Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 17, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2020 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-38311 | ||
Entity Registrant Name | Denali Therapeutics Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 46-3872213 | ||
Entity Address, Address Line One | 161 Oyster Point Blvd | ||
Entity Address, City or Town | South San Francisco | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 94080 | ||
City Area Code | 650 | ||
Local Phone Number | 866-8548 | ||
Title of 12(b) Security | Common Stock, par value $0.01 per share | ||
Trading Symbol | DNLI | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 850.6 | ||
Entity Common Stock, Shares Outstanding (in shares) | 120,984,085 | ||
Documents Incorporated by Reference | Portions of the registrant’s Definitive Proxy Statement relating to the registrant’s 2020 Annual Meeting of Stockholders are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. Such Definitive Proxy Statement will be filed with the Securities and Exchange Commission within 120 days after the end of the registrant’s 2020 fiscal year ended December 31, 2020. | ||
Document Fiscal Year Focus | 2020 | ||
Amendment Flag | false | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001714899 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 507,144 | $ 79,449 |
Short-term marketable securities | 962,553 | 335,907 |
Cost sharing reimbursements due from related party | 5,674 | 0 |
Prepaid expenses and other current assets | 20,284 | 14,675 |
Total current assets | 1,495,655 | 430,031 |
Long-term marketable securities | 32,699 | 39,886 |
Property and equipment, net | 40,846 | 46,732 |
Operating lease right-of-use asset | 32,618 | 33,923 |
Other non-current assets | 2,462 | 2,659 |
Total assets | 1,604,280 | 553,231 |
Current liabilities: | ||
Accounts payable | 1,071 | 2,590 |
Accrued expenses and other current liabilities | 47,145 | 24,015 |
Related party contract liability, current | 3,569 | 0 |
Contract liabilities, current | 19,914 | 18,739 |
Total current liabilities | 71,699 | 45,344 |
Related party contract liability, less current portion | 293,849 | 0 |
Contract liabilities, less current portion | 23,325 | 43,753 |
Operating lease liability, less current portion | 64,175 | 68,865 |
Other non-current liabilities | 701 | 379 |
Total liabilities | 453,749 | 158,341 |
Commitments and contingencies (Note 9) | ||
Stockholders' equity: | ||
Convertible preferred stock, $0.01 par value; 40,000,000 shares authorized as of December 31, 2020 and December 31, 2019; 0 shares issued and outstanding as of December 31, 2020 and December 31, 2019 | 0 | 0 |
Common stock, $0.01 par value; 400,000,000 shares authorized as of December 31, 2020 and December 31, 2019; 120,531,333 and 96,189,935 shares issued and outstanding as of December 31, 2020 and December 31, 2019, respectively | 1,531 | 1,288 |
Additional paid-in capital | 1,503,660 | 818,803 |
Accumulated other comprehensive income (loss) | (245) | 350 |
Accumulated deficit | (354,415) | (425,551) |
Total stockholders’ equity | 1,150,531 | 394,890 |
Total liabilities and stockholders’ equity | $ 1,604,280 | $ 553,231 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Statement of Financial Position [Abstract] | ||
Convertible preferred stock, par value (usd per share) | $ 0.01 | $ 0.01 |
Convertible preferred stock, shares authorized (in shares) | 40,000,000 | 40,000,000 |
Convertible preferred stock, shares issued (in shares) | 0 | 0 |
Convertible preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (usd per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 400,000,000 | 400,000,000 |
Common stock, shares issued (in shares) | 120,531,333 | 96,189,935 |
Common stock, shares outstanding (in shares) | 120,531,333 | 96,189,935 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | ||
Collaboration revenue: | ||||
Collaboration revenue from customers | $ 335,561 | [1] | $ 26,320 | $ 129,100 |
Other collaboration revenue | 98 | 358 | 60 | |
Total collaboration revenue | 335,659 | 26,678 | 129,160 | |
Operating expenses: | ||||
Research and development expense | 212,615 | [2] | 193,382 | 143,183 |
General and administrative | 60,326 | 46,480 | 32,349 | |
Total operating expenses | 272,941 | 239,862 | 175,532 | |
Income (loss) from operations | 62,718 | (213,184) | (46,372) | |
Interest and other income, net | 9,241 | 15,219 | 10,132 | |
Income (loss) before income taxes | 71,959 | (197,965) | (36,240) | |
Income tax (expense) benefit | (823) | 351 | 0 | |
Net income (loss) | 71,136 | (197,614) | (36,240) | |
Other comprehensive income (loss): | ||||
Net unrealized gain (loss) on marketable securities, net of tax | (595) | 999 | (281) | |
Comprehensive income (loss) | $ 70,541 | $ (196,615) | $ (36,521) | |
Net income (loss) per share: | ||||
Basic net income (loss) per share (usd per share) | $ 0.65 | $ (2.07) | $ (0.39) | |
Diluted net income (loss) per share (usd per share) | $ 0.63 | $ (2.07) | $ (0.39) | |
Weighted-average shares used in calculating: | ||||
Basic net income (loss) per share (in shares) | 108,974,137 | 95,608,208 | 92,621,991 | |
Diluted net income (loss) per share (in shares) | 112,703,108 | 95,608,208 | 92,621,991 | |
[1] | Includes related party collaboration revenue from customer of $307,437. | |||
[2] | Includes an offset to expense from related party cost reimbursement of $9,260. |
Consolidated Statements of Op_2
Consolidated Statements of Operations and Comprehensive Income (Loss) (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Income Statement [Abstract] | |
Collaboration revenue from customers, related party | $ 307,437 |
Offset to research and development expense, related party cost reimbursement | $ 9,260 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2017 | 87,480,362 | ||||
Beginning balance at Dec. 31, 2017 | $ 465,796 | $ 1,201 | $ 656,660 | $ (368) | $ (191,697) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock in connection with Takeda Collaboration Agreement (in shares) | 4,214,559 | ||||
Issuance of common stock in connection with the Takeda Collaboration Agreement | 94,406 | $ 42 | 94,364 | ||
Issuances under equity incentive plans (in shares) | 792,939 | ||||
Issuances under equity incentive plans | 3,999 | $ 8 | 3,991 | ||
Vesting of early exercised common stock (in shares) | 234,372 | ||||
Vesting of early exercised common stock | 374 | $ 3 | 371 | ||
Vesting of restricted stock awards (2018) restricted stock awards and units (2019) and restricted stock units (2020) (in shares) | 1,940,203 | ||||
Vesting of restricted stock awards (2018) restricted stock awards and units (2019) and restricted stock units (2020) | 0 | $ 19 | (19) | ||
Stock-based compensation | 18,791 | 18,791 | |||
Net Income (loss) | (36,240) | (36,240) | |||
Other comprehensive income (loss) | (281) | (281) | |||
Ending balance (in shares) at Dec. 31, 2018 | 94,662,435 | ||||
Ending balance at Dec. 31, 2018 | 546,845 | $ 1,273 | 774,158 | (649) | (227,937) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuances under equity incentive plans (in shares) | 973,012 | ||||
Issuances under equity incentive plans | 6,190 | $ 9 | 6,181 | ||
Vesting of early exercised common stock (in shares) | 135,424 | ||||
Vesting of early exercised common stock | 92 | $ 2 | 90 | ||
Vesting of restricted stock awards (2018) restricted stock awards and units (2019) and restricted stock units (2020) (in shares) | 419,064 | ||||
Vesting of restricted stock awards (2018) restricted stock awards and units (2019) and restricted stock units (2020) | 0 | $ 4 | (4) | ||
Stock-based compensation | 38,378 | 38,378 | |||
Net Income (loss) | (197,614) | (197,614) | |||
Other comprehensive income (loss) | $ 999 | 999 | |||
Ending balance (in shares) at Dec. 31, 2019 | 96,189,935 | 96,189,935 | |||
Ending balance at Dec. 31, 2019 | $ 394,890 | $ 1,288 | 818,803 | 350 | (425,551) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Issuance of common stock in follow-on offering, net of issuance costs of 632 (in shares) | 9,000,000 | ||||
Issuance of common stock in follow-on offering, net of issuance costs of $632 | 193,948 | $ 90 | 193,858 | ||
Issuance of common stock in connection with the Biogen Stock Purchase Agreement (in shares) | 13,310,243 | ||||
Issuance of common stock in connection with the Biogen Stock Purchase Agreement | 420,146 | $ 133 | 420,013 | ||
Issuances under equity incentive plans (in shares) | 1,722,058 | ||||
Issuances under equity incentive plans | 20,655 | $ 17 | 20,638 | ||
Vesting of restricted stock awards (2018) restricted stock awards and units (2019) and restricted stock units (2020) (in shares) | 309,097 | ||||
Vesting of restricted stock awards (2018) restricted stock awards and units (2019) and restricted stock units (2020) | 0 | $ 3 | (3) | ||
Stock-based compensation | 50,351 | 50,351 | |||
Net Income (loss) | 71,136 | 71,136 | |||
Other comprehensive income (loss) | $ (595) | (595) | |||
Ending balance (in shares) at Dec. 31, 2020 | 120,531,333 | 120,531,333 | |||
Ending balance at Dec. 31, 2020 | $ 1,150,531 | $ 1,531 | $ 1,503,660 | $ (245) | $ (354,415) |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Common Stock | |
Common stock issuance costs | $ 632 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Operating activities | |||
Net income (loss) | $ 71,136 | $ (197,614) | $ (36,240) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Depreciation and amortization | 8,531 | 7,991 | 7,415 |
Stock-based compensation expense | 50,351 | 38,378 | 18,791 |
Net amortization of premiums and (discounts) on marketable securities | 55 | (5,019) | (2,705) |
Non-cash adjustment to operating lease expense | (2,360) | 2,117 | 0 |
Other non-cash items | 38 | (351) | (36) |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other assets | (10,569) | 6,675 | (18,290) |
Accounts payable | (1,623) | 1,033 | (526) |
Accruals and other current liabilities | 22,106 | 1,500 | 9,113 |
Contract liabilities | (19,253) | (6,286) | 68,777 |
Related party contract liability | 297,418 | 0 | 0 |
Deferred rent | 0 | 0 | 3,438 |
Other non-current liabilities | 322 | 0 | 379 |
Net cash provided by (used in) operating activities | 416,152 | (151,576) | 50,116 |
Investing activities | |||
Purchases of marketable securities | (1,285,468) | (369,696) | (557,930) |
Purchases of property and equipment | (3,095) | (17,919) | (3,393) |
Maturities and sales of marketable securities | 665,357 | 535,327 | 273,901 |
Net cash provided by (used in) investing activities | (623,206) | 147,712 | (287,422) |
Financing activities | |||
Proceeds from issuance of common stock in connection with Collaboration Agreements | 420,146 | 0 | 94,406 |
Proceeds from public offering of common stock, net of issuance costs | 193,948 | 0 | 0 |
Proceeds from exercise of awards under equity incentive plans | 20,655 | 6,190 | 3,999 |
Net cash provided by financing activities | 634,749 | 6,190 | 97,019 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 427,695 | 2,326 | (140,287) |
Cash, cash equivalents and restricted cash at beginning of year | 80,949 | 78,623 | 218,910 |
Cash, cash equivalents and restricted cash at end of year | 508,644 | 80,949 | 78,623 |
Supplemental disclosures of cash flow information | |||
Tenant improvements provided by the landlord | 0 | 11,343 | 14,561 |
Property and equipment purchases accrued but not yet paid | 67 | 0 | 335 |
Common Stock | |||
Financing activities | |||
Payments of issuance costs related to issuance for stock | 0 | 0 | (1,342) |
Preferred Stock | |||
Financing activities | |||
Payments of issuance costs related to issuance for stock | $ 0 | $ 0 | $ (44) |
Significant Accounting Policies
Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | Significant Accounting Policies Organization and Description of Business Denali Therapeutics Inc. ("Denali" or the “Company”) is a biopharmaceutical company, incorporated in Delaware, that discovers and develops therapeutics to defeat neurodegenerative diseases. The Company is headquartered in South San Francisco, California. Basis of Presentation These consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Principles of Consolidation These consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation. For the Company and its subsidiary, the functional currency has been determined to be U.S. dollars. Monetary assets and liabilities denominated in foreign currency are remeasured at period-end exchange rates. Non-monetary assets and liabilities denominated in foreign currencies are remeasured at historical rates. Foreign currency transaction gains and losses resulting from remeasurement are recognized in interest and other income, net in the Consolidated Statements of Operations and Comprehensive Income (Loss). Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported amounts of expenses during the reporting period. Actual results could differ from those estimates, and such differences could be material to the Consolidated Balance Sheets and Consolidated Statements of Operations and Comprehensive Income (Loss). Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, marketable securities and forward foreign currency exchange contracts. Substantially all of the Company’s cash and cash equivalents are deposited in accounts with financial institutions that management believes are of high credit quality. Such deposits have and will continue to exceed federally insured limits. The Company maintains its cash with accredited financial institutions and accordingly, such funds are subject to minimal credit risk. The Company’s investment policy limits investments to certain types of securities issued by the U.S. government, its agencies and institutions with investment-grade credit ratings and places restrictions on maturities and concentration by type and issuer. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents and marketable securities and issuers of marketable securities to the extent recorded on the Consolidated Balance Sheets . As of December 31, 2020 and 2019, the Company had no off-balance sheet concentrations of credit risk. The Company is exposed to counterparty credit risk on all of its derivative financial instruments. The Company has established and maintains strict counterparty credit guidelines and enters into hedges only with financial institutions that are investment grade or better to minimize the Company’s exposure to potential defaults. The Company does not require collateral to be pledged under these agreements. The Company is subject to a number of risks similar to other early-stage biopharmaceutical companies, including, but not limited to, the need to obtain adequate additional funding, possible failure of current or future preclinical testing or clinical trials, its reliance on third parties to conduct its clinical trials, the need to obtain regulatory and marketing approvals for its product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s product candidates, its right to develop and commercialize its product candidates pursuant to the terms and conditions of the licenses granted to the Company, protection of proprietary technology, the ability to make milestone, royalty or other payments due under any license or collaboration agreements, and the need to secure and maintain adequate manufacturing arrangements with third parties. If the Company does not successfully commercialize or partner any of its product candidates, it will be unable to generate product revenue or achieve profitability. The COVID-19 pandemic has caused increased risk and uncertainty for the Company. Credit risk associated with investments in securities may increase if any institution with which the Company has an investment is significantly impacted by the COVID-19 pandemic. As of December 31, 2020, the Company has not realized any losses on its cash deposits or investments. Further, COVID-19 may impact the timelines and progress of the Company's preclinical activities and clinical trials and may impact its ability to raise capital in the near term. Convertible Preferred Stock The Company is authorized to issue 40.0 million shares of preferred stock in one or more series and to fix the powers, designations, preferences and relative participating option or other rights thereof, including dividend rights, conversion rights, voting rights, redemption terms, liquidation preferences and the number of shares constituting any series, without any further vote or action by the Company’s shareholders. As of December 31, 2020 and 2019, the Company had no shares of preferred stock issued or outstanding. Segments The Company has one operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for the purposes of allocating resources. Fair Value of Financial Instruments Accounting Standards Codification ("ASC") Topic 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability, and are developed based on the best information available in the circumstances. ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes between the following: Level 1 – inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 – inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 3 – inputs are unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The carrying amounts reflected in the Consolidated Balance Sheets for cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued liabilities approximate their fair values, due to their short-term nature. Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with original maturities of 90 days or less at the date of purchase to be cash and cash equivalents. Cash equivalents are reported at fair value. Cash, cash equivalents, and restricted cash reported within the Consolidated Statements of Cash Flows is composed of Cash and Cash equivalents reported in the Consolidated Balance Sheets and $1.5 million of restricted cash for the letter of credit for the Company’s headquarters building lease which is included within other non-current assets in the Consolidated Balance Sheets. Marketable Securities The Company generally invests its excess cash in money market funds and investment grade short to intermediate-term fixed income securities. Such investments are included in cash and cash equivalents, short-term marketable securities, or long-term marketable securities on the Consolidated Balance Sheets, are considered available-for-sale, and reported at fair value with net unrealized gains and losses included as a component of stockholders’ equity. The Company classifies investments in securities with remaining maturities of less than one year, or where its intent is to use the investments to fund current operations or to make them available for current operations, as short-term investments. The Company classifies investments in securities with remaining maturities of over one year as long-term investments. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest and other income, net in the Consolidated Statements of Operations and Comprehensive Income (Loss). Realized gains and losses and declines in value determined to be due to credit losses on marketable securities, if any, are included in interest and other income, net. The Company periodically evaluates the need for an allowance for credit losses. This evaluation includes consideration of several qualitative and quantitative factors, including whether it has plans to sell the security, whether it is more likely than not it will be required to sell any marketable securities before recovery of its amortized cost basis, and if the entity has the ability and intent to hold the security to maturity, and the portion of any unrealized loss that is the result of a credit loss. Factors considered in making these evaluations include quoted market prices, recent financial results and operating trends, implied values from any recent transactions or offers of investee securities, credit quality of debt instrument issuers, expected cash flows from securities, other publicly available information that may affect the value of the marketable security, duration and severity of the decline in value, and the Company's strategy and intentions for holding the marketable security. Accounts Receivable Accounts receivable are included within prepaid expenses and other current assets on the Consolidated Balance Sheets. The accounts receivable balance represents amounts receivable from the Company's collaboration partners, net of an allowance for credit losses, if required. Derivatives and Hedging Activities The Company measures its derivative instruments at fair value, and accounts for them as either assets or liabilities included within prepaid expenses and other current assets and accruals and other current liabilities, respectively, on the Consolidated Balance Sheets. Derivatives are adjusted to fair value through interest and other income, net in the Consolidated Statements of Operations and Comprehensive Income (Loss). Property and Equipment, Net Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method over the related estimated useful lives as presented in the table below. Significant additions and improvements are capitalized, while repairs and maintenance are charged to expense as incurred. Asset Estimated useful life Leasehold improvements Shorter of life of asset or lease term Manufacturing and laboratory equipment five years Computer hardware and software three years Office furniture and equipment five years Impairment of Long-Lived Assets The Company periodically evaluates property and equipment for impairment whenever events or changes in circumstances indicate that a potential impairment may have occurred. If such events or changes in circumstances arise, the Company compares the carrying amount of the long-lived assets to the estimated future undiscounted cash flows expected to be generated by the long-lived assets. If the estimated aggregate undiscounted cash flows are less than the carrying amount of the long-lived assets, an impairment charge, calculated as the amount by which the carrying amount of the assets exceeds the fair value of the assets, is recorded. The fair value of the long-lived assets is determined based on the estimated discounted cash flows expected to be generated from the long-lived assets. The Company has not recorded any such impairment charges during the years presented. Leases The Company adopted Accounting Standards Update ("ASU") No. 2016-02, Leases as of January 1, 2019. A determination is made as to whether an arrangement is a lease at inception. A right-of-use (“ROU”) asset and operating lease liability is recognized for identified operating leases in the Consolidated Balance Sheets. The changes in operating lease ROU assets and operating lease liabilities are presented net within non-cash adjustment to operating lease expense in the Consolidated Statements of Cash Flows. ROU assets represent the Company’s right to use the underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments due over the lease term, with the ROU assets adjusted for lease incentives received. When determining the present value of lease payments, the Company uses its incremental borrowing rate on the date of lease commencement, or the rate implicit in the lease, if known. The Company does not assume renewals in its determination of the lease term unless the renewals are deemed by management to be reasonably certain at lease inception. Leases with an initial term of 12 months or less are not recorded on the balance sheet, unless they include an option to purchase the underlying asset that the Company is reasonably certain to exercise. The Company recognizes lease expenses on a straight-line basis over the lease term. The Company has leases with lease and non-lease components, which the Company has elected to account for as a single lease component. Revenue Recognition License and Collaboration Revenue The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and, therefore, within the scope of Topic 606. For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently, generally by analogy to Topic 606. The accounting treatment pursuant to Topic 606 is outlined below. The terms of licensing and collaboration agreements entered into typically include payment of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply and research and development services and royalties on net sales of licensed products. Each of these payments results in license, collaboration and other revenue, except for revenues from royalties on net sales of licensed products, which are classified as royalty revenue. The core principle of Topic 606 is to recognize revenue when promised goods or services are transferred to customers in an amount that reflects the consideration that is expected to be received in exchange for those goods or services. The Company may also receive reimbursement or make payments to a collaboration partner to satisfy cost sharing requirements. These payments are accounted for pursuant to ASC 808 and are recorded as an offset or increase to research and development expenses, respectively. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. Amounts received prior to satisfying the revenue recognition criteria are recorded as contract liabilities in the Company’s Consolidated Balance Sheets. If the related performance obligation is expected to be satisfied within the next twelve months this will be classified in current liabilities. Amounts recognized as revenue prior to the Company having an unconditional right (other than a right that is conditioned only on the passage of time) to receipt are recorded as contract assets in the Company's Consolidated Balance Sheets. If the Company expects to have an unconditional right to receive the consideration in the next twelve months, this will be classified in current assets. A net contract asset or liability is presented for each contract with a customer. At contract inception, the Company assesses the goods or services promised in a contract with a customer and identifies those distinct goods and services that represent a performance obligation. A promised good or service may not be identified as a performance obligation if it is immaterial in the context of the contract with the customer, if it is not separately identifiable from other promises in the contract (either because it is not capable of being separated or because it is not separable in the context of the contract), or if the promised good or service does not provide the customer with a material right. The Company considers the terms of the contract to determine the transaction price. The transaction price is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods or services to a customer. The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Variable consideration will only be included in the transaction price when it is not considered constrained, which is when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. If it is determined that multiple performance obligations exist, the transaction price is allocated at the inception of the agreement to all identified performance obligations based on the relative standalone selling prices ("SSP"). The relative SSP for each deliverable is estimated using external sourced evidence if it is available. If external sourced evidence is not available, the Company uses its best estimate of the SSP for the deliverable. Revenue is recognized when, or as, the Company satisfies a performance obligation by transferring a promised good or service to a customer. An asset is transferred when, or as, the customer obtains control of that asset, which for a service is considered to be as the services are received and used. The Company recognizes revenue over time by measuring the progress toward complete satisfaction of the relevant performance obligation using an appropriate input or output method based on the nature of the service promised to the customer. After contract inception, the transaction price is reassessed at every period end and updated for changes such as resolution of uncertain events. Any change in the transaction price is allocated to the performance obligations on the same basis as at contract inception, or to a single performance obligation as applicable. Management may be required to exercise considerable judgment in estimating revenue to be recognized. Judgment is required in identifying performance obligations, estimating the transaction price, estimating the SSP of identified performance obligations, which may include forecasted revenue, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success, and estimating the progress towards satisfaction of performance obligations. Research and Development Expenses Research and development costs are expensed as incurred. Research and development costs consist of salaries and other personnel related expenses, including associated stock–based compensation, consulting fees, lab supplies, and facility costs, as well as fees paid to other entities that conduct certain research, development and manufacturing activities on behalf of the Company. Where the Company shares costs with collaboration partners, such as in the Biogen Collaboration Agreement, research and development expenses may include cost sharing reimbursements from or payments to the collaboration partner, respectively. Nonrefundable advance payments for goods and services that will be used or received in future research and development activities are deferred and recognized as expense in the period in which the related goods are delivered or services are performed. The Company has acquired and may continue to acquire the rights to develop and commercialize new product candidates from third parties. The upfront payments to acquire license, product or rights, as well as any future milestone payments, are immediately recognized as research and development expense provided that there is no alternative future use of the rights in other research and development projects. Stock-Based Compensation The Company’s stock-based compensation programs grant awards that have included stock options, restricted stock units, restricted stock awards, and shares issued under its employee stock purchase plan. Grants are awarded to employees, including directors, and non-employees. The Company measures compensation expense for all stock-based awards at the grant date based on the fair value measurement of the award, which for non-employee stock-based awards became effective subsequent to the adoption of ASU No. 2018-07, Stock C ompensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting on September 30, 2018. The expense is recorded on a straight-line basis over the requisite service period, which is generally the vesting period, for the entire award. Expense is adjusted for actual forfeitures of unvested awards as they occur. The Company calculates the fair value measurement of stock options using the Black-Scholes valuation model. The Company uses the fair value of our common stock to determine the fair value of restricted stock awards. Income Taxes Income taxes are accounted for using the liability method, under which deferred tax assets and liabilities are determined based on the temporary differences between the financial reporting and tax bases of assets and liabilities and consideration is given to net operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using the enacted tax rates that are expected to be in effect when the differences are expected to reverse. The Company assesses the likelihood that deferred tax assets will be recovered from future taxable income, and a valuation allowance is established when necessary to reduce deferred tax assets to the amounts more likely than not expected to be realized. The Company recognizes and measures uncertain tax positions using a two–step approach. The first step is to evaluate the tax position taken or expected to be taken by determining whether the weight of available evidence indicates that it is more likely than not that the tax position will be sustained in an audit, including resolution of any related appeals or litigation processes. The second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon ultimate settlement. Significant judgment is required to evaluate uncertain tax positions. The Company evaluates uncertain tax positions on a regular basis. The evaluations are based on a number of factors, including changes in facts and circumstances, changes in tax law, correspondence with tax authorities during the course of the audit, and effective settlement of audit issues. Previously recognized tax positions that no longer meet the more-likely-than-not threshold are derecognized in the first subsequent financial reporting period in which that threshold is no longer met. The Company’s policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. Comprehensive Income (Loss) Comprehensive income (loss) is composed of net income (loss) and certain changes in stockholders’ equity that are excluded from net income (loss), primarily unrealized gains or losses on the Company’s marketable securities. Net Income (Loss) per Share Basic net income (loss) per share is calculated by dividing the net income (loss) by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net income (loss) per share is computed based on the treasury stock method by dividing net income by the weighted-average number of common shares outstanding during the period plus potentially dilutive common equivalent shares outstanding. However, where there is a net loss per ordinary share, no adjustment is made for potentially issuable ordinary shares since their effect would be anti-dilutive. In this case, diluted net loss per share is equal to basic net loss per share. Recently Issued Accounting Pronouncement In December 2019, the Financial Accounting Standards Board ("FASB") issued ASU No. 2019-12, Income Taxes (Topic 740) Simplifying the Accounting for Income Taxes. ASU No. 2019-12 modifies ASC 740 to simplify several aspects of accounting for income taxes, including eliminating certain exceptions to the guidance in ASC 740 related to the approach for intraperiod tax allocation. The guidance is effective for fiscal years beginning after December 15, 2020 and interim periods within those fiscal years, with early adoption permitted, and is required to be adopted prospectively, with the exception of certain specific amendments. The Company is currently finalizing its assessment of the impact of this ASU and does not expect it to have a material impact on its Consolidated Financial Statements. Recently Adopted Accounting Pronouncement In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments . ASU 2016-13 requires measurement and recognition of expected credit losses for financial assets. In April 2019, the FASB issued clarification to ASU 2016-13 within ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging , and Topic 825, Financial Instruments . The Company adopted this standard as of January 1, 2020 using a modified retrospective approach. Adoption of the standard did not have a material impact on the Consolidated Financial Statements. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements Assets and liabilities measured at fair value at each balance sheet date are as follows (in thousands): December 31, 2020 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 335,284 $ — $ — $ 335,284 U.S. government treasuries 149,997 — — 149,997 Short-term marketable securities: U.S. government treasuries 878,938 — — 878,938 U.S. government agency securities — 25,217 — 25,217 Corporate debt securities — 27,180 — 27,180 Commercial paper — 31,218 — 31,218 Long-term marketable securities: U.S. government treasuries 2,561 — — 2,561 Corporate debt securities — 30,138 — 30,138 Foreign currency derivative contracts — 185 — 185 Total $ 1,366,780 $ 113,938 $ — $ 1,480,718 Liabilities: Foreign currency derivative contracts $ — $ 11 $ — $ 11 Total $ — $ 11 $ — $ 11 December 31, 2019 Level 1 Level 2 Level 3 Total Assets: Cash equivalents Money market funds $ 54,163 $ — $ — $ 54,163 U.S. government treasuries 15,989 — — 15,989 Short-term marketable securities: U.S. government treasuries 250,070 — — 250,070 U.S. government agency securities — 2,000 — 2,000 Corporate debt securities — 53,479 — 53,479 Commercial paper — 30,358 — 30,358 Long-term marketable securities: U.S. government treasuries 13,869 — — 13,869 Corporate debt securities — 26,017 — 26,017 Foreign currency derivative contracts — 85 — 85 Total $ 334,091 $ 111,939 $ — $ 446,030 Liabilities: Foreign currency derivative contracts $ — $ 8 $ — $ 8 Total $ — $ 8 $ — $ 8 The Company’s Level 2 securities are valued using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly. There were no transfers of assets or liabilities between the fair value measurement levels during the years ended December 31, 2020 or 2019. |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities All marketable securities were considered available-for-sale at December 31, 2020 and 2019. On a recurring basis, the Company records its marketable securities at fair value using Level 1 or Level 2 inputs as discussed in Note 2, "Fair Value Measurements". The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s marketable securities by major security type at each balance sheet date are summarized in the tables below (in thousands): December 31, 2020 Amortized Cost Unrealized Holding Gains Unrealized Holding Losses Aggregate Fair Value Short-term marketable securities: U.S. government treasuries (1) $ 878,906 $ 44 $ (12) $ 878,938 U.S. government agency securities (2) 25,214 5 (2) 25,217 Corporate debt securities 27,101 79 — 27,180 Commercial paper 31,218 — — 31,218 Total short-term marketable securities 962,439 128 (14) 962,553 Long-term marketable securities: U.S. government treasuries 2,561 — — 2,561 Corporate debt securities (3) 30,147 2 (11) 30,138 Total long-term marketable securities 32,708 2 (11) 32,699 Total $ 995,147 $ 130 $ (25) $ 995,252 __________________________________________________ (1) Unrealized holding losses on 19 securities with an aggregate fair value of $369.9 million. (2) Unrealized holding losses on 2 securities with an aggregate fair value of $10.1 million. (3) Unrealized holding loss on 1 security with an aggregate fair value of $20.1 million. December 31, 2019 Amortized Cost Unrealized Holding Gains Unrealized Holding Losses Aggregate Fair Value Short-term marketable securities: U.S. government treasuries (1) $ 249,478 $ 594 $ (2) $ 250,070 U.S. government agency securities 1,999 1 — 2,000 Corporate debt securities (2) 53,396 94 (11) 53,479 Commercial paper 30,358 — — 30,358 Total short-term marketable securities 335,231 689 (13) 335,907 Long-term marketable securities: U.S. government treasuries (3) 13,865 6 (2) 13,869 Corporate debt securities (4) 25,998 34 (15) 26,017 Total long-term marketable securities 39,863 40 (17) 39,886 Total $ 375,094 $ 729 $ (30) $ 375,793 __________________________________________________ (1) Unrealized holding losses on 2 securities with an aggregate fair value of $9.3 million. (2) Unrealized holding losses on 4 securities with an aggregate fair value of $25.9 million. (3) Unrealized holding loss on 1 security with an aggregate fair value of $10.1 million. (4) Unrealized holding losses on 3 securities with an aggregate fair value of $17.2 million. As of December 31, 2020 and 2019, some of the Company’s marketable securities were in an unrealized loss position. The Company has not recognized an allowance for credit losses as of December 31, 2020 and there was no other-than-temporary impairment as of December 31, 2019 . The Company determined that it had the ability and intent to hold all marketable securities that have been in a continuous loss position until maturity or recovery. Further, these marketable securities were initially, and continue to be, held with investment grade, high credit quality institutions. All marketable securities with unrealized losses as of each balance sheet date have been in a loss position for less than twelve months or the loss is not material. The Company recorded unrealized gains on marketable securities in other comprehensive income for the year ended December 31, 2019. As a result, the Company recorded a tax benefit of 0.4 million for the year ended December 31, 2019 on the Consolidated Statements of Operations and Comprehensive Income (Loss) and a corresponding tax charge in other comprehensive income. There was no unrealized gain on marketable securities in other comprehensive income for the years ended December 31, 2020, or 2018, and as such there was no tax benefit recorded for the years ended December 31, 2020 and 2018 on the Consolidated Statements of Operations and Comprehensive Income (Loss) . All of the Company’s marketable securities have an effective maturity of less than two years. |
Derivative Financial Instrument
Derivative Financial Instruments | 12 Months Ended |
Dec. 31, 2020 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Derivative Financial Instruments | Derivative Financial Instruments Foreign Currency Exchange Rate Exposure The Company uses forward foreign currency exchange contracts to hedge certain operational exposures resulting from potential changes in foreign currency exchange rates. Such exposures result from portions of the Company's forecasted cash flows being denominated in currencies other than the U.S. dollar, primarily the Euro and British Pound. The derivative instruments the Company uses to hedge this exposure are not designated as cash flow hedges, and as a result, changes in their fair value are recorded in interest and other income, net, on the Company's Consolidated Statements of Operations and Comprehensive Income (Loss). The fair values of forward foreign currency exchange contracts are estimated using current exchange rates and interest rates and take into consideration the current creditworthiness of the counterparties. Information regarding the specific instruments used by the Company to hedge its exposure to foreign currency exchange rate fluctuations is provided below. The following table summarizes the Company’s forward foreign currency exchange contracts outstanding as of December 31, 2020 and 2019 (notional amounts in thousands): Foreign Exchange Contracts Number of Contracts Aggregate Notional (1) Amount in Foreign Currency Maturity Euros 26 3,855 Jan 2021 - Nov 2021 British Pounds 21 2,658 Jan 2021 - Nov 2021 Total at December 31, 2020 47 Euros 23 1,500 Jan 2020 - Nov 2020 British Pounds 15 2,285 Jan 2020 - Jun 2020 Swiss Francs 10 129 Jan 2020 - Aug 2020 Total at December 31, 2019 48 _________________________________________________ (1) The notional amount represents the net amount of foreign currency that will be received upon maturity of the forward contracts. Immaterial derivative liabilities are recorded on the Consolidated Balance Sheets as of December 31, 2020, and 2019. A derivative asset balance of $0.2 million is recorded in prepaid expenses and other current assets on the Consolidated Balance Sheets as of December 31, 2020 and an immaterial derivative asset balance is recorded in prepaid expenses and other current assets on the Consolidated Balance Sheets |
Acquisition
Acquisition | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Acquisition | Acquisition In August 2016, the Company entered into a License and Collaboration Agreement (“F-star Collaboration Agreement”) with F-star Gamma Limited (“F-star Gamma”), F-star Biotechnologische Forschungs-und Entwicklungsges M.B.H ("F-star GmbH") and F-star Biotechnology Limited ("F-star Ltd") (collectively, “F-star”) to leverage F-star’s modular antibody technology and the Company’s expertise in the development of therapies for neurodegenerative diseases. Under the F-star Collaboration Agreement, the Company made payments to F-star totaling $11.5 million. In connection with the entry into the F-star Collaboration Agreement, the Company also purchased an option for an upfront option fee of $0.5 million (the “buy-out-option”), to acquire all of the outstanding shares of F-star Gamma pursuant to a pre-negotiated buy-out option agreement (the “Option Agreement”). In May 2018, the Company exercised the Option Agreement and entered into a Share Purchase Agreement (the “Purchase Agreement”) with the shareholders of F-star Gamma and Shareholder Representative Services LLC, pursuant to which the Company acquired all of the outstanding shares of F-star Gamma (the “Acquisition”). As a result of the Acquisition, F-star Gamma became a wholly-owned subsidiary of the Company and the Company changed the entity’s name to Denali BBB Holding Limited. In addition, the Company became a direct licensee of certain intellectual property of F-star Ltd by way of the Company’s assumption of F-star Gamma’s license agreement with F-star Ltd, dated August 24, 2016, (the “F-star Gamma License”). The Company made initial exercise payments under the Purchase Agreement and the F-star Gamma License, in the aggregate, of $17.8 million. In addition, the Company is required to make future contingent payments, to F-star Ltd and the former shareholders of F-star Gamma, up to a maximum amount of $447.0 million in the aggregate upon the achievement of certain defined preclinical, clinical, regulatory and commercial milestones. These include up to $27.0 million in preclinical contingent payments, $50.0 million in clinical contingent payments, $120.0 million in regulatory contingent payments and $250.0 million in commercial contingent payments. The amount of the contingent payments will vary based on whether F-star delivers an Fcab (constant Fc-domains with antigen-binding activity) that meets pre-defined criteria and whether the Fcab has been identified solely by the Company or solely by F-star or jointly by the Company and F-star. The Company concluded that the assets acquired and liabilities assumed upon the exercise of the Option Agreement did not meet the accounting definition of a business, and as such, the acquisition was accounted for as an asset purchase. As the transaction was accounted for as an asset purchase rather than a business combination, the Company did not recognize any contingent consideration on the acquisition date. To date, the Company has paid consideration of $19.8 million in the aggregate, consisting of up-front and contingent consideration, all of which was recorded as research and development expense as incurred. The Company recognized $1.5 million of contingent consideration as research and development expense for the year ended December 31, 2019. There was no contingent consideration recognized for the year ended December 31, 2020. Any future contingent consideration is expected to be recognized as incurred in research and development expense on the Consolidated Statements of Operations and Comprehensive Income (Loss). Under the F-star Collaboration Agreement, the Company is responsible for certain research costs incurred by F-star Ltd in conducting activities under an agreed development plan for each Fcab, for up to 24 months after the target Fcab is accepted. The Company's responsibility for research costs under the first development plan related to an Fcab that targets the transferrin receptor was completed during the year ended December 31, 2018. The responsibility for costs under the second development plan related to an undisclosed Fcab target commenced in February 2019. The Company recognized $1.2 million, $1.1 million, and $0.8 million in research and development expense related to the funding of F-star activities under these development plans during the years ended December 31, 2020, 2019, and 2018, respectively. |
Collaboration Agreements
Collaboration Agreements | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaboration Agreements | Collaboration Agreements Biogen Provisional Biogen Collaboration Agreement and Common Stock Purchase Agreement On August 5, 2020, the Company entered into a binding Provisional Collaboration and License Agreement (“Provisional Biogen Collaboration Agreement”) with Biogen Inc.’s subsidiaries, Biogen MA Inc. (“BIMA”) and Biogen International GmbH (“BIG”) (BIMA and BIG, collectively, “Biogen”) pursuant to which the Company granted Biogen a license to co-develop and co-commercialize Denali’s small molecule LRRK2 inhibitor program (the “LRRK2 Program”), an option in respect of each of (i) the Company’s amyloid beta program utilizing the Company's Transport Vehicle ("TV") technology platform to cross the blood-brain barrier ("BBB") and (ii) one other unnamed program also utilizing the Company's TV technology platform (the “Option Programs”), and a right of first negotiation with respect to two additional unnamed programs for indications within Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis ("ALS") or multiple sclerosis utilizing the Company's TV technology platform (the “ROFN Programs”) should the Company decide to seek a collaboration with a third party for such programs. The Provisional Biogen Collaboration Agreement was a binding agreement, which became effective on the closing of the Common Stock Purchase Agreement ("SPA"), as described further below. The Provisional Biogen Collaboration Agreement expired in October 2020 upon the execution of a Definitive LRRK2 Collaboration and License Agreement (“LRRK2 Agreement”) with Biogen on October 4, 2020 and a Right of First Negotiation, Option and License Agreement (the “ROFN and Option Agreement”) on October 6, 2020 (collectively, the "Biogen Collaboration Agreement"). Under the terms of the Provisional Biogen Collaboration Agreement, Biogen was obligated to pay the Company a $560.0 million upfront payment, payable upon execution of the Biogen Collaboration Agreement, which occurred in October 2020. With respect to the LRRK2 Program, Biogen is required to make milestone payments up to approximately $1.125 billion upon achievement of certain development and sales milestone events. Such milestone payments include $375.0 million in development, $375.0 million upon first commercial sale, and $375.0 million in net sales-based milestones. The Company will share 50% of the profits and losses with Biogen for LRRK2 Products in the United States, and 40% of such profits and losses in China. The Company will be entitled to receive royalties in the high teens to low twenties percentages on net sales for LRRK2 Products outside of the United States and China. Under the terms of the Provisional Biogen Collaboration Agreement, through the effective date of the Biogen Collaboration Agreement, the Company conducted and controlled LRRK2 clinical development. Subsequently, the Company and Biogen are jointly developing LRRK2 Products pursuant to a clinical development plan set forth within the LRRK2 Agreement. The parties share responsibility and costs for global development of LRRK2 Products pursuant to a mutually agreed development plan and budget ("LRRK2 Development Activities"), with Biogen funding 60% and the Company funding 40% of such costs. The Company may opt out of development cost sharing worldwide and, upon such election, from any further profit-sharing from the LRRK2 Program. The Company also has the right to opt-out of the profit sharing arrangement for the LRRK2 Program or for only those LRRK2 Products that do not penetrate the BBB (“Peripheral LRRK2 Products”), in each of the United States and China. After such an opt out, the Company will no longer be obligated to share in the development and commercialization costs for, or be entitled to share in the applicable revenues from, such LRRK2 Program (or from the Peripheral LRRK2 Products) for such country, as applicable. If the Company chooses to exercise its opt out rights, the Company will be entitled to receive tiered royalties on net sales of the applicable LRRK2 Program in the relevant country (or countries). The royalty rates for the applicable LRRK2 Program will be a percentage in the high teens to low twenties, but may increase to the mid-twenties if the Company has met certain co-funding thresholds or there has been a first commercial sale at the time of the Company's election. In addition to the LRRK2 Program, Biogen received an exclusive option to license two preclinical programs enabled by the Company's TV technology platform, which platform aims to improve brain uptake of biotherapeutics, including its Antibody Transport Vehicle ("ATV"): Abeta program ("ATV-enabled anti-amyloid beta program") and a second program utilizing the Company's TV technology for an unnamed target ("TV program"), excluding small molecules, Adeno-associated viruses ("AAV") and oligonucleotides. Biogen’s option may be exercised up to initiation of investigational new drug ("IND")-enabling studies for each program and continues for each program until a specified period of time after delivery of an option data package, or thirty Further, Biogen will have the right of first negotiation ("ROFN") on two additional TV-enabled therapeutics within Alzheimer’s disease, Parkinson’s disease, ALS or multiple sclerosis should the Company decide to seek a collaboration with a third party for such programs, but this does not include any of the Company’s small molecule, AAV or oligonucleotide programs. The ROFN period continues until seven years after the effective date of the Provisional Biogen Collaboration Agreement or the date on which the Company has offered Biogen two ROFN Programs, whichever is earlier. However, if the Company does not execute an agreement with a third party with respect to a particular ROFN Program offered to Biogen within a specified amount of time, Biogen will have one additional right to exercise the ROFN again with respect to such ROFN Program. In connection with the Provisional Biogen Collaboration Agreement, the Company entered into a common stock purchase agreement (the "Stock Purchase Agreement") with BIMA on August 5, 2020, pursuant to which the Company agreed to issue and sell, and BIMA agreed to purchase, 13,310,243 shares of the Company’s common stock (the “Shares”) for an aggregate purchase price of $465.0 million pursuant to the terms and conditions thereof. Since the shares of common stock owned by Biogen as of December 31, 2020 represent more than 10% of the voting interest of the Company, Biogen is considered a related party as defined in ASC 850. Management determined that it was appropriate to account for the Provisional Biogen Collaboration Agreement and the SPA as one arrangement because they were entered into at the same time with interrelated financial terms. On September 22, 2020, the Company closed the sale of the Shares to BIMA pursuant to the Stock Purchase Agreement. The estimated fair market value of the Shares issued to BIMA was $420.1 million, based on the closing stock price of $35.87 on the date of issuance adjusted by a discount for lack of marketability due to certain holding period restrictions, which was valued using an option pricing model. This stock issuance resulted in a $44.9 million premium paid to the Company above the estimated fair value of the Company's common stock (the "Stock Premium"), which forms part of the transaction price for the Provisional Biogen Collaboration Agreement. Upon inception, the Company identified the LRRK2 license as the only distinct performance obligation under ASC 606 associated with the Provisional Biogen Collaboration Agreement. No performance obligations were identified related to the Option or ROFN Programs since the relevant financial and operational terms were not considered to be sufficiently defined in the Provisional Biogen Collaboration Agreement to allow the Company to determine its obligations. Further, the Company was required to perform interim LRRK2 development activities subject to cost sharing in the period prior to finalization of the clinical development plan set forth within the LRRK2 Agreement. At inception, there was no transaction price for the Provisional Biogen Collaboration Agreement. On September 22, 2020, as noted above, the $44.9 million Stock Premium was included in the transaction price. All other potential future payments were considered constrained at inception through execution of the Biogen Collaboration Agreement since they were all contingent on the execution of the Biogen Collaboration Agreement. Through execution of the Biogen Collaboration Agreement, management determined that no performance obligation was satisfied or delivered to Biogen. Since no performance obligation had been satisfied, no related party revenue was recognized under ASC 606 prior to execution of the Biogen Collaboration Agreement. Biogen Collaboration Agreement The Company entered into the LRRK2 Agreement with Biogen on October 4, 2020 and the ROFN and Option Agreement on October 6, 2020. Collectively these are known as the Biogen Collaboration Agreement, the material terms of which are consistent with, and supersede, the Provisional Biogen Collaboration Agreement discussed above. Under the ROFN and Option Agreement, with respect to the options granted by the Company to Biogen, Biogen is obligated to pay to the Company an aggregate of up to $270.0 million in option exercise and development milestone payments, up to $325.0 million upon first commercial sale, and up to $290.0 million of net sales-based milestone payments, following the achievement of certain prespecified milestone events and if Biogen exercises both of its options. Furthermore, Biogen is obligated to pay to the Company royalties in the mid-single digit to mid-teens percentages, depending on the program for which Biogen exercises its option and upon the achievement of certain sales thresholds. In October 2020, the Company received upfront payments totaling $560.0 million pursuant to the Biogen Collaboration Agreement. The Biogen Collaboration Agreement is considered a contract modification to the Provisional Biogen Collaboration Agreement and will be accounted for as a termination of the provisional agreement and commencement of a new contract. The Company identified the following distinct performance obligations associated with the Biogen Collaboration Agreement that had not yet been delivered under the original contract: the LRRK2 Program license, the research services for the ATV:Abeta and TV programs (“Option Research Services”) which include option joint steering committee ("JSC") participation, and a material right for an option under the ROFN and Option Agreement. Further, the LRRK2 Development Activities which includes LRRK2 JSC and joint development committee (“JDC”) participation was identified as a unit of account under ASC 808. The LRRK2 Development Activities, JSC and JDC participation are considered to be a single unit of account since the development activities are highly interrelated with the JSC and JDC involvement and these are not distinct in the context of the contract. Further, the same was considered to be true for the option research services and option JSC participation performance obligation. The Company believes that the Biogen Collaboration Agreement is a collaboration arrangement as defined in ASC 808, Collaborative Agreements. The Company also believes that Biogen meets the definition of a customer as defined in ASC 606, Revenue From Contracts With Customers for all of the performance obligations identified at inception except for the LRRK2 Development Activities. Since ASC 808 does not address recognition and measurement, the Company looked to other accounting literature for guidance where the performance obligation does not fall under ASC 606, and determined that for the interim LRRK2 development activities subject to cost sharing provisions, the guidance in ASC 730, Research and Development should be applied. The transaction price at inception included fixed consideration consisting of the upfront fee of $560.0 million and the $44.9 million premium on the sale of common stock. All potential future milestones and other payments were considered constrained at the inception of the Biogen Collaboration Agreement since the Company could not conclude it was probable that a significant reversal in the amount recognized would not occur. From inception of the Biogen Collaboration Agreement through December 31, 2020 , there was no change to the transaction price. The respective standalone value for each of the performance obligations was determined by applying the SSP method and the transaction price was allocated based on the relative SSP method with revenue recognition timing to be determined either by delivery, resolution of an option, or the provision of services. The Company used an adjusted market assessment approach to estimate the selling price for the LRRK2 Program license, an expected cost plus margin approach for estimating the Option Research Services and estimated the intrinsic value of the material right for the option, taking into account the likelihood that an option would be exercised. The LRRK2 Program license was delivered on or around the effective date of the Biogen Collaboration Agreement and the revenue allocated to this performance obligation was recognized during the year ended December 31, 2020 . The Option Research Services are expected to be delivered over time as the services are performed, with revenue being recognized over time based on costs incurred to perform the services, since the level of costs incurred over time is thought to best reflect the transfer of services to Biogen. Revenue allocated to the material right for an option under the ROFN and Option Agreement is deferred as a contract liability until the option opt in period ends, expiration or ROFN and Option Agreement termination. The LRRK2 Development Activities cost sharing reimbursements or expenses will be recognized over time as earned or incurred, since this is believed to directly correlate to the value of the services performed. A related party contract liability of $297.4 million was recorded on the Consolidated Balance Sheet as of December 31, 2020 . Approximately $288.9 million of this contract liability relates to the revenue allocated to the material right for an option under the ROFN and Option Agreement which is being deferred until resolution of the option which is expected to be several years from the balance sheet date, and $8.5 million of this contract liability relates to the portion of the Option Research Services performance obligation yet to be satisfied, with such amount to be recognized over the estimated period of the services, which is expected to be several years. The Company recorded $9.3 million of cost sharing reimbursements for interim LRRK2 development activities and LRRK2 Development Activities as an offset to research and development expenses in the Consolidated Statement of Operations and Comprehensive Income for the year ended December 31, 2020, of which $5.7 million was recorded as cost sharing reimbursements due from Biogen on the Consolidated Balance Sheet as of December 31, 2020 . In assessing the Biogen Collaboration Agreement, management exercised considerable judgment in estimating revenue to be recognized, specifically related to estimating the discount for lack of marketability associated with the stock issuance, determining the separate performance obligations under the Biogen Collaboration Agreement, and estimating the standalone selling price of those performance obligations. As of December 31, 2020 , the Company had not achieved any milestones or recorded any product sales under the Biogen Collaboration Agreement. Sanofi In October 2018, the Company entered into a Collaboration and License Agreement ("Sanofi Collaboration Agreement") with Genzyme Corporation, a wholly owned subsidiary of Sanofi S.A. ("Sanofi") pursuant to which certain small molecule CNS and peripheral receptor interacting serine/threonine protein kinase 1 ("RIPK1") inhibitors contributed by Sanofi and by the Company will be developed and commercialized. The Sanofi Collaboration Agreement became effective in November 2018 at which time Sanofi paid the Company an upfront payment of $125.0 million. Under the Sanofi Collaboration Agreement, the Company is eligible to receive milestone payments from Sanofi up to approximately $1.1 billion upon achievement of certain clinical, regulatory and sales milestone events. Such milestone payments include $215.0 million in clinical milestone payments and $385.0 million in regulatory milestone payments for CNS Products, as defined, that are developed and approved in the United States, by the European Medicines Agency ("EMA") and in Japan for three indications, including Alzheimer's disease. These milestones also include $120.0 million in clinical milestone payments, $175.0 million in regulatory milestone payments and $200.0 million in commercial milestone payments for Peripheral Products, as defined, that are developed and approved in the United States, by the EMA and Japan for three indications. The Company will share profits and losses equally with Sanofi for CNS Products sold in the United States and China, and receive variable royalties on net sales for CNS Products sold outside of the United States and China and for Peripheral Products sold worldwide. The Company and Sanofi will jointly develop CNS Products pursuant to a global development plan. The Company will be responsible, at its own cost, for conducting Phase 1 and Phase 2 trials for CNS Products in Alzheimer’s disease and any activities required to support such clinical trials and specific for Alzheimer’s disease ("Denali CNS Development Activities"). The Company conducted, at Sanofi’s cost, a Phase 1b trial for the initial lead CNS penetrant RIPK1 inhibitor, DNL747 (SAR443060), in ALS. In June 2020, the Company announced that clinical activities on DNL747 would be paused and efforts focused on the development of the backup preclinical candidate, DNL788 (SAR443820). Other than with the Denali CNS Development Activities, Sanofi is responsible, at its cost, for all other Phase 1 and Phase 2 trials for CNS Products, including for ALS and multiple sclerosis. Sanofi will lead the conduct of all Phase 3 and later stage development trials for CNS Products, with Sanofi and the Company funding 70% and 30% of such costs, respectively. Sanofi will also lead the commercialization activities globally for CNS Products, subject to certain options that the Company has to conduct co-commercialization activities with respect to each CNS Product in the United States and China. Sanofi will be responsible, at its cost, for conducting activities relating to the development and commercialization of all Peripheral Products. Denali will be entitled to receive tiered royalties in the low- to mid- teen percentages on net sales of Peripheral Products. The Company identified the following distinct performance obligations associated with the Sanofi Collaboration Agreement upon inception: the CNS program license, the Peripheral program license, the Phase 1 and Phase 2 trials for CNS Products for Alzheimer’s disease ("Alzheimer's Disease Services"), and the Phase 1b trial for DNL747 for ALS and associated activities ("Retained Activities"). The Company believes that the Sanofi Collaboration Agreement is a collaboration arrangement as defined in ASC 808, Collaborative Agreements. The Company also believes that Sanofi meets the definition of a customer as defined in ASC 606, Revenue From Contracts With Customers for three of the performance obligations identified at inception, but does not meet the definition of a customer for the Alzheimer's Disease Services. Further, Sanofi does not meet the definition of a customer for all Phase 3 and later stage development trials for CNS Products led by Sanofi for which the Company will fund 30% of total costs. Since ASC 808 does not address recognition and measurement, the Company looked to other accounting literature for guidance where the performance obligation does not fall under ASC 606, and determined that for the Alzheimer's Disease Services, the guidance in ASC 606 should be analogized for the recognition, measurement and reporting of this performance obligation, and for the cost sharing provisions, the Company determined that the guidance in ASC 730, Research and Development should be applied. The transaction price at inception included upfront fixed consideration of $125.0 million. All potential future milestones and other payments were considered constrained at the inception of the Sanofi Collaboration Agreement since the Company could not conclude it was probable that a significant reversal in the amount recognized would not occur. The transaction price increased by $1.0 million, $10.4 million and $2.3 million, for the years ended December 31, 2020, 2019 and 2018, respectively, related to costs incurred for Retained Activities that were no longer constrained. Additionally, the $10.0 million milestone triggered by the commencement of a DNL758 (SAR443122) Phase 1 clinical trial in healthy volunteers was included in the increase in transaction price for the year ended December 31, 2019. The respective standalone value for each of the performance obligations was determined by applying the SSP method and the transaction price allocated based on the relative SSP method with revenue recognition timing to be determined either by delivery or the provision of services. The Company used an adjusted market assessment approach to estimate the selling price for the program licenses, and an expected cost plus margin approach for estimating the Alzheimer’s Disease Services and the Retained Activities. The program licenses and existing know-how were delivered on the effective date of the Sanofi Collaboration Agreement. The Alzheimer’s Disease Services and the Retained Activities were expected to be delivered over time as the services are performed. For the Alzheimer's Disease Services, revenue will be recognized over time using the input method, based on costs incurred to perform the services, since the level of costs incurred over time is thought to best reflect the transfer of services to Sanofi. For the Retained Activities, revenue will be recognized over time using the output method, based on amounts invoiced to Sanofi, since this is believed to directly correlate to the value of the services performed. A contract liability of $3.4 million and $3.5 million was recorded on the Consolidated Balance Sheets as of December 31, 2020 and 2019 , respectively. This contract liability relates to the portion of the Alzheimer's Disease Services performance obligation yet to be satisfied, with such amounts to be recognized over the estimated period of the services, which is expected to be several years. The Company recorded a receivable associated with the Sanofi Collaboration Agreement on the Consolidated Balance Sheets as of December 31, 2020 and 2019 of $44,303 and $1.2 million, respectively. In assessing the Sanofi Collaboration Agreement, management is required to exercise considerable judgment in estimating revenue to be recognized. Management applies judgment in determining the separate performance obligations, in estimating the selling price, in determining when control was transferred to Sanofi for the licenses, and in estimating total future costs when using the input method. Through December 31, 2020, the Company has received milestone payments of $10.0 million and has not recorded any product sales under the Sanofi Collaboration Agreement. Takeda In January 2018, the Company entered into a Collaboration and Option Agreement ("Takeda Collaboration Agreement") with Takeda Pharmaceutical Company Limited ("Takeda"), pursuant to which the Company granted Takeda an option to develop and commercialize, jointly with the Company, certain biologic products that are enabled by the Company's BBB delivery technology and intended for the treatment of neurodegenerative disorders. The programs were the Company ’s ATV:BACE1/Tau, and ATV:TREM2 and PTV:PGRN programs. The Takeda Collaboration Agreement became effective in February 2018, at which time Takeda paid the Company an upfront payment of $40.0 million. Takeda may pay up to an aggregate of $25.0 million with respect to each of the three programs directed to a target and based upon the achievement of certain preclinical milestone events, up to $75.0 million in total, $5.0 million of which was paid upon the Takeda Collaboration Agreement becoming effective. In February 2019, the agreem ent was amended to replace the ATV:BACE1/Tau program with the ATV:Tau program. The amendment did not have a material impact to the consolidated financial statements. Under the Takeda Collaboration Agreement and unless otherwise agreed jointly between both parties, the Company will be responsible, at its cost, for conducting activities relating to pre-IND development of biologic products directed to the three identified targets and enabled by its BBB delivery technology targeting TfR during the applicable research period. The period through which the option can be exercised continues for each target until the first biologic product directed to the relevant target is IND-ready or approximately five years after selection of the target, whichever is earlier. If Takeda exercises its option with respect to a particular target, then Takeda will have the right to develop and commercialize, jointly with the Company, a specified number of biologic products enabled by its BBB delivery technology that were developed during the research period and which are directed to the relevant target. The Company will grant to Takeda a co-exclusive license under the intellectual property the Company controls related to those biologic products. Takeda is obligated to pay the Company a $5.0 million option fee for each target for which Takeda exercises its option, up to $15.0 million in total. In addition, if Takeda exercises its option for all three collaboration programs, Takeda may be obligated to pay the Company up to an aggregate of $407.5 million upon achievement of certain clinical milestone events and up to an aggregate of $300.0 million in regulatory milestone events relating to receipt of regulatory approval in the United States, certain European countries and Japan. Takeda may also be obligated to pay the Company up to $75.0 million per biologic product upon achievement of a certain sales-based milestone, or an aggregate of $225.0 million if one biologic product from each program achieves this milestone. If Takeda exercises its option for a particular target, the Company and Takeda will share equally in the development and commercialization costs, and, if applicable, the profits, for each collaboration program. Pursuant to the terms of the Takeda Collaboration Agreement, the Company entered into a common stock purchase agreement (the "Stock Purchase Agreement") with Takeda on January 3, 2018, pursuant to which Takeda purchased 4,214,559 shares of the Company’s common stock (the "Shares") for an aggregate purchase price of $110.0 million. The sale of the Shares closed on February 23, 2018. The fair market value of the common stock sold to Takeda was $94.4 million, based on the closing stock price of $22.40 on the date of issuance, resulting in a $15.6 million premium paid to the Company above the fair value of the Company's common stock which was credited to contract liability in the Company's Consolidated Balance Sheets. The Company believes that the Takeda Collaboration Agreement is a collaboration arrangement as defined in ASC 808, Collaborative Agreements. Further, during the research period, the Company believes that the arrangement is a contract with a customer as defined in ASC 606, Revenue From Contracts With Customers . The Takeda Collaboration Agreement and the Stock Purchase Agreement are being accounted for as one arrangement because they were entered into at the same time with interrelated financial terms. The Company identified performance obligations during the research period consisting of the license, the development options, and joint steering committee ("JSC") participation together with the research services for each collaboration program. The license rights, JSC involvement, option and research services are considered to be a single performance obligation for each program since the research services are highly interrelated with the option and JSC involvement and will significantly modify the license. The performance obligations under each of the three programs are separate since the activities and risks under the programs are distinct. The Company determined that all other goods or services which are contingent upon Takeda exercising its option for each program were not considered performance obligations at the inception of the Takeda Collaboration Agreement. The transaction price at inception included fixed consideration consisti ng of the upfron t fee of $40.0 million, the $15.6 million premium on the sale of common stock, and the first preclinical milestone payment of $5.0 million . It also included variable consideration of $26.0 million relating to future milestones that were not constrained. The amount of variable consideration was estimated using the most likely amount method. The remaining $44.0 million of preclinical milestones were considered constrained at the inception of the Takeda Collaboration Agreement since the Company could not conclude it is probable that a significant reversal in the amount recognized will not occur. Additionally, cost and profit-sharing income, and the development and commercial milestones as outlined above, have not been considered given Takeda has not exercised its options for the development and commercial phases for any program. There was no change in the transaction price during the years ended December 31, 2020, 2019 and 2018. This will be reassessed at each reporting period. The transaction price has been ascribed in its entirety to the three performance obligations identified in the research term of the Takeda Collaboration Agreement. Revenue is recognized when, or as, the Company satisfies its performance obligations by transferring the promised services to Takeda. Revenue is being recognized over time using the input method, based on costs incurred to perform the research services, since the level of costs incurred over time is thought to best reflect the transfer of services to Takeda. There were no material changes in estimates during the years ended December 31, 2020 and 2019. A contract liability of $39.8 million and $59.0 million was recorded on the Consolidated Balance Sheets as of December 31, 2020 and 2019, respectively. This contract liability relates to the three performance obligations identified, with such amounts to be recognized over the estimated period of the pre-IND research services, which is expected to be several years. In December 2020 and January 2021, GLP toxicology studies were initiated for PTV:PGRN and ATV:TREM2, respectively, triggering the second preclinical milestone payments of $8.0 million for each program. There was a receivable of $8.0 million for the PTV:PGRN milestone as of December 31, 2020 and no receivable as of December 31, 2019, related to the Takeda Collaboration Agreement. The second preclinical milestone payment for PTV:PGRN was received in January 2021. Revenue recognized relating to future milestone payments of $4.6 million and $2.4 million, which the Company concluded is probable that a significant reversal in the amount recognized will not occur, is presented net in the contract liability on the Consolidated Balance Sheets as of December 31, 2020 and 2019, respectively. In assessing the Takeda Collaboration Agreement, management is required to exercise considerable judgment in estimating revenue to be recognized. Management applies judgment in determining the separate performance obligations in the research period, estimating variable consideration, and estimating total future costs when using the input method. There is some increase in the judgment required in estimating the timing of future costs due to the COVID-19 pandemic. This is because it is challenging to predict the duration and extent of the impact of the COVID-19 pandemic on the third-party service providers assisting with the Company's ATV:Tau, ATV:TREM2 and PTV:PGRN programs. This may impact the split between current and non-current contract liability on the Consolidated Balan |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License Agreements | License Agreements Genentech In June 2016, the Company entered into an Exclusive License Agreement with Genentech, Inc. (“Genentech”). The agreement gives the Company access to Genentech’s LRRK2 inhibitor small molecule program for Parkinson's disease. Under the agreement, Genentech granted the Company (i) an exclusive, worldwide, sublicensable license under Genentech’s rights to certain patents and patent applications directed to small molecule compounds which bind to and inhibit LRRK2 and (ii) a non-exclusive, worldwide, sublicensable license to certain related know-how, in each case, to develop and commercialize certain compounds and licensed products incorporating any such compound. The Company may owe Genentech milestone payments upon the achievement of certain development, regulatory, and commercial milestones, up to a maximum of $315.0 million in the aggregate. These milestones include up to $37.5 million in clinical milestone payments, $102.5 million in regulatory milestone payments and $175.0 million in commercial milestone payments. In addition, the Company may owe royalties on net sales of licensed products ranging from low to high single-digit percentages. Under the terms of our LRRK2 Agreement with Biogen, Biogen is responsible for 50% of any payment obligation to Genentech under this agreement accruing after October 4, 2020. To date, the Company has paid Genentech $12.5 million |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Components | Balance Sheet Components Property and Equipment, Net Property and equipment, net consists of the following (in thousands): As of December 31, 2020 2019 Lab equipment $ 24,216 $ 21,846 Leasehold improvements 34,738 34,563 Computers equipment and purchased software 1,254 1,156 Furniture and fixtures 1,440 1,440 Total property and equipment 61,648 59,005 Less: accumulated depreciation (20,802) (12,273) Total property and equipment, net $ 40,846 $ 46,732 Depreciation expense was $8.5 million , $8.0 million and $7.4 million for the years ended December 31, 2020, 2019 and 2018, respectively. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consists of the following (in thousands): As of December 31, 2020 2019 Accrued compensation $ 20,503 $ 8,739 Accrued clinical costs 6,497 5,042 Accrued manufacturing costs 7,140 2,027 Accrued other research & development costs 5,278 3,224 Accrued general and administrative, shared costs, and other current liabilities 3,037 1,318 Operating lease liability, current 4,690 3,665 Total accrued expenses and other current liabilities $ 47,145 $ 24,015 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Lease Obligations In May 2018, the Company entered into an amendment to its operating lease for its former corporate headquarters in South San Francisco (the "Headquarters Lease Amendment") to relocate and expand its headquarters to 148,020 rentable square feet in a building in South San Francisco, California (the "New Premises"). The Headquarters Lease Amendment has a contractual term of ten years from the legal commencement date, which was April 1, 2019 when the building was ready for occupancy. For accounting purposes, the lease commencement date was determined to be August 1, 2018, which was the date at which the Company was deemed to have obtained control over the property. The Company has an option to extend the lease term for a period of ten years by giving the landlord written notice of the election to exercise the option at least nine months, but not more than twelve months, prior to the expiration of the Headquarters Lease Amendment lease term. The Company determined that this renewal was not reasonably certain at lease inception. The Headquarters Lease Amendment provides for monthly base rent amounts escalating over the term of the lease. In addition, the Headquarters Lease Amendment provided a tenant improvement allowance ("TIA") of up to $25.9 million, which was fully utilized, of which $4.4 million will be repaid to the landlord in the form of additional monthly rent. This is recorded as leasehold improvement assets and an offset to the lease ROU asset on the Consolidated Balance Sheets. The Company is also required to pay the operating expenses for the New Premises, such as taxes and insurance, which are treated as variable lease payments. Management exercised judgment in applying the requirements of ASC 842, including the determination as to whether certain contracts contain a lease and for the Headquarters Lease Amendment, the discount rate used to determine the measurement of the lease liability. As the implicit rate of the Headquarters Lease Amendment was not known, the Company estimated a 9.0% discount rate, which was management’s estimate of the Company’s incremental borrowing rate. To estimate the incremental borrowing rate, management considered observable debt yields of comparable market instruments, as well as benchmarks within the Headquarters Lease Amendment that may be indicative of the rate implicit in the lease. Total operating lease costs, including variable and short-term lease costs, was $11.1 million and $10.2 million for the year ended December 31, 2020 and 2019, respectively. Rent expense excluding amortization of leasehold improvements was $6.0 million for the year ended December 31, 2018. Operating lease liabilities are calculated as the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, the Company uses its incremental borrowing rate based on the information available at the lease commencement date. As of December 31, 2020, the weighted average remaining lease term is 8.3 years and the weighted average discount rate used to determine the operating lease liability was 9.0%. Cash paid for amounts included in the measurement of lease liabilities for the year ended December 31, 2020 was $9.7 million and was included in net cash used in operating activities in the Company's Consolidated Statements of Cash Flows. The following table reconciles the undiscounted cash flows for the next five years and total of the remaining years to the operating lease liabilities recorded in the Consolidated Balance Sheet as of December 31, 2020 (in thousands): Year Ended December 31: 2021 $ 10,391 2022 10,731 2023 11,083 2024 11,447 2025 11,824 Thereafter 42,250 Total undiscounted lease payments 97,726 Present value adjustment (28,861) Net operating lease liabilities $ 68,865 In October 2018, the Company entered into a sublease agreement ("Sublease Agreement") to sublease approximately 36,835 rentable square feet of space in its New Premises. The Sublease Agreement has a term of five years from the commencement date of April 12, 2019 and provides for the Company to receive monthly base rent amounts escalating over the term of the lease. The Company also passes through a portion of the operating expenses, such as taxes and insurance for the New Premises to the sublessee, which are treated as variable sublease income. Total sublease income, including rent and variable sublease cost reimbursements, was $3.6 million and $2.6 million for the year ended December 31, 2020 and 2019, respectively. There was no sublease income for the year ended December 31, 2018. The following table details the future undiscounted cash inflows relating to the Company's Sublease Agreement as of December 31, 2020 (in thousands): Year Ended December 31: 2021 $ 2,925 2022 3,009 2023 3,096 2024 876 2025 and thereafter — Total undiscounted sublease receipts $ 9,906 Indemnification In the ordinary course of business, the Company may provide indemnifications of varying scope and terms to vendors, lessors, business partners, board members, officers, and other parties with respect to certain matters, including, but not limited to, losses arising out of breach of such agreements, services to be provided by the Company, negligence or willful misconduct of the Company, violations of law by the Company, or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with directors and certain officers and employees that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors, officers or employees. No demands have been made upon the Company to provide indemnification under such agreements, and thus, there are no claims that the Company is aware of that could have a material effect on the Company’s Consolidated Balance Sheets , Consolidated Statements of Operations and Comprehensive Income (Loss), or Consolidated Statements of Cash Flows. Commitments Effective September 2017, the Company entered into a Development and Manufacturing Services Agreement as amended (“DMSA”) with Lonza Sales AG (“Lonza”) for the development and manufacture of biologic products. Under the DMSA, the Company will execute purchase orders based on project plans authorizing Lonza to provide development and manufacturing services with respect to certain of the Company's antibody and enzyme products, and will pay for the services provided and batches delivered in accordance with the DMSA and project plan. Unless earlier terminated, the DMSA will expire on September 6, 2022. As of December 31, 2020 and 2019, the Company had open purchase orders for biological product development and manufacturing costs totaling $33.0 million and $21.2 million, respectively. The activities under these purchase orders are expected to be completed by February 2028. As of December 31, 2020 and 2019, the Company had total non-cancellable purchase commitments of $27.1 million and $11.2 million, respectively, under the DMSA. During the years ended December 31, 2020, 2019 and 2018, the Company incurred costs of $10.8 million, $12.7 million, and $3.9 million, respectively, and made payments of $7.3 million, $12.5 million, and $3.4 million respectively, for the development and manufacturing services rendered under the DMSA. In the normal course of business, the Company enters into various firm purchase commitments primarily related to research and development activities. The Company had contractual obligations under license and other agreements of $4.8 million and $1.1 million as of December 31, 2020 and 2019, respectively. Contingencies From time to time, the Company may be involved in lawsuits, arbitration, claims, investigations and proceedings consisting of intellectual property, employment and other matters which arise in the ordinary course of business. The Company records accruals for loss contingencies to the extent that the Company concludes that it is probable that a liability has been incurred and the amount of the related loss can be reasonably estimated. On September 10, 2020, the Company and all Directors were named in a shareholder derivative action filed in the Delaware Court of Chancery challenging the compensation paid to the Company's Directors since the IPO in December 2017. On January 13, 2021, the parties to the derivative action entered into a settlement agreement, subject to Court approval and certain other closing conditions, the terms of which were disclosed via Form 8-K filed on February 5, 2021. Amounts owed by the Company pursuant to the settlement agreement are not material to the Company. |
Stock-Based Awards
Stock-Based Awards | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Awards | Stock-Based Awards 2017 Equity Incentive Plan In December 2017, the Company adopted the 2017 Equity Incentive Plan (the “2017 Plan”), which initially reserved approximately 6.4 million shares of common stock for the issuance of stock options, restricted stock and other stock awards, to employees, non-employee directors, and consultants under terms and provisions established by the Board of Directors and approved by the stockholders. The 2017 Plan provides that the number of shares reserved and available for issuance under the 2017 Plan will automatically increase each January 1, beginning on January 1, 2019, by the lesser of (i) 10.0 million shares, (ii) 5% of the outstanding shares on the last day of the immediately preceding fiscal year, or (iii) such number of shares determined by the administrator of the 2017 Plan. In January 2020, common stock available for issuance under the 2017 Plan was increased by approximately 4.8 million shares as a result of this automatic increase provision. Awards granted under the 2017 Plan expire no later than ten years from the date of grant. For stock options, the option price shall not be less than 100% of the estimated fair value of the Company's common stock on the day of grant. Options granted typically vest over a four - year period but may be granted with different vesting terms. 2015 Stock Incentive Plan In May 2015, the Company adopted the 2015 Stock Incentive Plan (the “2015 Plan”), which as amended, reserved approximately 8.3 million shares of common stock for the issuance of stock options, restricted stock and other stock awards, to employees, non-employee directors, and consultants under terms and provisions established by the Board of Directors and approved by the stockholders. Awards granted under the 2015 Plan expire no later than ten years from the date of grant. For stock options, the option price shall not be less than 100% of the estimated fair value of the Company's common stock on the day of grant. Options granted typically vest over a four-year period but may be granted with different vesting terms. Upon adoption of the 2017 Plan, no new awards or grants are permitted under the 2015 Plan, and the approximately 0.2 million shares that were then unissued and available for future award under the 2015 Plan became available under the 2017 Plan . The 2015 Plan will continue to govern restricted stock awards and option awards previously granted thereunder. As of December 31, 2020 and 2019, there were approxim ately 3.7 million and 3.4 million common shares available for the Company to grant under the 2017 Plan, respectively. Stock Option Activity The following table summarizes option award activity under the 2017 Plan and the 2015 Plan: Number of Options Weighted- Average Exercise Price Weighted- Average remaining contractual life (years) Aggregate Intrinsic Value (in thousands) Balance at December 31, 2019 11,640,734 $ 12.96 7.79 $ 51,879 Options granted 3,518,298 26.24 Options exercised (1,487,426) 11.55 Options forfeited (711,680) 20.57 Balance at December 31, 2020 12,959,926 $ 16.31 7.37 $ 874,026 Options vested and expected to vest at December 31, 2020 11,215,194 $ 18.75 7.79 $ 717,292 Options exercisable at December 31, 2020 5,301,186 $ 14.28 6.95 $ 368,335 Aggregate intrinsic value represents the difference between the fair value of the Company's common stock and the exercise price of outstanding options. The total intrinsic value of options exercised was $43.8 million, $13.1 million, and $9.8 million for the years ended December 31, 2020, 2019 and 2018, respectively. During the years ended December 31, 2020, 2019, and 2018 the weighted-average grant-date fair value of the options vested was $11.51, $10.09, and $3.85 per share, respectively. The weighted-average grant date fair value of all options granted during the years ended December 31, 2020, 2019 and 2018 was $15.67, $11.86, and $14.79 per share, respectively. Stock Options Granted to Employees with Service-Based Vesting The estimated fair value of stock options granted to employees were calculated using the Black-Scholes option-pricing model using the following assumptions: Year Ended December 31, 2020 2019 2018 Expected term (in years) 5.50 - 6.08 5.50 - 6.08 5.50 - 6.08 Volatility 65.2% - 67.1% 65.5% - 77.8% 79.4% - 87.4% Risk-free interest rate 0.3% - 1.7% 1.5% - 2.6% 2.6% - 3.1% Dividend yield — — — Expected Term: The expected term represents the period that the options granted are expected to be outstanding and is determined using the simplified method (based on the mid-point between the vesting date and the end of the contractual term). Expected Volatility: The Company uses an average historical stock price volatility of comparable public companies within the biotechnology and pharmaceutical industry that were deemed to be representative of future stock price trends as the Company does not have sufficient trading history for its common stock. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Risk-Free Interest Rate: The Company based the risk-free interest rate over the expected term of the options based on the constant maturity rate of U.S. Treasury securities with similar maturities as of the date of the grant. Expected Dividend Yield: The Company has not paid and does not anticipate paying any dividends in the near future. Therefore, the expected dividend yield was zero. Performance and Market Contingent Stock Options Granted to Employees In August and November 2015, the Board of Directors granted approximately 1.6 million and 0.1 million shares of performance- and market- contingent awards to members of the senior management team, respectively. These awards have an exercise price of $0.68 per share. These awards have two separate market triggers for vesting based upon either (i) the successful achievement of stepped target closing prices on a national securities exchange for 90 consecutive trading days later than 180 days after the Company’s initial public offering for its common stock, or (ii) stepped target prices for a change in control transaction. In the event that neither of these market triggers are achieved by the specified timelines, such awards will terminate with respect to that portion of the shares. The expense recognized associated with these performance- and market- contingent awards was $0.3 million of general and administrative expense during the year ended December 31, 2020, and $5.2 million and $0.5 million of general and administrative expense and research and development expense, respectively, for the year ended December 31, 2019. The Company used a lattice model with a Monte Carlo simulation to value these stock options. This valuation methodology utilized the estimated fair value of the Company’s common stock on grant date and several key assumptions, including expected volatility of the Company’s stock price based on comparable public companies, risk-free rates of return and expected dividend yield. Restricted Stock Activity Under the 2017 Plan, the Company may grant restricted stock awards ("RSAs"), which represent restricted shares of issued common stock for which the recipient's rights in the stock are restricted until the shares are vested, and restricted stock units ("RSUs"), which represent a commitment to issue shares of common stock in the future upon vesting. The fair value of restricted stock underlying the RSAs and RSUs is determined based on the closing market price of the Company's common stock on the date of grant. Aggregated information regarding RSUs granted under the Plan for the year ended December 31, 2020 is summarized below: Share Awards & Units Weighted-Average Fair Value at Date of Grant per Share Unvested at December 31, 2019 882,636 $ 18.67 Granted 1,903,041 29.31 Vested and released (309,097) 19.23 Forfeited (174,901) 30.94 Unvested at December 31, 2020 2,301,679 $ 27.08 Expected to vest – December 31, 2020 2,301,679 $ 27.08 The aggregate intrinsic value of RSUs is calculated as the closing price per share of the Company's common stock on the last trading day of the fiscal period, multiplied by the number of RSUs expected to vest. The total intrinsic value of RSUs expected to vest was $192.8 million as of December 31, 2020. During the years ended December 31, 2019 and 2018 the weighted-average grant-date fair value of RSUs granted was $18.86 and $15.92, respectively. The total fair value of RSUs that vested during the year ended December 31, 2020 was $8.7 million , and of RSUs and RSAs that vested during the years ended December 31, 2019, and 2018 (measured on the date of vesting) was $8.8 million , and $37.0 million , respectively. Employee Stock Purchase Plan In December 2017, the Company adopted the 2017 Employee Stock Purchase Plan (the “2017 ESPP”), which initially reserved 1.0 million shares of common stock for employee purchases under terms and provisions established by the Board of Directors. The 2017 ESPP provides that the number of shares reserved and available for issuance under the 2017 ESPP will automatically increase each January 1, beginning on January 1, 2020, by the lesser of (i) 2.0 million shares, (ii) 1% of the outstanding shares on the last day of the immediately preceding fiscal year, or (iii) such number of shares determined by the administrator of the 2017 Plan. In January 2020, common stock available for issuance under the 2017 ESPP was increased by approximately 1.0 million shares as a result of this automatic increase provision. Under the 2017 ESPP, employees may purchase common stock through payroll deductions at a price equal to 85% of the lower of the fair market value of common stock on the first trading day of each offering period or on the exercise date. The 2017 ESPP provides for consecutive, overlapping 12-month offering periods. The offering periods are scheduled to start on the first trading day on or after May 31 or November 30 of each year, except for the first offering period which commenced on December 8, 2017, the first trading day after the effective date of the Company’s initial public offering. Contributions under the 2017 ESPP are limited to a maximum of 15% of an employee's eligible compensation. We issued 0.2 million shares of common stock under the 2017 ESPP during each of the years ended December 31, 2020, 2019 , and 2018. Stock-Based Compensation Expense The Company’s results of operations include expenses relating to stock-based compensation as follows (in thousands): Year Ended December 31, 2020 2019 2018 Research and development $ 29,002 $ 19,261 $ 10,093 General and administrative 21,349 19,117 8,698 Total $ 50,351 $ 38,378 $ 18,791 As of December 31, 2020, total unamortized stock-based compensation expense related to employee and non-employee awards was $125.4 million . The weighted-average period over which such stock-based compensation expense will be recognized is approximately 2.8 years. For the year ended December 31, 2020 , tax benefit realized related to awards vested or exercised during the period was $1.0 million. There was no tax benefit realized related to awards vested or exercised during the years ended December 31, 2019 and 2018. There is no tax benefit on total stock-based compensation expense for the years ended December 31, 2020 , 2019 |
Defined Contribution Plan
Defined Contribution Plan | 12 Months Ended |
Dec. 31, 2020 | |
Retirement Benefits [Abstract] | |
Defined Contribution Plan | Defined Contribution Plan The Company sponsors a 401(k) retirement savings plan for the benefit of its employees, including Denali's named executive officers, who satisfy certain eligibility requirements. Under the 401(k) plan, eligible employees may elect to defer a portion of their compensation, within the limits prescribed by the Code, on a pre-tax or after-tax (Roth) basis through contributions to the 401(k) plan. The 401(k) plan authorizes employer safe harbor contributions. The 401(k) plan is intended to qualify under Sections 401(a) and 501(a) of the Code. As a tax-qualified retirement plan, pre-tax contributions to the 401(k) plan and earnings on those pre-tax contributions are not taxable to the employees until distributed from the 401(k) plan, and earnings on Roth contributions are not taxable when distributed from the 401(k) plan. The Company made contributions to the Plan for eligible participants, and recorded contribution expenses o f $1.9 million , $1.6 million, and $0.9 million for the years ended December 31, 2020, 2019, and 2018 , respectively. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The provision for income taxes consisted of the following (in thousands): Year Ended December 31, 2020 2019 Current: U.S. Federal $ — $ — U.S. State 823 — Foreign — — Total Current $ 823 $ — Deferred: U.S. Federal $ — $ (338) U.S. State — (13) Foreign — — Total deferred $ — $ (351) The reconciliation of federal statutory income tax rate to our effective income tax rate is as follows: Year Ended December 31, 2020 2019 2018 Taxes at the U.S. statutory tax rate 21.0 % 21.0 % 21.0 % Effect of Tax Act 1.1 — — Change in valuation allowance (4.0) (24.4) (20.7) Research tax credits (9.2) 3.5 10.2 Stock-based compensation (7.9) 0.1 (0.7) Nondeductible acquisition-related costs — — (9.5) Other 0.1 (0.1) (0.3) Total provision for income taxes 1.1 % 0.1 % — % The effective tax rate for the year ended December 31, 2020 is different from the federal statutory tax rate primarily due to research tax credits, stock-based compensation deductions and the valuation allowance against deferred tax assets. For the years ended December 31, 2019 and 2018, the difference is primarily due to the valuation allowance against deferred tax assets. Deferred Income Taxes The components of the Company’s net deferred tax assets are as follows (in thousands): December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 54,110 $ 56,612 Tax credit carryforwards 27,411 19,133 Contract liabilities 15,344 13,516 Operating lease liability 17,179 15,686 Stock-based compensation 18,709 9,513 Accruals and other 17,767 11,815 Gross deferred tax assets 150,520 126,275 Valuation allowance (133,054) (112,713) Net deferred tax assets 17,466 13,562 Deferred tax liabilities: Property and equipment (9,329) (6,225) Operating lease right-of-use asset (8,137) (7,337) Net deferred tax assets $ — $ — Recognition of deferred tax assets is appropriate when realization of such assets is more likely than not. Based upon the weight of available evidence, especially the uncertainties surrounding the realization of deferred tax assets through future taxable income, the Company believes it is not more likely than not that the deferred tax assets will be fully realizable. Accordingly, the Company has provided a 100% valuation allowance against its net deferred tax assets as of December 31, 2020 and 2019. There was an increase in the net valuation allowance of $20.3 million during the year ended December 31, 2020. As of December 31, 2020, the Company has federal net operating loss (“NOL”) carryforwards of approximately $212.7 million , which are available to reduce future taxable income, and has federal R&D and orphan drug tax credits of approximately $20.4 million and $3.3 million respectively, both of which may be used to offset future tax liabilities. The federal NOL and federal tax credit carryforwards will begin to expire in 2035. The Company also has state NOL carryforwards of approximately $133.9 million , which are available to reduce future taxable income, and has state tax credits of approximately $13.6 million which may be used to offset future tax liabilities. The state NOL will begin to expire in 2035 and the state tax credit carryforwards will be carried forward indefinitely. The NOL and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service (“IRS”) and state tax authorities and may become subject to an annual limitation in the event of certain future cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. Annual limitations may result in expiration of net operating loss and tax credit carryforwards before some or all of such amounts have been utilized. The Company follows the provisions of ASC 740 , Accounting for Income Taxes , and the accounting guidance related to accounting for uncertainty in income taxes. The Company determines its uncertain tax positions based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings is more likely than not to be sustained upon examination by the relevant income tax authorities. A reconciliation of the beginning and ending amounts of unrecognized tax benefits is as follows (in thousands): December 31, 2020 2019 2018 Unrecognized tax benefits at January 1 $ 5,299 $ 2,642 $ 1,146 Additions for tax positions taken in a prior year — 107 — Additions for tax positions taken in the current year 3,009 2,595 1,506 Reductions for tax positions taken in the prior year (169) (45) (10) Unrecognized tax benefits at December 31 $ 8,139 $ 5,299 $ 2,642 If recognized, $0.3 million of the unrecognized tax benefits would reduce the annual effective tax rate for the year ended December 31, 2020, primarily due to corresponding adjustments to the valuation allowance. If recognized, none of the unrecognized tax benefits would reduce the annual effective tax rate for the year ended December 31, 2019. The Company will recognize both accrued interest and penalties related to unrecognized benefits in income tax expense. As of December 31, 2020, no liability has been recorded for potential interest or penalties. The Company does not expect the unrecognized tax benefits to change significantly over the next 12 months. Since the Company is in a loss carryforward position, the Company is generally subject to examination by the U.S. federal, state and local income tax authorities for all tax years in which a loss carryforward is available. |
Net Income (Loss) and Net Incom
Net Income (Loss) and Net Income (Loss) Per Share | 12 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) and Net Income (Loss) Per Share | Net Income (Loss) and Net Income (Loss) Per Share The following table sets forth the computation of the basic and diluted net income (loss) per share (in thousands, except share and per share data): Year Ended December 31, 2020 2019 2018 Numerator: Net income (loss) $ 71,136 $ (197,614) $ (36,240) Denominator: Weighted average number of shares outstanding, basic 108,974,137 95,608,208 92,621,991 Dilutive effect of outstanding common stock options, ESPP shares issuable, and restricted shares 3,728,971 — — Weighted average number of shares outstanding, diluted 112,703,108 95,608,208 92,621,991 Net income (loss) per share, basic $ 0.65 $ (2.07) $ (0.39) Net income (loss) per share, diluted $ 0.63 $ (2.07) $ (0.39) Potentially dilutive securities that were not included in the diluted per share calculations for the years ended December 31, 2020, 2019 and 2018 because they would be anti-dilutive were as follows: Year Ended December 31, 2020 2019 2018 Options issued and outstanding and ESPP shares issuable 3,286,045 11,921,434 9,789,594 Restricted shares subject to future vesting 879,792 882,636 503,243 Early exercised common stock subject to future vesting — — 135,424 Total 4,165,837 12,804,070 10,428,261 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party TransactionsOn September 22, 2020, upon becoming an owner of record of more than 10% of the voting interest in the Company, Biogen became a related party under ASC 850. Refer to Note 6, "Collaboration Agreements" for further information. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Organization and Description of Business | Organization and Description of Business Denali Therapeutics Inc. ("Denali" or the “Company”) is a biopharmaceutical company, incorporated in Delaware, that discovers and develops therapeutics to defeat neurodegenerative diseases. The Company is headquartered in South San Francisco, California. |
Basis of Presentation | Basis of PresentationThese consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). |
Principles of Consolidation | Principles of Consolidation These consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary. All intercompany balances and transactions have been eliminated in consolidation. For the Company and its subsidiary, the functional currency has been determined to be U.S. dollars. Monetary assets and liabilities denominated in foreign currency are remeasured at period-end exchange rates. Non-monetary assets and liabilities denominated in foreign currencies are remeasured at historical rates. Foreign currency transaction gains and losses resulting from remeasurement are recognized in interest and other income, net in the Consolidated Statements of Operations and Comprehensive Income (Loss). |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires the Company to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported amounts of expenses during the reporting period. Actual results could differ from those estimates, and such differences could be material to the Consolidated Balance Sheets and Consolidated Statements of Operations and Comprehensive Income (Loss). |
Concentration of Credit Risk and Other Risks and Uncertainties | Concentration of Credit Risk and Other Risks and Uncertainties Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents, marketable securities and forward foreign currency exchange contracts. Substantially all of the Company’s cash and cash equivalents are deposited in accounts with financial institutions that management believes are of high credit quality. Such deposits have and will continue to exceed federally insured limits. The Company maintains its cash with accredited financial institutions and accordingly, such funds are subject to minimal credit risk. The Company’s investment policy limits investments to certain types of securities issued by the U.S. government, its agencies and institutions with investment-grade credit ratings and places restrictions on maturities and concentration by type and issuer. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash, cash equivalents and marketable securities and issuers of marketable securities to the extent recorded on the Consolidated Balance Sheets . As of December 31, 2020 and 2019, the Company had no off-balance sheet concentrations of credit risk. The Company is exposed to counterparty credit risk on all of its derivative financial instruments. The Company has established and maintains strict counterparty credit guidelines and enters into hedges only with financial institutions that are investment grade or better to minimize the Company’s exposure to potential defaults. The Company does not require collateral to be pledged under these agreements. The Company is subject to a number of risks similar to other early-stage biopharmaceutical companies, including, but not limited to, the need to obtain adequate additional funding, possible failure of current or future preclinical testing or clinical trials, its reliance on third parties to conduct its clinical trials, the need to obtain regulatory and marketing approvals for its product candidates, competitors developing new technological innovations, the need to successfully commercialize and gain market acceptance of the Company’s product candidates, its right to develop and commercialize its product candidates pursuant to the terms and conditions of the licenses granted to the Company, protection of proprietary technology, the ability to make milestone, royalty or other payments due under any license or collaboration agreements, and the need to secure and maintain adequate manufacturing arrangements with third parties. If the Company does not successfully commercialize or partner any of its product candidates, it will be unable to generate product revenue or achieve profitability. |
Segments | Segments The Company has one operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations on a consolidated basis for the purposes of allocating resources. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments Accounting Standards Codification ("ASC") Topic 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability, and are developed based on the best information available in the circumstances. ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes between the following: Level 1 – inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. Level 2 – inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 3 – inputs are unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. Financial assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The carrying amounts reflected in the Consolidated Balance Sheets for cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued liabilities approximate their fair values, due to their short-term nature. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The Company considers all highly liquid investments with original maturities of 90 days or less at the date of purchase to be cash and cash equivalents. Cash equivalents are reported at fair value. |
Marketable Securities | Marketable Securities The Company generally invests its excess cash in money market funds and investment grade short to intermediate-term fixed income securities. Such investments are included in cash and cash equivalents, short-term marketable securities, or long-term marketable securities on the Consolidated Balance Sheets, are considered available-for-sale, and reported at fair value with net unrealized gains and losses included as a component of stockholders’ equity. The Company classifies investments in securities with remaining maturities of less than one year, or where its intent is to use the investments to fund current operations or to make them available for current operations, as short-term investments. The Company classifies investments in securities with remaining maturities of over one year as long-term investments. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest and other income, net in the Consolidated Statements of Operations and Comprehensive Income (Loss). Realized gains and losses and declines in value determined to be due to credit losses on marketable securities, if any, are included in interest and other income, net. |
Accounts Receivable | Accounts ReceivableAccounts receivable are included within prepaid expenses and other current assets on the Consolidated Balance Sheets. The accounts receivable balance represents amounts receivable from the Company's collaboration partners, net of an allowance for credit losses, if required. |
Derivatives and Hedging Activities | Derivatives and Hedging Activities The Company measures its derivative instruments at fair value, and accounts for them as either assets or liabilities included within prepaid expenses and other current assets and accruals and other current liabilities, respectively, on the Consolidated Balance Sheets. Derivatives are adjusted to fair value through interest and other income, net in the Consolidated Statements of Operations and Comprehensive Income (Loss). |
Property and Equipment, Net | Property and Equipment, Net Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is computed using the straight-line method over the related estimated useful lives as presented in the table below. Significant additions and improvements are capitalized, while repairs and maintenance are charged to expense as incurred. Asset Estimated useful life Leasehold improvements Shorter of life of asset or lease term Manufacturing and laboratory equipment five years Computer hardware and software three years Office furniture and equipment five years |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company periodically evaluates property and equipment for impairment whenever events or changes in circumstances indicate that a potential impairment may have occurred. If such events or changes in circumstances arise, the Company compares the carrying amount of the long-lived assets to the estimated future undiscounted cash flows expected to be generated by the long-lived assets. If the estimated aggregate undiscounted cash flows are less than the carrying amount of the long-lived assets, an impairment charge, calculated as the amount by which the carrying amount of the assets exceeds the fair value of the assets, is recorded. The fair value of the long-lived assets is determined based on the estimated discounted cash flows expected to be generated from the long-lived assets. The Company has not recorded any such impairment charges during the years presented. |
Leases | Leases The Company adopted Accounting Standards Update ("ASU") No. 2016-02, Leases as of January 1, 2019. A determination is made as to whether an arrangement is a lease at inception. A right-of-use (“ROU”) asset and operating lease liability is recognized for identified operating leases in the Consolidated Balance Sheets. The changes in operating lease ROU assets and operating lease liabilities are presented net within non-cash adjustment to operating lease expense in the Consolidated Statements of Cash Flows. ROU assets represent the Company’s right to use the underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the lease commencement date based on the present value of lease payments due over the lease term, with the ROU assets adjusted for lease incentives received. When determining the present value of lease payments, the Company uses its incremental borrowing rate on the date of lease commencement, or the rate implicit in the lease, if known. The Company does not assume renewals in its determination of the lease term unless the renewals are deemed by management to be reasonably certain at lease inception. |
Revenue Recognition | Revenue Recognition License and Collaboration Revenue The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and, therefore, within the scope of Topic 606. For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently, generally by analogy to Topic 606. The accounting treatment pursuant to Topic 606 is outlined below. The terms of licensing and collaboration agreements entered into typically include payment of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply and research and development services and royalties on net sales of licensed products. Each of these payments results in license, collaboration and other revenue, except for revenues from royalties on net sales of licensed products, which are classified as royalty revenue. The core principle of Topic 606 is to recognize revenue when promised goods or services are transferred to customers in an amount that reflects the consideration that is expected to be received in exchange for those goods or services. The Company may also receive reimbursement or make payments to a collaboration partner to satisfy cost sharing requirements. These payments are accounted for pursuant to ASC 808 and are recorded as an offset or increase to research and development expenses, respectively. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. Amounts received prior to satisfying the revenue recognition criteria are recorded as contract liabilities in the Company’s Consolidated Balance Sheets. If the related performance obligation is expected to be satisfied within the next twelve months this will be classified in current liabilities. Amounts recognized as revenue prior to the Company having an unconditional right (other than a right that is conditioned only on the passage of time) to receipt are recorded as contract assets in the Company's Consolidated Balance Sheets. If the Company expects to have an unconditional right to receive the consideration in the next twelve months, this will be classified in current assets. A net contract asset or liability is presented for each contract with a customer. At contract inception, the Company assesses the goods or services promised in a contract with a customer and identifies those distinct goods and services that represent a performance obligation. A promised good or service may not be identified as a performance obligation if it is immaterial in the context of the contract with the customer, if it is not separately identifiable from other promises in the contract (either because it is not capable of being separated or because it is not separable in the context of the contract), or if the promised good or service does not provide the customer with a material right. The Company considers the terms of the contract to determine the transaction price. The transaction price is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods or services to a customer. The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Variable consideration will only be included in the transaction price when it is not considered constrained, which is when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur. If it is determined that multiple performance obligations exist, the transaction price is allocated at the inception of the agreement to all identified performance obligations based on the relative standalone selling prices ("SSP"). The relative SSP for each deliverable is estimated using external sourced evidence if it is available. If external sourced evidence is not available, the Company uses its best estimate of the SSP for the deliverable. Revenue is recognized when, or as, the Company satisfies a performance obligation by transferring a promised good or service to a customer. An asset is transferred when, or as, the customer obtains control of that asset, which for a service is considered to be as the services are received and used. The Company recognizes revenue over time by measuring the progress toward complete satisfaction of the relevant performance obligation using an appropriate input or output method based on the nature of the service promised to the customer. After contract inception, the transaction price is reassessed at every period end and updated for changes such as resolution of uncertain events. Any change in the transaction price is allocated to the performance obligations on the same basis as at contract inception, or to a single performance obligation as applicable. Management may be required to exercise considerable judgment in estimating revenue to be recognized. Judgment is required in identifying performance obligations, estimating the transaction price, estimating the SSP of identified performance obligations, which may include forecasted revenue, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success, and estimating the progress towards satisfaction of performance obligations. |
Research and Development Expenses | Research and Development Expenses Research and development costs are expensed as incurred. Research and development costs consist of salaries and other personnel related expenses, including associated stock–based compensation, consulting fees, lab supplies, and facility costs, as well as fees paid to other entities that conduct certain research, development and manufacturing activities on behalf of the Company. Where the Company shares costs with collaboration partners, such as in the Biogen Collaboration Agreement, research and development expenses may include cost sharing reimbursements from or payments to the collaboration partner, respectively. Nonrefundable advance payments for goods and services that will be used or received in future research and development activities are deferred and recognized as expense in the period in which the related goods are delivered or services are performed. The Company has acquired and may continue to acquire the rights to develop and commercialize new product candidates from third parties. The upfront payments to acquire license, product or rights, as well as any future milestone payments, are immediately recognized as research and development expense provided that there is no alternative future use of the rights in other research and development projects. |
Stock-Based Compensation | Stock-Based Compensation The Company’s stock-based compensation programs grant awards that have included stock options, restricted stock units, restricted stock awards, and shares issued under its employee stock purchase plan. Grants are awarded to employees, including directors, and non-employees. The Company measures compensation expense for all stock-based awards at the grant date based on the fair value measurement of the award, which for non-employee stock-based awards became effective subsequent to the adoption of ASU No. 2018-07, Stock C ompensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting on September 30, 2018. The expense is recorded on a straight-line basis over the requisite service period, which is generally the vesting period, for the entire award. Expense is adjusted for actual forfeitures of unvested awards as they occur. The Company calculates the fair value measurement of stock options using the Black-Scholes valuation model. |
Income Taxes | Income Taxes Income taxes are accounted for using the liability method, under which deferred tax assets and liabilities are determined based on the temporary differences between the financial reporting and tax bases of assets and liabilities and consideration is given to net operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using the enacted tax rates that are expected to be in effect when the differences are expected to reverse. The Company assesses the likelihood that deferred tax assets will be recovered from future taxable income, and a valuation allowance is established when necessary to reduce deferred tax assets to the amounts more likely than not expected to be realized. The Company recognizes and measures uncertain tax positions using a two–step approach. The first step is to evaluate the tax position taken or expected to be taken by determining whether the weight of available evidence indicates that it is more likely than not that the tax position will be sustained in an audit, including resolution of any related appeals or litigation processes. The second step is to measure the tax benefit as the largest amount that is more than 50% likely to be realized upon ultimate settlement. Significant judgment is required to evaluate uncertain tax positions. The Company evaluates uncertain tax positions on a regular basis. The evaluations are based on a number of factors, including changes in facts and circumstances, changes in tax law, correspondence with tax authorities during the course of the audit, and effective settlement of audit issues. Previously recognized tax positions that no longer meet the more-likely-than-not threshold are derecognized in the first subsequent financial reporting period in which that threshold is no longer met. The Company’s policy is to recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income (loss) is composed of net income (loss) and certain changes in stockholders’ equity that are excluded from net income (loss), primarily unrealized gains or losses on the Company’s marketable securities. |
Net Income (Loss) per Share | Net Income (Loss) per Share Basic net income (loss) per share is calculated by dividing the net income (loss) by the weighted-average number of shares of common stock outstanding during the period, without consideration for common stock equivalents. Diluted net income (loss) per share is computed based on the treasury stock method by dividing net income by the weighted-average number of common shares outstanding during the period plus potentially dilutive common equivalent shares outstanding. However, where there is a net loss per ordinary share, no adjustment is made for potentially issuable ordinary shares since their effect would be anti-dilutive. In this case, diluted net loss per share is equal to basic net loss per share. |
Recently Issued and Recently Adopted Accounting Pronouncements | Recently Issued Accounting Pronouncement In December 2019, the Financial Accounting Standards Board ("FASB") issued ASU No. 2019-12, Income Taxes (Topic 740) Simplifying the Accounting for Income Taxes. ASU No. 2019-12 modifies ASC 740 to simplify several aspects of accounting for income taxes, including eliminating certain exceptions to the guidance in ASC 740 related to the approach for intraperiod tax allocation. The guidance is effective for fiscal years beginning after December 15, 2020 and interim periods within those fiscal years, with early adoption permitted, and is required to be adopted prospectively, with the exception of certain specific amendments. The Company is currently finalizing its assessment of the impact of this ASU and does not expect it to have a material impact on its Consolidated Financial Statements. Recently Adopted Accounting Pronouncement In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments . ASU 2016-13 requires measurement and recognition of expected credit losses for financial assets. In April 2019, the FASB issued clarification to ASU 2016-13 within ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging , and Topic 825, Financial Instruments . The Company adopted this standard as of January 1, 2020 using a modified retrospective approach. Adoption of the standard did not have a material impact on the Consolidated Financial Statements. |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Estimated Useful Life | Depreciation is computed using the straight-line method over the related estimated useful lives as presented in the table below. Significant additions and improvements are capitalized, while repairs and maintenance are charged to expense as incurred. Asset Estimated useful life Leasehold improvements Shorter of life of asset or lease term Manufacturing and laboratory equipment five years Computer hardware and software three years Office furniture and equipment five years |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value | Assets and liabilities measured at fair value at each balance sheet date are as follows (in thousands): December 31, 2020 Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 335,284 $ — $ — $ 335,284 U.S. government treasuries 149,997 — — 149,997 Short-term marketable securities: U.S. government treasuries 878,938 — — 878,938 U.S. government agency securities — 25,217 — 25,217 Corporate debt securities — 27,180 — 27,180 Commercial paper — 31,218 — 31,218 Long-term marketable securities: U.S. government treasuries 2,561 — — 2,561 Corporate debt securities — 30,138 — 30,138 Foreign currency derivative contracts — 185 — 185 Total $ 1,366,780 $ 113,938 $ — $ 1,480,718 Liabilities: Foreign currency derivative contracts $ — $ 11 $ — $ 11 Total $ — $ 11 $ — $ 11 December 31, 2019 Level 1 Level 2 Level 3 Total Assets: Cash equivalents Money market funds $ 54,163 $ — $ — $ 54,163 U.S. government treasuries 15,989 — — 15,989 Short-term marketable securities: U.S. government treasuries 250,070 — — 250,070 U.S. government agency securities — 2,000 — 2,000 Corporate debt securities — 53,479 — 53,479 Commercial paper — 30,358 — 30,358 Long-term marketable securities: U.S. government treasuries 13,869 — — 13,869 Corporate debt securities — 26,017 — 26,017 Foreign currency derivative contracts — 85 — 85 Total $ 334,091 $ 111,939 $ — $ 446,030 Liabilities: Foreign currency derivative contracts $ — $ 8 $ — $ 8 Total $ — $ 8 $ — $ 8 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Available for Sale Securities | The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s marketable securities by major security type at each balance sheet date are summarized in the tables below (in thousands): December 31, 2020 Amortized Cost Unrealized Holding Gains Unrealized Holding Losses Aggregate Fair Value Short-term marketable securities: U.S. government treasuries (1) $ 878,906 $ 44 $ (12) $ 878,938 U.S. government agency securities (2) 25,214 5 (2) 25,217 Corporate debt securities 27,101 79 — 27,180 Commercial paper 31,218 — — 31,218 Total short-term marketable securities 962,439 128 (14) 962,553 Long-term marketable securities: U.S. government treasuries 2,561 — — 2,561 Corporate debt securities (3) 30,147 2 (11) 30,138 Total long-term marketable securities 32,708 2 (11) 32,699 Total $ 995,147 $ 130 $ (25) $ 995,252 __________________________________________________ (1) Unrealized holding losses on 19 securities with an aggregate fair value of $369.9 million. (2) Unrealized holding losses on 2 securities with an aggregate fair value of $10.1 million. (3) Unrealized holding loss on 1 security with an aggregate fair value of $20.1 million. December 31, 2019 Amortized Cost Unrealized Holding Gains Unrealized Holding Losses Aggregate Fair Value Short-term marketable securities: U.S. government treasuries (1) $ 249,478 $ 594 $ (2) $ 250,070 U.S. government agency securities 1,999 1 — 2,000 Corporate debt securities (2) 53,396 94 (11) 53,479 Commercial paper 30,358 — — 30,358 Total short-term marketable securities 335,231 689 (13) 335,907 Long-term marketable securities: U.S. government treasuries (3) 13,865 6 (2) 13,869 Corporate debt securities (4) 25,998 34 (15) 26,017 Total long-term marketable securities 39,863 40 (17) 39,886 Total $ 375,094 $ 729 $ (30) $ 375,793 __________________________________________________ (1) Unrealized holding losses on 2 securities with an aggregate fair value of $9.3 million. (2) Unrealized holding losses on 4 securities with an aggregate fair value of $25.9 million. (3) Unrealized holding loss on 1 security with an aggregate fair value of $10.1 million. (4) Unrealized holding losses on 3 securities with an aggregate fair value of $17.2 million. |
Derivative Financial Instrume_2
Derivative Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Summary of Forward Foreign Currency Exchange Contracts Outstanding | The following table summarizes the Company’s forward foreign currency exchange contracts outstanding as of December 31, 2020 and 2019 (notional amounts in thousands): Foreign Exchange Contracts Number of Contracts Aggregate Notional (1) Amount in Foreign Currency Maturity Euros 26 3,855 Jan 2021 - Nov 2021 British Pounds 21 2,658 Jan 2021 - Nov 2021 Total at December 31, 2020 47 Euros 23 1,500 Jan 2020 - Nov 2020 British Pounds 15 2,285 Jan 2020 - Jun 2020 Swiss Francs 10 129 Jan 2020 - Aug 2020 Total at December 31, 2019 48 _________________________________________________ (1) The notional amount represents the net amount of foreign currency that will be received upon maturity of the forward contracts. |
Collaboration Agreements (Table
Collaboration Agreements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Summary of Collaboration Revenue | Revenue disaggregated by collaboration agreement and performance obligation is as follows (in thousands): Year Ended December 31, 2020 2019 2018 Takeda Collaboration Agreement (1) $ 27,155 $ 5,926 $ 5,677 Sanofi Collaboration Agreement: CNS Program License — — 73,932 Peripheral Program License — 10,000 47,148 Alzheimer's Disease Services (2) 98 358 60 Retained Activities 969 10,394 2,343 Total Sanofi Collaboration Revenue 1,067 20,752 123,483 Biogen Collaboration Agreement: LRRK2 Program License 306,545 — — Option Research Services 892 — — Total Biogen Collaboration Revenue 307,437 — — Total Collaboration Revenue $ 335,659 $ 26,678 $ 129,160 _________________________________________________ (1) $19.6 million of revenue for the year ended December 31, 2020 was included in the contract liability balance at the beginning of the year. All of the revenue recognized in the year ended December 31, 2019 was included in the contract liability balance at the beginning of the year. There was no deferred revenue at the beginning of the year ended December 31, 2018. (2) Revenue for the years ended December 31, 2020 and 2019 represent amounts that were included in the contract liability balance at the beginning of the respective year. There was no deferred revenue at the beginning of the year ended December 31, 2018. |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Scheduled of Property and Equipment, Net | Property and equipment, net consists of the following (in thousands): As of December 31, 2020 2019 Lab equipment $ 24,216 $ 21,846 Leasehold improvements 34,738 34,563 Computers equipment and purchased software 1,254 1,156 Furniture and fixtures 1,440 1,440 Total property and equipment 61,648 59,005 Less: accumulated depreciation (20,802) (12,273) Total property and equipment, net $ 40,846 $ 46,732 |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consists of the following (in thousands): As of December 31, 2020 2019 Accrued compensation $ 20,503 $ 8,739 Accrued clinical costs 6,497 5,042 Accrued manufacturing costs 7,140 2,027 Accrued other research & development costs 5,278 3,224 Accrued general and administrative, shared costs, and other current liabilities 3,037 1,318 Operating lease liability, current 4,690 3,665 Total accrued expenses and other current liabilities $ 47,145 $ 24,015 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Company's Future Minimum Lease Commitments | The following table reconciles the undiscounted cash flows for the next five years and total of the remaining years to the operating lease liabilities recorded in the Consolidated Balance Sheet as of December 31, 2020 (in thousands): Year Ended December 31: 2021 $ 10,391 2022 10,731 2023 11,083 2024 11,447 2025 11,824 Thereafter 42,250 Total undiscounted lease payments 97,726 Present value adjustment (28,861) Net operating lease liabilities $ 68,865 |
Summary of Company's Future Minimum Lease Receivables | The following table details the future undiscounted cash inflows relating to the Company's Sublease Agreement as of December 31, 2020 (in thousands): Year Ended December 31: 2021 $ 2,925 2022 3,009 2023 3,096 2024 876 2025 and thereafter — Total undiscounted sublease receipts $ 9,906 |
Stock-Based Awards (Tables)
Stock-Based Awards (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity | The following table summarizes option award activity under the 2017 Plan and the 2015 Plan: Number of Options Weighted- Average Exercise Price Weighted- Average remaining contractual life (years) Aggregate Intrinsic Value (in thousands) Balance at December 31, 2019 11,640,734 $ 12.96 7.79 $ 51,879 Options granted 3,518,298 26.24 Options exercised (1,487,426) 11.55 Options forfeited (711,680) 20.57 Balance at December 31, 2020 12,959,926 $ 16.31 7.37 $ 874,026 Options vested and expected to vest at December 31, 2020 11,215,194 $ 18.75 7.79 $ 717,292 Options exercisable at December 31, 2020 5,301,186 $ 14.28 6.95 $ 368,335 |
Summary of Assumptions Used for Estimating the Fair Value of Stock Granted | Stock Options Granted to Employees with Service-Based Vesting The estimated fair value of stock options granted to employees were calculated using the Black-Scholes option-pricing model using the following assumptions: Year Ended December 31, 2020 2019 2018 Expected term (in years) 5.50 - 6.08 5.50 - 6.08 5.50 - 6.08 Volatility 65.2% - 67.1% 65.5% - 77.8% 79.4% - 87.4% Risk-free interest rate 0.3% - 1.7% 1.5% - 2.6% 2.6% - 3.1% Dividend yield — — — |
Summary of Restricted Stock Activity | Aggregated information regarding RSUs granted under the Plan for the year ended December 31, 2020 is summarized below: Share Awards & Units Weighted-Average Fair Value at Date of Grant per Share Unvested at December 31, 2019 882,636 $ 18.67 Granted 1,903,041 29.31 Vested and released (309,097) 19.23 Forfeited (174,901) 30.94 Unvested at December 31, 2020 2,301,679 $ 27.08 Expected to vest – December 31, 2020 2,301,679 $ 27.08 |
Summary of Stock-Based Compensation Expense | The Company’s results of operations include expenses relating to stock-based compensation as follows (in thousands): Year Ended December 31, 2020 2019 2018 Research and development $ 29,002 $ 19,261 $ 10,093 General and administrative 21,349 19,117 8,698 Total $ 50,351 $ 38,378 $ 18,791 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision for Income Taxes | The provision for income taxes consisted of the following (in thousands): Year Ended December 31, 2020 2019 Current: U.S. Federal $ — $ — U.S. State 823 — Foreign — — Total Current $ 823 $ — Deferred: U.S. Federal $ — $ (338) U.S. State — (13) Foreign — — Total deferred $ — $ (351) |
Schedule of Effective Tax Rate Reconciliation | The reconciliation of federal statutory income tax rate to our effective income tax rate is as follows: Year Ended December 31, 2020 2019 2018 Taxes at the U.S. statutory tax rate 21.0 % 21.0 % 21.0 % Effect of Tax Act 1.1 — — Change in valuation allowance (4.0) (24.4) (20.7) Research tax credits (9.2) 3.5 10.2 Stock-based compensation (7.9) 0.1 (0.7) Nondeductible acquisition-related costs — — (9.5) Other 0.1 (0.1) (0.3) Total provision for income taxes 1.1 % 0.1 % — % |
Schedule of Deferred Tax Assets and Liabilities | The components of the Company’s net deferred tax assets are as follows (in thousands): December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 54,110 $ 56,612 Tax credit carryforwards 27,411 19,133 Contract liabilities 15,344 13,516 Operating lease liability 17,179 15,686 Stock-based compensation 18,709 9,513 Accruals and other 17,767 11,815 Gross deferred tax assets 150,520 126,275 Valuation allowance (133,054) (112,713) Net deferred tax assets 17,466 13,562 Deferred tax liabilities: Property and equipment (9,329) (6,225) Operating lease right-of-use asset (8,137) (7,337) Net deferred tax assets $ — $ — |
Schedule of Reconciliation of Unrecognized Tax Benefits | A reconciliation of the beginning and ending amounts of unrecognized tax benefits is as follows (in thousands): December 31, 2020 2019 2018 Unrecognized tax benefits at January 1 $ 5,299 $ 2,642 $ 1,146 Additions for tax positions taken in a prior year — 107 — Additions for tax positions taken in the current year 3,009 2,595 1,506 Reductions for tax positions taken in the prior year (169) (45) (10) Unrecognized tax benefits at December 31 $ 8,139 $ 5,299 $ 2,642 |
Net Income (Loss) and Net Inc_2
Net Income (Loss) and Net Income (Loss) Per Share (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
Summary of Computation of Basic and Diluted Net Loss Per Share | The following table sets forth the computation of the basic and diluted net income (loss) per share (in thousands, except share and per share data): Year Ended December 31, 2020 2019 2018 Numerator: Net income (loss) $ 71,136 $ (197,614) $ (36,240) Denominator: Weighted average number of shares outstanding, basic 108,974,137 95,608,208 92,621,991 Dilutive effect of outstanding common stock options, ESPP shares issuable, and restricted shares 3,728,971 — — Weighted average number of shares outstanding, diluted 112,703,108 95,608,208 92,621,991 Net income (loss) per share, basic $ 0.65 $ (2.07) $ (0.39) Net income (loss) per share, diluted $ 0.63 $ (2.07) $ (0.39) |
Schedule of Dilutive Securities Not Included in Diluted Per Share Calculations | Potentially dilutive securities that were not included in the diluted per share calculations for the years ended December 31, 2020, 2019 and 2018 because they would be anti-dilutive were as follows: Year Ended December 31, 2020 2019 2018 Options issued and outstanding and ESPP shares issuable 3,286,045 11,921,434 9,789,594 Restricted shares subject to future vesting 879,792 882,636 503,243 Early exercised common stock subject to future vesting — — 135,424 Total 4,165,837 12,804,070 10,428,261 |
Significant Accounting Polici_4
Significant Accounting Policies - Narrative (Details) | 12 Months Ended | |
Dec. 31, 2020USD ($)Segmentshares | Dec. 31, 2019USD ($)shares | |
Accounting Policies [Abstract] | ||
Off-balance sheet concentrations of credit risk | $ | $ 0 | $ 0 |
Convertible preferred stock, shares authorized (in shares) | 40,000,000 | 40,000,000 |
Convertible preferred stock, shares issued (in shares) | 0 | 0 |
Convertible preferred stock, shares outstanding (in shares) | 0 | 0 |
Number of operating segments | Segment | 1 | |
Restricted cash | $ | $ 1,500,000 |
Significant Accounting Polici_5
Significant Accounting Policies - Property and Equipment, Net (Details) | 12 Months Ended |
Dec. 31, 2020 | |
Manufacturing and laboratory equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 5 years |
Computer hardware and software | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 3 years |
Office furniture and equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 5 years |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Assets: | ||
Fair value | $ 995,252 | $ 375,793 |
Foreign currency derivative contracts | 185 | 85 |
Total | 1,480,718 | 446,030 |
Liabilities: | ||
Foreign currency derivative contracts | 11 | 8 |
Total | 11 | 8 |
Money market funds | ||
Assets: | ||
Cash equivalents | 335,284 | 54,163 |
U.S. government treasuries | ||
Assets: | ||
Cash equivalents | 149,997 | 15,989 |
Short-term marketable securities | U.S. government treasuries | ||
Assets: | ||
Fair value | 878,938 | 250,070 |
Short-term marketable securities | U.S. government agency securities | ||
Assets: | ||
Fair value | 25,217 | 2,000 |
Short-term marketable securities | Corporate debt securities | ||
Assets: | ||
Fair value | 27,180 | 53,479 |
Short-term marketable securities | Commercial paper | ||
Assets: | ||
Fair value | 31,218 | 30,358 |
Long-term marketable securities | U.S. government treasuries | ||
Assets: | ||
Fair value | 2,561 | 13,869 |
Long-term marketable securities | Corporate debt securities | ||
Assets: | ||
Fair value | 30,138 | 26,017 |
Level 1 | ||
Assets: | ||
Foreign currency derivative contracts | 0 | 0 |
Total | 1,366,780 | 334,091 |
Liabilities: | ||
Foreign currency derivative contracts | 0 | 0 |
Total | 0 | 0 |
Level 1 | Money market funds | ||
Assets: | ||
Cash equivalents | 335,284 | 54,163 |
Level 1 | U.S. government treasuries | ||
Assets: | ||
Cash equivalents | 149,997 | 15,989 |
Level 1 | Short-term marketable securities | U.S. government treasuries | ||
Assets: | ||
Fair value | 878,938 | 250,070 |
Level 1 | Short-term marketable securities | U.S. government agency securities | ||
Assets: | ||
Fair value | 0 | 0 |
Level 1 | Short-term marketable securities | Corporate debt securities | ||
Assets: | ||
Fair value | 0 | 0 |
Level 1 | Short-term marketable securities | Commercial paper | ||
Assets: | ||
Fair value | 0 | 0 |
Level 1 | Long-term marketable securities | U.S. government treasuries | ||
Assets: | ||
Fair value | 2,561 | 13,869 |
Level 1 | Long-term marketable securities | Corporate debt securities | ||
Assets: | ||
Fair value | 0 | 0 |
Level 2 | ||
Assets: | ||
Foreign currency derivative contracts | 185 | 85 |
Total | 113,938 | 111,939 |
Liabilities: | ||
Foreign currency derivative contracts | 11 | 8 |
Total | 11 | 8 |
Level 2 | Money market funds | ||
Assets: | ||
Cash equivalents | 0 | 0 |
Level 2 | U.S. government treasuries | ||
Assets: | ||
Cash equivalents | 0 | 0 |
Level 2 | Short-term marketable securities | U.S. government treasuries | ||
Assets: | ||
Fair value | 0 | 0 |
Level 2 | Short-term marketable securities | U.S. government agency securities | ||
Assets: | ||
Fair value | 25,217 | 2,000 |
Level 2 | Short-term marketable securities | Corporate debt securities | ||
Assets: | ||
Fair value | 27,180 | 53,479 |
Level 2 | Short-term marketable securities | Commercial paper | ||
Assets: | ||
Fair value | 31,218 | 30,358 |
Level 2 | Long-term marketable securities | U.S. government treasuries | ||
Assets: | ||
Fair value | 0 | 0 |
Level 2 | Long-term marketable securities | Corporate debt securities | ||
Assets: | ||
Fair value | 30,138 | 26,017 |
Level 3 | ||
Assets: | ||
Foreign currency derivative contracts | 0 | 0 |
Total | 0 | 0 |
Liabilities: | ||
Foreign currency derivative contracts | 0 | 0 |
Total | 0 | 0 |
Level 3 | Money market funds | ||
Assets: | ||
Cash equivalents | 0 | 0 |
Level 3 | U.S. government treasuries | ||
Assets: | ||
Cash equivalents | 0 | 0 |
Level 3 | Short-term marketable securities | U.S. government treasuries | ||
Assets: | ||
Fair value | 0 | 0 |
Level 3 | Short-term marketable securities | U.S. government agency securities | ||
Assets: | ||
Fair value | 0 | 0 |
Level 3 | Short-term marketable securities | Corporate debt securities | ||
Assets: | ||
Fair value | 0 | 0 |
Level 3 | Short-term marketable securities | Commercial paper | ||
Assets: | ||
Fair value | 0 | 0 |
Level 3 | Long-term marketable securities | U.S. government treasuries | ||
Assets: | ||
Fair value | 0 | 0 |
Level 3 | Long-term marketable securities | Corporate debt securities | ||
Assets: | ||
Fair value | $ 0 | $ 0 |
Marketable Securities - Summary
Marketable Securities - Summary of Available for Sale Securities (Details) $ in Thousands | Dec. 31, 2020USD ($)security | Dec. 31, 2019USD ($)security |
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | $ 995,147 | $ 375,094 |
Unrealized Holding Gains | 130 | 729 |
Unrealized Holding Losses | (25) | (30) |
Aggregate Fair Value | 995,252 | 375,793 |
Short-term marketable securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 962,439 | 335,231 |
Unrealized Holding Gains | 128 | 689 |
Unrealized Holding Losses | (14) | (13) |
Aggregate Fair Value | 962,553 | 335,907 |
Short-term marketable securities | U.S. government treasuries | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 878,906 | 249,478 |
Unrealized Holding Gains | 44 | 594 |
Unrealized Holding Losses | (12) | (2) |
Aggregate Fair Value | $ 878,938 | $ 250,070 |
Number of securities held in unrealized holding loss position | security | 19 | 2 |
Aggregate fair value, unrealized holding loss position | $ 369,900 | $ 9,300 |
Short-term marketable securities | U.S. government agency securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 25,214 | 1,999 |
Unrealized Holding Gains | 5 | 1 |
Unrealized Holding Losses | (2) | 0 |
Aggregate Fair Value | $ 25,217 | 2,000 |
Number of securities held in unrealized holding loss position | security | 2 | |
Aggregate fair value, unrealized holding loss position | $ 10,100 | |
Short-term marketable securities | Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 27,101 | 53,396 |
Unrealized Holding Gains | 79 | 94 |
Unrealized Holding Losses | 0 | (11) |
Aggregate Fair Value | 27,180 | $ 53,479 |
Number of securities held in unrealized holding loss position | security | 4 | |
Aggregate fair value, unrealized holding loss position | $ 25,900 | |
Short-term marketable securities | Commercial paper | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 31,218 | 30,358 |
Unrealized Holding Gains | 0 | 0 |
Unrealized Holding Losses | 0 | 0 |
Aggregate Fair Value | 31,218 | 30,358 |
Long-term marketable securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 32,708 | 39,863 |
Unrealized Holding Gains | 2 | 40 |
Unrealized Holding Losses | (11) | (17) |
Aggregate Fair Value | 32,699 | 39,886 |
Long-term marketable securities | U.S. government treasuries | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 2,561 | 13,865 |
Unrealized Holding Gains | 0 | 6 |
Unrealized Holding Losses | 0 | (2) |
Aggregate Fair Value | 2,561 | $ 13,869 |
Number of securities held in unrealized holding loss position | security | 1 | |
Aggregate fair value, unrealized holding loss position | $ 10,100 | |
Long-term marketable securities | Corporate debt securities | ||
Debt Securities, Available-for-sale [Line Items] | ||
Amortized Cost | 30,147 | 25,998 |
Unrealized Holding Gains | 2 | 34 |
Unrealized Holding Losses | (11) | (15) |
Aggregate Fair Value | $ 30,138 | $ 26,017 |
Number of securities held in unrealized holding loss position | security | 1 | 3 |
Aggregate fair value, unrealized holding loss position | $ 20,100 | $ 17,200 |
Marketable Securities - Narrati
Marketable Securities - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Investments, Debt and Equity Securities [Abstract] | |||
Allowance for credit losses | $ 0 | ||
Other-than-temporary impairment | $ 0 | ||
Tax charge in other comprehensive income | 0 | $ 400,000 | $ 0 |
Unrealized gain on marketable securities | $ 0 | $ 0 | |
Effective maturity (less than) | 2 years |
Derivative Financial Instrume_3
Derivative Financial Instruments - Summary of Forward Foreign Currency Exchange Contracts Outstanding (Details) - Designated as Hedging Instrument € in Thousands, £ in Thousands, SFr in Thousands | Dec. 31, 2020EUR (€)derivative_instrument | Dec. 31, 2020GBP (£)derivative_instrument | Dec. 31, 2019EUR (€)derivative_instrument | Dec. 31, 2019GBP (£)derivative_instrument | Dec. 31, 2019CHF (SFr)derivative_instrument |
Euros | |||||
Derivative [Line Items] | |||||
Number of Contracts | 26 | 26 | 23 | 23 | 23 |
Aggregate Notional Amount in Foreign Currency | € | € 3,855 | € 1,500 | |||
British Pounds | |||||
Derivative [Line Items] | |||||
Number of Contracts | 21 | 21 | 15 | 15 | 15 |
Aggregate Notional Amount in Foreign Currency | £ | £ 2,658 | £ 2,285 | |||
Swiss Francs | |||||
Derivative [Line Items] | |||||
Number of Contracts | 10 | 10 | 10 | ||
Aggregate Notional Amount in Foreign Currency | SFr | SFr 129 | ||||
Foreign Exchange Contracts | |||||
Derivative [Line Items] | |||||
Number of Contracts | 47 | 47 | 48 | 48 | 48 |
Derivative Financial Instrume_4
Derivative Financial Instruments - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Derivative [Line Items] | |||
Derivative liability | $ 11 | $ 8 | |
Derivative asset | 185 | 85 | |
Net gain (loss) on derivative instruments | 100 | 200 | $ (200) |
Foreign Exchange Contracts | |||
Derivative [Line Items] | |||
Derivative liability | 0 | 0 | |
Prepaid Assets and Other Current Assets | |||
Derivative [Line Items] | |||
Derivative asset | $ 200 | $ 0 |
Acquisition - Narrative (Detail
Acquisition - Narrative (Details) - USD ($) $ in Thousands | May 30, 2018 | Aug. 24, 2016 | Aug. 31, 2016 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2020 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Research and development expense | $ 212,615 | [1] | $ 193,382 | $ 143,183 | ||||
Collaborative Arrangement with F-Star and Acquisition of F-Star Gamma | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Upfront payment | $ 11,500 | |||||||
Upfront option fee | $ 500 | |||||||
Contingent consideration recognized | $ 0 | 0 | 1,500 | |||||
Total upfront and contingent consideration | $ 19,800 | |||||||
Maximum development plan period for research costs | 24 months | |||||||
Research and development expense | $ 1,200 | $ 1,100 | $ 800 | |||||
Exercise of buy-out option | Collaborative Arrangement with F-Star and Acquisition of F-Star Gamma | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Initial option exercise payments | $ 17,800 | |||||||
Exercise of buy-out option | Collaborative Arrangement with F-Star and Acquisition of F-Star Gamma | Preclinical | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Contingent payments upon achievement of milestones | 27,000 | |||||||
Exercise of buy-out option | Collaborative Arrangement with F-Star and Acquisition of F-Star Gamma | Clinical | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Contingent payments upon achievement of milestones | 50,000 | |||||||
Exercise of buy-out option | Collaborative Arrangement with F-Star and Acquisition of F-Star Gamma | Regulatory | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Contingent payments upon achievement of milestones | 120,000 | |||||||
Exercise of buy-out option | Collaborative Arrangement with F-Star and Acquisition of F-Star Gamma | Commercial | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Contingent payments upon achievement of milestones | 250,000 | |||||||
Maximum | Exercise of buy-out option | Collaborative Arrangement with F-Star and Acquisition of F-Star Gamma | ||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||||
Contingent payments upon achievement of milestones | $ 447,000 | |||||||
[1] | Includes an offset to expense from related party cost reimbursement of $9,260. |
Collaboration Agreements - Biog
Collaboration Agreements - Biogen (Details) | Sep. 22, 2020USD ($)$ / sharesshares | Aug. 05, 2020USD ($)program | Oct. 31, 2020USD ($) | Oct. 05, 2020USD ($) | Dec. 31, 2020USD ($)milestone | Dec. 31, 2020USD ($)milestone | Oct. 06, 2020USD ($)program | Dec. 31, 2019USD ($) | Nov. 30, 2018 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Offset to research and development expense, related party cost reimbursement | $ 9,260,000 | ||||||||
Cost sharing reimbursements due | $ 5,674,000 | 5,674,000 | $ 0 | ||||||
Provisional Collaboration Agreement | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Funded percentage | 40.00% | ||||||||
Provisional Collaboration Agreement | United States | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Agreed share of commercial profit (loss) percentage | 50.00% | ||||||||
Provisional Collaboration Agreement | China | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Agreed share of commercial profit (loss) percentage | 40.00% | ||||||||
Provisional Collaboration Agreement | Biogen | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Funded percentage | 60.00% | ||||||||
Collaborative Arrangement | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Funded percentage | 30.00% | ||||||||
Biogen | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Contract liability | $ 297,400,000 | $ 297,400,000 | |||||||
Biogen | Provisional Collaboration Agreement | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upfront payment, to be received | $ 560,000,000 | ||||||||
Milestone payments upon achievement of certain development, first commercial sale, and net sales based milestones | 1,125,000,000 | ||||||||
Development milestone payments | 375,000,000 | ||||||||
First commercial sale milestone payments | 375,000,000 | ||||||||
Net sales-based milestone payments | $ 375,000,000 | ||||||||
Performance obligation satisfied | $ 0 | ||||||||
Number of milestones achieved | milestone | 0 | 0 | |||||||
Biogen | Provisional Collaboration Agreement | Related Party | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Revenue recognized | $ 0 | ||||||||
Biogen | Provisional Collaboration Agreement | Share Purchase Agreement | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Number of common stock (in shares) | shares | 13,310,243 | ||||||||
Purchase price | $ 465,000,000 | ||||||||
Fair market value of common stock | $ 420,100,000 | ||||||||
Closing stock price (usd per share) | $ / shares | $ 35.87 | ||||||||
Premium on sale of common stock | $ 44,900,000 | ||||||||
Transaction price | $ 0 | ||||||||
Biogen | Provisional Collaboration Agreement | Transport Vehicle (TV) Technology Platform, Unnamed Program | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Number of programs | program | 1 | ||||||||
Biogen | Provisional Collaboration Agreement | Transport Vehicle (TV) Technology Program, Unnamed Program, Right Of First Negotiation Programs (ROFN) | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Number of additional programs, if circumstances met | program | 2 | ||||||||
Biogen | Provisional Collaboration Agreement | Transport Vehicle (TV)Technology Platform, Preclinical Programs | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Number of programs | program | 2 | ||||||||
Term of agreement, number of business days after 5th anniversary date of the effective date of the agreement | 30 days | ||||||||
Biogen | Provisional Collaboration Agreement | Transport Vehicle Technology Platform, Right Of First Negotiation Programs | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Number of additional programs, if circumstances met | program | 2 | ||||||||
Right of first negotiation (ROFN) term, period of time after effective date of agreement, if circumstances met | 7 years | ||||||||
Right of first negotiation (ROFN) term, additional program criteria | program | 2 | ||||||||
Number of additional programs, no third party agreement executed, if circumstances met | program | 1 | ||||||||
Biogen | ROFN and Option Agreement | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Number of performance obligations | program | 0 | ||||||||
Aggregate option exercise and development milestone payments, to be received | $ 270,000,000 | ||||||||
First commercial sale milestone payments, to be received | 325,000,000 | ||||||||
Net sales-based milestone payments, to be received | $ 290,000,000 | ||||||||
Contract liability | $ 288,900,000 | $ 288,900,000 | |||||||
Biogen | Biogen Collaboration Agreement | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Upfront payment | $ 560,000,000 | ||||||||
Transaction price, change | 0 | ||||||||
Offset to research and development expense, related party cost reimbursement | 9,300,000 | ||||||||
Cost sharing reimbursements due | 5,700,000 | 5,700,000 | |||||||
Biogen | Biogen Collaboration Agreement | Option Research Services | Related Party | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Contract liability | $ 8,500,000 | $ 8,500,000 |
Collaboration Agreements - Sano
Collaboration Agreements - Sanofi (Details) | 1 Months Ended | 12 Months Ended | 27 Months Ended | ||||
Jul. 31, 2019USD ($) | Nov. 30, 2018USD ($)indication | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2020USD ($) | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Number of indications | indication | 3 | ||||||
Collaboration revenue from customers | $ 335,561,000 | [1] | $ 26,320,000 | $ 129,100,000 | |||
Collaborative Arrangement | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Funded percentage | 30.00% | ||||||
Sanofi | Collaborative Arrangement | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Funded percentage | 70.00% | ||||||
Sanofi | Collaborative Arrangement | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Upfront payment | $ 125,000,000 | ||||||
Milestone payments upon achievement of certain clinical, regulatory and sales milestone events | 1,100,000,000 | ||||||
Collaboration revenue from customers | $ 10,000,000 | ||||||
Receivable | 44,303 | 1,200,000 | 44,303 | ||||
Sanofi | Collaborative Arrangement | CNS Product | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Clinical milestone payment | 215,000,000 | ||||||
Regulatory milestone payment | 385,000,000 | ||||||
Sanofi | Collaborative Arrangement | Peripheral Program License | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Clinical milestone payment | 120,000,000 | ||||||
Regulatory milestone payment | 175,000,000 | ||||||
Commercial milestone payments | $ 200,000,000 | ||||||
Sanofi | Collaborative Arrangement | Retained Activities | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Transaction price increase | $ 1,000,000 | $ 10,400,000 | $ 2,300,000 | ||||
Sanofi | Collaborative Arrangement | Milestone Triggered | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Collaboration revenue from customers | $ 10,000,000 | ||||||
Sanofi | Collaborative Arrangement | Product | |||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||
Collaboration revenue from customers | $ 0 | ||||||
[1] | Includes related party collaboration revenue from customer of $307,437. |
Collaboration Agreements - Sa_2
Collaboration Agreements - Sanofi Performance Obligation (Details) - USD ($) $ in Millions | Dec. 31, 2020 | Dec. 31, 2019 |
Alzheimer's Disease Services | ||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction [Line Items] | ||
Performance obligation | $ 3.4 | $ 3.5 |
Collaboration Agreements - Take
Collaboration Agreements - Takeda (Details) | Feb. 23, 2018USD ($)targetprogram$ / sharesshares | Jan. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Collaboration revenue from customers | $ 335,561,000 | [1] | $ 26,320,000 | $ 129,100,000 | ||
Takeda Pharmaceutical Company Limited | Collaborative Arrangement | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Upfront payment | $ 40,000,000 | |||||
Number of programs | program | 3 | |||||
Preclinical milestone payment received | $ 5,000,000 | |||||
Number of targets | target | 3 | |||||
Target option period | 5 years | |||||
Option fee | $ 5,000,000 | |||||
Variable consideration relating to future milestones | 26,000,000 | |||||
Remaining preclinical milestones, cost and profit sharing income, and the development and commercial milestones | $ 44,000,000 | |||||
Transaction price, change | 0 | 0 | $ 0 | |||
Number of performance obligations | program | 3 | |||||
Contract liability | 39,800,000 | 59,000,000 | ||||
Preclinical milestone payment earned not yet received | 0 | |||||
Revenue recognized related to future milestone payments presented net in the contract liability | 4,600,000 | $ 2,400,000 | ||||
Takeda Pharmaceutical Company Limited | Collaborative Arrangement | Milestone Triggered | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Collaboration revenue from customers | 15,000,000 | |||||
Takeda Pharmaceutical Company Limited | Collaborative Arrangement | Product | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Collaboration revenue from customers | 0 | |||||
Takeda Pharmaceutical Company Limited | Collaborative Arrangement | Share Purchase Agreement | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Number of common stock (in shares) | shares | 4,214,559 | |||||
Purchase price | $ 110,000,000 | |||||
Fair market value of common stock | $ 94,400,000 | |||||
Closing stock price (usd per share) | $ / shares | $ 22.40 | |||||
Premium on sale of common stock | $ 15,600,000 | |||||
Takeda Pharmaceutical Company Limited | Collaborative Arrangement | Maximum | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Preclinical milestone payments per program | 25,000,000 | |||||
Total aggregate payments due upon achievement of certain preclinical milestone events | 75,000,000 | |||||
Aggregated option exercise fee | 15,000,000 | |||||
Total aggregate payments due upon achievement of certain clinical and regulatory milestone events | 407,500,000 | |||||
Regulatory milestone payment | 300,000,000 | |||||
Milestone payments per biologic product upon achievement of a certain sales-based milestone | 75,000,000 | |||||
Milestone payments upon achievement of biologic product from each program | $ 225,000,000 | |||||
Takeda Pharmaceutical Company Limited | Collaborative Arrangement, PTV:PGRN | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Preclinical milestone payment earned not yet received | $ 8,000,000 | |||||
Takeda Pharmaceutical Company Limited | Collaborative Arrangement, PTV:PGRN | Subsequent Event | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Preclinical milestone payment received | $ 8,000,000 | |||||
Takeda Pharmaceutical Company Limited | Collaborative Arrangement, ATV:TREM2 | Subsequent Event | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Preclinical milestone payment earned not yet received | $ 8,000,000 | |||||
[1] | Includes related party collaboration revenue from customer of $307,437. |
Collaboration Agreements - Summ
Collaboration Agreements - Summary of Collaboration Revenue (Details) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 01, 2018 | ||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Collaborative revenue, revenue from contract with customer | $ 335,561,000 | [1] | $ 26,320,000 | $ 129,100,000 | |
Collaborative revenue, excluding revenue from contract with customer | 98,000 | 358,000 | 60,000 | ||
Total Collaboration Revenue | 335,659,000 | 26,678,000 | 129,160,000 | ||
Takeda Collaboration Agreement | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Collaborative revenue, revenue from contract with customer | 27,155,000 | 5,926,000 | 5,677,000 | ||
Revenue recognized included in the contract liability balance at the beginning of the year | 19,600,000 | ||||
Contract liability | $ 0 | ||||
Sanofi Collaboration Agreement | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total Collaboration Revenue | 1,067,000 | 20,752,000 | 123,483,000 | ||
Sanofi Collaboration Agreement | CNS Program License | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Collaborative revenue, revenue from contract with customer | 0 | 0 | 73,932,000 | ||
Sanofi Collaboration Agreement | Peripheral Program License | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Collaborative revenue, revenue from contract with customer | 0 | 10,000,000 | 47,148,000 | ||
Sanofi Collaboration Agreement | Alzheimer's Disease Services | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Collaborative revenue, excluding revenue from contract with customer | 98,000 | 358,000 | 60,000 | ||
Contract liability | $ 0 | ||||
Sanofi Collaboration Agreement | Retained Activities | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Collaborative revenue, revenue from contract with customer | 969,000 | 10,394,000 | 2,343,000 | ||
Biogen Collaboration Agreement | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Total Collaboration Revenue | 307,437,000 | 0 | 0 | ||
Biogen Collaboration Agreement | LRRK2 Program License | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Collaborative revenue, revenue from contract with customer | 306,545,000 | 0 | 0 | ||
Biogen Collaboration Agreement | Option Research Services | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Collaborative revenue, revenue from contract with customer | $ 892,000 | $ 0 | $ 0 | ||
[1] | Includes related party collaboration revenue from customer of $307,437. |
License Agreements - Narrative
License Agreements - Narrative (Details) - Genentech - USD ($) | 1 Months Ended | 12 Months Ended | 55 Months Ended | |||
Jun. 30, 2016 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2020 | Oct. 05, 2020 | |
Biogen | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Payment obligation responsibility | 50.00% | |||||
Clinical | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Milestone payments upon achievement of specified clinical and regulatory milestones | $ 37,500,000 | |||||
Regulatory | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Milestone payments upon achievement of specified clinical and regulatory milestones | 102,500,000 | |||||
Commercial | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Milestone payments upon achievement of specified clinical and regulatory milestones | 175,000,000 | |||||
License Agreement | Research and development | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Upfront fee paid | $ 0 | $ 0 | $ 0 | $ 12,500,000 | ||
Maximum | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Milestone payments upon achievement of specified clinical and regulatory milestones | $ 315,000,000 |
Balance Sheet Components - Prop
Balance Sheet Components - Property and Equipment, Net (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | $ 61,648 | $ 59,005 | |
Less: accumulated depreciation | (20,802) | (12,273) | |
Total property and equipment, net | 40,846 | 46,732 | |
Depreciation expense | 8,531 | 7,991 | $ 7,415 |
Lab equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 24,216 | 21,846 | |
Leasehold improvements | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 34,738 | 34,563 | |
Computers equipment and purchased software | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 1,254 | 1,156 | |
Furniture and fixtures | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | $ 1,440 | $ 1,440 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Accrued compensation | $ 20,503 | $ 8,739 |
Accrued clinical costs | 6,497 | 5,042 |
Accrued manufacturing costs | 7,140 | 2,027 |
Accrued other research & development costs | 5,278 | 3,224 |
Accrued general and administrative, shared costs, and other current liabilities | $ 3,037 | $ 1,318 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilitiesCurrent | us-gaap:OtherLiabilitiesCurrent |
Operating lease liability, current | $ 4,690 | $ 3,665 |
Total accrued expenses and other current liabilities | $ 47,145 | $ 24,015 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) $ in Millions | May 02, 2018USD ($)ft² | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Oct. 31, 2018ft² |
Loss Contingencies [Line Items] | |||||
Discount rate (as a percentage) | 9.00% | ||||
Operating lease costs | $ 11.1 | $ 10.2 | |||
Rent expense | $ 6 | ||||
Weighted average remaining lease term | 8 years 3 months 18 days | ||||
Weighted-average discount rate (as a percentage) | 9.00% | ||||
Cash paid for lease liabilities | $ 9.7 | ||||
Sublease income | 3.6 | 2.6 | |||
Sublease income | 0 | ||||
Contractual obligation | 4.8 | 1.1 | |||
DMSA | |||||
Loss Contingencies [Line Items] | |||||
Purchase order executed | 33 | 21.2 | |||
Costs incurred | 10.8 | 12.7 | 3.9 | ||
Payments for development and manufacturing services | 7.3 | 12.5 | $ 3.4 | ||
Non-Cancellable Purchase Commitments | |||||
Loss Contingencies [Line Items] | |||||
Non-refundable purchase commitments | $ 27.1 | $ 11.2 | |||
Headquarters Lease | |||||
Loss Contingencies [Line Items] | |||||
Area under lease | ft² | 148,020 | ||||
Lease period | 10 years | ||||
Lease renewal option term | 10 years | ||||
Headquarters Lease | Landlord Funded Tenant Improvements | |||||
Loss Contingencies [Line Items] | |||||
Tenant improvement allowance repayable in rent | $ 4.4 | ||||
New Premises Sublease Agreement | |||||
Loss Contingencies [Line Items] | |||||
Rentable square feet | ft² | 36,835 | ||||
Sublease term | 5 years | ||||
Minimum | Headquarters Lease | |||||
Loss Contingencies [Line Items] | |||||
Lease renewal notice period | 9 months | ||||
Maximum | Headquarters Lease | |||||
Loss Contingencies [Line Items] | |||||
Lease renewal notice period | 12 months | ||||
Maximum | Headquarters Lease | Landlord Funded Tenant Improvements | |||||
Loss Contingencies [Line Items] | |||||
Leasehold improvements | $ 25.9 |
Commitments and Contingencies_2
Commitments and Contingencies - Summary of Company's Future Minimum Lease Commitments (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2021 | $ 10,391 |
2022 | 10,731 |
2023 | 11,083 |
2024 | 11,447 |
2025 | 11,824 |
Thereafter | 42,250 |
Total undiscounted lease payments | 97,726 |
Present value adjustment | (28,861) |
Net operating lease liabilities | $ 68,865 |
Commitments and Contingencies_3
Commitments and Contingencies - Summary of Company's Future Minimum Lease Receivables (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2021 | $ 2,925 |
2022 | 3,009 |
2023 | 3,096 |
2024 | 876 |
2025 and thereafter | 0 |
Total undiscounted sublease receipts | $ 9,906 |
Stock-Based Awards - Narrative
Stock-Based Awards - Narrative (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||
Dec. 31, 2017 | Nov. 30, 2015 | Aug. 31, 2015 | May 31, 2015 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Aggregate intrinsic value of options exercised | $ 43,800,000 | $ 13,100,000 | $ 9,800,000 | |||||
Weighted-average grant date fair value of options vested (usd per share) | $ 11.51 | $ 10.09 | $ 3.85 | |||||
Weighted-average grant date fair value of options granted (usd per share) | $ 15.67 | $ 11.86 | $ 14.79 | |||||
Dividends paid | $ 0 | |||||||
Dividend yield | 0.00% | |||||||
Stock options granted (in shares) | 3,518,298 | |||||||
Exercise price (usd per share) | $ 11.55 | |||||||
Share-based compensation, expense recognized | $ 50,351,000 | $ 38,378,000 | $ 18,791,000 | |||||
Tax benefit realized, related to awards vested or exercised | 1,000,000 | 0 | 0 | |||||
General and administrative | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share-based compensation, expense recognized | 21,349,000 | 19,117,000 | 8,698,000 | |||||
Research and development | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share-based compensation, expense recognized | $ 29,002,000 | 19,261,000 | $ 10,093,000 | |||||
Performance and Market Contingent Stock Options | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Stock options granted (in shares) | 100,000 | 1,600,000 | ||||||
Exercise price (usd per share) | $ 0.68 | $ 0.68 | ||||||
Vesting trigger, number of consecutive trading days | 90 days | |||||||
Vesting trigger, number of days after IPO | 180 days | |||||||
Performance and Market Contingent Stock Options | General and administrative | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share-based compensation, expense recognized | $ 300,000 | 5,200,000 | ||||||
Performance and Market Contingent Stock Options | Research and development | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Share-based compensation, expense recognized | $ 500,000 | |||||||
Restricted Stock Units (RSUs) | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Intrinsic value of units expected to vest | $ 192,800,000 | |||||||
Weighted-average grant-date fair value, granted (usd per share) | $ 29.31 | $ 18.86 | $ 15.92 | |||||
Fair value of units vested | $ 8,700,000 | |||||||
Restricted Stock Awards and Restricted Stock Units (RSUs) | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Fair value of units vested | $ 8,800,000 | $ 37,000,000 | ||||||
2017 Employee Stock Purchase Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common stock reserved for issuance (in shares) | 1,000,000 | |||||||
Number of additional shares allowable under the plan (in shares) | 2,000,000 | 1,000,000 | ||||||
Percent of outstanding shares (as a percentage) | 1.00% | |||||||
Common stock purchase discounted rate for employees | 85.00% | |||||||
Maximum employee contribution to ESPP, percent of base compensation | 15.00% | |||||||
Stock issued during period (in shares) | 200,000 | 200,000 | 200,000 | |||||
Stock Options | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Dividend yield | 0.00% | 0.00% | 0.00% | |||||
Unamortized stock- based compensation expense related to unvested stock options | $ 125,400,000 | |||||||
Expected weighted average period | 2 years 9 months 18 days | |||||||
Total stock-based compensation expense, tax benefit | $ 0 | $ 0 | $ 0 | |||||
2017 Equity Incentive Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common stock reserved for issuance (in shares) | 6,400,000 | |||||||
Number of additional shares allowable under the plan (in shares) | 10,000,000 | 4,800,000 | ||||||
Percent of outstanding shares (as a percentage) | 5.00% | |||||||
Number of shares available for grant (in shares) | 3,700,000 | 3,400,000 | ||||||
2017 Equity Incentive Plan | Maximum | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Award expiration period | 10 years | |||||||
2017 Equity Incentive Plan | Minimum | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Percentage of option price of estimated fair value on grant date | 100.00% | |||||||
Award vesting period | 4 years | |||||||
2015 Stock Incentive Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common stock reserved for issuance (in shares) | 8,300,000 | |||||||
Number of shares available for grant (in shares) | 0 | |||||||
2015 Stock Incentive Plan | Maximum | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Award expiration period | 10 years | |||||||
2015 Stock Incentive Plan | Minimum | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Percentage of option price of estimated fair value on grant date | 100.00% | |||||||
Award vesting period | 4 years | |||||||
Shares Transferred As Available For Issuance From 2015 Plan to 2017 Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Number of shares available for grant (in shares) | 200,000 |
Stock-Based Awards - Summary of
Stock-Based Awards - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Options | ||
Beginning balance (in shares) | 11,640,734 | |
Granted (in shares) | 3,518,298 | |
Exercised (in shares) | (1,487,426) | |
Forfeited (in shares) | (711,680) | |
Ending balance (in shares) | 12,959,926 | 11,640,734 |
Options, vested and expected to vest (in shares) | 11,215,194 | |
Options, exercisable (in shares) | 5,301,186 | |
Weighted- Average Exercise Price | ||
Beginning balance (usd per share) | $ 12.96 | |
Granted (usd per share) | 26.24 | |
Exercised (usd per share) | 11.55 | |
Forfeited (usd per share) | 20.57 | |
Ending balance (usd per share) | 16.31 | $ 12.96 |
Options, vested and expected to vest (in shares) | 18.75 | |
Options, exercisable (in shares) | $ 14.28 | |
Stock Option Activity, Additional Disclosures | ||
Weighted- Average remaining contractual life (years) | 7 years 4 months 13 days | 7 years 9 months 14 days |
Weighted-Average remaining contractual life (years), Options vested and expected to vest | 7 years 9 months 14 days | |
Weighted-Average remaining contractual life (years), Options exercisable | 6 years 11 months 12 days | |
Aggregate Intrinsic Value (in thousands) | $ 874,026 | $ 51,879 |
Aggregate Intrinsic Value (in thousands), Options vested and expected to vest | 717,292 | |
Aggregate Intrinsic Value (in thousands), Options exercisable | $ 368,335 |
Stock-Based Awards - Summary _2
Stock-Based Awards - Summary of Assumptions Used for Estimating the Fair Value of Stock Options Granted (Details) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Dividend yield | 0.00% | ||
Stock Options | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Volatility, minimum | 65.20% | 65.50% | 79.40% |
Volatility, maximum | 67.10% | 77.80% | 87.40% |
Risk-free interest rate, minimum | 0.30% | 1.50% | 2.60% |
Risk-free interest rate, maximum | 1.70% | 2.60% | 3.10% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Stock Options | Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 5 years 6 months | 5 years 6 months | 5 years 6 months |
Stock Options | Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected term (in years) | 6 years 29 days | 6 years 29 days | 6 years 29 days |
Stock-Based Awards - Summary _3
Stock-Based Awards - Summary of Restricted Stock Activity (Details) - Restricted Stock Units (RSUs) - $ / shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share Awards & Units | |||
Beginning balance (in shares) | 882,636 | ||
Granted (in shares) | 1,903,041 | ||
Vested and released (in shares) | (309,097) | ||
Forfeited (in shares) | (174,901) | ||
Ending balance (in shares) | 2,301,679 | 882,636 | |
Expected to vest (in shares) | 2,301,679 | ||
Weighted-Average Fair Value at Date of Grant per Share | |||
Beginning balance (usd per share) | $ 18.67 | ||
Granted (usd per share) | 29.31 | $ 18.86 | $ 15.92 |
Vested and released (usd per share) | 19.23 | ||
Forfeited (usd per share) | 30.94 | ||
Ending balance (usd per share) | 27.08 | $ 18.67 | |
Expected to vest (usd per share) | $ 27.08 |
Stock-Based Awards - Summary _4
Stock-Based Awards - Summary of Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total | $ 50,351 | $ 38,378 | $ 18,791 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total | 29,002 | 19,261 | 10,093 |
General and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Total | $ 21,349 | $ 19,117 | $ 8,698 |
Defined Contribution Plan - Nar
Defined Contribution Plan - Narrative (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |||
Contribution expenses | $ 1.9 | $ 1.6 | $ 0.9 |
Income Taxes - Provision for In
Income Taxes - Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Current: | ||
U.S. Federal | $ 0 | $ 0 |
U.S. State | 823 | 0 |
Foreign | 0 | 0 |
Total Current | 823 | 0 |
Deferred: | ||
U.S. Federal | 0 | (338) |
U.S. State | 0 | (13) |
Foreign | 0 | 0 |
Total deferred | $ 0 | $ (351) |
Income Taxes - Effective Tax Ra
Income Taxes - Effective Tax Rate Reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Taxes at the U.S. statutory tax rate | 21.00% | 21.00% | 21.00% |
Effect of Tax Act | 1.10% | 0.00% | 0.00% |
Change in valuation allowance | (4.00%) | (24.40%) | (20.70%) |
Research tax credits | (9.20%) | 3.50% | 10.20% |
Stock-based compensation | (7.90%) | 0.10% | (0.70%) |
Nondeductible acquisition-related costs | 0.00% | 0.00% | (9.50%) |
Other | 0.10% | (0.10%) | (0.30%) |
Total provision for income taxes | 1.10% | 0.10% | 0.00% |
Income Taxes - Schedule of Defe
Income Taxes - Schedule of Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 54,110 | $ 56,612 |
Tax credit carryforwards | 27,411 | 19,133 |
Contract liabilities | 15,344 | 13,516 |
Operating lease liability | 17,179 | 15,686 |
Stock-based compensation | 18,709 | 9,513 |
Accruals and other | 17,767 | 11,815 |
Gross deferred tax assets | 150,520 | 126,275 |
Valuation allowance | (133,054) | (112,713) |
Net deferred tax assets | 17,466 | 13,562 |
Deferred tax liabilities: | ||
Property and equipment | (9,329) | (6,225) |
Operating lease right-of-use asset | (8,137) | (7,337) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | |||
Unrecognized tax benefits at January 1 | $ 5,299 | $ 2,642 | $ 1,146 |
Additions for tax positions taken in a prior year | 0 | 107 | 0 |
Additions for tax positions taken in the current year | 3,009 | 2,595 | 1,506 |
Reductions for tax positions taken in the prior year | (169) | (45) | (10) |
Unrecognized tax benefits at December 31 | $ 8,139 | $ 5,299 | $ 2,642 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Operating Loss Carryforwards [Line Items] | ||
Valuation allowance against net deferred tax assets (as a percentage) | 100.00% | 100.00% |
Net valuation allowance increase | $ 20,300,000 | |
Unrecognized tax benefits that would reduce the annual effective tax rate, if recognized | 300,000 | $ 0 |
Liability recorded for potential interest or penalties | 0 | |
Expected change to unrecognized tax benefit | 0 | |
Federal authority | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforward | 212,700,000 | |
Federal authority | Research Tax Credit Carryforward | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforward | 20,400,000 | |
Federal authority | Orphan Drug Tax Credit Carryforward | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carryforward | 3,300,000 | |
State authority | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carryforward | 133,900,000 | |
Tax credit carryforward | $ 13,600,000 |
Net Income (Loss) and Net Inc_3
Net Income (Loss) and Net Income (Loss) Per Share - Calculation of Basic and Diluted Net Loss (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Numerator: | |||
Net income (loss) | $ 71,136 | $ (197,614) | $ (36,240) |
Denominator: | |||
Weighted average number of shares outstanding, basic (in shares) | 108,974,137 | 95,608,208 | 92,621,991 |
Dilutive effect of outstanding common stock options, ESPP shares issuable, and restricted shares (in shares) | 3,728,971 | 0 | 0 |
Weighted average number of shares outstanding, diluted (in shares) | 112,703,108 | 95,608,208 | 92,621,991 |
Net income (loss) per share, basic (usd per share) | $ 0.65 | $ (2.07) | $ (0.39) |
Net income (loss) per share, diluted (usd per share) | $ 0.63 | $ (2.07) | $ (0.39) |
Net Income (Loss) and Net Inc_4
Net Income (Loss) and Net Income (Loss) Per Share - Schedule of Dilutive Securities Not Included in Diluted Per Share Calculations (Details) - shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total (in shares) | 4,165,837 | 12,804,070 | 10,428,261 |
Options issued and outstanding and ESPP shares issuable | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total (in shares) | 3,286,045 | 11,921,434 | 9,789,594 |
Restricted shares subject to future vesting | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total (in shares) | 879,792 | 882,636 | 503,243 |
Early exercised common stock subject to future vesting | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Total (in shares) | 0 | 0 | 135,424 |