Cover Page
Cover Page - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Feb. 22, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Entity Central Index Key | 0001576263 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Current Fiscal Year End Date | --12-31 | ||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Transition Report | false | ||
Entity File Number | 001-35921 | ||
Entity Registrant Name | MIRATI THERAPEUTICS, INC. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 46-2693615 | ||
Entity Address, Address Line One | 3545 Cray Court, | ||
Entity Address, City or Town | San Diego, | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92121 | ||
City Area Code | 858 | ||
Local Phone Number | 332-3410 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | MRTX | ||
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 | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 3,700,000,000 | ||
Entity Common Stock, Shares Outstanding | 58,037,830 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Audit Information [Abstract] | |
Auditor Name | Ernst & Young LLP |
Auditor Location | San Diego, California |
Auditor Firm ID | 42 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets | ||
Cash and cash equivalents | $ 235,260,000 | $ 413,083,000 |
Short-term investments | 848,577,000 | 1,078,257,000 |
Accounts receivable, net | 865,000 | 0 |
Inventory | 3,020,000 | 0 |
Other current assets | 21,239,000 | 16,643,000 |
Total current assets | 1,108,961,000 | 1,507,983,000 |
Property and equipment, net | 17,540,000 | 15,824,000 |
Intangible asset, net | 14,914,000 | 0 |
Long-term investment | 3,465,000 | 8,218,000 |
Right-of-use asset | 36,122,000 | 37,700,000 |
Other long-term assets | 21,645,000 | 19,049,000 |
Total assets | 1,202,647,000 | 1,588,754,000 |
Current liabilities | ||
Accounts payable | 38,861,000 | 35,163,000 |
Accrued liabilities | 120,587,000 | 108,495,000 |
Total current liabilities | 159,448,000 | 143,658,000 |
Lease liability | 43,661,000 | |
Other liabilities | 3,022,000 | 2,179,000 |
Total liabilities | 206,131,000 | 191,716,000 |
Commitments and contingencies (see Note 15) | ||
Shareholders’ equity | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized; none issued and outstanding at both December 31, 2022 and 2021 | 0 | 0 |
Common stock, $0.001 par value; 100,000,000 authorized; 57,854,559 and 55,356,904 issued and outstanding at December 31, 2022 and 2021, respectively | 58,000 | 55,000 |
Additional paid-in capital | 3,453,066,000 | 3,099,937,000 |
Accumulated other comprehensive (loss) income | (3,719,000) | 9,068,000 |
Accumulated deficit | (2,452,889,000) | (1,712,022,000) |
Total shareholders’ equity | 996,516,000 | 1,397,038,000 |
Total liabilities and shareholders’ equity | $ 1,202,647,000 | $ 1,588,754,000 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (USD per share) | $ 0.001 | $ 0.001 |
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) | $ 0.001 | $ 0.001 |
Common stock authorized (shares) | 100,000,000 | 100,000,000 |
Common stock issued (shares) | 57,854,559 | 55,356,904 |
Common stock outstanding (shares) | 57,854,559 | 55,356,904 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Total revenue | $ 12,436 | $ 72,092 | $ 13,398 |
Revenue | |||
Total revenue | 12,436 | 72,092 | 13,398 |
Operating expenses | |||
Cost of product revenue | 600 | 0 | 0 |
Research and development | 531,627 | 508,594 | 299,349 |
Selling, general and administrative | 239,798 | 136,679 | 83,412 |
Total operating expenses | 772,025 | 645,273 | 382,761 |
Loss from operations | (759,589) | (573,181) | (369,363) |
Other income (expense), net | 19,230 | (5,304) | 11,426 |
Net loss before tax | (740,359) | (578,485) | (357,937) |
Income tax expense | 508 | 3,299 | 0 |
Net loss | (740,867) | (581,784) | (357,937) |
Foreign currency translation adjustment | (9,563) | 0 | 0 |
Unrealized loss on available-for-sale investments | 3,224 | 691 | 130 |
Comprehensive loss | $ (753,654) | $ (582,475) | $ (358,067) |
Basic net loss per share (USD per share) | $ (13.18) | $ (11.21) | $ (7.96) |
Diluted net loss per share (USD per share) | $ (13.18) | $ (11.21) | $ (7.96) |
Weighted average common shares outstanding, basic (shares) | 56,232,249 | 51,882,538 | 44,987,555 |
Weighted average common shares outstanding, diluted (shares) | 56,232,249 | 51,882,538 | 44,987,555 |
Product revenue, net | |||
Total revenue | $ 713 | $ 0 | $ 0 |
Revenue | |||
Total revenue | 713 | 0 | 0 |
License and collaboration revenues | |||
Total revenue | 11,723 | 72,092 | 13,398 |
Revenue | |||
Total revenue | $ 11,723 | $ 72,092 | $ 13,398 |
CONSOLIDATED STATEMENTS OF CHAN
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional paid-in capital | Accumulated other comprehensive income (loss) | Accumulated deficit |
Balance at beginning of period (shares) at Dec. 31, 2019 | 39,517,329 | ||||
Balance at beginning of period at Dec. 31, 2019 | $ 382,295 | $ 40 | $ 1,144,667 | $ 9,889 | $ (772,301) |
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (357,937) | (357,937) | |||
Issuance of common stock and warrants, net of issuance costs (shares) | 8,124,168 | ||||
Issuance of common stock, net of issuance costs | 1,203,617 | $ 8 | 1,203,609 | ||
Share-based compensation expense | 85,847 | 85,847 | |||
Issuance of common stock from ESPP (shares) | 14,436 | ||||
Issuance of common stock from ESPP | 1,206 | 1,206 | |||
Issuance of common stock under equity incentive plans (shares) | 1,319,901 | ||||
Issuance of common stock under equity incentive plans | $ 45,891 | $ 1 | 45,890 | ||
Net exercise of warrants (shares) | 1,400,000 | 1,463,235 | |||
Net exercise of warrants | $ 0 | $ 1 | (1) | ||
Unrealized gain (loss) on investments | (130) | (130) | |||
Foreign currency translation adjustment | 0 | ||||
Balance at end of period (shares) at Dec. 31, 2020 | 50,439,069 | ||||
Balance at end of period at Dec. 31, 2020 | 1,360,789 | $ 50 | 2,481,218 | 9,759 | (1,130,238) |
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (581,784) | (581,784) | |||
Issuance of common stock and warrants, net of issuance costs (shares) | 3,448,275 | ||||
Issuance of common stock, net of issuance costs | 474,697 | $ 3 | 474,694 | ||
Share-based compensation expense | 113,502 | 113,502 | |||
Issuance of common stock from ESPP (shares) | 20,672 | ||||
Issuance of common stock from ESPP | 2,567 | 2,567 | |||
Issuance of common stock under equity incentive plans (shares) | 825,074 | ||||
Issuance of common stock under equity incentive plans | $ 27,958 | $ 1 | 27,957 | ||
Net exercise of warrants (shares) | 623,814 | 623,814 | |||
Net exercise of warrants | $ 0 | $ 1 | (1) | ||
Unrealized gain (loss) on investments | (691) | (691) | |||
Foreign currency translation adjustment | $ 0 | ||||
Balance at end of period (shares) at Dec. 31, 2021 | 55,356,904 | 55,356,904 | |||
Balance at end of period at Dec. 31, 2021 | $ 1,397,038 | $ 55 | 3,099,937 | 9,068 | (1,712,022) |
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (740,867) | (740,867) | |||
Issuance of common stock and warrants, net of issuance costs (shares) | 1,880,097 | ||||
Issuance of common stock, net of issuance costs | 155,011 | $ 2 | 155,009 | ||
Share-based compensation expense | 186,188 | 186,188 | |||
Issuance of common stock from ESPP (shares) | 59,732 | ||||
Issuance of common stock from ESPP | 2,008 | 2,008 | |||
Issuance of common stock under equity incentive plans (shares) | 557,826 | ||||
Issuance of common stock under equity incentive plans | 9,925 | $ 1 | 9,924 | ||
Unrealized gain (loss) on investments | (3,224) | (3,224) | |||
Foreign currency translation adjustment | $ (9,563) | (9,563) | |||
Balance at end of period (shares) at Dec. 31, 2022 | 57,854,559 | 57,854,559 | |||
Balance at end of period at Dec. 31, 2022 | $ 996,516 | $ 58 | $ 3,453,066 | $ (3,719) | $ (2,452,889) |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Operating activities: | |||
Net loss | $ (740,867) | $ (581,784) | $ (357,937) |
Non-cash adjustments reconciling net loss to operating cash flows | |||
Non-cash consideration earned from license agreement | 0 | 0 | (11,424) |
Change in fair value of long-term investment | 4,753 | 7,411 | (4,205) |
Depreciation and amortization expense | 2,929 | 1,781 | 641 |
Amortization of premium and accretion of discounts on investments | (4,200) | 4,702 | (674) |
Share-based compensation expense | 186,188 | 113,502 | 85,847 |
Loss on disposal of fixed assets | 294 | 0 | 0 |
Foreign currency adjustments | (9,563) | 0 | 0 |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | (865) | 0 | 0 |
Inventory | (3,020) | 0 | 0 |
Other current assets | (4,596) | (3,107) | (4,180) |
Other long-term assets | (2,596) | (9,892) | (3,424) |
Right-of-use asset | 1,558 | 2,210 | 582 |
Lease liability | 4,285 | 5,315 | (652) |
Accounts payable, accrued liabilities and other liabilities | (4,870) | 71,062 | 23,895 |
Cash flows used in operating activities | (570,570) | (388,800) | (271,531) |
Investing activities: | |||
Purchases of short-term investments | (956,704) | (1,422,729) | (662,824) |
Sales and maturities of short-term investments | 1,187,358 | 843,623 | 527,334 |
Purchases of property and equipment | (4,851) | (9,795) | (4,367) |
Cash flows provided by (used in) investing activities | 225,803 | (588,901) | (139,857) |
Financing activities: | |||
Proceeds from issuance of common stock, net of issuance costs | 155,011 | 474,697 | 1,203,617 |
Proceeds from issuance of common stock under equity incentive plans | 9,925 | 27,958 | 45,891 |
Proceeds from issuances under employee stock purchase plan | 2,008 | 2,567 | 1,206 |
Cash flows provided by financing activities | 166,944 | 505,222 | 1,250,714 |
(Decrease) increase in cash, cash equivalents and restricted cash | (177,823) | (472,479) | 839,326 |
Cash, cash equivalents and restricted cash, beginning of year | 413,703 | 886,182 | 46,856 |
Cash, cash equivalents and restricted cash, end of year | 235,880 | 413,703 | 886,182 |
Reconciliation of cash, cash equivalents and restricted cash, end of year: | |||
Cash and cash equivalents | 235,260 | 413,083 | 885,562 |
Restricted cash included in other long-term assets | 620 | 620 | 620 |
Total cash, cash equivalents and restricted cash | 235,880 | 413,703 | 886,182 |
Supplemental disclosures of non-cash investing activities: | |||
Accrued capital expenditures | 0 | 583 | 292 |
Capitalized intangible asset included in accrued liabilities | 15,000 | 0 | 0 |
Allowance utilized for tenant improvements | 0 | 0 | 2,015 |
Initial recognition of operating right-of-use asset | 0 | 0 | 39,890 |
Initial recognition of operating lease liability | $ 0 | $ 0 | $ 41,905 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Description of BusinessMirati Therapeutics, Inc. (“Mirati” or the “Company”) is a commercial-stage oncology company developing product candidates to address the genetic and immunological promoters of cancer. The Company was incorporated under the laws of the State of Delaware on April 29, 2013 as Mirati Therapeutics, Inc. and is located in San Diego, California. The Company has a wholly-owned subsidiary, Mirati Therapeutics B.V. (“Mirati B.V.”), which was formed on August 3, 2021 in Amsterdam, Netherlands, and a wholly-owned subsidiary, Mirati Therapeutics (Suisse) GmbH (“Mirati Suisse”), which was formed on May 24, 2022 in Zug, Switzerland. The Company operates as one business segment, primarily in the United States. The Company’s common stock has been listed on the Nasdaq Global Select Market since June 5, 2018, and was previously listed on the Nasdaq Capital Market since July 15, 2013, under the ticker symbol “MRTX.”The Company’s former wholly-owned subsidiary in Canada, MethylGene, Inc. (“MethylGene”), which was formed on May 8, 2013 pursuant to an arrangement agreement between the Company and MethylGene, was reorganized in 2022 and formally dissolved in December 2022. As a result of the reorganization, the Company recognized a gain of $9.5 million within other income during the year ended December 31, 2022, which represented the cumulative foreign currency translation gain within accumulated other comprehensive income. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Presentation These consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). These consolidated financial statements include the accounts of the Company, Mirati B.V., Mirati Suisse, and MethylGene (until its dissolution in December 2022). All significant inter-company transactions, balances and expenses have been eliminated upon consolidation. These consolidated financial statements are presented in United States (“U.S.”) Dollars, which is also the functional currency of the Company. Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Reported amounts and footnote disclosures reflect the overall economic conditions that are most likely to occur and anticipated measures management intends to take. Actual results could differ materially from those estimates. Estimates and assumptions are reviewed quarterly. Any revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected. Cash, Cash Equivalents and Short-term Investments Cash and cash equivalents consist of cash and highly liquid securities with original maturities at the date of acquisition of ninety days or less. Investments with an original maturity of more than ninety days are considered short-term investments and have been classified by management as available-for-sale. These investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current consolidated balance sheet date, which reflects management’s intention to use the proceeds from sales of these securities to fund its operations, as necessary. Such investments are carried at fair value, and the unrealized gains and losses are reported as a component of accumulated other comprehensive income in shareholders’ equity until realized. Realized gains and losses from the sale of available-for-sale securities, if any, are determined on a specific identification basis. Concentration of Credit Risk The Company invests its excess cash in accordance with its investment policy. The Company’s investments are comprised primarily of commercial paper and debt instruments of financial institutions, corporations, U.S. government-sponsored agencies and the U.S. Treasury. The Company mitigates credit risk by maintaining a diversified portfolio and limiting the amount of investment exposure as to institution, maturity and investment type. Financial instruments that potentially subject the Company to significant credit risk consist principally of cash equivalents and short-term investments. Accounts Receivable, net Accounts receivable, net consists of trade receivables which are amounts due from customers related to product sales. The Company records trade receivables net of chargebacks, invoice discounts, distribution service fees and any allowances for doubtful accounts for potential credit losses. An allowance for doubtful accounts is determined based on the financial condition and creditworthiness of customers and the Company considers economic factors and events or trends expected to affect future collections experience. Any allowance would reduce the net receivables to the amount that is expected to be collected. The payment history of the Company’s customers will be considered in future assessments of collectibility as these patterns are established over a longer period of time. As of December 31, 2022, the Company determined an allowance for doubtful accounts was not required. The Company did not have trade receivables as of December 31, 2021. Inventory The Company began capitalizing inventory for KRAZATI, which received approval by the U.S. Food and Drug Administration (“FDA”) and launched commercially in the U.S. in December 2022. KRAZATI is approved for the treatment of adult patients with KRAS G12C-mutated non-small cell lung cancer (“NSCLC”) who have received at least one prior systemic therapy. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred. Inventory is comprised of raw materials, work-in-process and finished goods, and includes costs related to third-party contract manufacturing, packaging, freight-in and overhead. Inventory is stated at the lower of cost or net realizable value with cost based on the first-in-first-out method. The Company performs an assessment of recoverability of capitalized inventory during each reporting period based on an analysis of forecasted demand compared to quantities on hand and any firm purchase orders, as well as product shelf life, and writes down any excess, obsolete or unsaleable inventory to its estimated realizable value in the period which the impairment is first identified. Such write downs, should they occur, are charged to cost of product revenue in the consolidated statement of operations and comprehensive loss. As of December 31, 2022, the Company did not identify any impaired inventory. Revenue Recognition The Company recognizes revenue in accordance with the guidance of Revenue From Contracts With Customers , Accounting Standards Codification (“ASC”) Topic 606 (“Topic 606”). Under Topic 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements the Company determines are within the scope of Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Product revenue, net The Company’s product revenue consists of sales of KRAZATI. The Company sells KRAZATI principally to specialty pharmacies and specialty distributors, which are referred to as the Company’s customers. These customers subsequently resell the product to healthcare providers and patients. Revenues from product sales are recognized when the customer obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the customer. The Company records revenues from product sales at the net sales price, or transaction price, which includes estimates of variable consideration for which reserves are established primarily from chargebacks, government and commercial rebates, incentives, product returns, trade discounts and other allowances that are offered in contracts between the Company and its customers, healthcare providers and other third-party payors relating to the sales of its product. These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of trade receivables, if the amount is deductible by the customer from payments to the Company, which is included within accounts receivable, net on the consolidated balance sheet, or a current liability, if the amount is payable by the Company to a customer or third-party, which is included within accrued liabilities on the consolidated balance sheet. The Company estimates the amount of variable consideration to include in the transaction price using the expected value method. These estimates take into consideration relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, forecasted customer buying and payment patterns, and the Company’s historical experience that will develop over time as KRAZATI is the Company’s first commercial product. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of its contracts. The amount of variable consideration may be constrained and is included in the transaction price only to the extent that it is probable that a significant reversal of the amount of cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenues and earnings in the period such variances become known. The following are the components of variable consideration related to product revenue: Chargebacks. Chargebacks relate to contracts with various third-party payors, including governmental healthcare programs, managed care providers, group purchasing organizations and other organizations, that generally purchase the product from a specialty distributor at a discounted price. The specialty distributor, in turn, charges back to the Company the difference between the price initially paid by the specialty distributor and the discounted price paid to the specialty distributor by its contracted customer. The allowance for chargebacks is based on actual chargebacks received and an estimate of sales by the specialty distributor to its contracted customers. These reserves are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue. Government rebates. The Company is subject to discount obligations under Medicare, Medicaid, and other governmental healthcare programs in the U.S. The Company’s estimates of rebates are based on the government-mandated discounts, which are statutorily-defined and applicable to these government funded programs. These reserves are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue and the accrual of an estimated liability. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom it will owe an additional liability under the Medicare Part D program. Commercial rebates. The Company contracts with various private payor organizations and group purchasing organizations for the payment of rebates with respect to the utilization of its product. The Company’s estimates for the expected utilization of rebates are based on customer and payor data received from the specialty pharmacies and specialty distributors and historical utilization rates that will develop over time as KRAZATI is the Company’s first commercial product. These reserves are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue and the accrual of an estimated liability. Incentives. The Company offers incentives such as co-payment assistance to commercially insured patients in the U.S. who meet certain eligibility requirements. The Company may provide financial assistance to participating patients with prescription drug co-payments required by the patients’ insurance provider, up to a specified dollar amount. These reserves are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue and the accrual of an estimated liability. Product returns. Generally, the Company’s customers have the right to return product for a limited time before and after its expiration date. Since the Company does not have its own returns experience, it estimates returns based on available industry data for comparable products in the market as well as other information, such as visibility into the inventory remaining in the distribution channel and expiration date. As the Company distributes its product and establishes historical sales over a longer period of time, the Company will be able to place more reliance on historical purchasing, demand and return patterns of its customers when evaluating its reserves for product returns. The estimate for product returns is recorded as an accrued liability and a reduction of revenue in the period the related product sales are recognized. Trade allowances. The Company may provide invoice discounts on product sales to its customers for prompt payment based on contractual terms. These discounts are recorded as a reduction of revenue in the period the related product revenue is recognized. Trade receivables are recorded net of the allowance for these discounts. The Company also pays fees to its distributors for their services. The Company has determined such services are not distinct from the Company’s sale of product to its customers and therefore records these payments as a reduction of revenue in the period the related product revenue is recognized. To the extent the services received are distinct from the Company’s sale of product to its customers, these payments will be recorded within selling, general and administrative expense in the consolidated statement of operations and comprehensive loss. License and collaboration revenues The Company’s license and collaboration revenues have been generated primarily through collaborative research, development, manufacture and commercialization agreements. The terms of these agreements generally include the license of intellectual property and associated know-how and the provision of other goods and services. Payments to the Company under these arrangements typically include one or more of the following: non-refundable, upfront license fees; manufacturing supply services; milestone payments; and royalties on future product sales. License of Intellectual Property . If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue associated with the bundled performance obligation. Manufacturing Supply Services . The Company’s obligation under the agreements may include the initial supply of material for clinical development. If determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue allocated to this performance obligation when the collaborative partner obtains control of the goods. If determined not to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue allocated to the combined performance obligation as the related performance obligations are satisfied. Milestone Payments. At the inception of each arrangement that includes milestone payments based upon the achievement of specified clinical development, regulatory and/or sales milestones, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price. If it is probable that a significant revenue reversal would not occur, the associated milestone amount is included in the transaction price. Milestone payments that are dependent on factors outside of the Company’s control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. These payments are fully constrained and therefore are not included in the transaction price. At the end of each reporting period, the Company re-evaluates the probability of achievement of each milestone and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect the reported amount of license and collaboration revenues in the period of adjustment. Royalties. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). Property and Equipment, Net Property and equipment is stated at historical cost less accumulated depreciation. Historical cost includes expenditures that are directly attributable to the acquisition of the items. All repairs and maintenance are charged to consolidated net loss during the financial period in which they are incurred. Depreciation of property and equipment is calculated using the straight-line method over the estimated useful lives of the assets, as follows: Computer equipment 3 years Office and other equipment 6 years Laboratory equipment 6 years Leasehold improvements The lesser of the lease term or the life of the asset Upon disposal or impairment of property and equipment, the cost and related accumulated depreciation is removed from the consolidated financial statements and the net amount, less any proceeds, is included in consolidated net loss. Intangible Asset, Net The Company’s finite-lived intangible asset resulted from the capitalization of a milestone payment due under a license and collaboration agreement in connection with the first commercial sale of KRAZATI in the U.S. in December 2022. The intangible asset will be amortized on a straight-line basis over its remaining useful life, which is estimated to be the remaining patent life of KRAZATI. Amortization expense is recorded as cost of product revenue in the consolidated statement of operations and comprehensive loss. Impairment of Long-Lived Assets The Company reviews its long-lived assets, including property and equipment and finite-lived intangible assets, for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. If such circumstances are determined to exist, an estimate of undiscounted future cash flows produced by the long-lived asset, including its eventual residual value, is compared to the carrying value to determine whether impairment exists. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written-down to their estimated fair values. Fair value is estimated through discounted cash flow models to project cash flows from the asset. The Company recognized no impairment charges for the years ended December 31, 2022, 2021 and 2020. Cost of Product Revenue Cost of product revenue includes direct and indirect costs related to the manufacturing and distribution of KRAZATI, including materials, third-party manufacturing costs, packaging services, freight-in, overhead, royalties payable on net sales of KRAZATI and inventory reserves. All product costs incurred prior to FDA approval of KRAZATI in December 2022 were charged to research and development expense. Share-Based Compensation Expense The Company measures and recognizes compensation expense for share-based payments based on estimated fair value as of the grant date. The fair value of restricted stock units is determined using the intrinsic value method. The fair value of performance stock units, which vest based on the achievement of pre-established performance goals, is determined using the intrinsic value method and the probability that the specified performance criteria will be met. The fair value of stock options is determined using the Black-Scholes option-pricing model. The Black-Scholes option-pricing model requires the use of certain estimates and assumptions that affect the amount of share-based compensation expense recognized in the Company’s consolidated financial statements. These assumptions include the expected volatility of the Company’s stock price, expected term of the options, the risk-free interest rate and expected dividend yields. Share-based compensation expense is recognized using the graded accelerated vesting method. Research and Development Expenses Research and development expenses are charged to consolidated net loss in the period in which they are incurred and are comprised of the following types of costs incurred in performing research and development activities: contract services for clinical trials and related clinical manufacturing costs, salaries and benefits including share-based compensation expense, costs for allocated facilities and depreciation of equipment and license fees paid in connection with the Company’s early discovery efforts. Selling, General and Administrative Expenses Selling, general and administrative expenses consist primarily of salaries and related benefits, including share-based compensation expense, related to the Company’s executive, finance, legal, commercial and support functions. Other selling, general and administrative expenses include commercial activities such as marketing, professional fees, rent and utilities and insurance. Leases The Company determines if an arrangement is a lease at inception. Lease right-of-use assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to make lease payments arising from the lease. For operating leases with an initial term greater than 12 months, the Company recognizes operating lease right-of-use assets and operating lease liabilities based on the present value of lease payments over the lease term at the commencement date. Operating lease right-of-use assets are comprised of the lease liability plus any lease payments made and excludes lease incentives. Lease terms include options to renew or terminate the lease when the Company is reasonably certain that the renewal option will be exercised or when it is reasonably certain that the termination option will not be exercised. For the Company's operating leases, if the interest rate used to determine the present value of future lease payments is not readily determinable, the Company estimates its incremental borrowing rate as the discount rate for the lease. The Company's incremental borrowing rate is estimated to approximate the interest rate on a collateralized basis with similar terms and payments, and in similar economic environments. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company has elected the practical expedient to not separate lease and non-lease components. Income Taxes Income taxes have been accounted for using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates applicable to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in net loss in the period that includes the enactment date. A valuation allowance against deferred tax assets is recorded if, based upon the weight of all available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. For uncertain tax positions that meet “a more likely than not” threshold, the Company recognizes the benefit of uncertain tax positions in the consolidated financial statements. Segment Reporting Operating segments are components of a business where separate discrete financial information is available for evaluation by the chief operating decision-maker for purposes of making decisions regarding resource allocation and assessing performance. To date, the Company and the chief operating decision-maker has viewed its operations and managed its business as one segment operating primarily in the United States. Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration for common share equivalents as they are anti-dilutive. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and common share equivalents outstanding for the period, as well as certain shares that are contingently issuable. Common share equivalents outstanding, determined using the treasury stock method, are comprised of shares that may be issued under the Company’s stock option and warrant agreements, as well as restricted stock units and performance stock units. The following table presents the weighted average number of common share equivalents, calculated using the treasury stock method, as well as certain shares that are contingently issuable, not included in the calculation of diluted net loss per share due to the anti-dilutive effect of the securities: Year Ended December 31, 2022 2021 2020 Common stock options 1,194,371 2,358,594 2,503,294 Common stock warrants 7,605,711 7,713,576 9,210,824 Unvested restricted stock units and performance stock units 1,748,730 656,158 347,261 Total 10,548,812 10,728,328 12,061,379 Recently Issued and Recently Adopted Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. The Company has evaluated recently issued accounting pronouncements and does not believe any will have a material impact on the Company’s consolidated financial statements or related financial statement disclosures. |
Investments
Investments | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | Investments The following tables summarize the Company’s short-term investments (in thousands): As of December 31, 2022 Maturity Amortized cost Gross unrealized gains Gross unrealized losses Estimated fair value Corporate debt securities 2 years or less $ 95,195 $ — $ (662) $ 94,533 Commercial paper 1 year or less 443,489 65 (811) 442,743 U.S. Agency bonds 2 years or less 90,351 22 (434) 89,939 U.S. Treasury bills 2 years or less 223,216 8 (1,862) 221,362 $ 852,251 $ 95 $ (3,769) $ 848,577 As of December 31, 2021 Maturity Amortized cost Gross unrealized gains Gross unrealized losses Estimated fair value Corporate debt securities 2 years or less $ 236,170 $ 36 $ (248) $ 235,958 Commercial paper 1 year or less 621,947 127 (95) 621,979 U.S. Agency bonds 1 year or less 58,092 — — 58,092 U.S. Treasury bills 2 years or less 162,500 — (272) 162,228 $ 1,078,709 $ 163 $ (615) $ 1,078,257 The Company has classified all of its short-term investments as available-for-sale as the sale of such securities may be required prior to maturity to implement management strategies, and accordingly, carries these investments at fair value. As of December 31, 2022 and 2021, the unrealized losses for available-for-sale investments were non-credit related, and the Company does not intend to sell the investments before recovery of their amortized cost basis, which may be at the time of maturity. As of December 31, 2022 and 2021, no allowance for credit losses was recorded. During the years ended December 31, 2022, 2021 and 2020, the Company did not recognize any impairment losses related to investments. The long-term investment balance of $3.5 million and $8.2 million as of December 31, 2022 and 2021, respectively, is comprised of 588,235 shares of ORIC Pharmaceuticals, Inc. (“ORIC”) common stock which were acquired in 2020. The investment is carried at fair value which, as of December 31, 2022, is based on the closing price of ORIC’s common stock on the last trading day of the reporting period. As of December 31, 2021, the fair value was based on the closing price of ORIC’s common stock on the last trading day of the reporting period and was adjusted for a discount for lack of marketability due to an eighteen-month lock-up period which expired in the first quarter of 2022. The Company records any change in fair value within other income (expense) |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company has certain financial assets and liabilities recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements. The authoritative guidance for fair value measurements defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or the most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Market participants are buyers and sellers in the principal market that are (i) independent, (ii) knowledgeable, (iii) able to transact, and (iv) willing to transact. The guidance prioritizes the inputs used in measuring fair value into the following hierarchy: • Level 1- Quoted prices (unadjusted) in active markets for identical assets or liabilities; • Level 2- Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable; and • Level 3- Unobservable inputs in which little or no market activity exists, therefore requiring an entity to develop its own assumptions about the assumptions that market participants would use in pricing. The following tables summarize the assets measured at fair value on a recurring basis (in thousands): December 31, 2022 Total Level 1 Level 2 Level 3 Assets Cash and cash equivalents: Cash $ 53,033 $ 53,033 $ — $ — Money market funds 174,262 174,262 — — U.S. Agency bonds 7,965 — 7,965 — Total cash and cash equivalents 235,260 227,295 7,965 — Short-term investments: U.S. Treasury bills 221,362 221,362 — — Corporate debt securities 94,533 — 94,533 — Commercial paper 442,743 — 442,743 — U.S. Agency bonds 89,939 — 89,939 — Total short-term investments 848,577 221,362 627,215 — Long-term investment: ORIC Pharmaceuticals, Inc. 3,465 3,465 — — Total $ 1,087,302 $ 452,122 $ 635,180 $ — December 31, 2021 Total Level 1 Level 2 Level 3 Assets Cash and cash equivalents: Cash $ 19,347 $ 19,347 $ — $ — Money market funds 393,736 393,736 — — Total cash and cash equivalents 413,083 413,083 — — Short-term investments: U.S. Treasury bills 162,228 162,228 — — Corporate debt securities 235,958 — 235,958 — Commercial paper 621,979 — 621,979 — U.S. Agency bonds 58,092 — 58,092 — Total short-term investments 1,078,257 162,228 916,029 — Long-term investment: ORIC Pharmaceuticals, Inc. 8,218 — — 8,218 Total $ 1,499,558 $ 575,311 $ 916,029 $ 8,218 The Company’s investments in Level 1 assets are valued based on publicly available quoted market prices for identical securities as of December 31, 2022 and 2021. The Company determines the fair value of Level 2 related securities with the aid of valuations provided by third parties using proprietary valuation models and analytical tools. These valuation models and analytical tools use market pricing or prices for similar instruments that are both objective and publicly available, including matrix pricing or reported trades, benchmark yields, broker/dealer quotes, issuer spreads, two-sided markets, benchmark securities, bids and/or offers. The Company’s long-term investment in ORIC as of December 31, 2021 was considered a Level 3 fair value measurement and utilized a combination of the Asian Protective Put Option and Finnerty Put Option fair value techniques with unobservable inputs of 69% volatility and an expected term of 0.1 years to determine the discount for lack of marketability of 5.0%. In the first quarter of 2022, the eighteen-month lock-up period expired, and because ORIC common stock is quoted in an active market, it meets the criteria of a Level 1 investment. In the first quarter of 2022, the Company transferred the investment in ORIC from a Level 3 fair value measurement to a Level 1 fair value measurement. See Note 10 for further details on the license agreement with ORIC. The following table represents the changes in estimated fair value of the Company’s Level 3 investment (in thousands): Balance as of December 31, 2020 $ 15,629 Change in fair value (7,411) Balance as of December 31, 2021 $ 8,218 Change in fair value at lock-up expiration (3,100) Transfer from Level 3 to Level 1 at lock-up expiration (5,118) Balance as of December 31, 2022 $ — Other than the investment in ORIC described above, there were no transfers between fair value measurement levels in the years ended December 31, 2022 and 2021. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory consisted of the following (in thousands): December 31, 2022 2021 Raw materials $ — $ — Work-in-process 2,994 — Finished goods 26 — Total inventory $ 3,020 $ — All of the Company’s inventory relates to the manufacturing of KRAZATI subsequent to FDA approval in December 2022. There were no inventory write downs during the year ended December 31, 2022. |
Other Current Assets and Other
Other Current Assets and Other Long-Term Assets | 12 Months Ended |
Dec. 31, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Other Current Assets and Other Long-Term Assets | Other current assets and other long-term assets consisted of the following (in thousands): December 31, 2022 2021 Other current assets: Prepaid expenses $ 15,207 $ 11,895 Deposits and other receivables 3,162 2,235 Interest receivables 2,870 2,513 Total other current assets $ 21,239 $ 16,643 Other long-term assets: Deposits and prepaid expenses $ 21,025 $ 18,429 Restricted cash 620 620 Total other long-term assets $ 21,645 $ 19,049 |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and equipment, net consisted of the following (in thousands): December 31, 2022 2021 Laboratory equipment $ 14,027 $ 9,733 Leasehold improvements 6,482 6,275 Office and other equipment 2,165 2,131 Computer equipment 354 507 Gross property and equipment 23,028 18,646 Less: Accumulated depreciation (5,488) (2,822) Property and equipment, net $ 17,540 $ 15,824 |
Accrued Liabilities and Other L
Accrued Liabilities and Other Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Liabilities and Other Liabilities [Abstract] | |
Accrued Liabilities and Other Liabilities | Accrued liabilities and other liabilities consisted of the following (in thousands): December 31, 2022 2021 Accrued liabilities: Accrued clinical expense $ 37,604 $ 29,038 Accrued manufacturing expense 6,605 34,153 Accrued development expense 20,107 10,910 Accrued compensation and benefits 40,208 25,845 Accrued commercial expense 3,941 3,650 Accrued adjustments to product revenue 152 — Lease liability (current) 7,844 1,341 Other accrued expenses 4,126 3,558 Total accrued liabilities $ 120,587 $ 108,495 Other liabilities $ 3,022 $ 2,179 |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2022 | |
Research and Development [Abstract] | |
Revenue | Product revenue, net The Company’s product revenue is related to U.S. sales of KRAZATI, which it began shipping to customers in December 2022. Revenue is reduced at the time of recognition for the Company’s best estimate of chargebacks, government and commercial rebates, incentives, returns, trade discounts and other allowances to which customers are entitled. These reductions are currently attributed to various commercial arrangements. As of December 31, 2022, the Company’s accounts receivable balance of $0.9 million on the consolidated balance sheet consisted of KRAZATI product sales receivable, net of chargebacks, discounts and allowances of $0.1 million. The Company did not have an accounts receivable balance as of December 31, 2021. As of December 31, 2022, the Company’s government and commercial rebates, program incentives and provision for product returns totaled $0.2 million and are included in accrued liabilities on the consolidated balance sheets. The Company did not have product reserves as of December 31, 2021. BeiGene Agreement Terms of Agreement On January 7, 2018, the Company and BeiGene Ltd, (“BeiGene”) entered into a Collaboration and License Agreement (the “BeiGene Agreement”), pursuant to which the Company and BeiGene agreed to collaboratively develop sitravatinib in Asia (excluding Japan and certain other countries), Australia and New Zealand (collectively, the “BeiGene Licensed Territory”). Under the BeiGene Agreement, the Company granted BeiGene an exclusive license to develop, manufacture and commercialize sitravatinib in the BeiGene Licensed Territory, with the Company retaining exclusive rights for the development, manufacture and commercialization of sitravatinib outside the BeiGene Licensed Territory. As consideration for the rights granted to BeiGene under the BeiGene Agreement, BeiGene paid the Company a non-refundable, non-creditable up-front fee of $10.0 million. BeiGene is also required to make milestone payments to the Company of up to an aggregate of $123.0 million upon the first achievement of specified clinical, regulatory and sales milestones. The BeiGene Agreement additionally provides that BeiGene is obligated to pay the Company royalties at tiered percentage rates ranging from mid-single digits to twenty percent on annual net sales of licensed products in the BeiGene Licensed Territory, subject to reduction under specified circumstances. The BeiGene Agreement also provides that the Company will supply BeiGene with sitravatinib for use in BeiGene’s development activities in the BeiGene Licensed Territory. The BeiGene Agreement will terminate upon the expiration of the last royalty term for the licensed products, which is the latest of (i) the date of expiration of the last valid patent claim related to the licensed products under the BeiGene Agreement, (ii) ten years after the first commercial sale of a licensed product and (iii) the expiration of any regulatory exclusivity as to a licensed product. BeiGene may terminate the BeiGene Agreement at any time by providing 60 days prior written notice to the Company. Either party may terminate the BeiGene Agreement upon a material breach by the other party that remains uncured following 60 days after the date of written notice of such breach or upon certain bankruptcy events. In addition, the Company may terminate the BeiGene Agreement upon written notice to BeiGene under specified circumstances if BeiGene challenges the licensed patent rights. Revenue Recognition The Company evaluated the BeiGene Agreement under Topic 606. At the time it entered into the BeiGene Agreement, the Company determined the transaction price was equal to the up-front fee of $10.0 million. The transaction price was allocated to the performance obligations on the basis of the relative stand-alone selling price estimated for each performance obligation. In estimating the stand-alone selling price for each performance obligation, the Company developed assumptions that require judgment and included forecasted revenues, expected development timelines, discount rates, probabilities of technical and regulatory success and costs for manufacturing clinical supplies. As such, of the up-front fee, the Company allocated $9.5 million to the license of the Company’s intellectual property, bundled with the associated know-how, and the remaining $0.5 million to the initial obligation to supply sitravatinib for clinical development in the BeiGene Licensed Territory. Licenses of Intellectual Property. The license to the Company’s intellectual property, bundled with the associated know-how, represents a distinct performance obligation and the Company recognized the full revenue amount of $9.5 million related to this performance obligation as license and collaboration revenues in 2018. Manufacturing Supply Services. The Company’s initial obligation to supply sitravatinib for clinical development in the BeiGene Licensed Territory represents a distinct performance obligation, and the $0.5 million initial supply obligation was fully recognized as license and collaboration revenues as of December 31, 2020. Although the initial performance obligation was satisfied, BeiGene may request additional sitravatinib in the future for clinical development in the BeiGene Licensed Territory. No revenue was recognized as license and collaboration revenues related to this performance obligation for the year ended December 31, 2022. The Company recognized $0.4 million as license and collaboration revenues related to this performance obligation for the year ended December 31, 2021. The Company recognized $2.0 million as license and collaboration revenues related to this performance obligation for the year ended December 31, 2020, of which $1.8 million relates to cost-sharing payments due from BeiGene, and $0.2 million relates to recognition from the deferred revenue balance. The Company recorded a cost-sharing receivable from BeiGene within other current assets on the consolidated balance sheets of $0.3 million as of December 31, 2021. The Company was not owed a cost-sharing receivable from BeiGene as of December 31, 2022. Milestone Payments. The Company is entitled to development milestones under the BeiGene Agreement and certain regulatory milestone payments which are paid upon receipt of regulatory approvals within the BeiGene Licensed Territory. No milestone payments were earned during the year ended December 31, 2022. The Company earned a $5.0 million milestone payment related to the initiation of the first pivotal clinical trial in the BeiGene Licensed Territory during the year ended December 31, 2021, and did not earn any milestone payments during the year ended December 31, 2020. The Company evaluated whether the remaining milestones are considered probable of being reached and determined that their achievement is highly dependent on factors outside of the Company’s control. Therefore, these payments have been fully constrained and are not included in the transaction price. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of each milestone and any related constraint, and if necessary, adjust its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect the reported amount of license and collaboration revenues in the period of adjustment. Royalties. As the license is deemed to be the predominant item to which sales-based royalties relate, the Company will recognize revenue when the related sales occur. No royalty revenue was recognized during the years ended December 31, 2022, 2021, or 2020. Pfizer Agreement In October 2014, the Company entered into a drug discovery collaboration and option agreement with Array BioPharma, Inc. (“Array,” acquired by Pfizer Inc. (“Pfizer”) in July 2019) whereby Array provided services to facilitate the discovery, optimization and development of small molecule compounds that bind and specifically inhibit KRAS G12C. In June 2017, the two parties entered into a second, separate discovery collaboration and option agreement whereby Array provided services to facilitate the discovery, optimization and development of small molecule compounds that bind and specifically inhibit KRAS G12D. Both agreements established an option mechanism which enabled the Company to elect an exclusive worldwide license under the technology for the development and commercialization of certain products based on these compounds. Under the agreements, following the joint discovery periods, which have since concluded, the Company exercised its options to retain exclusive worldwide licenses to develop, manufacture and commercialize inhibitors of KRAS G12C and KRAS G12D, including, but not limited to, adagrasib and MRTX1133. Under each agreement, Pfizer is entitled to potential development milestone payments of up to $9.3 million from the Company, and tiered sales milestone payments of up to $337.0 million based upon worldwide net sales, and tiered royalties in the high single digits to mid-teens on worldwide net sales of products arising from the collaborations. Under the agreements, the Company has incurred $9.5 million in development milestone payments and a $15.0 million milestone payment relating to the first commercial sale of KRAZATI in the U.S. from inception through December 31, 2022. For the year ended December 31, 2022, the Company incurred a $15.0 million milestone payment relating to the first commercial sale of KRAZATI in the U.S., which was capitalized as in-process research and development as of December 31, 2022. For the year ended December 31, 2021, the Company incurred expenses under these agreements of $5.0 million related to initiation of the first Phase 3 trial for adagrasib. For the year ended December 31, 2020, the Company incurred expenses of $4.8 million, consisting of a $3.0 million milestone payment for initiation of the first Phase 2 trial for adagrasib, a $0.3 million milestone payment for initiation of the first regulatory toxicology study for MRTX1133, and $1.5 million in research and development services. The royalty term for each agreement is payable on a country-by-country and product-by-product basis, and separately will terminate at the later of (i) the date of expiration of the last valid patent claim within the collaboration patent rights or the Pfizer background technology covering such product in the country in which such product is sold at the time of such sale, or (ii) ten years after the first commercial sale of such product in such country. The Company may terminate each agreement at any time by providing 60 days prior written notice to Pfizer. Either party may terminate each agreement upon a material breach by the other party that remains uncured following 60 days after the date of written notice of such breach or upon certain bankruptcy events. ORIC Pharmaceuticals Agreement Terms of Agreement On August 3, 2020, the Company entered into a license agreement with ORIC Pharmaceuticals, Inc. (“ORIC”) pursuant to which the Company granted to ORIC an exclusive, worldwide license to develop and commercialize the Company’s allosteric polycomb repressive complex 2 (“PRC2”) inhibitors for all indications (the “ORIC Agreement”). In accordance with the terms of the ORIC Agreement, in exchange for such license, ORIC issued 588,235 shares of its common stock (the “Shares”) to the Company on August 3, 2020. The Shares were issued under a stock issuance agreement entered into between ORIC and the Company, dated August 3, 2020. During the eighteen-month period following the date of the stock issuance agreement, the Company was subject to certain transfer restrictions. ORIC is not obligated to pay the Company milestone payments or royalty payments under the ORIC Agreement. Unless terminated earlier, the ORIC Agreement will continue in effect on a country-by-country and licensed product-by-licensed product basis until the later (a) the expiration of the last valid claim of a licensed patent covering such licensed product in such country or (b) ten years after the first commercial sale of such licensed product in such country. Following the expiration of the ORIC Agreement, ORIC will retain its licenses under the intellectual property the Company licensed to ORIC on a royalty-free basis. The Company and ORIC may each terminate the ORIC Agreement if the other party materially breaches the terms of such agreement, subject to specified notice and cure provisions, or enters into bankruptcy or insolvency proceedings. The Company may terminate the agreement if ORIC challenges any of the patent rights licensed to ORIC by the Company or if ORIC discontinues development of licensed products for a specified period of time. ORIC also has the right to terminate the ORIC Agreement without cause by providing prior written notice to the Company. Revenue Recognition The Company accounted for the ORIC Agreement under Topic 606 and identified the granting of an exclusive, worldwide license to develop and commercialize the Company’s allosteric PRC2 inhibitors for all indications as a distinct performance obligation since ORIC can benefit from the license on its own by developing and commercializing the underlying product using its own resources. In determining the transaction price, the Company received the Shares as non-cash consideration. The Company allocated the entire transaction price to the distinct performance obligation described above, and the license and related know-how was transferred to ORIC during the third quarter of 2020. Therefore, the Company recognized the entire transaction price of $11.4 million during 2020 and classified the amount as license and collaboration revenues in its consolidated statements of operations and comprehensive loss. The Shares are carried at fair value and are recorded on the consolidated balance sheet as a long-term investment. Any change in fair value is recorded within other income (expense) Zai Agreement Terms of Agreement On May 28, 2021, the Company and Zai Lab Ltd. (“Zai”) entered into a Collaboration and License Agreement (the “Zai Agreement”), pursuant to which the Company and Zai agreed to collaboratively develop adagrasib in China, Hong Kong, Macau and Taiwan (collectively, the “Zai Licensed Territory”). Under the Zai Agreement, the Company granted Zai the rights to research, develop, manufacture and exclusively commercialize adagrasib in all indications in the Zai Licensed Territory, with the Company retaining exclusive rights for the development, manufacture and commercialization of adagrasib outside the Zai Licensed Territory and certain co-commercialization, manufacture, and development rights in the Zai Licensed Territory. Zai is obligated to participate in selected global, registration-enabling clinical trials and enroll patients in the Zai Licensed Territory at Zai’s expense. As consideration for the rights granted to Zai under the Zai Agreement, Zai agreed to pay the Company a non-refundable, non-creditable up-front fee of $65.0 million. Under the Zai Agreement, the Company is entitled to potential development and regulatory-based milestone payments of up to $93.0 million, and tiered sales milestone payments of up to $180.0 million based on net sales in the Zai Licensed Territory. The Zai Agreement additionally provides that Zai is obligated to pay to the Company royalties at tiered percentage rates ranging from the high-teens to the low-twenties on annual net sales of licensed products in the Zai Licensed Territory, subject to reduction under specified circumstances. The Zai Agreement also provides that the Company will supply Zai with adagrasib for use in Zai’s development activities in the Zai Licensed Territory at Zai’s expense. The Zai Agreement will terminate on a licensed product-by-licensed product basis and on a region-by-region basis in the Zai Licensed Territory, upon the later to occur of (i) the date of expiration of the last valid claim covering such licensed product in such region, (ii) the date that is ten years after the date of the first commercial sale in such region and (iii) the expiration date of any regulatory exclusivity for such licensed product in such region, or for a co-commercialized product on the date the parties agree to terminate such co-commercialization, or in its entirety upon the expiration of all payment obligations under the Zai Agreement. Zai may terminate the Zai Agreement at any time by providing 12 months’ notice to the Company. Either party may terminate the Zai Agreement upon a material breach by the other party that remains uncured or upon certain bankruptcy events. In addition, the Company may terminate the Zai Agreement if Zai challenges the licensed patent rights. Revenue Recognition The Company evaluated the Zai Agreement under Topic 606. The Company determined that two performance obligations existed: (1) the license to intellectual property, bundled with the associated know-how and (2) the Company’s initial obligation to supply adagrasib for clinical development in the Zai Licensed Territory. At the time it entered into the Zai Agreement, the Company determined the transaction price was equal to $66.6 million, which includes the up-front fee and other incidental amounts. In estimating the stand-alone selling price for each performance obligation, the Company developed assumptions that require judgment and included forecasted revenues, expected development timelines, discount rates, probabilities of technical and regulatory success, forecasted costs for manufacturing clinical supplies and cost savings related to Zai’s participation in selected trials. The Company allocated the full transaction price to the license to the Company’s intellectual property, bundled with the associated know-how. The Company concluded the variable payments related to the Company’s initial obligation to supply adagrasib for clinical development in the Zai Licensed Territory relate specifically to the Company’s efforts to satisfy this performance obligation and the obligation to provide the initial clinical supply approximates the stand-alone selling price. Payments under the Zai Agreement are subject to foreign tax withholdings. Licenses of Intellectual Property. The license to the Company’s intellectual property, bundled with the associated know-how, represents a distinct performance obligation. The license and associated know-how was transferred to Zai during the year ended December 31, 2021 and, therefore during 2021, the Company recognized the full revenue amount of $66.6 million as license and collaboration revenues and $3.3 million as income tax expense in its consolidated statements of operations and comprehensive loss. Manufacturing Supply Services. The Company’s initial obligation to supply adagrasib for clinical development in the Zai Licensed Territory represents a distinct performance obligation. As such, the Company will recognize revenue when Zai obtains control of the goods. The Company recognized $1.5 million of revenue related to this performance obligation for the year ended December 31, 2022. No revenue related to this performance obligation was recognized for the year ended December 31, 2021. The Company may also become responsible for manufacturing adagrasib for commercial supply and will receive reimbursement that approximates stand-alone selling prices. Milestone Payments. The Company is entitled to development milestone payments and certain regulatory and sales milestone payments which are paid upon achievement of the development milestones, upon receipt of regulatory approvals and annual net sales thresholds within the Zai Licensed Territory under the Zai Agreement. The Company earned a $5.0 million milestone payment related to the initiation of the first pivotal clinical trial of adagrasib for the first indication in China and a $5.0 million milestone payment related to the initiation of the first pivotal clinical trial of adagrasib for the second indication in China and recognized $0.5 million as income tax expense during the year ended December 31, 2022. No milestone payments were earned during the year ended December 31, 2021. The Company evaluated whether or not the milestones are considered probable of being reached and determined that their achievement is highly dependent on factors outside of the Company’s control. These payments have been fully constrained and therefore are not included in the transaction price. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of each milestone and any related constraint and, if necessary, adjust its estimate of the overall transaction price. Any such adjustments will be recorded on a cumulative catch-up basis, which would affect the reported amount of license and collaboration revenues in the period of adjustment. Royalties. As the license is deemed to be the predominant item to which sales-based royalties relate, the Company will recognize revenue when the related sales occur. No royalty revenue was recognized during the years ended December 31, 2022 or 2021. |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Shareholders' Equity | Common Stock The following shares were reserved for future issuance: December 31, 2022 Common stock options outstanding 5,537,791 Restricted stock units outstanding 2,161,765 Warrants to purchase common stock 7,605,811 Employee Stock Purchase Plan 48,032 Shares available for grant 4,520,741 Total 19,874,140 Sale of Common Stock In November 2021, the Company issued and sold 3,448,275 shares of its common stock at a public offering price of $145.00 per share. After deducting underwriter discounts, commissions and estimated offering expenses, the Company received net proceeds from the transaction of $474.7 million. In October 2020, the Company issued and sold 4,585,706 shares of its common stock at a public offering price of $202.00 per share. After deducting underwriter discounts, commissions and estimated offering expenses, the Company received net proceeds from the transaction of approximately $879.6 million. In January 2020, the Company issued and sold 3,538,462 shares of its common stock at a public offering price of $97.50 per share. After deducting underwriter discounts, commissions and offering expenses, the Company received net proceeds from the transaction of $324.0 million. At the Market Facility On July 2, 2020, the Company entered into a sales agreement pursuant to which the Company may, from time to time, sell shares of the Company’s common stock, par value $0.001 per share, having an aggregate offering price of up to $200.0 million. On July 2, 2021, the Company entered into an amended and restated sales agreement pursuant to which the Company may, from time to time, sell shares of the Company’s common stock, par value $0.001 per share, having an aggregate offering price of up to $500.0 million. During the year ended December 31, 2022, the Company issued and sold 1,880,097 shares of common stock under this sales agreement generating net proceeds of $155.0 million. During the years ended December 31, 2021 and 2020, no shares of common stock were issued and sold under this agreement. As of December 31, 2022, the Company has issued and sold an aggregate of 1,880,097 shares of common stock pursuant to this sales agreement. Warrants As of December 31, 2022, the following warrants for common stock were issued and outstanding: Issue Date Expiration Date Exercise Price Number of Warrants Outstanding January 11, 2017 None $ 0.001 3,578,036 November 20, 2017 None $ 0.001 3,669,360 June 11, 2018 None $ 0.001 358,415 7,605,811 During the year ended December 31, 2022, no warrants were exercised. During the year ended December 31, 2021, 623,821 warrants for shares of the Company’s common stock were exercised via cashless exercise, resulting in the issuance of 623,814 shares of common stock. During the year ended December 31, 2020, 1,400,012 warrants for shares of the Company’s common stock were exercised via cashless exercise, resulting in the issuance of 1,400,000 shares of common stock, and 63,235 warrants for shares of the common stock were exercised for cash, generating immaterial net proceeds. |
Share-Based Compensation
Share-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | Equity Incentive Plan In May 2013 the Company’s Board of Directors adopted the 2013 Equity Incentive Plan (the “2013 Plan”). The Company’s Board of Directors and stockholders approved an amendment to the 2013 Plan in 2021 to, among other things, increase the aggregate number of shares of common stock authorized for issuance under the 2013 Plan by 2.5 million shares. In May 2022, the 2022 Equity Incentive Plan (the “2022 Plan”) was approved by the Company’s Board of Directors and stockholders as the successor to the 2013 Plan. All shares available under the 2013 Plan were transferred to the 2022 Plan and the aggregate number of shares of common stock authorized for issuance under the 2022 Plan was increased by 3.5 million shares. As of December 31, 2022, there were approximately 4.1 million shares available to be granted from the 2022 Plan. In December 2019, the Company’s Board of Directors adopted the Inducement Plan, reserving shares of the Company’s common stock for issuance of stock options and other equity-based awards to new employees who satisfy the standards for inducement grants in accordance with the Nasdaq Stock Market LLC listing rules. In July 2022, the Company's Board of Directors approved an amendment to the Inducement Plan to increase the aggregate number of shares of common stock authorized for issuance by 1.0 million shares. As of December 31, 2022, there were 0.4 million shares available to be issued from the Inducement Plan. As of December 31, 2022, share-based compensation awards consist of incentive and non-qualified stock options, restricted stock units, and performance stock units. Stock options granted under each of the plans must have an exercise price equal to at least 100% of the fair market value of the Company’s common stock on the date of grant and generally vest over four years. Stock options granted under the 2013 Plan, the 2022 Plan and the Inducement Plan have a contractual term of ten years. Stock Options The following table summarizes the Company’s stock option activity and related information for the year ended December 31, 2022: Number of Weighted Weighted-Average Remaining Contractual Term (years) Aggregate Intrinsic Value (millions) Balance outstanding as of December 31, 2021 4,532,252 $ 85.38 Granted 1,690,707 $ 94.43 Exercised (272,434) $ 36.43 Forfeited and expired (412,734) $ 132.27 Balance outstanding as of December 31, 2022 5,537,791 $ 87.05 6.7 $ 33.0 Options exercisable at December 31, 2022 3,187,936 $ 68.49 5.1 $ 32.4 The total intrinsic value of stock options exercised was $15.5 million, $91.1 million and $121.5 million for the years ended December 31, 2022, 2021 and 2020, respectively. The Company received total cash of $9.9 million, $28.0 million and $45.9 million for the exercise of options for the years ended December 31, 2022, 2021 and 2020, respectively. The total fair value of options vested during the years ended December 31, 2022, 2021 and 2020 was $73.9 million, $58.3 million and $52.1 million, respectively. The fair value of options granted is estimated at the date of grant using the Black-Scholes option pricing model. Forfeitures are accounted for as incurred as a reversal of any share-based compensation expense related to options that will not vest. The assumptions used for the specified reporting periods and the resulting estimates of weighted-average estimated fair value per share of options granted during those periods are as follows: Year Ended December 31, 2022 2021 2020 Risk-free interest rate 2.4% 0.8% 1.1% Dividend yield —% —% —% Volatility factor 74.5% 76.9% 81.5% Expected term (in years) 5.1 5.1 5.6 Weighted-average estimated fair value per share $58.11 $110.43 $77.92 Risk-Free Interest Rate - The risk-free interest rate is the rate for periods equal to the expected term of the stock option based on U.S. Treasury zero-coupon bonds. Dividend Yield - The dividend yield is based on the Company’s history and expectation of dividend payouts. The Company has not paid, and does not intend to pay dividends. Volatility Factor - The expected volatility assumption was determined by examining the historical volatility of the Company’s stock. Expected Term - The expected term represents the weighted-average period the stock options are expected to be outstanding. The total compensation cost not yet recognized as of December 31, 2022 related to non-vested option awards was $79.0 million which will be recognized over a weighted-average period of 1.3 years. Restricted Stock Units (“RSUs”) The Company began issuing RSUs during 2020. RSUs generally vest annually over four years and are subject to continued service. A summary of the Company’s RSU activity for the year ended December 31, 2022 is as follows: Number of Weighted Average Grant Date Fair Value Aggregate Intrinsic Value (millions) Balance outstanding as of December 31, 2021 720,567 $ 156.55 Granted 1,571,697 $ 83.78 Released (217,542) $ 152.95 Canceled/forfeited (193,048) $ 124.21 Balance outstanding as of December 31, 2022 1,881,674 $ 99.51 $ 85.3 The total fair value of RSUs that vested during the year ended December 31, 2022 was $33.3 million. The total compensation cost not yet recognized as of December 31, 2022 related to non-vested RSUs was $99.8 million, which will be recognized over a weighted-average period of 1.5 years. Performance Stock Units (“PSUs”) The Company began issuing PSUs during 2020. PSUs generally begin to vest upon achievement of certain performance goals and are subject to continued service. A summary of the Company’s PSU activity for the year ended December 31, 2022 is as follows: Number of Weighted Average Grant Date Fair Value Aggregate Intrinsic Value (millions) Balance outstanding as of December 31, 2021 281,611 $ 157.58 Granted 99,050 $ 35.57 Released (67,850) $ 158.89 Canceled/forfeited (32,720) $ 150.31 Balance outstanding as of December 31, 2022 280,091 $ 114.96 $ 12.7 The total fair value of PSUs that vested during the year ended December 31, 2022 was $10.8 million. The total compensation cost not yet recognized as of December 31, 2022 related to non-vested PSUs was $15.8 million, which will be recognized over a weighted-average period of 1.3 years. Total share-based compensation expense by consolidated statement of operations and comprehensive loss classification is presented below (in thousands): Year ended December 31, 2022 2021 2020 Research and development expense $ 113,544 $ 68,496 $ 48,044 Selling, general and administrative expense 72,644 45,006 37,803 $ 186,188 $ 113,502 $ 85,847 For the years ended December 31, 2022, 2021 and 2020, no share-based compensation expense was capitalized and there were no recognized tax benefits associated with the share-based compensation charge. 2013 Employee Stock Purchase Plan In May 2013, the Company’s Board of Directors adopted and the stockholders approved the 2013 Employee Stock Purchase Plan (the “ESPP”). In December 2014, the ESPP became effective and the first purchase period began. The ESPP permits eligible employees to make payroll deductions to purchase up to $25,000 of the Company’s common stock on regularly scheduled purchase dates at a discount. Offering periods under the ESPP are not more than six months in duration and shares are purchased at 85% of the lower of the closing price for the Company’s common stock on the first day of the offering period or the date of purchase. The ESPP initially authorized the issuance of 300,000 shares of the Company’s common stock pursuant |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plan | The Company has a defined contribution 401(k) plan (the “Plan”) for all employees. Employees are eligible to participate in the Plan if they are at least 21 years of age or older. Under the terms of the Plan, employees may make voluntary contributions as a percentage of compensation. The Company matches up to 5% of an employee’s earnings, subject to Internal Revenue Service limitations. Expense associated with the Company’s matching contribution totaled $4.6 million, $2.5 million and $1.3 million for the years ended December 31, 2022, 2021 and 2020 respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | The income tax expense recorded during the year ended December 31, 2022 of $0.5 million was related to foreign withholding taxes on the milestone payment received in connection with the Zai Agreement. The income tax expense recorded during the year ended December 31, 2021 of $3.3 million was related to foreign withholding taxes on the up-front fee in connection with the Zai Agreement. The Company had no federal income tax expense and immaterial state tax expense for the year ended December 31, 2020. The differences between the effective income tax rate and the statutory tax rates during the years ended 2022, 2021 and 2020 are as follows (in thousands): Year Ended December 31, 2022 2021 2020 Net loss before tax $ (740,359) $ (578,485) $ (357,937) Statutory U.S. federal tax rate 21.00 % 21.00 % 21.00 % Tax computed at federal statutory rate (155,475) (121,482) (75,167) State income taxes, net of federal benefit (2,305) (4,657) (13,490) Increase (decrease) in taxes recoverable resulting from: Effect of change in valuation allowance 198,064 150,487 110,985 Non-deductible share-based compensation 6,754 4,783 2,724 Tax deductions for share-based compensation 3,876 (17,243) (17,991) Tax credits (73,383) (30,289) (15,672) Dissolution of Canadian entity 24,761 — — Foreign withholding taxes 508 3,299 — Change in tax rate (11,224) 2,972 — Unrecognized tax benefits 6,965 7,573 3,857 Return to provision and other true-ups (3,871) 115 25 Non-deductible officers’ compensation 5,969 8,318 4,697 Other differences (131) (577) 32 Income tax expense $ 508 $ 3,299 $ — Deferred Tax The following table summarizes the significant components of the Company’s deferred tax assets (in thousands): December 31, 2022 2021 Deferred tax assets: Tangible and intangible depreciable assets $ 183,129 $ 29,576 Stock compensation 46,013 26,738 Provisions 12,385 5,740 Lease liability 11,739 9,916 Non-current investment 1,814 673 Net operating loss carryforward 254,820 299,204 Capital loss carryforward — 89 Canada scientific research and experimental development expenditures — 5,471 U.S. research and development tax credits 118,019 51,550 Total gross deferred tax assets 627,919 428,957 Less valuation allowance (619,686) (421,044) Net deferred tax assets $ 8,233 $ 7,913 Deferred tax liabilities: Right-of-use asset $ (8,233) $ (7,913) Net deferred income taxes $ — $ — The total valuation allowance increased by $198.6 million for the year ended December 31, 2022. The Company has established a full valuation allowance against its net deferred tax assets as of December 31, 2022 due to the uncertainty surrounding the realization of such assets as evidenced by the cumulative losses from operations through December 31, 2022. At December 31, 2022, the Company’s net operating loss carry forwards (“NOLs”) for U.S. federal, California, and other state income tax purposes were $1.1 billion, $271.8 million and $1.6 million, respectively. The U.S. federal and California NOLs begin to expire in 2033, and the other state NOLs begin to expire at various dates starting in 2037. The future utilization of the U.S. federal and state NOL and credit carryforwards to offset future taxable income and tax, respectively, may be subject to an annual limitation as a result of ownership changes that may have occurred previously or may occur in the future. The Tax Reform Act of 1986 (the “Act”) limits a company’s ability to utilize certain tax credit carryforwards and net operating loss carryforwards in the event of a cumulative change in ownership in excess of 50% (by value) as defined in the Act. During 2017, the Company completed a study to assess whether an ownership change, as defined by Section 382 of the Act, had occurred from the Company’s formation through December 31, 2017. The results of the study have been extended through December 31, 2022. Based upon the study, the Company determined an ownership change had occurred during 2017, causing the annual utilization of the NOL and credit carryforwards to be limited. The Company does not believe any of the NOL and credit carryforwards generated through December 31, 2022 would expire solely as a result of annual limitations on the utilization of those attributes. The Company has research and development tax credit carryforwards for U.S. federal and state income tax purposes as of December 31, 2022 of $69.7 million and $30.0 million, respectively. The federal credits will begin to expire in 2033 unless utilized and the state credits will begin to expire in 2036. Further, the Company has orphan drug tax credit carryforwards for U.S. federal income tax purposes as of December 31, 2022 of $49.0 million. The credits will begin to expire in 2041 unless previously utilized. For Canadian Federal and provincial income tax purposes, the Company’s Canadian NOLs and credits for federal scientific research and experimental development expenditures no longer exist as MethylGene was dissolved during 2022. The Company files income tax returns in the U.S. (federal and state), Netherlands, Switzerland, and will file final returns in Canada (federal and provincial). The Company’s U.S. operations have not been audited for any open taxation years. The Company has experienced losses for U.S. tax purposes and therefore, the taxation authorities may review any loss year, if and when the losses are utilized. A reconciliation of the beginning and ending amounts of unrecognized tax positions are as follows (in thousands): December 31, 2022 2021 2020 Unrecognized tax positions, beginning of year $ 24,817 $ 17,046 $ 12,916 Gross increase — current period tax positions 9,115 7,849 4,130 Gross decrease — current period tax positions — — — Gross decrease — prior period tax positions (1,940) (78) — Gross increase — prior period tax positions — — — Expiration of statute of limitations — — — Unrecognized tax positions, end of year $ 31,992 $ 24,817 $ 17,046 If recognized, none of the unrecognized tax positions would impact the Company’s income tax benefit or effective tax rate as long as the Company’s net deferred tax assets remain subject to a full valuation allowance. The Company does not expect any significant increases or decreases to the Company’s unrecognized tax positions within the next 12 months. The Company recognizes interest and penalties related to unrecognized tax benefits in income tax expense. The Company had no accrual for interest or penalties on tax matters as of December 31, 2022, 2021 and 2020. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments On June 30, 2020, the Company entered into an amended and restated lease agreement (the “Amended and Restated Lease”) for office and laboratory space located in San Diego, California, for the Company’s corporate headquarters. The Amended and Restated Lease supersedes in its entirety the original lease agreement for the Company’s future corporate headquarters dated as of August 22, 2019. The Amended and Restated Lease has a lease term of 12 years (“Lease Term”), unless terminated earlier. The Lease Term has an initial abatement period, and the initial base rent payable will be approximately $0.6 million per month following the abatement period, which amount will increase by 3% per year over the Lease Term. The Company also received incentives from the landlord for tenant improvements. During 2020, the underlying asset was available for use by the Company to construct tenant improvements and therefore, the Lease Term was considered to have commenced. The Amended and Restated Lease is considered to be an operating lease, and the Company used a discount rate of 12% to calculate the value of its lease payments over the Lease Term. As of December 31, 2022, the consolidated balance sheet includes an operating right-of-use asset of $36.1 million and a total operating lease liability of $51.5 million, of which $7.8 million is a current lease liability and included in accrued liabilities As of December 31, 2022, the approximate future minimum lease payments under the Amended and Restated Lease are as follows (in thousands): Operating Lease 2023 $ 7,844 2024 8,080 2025 8,322 2026 8,572 2027 8,829 Thereafter 50,857 Total operating lease payments (†) 92,504 Less: Amount representing interest (40,999) Total lease liability $ 51,505 ____________________ † The Company has an early termination right in 2028 in which the total contractual obligation would be reduced by $41.1 million. On June 24, 2014, the Company entered into a lease agreement for office and laboratory space located in San Diego, California. The office space under the lease was the Company’s corporate headquarters. The initial monthly rent was $24,100 per month and was subject to a 3% annual rent increase. In addition to such base monthly rent, the Company was obligated to pay certain customary amounts for its share of operating expenses and facility amenities. The original lease provided for expiration on January 31, 2018, and the Company entered into subsequent amendments to the original lease to extend the lease term to July 2021. All other terms and covenants from the original lease agreement remain unchanged. Legal Proceedings The Company is subject to various claims, complaints and legal actions that arise from time to time in the normal course of business, including commercial insurance, product liability, intellectual property and employment related matters. In addition, from time to time the Company may bring claims or initiate lawsuits against various third parties with respect to matters arising out of the ordinary course of its business, including commercial and employment related matters. In November 2022, the Company filed a civil lawsuit in Shanghai Intellectual Property Court against InventisBio Co., Ltd., its wholly-owned subsidiary InventisBio LLC, and its deputy general manager and director Xing Dai (collectively, the “Defendants”). The lawsuit seeks to protect the Company’s intellectual property rights and alleges the Defendants misappropriated the trade secrets of the Company in connection with a certain pre-clinical research project of the Defendants. The Company seeks an injunction immediately enjoining the Defendants from improperly obtaining, disclosing, using, sharing and otherwise misappropriating the trade secrets of the Company, a declaratory judgment that ownership of the relevant patents and patent applications belongs to the Company, and other related relief. A trial date has not been set. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation These consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). These consolidated financial statements include the accounts of the Company, Mirati B.V., Mirati Suisse, and MethylGene (until its dissolution in December 2022). All significant inter-company transactions, balances and expenses have been eliminated upon consolidation. These consolidated financial statements are presented in United States (“U.S.”) Dollars, which is also the functional currency of the Company. |
Use of Estimates | Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. Reported amounts and footnote disclosures reflect the overall economic conditions that are most likely to occur and anticipated measures management intends to take. Actual results could differ materially from those estimates. Estimates and assumptions are reviewed quarterly. Any revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected. |
Cash, Cash Equivalents, and Short-term Investments | Cash, Cash Equivalents and Short-term InvestmentsCash and cash equivalents consist of cash and highly liquid securities with original maturities at the date of acquisition of ninety days or less. Investments with an original maturity of more than ninety days are considered short-term investments and have been classified by management as available-for-sale. These investments are classified as current assets, even though the stated maturity date may be one year or more beyond the current consolidated balance sheet date, which reflects management’s intention to use the proceeds from sales of these securities to fund its operations, as necessary. Such investments are carried at fair value, and the unrealized gains and losses are reported as a component of accumulated other comprehensive income in shareholders’ equity until realized. Realized gains and losses from the sale of available-for-sale securities, if any, are determined on a specific identification basis. |
Concentration of Credit Risk | Concentration of Credit Risk The Company invests its excess cash in accordance with its investment policy. The Company’s investments are comprised primarily of commercial paper and debt instruments of financial institutions, corporations, U.S. government-sponsored agencies and the U.S. Treasury. The Company mitigates credit risk by maintaining a diversified portfolio and limiting the amount of investment exposure as to institution, maturity and investment type. Financial instruments that potentially subject the Company to significant credit risk consist principally of cash equivalents and short-term investments. |
Accounts Receivable, net | Accounts Receivable, net Accounts receivable, net consists of trade receivables which are amounts due from customers related to product sales. The Company records trade receivables net of chargebacks, invoice discounts, distribution service fees and any allowances for doubtful accounts for potential credit losses. An allowance for doubtful accounts is determined based on the financial condition and creditworthiness of customers and the Company considers economic factors and events or trends expected to affect future collections experience. Any allowance would reduce the net receivables to the amount that is expected to be collected. The payment history of the Company’s customers will be considered in future assessments of collectibility as these patterns are established over a longer period of time. As of December 31, 2022, the Company determined an allowance for doubtful accounts was not required. The Company did not have trade receivables as of December 31, 2021. |
Inventory | Inventory The Company began capitalizing inventory for KRAZATI, which received approval by the U.S. Food and Drug Administration (“FDA”) and launched commercially in the U.S. in December 2022. KRAZATI is approved for the treatment of adult patients with KRAS G12C-mutated non-small cell lung cancer (“NSCLC”) who have received at least one prior systemic therapy. Prior to regulatory approval, all direct and indirect manufacturing costs were charged to research and development expense in the period incurred. Inventory is comprised of raw materials, work-in-process and finished goods, and includes costs related to third-party contract manufacturing, packaging, freight-in and overhead. Inventory is stated at the lower of cost or net realizable value with cost based on the first-in-first-out method. The Company performs an assessment of recoverability of capitalized inventory during each reporting period based on an analysis of forecasted demand compared to quantities on hand and any firm purchase orders, as well as product shelf life, and writes down any excess, obsolete or unsaleable inventory to its estimated realizable value in the period which the impairment is first identified. Such write downs, should they occur, are charged to cost of product revenue in the consolidated statement of operations and comprehensive loss. As of December 31, 2022, the Company did not identify any impaired inventory. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with the guidance of Revenue From Contracts With Customers , Accounting Standards Codification (“ASC”) Topic 606 (“Topic 606”). Under Topic 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements the Company determines are within the scope of Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Product revenue, net The Company’s product revenue consists of sales of KRAZATI. The Company sells KRAZATI principally to specialty pharmacies and specialty distributors, which are referred to as the Company’s customers. These customers subsequently resell the product to healthcare providers and patients. Revenues from product sales are recognized when the customer obtains control of the Company’s product, which occurs at a point in time, typically upon delivery to the customer. The Company records revenues from product sales at the net sales price, or transaction price, which includes estimates of variable consideration for which reserves are established primarily from chargebacks, government and commercial rebates, incentives, product returns, trade discounts and other allowances that are offered in contracts between the Company and its customers, healthcare providers and other third-party payors relating to the sales of its product. These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of trade receivables, if the amount is deductible by the customer from payments to the Company, which is included within accounts receivable, net on the consolidated balance sheet, or a current liability, if the amount is payable by the Company to a customer or third-party, which is included within accrued liabilities on the consolidated balance sheet. The Company estimates the amount of variable consideration to include in the transaction price using the expected value method. These estimates take into consideration relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, forecasted customer buying and payment patterns, and the Company’s historical experience that will develop over time as KRAZATI is the Company’s first commercial product. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of its contracts. The amount of variable consideration may be constrained and is included in the transaction price only to the extent that it is probable that a significant reversal of the amount of cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenues and earnings in the period such variances become known. The following are the components of variable consideration related to product revenue: Chargebacks. Chargebacks relate to contracts with various third-party payors, including governmental healthcare programs, managed care providers, group purchasing organizations and other organizations, that generally purchase the product from a specialty distributor at a discounted price. The specialty distributor, in turn, charges back to the Company the difference between the price initially paid by the specialty distributor and the discounted price paid to the specialty distributor by its contracted customer. The allowance for chargebacks is based on actual chargebacks received and an estimate of sales by the specialty distributor to its contracted customers. These reserves are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue. Government rebates. The Company is subject to discount obligations under Medicare, Medicaid, and other governmental healthcare programs in the U.S. The Company’s estimates of rebates are based on the government-mandated discounts, which are statutorily-defined and applicable to these government funded programs. These reserves are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue and the accrual of an estimated liability. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom it will owe an additional liability under the Medicare Part D program. Commercial rebates. The Company contracts with various private payor organizations and group purchasing organizations for the payment of rebates with respect to the utilization of its product. The Company’s estimates for the expected utilization of rebates are based on customer and payor data received from the specialty pharmacies and specialty distributors and historical utilization rates that will develop over time as KRAZATI is the Company’s first commercial product. These reserves are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue and the accrual of an estimated liability. Incentives. The Company offers incentives such as co-payment assistance to commercially insured patients in the U.S. who meet certain eligibility requirements. The Company may provide financial assistance to participating patients with prescription drug co-payments required by the patients’ insurance provider, up to a specified dollar amount. These reserves are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue and the accrual of an estimated liability. Product returns. Generally, the Company’s customers have the right to return product for a limited time before and after its expiration date. Since the Company does not have its own returns experience, it estimates returns based on available industry data for comparable products in the market as well as other information, such as visibility into the inventory remaining in the distribution channel and expiration date. As the Company distributes its product and establishes historical sales over a longer period of time, the Company will be able to place more reliance on historical purchasing, demand and return patterns of its customers when evaluating its reserves for product returns. The estimate for product returns is recorded as an accrued liability and a reduction of revenue in the period the related product sales are recognized. Trade allowances. The Company may provide invoice discounts on product sales to its customers for prompt payment based on contractual terms. These discounts are recorded as a reduction of revenue in the period the related product revenue is recognized. Trade receivables are recorded net of the allowance for these discounts. The Company also pays fees to its distributors for their services. The Company has determined such services are not distinct from the Company’s sale of product to its customers and therefore records these payments as a reduction of revenue in the period the related product revenue is recognized. To the extent the services received are distinct from the Company’s sale of product to its customers, these payments will be recorded within selling, general and administrative expense in the consolidated statement of operations and comprehensive loss. License and collaboration revenues The Company’s license and collaboration revenues have been generated primarily through collaborative research, development, manufacture and commercialization agreements. The terms of these agreements generally include the license of intellectual property and associated know-how and the provision of other goods and services. Payments to the Company under these arrangements typically include one or more of the following: non-refundable, upfront license fees; manufacturing supply services; milestone payments; and royalties on future product sales. License of Intellectual Property . If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue associated with the bundled performance obligation. Manufacturing Supply Services . The Company’s obligation under the agreements may include the initial supply of material for clinical development. If determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue allocated to this performance obligation when the collaborative partner obtains control of the goods. If determined not to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue allocated to the combined performance obligation as the related performance obligations are satisfied. Milestone Payments. At the inception of each arrangement that includes milestone payments based upon the achievement of specified clinical development, regulatory and/or sales milestones, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price. If it is probable that a significant revenue reversal would not occur, the associated milestone amount is included in the transaction price. Milestone payments that are dependent on factors outside of the Company’s control, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. These payments are fully constrained and therefore are not included in the transaction price. At the end of each reporting period, the Company re-evaluates the probability of achievement of each milestone and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect the reported amount of license and collaboration revenues in the period of adjustment. Royalties. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). |
Property and Equipment, Net | Property and Equipment, Net Property and equipment is stated at historical cost less accumulated depreciation. Historical cost includes expenditures that are directly attributable to the acquisition of the items. All repairs and maintenance are charged to consolidated net loss during the financial period in which they are incurred. Depreciation of property and equipment is calculated using the straight-line method over the estimated useful lives of the assets, as follows: Computer equipment 3 years Office and other equipment 6 years Laboratory equipment 6 years Leasehold improvements The lesser of the lease term or the life of the asset Upon disposal or impairment of property and equipment, the cost and related accumulated depreciation is removed from the consolidated financial statements and the net amount, less any proceeds, is included in consolidated net loss. |
Intangible Asset, Net | Intangible Asset, Net The Company’s finite-lived intangible asset resulted from the capitalization of a milestone payment due under a license and collaboration agreement in connection with the first commercial sale of KRAZATI in the U.S. in December 2022. The intangible asset will be amortized on a straight-line basis over its remaining useful life, which is estimated to be the remaining patent life of KRAZATI. Amortization expense is recorded as cost of product revenue in the consolidated statement of operations and comprehensive loss. |
Impairment of Long-Lived Assets | Impairment of Long-Lived AssetsThe Company reviews its long-lived assets, including property and equipment and finite-lived intangible assets, for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. If such circumstances are determined to exist, an estimate of undiscounted future cash flows produced by the long-lived asset, including its eventual residual value, is compared to the carrying value to determine whether impairment exists. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written-down to their estimated fair values. Fair value is estimated through discounted cash flow models to project cash flows from the asset. |
Cost of Product Revenue | Cost of Product RevenueCost of product revenue includes direct and indirect costs related to the manufacturing and distribution of KRAZATI, including materials, third-party manufacturing costs, packaging services, freight-in, overhead, royalties payable on net sales of KRAZATI and inventory reserves. All product costs incurred prior to FDA approval of KRAZATI in December 2022 were charged to research and development expense. |
Share-Based Compensation Expense | Share-Based Compensation Expense The Company measures and recognizes compensation expense for share-based payments based on estimated fair value as of the grant date. The fair value of restricted stock units is determined using the intrinsic value method. The fair value of performance stock units, which vest based on the achievement of pre-established performance goals, is determined using the intrinsic value method and the probability that the specified performance criteria will be met. The fair value of stock options is determined using the Black-Scholes option-pricing model. The Black-Scholes option-pricing model requires the use of certain estimates and assumptions that affect the amount of share-based compensation expense recognized in the Company’s consolidated financial statements. These assumptions include the expected volatility of the Company’s stock price, expected term of the options, the risk-free interest rate and expected dividend yields. Share-based compensation expense is recognized using the graded accelerated vesting method. |
Research and Development Expenses | Research and Development ExpensesResearch and development expenses are charged to consolidated net loss in the period in which they are incurred and are comprised of the following types of costs incurred in performing research and development activities: contract services for clinical trials and related clinical manufacturing costs, salaries and benefits including share-based compensation expense, costs for allocated facilities and depreciation of equipment and license fees paid in connection with the Company’s early discovery efforts |
General and Administrative Expenses | Selling, General and Administrative ExpensesSelling, general and administrative expenses consist primarily of salaries and related benefits, including share-based compensation expense, related to the Company’s executive, finance, legal, commercial and support functions. Other selling, general and administrative expenses include commercial activities such as marketing, professional fees, rent and utilities and insurance. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Lease right-of-use assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to make lease payments arising from the lease. For operating leases with an initial term greater than 12 months, the Company recognizes operating lease right-of-use assets and operating lease liabilities based on the present value of lease payments over the lease term at the commencement date. Operating lease right-of-use assets are comprised of the lease liability plus any lease payments made and excludes lease incentives. Lease terms include options to renew or terminate the lease when the Company is reasonably certain that the renewal option will be exercised or when it is reasonably certain that the termination option will not be exercised. For the Company's operating leases, if the interest rate used to determine the present value of future lease payments is not readily determinable, the Company estimates its incremental borrowing rate as the discount rate for the lease. The Company's incremental borrowing rate is estimated to approximate the interest rate on a collateralized basis with similar terms and payments, and in similar economic environments. Lease expense for lease payments is recognized on a straight-line basis over the lease term. The Company has elected the practical expedient to not separate lease and non-lease components. |
Income Taxes | Income Taxes Income taxes have been accounted for using the asset and liability method. Under the asset and liability method, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates applicable to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in net loss in the period that includes the enactment date. A valuation allowance against deferred tax assets is recorded if, based upon the weight of all available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. For uncertain tax positions that meet “a more likely than not” threshold, the Company recognizes the benefit of uncertain tax positions in the consolidated financial statements. |
Segment Reporting | Segment Reporting Operating segments are components of a business where separate discrete financial information is available for evaluation by the chief operating decision-maker for purposes of making decisions regarding resource allocation and assessing performance. To date, the Company and the chief operating decision-maker has viewed its operations and managed its business as one segment operating primarily in the United States. |
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 common shares outstanding during the period, without consideration for common share equivalents as they are anti-dilutive. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and common share equivalents outstanding for the period, as well as certain shares that are contingently issuable. Common share equivalents outstanding, determined using the treasury stock method, are comprised of shares that may be issued under the Company’s stock option and warrant agreements, as well as restricted stock units and performance stock units. |
Recently Adopted Accounting Pronouncements | Recently Issued and Recently Adopted Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. The Company has evaluated recently issued accounting pronouncements and does not believe any will have a material impact on the Company’s consolidated financial statements or related financial statement disclosures. |
Fair Value Measurements | The authoritative guidance for fair value measurements defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or the most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Market participants are buyers and sellers in the principal market that are (i) independent, (ii) knowledgeable, (iii) able to transact, and (iv) willing to transact. The guidance prioritizes the inputs used in measuring fair value into the following hierarchy: • Level 1- Quoted prices (unadjusted) in active markets for identical assets or liabilities; • Level 2- Inputs other than quoted prices included within Level 1 that are either directly or indirectly observable; and • Level 3- Unobservable inputs in which little or no market activity exists, therefore requiring an entity to develop its own assumptions about the assumptions that market participants would use in pricing. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Estimated Useful Lives of Assets | Depreciation of property and equipment is calculated using the straight-line method over the estimated useful lives of the assets, as follows: Computer equipment 3 years Office and other equipment 6 years Laboratory equipment 6 years Leasehold improvements The lesser of the lease term or the life of the asset |
Schedule of Potentially Dilutive Securities Excluded from Earnings Per Share Calculation | The following table presents the weighted average number of common share equivalents, calculated using the treasury stock method, as well as certain shares that are contingently issuable, not included in the calculation of diluted net loss per share due to the anti-dilutive effect of the securities: Year Ended December 31, 2022 2021 2020 Common stock options 1,194,371 2,358,594 2,503,294 Common stock warrants 7,605,711 7,713,576 9,210,824 Unvested restricted stock units and performance stock units 1,748,730 656,158 347,261 Total 10,548,812 10,728,328 12,061,379 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Short-Term Investments | The following tables summarize the Company’s short-term investments (in thousands): As of December 31, 2022 Maturity Amortized cost Gross unrealized gains Gross unrealized losses Estimated fair value Corporate debt securities 2 years or less $ 95,195 $ — $ (662) $ 94,533 Commercial paper 1 year or less 443,489 65 (811) 442,743 U.S. Agency bonds 2 years or less 90,351 22 (434) 89,939 U.S. Treasury bills 2 years or less 223,216 8 (1,862) 221,362 $ 852,251 $ 95 $ (3,769) $ 848,577 As of December 31, 2021 Maturity Amortized cost Gross unrealized gains Gross unrealized losses Estimated fair value Corporate debt securities 2 years or less $ 236,170 $ 36 $ (248) $ 235,958 Commercial paper 1 year or less 621,947 127 (95) 621,979 U.S. Agency bonds 1 year or less 58,092 — — 58,092 U.S. Treasury bills 2 years or less 162,500 — (272) 162,228 $ 1,078,709 $ 163 $ (615) $ 1,078,257 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value on a Recurring Basis | The following tables summarize the assets measured at fair value on a recurring basis (in thousands): December 31, 2022 Total Level 1 Level 2 Level 3 Assets Cash and cash equivalents: Cash $ 53,033 $ 53,033 $ — $ — Money market funds 174,262 174,262 — — U.S. Agency bonds 7,965 — 7,965 — Total cash and cash equivalents 235,260 227,295 7,965 — Short-term investments: U.S. Treasury bills 221,362 221,362 — — Corporate debt securities 94,533 — 94,533 — Commercial paper 442,743 — 442,743 — U.S. Agency bonds 89,939 — 89,939 — Total short-term investments 848,577 221,362 627,215 — Long-term investment: ORIC Pharmaceuticals, Inc. 3,465 3,465 — — Total $ 1,087,302 $ 452,122 $ 635,180 $ — December 31, 2021 Total Level 1 Level 2 Level 3 Assets Cash and cash equivalents: Cash $ 19,347 $ 19,347 $ — $ — Money market funds 393,736 393,736 — — Total cash and cash equivalents 413,083 413,083 — — Short-term investments: U.S. Treasury bills 162,228 162,228 — — Corporate debt securities 235,958 — 235,958 — Commercial paper 621,979 — 621,979 — U.S. Agency bonds 58,092 — 58,092 — Total short-term investments 1,078,257 162,228 916,029 — Long-term investment: ORIC Pharmaceuticals, Inc. 8,218 — — 8,218 Total $ 1,499,558 $ 575,311 $ 916,029 $ 8,218 |
Schedule of Changes in Estimated Fair Value of Assets with Unobservable Inputs | The following table represents the changes in estimated fair value of the Company’s Level 3 investment (in thousands): Balance as of December 31, 2020 $ 15,629 Change in fair value (7,411) Balance as of December 31, 2021 $ 8,218 Change in fair value at lock-up expiration (3,100) Transfer from Level 3 to Level 1 at lock-up expiration (5,118) Balance as of December 31, 2022 $ — Other than the investment in ORIC described above, there were no transfers between fair value measurement levels in the years ended December 31, 2022 and 2021. |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | Inventory consisted of the following (in thousands): December 31, 2022 2021 Raw materials $ — $ — Work-in-process 2,994 — Finished goods 26 — Total inventory $ 3,020 $ — |
Other Current Assets and Othe_2
Other Current Assets and Other Long-Term Assets (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Schedule of Other Current Assets | Other current assets and other long-term assets consisted of the following (in thousands): December 31, 2022 2021 Other current assets: Prepaid expenses $ 15,207 $ 11,895 Deposits and other receivables 3,162 2,235 Interest receivables 2,870 2,513 Total other current assets $ 21,239 $ 16,643 Other long-term assets: Deposits and prepaid expenses $ 21,025 $ 18,429 Restricted cash 620 620 Total other long-term assets $ 21,645 $ 19,049 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment, net consisted of the following (in thousands): December 31, 2022 2021 Laboratory equipment $ 14,027 $ 9,733 Leasehold improvements 6,482 6,275 Office and other equipment 2,165 2,131 Computer equipment 354 507 Gross property and equipment 23,028 18,646 Less: Accumulated depreciation (5,488) (2,822) Property and equipment, net $ 17,540 $ 15,824 |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Finite-Lived Intangible Assets | Intangible asset, net consisted of the following (in thousands): December 31, 2022 2021 Gross carrying value $ 15,000 $ — Less: Accumulated amortization (86) — Intangible asset, net $ 14,914 $ — |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense | As of December 31, 2022, the estimated future amortization expense associated with the Company’s intangible asset is as follows (in thousands): 2023 $ 1,034 2024 1,034 2025 1,034 2026 1,034 2027 1,034 Thereafter 9,744 Total $ 14,914 |
Accrued Liabilities and Other_2
Accrued Liabilities and Other Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accrued Liabilities and Other Liabilities [Abstract] | |
Schedule of Accrued Liabilities and Other Liabilities | Accrued liabilities and other liabilities consisted of the following (in thousands): December 31, 2022 2021 Accrued liabilities: Accrued clinical expense $ 37,604 $ 29,038 Accrued manufacturing expense 6,605 34,153 Accrued development expense 20,107 10,910 Accrued compensation and benefits 40,208 25,845 Accrued commercial expense 3,941 3,650 Accrued adjustments to product revenue 152 — Lease liability (current) 7,844 1,341 Other accrued expenses 4,126 3,558 Total accrued liabilities $ 120,587 $ 108,495 Other liabilities $ 3,022 $ 2,179 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Schedule of Shares Reserved for Future Issuance | The following shares were reserved for future issuance: December 31, 2022 Common stock options outstanding 5,537,791 Restricted stock units outstanding 2,161,765 Warrants to purchase common stock 7,605,811 Employee Stock Purchase Plan 48,032 Shares available for grant 4,520,741 Total 19,874,140 |
Schedule of Warrants Issued and Outstanding | As of December 31, 2022, the following warrants for common stock were issued and outstanding: Issue Date Expiration Date Exercise Price Number of Warrants Outstanding January 11, 2017 None $ 0.001 3,578,036 November 20, 2017 None $ 0.001 3,669,360 June 11, 2018 None $ 0.001 358,415 7,605,811 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Stock Option Activity | The following table summarizes the Company’s stock option activity and related information for the year ended December 31, 2022: Number of Weighted Weighted-Average Remaining Contractual Term (years) Aggregate Intrinsic Value (millions) Balance outstanding as of December 31, 2021 4,532,252 $ 85.38 Granted 1,690,707 $ 94.43 Exercised (272,434) $ 36.43 Forfeited and expired (412,734) $ 132.27 Balance outstanding as of December 31, 2022 5,537,791 $ 87.05 6.7 $ 33.0 Options exercisable at December 31, 2022 3,187,936 $ 68.49 5.1 $ 32.4 |
Schedule of Assumptions Used in Fair Value Estimates | The assumptions used for the specified reporting periods and the resulting estimates of weighted-average estimated fair value per share of options granted during those periods are as follows: Year Ended December 31, 2022 2021 2020 Risk-free interest rate 2.4% 0.8% 1.1% Dividend yield —% —% —% Volatility factor 74.5% 76.9% 81.5% Expected term (in years) 5.1 5.1 5.6 Weighted-average estimated fair value per share $58.11 $110.43 $77.92 |
Schedule of Restricted Stock Units Activity and Performance Stock Units Activity | A summary of the Company’s RSU activity for the year ended December 31, 2022 is as follows: Number of Weighted Average Grant Date Fair Value Aggregate Intrinsic Value (millions) Balance outstanding as of December 31, 2021 720,567 $ 156.55 Granted 1,571,697 $ 83.78 Released (217,542) $ 152.95 Canceled/forfeited (193,048) $ 124.21 Balance outstanding as of December 31, 2022 1,881,674 $ 99.51 $ 85.3 Number of Weighted Average Grant Date Fair Value Aggregate Intrinsic Value (millions) Balance outstanding as of December 31, 2021 281,611 $ 157.58 Granted 99,050 $ 35.57 Released (67,850) $ 158.89 Canceled/forfeited (32,720) $ 150.31 Balance outstanding as of December 31, 2022 280,091 $ 114.96 $ 12.7 |
Schedule of Share-based Compensation Expense | Total share-based compensation expense by consolidated statement of operations and comprehensive loss classification is presented below (in thousands): Year ended December 31, 2022 2021 2020 Research and development expense $ 113,544 $ 68,496 $ 48,044 Selling, general and administrative expense 72,644 45,006 37,803 $ 186,188 $ 113,502 $ 85,847 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Effective Income Tax Reconciliation | The differences between the effective income tax rate and the statutory tax rates during the years ended 2022, 2021 and 2020 are as follows (in thousands): Year Ended December 31, 2022 2021 2020 Net loss before tax $ (740,359) $ (578,485) $ (357,937) Statutory U.S. federal tax rate 21.00 % 21.00 % 21.00 % Tax computed at federal statutory rate (155,475) (121,482) (75,167) State income taxes, net of federal benefit (2,305) (4,657) (13,490) Increase (decrease) in taxes recoverable resulting from: Effect of change in valuation allowance 198,064 150,487 110,985 Non-deductible share-based compensation 6,754 4,783 2,724 Tax deductions for share-based compensation 3,876 (17,243) (17,991) Tax credits (73,383) (30,289) (15,672) Dissolution of Canadian entity 24,761 — — Foreign withholding taxes 508 3,299 — Change in tax rate (11,224) 2,972 — Unrecognized tax benefits 6,965 7,573 3,857 Return to provision and other true-ups (3,871) 115 25 Non-deductible officers’ compensation 5,969 8,318 4,697 Other differences (131) (577) 32 Income tax expense $ 508 $ 3,299 $ — |
Schedule of Deferred Tax | The following table summarizes the significant components of the Company’s deferred tax assets (in thousands): December 31, 2022 2021 Deferred tax assets: Tangible and intangible depreciable assets $ 183,129 $ 29,576 Stock compensation 46,013 26,738 Provisions 12,385 5,740 Lease liability 11,739 9,916 Non-current investment 1,814 673 Net operating loss carryforward 254,820 299,204 Capital loss carryforward — 89 Canada scientific research and experimental development expenditures — 5,471 U.S. research and development tax credits 118,019 51,550 Total gross deferred tax assets 627,919 428,957 Less valuation allowance (619,686) (421,044) Net deferred tax assets $ 8,233 $ 7,913 Deferred tax liabilities: Right-of-use asset $ (8,233) $ (7,913) Net deferred income taxes $ — $ — |
Schedule of Unrecognized Tax Positions | A reconciliation of the beginning and ending amounts of unrecognized tax positions are as follows (in thousands): December 31, 2022 2021 2020 Unrecognized tax positions, beginning of year $ 24,817 $ 17,046 $ 12,916 Gross increase — current period tax positions 9,115 7,849 4,130 Gross decrease — current period tax positions — — — Gross decrease — prior period tax positions (1,940) (78) — Gross increase — prior period tax positions — — — Expiration of statute of limitations — — — Unrecognized tax positions, end of year $ 31,992 $ 24,817 $ 17,046 |
Commitment and Contingencies (T
Commitment and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments | As of December 31, 2022, the approximate future minimum lease payments under the Amended and Restated Lease are as follows (in thousands): Operating Lease 2023 $ 7,844 2024 8,080 2025 8,322 2026 8,572 2027 8,829 Thereafter 50,857 Total operating lease payments (†) 92,504 Less: Amount representing interest (40,999) Total lease liability $ 51,505 ____________________ † The Company has an early termination right in 2028 in which the total contractual obligation would be reduced by $41.1 million. |
Description of Business (Detail
Description of Business (Details) $ in Millions | 3 Months Ended | 12 Months Ended |
Dec. 31, 2022 USD ($) | Dec. 31, 2022 segment | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Number of Operating Segments | segment | 1 | |
Gain On Dissolution Of Subsidiary | $ | $ 9.5 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Estimated Useful Lives (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Computer equipment | |
Property and equipment | |
Estimated useful lives | 3 years |
Office and other equipment | |
Property and equipment | |
Estimated useful lives | 6 years |
Laboratory equipment | |
Property and equipment | |
Estimated useful lives | 6 years |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Accounting Policies [Abstract] | |||
Minimum Original Maturity Period of Marketable Securities | 90 days | ||
Asset impairment charges | $ 0 | $ 0 | $ 0 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Potentially Dilutive Shares (Details) - shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potentially dilutive securities not included in the calculation of diluted net loss per share (shares) | 10,548,812 | 10,728,328 | 12,061,379 |
Common stock options | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potentially dilutive securities not included in the calculation of diluted net loss per share (shares) | 1,194,371 | 2,358,594 | 2,503,294 |
Common stock warrants | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potentially dilutive securities not included in the calculation of diluted net loss per share (shares) | 7,605,711 | 7,713,576 | 9,210,824 |
Restricted Stock Units and Performance Stock Units | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Potentially dilutive securities not included in the calculation of diluted net loss per share (shares) | 1,748,730 | 656,158 | 347,261 |
Investments - Summary (Details)
Investments - Summary (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | $ 852,251 | $ 1,078,709 |
Gross unrealized gains | 95 | 163 |
Gross unrealized losses | (3,769) | (615) |
Estimated fair value | 848,577 | 1,078,257 |
Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | 95,195 | 236,170 |
Gross unrealized gains | 0 | 36 |
Gross unrealized losses | (662) | (248) |
Estimated fair value | $ 94,533 | $ 235,958 |
Corporate debt securities | Maximum | ||
Debt Securities, Available-for-sale [Line Items] | ||
Maturity | 2 years | 2 years |
Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | $ 443,489 | $ 621,947 |
Gross unrealized gains | 65 | 127 |
Gross unrealized losses | (811) | (95) |
Estimated fair value | $ 442,743 | $ 621,979 |
Commercial paper | Maximum | ||
Debt Securities, Available-for-sale [Line Items] | ||
Maturity | 1 year | 1 year |
U.S. Agency bonds | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | $ 90,351 | $ 58,092 |
Gross unrealized gains | 22 | 0 |
Gross unrealized losses | (434) | 0 |
Estimated fair value | $ 89,939 | $ 58,092 |
U.S. Agency bonds | Maximum | ||
Debt Securities, Available-for-sale [Line Items] | ||
Maturity | 2 years | 1 year |
U.S. Treasury bills | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | $ 223,216 | $ 162,500 |
Gross unrealized gains | 8 | 0 |
Gross unrealized losses | (1,862) | (272) |
Estimated fair value | $ 221,362 | $ 162,228 |
U.S. Treasury bills | Maximum | ||
Debt Securities, Available-for-sale [Line Items] | ||
Maturity | 2 years | 2 years |
Investments - Narrative (Detail
Investments - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of Investments [Line Items] | |||
Allowance for credit losses on available-for-sale investments | $ 0 | $ 0 | |
Debt Securities, Available-For-Sale, Impairment Loss | 0 | 0 | $ 0 |
Investments | 848,577,000 | 1,078,257,000 | |
Debt Securities, Available-for-Sale, Gain (Loss) | 4,800,000 | 7,400,000 | $ (4,200,000) |
Long-term investments | |||
Schedule of Investments [Line Items] | |||
Investments | $ 3,465,000 | $ 8,218,000 | |
ORIC | |||
Schedule of Investments [Line Items] | |||
Stock held in investment (shares) | 588,235 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash and cash equivalents | $ 235,260 | $ 413,083 |
Investments | 848,577 | 1,078,257 |
Total | 1,087,302 | 1,499,558 |
U.S. Agency bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash and cash equivalents | 7,965 | |
Investments | 89,939 | 58,092 |
U.S. Treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 221,362 | 162,228 |
Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 94,533 | 235,958 |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 442,743 | 621,979 |
Long-term investments | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 3,465 | 8,218 |
Cash | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash and cash equivalents | 53,033 | 19,347 |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash and cash equivalents | 174,262 | 393,736 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash and cash equivalents | 227,295 | 413,083 |
Investments | 221,362 | 162,228 |
Total | 452,122 | 575,311 |
Level 1 | U.S. Agency bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash and cash equivalents | 0 | |
Investments | 0 | 0 |
Level 1 | U.S. Treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 221,362 | 162,228 |
Level 1 | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Level 1 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Level 1 | Long-term investments | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 3,465 | 0 |
Level 1 | Cash | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash and cash equivalents | 53,033 | 19,347 |
Level 1 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash and cash equivalents | 174,262 | 393,736 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash and cash equivalents | 7,965 | 0 |
Investments | 627,215 | 916,029 |
Total | 635,180 | 916,029 |
Level 2 | U.S. Agency bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash and cash equivalents | 7,965 | |
Investments | 89,939 | 58,092 |
Level 2 | U.S. Treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Level 2 | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 94,533 | 235,958 |
Level 2 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 442,743 | 621,979 |
Level 2 | Long-term investments | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Level 2 | Cash | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash and cash equivalents | 0 | 0 |
Level 2 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash and cash equivalents | 0 | 0 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash and cash equivalents | 0 | 0 |
Investments | 0 | 0 |
Total | 0 | 8,218 |
Level 3 | U.S. Agency bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash and cash equivalents | 0 | |
Investments | 0 | 0 |
Level 3 | U.S. Treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Level 3 | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Level 3 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 0 |
Level 3 | Long-term investments | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Investments | 0 | 8,218 |
Level 3 | Cash | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash and cash equivalents | 0 | 0 |
Level 3 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Total cash and cash equivalents | $ 0 | $ 0 |
Fair Value Measurements - Narra
Fair Value Measurements - Narrative (Details) | Dec. 31, 2022 |
Volatility | |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Measurement input of investment | 0.69 |
Expected Term | |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Measurement input of investment | 0.1 |
Discount for Lack of Marketability | |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
Measurement input of investment | 0.050 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in Estimated Fair Value of Assets with Unobservable Inputs (Details) - Level 3 - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Balance at beginning of period | $ 8,218 | $ 15,629 |
Change in fair value | (3,100) | (7,411) |
Fair Value, Measurement with Unobservable Inputs Reconciliation, Recurring Basis, Asset, Transfers out of Level 3 | (5,118) | |
Balance at end of period | $ 0 | $ 8,218 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 0 | $ 0 |
Inventory, Work in Process, Gross | 2,994 | 0 |
Finished goods | 26 | 0 |
Inventory | $ 3,020 | $ 0 |
Other Current Assets and Othe_3
Other Current Assets and Other Long-Term Assets - Summary (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Prepaid expenses | $ 15,207 | $ 11,895 |
Deposits and other receivables | 3,162 | 2,235 |
Interest receivables | 2,870 | 2,513 |
Total other current assets | 21,239 | 16,643 |
Restricted cash | 620 | 620 |
Deposits and prepaid expenses | 21,025 | 18,429 |
Other long-term assets | $ 21,645 | $ 19,049 |
Property and Equipment, Net - S
Property and Equipment, Net - Summary (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property and equipment | ||
Gross property and equipment | $ 23,028 | $ 18,646 |
Less: Accumulated depreciation | (5,488) | (2,822) |
Property and equipment, net | 17,540 | 15,824 |
Laboratory equipment | ||
Property and equipment | ||
Gross property and equipment | 14,027 | 9,733 |
Leasehold improvements | ||
Property and equipment | ||
Gross property and equipment | 6,482 | 6,275 |
Office and other equipment | ||
Property and equipment | ||
Gross property and equipment | 2,165 | 2,131 |
Computer equipment | ||
Property and equipment | ||
Gross property and equipment | $ 354 | $ 507 |
Property and Equipment, Net - N
Property and Equipment, Net - Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation | $ 2.8 | $ 1.8 | $ 0.6 |
Intangible Assets, Net - Schedu
Intangible Assets, Net - Schedule of Intangibles (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Gross carrying value | $ 15,000 | $ 0 |
Less: Accumulated amortization | (86) | 0 |
Intangible asset, net | $ 14,914 | $ 0 |
Intangible Assets, Net - Narrat
Intangible Assets, Net - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Finite-Lived Intangible Asset, Useful Life | 14 years 6 months | ||
Less: Accumulated amortization | $ 86,000 | $ 0 | |
Amortization of Intangible Assets | $ 100,000 | $ 0 | $ 0 |
Intangible Assets, Net - Future
Intangible Assets, Net - Future Amortization (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2023 | $ 1,034 | |
2024 | 1,034 | |
2025 | 1,034 | |
2026 | 1,034 | |
2027 | 1,034 | |
Thereafter | 9,744 | |
Intangible asset, net | $ 14,914 | $ 0 |
Accrued Liabilities and Other_3
Accrued Liabilities and Other Liabilities - Summary (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued Liabilities and Other Liabilities [Abstract] | ||
Accrued clinical expense | $ 37,604,000 | $ 29,038,000 |
Accrued manufacturing expense | 6,605,000 | 34,153,000 |
Accrued development expense | 20,107,000 | 10,910,000 |
Accrued compensation and benefits | 40,208,000 | 25,845,000 |
Accrued commercial expense | 3,941,000 | 3,650,000 |
Accrued adjustments to product revenue | 152,000 | 0 |
Lease liability (current) | 7,844,000 | 1,341,000 |
Other accrued expenses | 4,126,000 | 3,558,000 |
Total accounts payable and accrued liabilities | 120,587,000 | 108,495,000 |
Other liabilities | $ 3,022,000 | $ 2,179,000 |
Revenue - Product Revenue (Deta
Revenue - Product Revenue (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Revenue from Contract with Customer [Abstract] | ||
Accounts receivable, net | $ 865,000 | $ 0 |
Chargebacks, Discounts, and Allowances | 100,000 | |
Accrued adjustments to product revenue | $ 152,000 | $ 0 |
Revenue - License and Collabora
Revenue - License and Collaboration Agreements- Narrative (Details) | 1 Months Ended | 12 Months Ended | ||||||
May 28, 2021 USD ($) | Aug. 03, 2020 USD ($) shares | Jan. 07, 2018 USD ($) | Oct. 31, 2014 | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Dec. 31, 2019 USD ($) | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Expenses related to collaboration agreement | $ 531,627,000 | $ 508,594,000 | $ 299,349,000 | |||||
Income tax expense | 508,000 | 3,299,000 | 0 | |||||
Unrealized gain (loss) on investments | $ (3,224,000) | (691,000) | (130,000) | |||||
Fair Value, Asset, Recurring Basis, Unobservable Input Reconciliation, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration] | Other Nonoperating Income (Expense) | |||||||
Milestone Payments | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Expenses related to collaboration agreement | 5,000,000 | |||||||
BeiGene Agreement | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Up-front fee received | $ 10,000,000 | |||||||
Revenue from performance obligation expected to be earned | $ 123,000,000 | |||||||
Termination of contract, period after first commercial sale of product | 10 years | |||||||
Period required for notice of termination of contract | 60 days | |||||||
Revenue from performance obligation earned | 500,000 | |||||||
Revenue | $ 0 | 0 | 0 | |||||
Contract with Customer, Milestone Payments Receivable | 0 | |||||||
BeiGene Agreement | Maximum | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Collaborative Arrangement, Research and Development Arrangement, Discovery and Collaboration Agreement, Royalty Percentage | 0.20 | |||||||
BeiGene Agreement | Licenses of Intellectual Property | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Revenue from performance obligation earned | $ 9,500,000 | |||||||
Contract with Customer, Milestone Payments Receivable | 5,000,000 | |||||||
BeiGene Agreement | Manufacturing Supply Services | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Revenue from performance obligation earned | 200,000 | |||||||
Revenue recognized | (2,000,000) | |||||||
Cost sharing receivable | 0 | 300,000 | ||||||
Revenue from Contract with Customer, Including Assessed Tax | 0 | 400,000 | ||||||
Contract with Customer, Liability, Revenue Recognized | 1,800,000 | |||||||
BeiGene Agreement | Milestone Payments | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Revenue recognized | 0 | 0 | ||||||
Pfizer Agreement | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Termination of contract, period after first commercial sale of product | 10 years | |||||||
Period required for notice of termination of contract | 60 days | |||||||
Expenses related to collaboration agreement | 4,800,000 | |||||||
Pfizer Agreement | Research and Development Services | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Expenses related to collaboration agreement | $ 1,500,000 | |||||||
ORIC Pharmaceuticals Agreement | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Stock received as part of stock issuance and license agreements (shares) | shares | 588,235 | |||||||
License agreement, period of transfer restrictions | 18 months | |||||||
License agreement, period of agreement after first commercial sale | 10 years | |||||||
ORIC Pharmaceuticals Agreement | Level 3 | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
License agreement, transaction price | $ 11,400,000 | |||||||
Zai Collaboration and License Agreement | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Collaboration Arrangement, Research and Development Arrangement, Up-Front Fee Received | $ 65,000,000 | |||||||
Collaborative Arrangement, Research and Development Arrangement, Discovery and Collaboration Agreement, Termination of Contract, Period after First Commercial Sale of Product | 10 years | |||||||
Collaboration Arrangement, Research and Development Arrangement, Contract to Perform for Others, Period Required for Notice of Termination of Contract | 12 months | |||||||
Collaboration Arrangement, Research and Development Arrangement, Transaction Price | $ 66,600,000 | |||||||
Contract with Customer, Milestone Payments Receivable | 5,000,000 | 0 | ||||||
Zai Collaboration and License Agreement | Licenses of Intellectual Property | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Revenue from Contract with Customer, Including Assessed Tax | 66,600,000 | |||||||
Income tax expense | 3,300,000 | |||||||
Zai Collaboration and License Agreement | Manufacturing Supply Services | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Revenue from Contract with Customer, Including Assessed Tax | 1,500,000 | 0 | ||||||
Zai Collaboration and License Agreement | Milestone Payments | adagrasib | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Income tax expense | 500,000 | |||||||
Zai Collaboration and License Agreement | Sales Milestone Payments | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Collaboration Arrangement, Research and Development Arrangement, Contract to Perform for Others, Compensation Expected to be Earned | 180,000,000 | |||||||
Zai Collaboration and License Agreement | Royalties | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Revenue | $ 0 | $ 0 | ||||||
Zai Collaboration and License Agreement | Development and Regulatory-Based Milestone Payments | ||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||
Collaboration Arrangement, Research and Development Arrangement, Contract to Perform for Others, Compensation Expected to be Earned | $ 93,000,000 |
Shareholders' Equity - Stock Re
Shareholders' Equity - Stock Reserved for Future Issuance (Details) | Dec. 31, 2022 shares |
Class of Stock [Line Items] | |
Common stock reserved for future issuance (shares) | 19,874,140 |
Employee Stock Purchase Plan | |
Class of Stock [Line Items] | |
Common stock reserved for future issuance (shares) | 48,032 |
Warrant | |
Class of Stock [Line Items] | |
Common stock reserved for future issuance (shares) | 7,605,811 |
Common stock options | |
Class of Stock [Line Items] | |
Common stock reserved for future issuance (shares) | 5,537,791 |
Restricted stock units | |
Class of Stock [Line Items] | |
Common stock reserved for future issuance (shares) | 2,161,765 |
Shares available for grant | |
Class of Stock [Line Items] | |
Common stock reserved for future issuance (shares) | 4,520,741 |
Shareholders' Equity - Narrativ
Shareholders' Equity - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | ||||||
Nov. 30, 2021 | Oct. 31, 2020 | Jan. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jul. 02, 2021 | Jul. 02, 2020 | |
Class of Stock [Line Items] | ||||||||
Stock issued in transaction (shares) | 3,448,275 | 4,585,706 | 3,538,462 | |||||
Sale price of common stock (USD per share) | $ 145 | $ 202 | $ 97.50 | |||||
Proceeds from sale of common stock | $ 474.7 | $ 879.6 | $ 324 | |||||
Common stock, par value (USD per share) | $ 0.001 | $ 0.001 | $ 0.001 | $ 0.001 | ||||
Aggregate offering price | $ 500 | $ 200 | ||||||
Number of warrants exercised via cashless exercises (shares) | 0 | 623,821 | 1,400,012 | |||||
Net exercise of warrants (shares) | 623,814 | 1,400,000 | ||||||
Exercise of warrants for cash (shares) | 63,235 | |||||||
At the Market Facility | ||||||||
Class of Stock [Line Items] | ||||||||
Stock issued in transaction (shares) | 1,880,097 | |||||||
Proceeds from sale of common stock | $ 155 | |||||||
Excess Stock, Shares Issued | 1,880,097 |
Shareholders' Equity - Warrants
Shareholders' Equity - Warrants Issued and Outstanding (Details) - $ / shares | Dec. 31, 2022 | Jun. 11, 2018 | Nov. 20, 2017 | Jan. 11, 2017 |
Class of Stock [Line Items] | ||||
Number of warrants (shares) | 7,605,811 | |||
Private Placement | January 11, 2017 Warrants | ||||
Class of Stock [Line Items] | ||||
Exercise price of warrants (USD per share) | $ 0.001 | |||
Number of warrants (shares) | 3,578,036 | |||
Private Placement | November 20, 2017 Warrants | ||||
Class of Stock [Line Items] | ||||
Exercise price of warrants (USD per share) | $ 0.001 | |||
Number of warrants (shares) | 3,669,360 | |||
Private Placement | June 11, 2018 Warrants | ||||
Class of Stock [Line Items] | ||||
Exercise price of warrants (USD per share) | $ 0.001 | |||
Number of warrants (shares) | 358,415 |
Share-Based Compensation - Narr
Share-Based Compensation - Narrative (Details) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jul. 31, 2022 | May 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Exercise price required percentage of fair market value | 100% | ||||
Award vesting period | 4 years | ||||
Intrinsic value of options exercised | $ 15,500,000 | $ 91,100,000 | $ 121,500,000 | ||
Cash received from exercise of stock options | 9,900,000 | 28,000,000 | 45,900,000 | ||
Fair value of options vested | 73,900,000 | 58,300,000 | 52,100,000 | ||
Compensation cost not yet recognized | $ 79,000,000 | ||||
Compensation cost not yet recognized, period for recognition | 1 year 3 months 18 days | ||||
Capitalized costs | $ 0 | 0 | 0 | ||
Tax benefit from compensation expense | $ 0 | $ 0 | $ 0 | ||
Restricted stock units | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Award vesting period | 4 years | ||||
Fair value of options vested | $ 33,300,000 | ||||
Compensation cost not yet recognized | $ 99,800,000 | ||||
Compensation cost not yet recognized, period for recognition | 1 year 6 months | ||||
Performance Share Units (PSUs) | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Fair value of options vested | $ 10,800,000 | ||||
Compensation cost not yet recognized | $ 15,800,000 | ||||
Compensation cost not yet recognized, period for recognition | 1 year 3 months 18 days | ||||
2013 Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Additional shares authorized (shares) | 3,500,000 | 2,500,000 | |||
Authorized amount for issuance (shares) | 4,100,000 | ||||
Stock option contractual terms | 10 years | ||||
Stock authorized for purchase | $ 25,000 | ||||
Purchase discount (as a percent) | 85% | ||||
Stock reserved for future issuance (shares) | 300,000 | ||||
Issuance of common stock from ESPP (shares) | 251,968 | ||||
Inducement Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Share-based Payment Arrangement, Option, Exercise Price Range, Shares Outstanding | 400,000 | 1,000,000 |
Share-Based Compensation - Stoc
Share-Based Compensation - Stock Option Activity (Details) $ / shares in Units, $ in Millions | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | |
Balance at beginning of year (shares) | shares | 4,532,252 |
Granted (shares) | shares | 1,690,707 |
Exercised (shares) | shares | (272,434) |
Canceled (shares) | shares | (412,734) |
Balance at end of year (shares) | shares | 5,537,791 |
Options exercisable at end of year (shares) | shares | 3,187,936 |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | |
Balance at beginning of year (USD per share) | $ / shares | $ 85.38 |
Granted (USD per share) | $ / shares | 94.43 |
Exercised (USD per share) | $ / shares | 36.43 |
Canceled (USD per share) | $ / shares | 132.27 |
Balance at end of year (USD per share) | $ / shares | 87.05 |
Options exercisable at end of year (USD per share) | $ / shares | $ 68.49 |
Options outstanding, Weighted-Average Remaining Contractual Term (years) | 6 years 8 months 12 days |
Options exercisable, Weighted-Average Remaining Contractual Term (years) | 5 years 1 month 6 days |
Options outstanding, Aggregate Intrinsic Value | $ | $ 33 |
Options exercisable, Aggregate Intrinsic Value | $ | $ 32.4 |
Share-Based Compensation - RSU
Share-Based Compensation - RSU and PSU Activity (Details) $ / shares in Units, $ in Millions | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Restricted stock units | |
Number of RSUs | |
Balance outstanding at beginning of period (shares) | shares | 720,567 |
Granted (shares) | shares | 1,571,697 |
Releases (shares) | shares | (217,542) |
Canceled/forfeited (shares) | shares | (193,048) |
Balance outstanding at end of period (shares) | shares | 1,881,674 |
Weighted Average Grant Date Fair Value | |
Balance outstanding at beginning of period (USD per share) | $ / shares | $ 156.55 |
Granted (USD per share) | $ / shares | 83.78 |
Releases (USD per share) | $ / shares | 152.95 |
Canceled/Forfeited (USD per share) | $ / shares | 124.21 |
Balance outstanding at end of period (USD per share) | $ / shares | $ 99.51 |
Aggregate Intrinsic Value (millions) | $ | $ 85.3 |
Performance Share Units (PSUs) | |
Number of RSUs | |
Balance outstanding at beginning of period (shares) | shares | 281,611 |
Granted (shares) | shares | 99,050 |
Releases (shares) | shares | (67,850) |
Canceled/forfeited (shares) | shares | (32,720) |
Balance outstanding at end of period (shares) | shares | 280,091 |
Weighted Average Grant Date Fair Value | |
Balance outstanding at beginning of period (USD per share) | $ / shares | $ 157.58 |
Granted (USD per share) | $ / shares | 35.57 |
Releases (USD per share) | $ / shares | 158.89 |
Canceled/Forfeited (USD per share) | $ / shares | 150.31 |
Balance outstanding at end of period (USD per share) | $ / shares | $ 114.96 |
Aggregate Intrinsic Value (millions) | $ | $ 12.7 |
Share-Based Compensation - Assu
Share-Based Compensation - Assumptions Used in Fair Value Estimates (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-Based Payment Arrangement [Abstract] | |||
Risk-free interest rate (as a percent) | 2.40% | 0.80% | 1.10% |
Dividend yield (as a percent) | 0% | 0% | 0% |
Volatility factor (as a percent) | 74.50% | 76.90% | 81.50% |
Expected term (in years) | 5 years 1 month 6 days | 5 years 1 month 6 days | 5 years 7 months 6 days |
Weighted average estimated fair value per share (USD per share) | $ 58.11 | $ 110.43 | $ 77.92 |
Share-Based Compensation - Shar
Share-Based Compensation - Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 186,188 | $ 113,502 | $ 85,847 |
Research and development expense | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | 113,544 | 68,496 | 48,044 |
Selling, general and administrative expense | |||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 72,644 | $ 45,006 | $ 37,803 |
Employee Benefit Plan - Narrati
Employee Benefit Plan - Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Retirement Benefits [Abstract] | |||
Proportion of employee contributions matched (as a percent) | 5% | 5% | |
Matching contribution amount | $ 4.6 | $ 2.5 | $ 1.3 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax [Line Items] | |||
Income tax expense | $ 508,000 | $ 3,299,000 | $ 0 |
Amount of increase in valuation allowance | (198,600,000) | ||
Accrual for interest or penalties on tax matters | 0 | 0 | 0 |
Foreign Tax Authority | |||
Income Tax [Line Items] | |||
Income tax expense | 500,000 | ||
US Federal | |||
Income Tax [Line Items] | |||
Income tax expense | $ 3,300,000 | $ 0 | |
Tax credit carryforward | 1,100,000,000 | ||
US Federal | Research Tax Credit Carryforward | |||
Income Tax [Line Items] | |||
Tax credit carryforward | 69,700,000 | ||
US Federal | Orphan Drug Tax Credit Carryforward | |||
Income Tax [Line Items] | |||
Tax credit carryforward | 49,000,000 | ||
US State | |||
Income Tax [Line Items] | |||
Tax credit carryforward | 1,600,000 | ||
US State | Research Tax Credit Carryforward | |||
Income Tax [Line Items] | |||
Tax credit carryforward | 30,000,000 | ||
CALIFORNIA | |||
Income Tax [Line Items] | |||
Tax credit carryforward | $ 271,800,000 |
Income Taxes - Effective Income
Income Taxes - Effective Income Tax Rate Reconciliation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Effective Income Tax Rate Reconciliation, Amount [Abstract] | |||
Net loss before tax | $ (740,359) | $ (578,485) | $ (357,937) |
Statutory combined U.S. federal and state tax rate (as a percent) | 21% | 21% | 21% |
Tax computed at federal statutory rate | $ (155,475) | $ (121,482) | $ (75,167) |
State income taxes, net of federal benefit | (2,305) | (4,657) | (13,490) |
Effect of change in valuation allowance | 198,064 | 150,487 | 110,985 |
Non-deductible share-based compensation | 6,754 | 4,783 | 2,724 |
Tax deductions for share-based compensation | 3,876 | (17,243) | (17,991) |
Tax credits | (73,383) | (30,289) | (15,672) |
Dissolution of Canadian entity | 24,761 | 0 | 0 |
Foreign withholding taxes | 508 | 3,299 | 0 |
Change in tax rate | (11,224) | 2,972 | 0 |
Unrecognized tax benefits | 6,965 | 7,573 | 3,857 |
Return to provision and other true-ups | (3,871) | 115 | 25 |
Non-deductible officers’ compensation | 5,969 | 8,318 | 4,697 |
Other differences | (131) | (577) | 32 |
Income tax expense | $ 508 | $ 3,299 | $ 0 |
Income Taxes - Net Deferred Inc
Income Taxes - Net Deferred Income Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Tangible and intangible depreciable assets | $ 183,129 | $ 29,576 |
Stock compensation | 46,013 | 26,738 |
Provisions | 12,385 | 5,740 |
Lease liability | 11,739 | 9,916 |
Non-current investment | 1,814 | 673 |
Net operating loss carryforward | 254,820 | 299,204 |
Capital loss carryforward | 0 | 89 |
Canada scientific research and experimental development expenditures | 0 | 5,471 |
U.S. research and development tax credits | 118,019 | 51,550 |
Total gross deferred tax assets | 627,919 | 428,957 |
Less valuation allowance | (619,686) | (421,044) |
Net deferred tax assets | 8,233 | 7,913 |
Deferred tax liabilities: | ||
Right-of-use asset | (8,233) | (7,913) |
Net deferred income taxes | $ 0 | $ 0 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Tax Positions (Details) - Canadian Federal - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Reconciliation of the beginning and ending gross amounts of unrecognized tax positions | |||
Unrecognized tax positions, beginning of year | $ 24,817 | $ 17,046 | $ 12,916 |
Gross increase — current period tax positions | 9,115 | 7,849 | 4,130 |
Gross decrease — current period tax positions | 0 | 0 | 0 |
Gross decrease — prior period tax positions | (1,940) | (78) | 0 |
Gross increase — prior period tax positions | 0 | 0 | 0 |
Expiration of statute of limitations | 0 | 0 | 0 |
Unrecognized tax positions, end of year | $ 31,992 | $ 24,817 | $ 17,046 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Lessee, Lease, Description [Line Items] | |||
Operating right-of-use asset | $ 36,122,000 | $ 37,700,000 | |
Total lease liability | 45,900,000 | ||
Lease liability (current) | 7,844,000 | $ 1,341,000 | |
Lease liability | $ 43,661,000 | ||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued liabilities | Accrued liabilities | |
Current Headquarters | |||
Lessee, Lease, Description [Line Items] | |||
Discount rate (as a percent) | 12% | ||
Operating right-of-use asset | $ 37,680,000 | ||
Total lease liability | $ 51,505,000 | 47,200,000 | |
Operating lease expense | 7,200,000 | ||
Lease liability (current) | 7,800,000 | 1,300,000 | |
Operating lease cost | 7,700,000 | $ 300,000 | |
Lease liability | $ 43,700,000 | $ 45,879,000 | |
Building | Future Headquarters | |||
Lessee, Lease, Description [Line Items] | |||
Lease term | 12 years | ||
Future monthly rent expense | $ 600,000 | ||
Annual rent increase (as a percent) | 3% | ||
Building | Current Headquarters | |||
Lessee, Lease, Description [Line Items] | |||
Annual rent increase (as a percent) | 3% | ||
Monthly rent expense | $ 24,100 |
Commitments and Contingencies_2
Commitments and Contingencies - Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Lessee, Lease, Description [Line Items] | ||
Total lease liability | $ 45,900 | |
Current Headquarters | ||
Lessee, Lease, Description [Line Items] | ||
2022 | $ 7,844 | |
2023 | 8,080 | |
2024 | 8,322 | |
2025 | 8,572 | |
2026 | 8,829 | |
Thereafter | 50,857 | |
Total operating lease payments | 92,504 | |
Less: Amount representing interest | (40,999) | |
Total lease liability | 51,505 | $ 47,200 |
Operating Lease, Lease Termination, Reduction of Lease Liability, Amount | $ 41,100 |
Uncategorized Items - mrtx-2022
Label | Element | Value |
Pfizer Discovery and Collaboration Agreement [Member] | Sales Milestone Payments [Member] | ||
Research and Development Arrangement, Discovery and Collaboration Agreement, Compensation Expected to be Paid | mrtx_ResearchandDevelopmentArrangementDiscoveryandCollaborationAgreementCompensationExpectedtobePaid | $ 337,000,000 |
Pfizer Discovery and Collaboration Agreement [Member] | Milestone Payments - Initiation of First Regulatory Toxicology Study for MRTZ1133 [Member] | ||
Research and Development Expense | us-gaap_ResearchAndDevelopmentExpense | 300,000 |
Pfizer Discovery and Collaboration Agreement [Member] | Development Milestone Payments [Member] | ||
Research and Development Arrangement, Discovery and Collaboration Agreement, Milestone Payments Paid | mrtx_ResearchandDevelopmentArrangementDiscoveryandCollaborationAgreementMilestonePaymentsPaid | 9,500,000 |
Research and Development Arrangement, Discovery and Collaboration Agreement, Compensation Expected to be Paid | mrtx_ResearchandDevelopmentArrangementDiscoveryandCollaborationAgreementCompensationExpectedtobePaid | 9,300,000 |
Pfizer Discovery and Collaboration Agreement [Member] | Milestone Payments - First Commercial Sale of KRAZATI [Member] | ||
Research and Development Arrangement, Discovery and Collaboration Agreement, Compensation Expected to be Paid | mrtx_ResearchandDevelopmentArrangementDiscoveryandCollaborationAgreementCompensationExpectedtobePaid | 15,000,000 |
Pfizer Discovery and Collaboration Agreement [Member] | Milestone Payments - Initiation of First Phase 1 Trial for MRTX849 [Member] | ||
Research and Development Expense | us-gaap_ResearchAndDevelopmentExpense | $ 3,000,000 |