued Liabilities (Tabl
Other Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Other Accrued Liabilities | Other accrued liabilities consist of the following: December 31, 2023 2022 (in thousands) Accrued compensation $ 10,769 $ 9,053 Accrued legal fees 9,202 186 Accrued professional fees 2,712 2,361 Accrued interest on convertible notes 1,325 1,325 Accrued other 990 279 Total other accrued liabilities $ 24,998 $ 13,204 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Company's Cash Equivalents and Investments | The following table summarizes the Company’s cash equivalents and investments: December 31, 2023 Gross Gross Estimated Amortized Unrealized Unrealized Fair Cost Gains Losses Value (in thousands) Cash equivalents: Money market funds $ 68,445 $ — $ — $ 68,445 Certificates of deposit 402 — — 402 Total $ 68,847 $ — $ — $ 68,847 December 31, 2022 Gross Gross Estimated Amortized Unrealized Unrealized Fair Cost Gains Losses Value (in thousands) Cash equivalents: Money market funds $ 105,078 $ — $ — $ 105,078 U.S. treasury notes 4,994 1 — 4,995 Certificates of deposit 401 — — 401 Short-term investments: U.S. treasury notes 42,089 2 (5) 42,086 Total $ 152,562 $ 3 $ (5) $ 152,560 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Schedule of the Company's Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following table presents the Company’s financial assets that have been measured at fair value on a recurring basis: Description Total Level 1 Level 2 Level 3 December 31, 2023 Assets: Money market funds $ 68,445 $ 68,445 $ — $ — Certificates of deposit 402 402 — — Total assets at fair value $ 68,847 $ 68,847 $ — $ — December 31, 2022 Assets: Money market funds $ 105,078 $ 105,078 $ — $ — Certificates of deposit 401 401 — — U.S. treasury notes 47,081 47,081 — — Total assets at fair value $ 152,560 $ 152,560 $ — $ — |
Liability Related to the Reve_2
Liability Related to the Revenue Interest Purchase Agreement (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Liability Related to the Revenue Interest Purchase Agreement | |
Summary of Revenue Interest Liability Activity | The following table summarizes the revenue interest liability activity during the years ended December 31, 2023 and 2022: (in thousands) Revenue interest liability at December 31, 2021 $ 257,039 Repayment upon execution of Amendment No. 3 (50,000) Interest expense recognized 44,590 Revenue interest payments (8,024) Revenue interest liability at December 31, 2022 $ 243,605 Interest expense recognized 46,679 Revenue interest payments (15,506) Revenue interest liability at December 31, 2023 $ 274,778 |
Stockholders' Deficit (Tables)
Stockholders' Deficit (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Summary of Warrants and Pre-funded Warrants Outstanding | The following table summarizes the warrants outstanding for the Company as of December 31, 2023 and 2022: December 31, 2023 December 31, 2022 Weighted average exercise price Warrants outstanding from 2021 agreement, expiring December 7, 2023 — 36,964,286 $ 9.00 Warrants outstanding from Warrant Amendment Agreements, expiring September 22, 2026 9,024,212 — $ 1.55 Warrants outstanding from Purchase Agreement, expiring September 22, 2026 27,320,000 — $ 1.55 Total warrants outstanding 36,344,212 36,964,286 |
Stock Compensation (Tables)
Stock Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Activity Relating to the Company's Options to Purchase Common Stock | The following table summarizes the activity relating to the Company’s options to purchase common stock for the year ended December 31, 2023: Weighted-Average Weighted-Average Remaining Number of Exercise Price Contractual Aggregate Options Per Share Term (Years) Intrinsic Value (in thousands) Outstanding at December 31, 2022 3,842,737 $ 27.75 4.86 $ 1,658 Granted 1,550,200 $ 3.53 Forfeited or cancelled (vested and unvested) (1,706,746) $ 35.69 Outstanding at December 31, 2023 3,686,191 $ 13.88 7.47 $ 584 Vested and expected to vest at December 31, 2023 3,686,191 $ 13.88 7.47 $ 584 Exercisable at December 31, 2023 1,706,622 $ 23.99 5.84 $ 20 The following table summarizes the activity relating to the Company’s performance-based stock options for the year ended December 31, 2023: Weighted-Average Weighted-Average Remaining Number of Exercise Price Contractual Aggregate PBSOs Per Share Term (Years) Intrinsic Value (in thousands) Outstanding at December 31, 2022 499,200 $ 6.73 9.32 $ 12 Granted 227,900 $ 1.62 Forfeited (65,250) $ 6.76 Outstanding at December 31, 2023 661,850 $ 4.97 8.63 $ 312 Vested and expected to vest at December 31, 2023 661,850 $ 4.97 8.63 $ 312 Exercisable at December 31, 2023 48,100 $ 8.94 5.87 $ — |
Schedule of Weighted-Average Assumptions Used to Compute the Stock-Based Compensation Costs for the Stock Options Granted to Employees | The following table shows the weighted-average assumptions used to compute the stock-based compensation costs for the stock options granted to employees during each of the two years ending December 31, 2023, using the Black-Scholes option-pricing model: Year ended December 31, 2023 2022 Risk-free interest rate 3.83 % 2.26 % Dividend yield — — Weighted-average expected life of options (years) 6.17 6.16 Volatility 79 % 81 % |
Summary of Activity Relating to the Company's RSUs | The following table summarizes the activity relating to the Company’s RSUs for the year ended December 31, 2023: Number of Weighted-Average RSUs Fair Value Per Share Outstanding and unvested at December 31, 2022 1,768,185 $ 8.80 Granted 2,456,485 $ 3.22 Forfeited or expired (342,876) $ 7.14 Vested (833,906) $ 8.07 Outstanding and unvested at December 31, 2023 3,047,888 $ 4.69 |
Schedule of Nonvested Performance-based Units Activity | The following table summarizes the activity relating to the Company's PBRSUs for the year ended December 31, 2023: Numbers of Weighted-Average PBRSU's Fair Value Per Share Outstanding and unvested at December 31, 2022 461,250 $ 9.50 Granted — $ — Forfeited (100,250) $ 11.50 Vested (200,725) $ 8.94 Outstanding and unvested at December 31, 2023 160,275 $ 8.94 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases [Abstract] | |
Schedule of Future Maturities of Operating Lease Liabilities | The following table summarizes the Company's future maturities of operating lease liabilities as of December 31, 2023: (in thousands) 2024 $ 1,838 2025 1,811 2026 1,140 2027 169 2028 144 Total lease payments 5,102 Less imputed interest (529) Total $ 4,573 |
Schedule of Supplemental Balance Sheet Information Related to Leases | The following table summarizes supplemental balance sheet information related to leases as of December 31, 2023: Operating Leases (in thousands) Total right of use operating lease assets $ 4,675 Operating lease liabilities (short-term) $ (1,553) Operating lease liabilities (long-term) (3,020) Total lease obligations under operating leases $ (4,573) |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of Reconciliation of the U.S. Statutory Income Tax Rate to the Company's Effective Tax Rate | A reconciliation of the U.S. statutory income tax rate to the Company’s effective tax rate is as follows: December 31, 2023 2022 Federal income tax (benefit) at statutory rate (21.0) % (21.0) % Change in state tax rate 0.2 % (0.5) % Permanent items 0.2 % 0.1 % Prior period adjustments 0.9 % (3.6) % Change in valuation allowance 19.7 % 25.0 % Effective income tax rate 0.0 % 0.0 % |
Summary of Income Tax Contingencies | December 31, 2023 2022 (in thousands) Balance at January 1 $ 2,099 $ 2,099 Reductions for tax positions of prior year — — Balance at December 31 2,099 2,099 |
Schedule of Significant Components of the Company's Deferred Tax Assets | Significant components of the Company’s deferred tax assets are summarized in the table below: December 31, 2023 2022 (in thousands) Deferred tax assets: Federal and state operating loss carryforwards $ 258,836 $ 242,584 Equity compensation 25,413 26,243 Capitalized research and development 37,998 26,480 R&D tax credits, net of reserves 18,887 18,887 Disallowed interest 43,239 29,979 Temporary differences 12,362 8,340 Total deferred tax assets 396,735 352,513 Deferred tax liabilities: Other (1,154) (400) Total deferred tax liabilities (1,154) (400) Valuation allowance (395,581) (352,113) Net deferred tax assets $ — $ — |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Schedule of Shares Outstanding Excluded from Computation of Earnings Per Share | The shares outstanding at the end of the respective periods presented below were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect: December 31, December 31, Common shares under option 3,686,191 3,842,737 Unvested RSUs 3,047,888 1,768,185 Shares issuable related to the ESPP — 27,558 Unvested PBRSUs 160,275 461,250 Common shares under PBSOs 661,850 499,200 Shares issuable upon conversion of convertible notes 8,007,010 8,007,010 Warrants for common stock 36,344,212 36,964,286 Total potential dilutive shares 51,907,426 51,570,226 |
The Company and Basis of Pres_2
The Company and Basis of Presentation (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||||
Jan. 18, 2024 USD ($) $ / shares shares | Jan. 02, 2024 USD ($) | Mar. 22, 2023 USD ($) $ / shares shares | Mar. 19, 2023 USD ($) $ / shares shares | Aug. 31, 2019 patient | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2020 product | Mar. 23, 2023 $ / shares | Dec. 31, 2021 $ / shares | |
Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||||
Products approved | product | 2 | |||||||||
Number of study patients | patient | 14,000 | |||||||||
Common stock, shares issued (in shares) | shares | 120,204,513 | 76,564,396 | ||||||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||||||
Proceeds from issuance of common stock, net of issuance costs | $ | $ 4,448 | $ 90,849 | ||||||||
Subsequent Event | ||||||||||
Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||||
Common stock, par value (in dollars per share) | $ 0.001 | |||||||||
Net proceeds | $ | $ 90,800 | |||||||||
First milestone payment | $ | $ 100,000 | |||||||||
Time required to pay cash portion | 15 days | |||||||||
Second milestone payment | $ | $ 25,000 | |||||||||
Subsequent Event | Minimum | ||||||||||
Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||||
Aggregate payment agreement | $ | $ 125,000 | |||||||||
Underwritten Public Offering | Subsequent Event | ||||||||||
Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||||
Common stock, par value (in dollars per share) | $ 0.001 | |||||||||
Exercise price (in dollars per share) | $ 1.50 | |||||||||
Net proceeds | $ | $ 90,800 | |||||||||
Issued stock (in shares) | shares | 56,700,000 | |||||||||
Price per share (in dollars per share) | $ 1.50 | |||||||||
Over Allotment Option | Subsequent Event | ||||||||||
Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||||
Issued stock (in shares) | shares | 8,505,000 | |||||||||
Option period | 30 days | |||||||||
Securities Purchase Agreement | ||||||||||
Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||||
Common stock, shares issued (in shares) | shares | 12,205,000 | |||||||||
Common stock, par value (in dollars per share) | $ 0.001 | |||||||||
Common stock purchasable under prefunded warrants (in shares) | shares | 20,965,747 | |||||||||
Common stock purchasable under warrants (in shares) | shares | 33,170,747 | |||||||||
Exercise price (in dollars per share) | $ 1.55 | |||||||||
Securities Purchase Agreement | Common Stock And Accompanying Warrant | ||||||||||
Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||||
Purchase price (in dollars per share) | $ 1.675 | |||||||||
Securities Purchase Agreement | Pre Funded Warrant And Accompanying Warrant | ||||||||||
Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||||
Purchase price (in dollars per share) | $ 1.674 | |||||||||
Warrant Amendment Agreements | ||||||||||
Organization, Consolidation and Presentation of Financial Statements [Line Items] | ||||||||||
Common stock purchasable under warrants (in shares) | shares | 9,024,212 | |||||||||
Exercise price (in dollars per share) | $ 1.55 | $ 1.55 | $ 1.55 | $ 9 | ||||||
Expiration term | 3 years 6 months | |||||||||
Additional consideration (in dollars per share) | $ 0.125 | |||||||||
Net proceeds | $ | $ 55,500 | $ 1,200 | ||||||||
Proceeds from issuance of common stock, net of issuance costs | $ | $ 51,300 | |||||||||
Proceeds from warrant amendment | $ | $ 1,100 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) | 12 Months Ended | |||
Nov. 23, 2022 USD ($) | Dec. 31, 2023 USD ($) segment customer revenue_source | Dec. 31, 2022 USD ($) customer | Dec. 31, 2021 USD ($) | |
Summary of Significant Accounting Policies [Line Items] | ||||
Restricted cash | $ 50,000,000 | |||
One time partial call | $ 50,000,000 | |||
Advertising expense | $ 15,600,000 | $ 11,300,000 | ||
Number of operating segments | segment | 1 | |||
Impairment losses | $ 0 | |||
Number revenue sources | revenue_source | 2 | |||
Total Revenues | $ 116,334,000 | $ 75,475,000 | ||
Trade Accounts Receivable | Accounts Receivable Risks | ||||
Summary of Significant Accounting Policies [Line Items] | ||||
Number of major customers | customer | 11 | 11 | ||
Revenue Benchmark | Accounts Receivable Risks | Three Largest Customers | ||||
Summary of Significant Accounting Policies [Line Items] | ||||
Risk percentage | 96% | |||
Revenue Benchmark | Product Concentration Risk | Three Largest Customers | ||||
Summary of Significant Accounting Policies [Line Items] | ||||
Risk percentage | 95% | |||
Product | ||||
Summary of Significant Accounting Policies [Line Items] | ||||
Total Revenues | $ 78,335,000 | $ 55,863,000 | ||
Minimum | Property and equipment | ||||
Summary of Significant Accounting Policies [Line Items] | ||||
Estimated useful lives | 3 years | |||
Maximum | Property and equipment | ||||
Summary of Significant Accounting Policies [Line Items] | ||||
Estimated useful lives | 10 years |
Collaborations with Third Par_2
Collaborations with Third Parties (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||||
Jan. 02, 2024 | Apr. 26, 2021 | Apr. 17, 2020 | Jan. 02, 2019 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2020 | |
Collaborations with Third Parties | |||||||
Total Revenues | $ 116,334 | $ 75,475 | |||||
Subsequent Event | |||||||
Collaborations with Third Parties | |||||||
First milestone payment | $ 100,000 | ||||||
Time required to pay cash portion | 15 days | ||||||
Second milestone payment | $ 25,000 | ||||||
Royalty Revenue From DSE And Sale Of Bulk Tablets | |||||||
Collaborations with Third Parties | |||||||
Total Revenues | 37,200 | 18,200 | |||||
Collaboration Revenue | |||||||
Collaborations with Third Parties | |||||||
Total Revenues | 37,999 | 19,612 | |||||
Minimum | Subsequent Event | |||||||
Collaborations with Third Parties | |||||||
Aggregate payment agreement | 125,000 | ||||||
Daiichi Sankyo Europe GmbH ("DSE") | Subsequent Event | |||||||
Collaborations with Third Parties | |||||||
Potential one-time cash payment upon milestone | $ 300,000 | ||||||
Daiichi Sankyo Europe GmbH ("DSE") | Minimum | Subsequent Event | Commitment Offering | |||||||
Collaborations with Third Parties | |||||||
Royalties on sales | 15% | ||||||
Daiichi Sankyo Europe GmbH ("DSE") | Maximum | Subsequent Event | Commitment Offering | |||||||
Collaborations with Third Parties | |||||||
Royalties on sales | 25% | ||||||
Daiichi Sankyo Europe GmbH ("DSE") | Collaborative Arrangement | |||||||
Collaborations with Third Parties | |||||||
Upfront cash payment | $ 150,000 | ||||||
Cash payment to the Company | $ 150,000 | ||||||
Daiichi Sankyo Europe GmbH ("DSE") | Collaborative Arrangement | Minimum | |||||||
Collaborations with Third Parties | |||||||
Percentage of royalties to be received on the net sales | 15% | ||||||
Daiichi Sankyo Europe GmbH ("DSE") | Collaborative Arrangement | Maximum | |||||||
Collaborations with Third Parties | |||||||
Percentage of royalties to be received on the net sales | 25% | ||||||
Otsuka Pharmaceutical Co Ltd | Exclusive Developmental Activities | |||||||
Collaborations with Third Parties | |||||||
Upfront cash payment | $ 60,000 | ||||||
Potential additional future payments | $ 450,000 | ||||||
Otsuka Pharmaceutical Co Ltd | Exclusive Developmental Activities | Collaboration Revenue | |||||||
Collaborations with Third Parties | |||||||
Total Revenues | 100 | 600 | |||||
Otsuka Pharmaceutical Co Ltd | Exclusive Developmental Activities | Minimum | |||||||
Collaborations with Third Parties | |||||||
Percentage of royalties to be received on the net sales | 15% | ||||||
Otsuka Pharmaceutical Co Ltd | Exclusive Developmental Activities | Maximum | |||||||
Collaborations with Third Parties | |||||||
Percentage of royalties to be received on the net sales | 30% | ||||||
Milestone payment, first JNDA submissions | $ 20,000 | ||||||
Milestone payment, first NHI Price Listing for NEXLETOL in the Otsuka Territory | 70,000 | ||||||
Milestone payment, achievement of the primary MACE in the CLEAR Outcomes study and CV risk reduction rate on the U.S. label | 50,000 | ||||||
Milestone payments related to total net sales achievements | $ 310,000 | ||||||
Daiichi Sankyo Co. Ltd | Collaborative Arrangement | |||||||
Collaborations with Third Parties | |||||||
Total Revenues | $ 700 | $ 800 | |||||
Consideration cash payment | $ 30,000 | ||||||
Payment to be received upon milestone | $ 175,000 | ||||||
Daiichi Sankyo Co. Ltd | Collaborative Arrangement | Minimum | |||||||
Collaborations with Third Parties | |||||||
Percentage of royalties to be received on the net sales | 5% | ||||||
Daiichi Sankyo Co. Ltd | Collaborative Arrangement | Maximum | |||||||
Collaborations with Third Parties | |||||||
Percentage of royalties to be received on the net sales | 20% |
Inventories, net (Details)
Inventories, net (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 61,890 | $ 26,558 |
Work in process | 1,728 | 6,548 |
Finished goods | 2,005 | 2,095 |
Total Inventory | $ 65,623 | $ 35,201 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) $ in Millions | Jan. 02, 2024 | May 04, 2023 | Mar. 27, 2023 |
Other Commitments [Line Items] | |||
Partner milestone payments | $ 300 | ||
Subsequent Event | |||
Other Commitments [Line Items] | |||
First milestone payment | $ 100 | ||
Time required to pay cash portion | 15 days | ||
Second milestone payment | $ 25 | ||
Minimum | Subsequent Event | |||
Other Commitments [Line Items] | |||
Aggregate payment agreement | $ 125 | ||
Cardiovascular Risk | Minimum | |||
Other Commitments [Line Items] | |||
Percentage of risk reduction | 20% | ||
Cardiovascular Risk Outcome Less than Twenty Percent | Minimum | |||
Other Commitments [Line Items] | |||
Partner milestone payments | $ 300 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property and Equipment | ||
Property and equipment, gross | $ 2,012 | $ 2,715 |
Less accumulated depreciation and amortization | 2,012 | 2,551 |
Property and equipment, net | 0 | 164 |
Depreciation expense | 164 | 500 |
Computer equipment | ||
Property and Equipment | ||
Property and equipment, gross | 249 | 278 |
Software | ||
Property and Equipment | ||
Property and equipment, gross | 968 | 968 |
Furniture, fixtures and other | ||
Property and Equipment | ||
Property and equipment, gross | 606 | 1,170 |
Leasehold improvements | ||
Property and Equipment | ||
Property and equipment, gross | $ 189 | $ 299 |
Other Accrued Liabilities (Deta
Other Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued compensation | $ 10,769 | $ 9,053 |
Accrued legal fees | 9,202 | 186 |
Accrued professional fees | 2,712 | 2,361 |
Accrued interest on convertible notes | 1,325 | 1,325 |
Accrued other | 990 | 279 |
Total other accrued liabilities | $ 24,998 | $ 13,204 |
Investments - Summary of Cash E
Investments - Summary of Cash Equivalents and Short-Term Investments (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Investments | ||
Amortized Cost | $ 68,847 | $ 152,562 |
Gross Unrealized Gains | 0 | 3 |
Gross Unrealized Losses | 0 | (5) |
Estimated Fair Value | 68,847 | 152,560 |
Cash Equivalents | Money market funds | ||
Investments | ||
Amortized Cost | 68,445 | 105,078 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | 68,445 | 105,078 |
Cash Equivalents | U.S. treasury notes | ||
Investments | ||
Amortized Cost | 4,994 | |
Gross Unrealized Gains | 1 | |
Gross Unrealized Losses | 0 | |
Estimated Fair Value | 4,995 | |
Cash Equivalents | Certificates of deposit | ||
Investments | ||
Amortized Cost | 402 | 401 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | 0 | 0 |
Estimated Fair Value | $ 402 | 401 |
Short-term Investments | U.S. treasury notes | ||
Investments | ||
Amortized Cost | 42,089 | |
Gross Unrealized Gains | 2 | |
Gross Unrealized Losses | (5) | |
Estimated Fair Value | $ 42,086 |
Investments - Narrative (Detail
Investments - Narrative (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Investments | ||
Accretion of premiums and discounts on investments | $ (412,000) | $ 279,000 |
Reclassification out of Accumulated Other Comprehensive Income | ||
Investments | ||
Unrealized gains (losses) | 0 | 0 |
Interest Income | ||
Investments | ||
Interest income on investments | 4,400,000 | 2,400,000 |
Other Nonoperating Income (Expense) | ||
Investments | ||
Accretion of premiums and discounts on investments | $ 400,000 | $ 200,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Fair value measurements | ||
Transfer of assets between levels | $ 0 | $ 0 |
Transfer of liabilities between levels | 0 | 0 |
Recurring fair value measurement | ||
Fair value measurements | ||
Total assets at fair value | 68,847,000 | 152,560,000 |
Recurring fair value measurement | Money market funds | ||
Fair value measurements | ||
Total assets at fair value | 68,445,000 | 105,078,000 |
Recurring fair value measurement | Certificates of deposit | ||
Fair value measurements | ||
Total assets at fair value | 402,000 | 401,000 |
Recurring fair value measurement | U.S. treasury notes | ||
Fair value measurements | ||
Total assets at fair value | 47,081,000 | |
Recurring fair value measurement | Level 1 | ||
Fair value measurements | ||
Total assets at fair value | 68,847,000 | 152,560,000 |
Recurring fair value measurement | Level 1 | Money market funds | ||
Fair value measurements | ||
Total assets at fair value | 68,445,000 | 105,078,000 |
Recurring fair value measurement | Level 1 | Certificates of deposit | ||
Fair value measurements | ||
Total assets at fair value | 402,000 | 401,000 |
Recurring fair value measurement | Level 1 | U.S. treasury notes | ||
Fair value measurements | ||
Total assets at fair value | 47,081,000 | |
Recurring fair value measurement | Level 2 | ||
Fair value measurements | ||
Total assets at fair value | 0 | 0 |
Recurring fair value measurement | Level 2 | Money market funds | ||
Fair value measurements | ||
Total assets at fair value | 0 | 0 |
Recurring fair value measurement | Level 2 | Certificates of deposit | ||
Fair value measurements | ||
Total assets at fair value | 0 | 0 |
Recurring fair value measurement | Level 2 | U.S. treasury notes | ||
Fair value measurements | ||
Total assets at fair value | 0 | |
Recurring fair value measurement | Level 3 | ||
Fair value measurements | ||
Total assets at fair value | 0 | 0 |
Recurring fair value measurement | Level 3 | Money market funds | ||
Fair value measurements | ||
Total assets at fair value | 0 | 0 |
Recurring fair value measurement | Level 3 | Certificates of deposit | ||
Fair value measurements | ||
Total assets at fair value | $ 0 | 0 |
Recurring fair value measurement | Level 3 | U.S. treasury notes | ||
Fair value measurements | ||
Total assets at fair value | $ 0 |
Liability Related to the Reve_3
Liability Related to the Revenue Interest Purchase Agreement - Summary (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||||
Nov. 23, 2022 | May 16, 2021 | Apr. 26, 2021 | Jun. 26, 2019 | Mar. 31, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Sep. 30, 2021 | |
Liability Related to the Revenue Interest Purchase Agreement | |||||||||
Restricted cash | $ 50,000,000 | ||||||||
One time partial call | $ 50,000,000 | ||||||||
Redemption percentage | 225% | ||||||||
Redemption amount | $ 400,000,000 | ||||||||
Remaining redemption amount | 372,600,000 | ||||||||
Interest expense recognized | 58,976,000 | $ 56,810,000 | |||||||
Revenue Interest Purchase Agreement (RIPA) | |||||||||
Liability Related to the Revenue Interest Purchase Agreement | |||||||||
Revenue interest liability | 274,778,000 | 243,605,000 | $ 257,039,000 | ||||||
Unamortized issuance costs | 200,000 | ||||||||
Interest expense recognized | 46,679,000 | 44,590,000 | |||||||
Revenue Interest Purchase Agreement (RIPA) | Oberland | |||||||||
Liability Related to the Revenue Interest Purchase Agreement | |||||||||
Proceeds from revenue interest liability | $ 125,000,000 | ||||||||
Total amount of subsequent installment, subject to RIPA terms and conditions | 75,000,000 | ||||||||
Amount of subsequent installment, subject to regulatory approval | 25,000,000 | ||||||||
Amount of subsequent installment, subject to achievement of Sales Threshold | 50,000,000 | ||||||||
Milestone amount for worldwide sales to receive the Third Payment | $ 100,000,000 | ||||||||
Trailing number of months sales must be at or above milestone amount | 6 months | 6 months | |||||||
Payment under the RIPA | $ 50,000,000 | $ 25,000,000 | |||||||
Revenue interest rate which will take effect if annual net sales equals or exceeds the Sales Threshold by December 31, 2021 | 2.50% | ||||||||
Initial revenue interest rate | 7.50% | ||||||||
Minimum amount of annual net sales to qualify for reduced revenue interest rate by December 31, 2021 | $ 350,000,000 | ||||||||
Percentage of invested capital received by December 31, 2024, to qualify for second reduced revenue interest rate | 100% | ||||||||
Revenue interest rate if annual net sales equal or exceed the Sales Threshold and if the Purchasers receive 100% of their invested capital by December 31, 2024 | 0.40% | ||||||||
Percentage of revenue interests payment on which agreement terminates after third anniversary | 195% | ||||||||
Cumulative Purchaser Payment adjustment | $ 177,777,778 | ||||||||
Percentage of revenues interests payment on which agreement terminates, after third anniversary | 225% | ||||||||
Net sales threshold | $ 350,000,000 | ||||||||
Repayment amount expected to pay in next twelve months | $ 34,800,000 | ||||||||
Effective annual imputed interest rate (as a percent) | 17.60% | ||||||||
Percentage of increase in royalty rate upon drawdown of third payment | 33.33% | ||||||||
Revenue Interest Purchase Agreement (RIPA) | Oberland | Net Sales Less Than $250 Million | |||||||||
Liability Related to the Revenue Interest Purchase Agreement | |||||||||
Initial revenue interest rate | 10% | ||||||||
Minimum amount of annual net sales to qualify for reduced revenue interest rate by December 31, 2021 | $ 250,000,000 | ||||||||
Hypothetical sales generated | 100,000,000 | ||||||||
Hypothetical repayment obligation | $ 10,000,000 | ||||||||
Revenue Interest Purchase Agreement (RIPA) | Oberland | Net Sales Greater Than $250 Million But Less Than $350 Million | |||||||||
Liability Related to the Revenue Interest Purchase Agreement | |||||||||
Revenue interest rate which will take effect if annual net sales equals or exceeds the Sales Threshold by December 31, 2021 | 3.30% | ||||||||
Minimum amount of annual net sales to qualify for reduced revenue interest rate by December 31, 2021 | $ 250,000,000 | ||||||||
Hypothetical sales generated | 100,000,000 | ||||||||
Hypothetical repayment obligation | 3,300,000 | ||||||||
Revenue Interest Purchase Agreement Amendment | |||||||||
Liability Related to the Revenue Interest Purchase Agreement | |||||||||
Loss on modification of debt | $ 100,000 | ||||||||
Revenue Interest Purchase Agreement Amendment | Oberland | |||||||||
Liability Related to the Revenue Interest Purchase Agreement | |||||||||
Revenue interest rate which will take effect if annual net sales equals or exceeds the Sales Threshold by December 31, 2021 | 3.33% | ||||||||
Initial revenue interest rate | 10% | ||||||||
Percentage of invested capital received by December 31, 2024, to qualify for second reduced revenue interest rate | 100% | ||||||||
Percentage of revenue interests payment on which agreement terminates, prior to the third anniversary of the closing date, if put option is exercised | 200% | ||||||||
Percentage of revenue interests payment on which agreement terminates, after the third anniversary of the closing date, if put option is exercised | 225% | ||||||||
Annual net sales threshold | $ 350,000,000 | ||||||||
Percentage of revenue interest payments received by December 31, 2024, to qualify for third payment applicable percentage | 100% | ||||||||
Percentage of cumulative purchaser payments | 100% | ||||||||
RIPA Amendment To The Security Agreement And Waiver | Oberland | |||||||||
Liability Related to the Revenue Interest Purchase Agreement | |||||||||
Specified net revenue | 15,000,000 | ||||||||
Deposit if threshold is not met | $ 50,000,000 | ||||||||
Restricted cash | $ 50,000,000 |
Liability Related to the Reve_4
Liability Related to the Revenue Interest Purchase Agreement - Summary of Interest Liability (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Liability From Sale Of Future Revenues [Roll Forward] | ||
Interest expense recognized | $ 58,976 | $ 56,810 |
Revenue interest payments | (15,506) | (8,024) |
Revenue Interest Purchase Agreement (RIPA) | ||
Liability From Sale Of Future Revenues [Roll Forward] | ||
Revenue interest liability, beginning balance | 243,605 | 257,039 |
Repayment upon execution of Amendment No. 3 | (50,000) | |
Interest expense recognized | 46,679 | 44,590 |
Revenue interest payments | (15,506) | (8,024) |
Revenue interest liability, ending balance | $ 274,778 | $ 243,605 |
Convertible Notes (Details)
Convertible Notes (Details) | 1 Months Ended | 12 Months Ended | ||||
Nov. 03, 2021 shares | Oct. 22, 2021 USD ($) $ / shares | Nov. 16, 2020 USD ($) $ / shares shares | Nov. 30, 2020 USD ($) day $ / shares | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares | |
Debt Instrument [Line Items] | ||||||
Purchase of capped call options associated with convertible notes | $ 46,000,000 | $ 46,000,000 | ||||
Prepayment of forward stock repurchase transaction | $ 55,000,000 | 55,000,000 | ||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | ||||
Underlying common stock (in shares) | shares | 1,994,198 | |||||
Shares delivered to the company (in shares) | shares | 448,698 | |||||
Capped Call | Common stock | ||||||
Debt Instrument [Line Items] | ||||||
Exercise price (in dollars per share) | $ / shares | $ 55.16 | |||||
Class of warrant or right, premium percentage | 100% | |||||
Convertible Senior Notes Due 2025 | Convertible Debt | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, face amount | $ 280,000,000 | |||||
Debt instrument, stated interest rate | 4% | |||||
Proceeds from debt, net of issuance costs | $ 271,100,000 | |||||
Debt instrument, convertible, conversion ratio | 0.0302151 | |||||
Debt instrument, convertible, conversion price (in dollars per share) | $ / shares | $ 33.096 | |||||
Debt instrument, redemption price, percentage | 100% | |||||
Aggregate principal amount | $ 15,000,000 | |||||
Floor price (in dollars per share) | $ / shares | $ 5.62 | |||||
Trading day averaging period | 5 days | |||||
Common stock exchanged (in shares) | shares | 1,094,848 | |||||
Long-term debt, gross | $ 265,000,000 | $ 265,000,000 | ||||
Debt issuance costs | 3,400,000 | 5,100,000 | ||||
Long-term debt | 261,600,000 | 259,900,000 | ||||
Debt interest expense | 12,300,000 | 12,200,000 | ||||
Debt instrument, fair value disclosure | $ 155,900,000 | $ 145,900,000 | ||||
Convertible Senior Notes Due 2025 | Convertible Debt | Period One | ||||||
Debt Instrument [Line Items] | ||||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | |||||
Debt instrument, convertible, threshold percentage of stock price trigger | 130% | |||||
Debt instrument, convertible, threshold trading days | day | 20 | |||||
Debt instrument, convertible, threshold consecutive trading days | day | 30 | |||||
Number of business days | day | 5 | |||||
Number of consecutive trading days | day | 5 | |||||
Debt instrument, convertible, threshold percentage of last reported sale price | 98% | |||||
Convertible Senior Notes Due 2025 | Convertible Debt | Period Two | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, convertible, threshold percentage of stock price trigger | 130% | |||||
Debt instrument, convertible, threshold trading days | day | 20 | |||||
Debt instrument, convertible, threshold consecutive trading days | day | 30 | |||||
Debt instrument, redemption price, percentage | 100% | |||||
Debt instrument, required amount outstanding | $ 125,000,000 |
Stockholders' Deficit (Details)
Stockholders' Deficit (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||||||||
Mar. 22, 2023 | Mar. 19, 2023 | Feb. 23, 2023 | Apr. 15, 2022 | Dec. 02, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 07, 2023 | Mar. 23, 2023 | Dec. 31, 2021 | |
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Warrants outstanding (in shares) | 36,344,212 | 36,964,286 | ||||||||
Common stock, shares issued (in shares) | 120,204,513 | 76,564,396 | ||||||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||||||
Issuance costs to additional paid in capital | $ 2,900 | |||||||||
Proceeds from issuance of common stock from ATM Program, net of issuance costs | $ 4,448 | $ 90,849 | ||||||||
The Warrants | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Exercise price (in dollars per share) | $ 1.55 | |||||||||
Pre Funded Warrant | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Warrants outstanding (in shares) | 0 | |||||||||
Adjustment to additional-paid-in-capital for warrants issued | $ 22,800 | |||||||||
Warrants exercised (in shares) | 20,965,747 | |||||||||
Warrants | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Warrants exercised (in shares) | 5,850,747 | |||||||||
Wainwright | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Warrants outstanding (in shares) | 36,964,286 | 0 | 36,964,286 | |||||||
Exercise price (in dollars per share) | $ 9 | $ 9 | ||||||||
Adjustment to additional-paid-in-capital for warrants issued | $ 61,900 | |||||||||
Warrants expired (in shares) | 27,940,074 | |||||||||
Securities Purchase Agreement | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Warrants outstanding (in shares) | 27,320,000 | 0 | ||||||||
Exercise price (in dollars per share) | $ 1.55 | |||||||||
Common stock, shares issued (in shares) | 12,205,000 | |||||||||
Common stock, par value (in dollars per share) | $ 0.001 | |||||||||
Common stock purchasable under prefunded warrants (in shares) | 20,965,747 | |||||||||
Common stock purchasable under warrants (in shares) | 33,170,747 | |||||||||
Securities Purchase Agreement | Common Stock And Accompanying Warrant | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Purchase price (in dollars per share) | $ 1.675 | |||||||||
Securities Purchase Agreement | Pre Funded Warrant And Accompanying Warrant | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Purchase price (in dollars per share) | $ 1.674 | |||||||||
Warrant Amendment Agreements | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Net proceeds | $ 55,500 | $ 1,200 | ||||||||
Warrants outstanding (in shares) | 9,024,212 | 0 | ||||||||
Exercise price (in dollars per share) | $ 1.55 | $ 1.55 | $ 1.55 | $ 9 | ||||||
Common stock purchasable under warrants (in shares) | 9,024,212 | |||||||||
Warrants exercisable into stock (in shares) | 9,024,212 | |||||||||
Additional consideration per amended warrant (in dollars per share) | $ 0.125 | |||||||||
Estimated offering expenses | $ 4,200 | |||||||||
Proceeds from issuance of common stock from ATM Program, net of issuance costs | $ 51,300 | |||||||||
Placement fees | $ 100 | |||||||||
Proceeds from warrant amendment | $ 1,100 | |||||||||
At The Market Program | ||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||
Authorized amount | $ 70,000 | $ 239,000 | ||||||||
Issued stock (in shares) | 3,312,908 | 13,043,797 | ||||||||
Net proceeds | $ 4,400 | $ 90,800 | ||||||||
Payments of stock issuance costs | $ 400 | $ 3,100 |
Stockholders' Deficit - Summary
Stockholders' Deficit - Summary of Warrants and Pre-funded Warrants Outstanding (Details) - $ / shares | Dec. 31, 2023 | Mar. 23, 2023 | Mar. 22, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 02, 2021 |
Subsidiary, Sale of Stock [Line Items] | ||||||
Warrants outstanding (in shares) | 36,344,212 | 36,964,286 | ||||
Wainwright | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Warrants outstanding (in shares) | 0 | 36,964,286 | 36,964,286 | |||
Exercise price (in dollars per share) | $ 9 | $ 9 | ||||
Warrant Amendment Agreements | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Warrants outstanding (in shares) | 9,024,212 | 0 | ||||
Exercise price (in dollars per share) | $ 1.55 | $ 1.55 | $ 1.55 | $ 9 | ||
Securities Purchase Agreement | ||||||
Subsidiary, Sale of Stock [Line Items] | ||||||
Warrants outstanding (in shares) | 27,320,000 | 0 | ||||
Exercise price (in dollars per share) | $ 1.55 |
Stock Compensation - Stock Opti
Stock Compensation - Stock Option and Incentive Plan (Details) - shares | Jun. 30, 2023 | May 31, 2022 |
Stock Option And Incentive Plan 2022 | ||
Stock compensation | ||
Number of commons stock shares available for issuance (in shares) | 10,650,000 | 4,400,000 |
Stock Compensation - Employee S
Stock Compensation - Employee Stock Purchase Plan (Details) - Employee Stock - USD ($) | 1 Months Ended | 12 Months Ended | |
Apr. 30, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | |
Stock compensation | |||
Maximum employee subscription rate | 10% | ||
Maximum employee subscription amount | $ 25,000 | ||
Purchase discount of employee stock | 15% | ||
Stock plan offering period | 6 months | ||
Stock-based compensation expense | $ 300,000 | $ 400,000 | |
Shares issued (in shares) | 610,506 | ||
Shares reserved for future issuance (in shares) | 214,494 |
Stock Compensation - Summary of
Stock Compensation - Summary of Plans (Details) - shares | 1 Months Ended | 12 Months Ended | ||
May 31, 2015 | Dec. 31, 2023 | Aug. 31, 2023 | Apr. 30, 2015 | |
2017 Inducement Equity Plan | ||||
Stock compensation | ||||
Number of commons stock shares available for issuance (in shares) | 2,650,000 | |||
2013 Stock Option and Incentive Plan | ||||
Stock compensation | ||||
Number of commons stock shares available for issuance (in shares) | 2,975,000 | 2,051,378 | ||
Increase in number of commons stock shares available for issuance (in shares) | 923,622 | |||
Increase in common stock shares reserved and available for issuance, as a percentage of common stock shares outstanding | 2.50% | |||
Incentive Stock Option And Restricted Stock Plan 2022, 2017 And 2013 | ||||
Stock compensation | ||||
Vesting percentage on the first anniversary of the option grant | 25% | |||
Period for which remainder of grant amount will vest on the first day of each calendar quarter | 3 years | |||
Expiration period | 10 years | |||
Period from cessation of employment within which options expire if not exercised | 90 days |
Stock Compensation - Options (D
Stock Compensation - Options (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Number of Options | ||
Outstanding at the beginning of period (in shares) | 3,842,737 | |
Granted (in shares) | 1,550,200 | |
Forfeited or expired (in shares) | (1,706,746) | |
Outstanding at the end of the period (in shares) | 3,686,191 | 3,842,737 |
Weighted-Average Exercise Price Per Share | ||
Outstanding at the beginning of period (in dollars per share) | $ 27.75 | |
Granted (in dollars per share) | 3.53 | |
Forfeited (in dollars per share) | 35.69 | |
Outstanding at the end of the period (in dollars per share) | $ 13.88 | $ 27.75 |
Weighted-Average Remaining Contractual Term (Years) | ||
Outstanding | 7 years 5 months 19 days | 4 years 10 months 9 days |
Aggregate Intrinsic Value | ||
Outstanding | $ 584 | $ 1,658 |
Information about the stock option plan | ||
Number of Options, exercisable (in shares) | 1,706,622 | |
Weighted-Average Exercise Price Per Share, exercisable (in dollars per share) | $ 23.99 | |
Weighted-Average Remaining Contractual Term, exercisable | 5 years 10 months 2 days | |
Aggregate Intrinsic Value, exercisable | $ 20 |
Stock Compensation - Valuation
Stock Compensation - Valuation Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | ||
Risk-free interest rate | 3.83% | 2.26% |
Dividend yield | 0% | 0% |
Weighted-average expected life of options (years) | 6 years 2 months 1 day | 6 years 1 month 28 days |
Volatility | 79% | 81% |
Stock Compensation - Additional
Stock Compensation - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stock compensation | ||
Weighted-average grant-date fair value (in dollars per share) | $ 2.51 | $ 3.38 |
Unrecognized stock-based compensation expense, options | $ 6.7 | |
Stock Options | ||
Stock compensation | ||
Stock-based compensation expense | 3.8 | $ 5.6 |
Stock based, amount capitalized | $ 0.2 | 0.6 |
Weighted-average period over which remaining unrecognized compensation cost will be recognized | 2 years 3 months 18 days | |
RSUs | ||
Stock compensation | ||
Stock-based compensation expense | $ 6.6 | 6.6 |
Stock based, amount capitalized | $ 0.4 | $ 0.7 |
Weighted-average period over which remaining unrecognized compensation cost will be recognized | 2 years 6 months | |
Unrecognized stock-based compensation expense | $ 13.2 | |
PBSOs | ||
Stock compensation | ||
Weighted-average grant-date fair value (in dollars per share) | $ 1.14 | $ 4.36 |
Stock-based compensation expense | $ 0.9 | $ 0.8 |
Unrecognized stock-based compensation expense, options | $ 0.5 | |
Weighted-average period over which remaining unrecognized compensation cost will be recognized | 2 months 12 days |
Stock Compensation - RSUs (Deta
Stock Compensation - RSUs (Details) - RSUs | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Number of RSUs | |
Outstanding and unvested at the beginning of period (in shares) | shares | 1,768,185 |
Granted (in shares) | shares | 2,456,485 |
Forfeited or expired (in shares) | shares | (342,876) |
Vested (in shares) | shares | (833,906) |
Outstanding and unvested at the ending of period (in shares) | shares | 3,047,888 |
Weighted-Average Fair Value Per Share | |
Outstanding and unvested at the beginning of period (in dollars per share) | $ / shares | $ 8.80 |
Granted (in dollars per share) | $ / shares | 3.22 |
Forfeited or expired (in dollars per share) | $ / shares | 7.14 |
Vested (in dollars per share) | $ / shares | 8.07 |
Outstanding and unvested at the at the end of the period (in dollars per share) | $ / shares | $ 4.69 |
Stock Compensation - PBRSU's (D
Stock Compensation - PBRSU's (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Weighted-Average Fair Value Per Share | ||
Weighted-average grant-date fair value (in dollars per share) | $ 2.51 | $ 3.38 |
Performance Shares | ||
Number of PBRSUs | ||
Outstanding and unvested at the beginning of period (in shares) | 461,250 | |
Granted (in shares) | 0 | |
Forfeited or expired (in shares) | (100,250) | |
Vested (in shares) | (200,725) | |
Outstanding and unvested at the ending of period (in shares) | 160,275 | 461,250 |
Weighted-Average Fair Value Per Share | ||
Outstanding and unvested at the beginning of period (in dollars per share) | $ 9.50 | |
Granted (in dollars per share) | 0 | |
Forfeited or expired (in dollars per share) | 11.50 | |
Vested (in dollars per share) | 8.94 | |
Outstanding and unvested at the at the end of the period (in dollars per share) | $ 8.94 | $ 9.50 |
Stock-based compensation expense | $ 0.4 | $ 1.8 |
Stock based, amount capitalized | 0.1 | $ 0.2 |
Unrecognized stock-based compensation expense | $ 0.2 | |
Weighted-average period over which remaining unrecognized compensation cost will be recognized | 2 months 12 days |
Stock Compensation - PBSOs (Det
Stock Compensation - PBSOs (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Number of Options | ||
Outstanding at the beginning of period (in shares) | 3,842,737 | |
Granted (in shares) | 1,550,200 | |
Outstanding at the end of the period (in shares) | 3,686,191 | 3,842,737 |
Weighted-Average Exercise Price Per Share | ||
Outstanding at the beginning of period (in dollars per share) | $ 27.75 | |
Granted (in dollars per share) | 3.53 | |
Outstanding at the end of the period (in dollars per share) | $ 13.88 | $ 27.75 |
Weighted-Average Remaining Contractual Term (Years) | ||
Outstanding | 7 years 5 months 19 days | 4 years 10 months 9 days |
Aggregate Intrinsic Value | ||
Outstanding | $ 584 | $ 1,658 |
Information about the stock option plan | ||
Number of Options, exercisable (in shares) | 1,706,622 | |
Weighted-Average Exercise Price Per Share, exercisable (in dollars per share) | $ 23.99 | |
Weighted-Average Remaining Contractual Term, exercisable | 5 years 10 months 2 days | |
Aggregate Intrinsic Value, exercisable | $ 20 | |
PBSOs | ||
Number of Options | ||
Outstanding at the beginning of period (in shares) | 499,200 | |
Granted (in shares) | 227,900 | |
Forfeited (in shares) | (65,250) | |
Outstanding at the end of the period (in shares) | 661,850 | 499,200 |
Weighted-Average Exercise Price Per Share | ||
Outstanding at the beginning of period (in dollars per share) | $ 6.73 | |
Granted (in dollars per share) | 1.62 | |
Forfeited (in dollars per share) | 6.76 | |
Outstanding at the end of the period (in dollars per share) | $ 4.97 | $ 6.73 |
Weighted-Average Remaining Contractual Term (Years) | ||
Outstanding | 8 years 7 months 17 days | 9 years 3 months 25 days |
Aggregate Intrinsic Value | ||
Outstanding | $ 312 | $ 12 |
Information about the stock option plan | ||
Number of Options, exercisable (in shares) | 48,100 | |
Weighted-Average Exercise Price Per Share, exercisable (in dollars per share) | $ 8.94 | |
Weighted-Average Remaining Contractual Term, exercisable | 5 years 10 months 13 days | |
Aggregate Intrinsic Value, exercisable | $ 0 |
Employee Benefit Plan (Details)
Employee Benefit Plan (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Retirement Benefits [Abstract] | ||
Contributions to the 401(k) Plan | $ 1.3 | $ 0.7 |
Leases - Narrative (Details)
Leases - Narrative (Details) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 USD ($) lease | Dec. 31, 2022 USD ($) | |
Leases | ||
Cash paid for the amounts included in the measurement of lease liabilities | $ 1 | $ 1.3 |
Operating lease costs | $ 1 | $ 1.2 |
Weighted-average remaining lease term of operating leases | 2 years 10 months 24 days | 4 years 8 months 12 days |
Weighted average discount rate | 7.50% | 7.70% |
Right of use assets obtained in exchange for lease obligations | $ 4.5 | $ 0.6 |
Additional operating and financing leases not yet commenced | lease | 45 | |
Principal Executive Office | ||
Leases | ||
Operating Lease term | 5 years | |
Automobile leases and IT equipment leases | ||
Leases | ||
Operating Lease term | 3 years |
Leases - Future Maturities and
Leases - Future Maturities and Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
2024 | $ 1,838 | |
2025 | 1,811 | |
2026 | 1,140 | |
2027 | 169 | |
2028 | 144 | |
Total lease payments | 5,102 | |
Less imputed interest | (529) | |
Total | 4,573 | |
Supplemental balance sheet information related to leases | ||
Right of use operating lease assets | 4,675 | $ 1,036 |
Operating lease liabilities (short-term) | (1,553) | (384) |
Operating lease liabilities (long-term) | (3,020) | $ (665) |
Total lease obligations under operating leases | $ (4,573) |
Income Taxes - Summary (Details
Income Taxes - Summary (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Provision for income taxes | |||
Provision for income taxes | $ 0 | $ 0 | |
Net deferred tax assets, before valuation allowance | 395,600,000 | 352,100,000 | |
Unrecognized tax benefits | 2,099,000 | 2,099,000 | $ 2,099,000 |
Research Tax Credit Carryforward | |||
Provision for income taxes | |||
Tax credit carryforward | 21,000,000 | ||
Federal | |||
Provision for income taxes | |||
Net operating loss carryforwards | 1,027,500,000 | 950,800,000 | |
Operating loss carryforwards, subject to expiration | 347,400,000 | ||
State | |||
Provision for income taxes | |||
Net operating loss carryforwards | $ 696,100,000 | $ 698,400,000 |
Income Taxes - Reconciliation (
Income Taxes - Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Reconciliation of the U.S. statutory income tax rate to the Company's effective tax rate | ||
Federal income tax (benefit) at statutory rate | (21.00%) | (21.00%) |
Change in state tax rate | 0.20% | (0.50%) |
Permanent items | 0.20% | 0.10% |
Prior period adjustments | 0.90% | (3.60%) |
Change in valuation allowance | 19.70% | 25% |
Effective income tax rate | 0% | 0% |
Income Taxes - Summary of Incom
Income Taxes - Summary of Income Tax Contingencies (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at January 1 | $ 2,099 | $ 2,099 |
Reductions for tax positions of prior year | 0 | 0 |
Balance at December 31 | $ 2,099 | $ 2,099 |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Federal and state operating loss carryforwards | $ 258,836 | $ 242,584 |
Equity compensation | 25,413 | 26,243 |
Capitalized research and development | 37,998 | 26,480 |
R&D tax credits, net of reserves | 18,887 | 18,887 |
Disallowed interest | 43,239 | 29,979 |
Temporary differences | 12,362 | 8,340 |
Total deferred tax assets | 396,735 | 352,513 |
Deferred tax liabilities: | ||
Other | (1,154) | (400) |
Total deferred tax liabilities | (1,154) | (400) |
Valuation allowance | (395,581) | (352,113) |
Net deferred tax assets | $ 0 | $ 0 |
Net Loss Per Common Share - Cal
Net Loss Per Common Share - Calculation of diluted net loss per share (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Net Income (Loss) Per Common Share | ||
Total potential dilutive shares (in shares) | 51,907,426 | 51,570,226 |
Common shares under option | ||
Net Income (Loss) Per Common Share | ||
Total potential dilutive shares (in shares) | 3,686,191 | 3,842,737 |
Unvested RSUs | ||
Net Income (Loss) Per Common Share | ||
Total potential dilutive shares (in shares) | 3,047,888 | 1,768,185 |
Shares issuable related to the ESPP | ||
Net Income (Loss) Per Common Share | ||
Total potential dilutive shares (in shares) | 0 | 27,558 |
Unvested PBRSUs | ||
Net Income (Loss) Per Common Share | ||
Total potential dilutive shares (in shares) | 160,275 | 461,250 |
Common shares under PBSOs | ||
Net Income (Loss) Per Common Share | ||
Total potential dilutive shares (in shares) | 661,850 | 499,200 |
Shares issuable upon conversion of convertible notes | ||
Net Income (Loss) Per Common Share | ||
Total potential dilutive shares (in shares) | 8,007,010 | 8,007,010 |
Warrants for common stock | ||
Net Income (Loss) Per Common Share | ||
Total potential dilutive shares (in shares) | 36,344,212 | 36,964,286 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Millions | Jan. 18, 2024 | Jan. 02, 2024 | May 04, 2023 | Mar. 27, 2023 | Dec. 31, 2023 | Dec. 31, 2022 |
Subsequent Event [Line Items] | ||||||
Partner milestone payments | $ 300 | |||||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | ||||
Subsequent Event | ||||||
Subsequent Event [Line Items] | ||||||
First milestone payment | $ 100 | |||||
Time required to pay cash portion | 15 days | |||||
Second milestone payment | $ 25 | |||||
Common stock, par value (in dollars per share) | $ 0.001 | |||||
Proceeds from stock offering, net | $ 90.8 | |||||
Subsequent Event | Commitment Offering | ||||||
Subsequent Event [Line Items] | ||||||
Issued stock (in shares) | 56,700,000 | |||||
Common stock, par value (in dollars per share) | $ 0.001 | |||||
Exercise price (in dollars per share) | $ 1.50 | |||||
Proceeds from stock offering, net | $ 90.8 | |||||
Subsequent Event | Over Allotment Option | ||||||
Subsequent Event [Line Items] | ||||||
Issued stock (in shares) | 8,505,000 | |||||
Option period | 30 days | |||||
Minimum | Subsequent Event | ||||||
Subsequent Event [Line Items] | ||||||
Aggregate payment agreement | $ 125 | |||||
Cardiovascular Risk Outcome Less than Twenty Percent | Minimum | ||||||
Subsequent Event [Line Items] | ||||||
Partner milestone payments | $ 300 | |||||
Cardiovascular Risk | Minimum | ||||||
Subsequent Event [Line Items] | ||||||
Percentage of risk reduction | 20% |