Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Feb. 21, 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 | 001-39614 | ||
Entity Registrant Name | TARSUS PHARMACEUTICALS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 81-4717861 | ||
Entity Address, Address Line One | 15440 Laguna Canyon Road, Suite 160 | ||
Entity Address, City or Town | Irvine | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92618 | ||
City Area Code | 949 | ||
Local Phone Number | 418-1801 | ||
Title of 12(b) Security | Common Stock, $0.0001 par value per share | ||
Trading Symbol | TARS | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Smaller Reporting Company | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 460 | ||
Entity Common Stock, Shares Outstanding | 34,218,886 | ||
Documents Incorporated by Reference | Portions of the information called for by Part III of this Annual Report on Form 10-K is hereby incorporated by reference to portions of the registrant’s definitive proxy statement for its 2024 annual meeting of stockholders, which will be filed with the Securities and Exchange Commission not later than 120 days after the registrant’s fiscal year ended December 31, 2023. | ||
Amendment Flag | false | ||
Entity Central Index Key | 0001819790 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2023 | |
Audit Information [Abstract] | |
Auditor Name | Ernst & Young LLP |
Auditor Location | Irvine, California |
Auditor Firm ID | 42 |
Balance Sheets
Balance Sheets - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 224,947,000 | $ 71,660,000 |
Marketable securities | 2,495,000 | 145,366,000 |
Accounts receivable, net | 16,621,000 | 0 |
Inventory | 3,107,000 | 0 |
Other receivables | 1,093,000 | 3,582,000 |
Prepaid expenses | 7,868,000 | 4,767,000 |
Total current assets | 256,131,000 | 225,375,000 |
Property and equipment, net | 1,468,000 | 957,000 |
Intangible assets, net | 3,867,000 | 0 |
Operating lease right-of-use assets | 1,880,000 | 575,000 |
Long-term investments | 631,000 | 371,000 |
Other assets | 1,514,000 | 585,000 |
Total assets | 265,491,000 | 227,863,000 |
Current liabilities: | ||
Accounts payable and other accrued liabilities | 23,691,000 | 9,910,000 |
Accrued payroll and benefits | 13,245,000 | 5,519,000 |
Total current liabilities | 36,936,000 | 15,429,000 |
Term loan, net | 29,819,000 | 19,434,000 |
Other long-term liabilities | 1,748,000 | 100,000 |
Total liabilities | 68,503,000 | 34,963,000 |
Commitments and contingencies (Note 8) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding | 0 | 0 |
Common stock, $0.0001 par value; 200,000,000 shares authorized; 34,211,190 shares issued and outstanding at December 31, 2023; 26,727,458 shares issued and outstanding at December 31, 2022 | 5,000 | 5,000 |
Additional paid-in capital | 441,641,000 | 301,732,000 |
Accumulated other comprehensive loss | (2,000) | (74,000) |
Accumulated deficit | (244,656,000) | (108,763,000) |
Total stockholders’ equity | 196,988,000 | 192,900,000 |
Total liabilities and stockholders’ equity | $ 265,491,000 | $ 227,863,000 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (usd per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, authorized (shares) | 10,000,000 | 10,000,000 |
Preferred stock, issued (shares) | 0 | 0 |
Preferred stock, outstanding (shares) | 0 | 0 |
Common stock, par value (usd per share) | $ 0.0001 | $ 0.0001 |
Common stock, authorized (shares) | 200,000,000 | 200,000,000 |
Common stock, issued (shares) | 34,211,190 | 26,727,458 |
Common stock, outstanding (shares) | 34,211,190 | 26,700,000 |
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 | $ 17,447 | $ 25,816 |
Operating expenses: | ||
Research and development | 50,312 | 42,624 |
Selling, general and administrative | 108,700 | 44,949 |
Total operating expenses | 160,605 | 88,528 |
Loss from operations | (143,158) | (62,712) |
Other income (expense): | ||
Interest income | 10,337 | 3,499 |
Interest expense | (3,346) | (2,199) |
Other (expense) income, net | (102) | 86 |
Unrealized gain (loss) on equity investments | 259 | (268) |
Change in fair value of equity warrants issued by licensee | 117 | (501) |
Total other income, net | 7,265 | 617 |
Loss before income taxes | (135,893) | (62,095) |
Benefit from income taxes | 0 | 4 |
Net loss | (135,893) | (62,091) |
Other comprehensive loss: | ||
Unrealized gain (loss) on marketable securities and cash equivalents | 72 | (74) |
Comprehensive loss | $ (135,821) | $ (62,165) |
Net loss per share, basic (in USD per share) | $ (4.62) | $ (2.52) |
Net loss per share, diluted (in USD per share) | $ (4.62) | $ (2.52) |
Weighted-average common shares outstanding, basic (shares) | 29,383,276 | 24,619,700 |
Weighted-average common shares outstanding, diluted (shares) | 29,383,276 | 24,619,700 |
Product sales, net | ||
Revenues: | ||
Total revenues | $ 14,729 | $ 0 |
Operating expenses: | ||
Cost of sales | 1,593 | 0 |
License fees and collaboration revenue | ||
Revenues: | ||
Total revenues | 2,718 | 25,816 |
Operating expenses: | ||
Cost of sales | $ 0 | $ 955 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Follow-On Public Offering | 2023 ATM Prospectus | Common Stock | Common Stock Follow-On Public Offering | Common Stock 2023 ATM Prospectus | Additional Paid-In Capital | Additional Paid-In Capital Follow-On Public Offering | Additional Paid-In Capital 2023 ATM Prospectus | Accumulated Other Comprehensive Loss | Accumulated Deficit |
Beginning balance (shares) at Dec. 31, 2021 | 20,698,737 | ||||||||||
Beginning balance at Dec. 31, 2021 | $ 166,730 | $ 4 | $ 213,398 | $ 0 | $ (46,672) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Net loss | (62,091) | (62,091) | |||||||||
Recognition of stock-based compensation expense | 13,460 | 13,460 | |||||||||
Issuance of common stock upon initial public offering, net of issuance costs (in shares) | 5,889,832 | ||||||||||
Issuance of common stock upon initial public offering, net of issuance costs | 74,234 | $ 1 | 74,233 | ||||||||
Lapse of repurchase obligation for stock option exercises, prior to vesting (shares) | 27,840 | ||||||||||
Lapse of repurchase obligation for stock option exercises, prior to vesting | $ 56 | 56 | |||||||||
Exercise of vested stock options (shares) | 40,979 | 40,979 | |||||||||
Exercise of vested stock options | $ 123 | 123 | |||||||||
Issuance of common stock upon the vesting of restricted stock units (shares) | 32,914 | ||||||||||
Shares issued in connection with the employee stock purchase plan (shares) | 37,156 | ||||||||||
Shares issued in connection with the employee stock purchase plan | 462 | 462 | |||||||||
Other comprehensive income | $ (74) | (74) | |||||||||
Ending balance (shares) at Dec. 31, 2022 | 26,700,000 | 26,727,458 | |||||||||
Ending balance at Dec. 31, 2022 | $ 192,900 | $ 5 | 301,732 | (74) | (108,763) | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Net loss | (135,893) | (135,893) | |||||||||
Recognition of stock-based compensation expense | $ 19,830 | 19,830 | |||||||||
Issuance of common stock upon initial public offering, net of issuance costs (in shares) | 6,069,449 | 1,000,000 | |||||||||
Issuance of common stock upon initial public offering, net of issuance costs | $ 99,303 | $ 19,199 | $ 99,303 | $ 19,199 | |||||||
Exercise of vested stock options (shares) | 136,310 | 136,310 | |||||||||
Exercise of vested stock options | $ 592 | 592 | |||||||||
Issuance of common stock upon the vesting of restricted stock units (shares) | 206,813 | ||||||||||
Shares issued in connection with the employee stock purchase plan (shares) | 71,160 | ||||||||||
Shares issued in connection with the employee stock purchase plan | 985 | 985 | |||||||||
Other comprehensive income | $ 72 | ||||||||||
Ending balance (shares) at Dec. 31, 2023 | 34,211,190 | 34,211,190 | |||||||||
Ending balance at Dec. 31, 2023 | $ 196,988 | $ 5 | $ 441,641 | $ (2) | $ (244,656) |
Statements of Stockholders' E_2
Statements of Stockholders' Equity (Parenthetical) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Stock issued, issuance costs | $ 5,300,000 | |
Follow-On Public Offering | ||
Stock issued, issuance costs | $ 6,900,000 | |
2023 ATM Prospectus | ||
Stock issued, issuance costs | $ 800,000 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash Flows From Operating Activities: | ||
Net loss | $ (135,893) | $ (62,091) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 744 | 325 |
Amortization of intangible assets | 133 | 0 |
Stock-based compensation | 19,830 | 13,460 |
Accretion of term loan-related costs | 385 | 309 |
Non-cash lease expense | 541 | 464 |
Amortization of discount on available-for-sale debt securities | 0 | (1,316) |
Net amortization/accretion on marketable securities | (3,163) | 0 |
Unrealized (gain) loss on equity investment | (259) | 268 |
Change in fair value of equity warrants issued by licensee | (117) | 501 |
Unrealized gain from transactions denominated in a foreign currency | 0 | 1 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (16,621) | 0 |
Inventory | (3,107) | 0 |
Other receivables | 2,490 | (3,490) |
Prepaid expenses | (2,889) | (721) |
Other non-current assets | (718) | (215) |
Accounts payable and other accrued liabilities | 13,240 | 821 |
Accrued payroll and benefits | 7,726 | 2,721 |
Other long-term liabilities | 185 | (67) |
Net cash used in by operating activities | (117,493) | (49,030) |
Cash Flows From Investing Activities: | ||
Proceeds from sales of marketable securities | 174,770 | 5,315 |
Purchases of marketable securities | (28,664) | (149,438) |
Intangible asset additions | (4,000) | 0 |
Purchases of property and equipment | (1,502) | (506) |
Net cash provided by (used in) investing activities | 140,604 | (144,629) |
Cash Flows From Financing Activities: | ||
Proceeds from term loan | 10,000 | 20,000 |
Proceeds from sale of common stock under employee stock purchase plan | 985 | 462 |
Proceeds from exercise of vested stock options | 592 | 123 |
Payment of deferred offering costs | 0 | (75) |
Payment of term loan issuance costs | 0 | (875) |
Net cash provided by financing activities | 130,176 | 93,987 |
Net increase (decrease) in cash and cash equivalents | 153,287 | (99,672) |
Cash and cash equivalents — beginning of year | 71,660 | 171,332 |
Cash and cash equivalents — end of year | 224,947 | 71,660 |
Supplemental Disclosures Noncash Investing and Financing Activities: | ||
Operating lease right-of-use asset obtained in exchange for operating lease liability | 1,846 | 0 |
Interest expense paid in cash | 2,880 | 1,675 |
Additions of property and equipment included within accounts payable and other accrued liabilities | 134 | 21 |
Follow-On Public Offering | ||
Cash Flows From Financing Activities: | ||
Proceeds from issuance of common stock | 99,355 | 74,352 |
2023 ATM Prospectus | ||
Cash Flows From Financing Activities: | ||
Proceeds from issuance of common stock | $ 19,244 | $ 0 |
Description of Business and Pre
Description of Business and Presentation of Financial Statements | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business and Presentation of Financial Statements | DESCRIPTION OF BUSINESS AND PRESENTATION OF FINANCIAL STATEMENTS Description of Business Tarsus Pharmaceuticals, Inc. (“Tarsus” or the “Company”) is a commercial stage biopharmaceutical company focused on the development and commercialization of therapeutics, starting with eye care. The Company launched XDEMVY ® (lotilaner ophthalmic solution) 0.25%, formerly known as TP-03, for the treatment of Demodex blepharitis, in August 2023, after receiving United States ("U.S") Food and Drug Administration ("FDA") approval in July 2023. Follow-On Public Offerings and ATM Prospectus In August 2023, the Company completed a follow-on public offering under its shelf registration statement on Form S-3 that was declared effective by the SEC on November 5, 2021 (the "2021 Shelf Registration Statement") of 5,714,285 shares of common stock at a public offering price of $17.50 per share (the "August 2023 Public Offering"). The Company also granted the underwriters a 30-day option to purchase up to 857,142 additional shares of its common stock at the public offering price. In September 2023, the underwriters partially exercised this option resulting in the Company's issuance of an additional 355,164 shares of common stock at the public offering price of $17.50 per share. The aggregate net proceeds received by the Company were approximately $99.3 million, after deducting underwriting discounts, commissions, and other offering-related expenses. In 2021 we filed the 2021 Shelf Registration Statement, issuable pursuant to the terms of an Open Market Sale Agreement™ (the "2021 ATM Prospectus") dated November 1, 2021 by and between the Company and Jefferies LLC, covering the sale of up to $100.0 million of our common stock. In connection with the August 2023 Public Offering, the Company terminated the 2021 ATM Prospectus. The Company did not have any sales of common stock pursuant to the 2021 ATM Prospectus. In November 2023, the Company filed a shelf registration statement on Form S-3 that was declared effective by the SEC on November 21, 2023, (the "2023 Shelf Registration Statement"), which replaced the 2021 Shelf Registration Statement and permits the Company to offer up to $300.0 million of common stock, preferred stock, debt securities and warrants in one or more offerings and in any combination, including in units from time to time. As part of the 2023 Shelf Registration Statement, the Company concurrently filed a sales agreement prospectus covering the sale of up to $100.0 million of common stock pursuant to an Open Market Sale Agreement (the "2023 ATM Prospectus") with Jefferies LLC ("Jefferies"). Under the terms of the 2023 ATM Prospectus, Jefferies will act as the Company's sales agent and is entitled to compensation for its services equal to 3% of the gross proceeds of any shares of common stock sold. In December 2023, the Company sold 1,000,000 shares of common stock under the 2023 ATM Prospectus for net proceeds of $19.2 million, after deducting broker commissions and offering-related expenses. In May 2022, the Company completed a follow-on public offering under its Shelf Registration Statement for an initial underwritten sale of 5,600,000 shares of its common stock at the public offering price of $13.50 per share. The Company also granted the underwriters a 30-day option to purchase up to 840,000 additional shares of its common stock at the public offering price. In June 2022, the underwriters partially exercised this option and the Company's sale of an additional 289,832 shares at the public offering price of $13.50 per share was concurrently completed. Total aggregate net proceeds received by the Company were approximately $74.2 million, after deducting underwriting discounts, commissions, and other offering-related expenses. Liquidity The Company has a limited operating history, limited history of product sales and has accumulated losses and negative cash flows from operations since inception. The Company has funded its inception-to-date operations through the IPO, Follow-on Public Offerings and the 2023 ATM Prospectus, as well as from proceeds from product sales, net, the China Out-License, and draws on the credit facility. The Company estimates that its existing capital resources will be sufficient to meet projected operating expense requirements for at least 12 months from the issuance date of the accompanying Financial Statements that have been prepared on a going-concern basis. The Company plans to fund its operations, capital funding and other liquidity needs using existing cash and investments and, to the extent available, cash generated from commercial operations. Management expects the Company to continue to incur operating losses for the foreseeable future and may be required to raise additional capital to fund its ongoing operations. However, no assurance can be given as to whether financing will be available on terms acceptable to the Company, or at all. If the Company is unable to raise additional funds as required, it may need to delay, reduce, or terminate some or all of its development programs and clinical trials. The Company may also be required to sell or license its rights to product candidates in certain territories or indications that it would otherwise prefer to develop and commercialize on its own and/or enter into collaborations and other arrangements to address its liquidity needs, which could materially and adversely affect its business and financial prospects, or even its ability to remain a going concern. Operating Segment The Company operates one reportable operating segment focused on the development and commercialization of therapeutics. To date, the Company has operated, managed and organized its business and financial information on an aggregate basis for the purpose of evaluating financial performance and the allocation of capital and personnel resources. The Company’s chief operating decision-maker (CODM), its Chief Executive Officer, reviews its operating results for the purpose of allocating resources and evaluating financial performance. Emerging Growth Company Status The Company is an emerging growth company, as defined in the Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"). Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies. The Company has irrevocably elected to not take this exemption. As a result, it will adopt new or revised accounting standards on the relevant effective dates on which adoption of such standards is required for other public companies that are not emerging growth companies. |
Summary of Significant Accounti
Summary of Significant Accounting Policies and Use of Estimates | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies and Use of Estimates | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES Basis of Presentation The accompanying Financial Statements have been prepared in accordance with generally accepted accounting principles (“GAAP”) in the U.S. and with the rules and regulations of the Securities and Exchange Commission (“SEC”). The preparation of financial statements in conformity with GAAP and with the rules and regulations of the SEC requires management to make informed estimates and assumptions that affect the amounts reported in these accompanying Financial Statements and Notes. These estimates and assumptions are based upon historical experience, knowledge of current events and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources and involve judgments with respect to numerous factors that are difficult to predict and may materially differ from the amounts ultimately realized and reported due to the inherent uncertainty of any estimate or assumption. Actual results could differ materially from those estimates and assumptions used in the preparation of the accompanying Financial Statements under different assumptions and conditions. The Company’s Financial Statements as of and for the year ended December 31, 2023 reflect the Company’s estimates of the impact of the macroeconomic and geopolitical environment, including the impact of inflation, higher interest rates, and foreign exchange rate fluctuations. The duration and the scope of these conditions cannot be predicted; therefore, the extent to which these conditions will directly or indirectly impact the Company’s business, results of operations and financial condition, is uncertain. The Company is not aware of any specific event or circumstance that would require an update to its estimates, judgments and assumptions or a revision of the carrying value of the Company’s assets or liabilities as of the issuance date of the accompanying Financial Statements. The accounting policies and estimates that most significantly impact the presented amounts within these accompanying Financial Statements are further described below: Cash and Cash Equivalents Cash and cash equivalents consist of bank deposits and highly liquid investments, including money market fund accounts, that are readily convertible into cash without penalty, with original maturities of three months or less from the purchase date. The carrying amounts reported in the accompanying Balance Sheets for cash and cash equivalents are valued at cost, which approximate their fair value. Marketable Securities and Long-Term Investments Marketable securities consist primarily of short-term fixed income investments carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities (see Note 3 ). Management determines the appropriate classification of its investments in fixed income securities at the time of purchase. Available-for-sale securities with original maturities beyond three months at the date of purchase, including those that have maturity dates beyond one year from the balance sheet date, are classified as current assets on the accompanying Balance Sheets due to their highly liquid nature and availability for use in current operations. Marketable securities are recorded at fair value with unrealized gains and losses reported as a component of accumulated other comprehensive loss within the accompanying Statements of Stockholders' Equity until realized. The Company periodically evaluates whether declines in fair values of its available-for-sale securities below their book value are other-than-temporary. This evaluation consists of several qualitative and quantitative factors regarding the severity and duration of the unrealized loss as well as the Company’s ability and intent to hold the available-for-sale security until a forecasted recovery occurs. The cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion, as well as interest and dividends, are included in interest income. Realized gains and losses as well as credit losses, if any, on marketable securities identified on a specific identification basis are included in other income (expense) on the accompanying Statements of Operations and Comprehensive Loss. The Company evaluated the underlying credit quality and credit ratings of the issuers during the period. To date, the Company has not identified any other-than-temporary declines in fair value of its investments and no credit losses associated with credit risk have occurred or have been recorded. Interest earned on marketable securities is included in interest income within the accompanying Statements of Operations and Comprehensive Loss. Long-term investments consist of holdings of common stock in the publicly-traded parent company of LianBio Ophthalmology Limited ("LianBio"), reflecting the intent to hold these shares for at least one year from the balance sheet date. These equity securities are designated as available-for-sale with associated unrealized gains or losses reported in other income (expense) within the Statements of Operations and Comprehensive Loss for each reported period. Accounts Receivable, Net Accounts receivable generally consists of amounts due from its customers, which includes pharmaceutical wholesalers and specialty pharmacy providers related to product sales of XDEMVY in the U.S. Payment terms are typically 30-60 days following delivery to customers. Accounts receivable are recorded net of discounts, chargebacks, allowances and other adjustments. The Company monitors the financial performance and creditworthiness of its customers so it can properly assess and respond to changes in their credit profile. The Company estimates the allowance for credit losses based on existing contractual payment terms, actual payment patterns of customers and individual customer circumstances. Amounts determined to be uncollectible are written off against the reserve when it is probable that the receivable will not be collected. The Company did not record a reserve for estimated credit losses during the year ended December 31, 2023. Inventory Inventory is valued at the lower-of-cost or net realizable value, with cost determined on a first-in, first-out (FIFO) basis. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and adjusts the value for any excess and obsolete inventory to net realizable value in the period in which the impairment is first identified and such charges are recorded as a component of cost of sales in the Statements of Operations and Comprehensive Loss. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required. The Company capitalizes inventory costs associated with products following regulatory approval when future commercialization is considered probable and the future economic benefit is expected to be realized. Product that may be used in clinical development programs are excluded from inventory and the costs are charged to research and development expense in the Statements of Operations and Comprehensive Loss as incurred, as long as they do not have an alternative use. Prior to FDA approval of XDEMVY in July 2023, costs related to the production of inventory were recorded as research and development expense on the Statements of Operations and Comprehensive Loss in the period incurred. Intangible Assets, Net Intangible assets are measured at fair value as of the acquisition date or, in the case of commercial milestone payments, the date they become due. The evaluation of intangible assets includes assessing the amortization period for which the asset is expected to contribute to the future cash flows of the Company. Intangible assets with finite useful lives are amortized over their estimated useful lives, primarily on a straight-line basis when the Company is unable to reliably estimate the pattern of cash flow. The carrying value of intangible assets as a result of achieving certain commercial milestones was $4.0 million as of December 31, 2023, and are amortized to cost of sales over their useful life of 10 years from the date of first commercial sale (see Note 8 ). Amortization expense for the year ended December 31, 2023 was $0.1 million. The Company had no intangible assets as of December 31, 2022. As of December 31, 2023, the expected future amortization expense for the Company's intangible assets is as follows: Amounts 2024 $ 400 2025 400 2026 400 2027 400 2028 400 Thereafter 1,867 Total future amortization $ 3,867 Long-lived assets, including intangibles, are evaluated for impairment whenever events or changes in circumstance indicate that the carrying value of an asset might not be fully recoverable. To do so, the Company compares the carrying value of the intangible asset to the undiscounted net cash flows over its remaining useful life, and if not recoverable, will estimate the fair value of the asset. If the fair value is less than the carrying amount, an impairment loss is recognized in the Statements of Operations and Comprehensive Loss. There have been no impairments of intangible assets for the year ended December 31, 2023. Fair Value Measurements Assets and liabilities recorded at fair value on a recurring basis in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: • Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date. • Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public. • Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The carrying amounts for financial instruments consisting of cash, cash equivalents, accounts receivable, net, accounts payable and accrued liabilities approximate fair value due to the short maturities for each. The Company's equity warrant holdings disclosed as other assets are carried at fair value based on unobservable market inputs (see Note 3 ). Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. The Company did not have any transfers of assets and liabilities between the levels of the fair value hierarchy during the years presented. Property and Equipment, Net Property and equipment, net are stated at historical cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets that range from three Leases The Company determines if an arrangement is or contains a lease at inception. Right-of-Use assets (“ROU assets”) represent the Company’s right to control an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the initial non-cancelable lease term, unless there is a renewal option that is reasonably certain to be exercised. The Company uses its incremental borrowing rate at the lease commencement date in determining the discount rate utilized to present value the future minimum lease payments since an implicit interest rate in each at-market lease agreement was not determinable. The Company has lease agreements with both lease and non-lease components, which are accounted for as a single component for all asset classes. Lease expense for the Company's operating leases are recognized on a straight-line basis over the lease term. The Company's variable lease costs, consisting primarily of real estate taxes, insurance costs, and common area maintenance, are expensed as incurred and excluded from the reported ROU assets and lease liabilities amounts presented in the accompanying Balance Sheets. The noncurrent portion of the operating lease liability is included in other long-term liabilities in the accompanying Balance Sheets. Rent expense is allocated to research and development and selling, general and administrative expenses in the accompanying Statements of Operations and Comprehensive Loss. Concentration Risk Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, marketable securities and accounts receivable. The Company maintains cash held on deposit at financial institutions in the U.S., including Silicon Valley Bank ("SVB"), a division of First Citizens Bank. These deposits are insured by the Federal Deposit Insurance Corporation ("FDIC") in an amount up to $250,000 for any depositor. To the extent the Company holds cash deposits in amounts that exceed the FDIC insurance limitation, it may incur a loss in the event of a failure of any of the financial institutions where it maintains deposits. The Company invests its excess cash in highly liquid investments, including money market fund accounts, that are readily convertible into cash without penalty. Management believes the Company is not exposed to significant credit risk due to the financial position of the depository institution, but will continue to monitor regularly and adjust, if needed, to mitigate risk, including any ongoing or new events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions. The Company has established guidelines regarding diversification of its investments and their maturities, which are designed to maintain principal and maximize liquidity. To date, the Company has not experienced any losses associated with this credit risk and continues to assess that this exposure is not significant. Major Customers The Company entered into agreements with certain limited specialty pharmacies and specialty distributors for the sale of XDEMVY in the U.S. The following table summarizes the percentage of the Company's product sales from each of its largest customers: Year Ended December 31, 2023 Customer A 37 % Customer B 24 % Customer C 14 % Customer D 13 % Customer E 11 % As of December 31, 2023, amounts due from these five customers each exceeded 10% of gross accounts receivable and accounted for approximately 100% of the accounts receivable balance on a combined basis. Major Suppliers The Company does not currently own manufacturing facilities and depends on an outsourced manufacturing strategy for the production of XDEMVY for commercial use and for the production of its other product candidates for clinical trials. The Company entered into agreements with third-party manufacturers that are approved for the commercial production of XDEMVY and third-party suppliers that are approved for XDEMVY's active pharmaceutical ingredient. Although there are potential sources of supply other than the Company's existing manufacturers and suppliers, any new supplier would be required to qualify under applicable regulatory requirements. The loss of certain manufacturers and third-party suppliers could result in a temporary disruption of the Company’s commercialization efforts. Revenue Recognition (i) Product Sales, Net The Company recognizes product sales, net of XDEMVY when a customer obtains control of promised goods or services, which occurs at a point in time, typically upon delivery of the Company's product to the customer. The Company records the amount of revenue that reflects the consideration that it expects to receive in exchange for those goods or services. The Company applies the following five-step model in order to determine this amount: (i) identification of the promised goods in the contract; (ii) determination of whether the promised goods are performance obligations, including whether they are capable of being distinct; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue as each performance obligation is satisfied. The Company sells XDEMVY to customers in the U.S., which became available for commercial sale during the third quarter of 2023. The Company sells XDEMVY to a limited number of specialty pharmacies and distributors (i.e., its customers) who in turn sell it directly to clinics, hospitals, pharmacies and federal healthcare programs. Revenue from product sales is primarily recognized upon physical delivery of the product (when the customer obtains control of the product), in return for agreed-upon consideration. Shipping and handling activities are considered to be fulfillment activities rather than a separate performance obligation and are recorded within selling, general and administrative expenses in the accompanying Statements of Operations and Comprehensive Loss. Revenues from product sales are recorded at the net sales price, or the transaction price, which may include fixed or variable consideration for (i) invoice discounts for prompt payment and distribution service fees, (ii) government and private payer rebates, chargebacks, discounts and fees, (iii) product returns and (iv) costs of co-pay assistance programs for patients, as well as other incentives. Estimates of variable consideration are calculated based on the actual product sales each reporting period and the nature of the variable consideration related to those sales. Where appropriate, the Company utilizes the expected value method to determine the appropriate amount for estimates of variable consideration based on factors such as the current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. The amount of variable consideration that is included in the transaction price may be constrained and is included in product sales, net only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. These estimates reflect the Company’s best estimate of the amount of consideration to which the Company expects to be entitled based on the terms of the contract. Actual amounts of consideration ultimately received may differ materially from estimates. If actual results in the future vary from estimates, the Company will adjust these estimates, which would affect product sales, net and earnings in the period such variances are adjusted. The Company categorizes product sales deduction estimates as follows: Distribution Service Fees: The Company engages with wholesalers and specialty pharmacies to distribute its products to end customers. The Company pays the wholesalers and certain specialty pharmacies a fee for services such as: inventory management, chargeback administration, and service level commitments. The Company estimates the amount of distribution services fees to be paid to the customers and adjusts the transaction price with the amount of such estimate at the time of sale to the customer. An accrued liability is recorded for unpaid distribution service fees. Prompt Pay Discounts: The Company provides its customers with a percentage discount on their invoice if the customers pay within the agreed upon timeframe. The Company expects that its customers will earn prompt pay discounts. The Company estimates the probability of customers paying promptly based on the percentage of discount outlined in the purchase agreement between the two parties, and deducts the full amount of these discounts from gross product sales and accounts receivable at the time revenue is recognized. Product Returns: The Company's customers are contractually permitted to return the product within the contractual allowable time before and after the applicable expiration date. In the initial sales period, the Company estimates its provision for returns based on industry data and adjusts the transaction price at the time of the product sale to the customer. Once sufficient history has been collected for product returns, the Company will utilize that history to inform its returns estimate. Once the product is returned, it is destroyed since it cannot be resold. Chargebacks: A chargeback is the difference between the Company's invoice price to the wholesaler and the wholesaler’s customer's contract price. The wholesaler tracks these sales and charges back the Company for the difference between the negotiated prices paid between the wholesaler's customers and wholesaler's acquisition cost. The Company estimates the percentage of goods sold that are eligible for chargeback and adjusts the transaction price and accounts receivable at the time of sale of the product to the customer. Co-payment Assistance: Patients who meet certain eligibility requirements may receive co-payment assistance. The Company records contra-revenue for co-payment assistance based on actual program participation and estimates of program redemption using data provided by third-party administrators. An accrued liability is recorded on unredeemed co-payment assistance related to products for which control has been transferred to the customer. Rebates and Discounts: The Company accrues rebates for contractually agreed-upon discounts with commercial insurance companies and mandated discounts under government programs such as the Medicaid Drug Rebate Program, Medicare Part D Prescription Drug Program, and other government health care programs in the U.S. The Company's estimates for expected utilization of commercial insurance rebates are based on data received from its customers. The Company's estimates for rebates under government programs are based on statutory discount rates and expected utilization as well as historical data it has accumulated since product launch. The Company’s rebate calculations may require estimates, including estimates of customer mix, to determine which product sales will be subject to rebates and the amount of such rebates. The Company updates its estimates and assumptions on a quarterly basis and records any necessary adjustments to revenue in the period identified. Rebates are generally invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known prior quarters’ unpaid rebates. If actual rebates vary from estimates, the Company may need to adjust accruals, which would affect product sales, net in the period of adjustment. An accrued liability is recorded for unpaid rebates related to product for which control has transferred to the customer. (ii) License Fees and Collaboration Revenue China Out-License License fees and collaboration revenue in the accompanying Statements of Operations and Comprehensive Loss has historically primarily related to one out-license agreement (the "China Out-License") that allows the third-party licensee to market the Company's TP-03 product candidate (representing functional intellectual property) in the People's Republic of China, Hong Kong, Macau, and Taiwan (the "China territory")— see Note 9 . The accounting and reporting of revenue for out-license arrangements requires significant judgment for: (a) identification of the number of performance obligations within the contract; (b) the contract’s transaction price for allocation (including variable consideration); (c) the stand-alone selling price for each identified performance obligation; and (d) the timing and amount of revenue recognition in each period. The China Out-License was analyzed under GAAP to determine whether the promised goods or services are distinct or must be accounted for as part of a combined performance obligation. In making these assessments, the Company considers factors such as the stage of development of the underlying intellectual property and the capabilities of the customer to develop the intellectual property on their own, and/or whether the required expertise is readily available. If the license is not distinct, the license is combined with other promised goods or services as a combined performance obligation for revenue recognition. The China Out-License arrangement included the following forms of consideration: (i) non-refundable upfront license payment; (ii) equity-based consideration; (iii) sales-based royalties; (iv) sales-based threshold milestones; (v) one-time payments for executing drug supply agreements; (vi) development milestone payments; and (vii) regulatory milestone payments. Revenue is recognized in proportion to the allocated transaction price when (or as) the respective performance obligation is satisfied. The Company evaluates the progress related to each milestone at each reporting period and, if necessary, adjusts the probability of achievement and related revenue recognition. The measure of progress, and thereby periods over which revenue is recognized, is subject to estimates by management and may change over the course of the agreement. Contractual Terms for Receipt of Payments A performance obligation is a promise in a contract to transfer a distinct good or service and is the unit of accounting. A contract’s transaction price is allocated among each distinct performance obligation based on relative standalone selling price and recognized when, or as, the applicable performance obligation is satisfied. The contractual terms that establish the Company’s right to collect specified amounts from its customers and that require contemporaneous evaluation and documentation under GAAP for the corresponding timing and amount of revenue recognition, are as follows: Upfront License Fees: The Company determines whether non-refundable license fee consideration is recognized at the time of contract execution (i.e., when the license is transferred to the customer and the customer is able to use and benefit from the license) or over the actual (or implied) contractual period of the China Out-License. The Company also evaluates whether it has any other requirements to provide substantive services that are inseparable from the performance obligation of the license transfer to determine whether any combined performance obligation is satisfied over time or at a point in time. Upfront payments may require deferral of revenue recognition to a future period until the Company performs obligations under these arrangements. Development Milestones: The Company utilizes the most likely amount method to estimate the amount of consideration to which it will be entitled for achievement of development milestones as these represent variable consideration. For those payments based on development milestones (e.g., patient dosing in a clinical study or the achievement of statistically significant clinical results), the Company assesses the probability that the milestone will be achieved, including its ability to control the timing or likelihood of achievement, and any associated revenue constraint. Given the high degree of uncertainty around the occurrence of these events, the Company determines the milestone and other contingent amounts to be constrained until the uncertainty associated with these payments is resolved. At each reporting period, the Company re-evaluates this associated revenue recognition constraint. Any resulting adjustments are recorded to revenue on a cumulative catch-up basis, and reflected in the financial statements in the period of adjustment. Regulatory Milestones: The Company utilizes the most likely amount method to estimate the consideration to which it will be entitled and recognizes revenue in the period regulatory approval occurs (the performance obligation is satisfied) as these represent variable consideration. Amounts constrained as variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company evaluates whether the milestones are considered probable of being reached and not otherwise constrained. Accordingly, due to the inherent uncertainty of achieving regulatory approval, associated milestones are deemed constrained for revenue recognition until achievement. Royalties: Under the sales-or-usage-based royalty exception the Company recognizes revenue based on the contractual percentage of the licensee’s sale of products to its customers at the later of (i) the occurrence of the related product sales or (ii) the date upon which the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue from the China Out-License. Sales Threshold Milestones: Similar to royalties, applying the sales-or-usage-based royalty exception, the Company recognizes revenue from sales threshold milestones at the later of (i) the period the licensee achieves the one-time annual product sales levels in their territories for which the Company is contractually entitled to a specified lump-sum receipt, or (ii) the date upon which the performance obligation to which some or all of the milestone has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any sales threshold milestone revenue from the China Out-License. The Company re-evaluates the measure of progress to each performance obligation in each reporting period as uncertain events are resolved and other changes in circumstances occur. Other License Fees and Collaboration Revenue License fees and collaboration revenue also includes revenue recognized from satisfaction of performance obligations under an existing clinical supply agreement. The Company recognizes revenue when a customer obtains control of the promised good or service. Revenue recognized under this arrangement for the year ended December 31, 2023 was $0.2 million. No revenue was recognized under this arrangement for the year ended December 31, 2022. Cost of Sales Cost of sales consists of direct and indirect costs related to the manufacturing and distribution of XDEMVY, including raw materials, third-party manufacturing costs, packaging services, freight, third-party royalties payable on the Company’s product sales, net and amortization of capitalized intangible assets associated with XDEMVY. Cost of sales may also include period costs related to certain inventory warehouse and distribution operations and inventory adjustment charges. The Company began capitalizing inventory costs upon FDA approval of XDEMVY in July 2023. Prior to FDA approval of XDEMVY, manufacturing and other inventory costs were recorded to research and development expenses in the Statements of Operations and Comprehensive Loss. Therefore, cost of sales of XDEMVY will reflect a lower average per unit cost until the related inventory is sold. Selling, General and Administrative Selling, general and administrative costs consist of salaries, benefits, stock-based compensation and other personnel-related |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | FAIR VALUE MEASUREMENTS Financial assets and liabilities subject to fair value measurements on a recurring basis and the level of inputs used in such measurements by major security type are presented in the following table: Year Ended December 31, 2023 Fair Value Measurements Level 1 Level 2 Level 3 Total Assets: Money market funds (1) $ 224,947 $ — $ — $ 224,947 Government-related debt securities — 2,495 — 2,495 Common stock in LianBio 631 — — 631 Equity warrants (for LianBio shares) — — 225 225 Total assets measured at fair value $ 225,578 $ 2,495 $ 225 $ 228,298 (1) This balance includes cash requirements settled on a nightly basis. Year Ended December 31, 2022 Fair Value Measurements Level 1 Level 2 Level 3 Total Assets: Money market funds (1) $ 64,685 $ — $ — $ 64,685 U.S. Treasury securities 69,644 — — 69,644 Commercial paper — 60,355 — 60,355 Corporate debt securities — 11,521 — 11,521 Government-related debt securities — 10,821 — 10,821 Common stock in LianBio 371 — — 371 Equity warrants (for LianBio shares) — — 108 108 Total assets measured at fair value $ 134,700 $ 82,697 $ 108 $ 217,505 (1) This balance includes cash requirements settled on a nightly basis. Money Market Funds and U.S. Treasury Securities Money market funds and U.S. Treasury securities are highly liquid investments and are actively traded with readily-available market prices that are publicly observable and independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy. Commercial Paper, Corporate Debt Securities, and Government-related Debt Securities Commercial paper, corporate debt securities and government-related debt securities were valued using Level 2 inputs that utilized industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. The Company reviews trading activity and pricing for these investments as of each measurement date. LianBio Common Stock and Equity Warrants In March 2021, contemporaneous with the China Out-License transaction, the Company and LianBio executed a warrant agreement for the Company to purchase, in three tranches, common shares in LianBio at an exercise price equal to common stock par value, which converted into warrants of the parent company of LianBio (a pharmaceutical company focused on the Greater China and other Asian markets; Nasdaq: LIAN; any references to common stock or warrants of LianBio shall refer to common stock or warrants of the publicly-traded parent of LianBio) in connection with LianBio's previous Initial Public Offering. The first two tranches were vested, exercised, and converted into 156,746 shares of LianBio common stock as of December 31, 2022 and are recognized at fair value within long-term investments on the Balance Sheets as of December 31, 2023 and 2022. The Company does not believe a reserve for credit losses is required for the LianBio common stock as of December 31, 2023 and 2022. LianBio common stock is classified within Level 1 of the fair value hierarchy, given its publicly reported price on the Nasdaq Global market. The third warrant tranche remains classified as Level 3 in the fair value hierarchy and is presented within other assets on the accompanying Balance Sheets as of December 31, 2023 and 2022. This warrant tranche remains classified as Level 3 in the fair value hierarchy. The most significant assumptions used in the option pricing valuation model as of each balance sheet date to determine its fair value include observable and unobservable inputs: LianBio common stock volatility (based on the historical volatility of similar companies); the probability of regulatory milestone achievement for vesting; and the application of an assumed discount rate. The estimated fair value of the equity warrants are remeasured each reporting period with adjustments reported within other income (expense) Value of equity warrants Fair value as of December 31, 2022 $ 108 Remeasurement of equity warrants 117 Fair value as of December 31, 2023 $ 225 Value of equity warrants Fair value as of December 31, 2021 $ 663 Remeasurement of equity warrants (501) Recognition of equity warrants 103 Exercise of the second tranche of equity warrants into LianBio common stock (157) Fair value as of December 31, 2022 $ 108 The fair value and amortized cost of cash equivalents and available-for-sale investments by major security type are presented in the following table: December 31, 2023 Amortized cost Unrealized gains Unrealized losses Estimated fair value Cash equivalents: Money market funds (1) $ 224,947 $ — $ — $ 224,947 Total cash equivalents $ 224,947 $ — $ — $ 224,947 Marketable securities: Government-related securities $ 2,496 $ — $ (1) $ 2,495 Total marketable securities $ 2,496 $ — $ (1) $ 2,495 Long-term investments: Common stock in LianBio $ 1,108 $ — $ (477) $ 631 Total long-term investments $ 1,108 $ — $ (477) $ 631 (1) This balance includes cash requirements settled on a nightly basis. December 31, 2022 Amortized cost Unrealized gains Unrealized losses Estimated fair value Cash equivalents: Money market funds (1) $ 64,685 $ — $ — $ 64,685 Government-related securities 4,978 — — 4,978 Commercial paper 1,997 — — 1,997 Total cash equivalents $ 71,660 $ — $ — $ 71,660 Marketable securities: U.S. Treasury securities $ 69,720 $ 5 $ (81) $ 69,644 Commercial paper 58,358 — — 58,358 Corporate debt securities 11,524 8 (11) 11,521 Government-related securities 5,838 5 — 5,843 Total marketable securities $ 145,440 $ 18 $ (92) $ 145,366 Long-term investments: Common stock in LianBio $ 1,231 $ — $ (860) $ 371 Total long-term investments $ 1,231 $ — $ (860) $ 371 (1) This balance includes cash requirements settled on a nightly basis. As of December 31, 2023, all available-for-sale debt securities had a maturity of 12 months or less. As of December 31, 2022, substantially all available-for-sale debt securities had a maturity of 12 months or less. Three securities had a contractual maturity between one |
Balance Sheet Account Detail
Balance Sheet Account Detail | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Account Detail | BALANCE SHEET ACCOUNT DETAIL The composition of selected captions within the accompanying Balance Sheets are summarized below: Inventory Inventory consists of the following: December 31, 2023 Raw materials $ 2,533 Work in progress 392 Finished goods 182 Inventory $ 3,107 Property and Equipment, Net Property and equipment, net consists of the following: December 31, 2023 2022 Furniture and fixtures $ 1,251 $ 714 Office equipment 660 197 Laboratory equipment 167 167 Leasehold improvements 680 425 Property and equipment, at cost 2,758 1,503 (Less): Accumulated depreciation and amortization (1,290) (546) Property and equipment, net $ 1,468 $ 957 Depreciation expense for the years ended December 31, 2023 and 2022 was $0.7 million an d $0.3 million, res pectively. Accounts Payable and Other Accrued Liabilities Accounts payable and other accrued liabilities consists of the following: December 31, 2023 2022 Trade accounts payable and other $ 18,149 $ 5,498 Accrued product sales deductions 4,867 — Accrued clinical studies 277 3,691 Operating lease liability, current 398 721 Accounts payable and other accrued liabilities $ 23,691 $ 9,910 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | STOCKHOLDERS’ EQUITY 2020 and 2016 Equity Incentive Plans The Company's Board of Directors and stockholders adopted and approved the Company's 2020 Equity Incentive Plan (the “2020 Plan”) in October 2020. The 2020 Plan replaced the Company's 2016 Equity Incentive Plan that was earlier adopted in December 2016 (the "2016 Plan"). However, awards outstanding under the 2016 Plan will continue to be governed by its original terms. The number of shares of the Company's common stock that were initially available for issuance under the 2020 Plan equaled the initial sum of 9,000,000 shares plus 2,432,980 shares that were then available for issuance under the 2016 Plan. The 2020 Plan provides for the following types of awards: incentive and non-statutory stock options, stock appreciation rights, restricted shares, and restricted stock units. The number of shares of common stock reserved for issuance under the 2020 Plan are increased automatically on the first business day of each fiscal year, commencing in 2021 and ending in 2030, by a number equal to the lesser of: (i) 4% of the shares of common stock outstanding on the last business day of the prior fiscal year; or (ii) the number of shares determined by the Company's Board of Directors. In general, to the extent that any awards under the 2020 Plan are forfeited, terminate, expire or lapse without the issuance of shares, or if the Company reacquires the shares subject to awards granted under the 2020 Plan, those shares will again become available for issuance under the 2020 Plan, as will shares applied to pay the exercise or purchase price of an award or to satisfy tax withholding obligations related to any award. Employee Stock Purchase Plan Under the terms of the Company's 2020 Employee Stock Purchase Plan ("ESPP"), eligible employees can purchase common stock through scheduled payroll deductions. The purchase price is equal to the closing price of the Company's common stock on the first or last day of the offering period (whichever is less), minus a 15% discount. To determine the value of ESPP expense to be recognized during each offering period, the Black-Scholes option-pricing model is used, in combination with the discounted employee price. A participant may purchase a maximum of 3,000 shares of common stock during a six-month offering period, not to exceed $25,000 at full market value on the offering date during each ESPP year. Beginning on January 1, 2021, and each January 1st thereafter, pursuant to the terms of the ESPP, the number of common stock available for issuance under the ESPP is automatically increased by an amount equal to the lesser of (i) one percent of the total number of shares of common stock outstanding on the last day of the year, (ii) 2.5 million shares, or (iii) a number determined by the board of directors. Common Stock Outstanding and Reserves for Future Issuance As of December 31, 2023 and 2022, the Company had 34.2 million and 26.7 million, respectively, of common stock issued and outstanding. Common stockholders have one vote for each share of common stock held and are entitled to receive dividends declared by the Company’s Board of Directors when legally available for distribution, then-subject to the dividend rights of the holders of preferred stock. For the years ended December 31, 2023 and 2022, no dividends were declared. The Company's outstanding equity awards and shares reserved for future issuance under its 2020 and 2016 Equity Incentive Plans and 2020 Employee Stock Purchase Plan are summarized below: December 31, 2023 2022 Common stock awards reserved for future issuance under 2020 and 2016 Equity Incentive Plans 7,054,222 8,346,738 Common stock awards reserved for future issuance under the 2020 Employee Stock Purchase Plan 2,859,434 2,663,319 Stock options issued and outstanding (unvested and vested) under 2020 and 2016 Equity Incentive Plans 4,760,366 3,899,342 Restricted stock units issued and outstanding (unvested) under 2020 Equity Incentive Plan 1,708,725 551,258 Total shares of common stock reserved 16,382,747 15,460,657 |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | STOCK-BASED COMPENSATION Stock-Based Compensation Expense Stock-based compensation expense was recognized in the accompanying Statements of Operations and Comprehensive Loss as follows: Year Ended 2023 2022 Cost of sales $ 190 $ — Research and development 5,833 3,736 Selling, general and administrative 13,807 9,724 Total stock-based compensation $ 19,830 $ 13,460 The fair value of granted stock options was estimated as of the date of grant using the Black-Scholes option-pricing model, based on the following inputs: Year Ended 2023 2022 Exercise price $12.48 to $18.78 $12.89 to $20.64 Expected term (in years) 6.25 6.25 Risk-free interest rate 3.38% to 4.83% 1.63% to 4.21% Weighted average volatility 69.7% to 73.3% 77.3% to 83.0% Dividend yield rate — — Weighted-average grant-date fair value per stock option $ 15.49 $ 18.37 Stock Option Activity Stock option activity during the years ended December 31, 2023 and 2022 was as follows: Number of Weighted- Weighted- Aggregate Intrinsic Value (1) Outstanding - December 31, 2021 2,759,830 $ 15.88 8.54 $ 33,641 Granted 1,227,123 18.37 Exercised (40,979) 3.01 Forfeited (46,632) 24.60 Expired — — Outstanding - December 31, 2022 3,899,342 16.69 8.07 $ 19,196 Granted 1,173,243 15.49 Exercised (136,310) 4.34 Forfeited (175,909) 20.34 Expired — — Outstanding - December 31, 2023 4,760,366 $ 16.62 7.53 $ 34,128 Vested - December 31, 2023 2,694,380 $ 15.21 6.69 $ 26,371 Unvested - December 31, 2023 2,065,986 $ 18.45 8.63 $ 7,757 ____________ (1) The aggregate intrinsic value is calculated as the difference between the exercise price of the options and the fair value of the Company's common stock as of December 31, 2023. The total grant-date fair value of options that vested during the years ended December 31, 2023 and 2022 was $26.4 million and $13.7 million, respectively. For the year ended December 31, 2023, the Company recorded stock-based compensation expense for stock options of $13.0 million. As of December 31, 2023, there was approximately $22.9 million of unrecognized compensation expense related to unvested stock options, which the Company expects to recognize over a weighted average period of 2.1 years. Restricted Stock Unit Activity Restricted stock unit activity during the year ended December 31, 2023 was as follows: Number of Weighted Average Value per Share Outstanding - December 31, 2021 17,251 $ 27.53 Granted 573,009 17.87 Vested (32,914) 24.17 Forfeited (6,088) 19.40 Outstanding - December 31, 2022 551,258 $ 17.78 Granted 1,442,677 15.95 Vested (206,813) 17.87 Forfeited (78,397) 16.02 Outstanding - December 31, 2023 1,708,725 $ 16.31 For the year ended December 31, 2023, the Company recorded stock-based compensation expense for restricted stock units of $6.5 million. As of December 31, 2023, there was approximately $23.3 million of unrecognized compensation expense related to unvested restricted stock units, which the Company expects to recognize over a weighted average period of 3.2 years. Employee Stock Purchase Plan Stock-based compensation expense related to the ESPP was $0.3 million and $0.3 million, respectively, for the years ended December 31, 2023 and 2022. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | NET LOSS PER SHARE The following table sets forth the computation of basic and diluted net loss per share: Year Ended December 31, 2023 2022 Net loss $ (135,893) $ (62,091) Weighted-average shares—basic and diluted 29,383,276 24,619,700 Net loss per share—basic and diluted $ (4.62) $ (2.52) The following outstanding and potentially dilutive securities were excluded from the calculation of diluted net loss per share because their impact under the treasury stock method and if-converted method would have been anti-dilutive for each period presented: Year Ended December 31, 2023 2022 Stock options, unexercised—vested and unvested 4,760,366 3,899,342 Restricted stock units—unvested 1,708,725 551,258 Total 6,469,091 4,450,600 |
Commitments & Contingencies
Commitments & Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments & Contingencies | COMMITMENTS & CONTINGENCIES Lease Agreements In the ordinary course of business, the Company enters into lease agreements with unaffiliated third parties for its facilities and office equipment. As of December 31, 2023, the Company had five active leases for adjacent office and laboratory suites in Irvine, California. On May 1, 2023 the Company amended the existing facilities lease, extending the term for three years through January 31, 2027. The below table summarizes the components of total lease expense: Year Ended December 31, 2023 2022 Operating lease expense $ 705 $ 569 Variable lease expense 391 244 Total lease expense $ 1,096 $ 813 As of December 31, 2023, the Company's facility leases had a remaining lease term of 3.1 years and a weighted-average incremental borrowing rate of 10%. The below table summarizes the (i) minimum lease payments over the next five years and thereafter, (ii) lease arrangement imputed interest, and (iii) present value of future lease payments: December 31, 2023 2024 $ 701 2025 789 2026 816 2027 68 2028 — Total future lease payments, undiscounted $ 2,374 (Less): Imputed interest (332) (Less): Tenant improvement allowance (129) Present value of operating lease payments $ 1,913 Operating lease liability, current 398 Operating lease liability, noncurrent 1,515 Total operating lease liability $ 1,913 In-License Agreements for Lotilaner Elanco In-License Agreement for Skin and Eye Disease or Conditions in Humans In January 2019, the Company executed a license agreement with Elanco Tiergesundheit AG (“Elanco”) for exclusive worldwide rights to certain intellectual property for the development and commercialization of lotilaner in the treatment or cure of any eye or skin disease or condition in humans, as amended in June 2022 (the "Eye and Derm Elanco Agreement"). The Company has sole financial responsibility for related development, regulatory, and commercialization activities. In March 2023, a clinical milestone was triggered to Elanco under the Eye and Derm Agreement upon enrollment of the first patient in the Phase 2a Galatea trial, evaluating the potential treatment of rosacea. The related milestone payment of $1.0 million was included in research and development expense in the accompanying Statements of Operations and Comprehensive Loss for the year ended December 31, 2023. The Company has made cash payments to Elanco under the Eye and Derm Agreement comprised of $1.0 million upfront upon contract execution in January 2019 and a total of $4.0 million for three specified clinical milestone achievements in September 2020, April 2021, and March 2023, which were all recorded in research and development expense in the Statements of Operations and Comprehensive Loss. During 2023, a milestone of $4.0 million was achieved and paid to Elanco upon the first commercial sale of XDEMVY in the U.S., which was recorded as an intangible asset in the accompanying Balance Sheet as of December 31, 2023. The Company is amortizing the intangible asset to cost of sales over its useful life of 10 years from the date of the first commercial sale. As of December 31, 2023, the Company is obligated to make further cash payments to Elanco of $2.0 million under the Eye and Derm Elanco Agreement upon achievement of the last clinical milestone in the treatment of human skin diseases using lotilaner and a maximum of $75.0 million for various commercial and sales threshold milestones for the treatment of human skin diseases and the treatment of blepharitis in humans using lotilaner. In addition, the Company is obligated to pay tiered contractual royalties to Elanco in the mid to high single digits of its net sales. If the Company receives certain types of payments from its sublicensees, it will be obligated to pay Elanco a variable percentage in the low to mid double-digits of such proceeds, until achievement of the first applicable regulatory approval of a product covered under the license. As a result of the commercialization of XDEMVY, the Company began accruing royalties payable to Elanco during 2023, which are recorded to cost of sales in the accompanying Statement of Operations and Comprehensive Loss for the year ended December 31, 2023 and accounts payable and other accrued liabilities in the accompanying Balance Sheet as of December 31, 2023. Royalty expense during the year ended December 31, 2023 was $0.7 million. Elanco In-License Agreement for All Other Diseases or Conditions in Humans In September 2020, the Company executed a license agreement with Elanco granting it a worldwide license to certain intellectual property for the development and commercialization of lotilaner for the treatment, palliation, prevention, or cure of all other diseases and conditions in humans (i.e., beyond that of the eye or skin), as amended in June 2022 (the "All Human Uses Elanco Agreement"). In September 2020, the Company issued Elanco 222,460 shares of its common stock with an estimated fair value of $3.1 million ($14.0003 per share, approximating the issuance price of the Company's Series C preferred stock in September 2020) . The Company made cash payments under the All Human Uses Elanco Agreement of $0.5 million related to a clinical milestone that was triggered in December 2022 upon enrollment of the first patient in the Phase 2a Carpo trial, for the potential treatment of Lyme disease. The Company is required to make further cash payments under this agreement upon the achievement of various clinical milestones up to an aggregate max imum of $4.0 million and variou s commercial and sales threshold milestones for an aggregate maximum of $77.0 million. In addition, the Company will be obligated to pay contractual royalties to Elanco in the single digits of its product sales, net. If the Company receives certain types of payments from its sublicensees, it will also be obligated to pay Elanco a variable percentage in the low to mid double-digits of such proceeds, until achievement of the first applicable regulatory approval of a product covered under the license. Employment Agreements The Company has entered into employment agreements with seven of its executive officers. These agreements provide for the payment of certain benefits upon separation of employment under specified circumstances, such as termination without cause, or termination in connection with a change in control event. Litigation Contingencies From time to time, the Company may be subject to various litigation and related matters arising in the ordinary course of business. The Company is currently not aware of any such matters where there is at least a reasonable probability that a material loss, if any, has been or will be incurred for financial statement recognition. Indemnities and Guarantees The Company has certain indemnity commitments, under which it may be required to make payments to its officers and directors in relation to certain transactions to the maximum extent permitted under applicable laws. The duration of these indemnities varies, and in certain cases, are indefinite and do not provide for any limitation of maximum payments. The Company has not been obligated to make any such payments to date and no liabilities have been recorded for this contingency in the accompanying Balance Sheets. |
Out-License Agreement
Out-License Agreement | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Out-License Agreement | OUT-LICENSE AGREEMENT Out-License of TP-03 Commercial Rights in the China Territory in March 2021 In March 2021, the Company entered into the China Out-License agreement with LianBio for its exclusive development and commercialization rights of TP-03 (lotilaner ophthalmic solution, 0.25%) in the China Territory, as defined in the agreement, for the treatment of Demodex blepharitis and Meibomian Gland Disease. LianBio is contractually responsible for all clinical development and commercialization activities and costs within the China Territory. The Company assessed this arrangement and identified the following material promises under the arrangement: (i) the exclusive license to research, develop, manufacture, commercialize, make, offer for sale, sell, and import TP-03 in the China Territory; and (ii) the research and development services in the form of clinical study materials for the respective Phase 2b/3 trial (Saturn-1) and Phase 3 (Saturn-2) TP-03 trials. The promises to provide research and development services for Saturn-1 and Saturn-2 clinical trials were evaluated and determined to be distinct promises in the contract and each of the two clinical trials are separate performance obligations apart from the promise to provide the license. The assessment of the initial transaction price for the China Out-License agreement included an analysis of amounts the Company expected to receive, which at contract inception consisted of: (i) the upfront cash payment of $15.0 million; (ii) a second cash payment of $10.0 million; (iii) a $10.0 million milestone that was determined to be within the control of the Company; and (iv) $1.2 million representing the initial fair value of the equity warrant. The Company accounted for each performance obligation as follows: Out-License The Company determined that this license was distinct based on an evaluation of the delivery of the functional license that was in the later stages of development, and it met the criteria for being distinct from the research and development services required under the China Out-License agreement. The Company determined the standalone selling price of this license using a discounted projected sales model and recognized as license fees and collaboration revenue the total allocated transaction price at contract inception, upon delivery of the license. Research and Development Services The standalone selling price of these performance obligations was determined using the adjusted market assessment approach. The Company analyzed costs expected to be incurred for each of the clinical trials through completion to estimate the price that a customer would be willing to pay for these services in order to benefit from the clinical trials. The Company determined that LianBio simultaneously benefited from the research and development services that are satisfied over time, as they were able to request and access the clinical trial data at any point through the trial completion. Therefore, the Company recognized the amounts allocated to the respective research and development performance obligations for Saturn-1 and Saturn-2 within license fees and collaboration revenue as the research and development services were provided using an input method, based on the costs incurred for each clinical trial and the total costs expected to be incurred to satisfy each performance obligation. The Company believes this method most faithfully depicted its performance in transferring the promised services during the expected period of time that each clinical trial was ongoing. The Company monitored the expected completion dates for each clinical trial and updated its estimated time to completion at each reporting period, as necessary. In February 2023, a specified milestone event was triggered based upon the signing of an agreement for which the Company has no ongoing obligations, resulting in $2.5 million recognized as license fees and collaboration revenue in the accompanying Statements of Operations for the year ended December 31, 2023. Through December 31, 2023, the Company received aggregate payments from LianBio totaling $82.5 million, comprised of initial consideration of $15.0 million and $67.5 million for the achievement of specified milestones. As of December 31, 2023 the Company is eligible to receive further consideration from LianBio upon the achievement of additional TP-03 events, including: (i) additional regulatory milestones and one-time payments of up to an aggregate of $22.5 million; (ii) China-Based TP-03 sales threshold milestone payments of up to an aggregate of $100.0 million; (iii) tiered low-to-high-teen royalties for China Territory TP-03 product sales; and (iv) vesting of a LianBio equity warrant upon certain regulatory milestones. On February 13, 2024, LianBio announced its plan to wind down its operations. As of the date of this filing, it is uncertain if and when the Company will receive any royalties or future milestone consideration under the China Out-License, including but not limited to the milestone achievement of an additional drug supply agreement execution. As part of the China Out-License with LianBio the Company granted Elanco an additional 187,500 shares of the Company's common stock that otherwise would have been issuable no later than the 18-month anniversary of the All Human Uses Elanco Agreement for its continued license exclusivity. These issued shares were valued at $5.5 million, based on the Company's closing stock price of $29.30 per share on the date this issuance became contractually required. The Company made a contractual payment in the amount of $2.5 million to Elanco following the receipt of $25 million of proceeds from LianBio during the second quarter of 2021. During the fourth quarter of 2022, the Company recognized $0.4 million of cost of license fees and collaboration revenue upon receipt of $10 million of cash proceeds from LianBio for the achievement of a clinical development milestone. There were no expenses recognized under the China-Out License for the year ended December 31, 2023. During the year ended December 31, 2022, the Company recognized $1.0 million of expense under the China-Out License within cost of license fees and collaboration revenue in the accompanying Statement of Operations and Comprehensive Loss. |
Credit Facility Agreement
Credit Facility Agreement | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Credit Facility Agreement | CREDIT FACILITY AGREEMENT On February 2, 2022, the Company executed the Credit Facility with Hercules Capital, Inc. ("Hercules") and SVB that expires on February 2, 2027. As security for the obligations under the agreement, the Company granted a continuing security interest in substantially all of the Company's assets, excluding intellectual property on which there is a negative pledge. Concurrent with the execution of the Credit Facility, the Company made a $20.0 million draw. On January 5, 2023, the Company entered into an amendment to the loan and security agreement (the "First Amendment"). The First Amendment set a maximum interest rate and updated the terms of prepayment under the Credit Facility and other certain specific conditions including an extended period for the Company to drawdown the $25.0 million tranche associated with the New Drug Application ("NDA") submission from March 15, 2023 to March 15, 2024, provided at least $5.0 million was drawn on or before March 15, 2023 and at least an additional $5.0 million was drawn on or before September 15, 2023. The Company did not incur any lender fees as part of this First Amendment. On August 23, 2023, the Company entered into a second amendment to the loan and security agreement (the "Second Amendment"). The Second Amendment updated the terms of the amount and proportion of the Company’s cash required to be maintained at SVB or affiliates of SVB. The Company did not incur any lender fees as part of this Second Amendment. On March 15, 2023 and September 15, 2023, respectively, the Company made separate draws of $5.0 million (including SVB's commitment of $1.25 million) from the $25.0 million tranche that became available upon submission of the NDA. As of December 31, 2023, the Credit Facility provides for a remaining aggregate principal amount of up to $125.0 million with tranched availability as follows: $15.0 million currently available related to the Company's NDA submission with the FDA for TP-03 in September 2022; $35.0 million currently available due to the FDA approval of XDEMVY in July 2023; $50.0 million available upon achievement of product sales, net thresholds; and $25.0 million available upon lender approval. Each of these tranches may be drawn down in $5.0 million increments at the Company's election. The Credit Facility requires interest-only payments through February 1, 2026, followed by 12 months of principal amortization, unless extended for one year to its maturity, upon meeting certain contractual conditions. All unpaid amounts under the Credit Facility become due on its February 2, 2027 expiry. Under the First Amendment, the outstanding principal draws accrue interest at a floating interest rate per annum equal to the greater of either (i) The Wall Street Journal ("WSJ") prime rate plus 4.45% with an aggregate cap of 11.45%, or (ii) 8.45%. At the execution date of the Credit Facility, the WSJ prime rate was 3.25% and increased to 8.50% as of December 31, 2023. The Company is required to pay a specified fee upon the earlier of (i) February 2, 2027, or (ii) the date the Company prepays, in full or in part, the outstanding principal balance of the Credit Facility ("End of Term Charge"). The current End of Term Charge of $1.4 million was derived by multiplying 4.75% by the $30.0 million outstanding principal balance as of December 31, 2023 and is accreted to interest expense through maturity. As of December 31, 2023 and 2022, the effective interest rate for the full term of the Credit Facility was 11.96% and 13.61%, respectively. During the year ended December 31, 2023 and 2022, the Company recognized interest expense on the accompanying Statements of Operations and Comprehensive Loss in connection with the Credit Facility as follows: Year Ended December 31, 2023 2022 Interest expense for term loan $ 2,961 $ 1,890 Accretion of end of term charge 264 174 Amortization of debt issuance costs 121 135 Total interest expense related to term loan $ 3,346 $ 2,199 The carrying value of the Credit Facility consists of principal outstanding less legal and administrative issuance costs that were recorded as a debt discount to the term loan, net and will continue to be accreted to interest expense using the effective interest method during its term. The principal balance of this Credit Facility and related accretion and amortization are reported on a combined basis as term loan, net on the accompanying Balance Sheets as follows: December 31, 2023 2022 Term loan, gross $ 30,000 $ 20,000 Debt issuance costs (875) (875) Accretion of end of term charge 438 174 Accumulated amortization of debt issuance costs 256 135 Term loan, net $ 29,819 $ 19,434 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | RELATED PARTY TRANSACTIONS The Company has a preexisting consulting agreement with a board member who was appointed in December 2021. This consulting agreement provides for annual cash compensation of approximately $0.2 million and option grants to purchase 45,134 shares of the Company’s common stock, with exercise prices ranging from $2.01 to $34.72 per share. This Consulting Agreement may be terminated by either party with ten days' notice and contains standard confidentiality, indemnification, and intellectual property assignment provisions in favor of the Company. During the year ended December 31, 2023 and 2022, the Company recorded $0.3 million and $0.3 million, respectively, of selling, general and administrative expenses in the accompanying Statements of Operations and Comprehensive Loss related to this consulting agreement. Sponsorship Activities In May 2023, a board member of the Company was appointed president of the American Society of Cataract and Refractive Surgery ("ASCRS"), a society dedicated to meeting the needs of anterior segment ophthalmic surgeons. During the year ended December 31, 2023, the Company recorded $0.4 million of selling, general and administrative expenses in the accompanying Statement of Operations and Comprehensive Loss for sponsorship and event-related activities associated with ASCRS. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES The components of loss from operations before benefit from income taxes were as follows: Year Ended 2023 2022 United States $ (135,893) $ (62,095) Total $ (135,893) $ (62,095) The benefit from income taxes from operations were as follows: Year Ended 2023 2022 Current: Federal $ — $ (4) State — — $ — $ (4) Deferred: Federal — — State — — — — Total income tax benefit $ — $ (4) A reconciliation of income taxes was computed by applying the federal statutory income tax rate in each period to the pretax loss for the years ended December 31, 2023 and 2022, and adjusted for certain classes of transactions, as summarized below: Year Ended 2023 2022 Expected tax benefit at statutory rate $ (28,537) $ (13,040) State income tax, net of federal benefit (4,403) (212) Permanent items 501 (22) Stock-based compensation 579 606 Executive compensation 1,484 988 Research and development credits (2,878) (1,753) State rate adjustment (1,815) 86 Change in fair value of equity warrants and equity securities (30) 91 Other 12 126 Change in valuation allowance 35,087 13,126 Income tax benefit $ — $ (4) Significant components of the deferred tax assets and liabilities were as follows: Year Ended 2023 2022 Deferred tax assets: Net operating loss carry forwards $ 25,881 $ 6,679 Research and development credit carryforwards 7,601 4,723 Capitalized research and development 15,892 7,634 Intangible assets 3,442 2,970 Stock-based compensation 3,747 2,119 Accruals 2,598 1,140 Other, net 1,842 59 Total deferred tax assets before valuation allowance 61,003 25,324 (Less): Valuation allowance (60,270) (25,201) Total deferred tax assets $ 733 $ 123 Deferred tax liabilities, net: Operating lease right-of-use assets (473) (123) Fixed assets (260) — Net deferred tax asset $ — $ — Deferred income taxes reflect the net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company maintains a valuation allowance against its net deferred tax assets due to the uncertainty that such assets will be realized and evaluates the recoverability of its deferred tax assets on at least an annual basis. The Company has determined that its deferred tax assets, with the exception of amounts supported by the reversal of taxable temporary differences, are not realizable. Consequently, the Company has recorded a valuation allowance on deferred tax assets of $60.3 million and $25.2 million at December 31, 2023 and 2022, respectively. At December 31, 2023, the Company has federal and state net operating loss carryforwards of approximat ely $107.8 million a nd $84.0 million, respectively. As a result of the Tax Cuts and Jobs Act of 2017 (the "Tax Act"), for U.S. income tax purposes, net operating losses generated prior to December 31, 2017 can be carried forward for up to 20 years, while net operating losses generated after December 31, 2017 can be carried forward indefinitely, but are limited to 80% utilization against taxable income. The Company’s total federal net operating loss of $107.8 million will not expire but will only be able to offset 80% of future taxable income within each year. The other state net operating losses will begin to expire in 2037. At December 31, 2023, the Company had federal and other state research and development tax credits of $7.4 million and $2.4 million, respectively. The federal research and development tax credits begin to expire in 2040 unless previously utilized, and the other state credit carryforwards begin to expire in 2037. The Internal Revenue Code ("IRC") Sections 382 and 383 limit annual use of NOL and research and development credit carryforwards in the event a cumulative change in ownership of more than 50% occurs within a three-year period. The Company has not yet completed an ownership change analysis. If a requisite ownership change occurs, the amount of remaining tax attribute carryforwards available to offset taxable income and income tax expense in future years may be restricted or eliminated. If eliminated, the related asset would be removed from deferred tax assets with a corresponding reduction in the valuation allowance. Due to the existence of the valuation allowance, limitations created by future ownership changes, if any, will not impact the Company’s effective tax rate. Uncertain tax positions are evaluated based upon the facts and circumstances that exist at each reporting period. Subsequent changes in judgement based upon new information may lead to changes in recognition, derecognition, and measurement. Adjustment may result, for example, upon resolution of an issue with the taxing authorities or expiration of a statute of limitations barring an assessment for an issue. The Company recognizes a tax benefit from an uncertain tax position when it is more-likely-than-not that it will be sustained upon examination by tax authorities. As of December 31, 2023, the Company had gross unrecognized tax benefits of $3.9 million, none of which would affect the effective tax rate if recognized. The Company does not anticipate any significant changes in its unrecognized tax benefits over the next 12 months. The Company's policy is to recognize the interest expense and/or penalties related to income tax matters as a component of income tax expense. The Company had no accrual for interest or penalties on the accompanying Balance Sheets at December 31, 2023 and has not recognized interest and/or penalties on the accompanying Statements of Operations for the years ended December 31, 2023 or 2022. The following table summarizes the changes to the gross unrecognized tax benefits: Year Ended 2023 2022 Balance at beginning of year $ 3,393 $ 3,045 Additions related to current year positions 468 349 Additions related to prior year positions 67 — Decreases related to prior year positions — (1) Balance at end of year $ 3,928 $ 3,393 The Company is subject to taxation in the U.S. Federal jurisdiction and various states. All tax years from inception are subject to examination by federal and state tax authorities. The Company’s practice is to recognize interest and penalties related to income tax matters in income tax expense. No interest or penalties related to income tax matters have been incurred at December 31, 2023 and 2022 and the years then ended. Further, the Company is not currently under examination by any federal, state, or local tax authority. |
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 | $ (135,893) | $ (62,091) |
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 and Use of Estimates (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Operating Segment | Operating Segment The Company operates one reportable operating segment focused on the development and commercialization of therapeutics. To date, the Company has operated, managed and organized its business and financial information on an aggregate basis for the purpose of evaluating financial performance and the allocation of capital and personnel resources. The Company’s chief operating decision-maker (CODM), its Chief Executive Officer, reviews its operating results for the purpose of allocating resources and evaluating financial performance. |
Basis of Presentation | Basis of Presentation The accompanying Financial Statements have been prepared in accordance with generally accepted accounting principles (“GAAP”) in the U.S. and with the rules and regulations of the Securities and Exchange Commission (“SEC”). The preparation of financial statements in conformity with GAAP and with the rules and regulations of the SEC requires management to make informed estimates and assumptions that affect the amounts reported in these accompanying Financial Statements and Notes. These estimates and assumptions are based upon historical experience, knowledge of current events and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources and involve judgments with respect to numerous factors that are difficult to predict and may materially differ from the amounts ultimately realized and reported due to the inherent uncertainty of any estimate or assumption. Actual results could differ materially from those estimates and assumptions used in the preparation of the accompanying Financial Statements under different assumptions and conditions. The Company’s Financial Statements as of and for the year ended December 31, 2023 reflect the Company’s estimates of the impact of the macroeconomic and geopolitical environment, including the impact of inflation, higher interest rates, and foreign exchange rate fluctuations. The duration and the scope of these conditions cannot be predicted; therefore, the extent to which these conditions will directly or indirectly impact the Company’s business, results of operations and financial condition, is uncertain. The Company is not aware of any specific event or circumstance that would require an update to its estimates, judgments and assumptions or a revision of the carrying value of the Company’s assets or liabilities as of the issuance date of the accompanying Financial Statements. |
Cash and Cash Equivalents | Cash and Cash Equivalents |
Marketable Securities and Long Term Investments | Marketable Securities and Long-Term Investments Marketable securities consist primarily of short-term fixed income investments carried at estimated fair value as determined based upon quoted market prices or pricing models for similar securities (see Note 3 ). Management determines the appropriate classification of its investments in fixed income securities at the time of purchase. Available-for-sale securities with original maturities beyond three months at the date of purchase, including those that have maturity dates beyond one year from the balance sheet date, are classified as current assets on the accompanying Balance Sheets due to their highly liquid nature and availability for use in current operations. Marketable securities are recorded at fair value with unrealized gains and losses reported as a component of accumulated other comprehensive loss within the accompanying Statements of Stockholders' Equity until realized. The Company periodically evaluates whether declines in fair values of its available-for-sale securities below their book value are other-than-temporary. This evaluation consists of several qualitative and quantitative factors regarding the severity and duration of the unrealized loss as well as the Company’s ability and intent to hold the available-for-sale security until a forecasted recovery occurs. The cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion, as well as interest and dividends, are included in interest income. Realized gains and losses as well as credit losses, if any, on marketable securities identified on a specific identification basis are included in other income (expense) on the accompanying Statements of Operations and Comprehensive Loss. The Company evaluated the underlying credit quality and credit ratings of the issuers during the period. To date, the Company has not identified any other-than-temporary declines in fair value of its investments and no credit losses associated with credit risk have occurred or have been recorded. Interest earned on marketable securities is included in interest income within the accompanying Statements of Operations and Comprehensive Loss. |
Accounts Receivable, Net | Accounts Receivable, Net |
Inventory | Inventory Inventory is valued at the lower-of-cost or net realizable value, with cost determined on a first-in, first-out (FIFO) basis. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and adjusts the value for any excess and obsolete inventory to net realizable value in the period in which the impairment is first identified and such charges are recorded as a component of cost of sales in the Statements of Operations and Comprehensive Loss. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required. The |
Intangible Assets, Net | Intangible Assets, Net |
Fair Value Measurements | Fair Value Measurements Assets and liabilities recorded at fair value on a recurring basis in the balance sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance on fair value measurements establishes a three-tier fair value hierarchy for disclosure of fair value measurements as follows: • Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date. • Level 2: Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public. • Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The carrying amounts for financial instruments consisting of cash, cash equivalents, accounts receivable, net, accounts payable and accrued liabilities approximate fair value due to the short maturities for each. The Company's equity warrant holdings disclosed as other assets are carried at fair value based on unobservable market inputs (see Note 3 ). Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. The Company did not have any transfers of assets and liabilities between the levels of the fair value hierarchy during the years presented. |
Property and Equipment, Net | Property and Equipment, Net Property and equipment, net are stated at historical cost less accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets that range from three |
Leases | Leases The Company determines if an arrangement is or contains a lease at inception. Right-of-Use assets (“ROU assets”) represent the Company’s right to control an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the initial non-cancelable lease term, unless there is a renewal option that is reasonably certain to be exercised. The Company uses its incremental borrowing rate at the lease commencement date in determining the discount rate utilized to present value the future minimum lease payments since an implicit interest rate in each at-market lease agreement was not determinable. The Company has lease agreements with both lease and non-lease components, which are accounted for as a single component for all asset classes. Lease expense for the Company's operating leases are recognized on a straight-line basis over the lease term. |
Concentration Risk | Concentration Risk Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, marketable securities and accounts receivable. The Company maintains cash held on deposit at financial institutions in the U.S., including Silicon Valley Bank ("SVB"), a division of First Citizens Bank. These deposits are insured by the Federal Deposit Insurance Corporation ("FDIC") in an amount up to $250,000 for any depositor. To the extent the Company holds cash deposits in amounts that exceed the FDIC insurance limitation, it may incur a loss in the event of a failure of any of the financial institutions where it maintains deposits. The Company invests its excess cash in highly liquid investments, including money market fund accounts, that are readily convertible into cash without penalty. Management believes the Company is not exposed to significant credit risk due to the financial position of the depository institution, but will continue to monitor regularly and adjust, if needed, to mitigate risk, including any ongoing or new events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions. The Company has established guidelines regarding diversification of its investments and their maturities, which are designed to maintain principal and maximize liquidity. To date, the Company has not experienced any losses associated with this credit risk and continues to assess that this exposure is not significant. Major Customers The Company entered into agreements with certain limited specialty pharmacies and specialty distributors for the sale of XDEMVY in the U.S. The following table summarizes the percentage of the Company's product sales from each of its largest customers: Year Ended December 31, 2023 Customer A 37 % Customer B 24 % Customer C 14 % Customer D 13 % Customer E 11 % As of December 31, 2023, amounts due from these five customers each exceeded 10% of gross accounts receivable and accounted for approximately 100% of the accounts receivable balance on a combined basis. Major Suppliers The Company does not currently own manufacturing facilities and depends on an outsourced manufacturing strategy for the production of XDEMVY for commercial use and for the production of its other product candidates for clinical trials. The Company entered into agreements with third-party manufacturers that are approved for the commercial production of XDEMVY and third-party suppliers that are approved for XDEMVY's active pharmaceutical ingredient. Although there are potential sources of supply other than the Company's existing manufacturers and suppliers, any new supplier would be required to qualify under applicable regulatory requirements. The loss of certain manufacturers and third-party suppliers could result in a temporary disruption of the Company’s commercialization efforts. |
Revenue Recognition | Revenue Recognition (i) Product Sales, Net The Company recognizes product sales, net of XDEMVY when a customer obtains control of promised goods or services, which occurs at a point in time, typically upon delivery of the Company's product to the customer. The Company records the amount of revenue that reflects the consideration that it expects to receive in exchange for those goods or services. The Company applies the following five-step model in order to determine this amount: (i) identification of the promised goods in the contract; (ii) determination of whether the promised goods are performance obligations, including whether they are capable of being distinct; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue as each performance obligation is satisfied. The Company sells XDEMVY to customers in the U.S., which became available for commercial sale during the third quarter of 2023. The Company sells XDEMVY to a limited number of specialty pharmacies and distributors (i.e., its customers) who in turn sell it directly to clinics, hospitals, pharmacies and federal healthcare programs. Revenue from product sales is primarily recognized upon physical delivery of the product (when the customer obtains control of the product), in return for agreed-upon consideration. Shipping and handling activities are considered to be fulfillment activities rather than a separate performance obligation and are recorded within selling, general and administrative expenses in the accompanying Statements of Operations and Comprehensive Loss. Revenues from product sales are recorded at the net sales price, or the transaction price, which may include fixed or variable consideration for (i) invoice discounts for prompt payment and distribution service fees, (ii) government and private payer rebates, chargebacks, discounts and fees, (iii) product returns and (iv) costs of co-pay assistance programs for patients, as well as other incentives. Estimates of variable consideration are calculated based on the actual product sales each reporting period and the nature of the variable consideration related to those sales. Where appropriate, the Company utilizes the expected value method to determine the appropriate amount for estimates of variable consideration based on factors such as the current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. The amount of variable consideration that is included in the transaction price may be constrained and is included in product sales, net only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. These estimates reflect the Company’s best estimate of the amount of consideration to which the Company expects to be entitled based on the terms of the contract. Actual amounts of consideration ultimately received may differ materially from estimates. If actual results in the future vary from estimates, the Company will adjust these estimates, which would affect product sales, net and earnings in the period such variances are adjusted. The Company categorizes product sales deduction estimates as follows: Distribution Service Fees: The Company engages with wholesalers and specialty pharmacies to distribute its products to end customers. The Company pays the wholesalers and certain specialty pharmacies a fee for services such as: inventory management, chargeback administration, and service level commitments. The Company estimates the amount of distribution services fees to be paid to the customers and adjusts the transaction price with the amount of such estimate at the time of sale to the customer. An accrued liability is recorded for unpaid distribution service fees. Prompt Pay Discounts: The Company provides its customers with a percentage discount on their invoice if the customers pay within the agreed upon timeframe. The Company expects that its customers will earn prompt pay discounts. The Company estimates the probability of customers paying promptly based on the percentage of discount outlined in the purchase agreement between the two parties, and deducts the full amount of these discounts from gross product sales and accounts receivable at the time revenue is recognized. Product Returns: The Company's customers are contractually permitted to return the product within the contractual allowable time before and after the applicable expiration date. In the initial sales period, the Company estimates its provision for returns based on industry data and adjusts the transaction price at the time of the product sale to the customer. Once sufficient history has been collected for product returns, the Company will utilize that history to inform its returns estimate. Once the product is returned, it is destroyed since it cannot be resold. Chargebacks: A chargeback is the difference between the Company's invoice price to the wholesaler and the wholesaler’s customer's contract price. The wholesaler tracks these sales and charges back the Company for the difference between the negotiated prices paid between the wholesaler's customers and wholesaler's acquisition cost. The Company estimates the percentage of goods sold that are eligible for chargeback and adjusts the transaction price and accounts receivable at the time of sale of the product to the customer. Co-payment Assistance: Patients who meet certain eligibility requirements may receive co-payment assistance. The Company records contra-revenue for co-payment assistance based on actual program participation and estimates of program redemption using data provided by third-party administrators. An accrued liability is recorded on unredeemed co-payment assistance related to products for which control has been transferred to the customer. Rebates and Discounts: The Company accrues rebates for contractually agreed-upon discounts with commercial insurance companies and mandated discounts under government programs such as the Medicaid Drug Rebate Program, Medicare Part D Prescription Drug Program, and other government health care programs in the U.S. The Company's estimates for expected utilization of commercial insurance rebates are based on data received from its customers. The Company's estimates for rebates under government programs are based on statutory discount rates and expected utilization as well as historical data it has accumulated since product launch. The Company’s rebate calculations may require estimates, including estimates of customer mix, to determine which product sales will be subject to rebates and the amount of such rebates. The Company updates its estimates and assumptions on a quarterly basis and records any necessary adjustments to revenue in the period identified. Rebates are generally invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known prior quarters’ unpaid rebates. If actual rebates vary from estimates, the Company may need to adjust accruals, which would affect product sales, net in the period of adjustment. An accrued liability is recorded for unpaid rebates related to product for which control has transferred to the customer. (ii) License Fees and Collaboration Revenue China Out-License License fees and collaboration revenue in the accompanying Statements of Operations and Comprehensive Loss has historically primarily related to one out-license agreement (the "China Out-License") that allows the third-party licensee to market the Company's TP-03 product candidate (representing functional intellectual property) in the People's Republic of China, Hong Kong, Macau, and Taiwan (the "China territory")— see Note 9 . The accounting and reporting of revenue for out-license arrangements requires significant judgment for: (a) identification of the number of performance obligations within the contract; (b) the contract’s transaction price for allocation (including variable consideration); (c) the stand-alone selling price for each identified performance obligation; and (d) the timing and amount of revenue recognition in each period. The China Out-License was analyzed under GAAP to determine whether the promised goods or services are distinct or must be accounted for as part of a combined performance obligation. In making these assessments, the Company considers factors such as the stage of development of the underlying intellectual property and the capabilities of the customer to develop the intellectual property on their own, and/or whether the required expertise is readily available. If the license is not distinct, the license is combined with other promised goods or services as a combined performance obligation for revenue recognition. The China Out-License arrangement included the following forms of consideration: (i) non-refundable upfront license payment; (ii) equity-based consideration; (iii) sales-based royalties; (iv) sales-based threshold milestones; (v) one-time payments for executing drug supply agreements; (vi) development milestone payments; and (vii) regulatory milestone payments. Revenue is recognized in proportion to the allocated transaction price when (or as) the respective performance obligation is satisfied. The Company evaluates the progress related to each milestone at each reporting period and, if necessary, adjusts the probability of achievement and related revenue recognition. The measure of progress, and thereby periods over which revenue is recognized, is subject to estimates by management and may change over the course of the agreement. Contractual Terms for Receipt of Payments A performance obligation is a promise in a contract to transfer a distinct good or service and is the unit of accounting. A contract’s transaction price is allocated among each distinct performance obligation based on relative standalone selling price and recognized when, or as, the applicable performance obligation is satisfied. The contractual terms that establish the Company’s right to collect specified amounts from its customers and that require contemporaneous evaluation and documentation under GAAP for the corresponding timing and amount of revenue recognition, are as follows: Upfront License Fees: The Company determines whether non-refundable license fee consideration is recognized at the time of contract execution (i.e., when the license is transferred to the customer and the customer is able to use and benefit from the license) or over the actual (or implied) contractual period of the China Out-License. The Company also evaluates whether it has any other requirements to provide substantive services that are inseparable from the performance obligation of the license transfer to determine whether any combined performance obligation is satisfied over time or at a point in time. Upfront payments may require deferral of revenue recognition to a future period until the Company performs obligations under these arrangements. Development Milestones: The Company utilizes the most likely amount method to estimate the amount of consideration to which it will be entitled for achievement of development milestones as these represent variable consideration. For those payments based on development milestones (e.g., patient dosing in a clinical study or the achievement of statistically significant clinical results), the Company assesses the probability that the milestone will be achieved, including its ability to control the timing or likelihood of achievement, and any associated revenue constraint. Given the high degree of uncertainty around the occurrence of these events, the Company determines the milestone and other contingent amounts to be constrained until the uncertainty associated with these payments is resolved. At each reporting period, the Company re-evaluates this associated revenue recognition constraint. Any resulting adjustments are recorded to revenue on a cumulative catch-up basis, and reflected in the financial statements in the period of adjustment. Regulatory Milestones: The Company utilizes the most likely amount method to estimate the consideration to which it will be entitled and recognizes revenue in the period regulatory approval occurs (the performance obligation is satisfied) as these represent variable consideration. Amounts constrained as variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company evaluates whether the milestones are considered probable of being reached and not otherwise constrained. Accordingly, due to the inherent uncertainty of achieving regulatory approval, associated milestones are deemed constrained for revenue recognition until achievement. Royalties: Under the sales-or-usage-based royalty exception the Company recognizes revenue based on the contractual percentage of the licensee’s sale of products to its customers at the later of (i) the occurrence of the related product sales or (ii) the date upon which the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue from the China Out-License. Sales Threshold Milestones: Similar to royalties, applying the sales-or-usage-based royalty exception, the Company recognizes revenue from sales threshold milestones at the later of (i) the period the licensee achieves the one-time annual product sales levels in their territories for which the Company is contractually entitled to a specified lump-sum receipt, or (ii) the date upon which the performance obligation to which some or all of the milestone has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any sales threshold milestone revenue from the China Out-License. The Company re-evaluates the measure of progress to each performance obligation in each reporting period as uncertain events are resolved and other changes in circumstances occur. Other License Fees and Collaboration Revenue License fees and collaboration revenue also includes revenue recognized from satisfaction of performance obligations under an existing clinical supply agreement. The Company recognizes revenue when a customer obtains control of the promised good or service. Revenue recognized under this arrangement for the year ended December 31, 2023 was $0.2 million. No revenue was recognized under this arrangement for the year ended December 31, 2022. Cost of Sales Cost of sales consists of direct and indirect costs related to the manufacturing and distribution of XDEMVY, including raw materials, third-party manufacturing costs, packaging services, freight, third-party royalties payable on the Company’s product sales, net and amortization of capitalized intangible assets associated with XDEMVY. Cost of sales may also include period costs related to certain inventory warehouse and distribution operations and inventory adjustment charges. The Company began capitalizing inventory costs upon FDA approval of XDEMVY in July 2023. Prior to FDA approval of XDEMVY, manufacturing and other inventory costs were recorded to research and development expenses in the Statements of Operations and Comprehensive Loss. Therefore, cost of sales of XDEMVY will reflect a lower average per unit cost until the related inventory is sold. |
Selling, General and Administrative | Selling, General and Administrative |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred or as certain upfront or milestone payments become contractually due to licensors upon the achievement of clinical or regulatory events. Research and development expenses include internal costs directly attributable to in-development programs, including the costs of salaries, payroll taxes, employee benefit and other employee-related costs (including stock-based compensation expense), license fees, materials, supplies, and the cost of services provided by outside contractors to conduct nonclinical studies, clinical trials and contract manufacturing activities. All costs associated with research and development are expensed as incurred. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with third-party service providers under the service agreements. As it relates to clinical trials, the financial terms of these contracts are subject to negotiations which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. Payments made prior to the receipt of goods or services to be used in research and development are capitalized until the goods or services are received. Such payments are evaluated for current or long-term classification based on when they will be realized. The Company's objective is to reflect the appropriate expense in its financial statements by matching those expenses with the period in which the services and efforts are expended. The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial taking into consideration discussions with applicable personnel and outside service providers. The clinical trial accrual is dependent in part upon the timely and accurate reporting of progress and efforts incurred from CROs, contract manufacturers and other third-party vendors. Although estimates are expected to be materially consistent with actual amounts incurred, the Company's understanding of the status and timing of services performed relative to the actual status and timing of services performed can vary and may result in changes in estimates in any particular period. The Company makes significant judgments and estimates in determining the accrued liabilities balance at each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. To date, there have been no material differences between estimates of such expenses and the amounts actually incurred. The Company has entered into, and may continue to enter into, license agreements to access and utilize certain technology. In each case, the Company evaluates if the license agreement results in the acquisition of an asset or a business. To date, none of the Company's license agreements have been considered an acquisition of a business. For asset acquisitions, the upfront payments to acquire such licenses, as well as any future milestone payments made before product approval that do not meet the definition of a derivative, are immediately recognized as research and development expense in the Statements of Operations and Comprehensive Loss when paid or become payable, provided there is no alternative future use of rights in other research and development projects. |
Stock-Based Compensation | Stock-Based Compensation The Company recognizes stock-based compensation expense for equity awards granted to employees, consultants, and members of its Board of Directors. Stock option awards are at an exercise price of not less than 100% of the fair market value of common stock on the respective date of grant. The grant date is the date the terms of the award are formally approved by the Company’s Board of Directors or its designee. The Company uses the Black-Scholes option pricing model to estimate the fair value of stock option awards as of the date of grant. The fair value of restricted stock units is representative of the closing market price of the Company's common stock on the date preceding the award grant-date. Stock awards granted typically have one method, if and when it concludes that it is highly probable that the performance condition will be achieved. At each reporting period, the Company reassesses the probability of the achievement of the performance vesting conditions. As applicable, the Company reverses previously recognized expense for unvested awards in the same period of forfeiture. The measurement of the fair value of stock option awards and recognition of stock-based compensation expense requires assumptions to be estimated by management that involve inherent uncertainties and the application of management’s judgment, including (a) the fair value of the Company’s common stock on the date of the option grant for all awards granted prior to the IPO, (b) the expected term of the stock option until its exercise by the recipient, (c) stock price volatility over the expected term, (d) the prevailing risk-free interest rate over the expected term, and (e) expected dividend payments over the expected term. All stock-based compensation expense is reported in the accompanying Statements of Operations and Comprehensive Loss within cost of sales, research and development expense or selling, general and administrative expense, based upon the assigned department of the award recipient. The measurement of the fair value of stock option awards and recognition of stock-based compensation expense requires assumptions to be estimated by management that involve inherent uncertainties and the application of management’s judgment, including: Fair Value of Common Stock — The fair value of the Company’s common stock is based on the closing quoted market price of its common stock as reported by the Nasdaq Global Select Market on the date of the option grant. Expected Term — The Company’s expected term represents the period that the Company’s stock option awards are expected to be outstanding. Management estimates the expected term of awarded stock options utilizing the simplified method (based on the mid-point between the vesting date and the end of the contractual term) to determine the expected term since the Company does not yet have sufficient exercise history. Expected Volatility — Prior to 2023, the Company did not have sufficient trading history for its common stock to use its own historical volatility. Management estimated the expected volatility based on a designated peer-group of publicly-traded companies for a look-back period (from the date of grant) that corresponded with the expected term of the awarded stock option. Beginning in January 2023, the Company began using its own historical stock price for expected volatility. Risk-Free Interest Rate — The Company estimates the risk-free interest rate based upon the U.S. Department of Treasury yield curve in effect at award grant date for the time period that corresponds with the expected term of the awarded stock option. Dividend Yield |
Income Taxes | Income Taxes Income taxes are accounted for using the asset and liability method. Deferred tax assets and liabilities are recorded based on the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the financial statements, as well as operating losses and tax credit carry forwards using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period of enactment. Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain due to the Company’s historical operating performance and recorded cumulative net losses in prior fiscal periods. A valuation allowance is recorded to reduce deferred tax assets, because based upon a weighting of positive and negative factors, it is more likely than not that these deferred tax assets will not be realized. If/when the Company were to determine that deferred tax assets are realizable, an adjustment to the corresponding valuation allowance would increase the net income in the period that such determination was made. The Company’s income tax returns are based on calculations and assumptions that are subject to examination by the Internal Revenue Service and other tax authorities. In addition, the calculation of the Company’s tax liabilities involves dealing with uncertainties in the application of complex tax regulations. The Company recognizes liabilities for uncertain tax positions based on a two-step process. The first step is to evaluate the tax position for recognition by determining if the weight of available evidence indicates that it is more likely than not that the position will be sustained on audit, including resolution of related appeals or litigation processes, if any. The second step is to measure the tax benefit as the largest amount that is more than 50% likely of being realized upon settlement. While the Company believes it has appropriate support for the positions taken on its tax returns, the Company regularly assesses the potential outcomes of examinations by tax authorities in determining the adequacy of its provision for income taxes. The Company continually assesses the likelihood and amount of potential revisions and adjusts the income tax provision, income taxes payable and deferred taxes in the period in which the facts that give rise to a revision become known. Interest and penalties related to unrecognized tax benefits, if any, are recorded as a component of income tax expense. |
Net Loss per Share | Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of shares of common stock outstanding for the period, without consideration for potential dilutive shares of common stock. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common stock equivalents outstanding for the period determined using the treasury-stock method and if-converted method as applicable. Due to net losses in all periods presented, all otherwise potentially dilutive securities are antidilutive, and accordingly, the reported basic net loss per share equals diluted net loss per share. |
Comprehensive Loss | Comprehensive Loss |
Recently Issued or Effective Accounting Standards | Recently Issued or Effective Accounting Standards Recently issued or effective accounting pronouncements that impact, or may have an impact, on the Company’s financial statements have been discussed within the footnote to which each relates. Other recent accounting pronouncements not disclosed in these Financial Statements have been determined by the Company’s management to have no impact, or an immaterial impact, on its current financial position, results of operations, or cash flows. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies and Use of Estimates (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Expected Future Amortization Expense | As of December 31, 2023, the expected future amortization expense for the Company's intangible assets is as follows: Amounts 2024 $ 400 2025 400 2026 400 2027 400 2028 400 Thereafter 1,867 Total future amortization $ 3,867 |
Product Sales from Each of our Largest Customers | The following table summarizes the percentage of the Company's product sales from each of its largest customers: Year Ended December 31, 2023 Customer A 37 % Customer B 24 % Customer C 14 % Customer D 13 % Customer E 11 % |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Financial instruments measured at fair value | Financial assets and liabilities subject to fair value measurements on a recurring basis and the level of inputs used in such measurements by major security type are presented in the following table: Year Ended December 31, 2023 Fair Value Measurements Level 1 Level 2 Level 3 Total Assets: Money market funds (1) $ 224,947 $ — $ — $ 224,947 Government-related debt securities — 2,495 — 2,495 Common stock in LianBio 631 — — 631 Equity warrants (for LianBio shares) — — 225 225 Total assets measured at fair value $ 225,578 $ 2,495 $ 225 $ 228,298 (1) This balance includes cash requirements settled on a nightly basis. Year Ended December 31, 2022 Fair Value Measurements Level 1 Level 2 Level 3 Total Assets: Money market funds (1) $ 64,685 $ — $ — $ 64,685 U.S. Treasury securities 69,644 — — 69,644 Commercial paper — 60,355 — 60,355 Corporate debt securities — 11,521 — 11,521 Government-related debt securities — 10,821 — 10,821 Common stock in LianBio 371 — — 371 Equity warrants (for LianBio shares) — — 108 108 Total assets measured at fair value $ 134,700 $ 82,697 $ 108 $ 217,505 (1) This balance includes cash requirements settled on a nightly basis. |
Changes in fair value of derivative asset | Value of equity warrants Fair value as of December 31, 2022 $ 108 Remeasurement of equity warrants 117 Fair value as of December 31, 2023 $ 225 Value of equity warrants Fair value as of December 31, 2021 $ 663 Remeasurement of equity warrants (501) Recognition of equity warrants 103 Exercise of the second tranche of equity warrants into LianBio common stock (157) Fair value as of December 31, 2022 $ 108 |
Summary of estimated value of cash, cash equivalents, marketable securities, and equity securities | The fair value and amortized cost of cash equivalents and available-for-sale investments by major security type are presented in the following table: December 31, 2023 Amortized cost Unrealized gains Unrealized losses Estimated fair value Cash equivalents: Money market funds (1) $ 224,947 $ — $ — $ 224,947 Total cash equivalents $ 224,947 $ — $ — $ 224,947 Marketable securities: Government-related securities $ 2,496 $ — $ (1) $ 2,495 Total marketable securities $ 2,496 $ — $ (1) $ 2,495 Long-term investments: Common stock in LianBio $ 1,108 $ — $ (477) $ 631 Total long-term investments $ 1,108 $ — $ (477) $ 631 (1) This balance includes cash requirements settled on a nightly basis. December 31, 2022 Amortized cost Unrealized gains Unrealized losses Estimated fair value Cash equivalents: Money market funds (1) $ 64,685 $ — $ — $ 64,685 Government-related securities 4,978 — — 4,978 Commercial paper 1,997 — — 1,997 Total cash equivalents $ 71,660 $ — $ — $ 71,660 Marketable securities: U.S. Treasury securities $ 69,720 $ 5 $ (81) $ 69,644 Commercial paper 58,358 — — 58,358 Corporate debt securities 11,524 8 (11) 11,521 Government-related securities 5,838 5 — 5,843 Total marketable securities $ 145,440 $ 18 $ (92) $ 145,366 Long-term investments: Common stock in LianBio $ 1,231 $ — $ (860) $ 371 Total long-term investments $ 1,231 $ — $ (860) $ 371 (1) This balance includes cash requirements settled on a nightly basis. |
Balance Sheet Account Detail (T
Balance Sheet Account Detail (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Inventory | Inventory consists of the following: December 31, 2023 Raw materials $ 2,533 Work in progress 392 Finished goods 182 Inventory $ 3,107 |
Property and equipment, net | Property and equipment, net consists of the following: December 31, 2023 2022 Furniture and fixtures $ 1,251 $ 714 Office equipment 660 197 Laboratory equipment 167 167 Leasehold improvements 680 425 Property and equipment, at cost 2,758 1,503 (Less): Accumulated depreciation and amortization (1,290) (546) Property and equipment, net $ 1,468 $ 957 |
Accounts payable and accrued liabilities | Accounts payable and other accrued liabilities consists of the following: December 31, 2023 2022 Trade accounts payable and other $ 18,149 $ 5,498 Accrued product sales deductions 4,867 — Accrued clinical studies 277 3,691 Operating lease liability, current 398 721 Accounts payable and other accrued liabilities $ 23,691 $ 9,910 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Stock details | : December 31, 2023 2022 Common stock awards reserved for future issuance under 2020 and 2016 Equity Incentive Plans 7,054,222 8,346,738 Common stock awards reserved for future issuance under the 2020 Employee Stock Purchase Plan 2,859,434 2,663,319 Stock options issued and outstanding (unvested and vested) under 2020 and 2016 Equity Incentive Plans 4,760,366 3,899,342 Restricted stock units issued and outstanding (unvested) under 2020 Equity Incentive Plan 1,708,725 551,258 Total shares of common stock reserved 16,382,747 15,460,657 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-based compensation | Stock-based compensation expense was recognized in the accompanying Statements of Operations and Comprehensive Loss as follows: Year Ended 2023 2022 Cost of sales $ 190 $ — Research and development 5,833 3,736 Selling, general and administrative 13,807 9,724 Total stock-based compensation $ 19,830 $ 13,460 |
Valuation assumptions of stock options | The fair value of granted stock options was estimated as of the date of grant using the Black-Scholes option-pricing model, based on the following inputs: Year Ended 2023 2022 Exercise price $12.48 to $18.78 $12.89 to $20.64 Expected term (in years) 6.25 6.25 Risk-free interest rate 3.38% to 4.83% 1.63% to 4.21% Weighted average volatility 69.7% to 73.3% 77.3% to 83.0% Dividend yield rate — — Weighted-average grant-date fair value per stock option $ 15.49 $ 18.37 |
Stock option activity | Stock option activity during the years ended December 31, 2023 and 2022 was as follows: Number of Weighted- Weighted- Aggregate Intrinsic Value (1) Outstanding - December 31, 2021 2,759,830 $ 15.88 8.54 $ 33,641 Granted 1,227,123 18.37 Exercised (40,979) 3.01 Forfeited (46,632) 24.60 Expired — — Outstanding - December 31, 2022 3,899,342 16.69 8.07 $ 19,196 Granted 1,173,243 15.49 Exercised (136,310) 4.34 Forfeited (175,909) 20.34 Expired — — Outstanding - December 31, 2023 4,760,366 $ 16.62 7.53 $ 34,128 Vested - December 31, 2023 2,694,380 $ 15.21 6.69 $ 26,371 Unvested - December 31, 2023 2,065,986 $ 18.45 8.63 $ 7,757 ____________ (1) |
Restricted stock unit activity | Restricted stock unit activity during the year ended December 31, 2023 was as follows: Number of Weighted Average Value per Share Outstanding - December 31, 2021 17,251 $ 27.53 Granted 573,009 17.87 Vested (32,914) 24.17 Forfeited (6,088) 19.40 Outstanding - December 31, 2022 551,258 $ 17.78 Granted 1,442,677 15.95 Vested (206,813) 17.87 Forfeited (78,397) 16.02 Outstanding - December 31, 2023 1,708,725 $ 16.31 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net loss per share, basis and diluted | The following table sets forth the computation of basic and diluted net loss per share: Year Ended December 31, 2023 2022 Net loss $ (135,893) $ (62,091) Weighted-average shares—basic and diluted 29,383,276 24,619,700 Net loss per share—basic and diluted $ (4.62) $ (2.52) |
Outstanding potentially dilutive securities | The following outstanding and potentially dilutive securities were excluded from the calculation of diluted net loss per share because their impact under the treasury stock method and if-converted method would have been anti-dilutive for each period presented: Year Ended December 31, 2023 2022 Stock options, unexercised—vested and unvested 4,760,366 3,899,342 Restricted stock units—unvested 1,708,725 551,258 Total 6,469,091 4,450,600 |
Commitments & Contingencies (Ta
Commitments & Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Components of lease cost | The below table summarizes the components of total lease expense: Year Ended December 31, 2023 2022 Operating lease expense $ 705 $ 569 Variable lease expense 391 244 Total lease expense $ 1,096 $ 813 |
Future contractual lease payments | The below table summarizes the (i) minimum lease payments over the next five years and thereafter, (ii) lease arrangement imputed interest, and (iii) present value of future lease payments: December 31, 2023 2024 $ 701 2025 789 2026 816 2027 68 2028 — Total future lease payments, undiscounted $ 2,374 (Less): Imputed interest (332) (Less): Tenant improvement allowance (129) Present value of operating lease payments $ 1,913 Operating lease liability, current 398 Operating lease liability, noncurrent 1,515 Total operating lease liability $ 1,913 |
Credit Facility Agreement (Tabl
Credit Facility Agreement (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Summary of Interest Expense | During the year ended December 31, 2023 and 2022, the Company recognized interest expense on the accompanying Statements of Operations and Comprehensive Loss in connection with the Credit Facility as follows: Year Ended December 31, 2023 2022 Interest expense for term loan $ 2,961 $ 1,890 Accretion of end of term charge 264 174 Amortization of debt issuance costs 121 135 Total interest expense related to term loan $ 3,346 $ 2,199 |
Balances of Credit Facility and Related Accretion and Amortization | The carrying value of the Credit Facility consists of principal outstanding less legal and administrative issuance costs that were recorded as a debt discount to the term loan, net and will continue to be accreted to interest expense using the effective interest method during its term. The principal balance of this Credit Facility and related accretion and amortization are reported on a combined basis as term loan, net on the accompanying Balance Sheets as follows: December 31, 2023 2022 Term loan, gross $ 30,000 $ 20,000 Debt issuance costs (875) (875) Accretion of end of term charge 438 174 Accumulated amortization of debt issuance costs 256 135 Term loan, net $ 29,819 $ 19,434 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Components of loss from operations before provision for income taxes | The components of loss from operations before benefit from income taxes were as follows: Year Ended 2023 2022 United States $ (135,893) $ (62,095) Total $ (135,893) $ (62,095) |
Components of provision for income taxes | The benefit from income taxes from operations were as follows: Year Ended 2023 2022 Current: Federal $ — $ (4) State — — $ — $ (4) Deferred: Federal — — State — — — — Total income tax benefit $ — $ (4) |
Reconciliation of income taxes | A reconciliation of income taxes was computed by applying the federal statutory income tax rate in each period to the pretax loss for the years ended December 31, 2023 and 2022, and adjusted for certain classes of transactions, as summarized below: Year Ended 2023 2022 Expected tax benefit at statutory rate $ (28,537) $ (13,040) State income tax, net of federal benefit (4,403) (212) Permanent items 501 (22) Stock-based compensation 579 606 Executive compensation 1,484 988 Research and development credits (2,878) (1,753) State rate adjustment (1,815) 86 Change in fair value of equity warrants and equity securities (30) 91 Other 12 126 Change in valuation allowance 35,087 13,126 Income tax benefit $ — $ (4) |
Significant components of deferred tax assets and liabilities | Significant components of the deferred tax assets and liabilities were as follows: Year Ended 2023 2022 Deferred tax assets: Net operating loss carry forwards $ 25,881 $ 6,679 Research and development credit carryforwards 7,601 4,723 Capitalized research and development 15,892 7,634 Intangible assets 3,442 2,970 Stock-based compensation 3,747 2,119 Accruals 2,598 1,140 Other, net 1,842 59 Total deferred tax assets before valuation allowance 61,003 25,324 (Less): Valuation allowance (60,270) (25,201) Total deferred tax assets $ 733 $ 123 Deferred tax liabilities, net: Operating lease right-of-use assets (473) (123) Fixed assets (260) — Net deferred tax asset $ — $ — |
Gross unrecognized tax benefits | The following table summarizes the changes to the gross unrecognized tax benefits: Year Ended 2023 2022 Balance at beginning of year $ 3,393 $ 3,045 Additions related to current year positions 468 349 Additions related to prior year positions 67 — Decreases related to prior year positions — (1) Balance at end of year $ 3,928 $ 3,393 |
Description of Business and P_2
Description of Business and Presentation of Financial Statements (Details) $ / shares in Units, $ in Millions | 1 Months Ended | 2 Months Ended | 12 Months Ended | |||||||
Nov. 09, 2023 USD ($) | Sep. 06, 2023 $ / shares shares | Aug. 04, 2023 $ / shares shares | Dec. 31, 2023 USD ($) shares | Aug. 31, 2023 USD ($) | Jun. 30, 2022 $ / shares shares | May 31, 2022 $ / shares shares | Nov. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) $ / shares | Dec. 31, 2023 segment | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||||||
Number of reportable segments | segment | 1 | |||||||||
Number of operating segments | segment | 1 | |||||||||
Follow-On Public Offering | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Stock issued (shares) | shares | 5,714,285 | 289,832 | 5,600,000 | |||||||
Price per share (usd per share) | $ / shares | $ 17.50 | $ 13.50 | $ 13.50 | $ 13.50 | ||||||
Stock issued, net proceeds | $ 99.3 | $ 74.2 | ||||||||
Underwriters' option | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Stock issued (shares) | shares | 355,164 | 857,142 | 840,000 | |||||||
Price per share (usd per share) | $ / shares | $ 17.50 | |||||||||
2021 ATM Prospectus | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Stock issued, authorized amount | $ 100 | |||||||||
2023 Shelf Registration Statement | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Stock issued, authorized amount | $ 300 | |||||||||
2023 ATM Prospectus | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||
Stock issued (shares) | shares | 1,000,000 | |||||||||
Stock issued, net proceeds | $ 19.2 | |||||||||
Stock issued, authorized amount | $ 100 | |||||||||
Percentage of gross proceeds | 3% |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies and Use of Estimates (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Allowance for credit loss | $ 0 | |
Intangible assets, net | 3,867,000 | $ 0 |
Amortization of intangible assets | 133,000 | 0 |
Total revenues | 17,447,000 | $ 25,816,000 |
Advertising expense | $ 9,400,000 | |
Common stock, percentage of fair market value | 100% | |
Expected term | 6 years 3 months | 6 years 3 months |
Expected dividend yield | 0% | 0% |
License And Collaboration, Other | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total revenues | $ 200,000 | $ 0 |
Five Customers | Accounts Receivable | Customer Concentration Risk | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Concentration risk | 100% | |
Intangible Assets, Milestone Payment | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Intangible assets, net | $ 4,000,000 | |
Useful life | 10 years | |
2016 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term | 10 years | |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Estimated useful lives | 3 years | |
Minimum | 2016 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Service condition for full vesting | 1 year | |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Estimated useful lives | 5 years | |
Maximum | 2016 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Service condition for full vesting | 4 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies and Use of Estimates - Expected Future Amortization Expense (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Accounting Policies [Abstract] | |
2024 | $ 400 |
2025 | 400 |
2026 | 400 |
2027 | 400 |
2028 | 400 |
Thereafter | 1,867 |
Total future amortization | $ 3,867 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies and Use of Estimates - Product Sales from Each of our Largest Customers (Details) - Revenue Benchmark - Customer Concentration Risk | 12 Months Ended |
Dec. 31, 2023 | |
Customer A | |
Concentration Risk [Line Items] | |
Concentration risk | 37% |
Customer B | |
Concentration Risk [Line Items] | |
Concentration risk | 24% |
Customer C | |
Concentration Risk [Line Items] | |
Concentration risk | 14% |
Customer D | |
Concentration Risk [Line Items] | |
Concentration risk | 13% |
Customer E | |
Concentration Risk [Line Items] | |
Concentration risk | 11% |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Instruments Measured at Fair Value (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Assets: | ||
Money market funds(1) | $ 224,947 | $ 71,660 |
Corporate debt securities | 2,495 | 145,366 |
Common stock in LianBio | 631 | 371 |
Equity warrants (for LianBio shares) | 225 | 108 |
Total assets measured at fair value | 228,298 | 217,505 |
U.S. Treasury securities | ||
Assets: | ||
Debt securities, available-for sale and cash equivalents | 69,644 | |
Corporate debt securities | 69,644 | |
Commercial paper | ||
Assets: | ||
Money market funds(1) | 1,997 | |
Debt securities, available-for sale and cash equivalents | 60,355 | |
Corporate debt securities | 58,358 | |
Corporate debt securities | ||
Assets: | ||
Corporate debt securities | 11,521 | |
Government-related debt securities | ||
Assets: | ||
Money market funds(1) | 4,978 | |
Debt securities, available-for sale and cash equivalents | 2,495 | 10,821 |
Corporate debt securities | 2,495 | 5,843 |
Money market funds(1) | ||
Assets: | ||
Money market funds(1) | 224,947 | 64,685 |
Level 1 | ||
Assets: | ||
Common stock in LianBio | 631 | 371 |
Equity warrants (for LianBio shares) | 0 | 0 |
Total assets measured at fair value | 225,578 | 134,700 |
Level 1 | U.S. Treasury securities | ||
Assets: | ||
Debt securities, available-for sale and cash equivalents | 69,644 | |
Level 1 | Commercial paper | ||
Assets: | ||
Debt securities, available-for sale and cash equivalents | 0 | |
Level 1 | Corporate debt securities | ||
Assets: | ||
Corporate debt securities | 0 | |
Level 1 | Government-related debt securities | ||
Assets: | ||
Debt securities, available-for sale and cash equivalents | 0 | 0 |
Level 1 | Money market funds(1) | ||
Assets: | ||
Money market funds(1) | 224,947 | 64,685 |
Level 2 | ||
Assets: | ||
Common stock in LianBio | 0 | 0 |
Equity warrants (for LianBio shares) | 0 | 0 |
Total assets measured at fair value | 2,495 | 82,697 |
Level 2 | U.S. Treasury securities | ||
Assets: | ||
Debt securities, available-for sale and cash equivalents | 0 | |
Level 2 | Commercial paper | ||
Assets: | ||
Debt securities, available-for sale and cash equivalents | 60,355 | |
Level 2 | Corporate debt securities | ||
Assets: | ||
Corporate debt securities | 11,521 | |
Level 2 | Government-related debt securities | ||
Assets: | ||
Debt securities, available-for sale and cash equivalents | 2,495 | 10,821 |
Level 2 | Money market funds(1) | ||
Assets: | ||
Money market funds(1) | 0 | 0 |
Level 3 | ||
Assets: | ||
Common stock in LianBio | 0 | 0 |
Equity warrants (for LianBio shares) | 225 | 108 |
Total assets measured at fair value | 225 | 108 |
Level 3 | U.S. Treasury securities | ||
Assets: | ||
Debt securities, available-for sale and cash equivalents | 0 | |
Level 3 | Commercial paper | ||
Assets: | ||
Debt securities, available-for sale and cash equivalents | 0 | |
Level 3 | Corporate debt securities | ||
Assets: | ||
Corporate debt securities | 0 | |
Level 3 | Government-related debt securities | ||
Assets: | ||
Debt securities, available-for sale and cash equivalents | 0 | 0 |
Level 3 | Money market funds(1) | ||
Assets: | ||
Money market funds(1) | $ 0 | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) $ in Millions | 1 Months Ended | ||
Mar. 31, 2021 tranche shares | Dec. 31, 2023 USD ($) security contract warrant | Dec. 31, 2022 contract | |
Debt Securities, Available-for-Sale [Line Items] | |||
Warrant tranches | tranche | 3 | ||
Number of vested warrants | warrant | 2 | ||
Equity securities (shares) | shares | 156,746 | ||
Number of securities with contractual maturity between one and five years | security | 3 | ||
Debt securities contractual maturity between one and five years, fair value | $ 4.6 | ||
Debt securities contractual maturity between one and five years, amortized cost | $ 4.6 | ||
Number of securities in continuous unrealized loss position for less than one year | contract | 1 | 24 | |
Available-for-sale, Contractual Maturity Less Than 12 Months | Minimum | |||
Debt Securities, Available-for-Sale [Line Items] | |||
Contractual maturity | 1 year | ||
Available-for-sale, Contractual Maturity Less Than 12 Months | Maximum | |||
Debt Securities, Available-for-Sale [Line Items] | |||
Contractual maturity | 5 years |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in Fair Value of Warrant (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Fair Value, Asset, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Other (expense) income, net | |
Warrant | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Fair value, beginning of period | $ 108 | $ 663 |
Remeasurement of equity warrants | 117 | (501) |
Recognition of equity warrants | 103 | |
Exercise of equity warrants into LianBio common stock | (157) | |
Fair value, end of period | $ 225 | $ 108 |
Fair Value Measurements - Estim
Fair Value Measurements - Estimated Fair Value of Cash, Cash Equivalents, Marketable Securities, and Equity Securities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Cash equivalents: | ||
Amortized cost | $ 224,947 | $ 71,660 |
Estimated fair value | 224,947 | 71,660 |
Marketable securities: | ||
Amortized cost | 2,496 | 145,440 |
Unrealized gains | 0 | 18 |
Unrealized losses | (1) | (92) |
Estimated fair value | 2,495 | 145,366 |
Long-term investments: | ||
Amortized cost | 1,108 | 1,231 |
Unrealized gains | 0 | 0 |
Unrealized losses | (477) | (860) |
Estimated fair value | 631 | 371 |
Money market funds(1) | ||
Cash equivalents: | ||
Amortized cost | 224,947 | 64,685 |
Estimated fair value | 224,947 | 64,685 |
Government-related debt securities | ||
Cash equivalents: | ||
Amortized cost | 4,978 | |
Estimated fair value | 4,978 | |
Marketable securities: | ||
Amortized cost | 2,496 | 5,838 |
Unrealized gains | 0 | 5 |
Unrealized losses | (1) | 0 |
Estimated fair value | $ 2,495 | 5,843 |
Commercial paper | ||
Cash equivalents: | ||
Amortized cost | 1,997 | |
Estimated fair value | 1,997 | |
Marketable securities: | ||
Amortized cost | 58,358 | |
Unrealized gains | 0 | |
Unrealized losses | 0 | |
Estimated fair value | 58,358 | |
Corporate debt securities | ||
Marketable securities: | ||
Amortized cost | 11,524 | |
Unrealized gains | 8 | |
Unrealized losses | (11) | |
Estimated fair value | 11,521 | |
U.S. Treasury securities | ||
Marketable securities: | ||
Amortized cost | 69,720 | |
Unrealized gains | 5 | |
Unrealized losses | (81) | |
Estimated fair value | $ 69,644 |
Balance Sheet Account Detail -
Balance Sheet Account Detail - Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Raw materials | $ 2,533 | |
Work in progress | 392 | |
Finished goods | 182 | |
Inventory | $ 3,107 | $ 0 |
Balance Sheet Account Detail _2
Balance Sheet Account Detail - Property and Equipment, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | $ 2,758 | $ 1,503 |
(Less): Accumulated depreciation and amortization | (1,290) | (546) |
Property and equipment, net | 1,468 | 957 |
Depreciation | 744 | 325 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 1,251 | 714 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 660 | 197 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 167 | 167 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | $ 680 | $ 425 |
Balance Sheet Account Detail _3
Balance Sheet Account Detail - Accounts Payable and Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Trade accounts payable and other | $ 18,149 | $ 5,498 |
Accrued product sales deductions | 4,867 | 0 |
Accrued clinical studies | 277 | 3,691 |
Operating lease liability, current | $ 398 | $ 721 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accounts payable and other accrued liabilities | Accounts payable and other accrued liabilities |
Accounts payable and other accrued liabilities | $ 23,691 | $ 9,910 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) | 12 Months Ended | ||
Dec. 31, 2023 USD ($) vote $ / shares shares | Dec. 31, 2022 $ / shares shares | Oct. 08, 2020 shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock, issued (shares) | 34,211,190 | 26,727,458 | |
Common stock, outstanding (shares) | 34,211,190 | 26,700,000 | |
Common stock voting rights, number of votes | vote | 1 | ||
Common stock dividends declared (usd per share) | $ / shares | $ 0 | $ 0 | |
Employee stock purchase plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock reserved for issuance, increase percentage | 1% | ||
ESPP discount percentage from market price, beginning of purchase period | 15% | ||
ESPP, maximum number of shares available for purchase by employee (shares) | 3,000 | ||
Offering period | 6 months | ||
ESPP, maximum number of shares available for purchase | $ | $ 25,000 | ||
Common stock reserved for future issuance, annual increase (shares) | 2,500,000 | ||
2020 Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock available for issuance (shares) | 9,000,000 | ||
Common stock reserved for issuance, increase percentage | 4% | ||
2016 Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Common stock available for issuance (shares) | 2,432,980 |
Stockholders' Equity - Shares R
Stockholders' Equity - Shares Reserved for Issuance (Details) - shares | Dec. 31, 2023 | Dec. 31, 2022 |
Equity [Abstract] | ||
Common stock awards reserved for future issuance (shares) | 7,054,222 | 8,346,738 |
Common stock reserved for future issuance under the 2020 Employee Stock Purchase Plan (shares) | 2,859,434 | 2,663,319 |
Stock options issued and outstanding (shares) | 4,760,366 | 3,899,342 |
Restricted stock units outstanding (shares) | 1,708,725 | 551,258 |
Total shares of common stock reserved (shares) | 16,382,747 | 15,460,657 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total grant-date fair value of options that vested during period | $ 26,400 | $ 13,700 |
Stock-based compensation expense | 19,830 | 13,460 |
Unrecognized compensation expense | 22,900 | |
Stock options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 13,000 | |
Unrecognized compensation expense, recognition period | 2 years 1 month 6 days | |
Restricted stock | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 6,500 | |
Unrecognized compensation expense, recognition period | 3 years 2 months 12 days | |
Unrecorded stock-based compensation expense | $ 23,300 | |
Employee stock purchase plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 300 | $ 300 |
Stock-Based Compensation - Expe
Stock-Based Compensation - Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | $ 19,830 | $ 13,460 |
Cost of sales | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | 190 | 0 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | 5,833 | 3,736 |
Selling, general and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | $ 13,807 | $ 9,724 |
Stock-Based Compensation - Valu
Stock-Based Compensation - Valuation Assumptions of Stock Options (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Expected term | 6 years 3 months | 6 years 3 months |
Risk-free interest rate, minimum | 3.38% | 1.63% |
Risk-free interest rate, maximum | 4.83% | 4.21% |
Expected volatility, minimum | 69.70% | 77.30% |
Expected volatility, maximum | 73.30% | 83% |
Expected dividend yield | 0% | 0% |
Weighted-average grant-date fair value per stock option (usd per share) | $ 15.49 | $ 18.37 |
Minimum | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Exercise price (estimated fair value per common share on grant date) (usd per share) | 12.48 | 12.89 |
Maximum | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Exercise price (estimated fair value per common share on grant date) (usd per share) | $ 18.78 | $ 20.64 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Number of Shares | |||
Beginning balance (shares) | 3,899,342 | 2,759,830 | |
Granted (shares) | 1,173,243 | 1,227,123 | |
Exercised (shares) | (136,310) | (40,979) | |
Forfeited (shares) | (175,909) | (46,632) | |
Expired (shares) | 0 | 0 | |
Ending balance (shares) | 4,760,366 | 3,899,342 | 2,759,830 |
Vested (shares) | 2,694,380 | ||
Unvested (shares) | 2,065,986 | ||
Weighted- Average Exercise Price/Share | |||
Beginning balance (usd per share) | $ 16.69 | $ 15.88 | |
Granted (usd per share) | 15.49 | 18.37 | |
Exercised (usd per share) | 4.34 | 3.01 | |
Forfeited (usd per share) | 20.34 | 24.60 | |
Expired (usd per share) | 0 | 0 | |
Ending balance (usd per share) | 16.62 | $ 16.69 | $ 15.88 |
Vested (usd per share) | 15.21 | ||
Unvested (usd per share) | $ 18.45 | ||
Weighted-Average Remaining Contractual Term | |||
Outstanding | 7 years 6 months 10 days | 8 years 25 days | 8 years 6 months 14 days |
Vested | 6 years 8 months 8 days | ||
Unvested | 8 years 7 months 17 days | ||
Aggregate Intrinsic Value (1) | |||
Outstanding | $ 34,128 | $ 19,196 | $ 33,641 |
Vested | 26,371 | ||
Unvested | $ 7,757 |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Unit Activity (Details) - Restricted stock - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Number of Shares | ||
Outstanding, beginning balance (shares) | 551,258 | 17,251 |
Granted (shares) | 1,442,677 | 573,009 |
Vested (shares) | (206,813) | (32,914) |
Forfeited (shares) | (78,397) | (6,088) |
Outstanding, ending balance (shares) | 1,708,725 | 551,258 |
Weighted Average Value per Share | ||
Outstanding, beginning balance (usd per share) | $ 17.78 | $ 27.53 |
Granted (usd per share) | 15.95 | 17.87 |
Vested (usd per share) | 17.87 | 24.17 |
Forfeited (usd per share) | 16.02 | 19.40 |
Outstanding, ending balance (usd per share) | $ 16.31 | $ 17.78 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Earnings Per Share [Abstract] | ||
Net loss | $ (135,893) | $ (62,091) |
Weighted-average common shares outstanding, basic (shares) | 29,383,276 | 24,619,700 |
Weighted-average common shares outstanding, diluted (shares) | 29,383,276 | 24,619,700 |
Net loss per share, basic (in USD per share) | $ (4.62) | $ (2.52) |
Net loss per share, diluted (in USD per share) | $ (4.62) | $ (2.52) |
Net Loss Per Share - Outstandin
Net Loss Per Share - Outstanding Potentially Dilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 6,469,091 | 4,450,600,000 |
Stock options, unexercised—vested and unvested | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 4,760,366 | 3,899,342,000 |
Restricted stock units—unvested | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total | 1,708,725 | 551,258,000 |
Commitments & Contingencies - F
Commitments & Contingencies - Facility Leases (Details) | Dec. 31, 2023 contract |
Commitments and Contingencies Disclosure [Abstract] | |
Number of leases | 5 |
Weighted average remaining lease term | 3 years 1 month 6 days |
Estimated incremental borrowing rate | 10% |
Commitment and Contingencies -
Commitment and Contingencies - Components of Lease Cost (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating lease expense | $ 705 | $ 569 |
Variable lease expense | 391 | 244 |
Total lease expense | $ 1,096 | $ 813 |
Commitments & Contingencies -_2
Commitments & Contingencies - Future Contractual Lease Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Commitments and Contingencies Disclosure [Abstract] | ||
2024 | $ 701 | |
2025 | 789 | |
2026 | 816 | |
2027 | 68 | |
2028 | 0 | |
Total future lease payments, undiscounted | 2,374 | |
(Less): Imputed interest | (332) | |
(Less): Tenant improvement allowance | (129) | |
Total operating lease liability | 1,913 | |
Operating lease liability, current | 398 | $ 721 |
Operating lease liability, noncurrent | $ 1,515 | |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other long-term liabilities | Other long-term liabilities |
Commitments & Contingencies - I
Commitments & Contingencies - In-License Agreements for Lotilaner (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | 31 Months Ended | ||||
Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Sep. 30, 2020 USD ($) $ / shares shares | Jan. 31, 2019 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2023 USD ($) arrangement | Dec. 31, 2022 USD ($) | Mar. 31, 2023 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Research and development | $ 50,312 | $ 42,624 | ||||||
Number of employment arrangements with executive officers | arrangement | 7 | |||||||
Intangible Assets, Milestone Payment | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Useful life | 10 years | |||||||
License agreement | Elanco | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Upfront payment | $ 1,000 | |||||||
Research and development | $ 400 | |||||||
Maximum milestone payments | $ 75,000 | |||||||
Common stock issued for license agreement (shares) | shares | 222,460 | |||||||
Common stock issued for license agreement, value | $ 3,100 | |||||||
Common stock issued for license agreement, share price (usd per share) | $ / shares | $ 14.0003 | |||||||
Future payments | 2,000 | |||||||
Royalty expense | 700 | |||||||
License agreement | Clinical milestones | Elanco | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Milestone payment | $ 1,000 | $ 500 | $ 4,000 | |||||
Maximum milestone payments | 4,000 | |||||||
License agreement | Commercial and sales milestones | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Maximum milestone payments | 77,000 | |||||||
License agreement | Commercial and sales milestones | Elanco | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Milestone payment | $ 4,000 |
Out-License Agreement (Details)
Out-License Agreement (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | 33 Months Ended | ||||
Mar. 26, 2021 | Feb. 28, 2023 | Mar. 31, 2021 | Dec. 31, 2022 | Jun. 30, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Amortized cost | $ 1,231 | $ 1,108 | $ 1,231 | $ 1,108 | ||||
Research and development | 50,312 | 42,624 | ||||||
License agreement | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Additional fixed shares of common stock (shares) | 187,500 | |||||||
Additional shares to be issued, value | $ 5,500 | |||||||
Additional shares to be issued (usd per share) | $ 29.30 | |||||||
LianBo | License agreement | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Upfront cash payment | $ 15,000 | |||||||
Cash milestone payment | 10,000 | |||||||
Amortized cost | 1,200 | |||||||
Revenue | 82,500 | |||||||
Upfront payment | $ 15,000 | 10,000 | $ 25,000 | |||||
Research and development | 0 | $ 1,000 | ||||||
LianBo | License agreement | Sales milestone | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Maximum milestone payments | 100,000 | 100,000 | ||||||
LianBo | License agreement | Milestone Determined by the Company | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Variable milestone payment | $ 10,000 | |||||||
LianBo | License agreement | Development and Regulatory Milestone | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Variable milestone payment | 67,500 | 67,500 | ||||||
Revenue | $ 2,500 | |||||||
Maximum milestone payments | 22,500 | 22,500 | ||||||
Elanco | License agreement | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Upfront payment | $ 2,500 | |||||||
Maximum milestone payments | $ 75,000 | $ 75,000 | ||||||
Research and development | $ 400 |
Credit Facility Agreement (Deta
Credit Facility Agreement (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||||
Dec. 31, 2023 | Sep. 15, 2023 | Mar. 15, 2023 | Feb. 02, 2022 | Dec. 31, 2023 | Jan. 05, 2023 | Dec. 31, 2022 | |
Debt Instrument [Line Items] | |||||||
Term loan, gross | $ 30,000 | $ 30,000 | $ 20,000 | ||||
Debt issuance costs | 875 | 875 | $ 875 | ||||
Line of Credit | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, aggregate principal amount | $ 125,000 | 125,000 | |||||
Draw on credit facility | $ 5,000 | $ 5,000 | $ 20,000 | ||||
Increments to draw on credit facility at company's election | $ 5,000 | ||||||
Interest rate | 8.45% | ||||||
Interest rate | 8.50% | 3.25% | |||||
End of term charge | 1,400 | ||||||
End of term charge, interest rate | 4.75% | ||||||
Term loan, gross | $ 30,000 | $ 30,000 | |||||
Debt instrument, effective interest rate | 11.96% | 11.96% | 13.61% | ||||
Line of Credit | Prime Rate | |||||||
Debt Instrument [Line Items] | |||||||
Variable rate | 4.45% | ||||||
Line of Credit | Prime Rate | Maximum | |||||||
Debt Instrument [Line Items] | |||||||
Variable rate | 11.45% | ||||||
Line of Credit | Credit Facility, Tranche One | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, aggregate principal amount | $ 15,000 | $ 15,000 | $ 25,000 | ||||
Line of Credit | Credit Facility, Tranche Two | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, aggregate principal amount | 35,000 | 35,000 | |||||
Line of Credit | Credit Facility, Tranche Three | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, aggregate principal amount | 50,000 | 50,000 | |||||
Line of Credit | Credit Facility, Tranche Four | |||||||
Debt Instrument [Line Items] | |||||||
Credit facility, aggregate principal amount | $ 25,000 | $ 25,000 | |||||
Line of Credit | Credit Facility, First Amendment, Tranche One | |||||||
Debt Instrument [Line Items] | |||||||
Increments to draw on credit facility at company's election | 5,000 | ||||||
Line of Credit | Credit Facility, First Amendment, Tranche Two | |||||||
Debt Instrument [Line Items] | |||||||
Increments to draw on credit facility at company's election | $ 5,000 | ||||||
Line of Credit | Credit Facility, Silicon Valley Bank Commitment | |||||||
Debt Instrument [Line Items] | |||||||
Draw on credit facility | $ 1,250 | $ 1,250 |
Credit Facility Agreement - Sum
Credit Facility Agreement - Summary of Interest Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Debt Disclosure [Abstract] | ||
Interest expense for term loan | $ 2,961 | $ 1,890 |
Accretion of end of term charge | 264 | 174 |
Amortization of debt issuance costs | 121 | 135 |
Total interest expense related to term loan | $ 3,346 | $ 2,199 |
Credit Facility Agreement - Bal
Credit Facility Agreement - Balances of Credit Facility and Related Accretion and Amortization (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
Term loan, gross | $ 30,000 | $ 20,000 |
Debt issuance costs | (875) | (875) |
Accretion of end of term charge | 438 | 174 |
Accumulated amortization of debt issuance costs | 256 | 135 |
Term loan, net | $ 29,819 | $ 19,434 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | |
Related Party Transaction [Line Items] | |||
Granted (shares) | 1,173,243 | 1,227,123 | |
Granted (usd per share) | $ 15.49 | $ 18.37 | |
Selling, general and administrative | $ 108,700 | $ 44,949 | |
Director | |||
Related Party Transaction [Line Items] | |||
Annual cash compensation | $ 200 | ||
Granted (shares) | 45,134 | ||
Termination period | 10 days | ||
Selling, general and administrative | $ 300 | 300 | |
Director | Minimum | |||
Related Party Transaction [Line Items] | |||
Granted (usd per share) | $ 2.01 | ||
Director | Maximum | |||
Related Party Transaction [Line Items] | |||
Granted (usd per share) | $ 34.72 | ||
Related Party | |||
Related Party Transaction [Line Items] | |||
Selling, general and administrative | $ 400 |
Income Taxes - Components of Lo
Income Taxes - Components of Loss from Operations Before Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
United States | $ (135,893) | $ (62,095) |
Loss before income taxes | $ (135,893) | $ (62,095) |
Income Taxes - Components of Pr
Income Taxes - Components of Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Current: | ||
Federal | $ 0 | $ (4) |
State | 0 | 0 |
Current Income Tax Expense (Benefit) | 0 | (4) |
Deferred: | ||
Federal | 0 | 0 |
State | 0 | 0 |
Deferred Income Tax Expense (Benefit) | 0 | 0 |
Income tax benefit | $ 0 | $ (4) |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Expected tax benefit at statutory rate | $ (28,537) | $ (13,040) |
State income tax, net of federal benefit | (4,403) | (212) |
Permanent items | 501 | (22) |
Stock-based compensation | 579 | 606 |
Executive compensation | 1,484 | 988 |
Research and development credits | (2,878) | (1,753) |
State rate adjustment | (1,815) | 86 |
Change in fair value of equity warrants and equity securities | (30) | 91 |
Other | 12 | 126 |
Change in valuation allowance | 35,087 | 13,126 |
Income tax benefit | $ 0 | $ (4) |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carry forwards | $ 25,881 | $ 6,679 |
Research and development credit carryforwards | 7,601 | 4,723 |
Capitalized research and development | 15,892 | 7,634 |
Intangible assets | 3,442 | 2,970 |
Stock-based compensation | 3,747 | 2,119 |
Accruals | 2,598 | 1,140 |
Other, net | 1,842 | 59 |
Total deferred tax assets before valuation allowance | 61,003 | 25,324 |
(Less): Valuation allowance | (60,270) | (25,201) |
Total deferred tax assets | 733 | 123 |
Deferred tax liabilities, net: | ||
Operating lease right-of-use assets | (473) | (123) |
Fixed assets | (260) | 0 |
Net deferred tax asset | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Operating Loss Carryforwards [Line Items] | |||
Valuation allowance on deferred tax assets | $ 60,270,000 | $ 25,201,000 | |
Net operating loss carryforwards | 107,800,000 | ||
Unrecognized tax benefits | 3,928,000 | 3,393,000 | $ 3,045,000 |
Unrecognized tax benefits that would affect effective tax rate if recognized | 0 | ||
Interest or penalties | 0 | $ 0 | |
Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 107,800,000 | ||
California | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards | 84,000,000 | ||
Research and development tax credit carryforwards | Federal | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carryforwards | 7,400,000 | ||
Research and development tax credit carryforwards | California | |||
Operating Loss Carryforwards [Line Items] | |||
Tax credit carryforwards | $ 2,400,000 |
Income Taxes - Gross Unrecogniz
Income Taxes - Gross Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2021 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at beginning of year | $ 3,393 | |
Additions related to current year positions | 468 | $ 349 |
Additions related to prior year positions | 67 | 0 |
Decreases related to prior year positions | 0 | (1) |
Balance at end of year | $ 3,928 | $ 3,045 |