Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2023 | May 04, 2023 | |
Cover [Abstract] | ||
Entity Central Index Key | 0001576263 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
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 $0.001 per share | |
Trading Symbol | MRTX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 58,186,881 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets | ||
Cash and cash equivalents | $ 241,925 | $ 235,260 |
Short-term investments | 660,369 | 848,577 |
Accounts receivable, net | 6,227 | 865 |
Inventory | 3,849 | 3,020 |
Other current assets | 26,980 | 21,239 |
Total current assets | 939,350 | 1,108,961 |
Property and equipment, net | 17,185 | 17,540 |
Intangible asset, net | 14,655 | 14,914 |
Long-term investment | 3,353 | 3,465 |
Right-of-use asset | 35,783 | 36,122 |
Other long-term assets | 23,435 | 21,645 |
Total assets | 1,033,761 | 1,202,647 |
Current liabilities | ||
Accounts payable | 22,320 | 38,861 |
Accrued liabilities | 102,280 | 120,587 |
Total current liabilities | 124,600 | 159,448 |
Lease liability | 43,227 | 43,661 |
Other liabilities | 3,304 | 3,022 |
Total liabilities | 171,131 | 206,131 |
Commitments and contingencies (see Note 11) | ||
Shareholders' equity | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized; none issued and outstanding at both March 31, 2023 and December 31, 2022 | 0 | 0 |
Common stock, $0.001 par value; 100,000,000 authorized; 58,148,416 and 57,854,559 issued and outstanding at March 31, 2023 and December 31, 2022, respectively | 58 | 58 |
Additional paid-in capital | 3,501,754 | 3,453,066 |
Accumulated other comprehensive loss | (1,707) | (3,719) |
Accumulated deficit | (2,637,475) | (2,452,889) |
Total shareholders' equity | 862,630 | 996,516 |
Total liabilities and shareholders' equity | $ 1,033,761 | $ 1,202,647 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
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) | 58,148,416 | 57,854,559 |
Common stock outstanding (shares) | 58,148,416 | 57,854,559 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Total revenue | $ 7,167 | $ 709 |
Revenue | ||
Total revenue | 7,167 | 709 |
Operating expenses | ||
Cost of product revenue | 558 | 0 |
Cost of product revenue - intangible asset amortization | 259 | 0 |
Research and development | 126,683 | 130,976 |
Selling, general and administrative | 73,490 | 53,951 |
Total operating expenses | 200,990 | 184,927 |
Loss from operations | (193,823) | (184,218) |
Other income (expense), net | 9,237 | (4,168) |
Net loss | (184,586) | (188,386) |
Foreign currency translation adjustment | (31) | 0 |
Unrealized gain (loss) on available-for-sale investments | 2,043 | (4,802) |
Comprehensive loss | $ (182,574) | $ (193,188) |
Basic net loss per share (USD per share) | $ (3.18) | $ (3.40) |
Diluted net loss per share (USD per share) | $ (3.18) | $ (3.40) |
Weighted average common shares outstanding, basic (shares) | 58,031,642 | 55,468,851 |
Weighted average common shares outstanding, diluted (shares) | 58,031,642 | 55,468,851 |
Product Revenue | ||
Total revenue | $ 6,291 | $ 0 |
Revenue | ||
Total revenue | 6,291 | 0 |
License and Collaboration Revenue | ||
Total revenue | 876 | 709 |
Revenue | ||
Total revenue | $ 876 | $ 709 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Common Stock | Additional paid-in capital | Accumulated other comprehensive loss | Accumulated deficit |
Balance at beginning of period (shares) at Dec. 31, 2021 | 55,356,904 | ||||
Balance at beginning 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 | (188,386) | (188,386) | |||
Share-based compensation expense | 42,905 | 42,905 | |||
Issuance of common stock under equity incentive plans (shares) | 154,572 | ||||
Issuance of common stock under equity incentive plans | 2,527 | $ 1 | 2,526 | ||
Unrealized gain (loss) on investments | (4,802) | (4,802) | |||
Foreign currency translation adjustment | 0 | ||||
Balance at end of period (shares) at Mar. 31, 2022 | 55,511,476 | ||||
Balance at end of period at Mar. 31, 2022 | $ 1,249,282 | $ 56 | 3,145,368 | 4,266 | (1,900,408) |
Balance at beginning of period (shares) at Dec. 31, 2022 | 57,854,559 | 57,854,559 | |||
Balance at beginning of period at Dec. 31, 2022 | $ 996,516 | $ 58 | 3,453,066 | (3,719) | (2,452,889) |
Increase (Decrease) in Stockholders' Equity | |||||
Net loss | (184,586) | (184,586) | |||
Share-based compensation expense | 46,961 | 46,961 | |||
Issuance of common stock under equity incentive plans (shares) | 293,857 | ||||
Issuance of common stock under equity incentive plans | 1,727 | $ 0 | 1,727 | ||
Unrealized gain (loss) on investments | 2,043 | 2,043 | |||
Foreign currency translation adjustment | $ (31) | (31) | |||
Balance at end of period (shares) at Mar. 31, 2023 | 58,148,416 | 58,148,416 | |||
Balance at end of period at Mar. 31, 2023 | $ 862,630 | $ 58 | $ 3,501,754 | $ (1,707) | $ (2,637,475) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating activities: | ||
Net loss | $ (184,586) | $ (188,386) |
Non-cash adjustments reconciling net loss to operating cash flows | ||
Change in fair value on long-term investment | 112 | 5,077 |
Depreciation and amortization expense | 1,075 | 629 |
Amortization of premium and accretion of discounts on investments | (5,168) | 982 |
Share-based compensation expense | 46,961 | 42,905 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (5,362) | 0 |
Inventory | (829) | 0 |
Other current assets | (5,741) | 0 |
Other long-term assets | (1,790) | (1,584) |
Right-of-use asset | 339 | 451 |
Lease liability | (376) | 1,431 |
Accounts payable, accrued liabilities and other liabilities | (34,817) | (21,974) |
Cash flows used in operating activities | (190,182) | (160,469) |
Investing activities: | ||
Purchases of short-term investments | (126,708) | (212,545) |
Sales and maturities of short-term investments | 322,128 | 263,240 |
Purchases of property and equipment | (269) | (1,140) |
Cash flows provided by investing activities | 195,151 | 49,555 |
Financing activities: | ||
Proceeds from issuance of common stock under equity incentive plans | 1,727 | 2,527 |
Cash flows provided by financing activities | 1,727 | 2,527 |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (31) | 0 |
Increase (decrease) in cash, cash equivalents and restricted cash | 6,665 | (108,387) |
Cash, cash equivalents and restricted cash, beginning of period | 235,880 | 413,703 |
Cash, cash equivalents and restricted cash, end of period | 242,545 | 305,316 |
Reconciliation of cash, cash equivalents and restricted cash, end of period: | ||
Cash and cash equivalents | 241,925 | 304,696 |
Restricted cash included in other long-term assets | 620 | 620 |
Total cash, cash equivalents and restricted cash | 242,545 | 305,316 |
Supplemental disclosures of non-cash investing activities: | ||
Accrued capital expenditures | $ 193 | $ 842 |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory consisted of the following (in thousands): March 31, December 31, 2023 2022 Raw materials $ — $ — Work-in-process 3,640 2,994 Finished goods 209 26 Total inventory $ 3,849 $ 3,020 |
Description of Business
Description of Business | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Mirati Therapeutics, Inc. (“Mirati” or the “Company”) is a commercial-stage oncology company focused on the discovery, design and delivery of breakthrough therapies that address areas of high unmet need, including lung cancer, and advancing product candidates targeting the genetic and immunological drivers 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 Mirati Therapeutics (Suisse) GmbH (“Mirati Suisse”), which was formed on May 24, 2022 in Zug, Switzerland, is a wholly-owned subsidiary of Mirati B.V. The Company’s former wholly-owned subsidiary in Canada, MethylGene, Inc., was formed on May 8, 2013 and was formally dissolved in the fourth quarter of 2022. 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.” |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Basis of Presentation The unaudited condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”) and, therefore, certain information and disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been omitted. In the opinion of management, the information reflects all adjustments necessary to make the results of operations for the interim periods a fair statement of such operations. All such adjustments are of a normal recurring nature. Interim results are not necessarily indicative of results for the full year. The condensed consolidated balance sheet as of December 31, 2022 has been derived from the audited consolidated financial statements at that date but does not include all information and footnotes required by U.S. GAAP for complete financial statements. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022. Use of Estimates The preparation of the Company’s unaudited condensed 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 revenue 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 collectability as these patterns are established over a longer period. As of March 31, 2023 and December 31, 2022, the Company determined an allowance for doubtful accounts was not required. 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 (adagrasib) 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 condensed consolidated statements of operations and comprehensive loss. As of March 31, 2023 and 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 condensed consolidated balance sheets, 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 condensed consolidated balance sheets. 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 and a reduction of trade receivables. 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 and a reduction of trade receivables 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 condensed consolidated statements 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). 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 condensed consolidated statements of operations and comprehensive loss. 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. 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. 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: Three Months Ended March 31, 2023 2022 Common stock options 698,734 1,531,327 Common stock warrants 7,605,642 7,605,737 Unvested restricted stock units and performance stock units 3,144,464 1,066,872 Total 11,448,840 10,203,936 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 condensed consolidated financial statements or related financial statement disclosures. |
Investments
Investments | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | The following tables summarize the Company’s short-term investments (in thousands): As of March 31, 2023 Maturity Amortized cost Gross unrealized gains Gross unrealized losses Estimated fair value Corporate debt securities 2 years or less $ 36,369 $ 2 $ (186) $ 36,185 Commercial paper 1 year or less 378,405 13 (564) 377,854 U.S. Agency bonds 2 years or less 98,148 42 (284) 97,906 U.S. Treasury bills 2 years or less 149,078 16 (670) 148,424 $ 662,000 $ 73 $ (1,704) $ 660,369 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 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 therefore, they are carried at fair value. As of March 31, 2023 and December 31, 2022, 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 March 31, 2023 and December 31, 2022, no allowance for credit losses was recorded. During the three months ended March 31, 2023 and 2022, the Company did not recognize any impairment losses related to investments. The long-term investment balance of $3.4 million and $3.5 million as of March 31, 2023 and December 31, 2022, respectively, is comprised of 588,235 shares of ORIC Pharmaceuticals, Inc. (“ORIC”) common stock which were acquired in 2020. As of March 31, 2023 and December 31, 2022, the investment is carried at fair value based on the closing price of ORIC’s common stock on the last trading day of the reporting period. The Company recorded losses of $0.1 million and $5.1 million for the three months ended March 31, 2023 and 2022, respectively, within other income (expense), net in the condensed consolidated statements of operations and comprehensive loss. The Company currently does not intend to sell ORIC shares within 12 months from March 31, 2023. See Note 4 for additional information related to the investment in ORIC. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
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): March 31, 2023 Total Level 1 Level 2 Level 3 Assets Cash and cash equivalents: Cash $ 8,962 $ 8,962 $ — $ — Money market funds 232,963 232,963 — — Total cash and cash equivalents 241,925 241,925 — — Short-term investments: U.S. Treasury bills 148,424 148,424 — — Corporate debt securities 36,185 — 36,185 — Commercial paper 377,854 — 377,854 — U.S. Agency bonds 97,906 — 97,906 — Total short-term investments 660,369 148,424 511,945 — Long-term investment: ORIC Pharmaceuticals, Inc. 3,353 3,353 — — Total $ 905,647 $ 393,702 $ 511,945 $ — 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 $ — The Company’s investments in Level 1 assets are valued based on publicly available quoted market prices for identical securities as of March 31, 2023 and December 31, 2022. 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 was considered a Level 3 fair value measurement during an eighteen-month lock-up period which required an adjustment for a discount for lack of marketability. During the lock-up period, the fair value measurement utilized a combination of the Asian Protective Put Option and Finnerty Put Option fair value techniques to determine the discount for lack of marketability. During the three months ended March 31, 2022, the eighteen-month lock-up period expired, and because ORIC common stock is quoted in an active market, it met the criteria of a Level 1 investment. During the three months ended March 31, 2022, the Company transferred the investment in ORIC from a Level 3 fair value measurement to a Level 1 fair value measurement. See Note 9 for further details on the license agreement with ORIC. The following table represents the change in estimated fair value of and transfer activity for the Company’s Level 3 investment (in thousands): 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 March 31, 2022 $ — Other than the investment in ORIC described above, there were no transfers between fair value measurement levels during the three months ended March 31, 2023 and 2022. |
Other Current Assets and Other
Other Current Assets and Other Long-Term Assets | 3 Months Ended |
Mar. 31, 2023 | |
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): March 31, December 31, 2023 2022 Other current assets: Prepaid expenses $ 19,245 $ 15,207 Deposits and other receivables 5,373 3,162 Interest receivables 2,362 2,870 Total other current assets $ 26,980 $ 21,239 Other long-term assets: Deposits and prepaid expenses $ 22,815 $ 21,025 Restricted cash 620 620 Total other long-term assets $ 23,435 $ 21,645 |
Accrued Liabilities and Other L
Accrued Liabilities and Other Liabilities | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities and Other Liabilities | Accrued liabilities and other liabilities consisted of the following (in thousands): March 31, December 31, 2023 2022 Accrued liabilities: Accrued clinical expense $ 45,495 $ 37,604 Accrued manufacturing expense 5,697 6,605 Accrued development expense 5,234 20,107 Accrued compensation and benefits 27,204 40,208 Accrued commercial expense 4,669 3,941 Accrued royalty expense 503 — Accrued adjustments to product revenue 1,052 152 Lease liability (current) 7,902 7,844 Other accrued expenses 4,524 4,126 Total accrued liabilities $ 102,280 $ 120,587 Other liabilities $ 3,304 $ 3,022 Other liabilities as of March 31, 2023 and December 31, 2022 consisted primarily of clinical trial-related liabilities. |
Revenue
Revenue | 3 Months Ended |
Mar. 31, 2023 | |
Research and Development [Abstract] | |
Revenue | Revenue Product revenue, net The Company’s product revenue is related to U.S. sales of KRAZATI. 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 March 31, 2023 and December 31, 2022, the Company’s accounts receivable balances of $6.2 million and $0.9 million, respectively, on the condensed consolidated balance sheets consisted of KRAZATI product sales receivable, net of chargebacks, discounts and allowances of $0.6 million and $0.1 million, respectively. As of March 31, 2023 and December 31, 2022, the Company’s government and commercial rebates, program incentives and provision for product returns totaled $1.1 million and $0.2 million, respectively, and are included in accrued liabilities on the condensed consolidated balance sheets. 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 related to this performance obligation was recognized for either the three months ended March 31, 2023 or 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 either the three months ended March 31, 2023 or 2022. 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 either the three months ended March 31, 2023 or 2022. 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 these 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 $10.5 million in development milestone payments and a $15.0 million commercial milestone payment relating to the first sale of KRAZATI in the U.S. from inception through March 31, 2023. The $15.0 million milestone payment relating to the first commercial sale of KRAZATI in the U.S. was capitalized as an intangible asset as of December 31, 2022 (see Note 7). 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 of (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 condensed consolidated statements of operations and comprehensive loss. The Shares are carried at fair value and are recorded on the condensed consolidated balance sheet as a long-term investment. Any change in fair value is recorded within other income (expense), net in the condensed consolidated statements of operations and comprehensive loss. 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 third quarter of 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 condensed 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 $0.9 million and $0.7 million of revenue related to this performance obligation for the three months ended March 31, 2023 and 2022, respectively. 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. No milestone payments were earned during either the three months ended March 31, 2023 or 2022. 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 either the three months ended March 31, 2023 or 2022. |
Intangible Assets, Net
Intangible Assets, Net | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets Disclosure | Intangible asset, net Intangible asset, net consisted of the following (in thousands): March 31, December 31, 2023 2022 Gross carrying value $ 15,000 $ 15,000 Less: Accumulated amortization (345) (86) Intangible asset, net $ 14,655 $ 14,914 The Company has a finite-lived intangible asset, resulting from the capitalization of a milestone payment under the license and collaboration agreement with Array BioPharma, Inc. (“Array,” acquired by Pfizer Inc. (“Pfizer”) in July 2019), in connection with the Company’s first commercial sale of KRAZATI in the U.S. in December 2022 (see Note 9). The Company began amortizing the intangible asset in December 2022 over a 14.5-year As of March 31, 2023, the estimated future amortization expense associated with the Company’s intangible asset is as follows (in thousands): Remainder of 2023 $ 775 2024 1,034 2025 1,034 2026 1,034 2027 1,034 Thereafter 9,744 Total $ 14,655 |
Warrants
Warrants | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Warrants | 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 three months ended March 31, 2023 and 2022, no shares of common stock were issued and sold under this sales agreement. As of March 31, 2023, the Company has issued and sold an aggregate of 1,880,097 shares of common stock pursuant to this sales agreement generating net proceeds of $155.0 million. Share-based Compensation Total share-based compensation expense included in the condensed consolidated statements of operations and comprehensive loss consisted of the following (in thousands): Three Months Ended March 31, 2023 2022 Research and development expense $ 24,639 $ 26,260 Selling, general and administrative expense 22,322 16,645 $ 46,961 $ 42,905 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and ContingenciesOn 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 current corporate headquarters, which supercedes the original lease agreement dated 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 March 31, 2023, the condensed consolidated balance sheet includes an operating right-of-use asset of $35.8 million and a total operating lease liability of $51.1 million, of which $7.9 million is a current lease liability and included in accrued liabilities, and $43.2 million is included in non-current lease liability. As of December 31, 2022, the condensed 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, and $43.7 million is included in non-current lease liability. For the three months ended March 31, 2023 and 2022, the Company recorded operating lease expense of $2.0 million and $1.9 million, respectively. As of March 31, 2023, the approximate future minimum lease payments under the Amended and Restated Lease are as follows (in thousands): Operating Lease Remainder of 2023 $ 5,926 2024 8,080 2025 8,322 2026 8,572 2027 8,829 Thereafter 50,857 Total operating lease payments (†) 90,586 Less: Amount representing interest (39,457) Total lease liability $ 51,129 ____________________ † The Company has an early termination right in 2028 in which the total contractual obligation would be reduced by $41.1 million. |
Shareholders' Equity
Shareholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Shareholders' Equity | 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 three months ended March 31, 2023 and 2022, no shares of common stock were issued and sold under this sales agreement. As of March 31, 2023, the Company has issued and sold an aggregate of 1,880,097 shares of common stock pursuant to this sales agreement generating net proceeds of $155.0 million. Share-based Compensation Total share-based compensation expense included in the condensed consolidated statements of operations and comprehensive loss consisted of the following (in thousands): Three Months Ended March 31, 2023 2022 Research and development expense $ 24,639 $ 26,260 Selling, general and administrative expense 22,322 16,645 $ 46,961 $ 42,905 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The unaudited condensed consolidated financial statements contained in this Quarterly Report on Form 10-Q have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”) and, therefore, certain information and disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been omitted. In the opinion of management, the information reflects all adjustments necessary to make the results of operations for the interim periods a fair statement of such operations. All such adjustments are of a normal recurring nature. Interim results are not necessarily indicative of results for the full year. The condensed consolidated balance sheet as of December 31, 2022 has been derived from the audited consolidated financial statements at that date but does not include all information and footnotes required by U.S. GAAP for complete financial statements. These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022. |
Use of Estimates | Use of Estimates The preparation of the Company’s unaudited condensed 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 revenue 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 and Cash Equivalents | Cash and cash equivalents consist of cash and highly liquid securities with original maturities at the date of acquisition of ninety days or less. |
Short-term Investments | 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. |
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 collectability as these patterns are established over a longer period. As of March 31, 2023 and December 31, 2022, the Company determined an allowance for doubtful accounts was not required. |
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 (adagrasib) 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 condensed consolidated statements of operations and comprehensive loss. As of March 31, 2023 and 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 condensed consolidated balance sheets, 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 condensed consolidated balance sheets. 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 and a reduction of trade receivables. 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 and a reduction of trade receivables 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 condensed consolidated statements 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). |
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 condensed consolidated statements of operations and comprehensive loss. |
Cost of Product Revenue | 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 |
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. |
Net Loss per Share | Net Loss per ShareBasic 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 and Recently Issued 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 condensed consolidated financial statements or related financial statement disclosures. |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | Inventory consisted of the following (in thousands): March 31, December 31, 2023 2022 Raw materials $ — $ — Work-in-process 3,640 2,994 Finished goods 209 26 Total inventory $ 3,849 $ 3,020 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Potentially Dilutive Securities not included in the Calculation of Diluted Net Loss per Share | 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: Three Months Ended March 31, 2023 2022 Common stock options 698,734 1,531,327 Common stock warrants 7,605,642 7,605,737 Unvested restricted stock units and performance stock units 3,144,464 1,066,872 Total 11,448,840 10,203,936 |
Investments (Tables)
Investments (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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 March 31, 2023 Maturity Amortized cost Gross unrealized gains Gross unrealized losses Estimated fair value Corporate debt securities 2 years or less $ 36,369 $ 2 $ (186) $ 36,185 Commercial paper 1 year or less 378,405 13 (564) 377,854 U.S. Agency bonds 2 years or less 98,148 42 (284) 97,906 U.S. Treasury bills 2 years or less 149,078 16 (670) 148,424 $ 662,000 $ 73 $ (1,704) $ 660,369 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 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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): March 31, 2023 Total Level 1 Level 2 Level 3 Assets Cash and cash equivalents: Cash $ 8,962 $ 8,962 $ — $ — Money market funds 232,963 232,963 — — Total cash and cash equivalents 241,925 241,925 — — Short-term investments: U.S. Treasury bills 148,424 148,424 — — Corporate debt securities 36,185 — 36,185 — Commercial paper 377,854 — 377,854 — U.S. Agency bonds 97,906 — 97,906 — Total short-term investments 660,369 148,424 511,945 — Long-term investment: ORIC Pharmaceuticals, Inc. 3,353 3,353 — — Total $ 905,647 $ 393,702 $ 511,945 $ — 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 $ — |
Schedule of Changes in Estimated Fair Value of Assets with Unobservable Inputs | The following table represents the change in estimated fair value of and transfer activity for the Company’s Level 3 investment (in thousands): 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 March 31, 2022 $ — |
Other Current Assets and Othe_2
Other Current Assets and Other Long-Term Assets (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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): March 31, December 31, 2023 2022 Other current assets: Prepaid expenses $ 19,245 $ 15,207 Deposits and other receivables 5,373 3,162 Interest receivables 2,362 2,870 Total other current assets $ 26,980 $ 21,239 Other long-term assets: Deposits and prepaid expenses $ 22,815 $ 21,025 Restricted cash 620 620 Total other long-term assets $ 23,435 $ 21,645 |
Accrued Liabilities and Other_2
Accrued Liabilities and Other Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Payables and Accruals [Abstract] | |
Schedule of Accounts Payable and Accrued Liabilities | Accrued liabilities and other liabilities consisted of the following (in thousands): March 31, December 31, 2023 2022 Accrued liabilities: Accrued clinical expense $ 45,495 $ 37,604 Accrued manufacturing expense 5,697 6,605 Accrued development expense 5,234 20,107 Accrued compensation and benefits 27,204 40,208 Accrued commercial expense 4,669 3,941 Accrued royalty expense 503 — Accrued adjustments to product revenue 1,052 152 Lease liability (current) 7,902 7,844 Other accrued expenses 4,524 4,126 Total accrued liabilities $ 102,280 $ 120,587 Other liabilities $ 3,304 $ 3,022 |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Finite-Lived Intangible Assets | Intangible asset, net consisted of the following (in thousands): March 31, December 31, 2023 2022 Gross carrying value $ 15,000 $ 15,000 Less: Accumulated amortization (345) (86) Intangible asset, net $ 14,655 $ 14,914 |
Schedule of Finite-Lived Intangible Assets, Future Amortization Expense | As of March 31, 2023, the estimated future amortization expense associated with the Company’s intangible asset is as follows (in thousands): Remainder of 2023 $ 775 2024 1,034 2025 1,034 2026 1,034 2027 1,034 Thereafter 9,744 Total $ 14,655 |
Commitment and Contingencies (T
Commitment and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Lease Payments | As of March 31, 2023, the approximate future minimum lease payments under the Amended and Restated Lease are as follows (in thousands): Operating Lease Remainder of 2023 $ 5,926 2024 8,080 2025 8,322 2026 8,572 2027 8,829 Thereafter 50,857 Total operating lease payments (†) 90,586 Less: Amount representing interest (39,457) Total lease liability $ 51,129 ____________________ † The Company has an early termination right in 2028 in which the total contractual obligation would be reduced by $41.1 million. |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Employee Service Share-based Compensation Allocation | Total share-based compensation expense included in the condensed consolidated statements of operations and comprehensive loss consisted of the following (in thousands): Three Months Ended March 31, 2023 2022 Research and development expense $ 24,639 $ 26,260 Selling, general and administrative expense 22,322 16,645 $ 46,961 $ 42,905 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 0 | $ 0 |
Work-in-process | 3,640 | 2,994 |
Finished goods | 209 | 26 |
Inventory | $ 3,849 | $ 3,020 |
Description of Business - Narra
Description of Business - Narrative (Details) | 3 Months Ended |
Mar. 31, 2023 segment | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of operating segments | 1 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Narrative (Details) | 3 Months Ended |
Mar. 31, 2023 | |
Marketable Securities | |
Minimum original maturity period of marketable securities | 90 days |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Antidilutive Securities (Details) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (shares) | 11,448,840 | 10,203,936 |
Common stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (shares) | 698,734 | 1,531,327 |
Common stock warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (shares) | 7,605,642 | 7,605,737 |
Unvested restricted stock units and performance stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive securities (shares) | 3,144,464 | 1,066,872 |
Investments - Summary (Details)
Investments - Summary (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | $ 662,000 | $ 852,251 |
Gross unrealized gains | 73 | 95 |
Gross unrealized losses | (1,704) | (3,769) |
Estimated fair value | 660,369 | 848,577 |
Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | 36,369 | 95,195 |
Gross unrealized gains | 2 | 0 |
Gross unrealized losses | (186) | (662) |
Estimated fair value | $ 36,185 | $ 94,533 |
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 | $ 378,405 | $ 443,489 |
Gross unrealized gains | 13 | 65 |
Gross unrealized losses | (564) | (811) |
Estimated fair value | $ 377,854 | $ 442,743 |
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 | $ 98,148 | $ 90,351 |
Gross unrealized gains | 42 | 22 |
Gross unrealized losses | (284) | (434) |
Estimated fair value | $ 97,906 | $ 89,939 |
U.S. Agency bonds | Maximum | ||
Debt Securities, Available-for-sale [Line Items] | ||
Maturity | 2 years | 2 years |
U.S. Treasury bills | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized cost | $ 149,078 | $ 223,216 |
Gross unrealized gains | 16 | 8 |
Gross unrealized losses | (670) | (1,862) |
Estimated fair value | $ 148,424 | $ 221,362 |
U.S. Treasury bills | Maximum | ||
Debt Securities, Available-for-sale [Line Items] | ||
Maturity | 2 years | 2 years |
Investments - Narrative (Detail
Investments - Narrative (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Schedule of Investments [Line Items] | |||
Allowance for credit losses on available-for-sale investments | $ 0 | $ 0 | |
Impairment loss on investments | 0 | $ 0 | |
Investments | (660,369,000) | (848,577,000) | |
Gain (loss) on investments | (100,000) | $ 5,100,000 | |
Long-term Investments | |||
Schedule of Investments [Line Items] | |||
Investments | $ (3,353,000) | $ (3,465,000) | |
ORIC | |||
Schedule of Investments [Line Items] | |||
Stock held in investment (shares) | 588,235 | 588,235 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | $ 241,925 | $ 235,260 |
Short-term investments: | 660,369 | 848,577 |
Total | 905,647 | 1,087,302 |
U.S. Treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 148,424 | 221,362 |
Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 36,185 | 94,533 |
Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 377,854 | 442,743 |
U.S. Agency bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 7,965 | |
Short-term investments: | 97,906 | 89,939 |
Long-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 3,353 | 3,465 |
Cash | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 8,962 | 53,033 |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 232,963 | 174,262 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 241,925 | 227,295 |
Short-term investments: | 148,424 | 221,362 |
Total | 393,702 | 452,122 |
Level 1 | U.S. Treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 148,424 | 221,362 |
Level 1 | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 0 | 0 |
Level 1 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 0 | 0 |
Level 1 | U.S. Agency bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 0 | |
Short-term investments: | 0 | 0 |
Level 1 | Long-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 3,353 | 3,465 |
Level 1 | Cash | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 8,962 | 53,033 |
Level 1 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 232,963 | 174,262 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 0 | 7,965 |
Short-term investments: | 511,945 | 627,215 |
Total | 511,945 | 635,180 |
Level 2 | U.S. Treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 0 | 0 |
Level 2 | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 36,185 | 94,533 |
Level 2 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 377,854 | 442,743 |
Level 2 | U.S. Agency bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 7,965 | |
Short-term investments: | 97,906 | 89,939 |
Level 2 | Long-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 0 | 0 |
Level 2 | Cash | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 0 | |
Level 2 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 0 | |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 0 | 0 |
Short-term investments: | 0 | 0 |
Total | 0 | 0 |
Level 3 | U.S. Treasury bills | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 0 | 0 |
Level 3 | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 0 | 0 |
Level 3 | Commercial paper | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 0 | 0 |
Level 3 | U.S. Agency bonds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 0 | |
Short-term investments: | 0 | 0 |
Level 3 | Long-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Short-term investments: | 0 | 0 |
Level 3 | Cash | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | 0 | 0 |
Level 3 | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash and cash equivalents: | $ 0 | $ 0 |
Fair Value Measurements - Chang
Fair Value Measurements - Changes in Estimated Fair Value of Assets with Unobservable Inputs (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2022 USD ($) | |
Level 3 | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Transfer from Level 3 to Level 1 at lock-up expiration | $ 5,118 |
Level 3 | |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Balance at beginning of period | 8,218 |
Change in fair value at lock-up expiration | (3,100) |
Balance at end of period | $ 0 |
Other Current Assets and Othe_3
Other Current Assets and Other Long-Term Assets - Summary (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Other current assets: | ||
Prepaid expenses | $ 19,245 | $ 15,207 |
Deposits and other receivables | 5,373 | 3,162 |
Interest receivables | 2,362 | 2,870 |
Total other current assets | 26,980 | 21,239 |
Other long-term assets: | ||
Deposits and prepaid expenses | 22,815 | 21,025 |
Restricted cash | 620 | 620 |
Other long-term assets | $ 23,435 | $ 21,645 |
Accrued Liabilities and Other_3
Accrued Liabilities and Other Liabilities - Summary (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Accrued liabilities: | ||
Accrued clinical expense | $ 45,495 | $ 37,604 |
Accrued manufacturing expense | 5,697 | 6,605 |
Accrued development expense | 5,234 | 20,107 |
Accrued compensation and benefits | 27,204 | 40,208 |
Accrued commercial expense | 4,669 | 3,941 |
Accrued royalty expense | 503 | 0 |
Accrued adjustments to product revenue | 1,052 | 152 |
Other accrued expenses | 4,524 | 4,126 |
Lease liability (current) | 7,902 | 7,844 |
Total accrued liabilities | 102,280 | 120,587 |
Other liabilities | $ 3,304 | $ 3,022 |
Revenue - Product Revenue, Net
Revenue - Product Revenue, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Revenue from Contract with Customer [Abstract] | ||
Accounts receivable, net | $ 6,227 | $ 865 |
Chargebacks, Discounts, and Allowances | (600) | (100) |
Accrued adjustments to product revenue | $ 1,052 | $ 152 |
Revenue- Narrative (Details)
Revenue- Narrative (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | 102 Months Ended | |||||
May 28, 2021 USD ($) | Aug. 03, 2020 USD ($) shares | Jan. 07, 2018 USD ($) | Oct. 31, 2014 | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Jun. 30, 2022 USD ($) | Mar. 31, 2023 USD ($) | Oct. 01, 2014 USD ($) | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Expenses related to collaboration agreement | $ 126,683,000 | $ 130,976,000 | |||||||
Unrealized gain (loss) on available-for-sale investments | 2,043,000 | (4,802,000) | |||||||
Total revenue | 7,167,000 | 709,000 | |||||||
Product Revenue | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Total revenue | 6,291,000 | 0 | |||||||
Milestone Payments | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Expenses related to collaboration agreement | 0 | ||||||||
BeiGene Agreement | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Non-refundable, non-creditable up-front fee | $ 10,000,000 | ||||||||
Milestone payments | $ 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 | ||||||||
Performance obligation, compensation to be earned | $ 500,000 | ||||||||
Milestone payments earned | 0 | 0 | |||||||
Royalty revenue | 0 | 0 | |||||||
BeiGene Agreement | Maximum | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Royalty percentage rate (up to) | 0.20 | ||||||||
BeiGene Agreement | Licenses of Intellectual Property | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Performance obligation, compensation to be earned | $ 9,500,000 | ||||||||
BeiGene Agreement | Manufacturing Supply Services | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Revenue recognized | 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 | ||||||||
Pfizer Agreement | Development Milestone Payments | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Potential development milestone payments | $ 9,300,000 | ||||||||
Development milestone payments | 1,000,000 | $ 10,500,000 | |||||||
Pfizer Agreement | Sales Milestone Payments | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Potential development milestone payments | $ 337,000,000 | ||||||||
Pfizer Agreement | Milestone Payments - First Commercial Sale of KRAZATI | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Potential development milestone payments | 15,000,000 | 15,000,000 | |||||||
Pfizer Agreement | Royalties | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Potential development milestone payments | 500,000 | $ 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] | |||||||||
One-time non-cash payment | $ 11,400,000 | ||||||||
Zai Agreement | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Period required for notice of termination of contract | 12 months | ||||||||
Milestone payments earned | 0 | ||||||||
Termination of contract, period after first commercial sale of product | 10 years | ||||||||
Up-front fee received | $ 65,000,000 | ||||||||
Transaction price of arrangement | 66,600,000 | ||||||||
Zai Agreement | Licenses of Intellectual Property | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Revenue recognized | $ 66,600,000 | ||||||||
Income tax recovery | $ 3,300,000 | ||||||||
Zai Agreement | Manufacturing Supply Services | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Revenue recognized | 900,000 | 700,000 | |||||||
Zai Agreement | Sales Milestone Payments | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Revenue from performance obligation expected to be earned | 180,000,000 | ||||||||
Zai Agreement | Development and Regulatory Milestone Payments | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Revenue from performance obligation expected to be earned | $ 93,000,000 | ||||||||
Zai Agreement | Royalties | |||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||||||
Royalty revenue | $ 0 | $ 0 |
Intangible Assets, Net - Schedu
Intangible Assets, Net - Schedule of Intangibles (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Gross carrying value | $ 15,000 | $ 15,000 |
Less: Accumulated amortization | (345) | (86) |
Intangible asset, net | $ 14,655 | $ 14,914 |
Intangible Assets, Net - Narrat
Intangible Assets, Net - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Finite-Lived Intangible Asset, Useful Life | 14 years 6 months | ||
Amortization of Intangible Assets | $ 0.3 | $ 0 |
Intangible Assets, Net - Future
Intangible Assets, Net - Future Amortization (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
Remainder of 2023 | $ 775 | |
2024 | 1,034 | |
2025 | 1,034 | |
2026 | 1,034 | |
2027 | 1,034 | |
Thereafter | 9,744 | |
Intangible asset, net | $ 14,655 | $ 14,914 |
Warrants - Summary (Details)
Warrants - Summary (Details) - Private Placement - $ / shares | Mar. 31, 2023 | Jun. 11, 2018 | Nov. 20, 2017 | Jan. 11, 2017 |
Class of Warrant or Right [Line Items] | ||||
Number of warrants outstanding (shares) | 7,605,811 | |||
January 11, 2017 Warrants | ||||
Class of Warrant or Right [Line Items] | ||||
Exercise price of warrants (USD per share) | $ 0.001 | |||
Number of warrants outstanding (shares) | 3,578,036 | |||
November 20, 2017 Warrants | ||||
Class of Warrant or Right [Line Items] | ||||
Exercise price of warrants (USD per share) | $ 0.001 | |||
Number of warrants outstanding (shares) | 3,669,360 | |||
June 11, 2018 Warrants | ||||
Class of Warrant or Right [Line Items] | ||||
Exercise price of warrants (USD per share) | $ 0.001 | |||
Number of warrants outstanding (shares) | 358,415 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Jun. 30, 2020 | |
Lessee, Lease, Description [Line Items] | ||||
Right-of-use asset | $ 35,783 | $ 36,122 | ||
Total lease liability | 51,500 | |||
Lease liability (current) | 7,902 | 7,844 | ||
Operating lease liability, noncurrent | $ 43,227 | 43,661 | ||
Current Headquarters | ||||
Lessee, Lease, Description [Line Items] | ||||
Discount rate (as a percent) | 12% | |||
Right-of-use asset | $ 35,800 | 36,100 | ||
Total lease liability | 51,129 | |||
Lease liability (current) | 7,900 | 7,800 | ||
Operating lease liability, noncurrent | 43,200 | $ 43,700 | ||
Operating lease cost | 2,000 | $ 1,900 | ||
Building | Future Headquarters | ||||
Lessee, Lease, Description [Line Items] | ||||
Lease term | 12 years | |||
Operating Lease, Future Monthly Rent Payment | $ 600 | |||
Annual rent increase (as a percent) | 3% |
Commitments and Contingencies_2
Commitments and Contingencies - Future Minimum Lease Payments (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Lessee, Lease, Description [Line Items] | ||
Total lease liability | $ 51,500 | |
Current Headquarters | ||
Lessee, Lease, Description [Line Items] | ||
Remainder of 2023 | $ 5,926 | |
2024 | 8,080 | |
2025 | 8,322 | |
2026 | 8,572 | |
2027 | 8,829 | |
Thereafter | 50,857 | |
Total operating lease payments | 90,586 | |
Less: Amount representing interest | (39,457) | |
Total lease liability | 51,129 | |
Reduction of lease liability, amount | $ 41,100 |
Shareholders' Equity - Narrativ
Shareholders' Equity - Narrative (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | ||||
Mar. 31, 2023 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Jul. 02, 2021 | Jul. 02, 2020 | |
Class of Stock [Line Items] | ||||||
Proceeds from sale of stock | $ 155 | |||||
Common stock, par value (USD per share) | $ 0.001 | $ 0.001 | $ 0.001 | |||
Common Stock | ||||||
Class of Stock [Line Items] | ||||||
Issuance of common stock under equity incentive plans (shares) | 293,857 | 154,572 | ||||
Proceeds from stock options exercised | $ 1.7 | $ 2.5 | ||||
At the Market Facility | ||||||
Class of Stock [Line Items] | ||||||
Stock issued in transaction (shares) | 0 | |||||
Common stock, par value (USD per share) | $ 0.001 | |||||
Aggregate offering price | $ 200 | |||||
Excess Stock, Shares Issued | 1,880,097 | 1,880,097 | ||||
Amended and Restated At the Market Facility | ||||||
Class of Stock [Line Items] | ||||||
Common stock, par value (USD per share) | $ 0.001 | |||||
Aggregate offering price | $ 500 |
Shareholders' Equity - Summary
Shareholders' Equity - Summary (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Allocated share-based compensation expense | $ 46,961 | $ 42,905 |
Research and development expense | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Allocated share-based compensation expense | 24,639 | 26,260 |
Selling, general and administrative expense | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Allocated share-based compensation expense | $ 22,322 | $ 16,645 |