Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2021 | May 04, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-35676 | |
Entity Registrant Name | PROTHENA CORPORATION PUBLIC LIMITED COMPANY | |
Entity Incorporation, State or Country Code | L2 | |
Entity Tax Identification Number | 98-1111119 | |
Entity Address, Address Line One | 77 Sir John Rogerson’s Quay, Block C | |
Entity Address, Address Line Two | Grand Canal Docklands | |
Entity Address, City or Town | Dublin 2, | |
Entity Address, Postal Zip Code | D02 VK60, | |
Entity Address, Country | IE | |
Country Region | 353 | |
City Area Code | 1 | |
Local Phone Number | 236-2500 | |
Title of 12(b) Security | Ordinary Shares, par value $0.01 per share | |
Trading Symbol | PRTA | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 44,175,792 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001559053 | |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 342,993 | $ 295,380 |
Accounts receivable | 1 | 15 |
Prepaid expenses and other current assets | 7,955 | 2,537 |
Restricted cash, current | 1,352 | 1,352 |
Total current assets | 352,301 | 299,284 |
Non-current assets: | ||
Property and equipment, net | 2,295 | 2,551 |
Operating lease right-of-use assets | 16,411 | 17,811 |
Deferred tax assets | 7,022 | 11,644 |
Restricted cash, non-current | 1,352 | 1,352 |
Other non-current assets | 338 | 333 |
Total non-current assets | 27,418 | 33,691 |
Total assets | 379,719 | 332,975 |
Current liabilities: | ||
Accounts payable | 4,212 | 4,117 |
Accrued research and development | 9,355 | 9,044 |
Income taxes payable, current | 0 | 36 |
Lease liability, current | 5,617 | 5,512 |
Other current liabilities | 4,272 | 7,139 |
Total current liabilities | 23,456 | 25,848 |
Non-current liabilities: | ||
Deferred revenue, non-current | 110,242 | 110,242 |
Lease liability, non-current | 10,884 | 12,326 |
Other liabilities | 553 | 553 |
Total non-current liabilities | 121,679 | 123,121 |
Total liabilities | 145,135 | 148,969 |
Commitments and contingencies (Note 6) | ||
Shareholders’ equity: | ||
Euro deferred shares, €22 nominal value: Authorized shares — 10,000 at March 31, 2021 and December 31, 2020. Issued and outstanding shares — none at March 31, 2021 and December 31, 2020. | 0 | 0 |
Ordinary shares, $0.01 par value: Authorized shares — 100,000,000 at March 31, 2021 and December 31, 2020. Issued and outstanding shares — 44,175,792 and 39,921,413 at March 31, 2021 and December 31, 2020, respectively | 442 | 399 |
Additional paid-in capital | 1,053,906 | 966,636 |
Accumulated deficit | (819,764) | (783,029) |
Total shareholders’ equity | 234,584 | 184,006 |
Total liabilities and shareholders’ equity | $ 379,719 | $ 332,975 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) | Mar. 31, 2021€ / sharesshares | Mar. 31, 2021$ / sharesshares | Dec. 31, 2020€ / sharesshares | Dec. 31, 2020$ / sharesshares |
Shareholders’ equity: | ||||
Euro deferred shares, nominal value (in euros per share) | € / shares | € 22 | € 22 | ||
Euro deferred shares, number of shares authorized (in shares) | 10,000 | 10,000 | 10,000 | 10,000 |
Euro deferred shares, number of issued shares (in shares) | 0 | 0 | 0 | 0 |
Euro deferred shares, number of outstanding shares (in shares) | 0 | 0 | 0 | 0 |
Ordinary shares, par value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | ||
Ordinary shares, number of authorized shares (in shares) | 100,000,000 | 100,000,000 | 100,000,000 | 100,000,000 |
Ordinary shares, number of issued shares (in shares) | 44,175,792 | 44,175,792 | 39,921,413 | 39,921,413 |
Ordinary shares, number of outstanding shares (in shares) | 44,175,792 | 44,175,792 | 39,921,413 | 39,921,413 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Total revenue | $ 160 | $ 141 |
Operating expenses: | ||
Research and development | 21,144 | 15,248 |
General and administrative | 11,125 | 9,741 |
Total operating expenses | 32,269 | 24,989 |
Loss from operations | (32,109) | (24,848) |
Other income (expense): | ||
Interest income, net | 11 | 1,137 |
Other income (expense), net | 23 | (24) |
Other income, net | 34 | 1,113 |
Loss before income taxes | (32,075) | (23,735) |
Provision for (benefit from) income taxes | 4,660 | (166) |
Net loss | $ (36,735) | $ (23,569) |
Basic and diluted net loss per share (in dollars per share) | $ (0.91) | $ (0.59) |
Shares used to compute basic and diluted net loss per share (in shares) | 40,250 | 39,909 |
Collaboration revenue | ||
Total revenue | $ 110 | $ 141 |
License revenue | ||
Total revenue | $ 50 | $ 0 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Operating activities | ||
Net loss | $ (36,735) | $ (23,569) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation and amortization | 304 | 384 |
Share-based compensation | 6,176 | 5,536 |
Deferred income taxes | 4,622 | (495) |
Amortization of right-of-use assets | 1,400 | 1,345 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 14 | (106) |
Prepaid and other assets | (5,259) | (4,278) |
Accounts payable, accruals and other liabilities | (2,851) | (748) |
Operating lease liabilities | (1,337) | (1,236) |
Net cash used in operating activities | (33,666) | (23,167) |
Investing activities | ||
Purchases of property and equipment | (48) | (22) |
Net cash used in investing activities | (48) | (22) |
Financing activities | ||
Proceeds from issuance of ordinary shares in public offering, net | 78,367 | 0 |
Proceeds from issuance of ordinary shares upon exercise of stock options | 2,960 | 151 |
Net cash provided by financing activities | 81,327 | 151 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 47,613 | (23,038) |
Cash, cash equivalents and restricted cash, beginning of the year | 298,084 | 378,427 |
Cash, cash equivalents and restricted cash, end of the period | 345,697 | 355,389 |
Supplemental disclosures of cash flow information | ||
Cash paid for income taxes, net | 402 | 417 |
Supplemental disclosures of non-cash investing and financing activities | ||
Acquisition of property and equipment included in accounts payable and accrued liabilities | 0 | 24 |
Receivable from option exercises | 123 | 0 |
Offering costs included in accounts payable and accrued liabilities | 313 | 0 |
Total cash, cash equivalents and restricted cash, end of the period | $ 345,697 | $ 355,389 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Shareholders' Equity - USD ($) $ in Thousands | Total | Ordinary Shares | Additional Paid-in Capital | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2019 | 39,898,561 | |||
Beginning balance at Dec. 31, 2019 | $ 272,921 | $ 399 | $ 944,407 | $ (671,885) |
Issuance of ordinary shares upon exercise of stock options (in shares) | 12,852 | |||
Issuance of ordinary shares upon exercise of stock options | 151 | $ 0 | 151 | |
APIC, Share-based Payment Arrangement, Increase for Cost Recognition | 5,536 | 5,536 | ||
Net loss | (23,569) | (23,569) | ||
Ending balance (in shares) at Mar. 31, 2020 | 39,911,413 | |||
Ending balance at Mar. 31, 2020 | 255,039 | $ 399 | 950,094 | (695,454) |
Beginning balance (in shares) at Dec. 31, 2020 | 39,921,413 | |||
Beginning balance at Dec. 31, 2020 | $ 184,006 | $ 399 | 966,636 | (783,029) |
Issuance of ordinary shares upon exercise of stock options (in shares) | 229,379 | 229,379 | ||
Issuance of ordinary shares upon exercise of stock options | $ 3,083 | $ 3 | 3,080 | |
Issuance of ordinary shares in underwritten public offering, net of issuance costs of $5.5 million (in shares) | 4,025,000 | |||
Issuance of ordinary shares in public offering, net of issuance costs of $5.5 million | 78,054 | $ 40 | 78,014 | |
APIC, Share-based Payment Arrangement, Increase for Cost Recognition | 6,176 | 6,176 | ||
Net loss | (36,735) | (36,735) | ||
Ending balance (in shares) at Mar. 31, 2021 | 44,175,792 | |||
Ending balance at Mar. 31, 2021 | $ 234,584 | $ 442 | $ 1,053,906 | $ (819,764) |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Shareholders' Equity (Parenthetical) $ in Millions | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Issuance costs | $ 5.5 |
Organization
Organization | 3 Months Ended |
Mar. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization | Organization Description of Business Prothena Corporation plc (“Prothena” or the “Company”) is a late-stage clinical company with a robust pipeline of novel investigational therapeutics built on protein dysregulation expertise with the potential to change the course of devastating rare peripheral amyloid and neurodegenerative diseases. Fueled by its deep scientific expertise built over decades of research, the Company is advancing a pipeline of therapeutic candidates for a number of indications and novel targets for which its ability to integrate scientific insights around neurological dysfunction and the biology of misfolded proteins can be leveraged. The Company’s wholly-owned programs include birtamimab for the potential treatment of AL amyloidosis, PRX004 for the potential treatment of ATTR amyloidosis, and a portfolio of programs for the potential treatment of Alzheimer’s disease including PRX012 that targets Aβ (Amyloid beta). The Company’s partnered programs include prasinezumab, in collaboration with Roche for the potential treatment of Parkinson’s disease and other related synucleinopathies, and programs that target tau (PRX005), TDP-43 and an undisclosed target in collaboration with Bristol Myers Squibb for the potential treatment of Alzheimer’s disease, amyotrophic lateral sclerosis (ALS). The Company was formed on September 26, 2012, under the laws of Ireland and re-registered as an Irish public limited company on October 25, 2012. The Company's ordinary shares began trading on The Nasdaq Global Market under the symbol “PRTA” on December 21, 2012, and currently trade on The Nasdaq Global Select Market. Liquidity and Business Risks As of March 31, 2021, the Company had an accumulated deficit of $819.8 million and cash and cash equivalents of $343.0 million. In March 2021, the Company sold an aggregate of 4,025,000 ordinary shares for net proceeds of approximately $78.1 million, after deducting the underwriting discount and estimated offering expenses, in an underwritten public offering. Based on the Company's business plans, management believes that the Company’s cash and cash equivalents at March 31, 2021, are sufficient to meet its obligations for at least the next twelve months. To operate beyond such period, or if the Company elects to increase its spending on research and development programs significantly above current long-term plans or enters into potential licenses and or other acquisitions of complementary technologies, products or companies, the Company may need additional capital. The Company expects to continue to finance future cash needs that exceed its cash from operating activities primarily through its current cash and cash equivalents, its collaborations with Roche and Bristol Myers Squibb, and, to the extent necessary, through proceeds from public or private equity or debt financings, loans and other collaborative agreements with corporate partners or other arrangements. The Company is subject to a number of risks, including but not limited to: the uncertainty of the Company’s research and development (“R&D”) efforts resulting in future successful commercial products; obtaining regulatory approval for its product candidates; its ability to successfully commercialize its product candidates, if approved; significant competition from larger organizations; reliance on the proprietary technology of others; dependence on key personnel; uncertain patent protection; dependence on corporate partners and collaborators; the outbreak of the novel strain of coronavirus SARS-CoV-2; and possible restrictions on reimbursement from governmental agencies and healthcare organizations, as well as other changes in the healthcare industry. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Basis of Preparation and Presentation of Financial Information These accompanying Unaudited Interim Condensed Consolidated Financial Statements have been prepared in accordance with the accounting principles generally accepted in the U.S. (“GAAP”) and with the instructions for Form 10-Q and Regulation S-X statements. Accordingly, they do not include all of the information and notes required for complete financial statements. These interim Condensed Consolidated Financial Statements should be read in conjunction with the Consolidated Financial Statements and Notes thereto contained in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 26, 2021 (the “2020 Form 10-K”). These Unaudited Interim Condensed Consolidated Financial Statements are presented in U.S. dollars, which is the functional currency of the Company and its consolidated subsidiaries. These Unaudited Interim Condensed Consolidated Financial Statements include the accounts of the Company and its consolidated subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Unaudited Interim Financial Information The accompanying Unaudited Interim Condensed Consolidated Financial Statements and related disclosures are unaudited, have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair presentation of the results of operations for the periods presented. The year-end condensed consolidated balance sheet data was derived from audited financial statements, however certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted. The condensed consolidated results of operations for any interim period are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period. Use of Estimates The preparation of the Condensed Consolidated Financial Statements in conformity with GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates, including critical accounting policies or estimates related to revenue recognition, share-based compensation, research and development expenses and leases. The Company bases its estimates on historical experience and on various other market specific and other relevant assumptions that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Because of the uncertainties inherent in such estimates, actual results may differ materially from these estimates. Significant Accounting Policies There were no significant changes to the accounting policies during the three months ended March 31, 2021, from the significant accounting policies described in Note 2 of the Notes to Consolidated Financial Statements in the 2020 Form 10-K. Segment and Concentration of Risks The Company operates in one segment. The Company’s chief operating decision maker (the “CODM”), its Chief Executive Officer, manages the Company’s operations on a consolidated basis for purposes of allocating resources. When evaluating the Company’s financial performance, the CODM reviews all financial information on a consolidated basis. Financial instruments that potentially subject the Company to concentration of credit risk consist of cash and cash equivalents and accounts receivable. The Company places its cash equivalents with high credit quality financial institutions and, by policy, limits the amount of credit exposure with any one financial institution. Deposits held with banks may exceed the amount of insurance provided on such deposits. The Company has not experienced any losses on its deposits of cash and cash equivalents and its credit risk exposure is up to the extent recorded on the Company's Consolidated Balance Sheet. The receivables recorded in the Condensed Consolidated Balance Sheet include amounts due from a Roche entity located in Switzerland. Collaboration revenue recorded in the Condensed Consolidated Statements of Operations consists of reimbursement from Roche for research and development services. The Company's credit risk exposure is up to the extent recorded on the Company's Condensed Consolidated Balance Sheet. As of March 31, 2021, $2.3 million of the Company’s property and equipment, net were held in the U.S. and none were in Ireland. As of December 31, 2020, $2.6 million of the Company's property and equipment, net were held in the U.S. and none were in Ireland. The Company does not own or operate facilities for the manufacture, packaging, labeling, storage, testing or distribution of nonclinical or clinical supplies of any of its drug candidates. The Company instead contracts with and relies on third-parties to manufacture, package, label, store, test and distribute all preclinical development and clinical supplies of our drug candidates, and it plans to continue to do so for the foreseeable future. The Company also relies on third-party consultants to assist in managing these third-parties and assist with its manufacturing strategy. Recent Accounting Pronouncements There were no new accounting pronouncements or changes to accounting pronouncements during the three months ended March 31, 2021 that are of significance or potential significance to the Company. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents. Fair value is an 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 such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. A three-tier fair value hierarchy is established as a basis for considering such assumptions and for inputs used in the valuation methodologies in measuring fair value: Level 1 — Observable inputs such as quoted prices (unadjusted) for identical assets or liabilities in active markets. Level 2 — Include other inputs that are based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model-based valuation techniques for which all significant inputs are observable in the market or can be derived from observable market data. Where applicable, these models project future cash flows and discount the future amounts to a present value using market-based observable inputs including interest rate curves, foreign exchange rates, and credit ratings. Level 3 — Unobservable inputs that are supported by little or no market activities, which would require the Company to develop its own assumptions. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The carrying amounts of certain financial instruments, such as cash equivalents, accounts receivable, accounts payable and accrued liabilities, approximate fair value due to their relatively short maturities, and low market interest rates, if applicable. Based on the fair value hierarchy, the Company classifies its cash equivalents within Level 1. This is because the Company values its cash equivalents using quoted market prices. The Company’s Level 1 securities consisted of $273.1 million and $226.1 million in money market funds included in cash and cash equivalents at March 31, 2021, and December 31, 2020, respectively. |
Composition of Certain Balance
Composition of Certain Balance Sheet Items | 3 Months Ended |
Mar. 31, 2021 | |
Composition of Certain Balance Sheet Items [Abstract] | |
Composition of Certain Balance Sheet Items | Composition of Certain Balance Sheet Items Property and Equipment, net Property and equipment, net consisted of the following (in thousands): March 31, December 31, 2021 2020 Machinery and equipment $ 9,350 $ 9,343 Leasehold improvements 1,318 1,278 Purchased computer software 1,424 1,423 12,092 12,044 Less: accumulated depreciation and amortization (9,797) (9,493) Property and equipment, net $ 2,295 $ 2,551 Depreciation expense was $0.3 million and $0.4 million for the three months ended March 31, 2021 and 2020, respectively. Other Current Liabilities Other current liabilities consisted of the following (in thousands): March 31, 2021 2020 Payroll and related expenses $ 3,516 $ 5,927 Professional services 510 696 Other 246 516 Other current liabilities $ 4,272 $ 7,139 |
Net Loss Per Ordinary Share
Net Loss Per Ordinary Share | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Net Income (Loss) Per Ordinary Share | Net Loss Per Ordinary Share Basic net income (loss) per ordinary share is calculated by dividing net income (loss) by the weighted-average number of ordinary shares outstanding during the period. Shares used in diluted net income per ordinary share would include the dilutive effect of ordinary shares potentially issuable upon the exercise of stock options outstanding. However, potentially issuable ordinary shares are not used in computing diluted net loss per ordinary share as their effect would be anti-dilutive due to the loss recorded during the three months ended March 31, 2021, and 2020, and therefore diluted net loss per share is equal to basic net loss per share. Net loss per ordinary share was determined as follows (in thousands, except per share amounts): Three Months Ended March 31, 2021 2020 Numerator: Net loss $ (36,735) $ (23,569) Denominator: Weighted-average ordinary shares outstanding 40,250 39,909 Net loss per share: Basic and diluted net loss per share $ (0.91) $ (0.59) The equivalent ordinary shares not included in diluted net loss per share because their effect would be anti-dilutive are as follows (in thousands): Three Months Ended March 31, 2021 2020 Stock options to purchase ordinary shares 8,825 8,412 |
Commitment and Contingencies
Commitment and Contingencies | 3 Months Ended |
Mar. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitment and Contingencies | Commitments and Contingencies Lease Commitments The Company currently has two leases relating to its facilities in South San Francisco and Dublin, Ireland. Current SSF Facility The Company has a noncancelable operating sublease (the “Lease”) covering 128,751 square feet of office and laboratory space in South San Francisco, California, U.S. (the “Current SSF Facility”). The Lease includes a free rent period and escalating rent payments and has a remaining lease term of 2.75 years that expires on December 31, 2023, unless terminated earlier. The Company's obligation to pay rent commenced on August 1, 2016. The Company is obligated to make lease payments totaling approximately $39.2 million over the lease term. The Lease further provides that the Company is obligated to pay to the sublandlord and master landlord certain costs, including taxes and operating expenses. The Lease is considered an operating lease under ASC 842. Prior to the Company's adoption of ASC 842, this Lease was considered a build-to-suit lease. The Company’s right-of-use asset and lease liability are determined based on the present value of minimum lease payments over the remaining lease term and the Company’s incremental borrowing rate based on information available as of January 1, 2019. The right-of-use asset also includes any lease prepayments made and excludes unamortized lease incentives including rent abatements and/or concessions and rent holidays. Tenant improvements made by the Company as a lessee, in which such improvements are deemed to be owned by the lessor, are viewed as lease prepayments by the Company and are included in the right-of-use asset. Lease expense is recognized on a straight-line basis over the expected lease term. Total operating lease cost was $1.6 million and $1.6 million for the three months ended March 31, 2021 and 2020, respectively. Total cash paid against the operating lease liability was $1.5 million and $1.5 million for the three months ended March 31, 2021 and 2020, respectively. The discount rate used to determine the lease liability was 4.25%. To estimate the Company's collateralized incremental borrowing rate, the Company inquired with banks that had a business relationship with the Company. Furthermore, the Company's operating lease in Dublin is not included in the lease liability and right-of-use asset recorded due to its nominal amount. As of March 31, 2021, the Company performed an evaluation of its other contracts with customers and suppliers in accordance with ASC 842 and have determined that, except for the leases described below and a nominal operating lease for office equipment, none of the Company’s contracts contain a lease. In connection with this Lease, the Company received a tenant improvement allowance of $14.2 million from the sublandlord and the master landlord, for the costs associated with the design, development and construction of tenant improvements for the Current SSF Facility. The Company is obligated to fund all costs incurred in excess of the tenant improvement allowance. The initial measurement of right-of-use asset for the Lease includes the tenant improvement added by the Company wherein the lessor was deemed the accounting owner, net of the tenant improvement allowance received from the sublandlord and the master landlord. The Company obtained a standby letter of credit in April 2016 in the initial amount of $4.1 million, which may be drawn down by the sublandlord in the event the Company fails to fully and faithfully perform all of its obligations under the Lease and to compensate the sublandlord for all losses and damages the sublandlord may suffer as a result of the occurrence of any default on the part of Company not cured within the applicable cure period. This standby letter of credit is collateralized by a certificate of deposit of the same amount which is classified as restricted cash. The Company was entitled to a $1.4 million reduction in the face amount of the standby letter of credit on the third anniversary of the contractual rent commencement, which was received in 2019, and another $1.4 million on the fifth anniversary of the contractual rent commencement. As a condition to the reduction of the standby letter of credit amount, no uncured default by the Company shall then exist under the Lease. As of March 31, 2021, none of the remaining standby letter of credit amount of $2.7 million has been used. Sub-Sublease of Current SSF Facility On July 18, 2018, the Company entered into a Sub-Sublease Agreement (the “Sub-Sublease”) with Assembly Biosciences, Inc. (the “Sub-Subtenant”) to sub-sublease approximately 46,641 square feet of office and laboratory space of the Current SSF Facility to the Sub-Subtenant. The Sub-Sublease is considered an operating lease under ASC 842. For the three months ended March 31, 2021 and 2020, the Company recorded $0.7 million and $0.7 million, respectively, of sub-lease rental income as an offset to its operating expenses. The Sub-Sublease provides for initial annual base rent for the complete Sub-Subleased Premises of approximately $2.7 million, with increases of approximately 3.5% in annual base rent on September 1, 2019 and each anniversary thereof. The Sub-Sublease rental income excludes reimbursements for executory costs received from the Sub-Subtenant. The Sub-Sublease became effective on September 24, 2018, and has a term of 5.2 years which terminates on December 15, 2023. The Sub-Sublease will terminate if the Lease or the corresponding master lease terminates. The Company or the Sub-Subtenant may elect, subject to limitations set forth in the Sub-Sublease, to terminate the Sub-Sublease following a material casualty or condemnation affecting the Subleased Premises. The Company may terminate the Sub-Sublease following an event of default, which is defined in the Sub-Sublease to include, among other things, non-payment of amounts owing by the Sub-Subtenant under the Sub-Sublease. The Company is required under the Lease to pay to the sublandlord 50% of that portion of the cash sums and other economic consideration received from the Sub-Subtenant that exceeds the base rent paid by the Company to the sublandlord after deducting certain of the Company’s costs. Dublin The Company entered into an agreement to lease 133 square feet of office space in Dublin, Ireland (the "Dublin Lease"). The current lease term expires on November 30, 2021. The Dublin Lease also has an automatic renewal clause, pursuant to which the agreement will be extended automatically for successive periods equal to the current term but no less than three months, unless the agreement is cancelled by the Company. This operating lease is not included in the lease liability and operating lease right-of-use asset recorded due to its nominal amount. As of March 31, 2021, the Company is obligated to make lease payments over the remaining term of the Dublin Lease of approximately €16,000, or $19,000 as converted using an exchange rate as of March 31, 2021. Future minimum payments under the above-described noncancelable operating leases, including a reconciliation to the lease liabilities recognized in the Condensed Consolidated Balance Sheets, and future minimum rentals to be received under the Sub-Sublease as of March 31, 2021, are as follows (in thousands): Year Ended December 31, Operating Leases Sub-Sublease Rental 2021 (9 months) 4,662 2,216 2022 6,350 3,047 2023 6,535 3,019 2024 — — Total 17,547 $ 8,282 Less: Present value adjustment (1,027) Nominal lease payments (19) Lease liability $ 16,501 Indemnity Obligations The Company has entered into indemnification agreements with its current and former directors and officers and certain key employees. These agreements contain provisions that may require the Company, among other things, to indemnify such persons against certain liabilities that may arise because of their status or service and advance their expenses incurred as a result of any indemnifiable proceedings brought against them. The obligations of the Company pursuant to the indemnification agreements continue during such time as the indemnified person serves the Company and continues thereafter until such time as a claim can be brought. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited; however, the Company has a director and officer liability insurance policy that limits its exposure and enables the Company to recover a portion of any future amounts paid. As a result of its insurance policy coverage, the Company believes the estimated fair value of these indemnification agreements is minimal. Accordingly, the Company had no liabilities recorded for these agreements as of March 31, 2021 and 2020. Other Commitments In the normal course of business, the Company enters into various firm purchase commitments primarily related to research and development activities. As of March 31, 2021, the Company had non-cancelable purchase commitments to suppliers for $11.9 million of which $3.6 million is included in accrued current liabilities, and contractual obligations under license agreements of $0.7 million of which $0.1 million is included in accrued current liabilities. The following is a summary of the Company's non-cancelable purchase commitments and contractual obligations as of March 31, 2021 (in thousands): Total 2021 2022 2023 2024 2025 Thereafter Purchase Obligations (1) $ 11,921 $ 11,921 $ — $ — $ — $ — $ — Contractual obligations under license agreements (2) 740 135 70 70 60 60 345 Total $ 12,661 $ 12,056 $ 70 $ 70 $ 60 $ 60 $ 345 ________________ (1) Purchase obligations consist of non-cancelable purchase commitments to suppliers. (2) Excludes future obligations pursuant to the cost-sharing arrangement under the Company's License Agreement with Roche. Amounts of such obligations, if any, cannot be determined at this time. |
Significant Agreements
Significant Agreements | 3 Months Ended |
Mar. 31, 2021 | |
Collaborative Agreement [Abstract] | |
License Agreements | Significant Agreements Roche License Agreement In December 2013, the Company through its wholly owned subsidiary Prothena Biosciences Limited and Prothena Biosciences Inc entered into a License, Development, and Commercialization Agreement (the “License Agreement”) with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (together, “Roche”) to develop and commercialize certain antibodies that target α - synuclein, including prasinezumab, which are referred to collectively as “Licensed Products.” Upon the effectiveness of the License Agreement in January 2014, the Company granted to Roche an exclusive, worldwide license to develop, make, have made, use, sell, offer to sell, import and export the Licensed Products. The Company retained certain rights to conduct development of the Licensed Products and an option to co-promote prasinezumab in the U.S. During the term of the License Agreement, the Company and Roche will work exclusively with each other to research and develop antibody products targeting alpha-synuclein (or α - synuclein) potentially including incorporation of Roche’s proprietary Brain Shuttle™ technology to potentially increase delivery of therapeutic antibodies to the brain. The License Agreement provided for Roche making an upfront payment to the Company of $30.0 million, which was received in February 2014; making a clinical milestone payment of $15.0 million upon initiation of the Phase 1 study for prasinezumab, which was received in May 2014; and making a clinical milestone payment of $30.0 million upon dosing of the first patient in the Phase 2 study for prasinezumab, which was achieved in June 2017. For prasinezumab, Roche is also obligated to pay: • up to $350.0 million upon the achievement of development, regulatory and various first commercial sales milestones; • up to an additional $175.0 million upon achievement of ex-U.S. commercial sales milestones; and • tiered, high single-digit to high double-digit royalties in the teens on ex-U.S. annual net sales, subject to certain adjustments. Roche bore 100% of the cost of conducting the research collaboration under the License Agreement during the research term, which expired December 31, 2017. In the U.S., the parties share all development and commercialization costs, as well as profits, all of which will be allocated 70% to Roche and 30% to the Company, for prasinezumab in the Parkinson’s disease indication, as well as any other Licensed Products and/or indications for which the Company opts in to participate in co-development and co-funding. After the completion of specific clinical trial activities, the Company may opt out of the co-development and cost and profit sharing on any co-developed Licensed Products and instead receive U.S. commercial sales milestones totaling up to $155.0 million and tiered, single-digit to high double-digit royalties in the teens based on U.S. annual net sales, subject to certain adjustments, with respect to the applicable Licensed Product. The Company filed an Investigational New Drug Application (“IND”) with the FDA for prasinezumab and subsequently initiated a Phase 1 study in 2014. Following the Phase 1 studies, Roche became primarily responsible for developing, obtaining and maintaining regulatory approval for and commercializing Licensed Products. Roche also became responsible for the clinical and commercial manufacture and supply of Licensed Products. In addition, the Company has an option under the License Agreement to co-promote prasinezumab in the U.S. in the Parkinson’s disease indication. If the Company exercises such option, it may also elect to co-promote additional Licensed Products in the U.S. approved for Parkinson’s disease. Outside the U.S., Roche will have responsibility for developing and commercializing the Licensed Products. Roche bears all costs that are specifically related to obtaining or maintaining regulatory approval outside the U.S. and will pay the Company a variable royalty based on annual net sales of the Licensed Products outside the U.S. While Roche will record product revenue from sales of the Licensed Products, the Company and Roche will share in the net profits and losses of sales of the prasinezumab for the Parkinson's disease indication in the U.S. on a 70%/30% basis with the Company receiving 30% of the profit and losses provided that the Company has not exercised its opt-out right. The License Agreement continues on a country-by-country basis until the expiration of all payment obligations under the License Agreement. The License Agreement may also be terminated (i) by Roche at will after the first anniversary of the effective date of the License Agreement, either in its entirety or on a Licensed Product-by-Licensed Product basis, upon 90 days’ prior written notice to the Company prior to first commercial sale and 180 days’ prior written notice to Prothena after first commercial sale, (ii) by either party, either in its entirety or on a Licensed Product-by-Licensed Product or region-by-region basis, upon written notice in connection with a material breach uncured 90 days after initial written notice, and (iii) by either party, in its entirety, upon insolvency of the other party. The License Agreement may be terminated by either party on a patent-by-patent and country-by-country basis if the other party challenges a given patent in a given country. The Company’s rights to co-develop Licensed Products under the License Agreement will terminate if the Company commences certain studies for certain types of competitive products. The Company’s rights to co-promote Licensed Products under the License Agreement will terminate if the Company commences a Phase 3 study for such competitive products. The License Agreement cannot be assigned by either party without the prior written consent of the other party, except to an affiliate of such party or in the event of a merger or acquisition of such party, subject to certain conditions. The License Agreement also includes customary provisions regarding, among other things, confidentiality, intellectual property ownership, patent prosecution, enforcement and defense, representations and warranties, indemnification, insurance, and arbitration and dispute resolution. Collaboration Accounting The License Agreement was evaluated under ASC 808, Collaborative Agreements. At the outset of the License Agreement, the Company concluded that it did not qualify as collaboration under ASC 808 because the Company does not share significant risks due to the net profit and loss split (under which Roche incurs substantially more of the costs of the collaboration) and because of the Company’s opt-out provision. The Company believes that Roche will be the principal in future sales transactions with third parties as Roche will be the primary obligor bearing inventory and credit risk. The Company will record its share of pre-tax commercial profit generated from the collaboration as collaboration revenue once the Company can conclude it is probable that a significant revenue reversal will not occur in future periods. Prior to commercialization of a Licensed Product, the Company’s portion of the expenses related to the License Agreement reflected on its income statement will be limited to R&D expenses. After commercialization, if the Company opts-in to co-detail commercialization, expenses related to commercial capabilities, including expenses related to the establishment of a field sales force and other activities to support the Company’s commercialization efforts, will be recorded as sales, general and administrative (“SG&A”) expense and will be factored into the computation of the profit and loss share. The Company will record the receivable related to commercialization activities as collaboration revenue once the Company can conclude it is probable that a significant revenue reversal will not occur in future periods. Performance Obligations The License Agreement was evaluated under ASC 606. The License Agreement includes the following distinct performance obligations: (1) the Company’s grant of an exclusive royalty bearing license, with the right to sublicense to develop and commercialize certain antibodies that target α - synuclein, including prasinezumab, and the initial know how transfer which was delivered at the effective date (the “Royalty Bearing License”); (2) the Company’s obligation to supply clinical material as requested by Roche for a period up to twelve months (the “Clinical Product Supply Obligation”); (3) the Company’s obligation to provide manufacturing related services to Roche for a period up to twelve months (the “Supply Services Obligation”); (4) the Company’s obligation to prepare and file the IND (the “IND Obligation”); and (5) the Company’s obligation to provide development activities under the development plan during Phase 1 clinical trials (the “Development Services Obligation”). Revenue allocated to the above performance obligations under the License Agreement are recognized when the Company has satisfied its obligations either at a point in time or over a period of time. The Company concluded that the Royalty Bearing License and the Clinical Product Supply Obligation were satisfied at a point in time. The Royalty Bearing License is considered to be a functional intellectual property, in which the revenue would be recognized at the point in time since (a) the Company concluded that the license to Roche has a significant stand-alone functionality, (b) the Company does not expect the functionality of the intellectual property to be substantially changed during the license period as a result of activities of Prothena, and (c) Prothena’s activities transfer a good or service to Roche. The Clinical Product Supply Obligation does not meet criteria for over time recognition; as such, the revenue related to such performance obligation was recognized the point in time at which Roche obtained control of manufactured supplies, which occurred during the first quarter of 2014. The Company concluded that the Supply Services Obligation, the IND Obligation and the Development Services Obligation were satisfied over time. The Company utilized an input method measure of progress by basing the recognition period on the efforts or inputs towards satisfying the performance obligation (i.e. costs incurred and the time elapsed to complete the related performance obligations). The Company determined that such input method provides an appropriate measure of progress toward complete satisfaction of such performance obligations. As of March 31, 2021, and December 31, 2020, there were no remaining performance obligations under License Agreement since the obligations related to research and development activities were only for the Phase 1 clinical trial and the remaining obligations were delivered or performed. Transaction Price According to ASC 606-10-32-2, the transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Factors considered in the determination of the transaction price include, among other things, estimated selling price of the license and costs for clinical supply and development costs. The initial transaction price under the License Agreement, pursuant to ASC 606, was $55.1 million, including $45.0 million for the Royalty Bearing License, $9.1 million for the IND and Development Services Obligations, and $1.1 million for the Supply Services Obligation. The $45.0 million for the Royalty Bearing License included the upfront payment of $30.0 million and the clinical milestone payment of $15.0 million upon initiation of the Phase 1 clinical trial of prasinezumab, both of which were made in 2014. The remaining transaction price amounts the Company expected to receive as reimbursements were based on costs expected to be paid to third parties and other costs to be incurred by the Company in order to satisfy its performance obligations. They are considered to be variable considerations not subject to constraint. The Company did not incur any incremental costs, such as commissions, to obtain or fulfill the License Agreement. Under ASC 606, the transaction price was allocated to the performance obligations as follows: $48.9 million to the Royalty Bearing License; $4.6 million to the IND and Development Services Obligations; $1.1 million to the Clinical Product Supply Obligation; and $0.6 million to the Supply Services Obligation. As of March 31, 2021, the aggregate amount of the transaction price allocated to the performance obligations that are unsatisfied is nil. Prior to the adoption of ASC 606, the transaction price was allocated to the deliverables as follows: $35.6 million to the Royalty Bearing License; $3.3 million to the IND and Development Services Obligations; $0.8 million to the Clinical Product Supply Obligation; and $0.4 million to the Supply Services Obligation. The Company allocated the initial transaction price to the Royalty Bearing License and other performance obligations using the relative selling price method based on its best estimate of selling price for the Royalty Bearing License and third party evidence for the remaining performance obligations. The best estimate of selling price for the Royalty Bearing License was based on a discounted cash flow model. The key assumptions used in the discounted cash flow model used to determine the best estimate of selling price for the Royalty Bearing License included the market opportunity for commercialization of prasinezumab in the U.S. and the royalty territory (for licensed products that are jointly funded the royalty territory is worldwide except for the U.S., and for all licensed products that are not jointly funded the Royalty Territory is worldwide), the probability of successfully developing and commercializing prasinezumab, the estimated remaining development costs for prasinezumab, and the estimated time to commercialization of prasinezumab. The Company concluded that a change in the assumptions used to determine the best estimate of selling price (“BESP”) of the license deliverable would not have a significant effect on the allocation of arrangement consideration. The Company’s discounted cash flow model included several market conditions and entity-specific inputs, including the likelihood that clinical trials for prasinezumab will be successful, the likelihood that regulatory approval will be obtained and the product commercialized, the appropriate discount rate, the market locations, size and potential market share of the product, the expected life of the product, and the competitive environment for the product. The market assumptions were generated using a patient-based forecasting approach, with key epidemiological, market penetration, dosing, compliance, length of treatment and pricing assumptions derived from primary and secondary market research, referenced from third-party sources. Significant Payment Terms Payments for development services are due within 45 days after receiving an invoice from the Company. Variable considerations related to clinical and regulatory milestone payments are constrained due to high likelihood of a revenue reversal. The payment term for all milestone payments are due within 45 days after the achievement of the relevant milestone and receipt by Roche of an invoice for such an amount from the Company. According to ASC 606-10-32-17, a significant financing component does not exist if a substantial amount of the consideration promised by the customer is variable, and the amount or timing of that consideration varies on the basis of the occurrence or nonoccurrence of a future event that is not substantially within the control of the customer or the entity. Since a “substantial amount of the consideration” promised by Roche to the Company is variable (i.e., is in the form of either milestone payments or sales-based royalties) and the amount of such variable consideration varies based upon the occurrence or nonoccurrence of future events that are not within the control of either Roche or the Company (i.e., are largely subject to regulatory approval), the License Agreement does not have a significant financing component. Optional Goods and Services An option for additional goods or services exists when a customer has a present contractual right that allows it to choose the amount of additional distinct goods or services that are purchased. Prior to the customer’s exercise of that right, the vendor is not presently obligated to provide those goods or services. ASC 606-10-25-18(j) requires recognition of an option as a distinct performance obligation when the option provides a customer with a material right. In addition to the distinct performance obligations noted above, the Company was obligated to provide indeterminate research services for up to three years ending in 2017 at rates that were not significantly discounted and fully reimbursable by Roche (the “Research Services”). The amount for any such Research Services was not fixed and determinable and was not at a significant incremental discount. There were no refund rights, concessions or performance bonuses to consider. The Company evaluated the obligation to perform Research Services under ASC 606-10-55-42 and 55-43 to determine whether it gave Roche a “material right”. According to ASC 606-10-55-43, if a customer has the option to acquire an additional good or services at a price that would reflect the standalone selling price for that good or service, that option does not provide the customer with a material right even if the option can be exercised only by entering into a previous contract. The Company concluded that Roche’s option to have the Company perform Research Services did not represent a “material right” to Roche that it would not have received without entering into the License Agreement. As a result, Roche’s option to acquire additional Research Services was not considered a performance obligation at the outset of the License Agreement under ASC 606. Accordingly, this deliverable will become new performance obligation for Prothena when Roche asks Prothena to conduct such Research Services. As of March 31, 2021 and December 31, 2020, there were no remaining Research Services performance obligations. Post Contract Deliverables Any development services provided by the Company after performance of the Development Service Obligation are not considered a contractual performance obligation under the License Agreement, since the License Agreement does not require the Company to provide any development services after completion of the Development Service Obligation. However, the collaboration’s Joint Steering Committee approved continued funding for additional development services to be provided by the Company (the “Additional Development Services”). Under the License Agreement the Company recognizes the reimbursements for Additional Development Services as collaboration revenue as earned. Revenue and Expense Recognition The Company recognized $0.1 million and $0.1 million as collaboration revenue from Roche for the three months ended March 31, 2021 and 2020, respectively. Cost sharing payments to Roche are recorded as R&D expenses. The Company recognized $4.4 million and $3.9 million in R&D expenses for payments made to Roche during the three months ended March 31, 2021 and 2020, respectively. The Company had accounts receivable from Roche of $1,000 and $3,000 at March 31, 2021 and December 31, 2020, respectively. Milestone Accounting Under the License Agreement, only if the U.S. and or global options are exercised, the Company is eligible to receive milestone payments upon the achievement of development, regulatory and various first commercial sales milestones. Milestone payments are evaluated under ASC Topic 606. Factors considered in this determination included scientific and regulatory risk that must be overcome to achieve each milestone, the level of effort and investment required to achieve the milestone, and the monetary value attributed to the milestone. Accordingly, the Company estimates payments in the transaction price based on the most likely approach, which considers the single most likely amount in a range of possible amounts related to the achievement of these milestones. Additionally, milestone payments are included in the transaction price only when the Company can conclude it is probable that a significant revenue reversal will not occur in future periods when the milestone is achieved. The Company excludes the milestone payments and royalties in the initial transaction price calculation because such payments are considered to be variable considerations with constraint. Such milestone payments and royalties will be recognized as revenue once the Company can conclude it is probable that a significant revenue reversal will not occur in future periods. The clinical and regulatory milestones under the License Agreement after the point at which the Company could opt-out are considered to be variable considerations with constraint due to the fact that active participation in the development activities that generate the milestones is not required under the License Agreement, and the Company can opt-out of these activities. There are no refunds or claw-back provisions and the milestones are uncertain of occurrence even after the Company has opted out. Based on this determination, these milestones will be recognized when the Company can conclude it is probable that a significant revenue reversal will not occur in future periods. Collaboration Agreement with Bristol Myers Squibb Overview On March 20, 2018, the Company, through its wholly owned subsidiary Prothena Biosciences Limited, entered into a Master Collaboration Agreement (the “Collaboration Agreement”) with Celgene Switzerland LLC (“Celgene”), a subsidiary of Celgene Corporation (which was acquired by Bristol Myers Squibb ("BMS") in November 2019), pursuant to which Prothena granted to Celgene a right to elect in its sole discretion to exclusively license rights both in the U.S. (the “US Rights”) and on a global basis (the “Global Rights”), with respect to the Company’s programs to develop and commercialize antibodies targeting Tau, TDP-43 and an undisclosed target (the “Collaboration Targets”). For each such program, BMS may exercise its US Rights at the IND filing, and if it so exercises such US Rights would also have a right to expand the license to Global Rights. If BMS exercises its US Rights for a program, then following the first to occur of (a) completion by the Company, in its discretion and at its cost, of Phase 1 clinical trials for such program or (b) the date on which BMS elects to assume responsibility for completing such Phase 1 clinical trials (at its cost), BMS would have decision making authority over development activities and all regulatory, manufacturing and commercialization activities in the U.S. The Collaboration Agreement provided for Celgene making an upfront payment to the Company of $100.0 million which was received in April 2018, plus future potential license exercise payments and regulatory and commercial milestones for each program under the Collaboration Agreement, as well as royalties on net sales of any resulting marketed products. In connection with the Collaboration Agreement, the Company and Celgene entered into a Share Subscription Agreement on March 20, 2018, under which Celgene subscribed to 1,174,536 of the Company’s ordinary shares for a price of $42.57 per share, for a total of approximately $50.0 million. BMS US and Global Rights and Licenses On a program-by-program basis, beginning on the effective date of the Collaboration Agreement and ending on the date that the IND Option term expires for such program (which generally occurs sixty days after the date on which Prothena delivers to BMS the first complete data package for an IND that was filed for a lead candidate from the relevant program), BMS may elect in its sole discretion to exercise its US Rights to receive an exclusive license to develop, manufacture and commercialize antibodies targeting the applicable Collaboration Target in the U.S. (the “US License”). If BMS exercises its US Rights for a collaboration program, it is obligated to pay the Company an exercise fee of approximately $80.0 million per program. Thereafter, following the first to occur of (a) completion by the Company, in its discretion and at its cost, of Phase 1 clinical trials for such program or (b) BMS’s election to assume responsibility to complete such Phase 1 clinical trials (at its cost), BMS would have the sole right to develop, manufacture and commercialize antibody products targeting the relevant Collaboration Target for such program (the “Collaboration Products”) in the U.S. On a program-by-program basis, following completion of a Phase 1 clinical trial for a collaboration program for which BMS has previously exercised its US Rights, BMS may elect in its sole discretion to exercise its Global Rights with respect to such collaboration program to receive a worldwide, exclusive license to develop, manufacture and commercialize antibodies targeting the applicable Collaboration Target (the “Global License”). If BMS exercises its Global Rights, BMS would be obligated to pay the Company an additional exercise fee of $55.0 million for such collaboration program. The Global Rights would then replace the US Rights for that collaboration program, and BMS would have decision making authority over developing, obtaining and maintaining regulatory approval for, manufacturing and commercializing the Collaboration Products worldwide. After BMS’s exercise of Global Rights for a collaboration program, the Company is eligible to receive up to $562.5 million in regulatory and commercial milestones per program. Following an exercise by BMS of either US Rights or Global Rights for such collaboration program, the Company will also be eligible to receive tiered royalties on net sales of Collaboration Products ranging from high single digit to high teen percentages, on a weighted average basis depending on the achievement of certain net sales thresholds. Such exercise fees, milestones and royalty payments are subject to certain reductions as specified in the Collaboration Agreement, the agreement for US Rights and the agreement for Global Rights. BMS will continue to pay royalties on a Collaboration Product-by-Collaboration Product and country-by-country basis, until the latest of (i) expiration of certain patents covering the Collaboration Product, (ii) expiration of all regulatory exclusivity for the Collaboration Product, and (iii) an agreed period of time after the first commercial sale of the Collaboration Product in the applicable country (the “Royalty Term”). Term and Termination The research term under the Collaboration Agreement continues for a period of six years, which BMS may extend for up to two additional 12-month periods by paying an extension fee of $10.0 million per extension period. The term of the Collaboration Agreement continues until the last to occur of the following: (i) expiration of the research term; (ii) expiration of all US Rights terms; and (iii) expiration of all Global Rights terms. The term of any US License or Global License would continue on a Licensed Product-by-Licensed Product and country-by-country basis until the expiration of all Royalty Terms under such agreement. The Collaboration Agreement may be terminated (i) by either party on a program-by-program basis if the other party remains in material breach of the Collaboration Agreement following a cure period to remedy the material breach, (ii) by BMS at will on a program-by-program basis or in its entirety, (iii) by either party, in its entirety, upon insolvency of the other party, or (iv) by Prothena, in its entirety, if BMS challenges a patent licensed by Prothena to BMS under the Collaboration Agreement. Share Subscription Agreement Pursuant to the terms of the Collaboration Agreement, the Company entered into a Share Subscription Agreement (the “SSA”) with Celgene, pursuant to which the Company issued, and Celgene subscribed for, 1,174,536 of the Company’s ordinary shares (the “Shares”) for an aggregate subscription price of approximately $50.0 million, pursuant to the terms and conditions thereof. Under the SSA, BMS (formerly Celgene) is subject to certain transfer restrictions. In addition, BMS will be entitled to request the registration of the Shares with the U.S. Securities and Exchange Commission on Form S-3ASR or Form S-3 following termination of the transfer restrictions if the Shares cannot be resold without restriction pursuant to Rule 144 promulgated under the U.S. Securities Act of 1933, as amended. Collaboration Accounting The Collaboration Agreement was evaluated under ASC 808, Collaborative Agreements. At the outset of the Collaboration Agreement, the Company concluded that it does not qualify as collaboration under ASC 808 because the Company does not share significant risks due to economics of the collaboration. Performance Obligations The Company assessed the Collaboration Agreement and concluded that it represented a contract with a customer within the scope of ASC 606. Per ASC 606, a performance obligation is defined as a promise to transfer a good or service or a series of distinct goods or services. At inception of the Collaboration Agreement, the Company is not obligated to transfer the US License or Global License to BMS unless BMS exercises its US Rights or Global Rights, respectively, and the Company is not obligated to perform development activities under the development plan during preclinical and Phase 1 clinical trials including the regulatory filing of the IND. The discovery, preclinical and clinical development activities performed by the Company are to be performed at the Company’s discretion and are not promised goods or services and therefore are not considered performance obligations under ASC 606, unless and until the Company agrees to perform the Phase 1 clinical studies (after the IND option exercise) that are determined to be performance obligations at the time the option is exercised. Per the terms of the Collaboration Agreement, the Company may conduct discovery activities to characterize, identify and generate antibodies to become collaboration candidates that target such Collaboration Target, and thereafter may pre-clinically develop collaboration candidates to identify lead candidates that target such Collaboration Target and file an IND with the U.S. Food and Drug Administration (the “FDA”) for a Phase 1 clinical trial for such lead candidates. In the event the Company agrees to be involved in a Phase 1 clinical study, the Company will further evaluate whether any such promise represents a performance obligation at the time the option is exercised. If it is concluded that the Company has obligated itself to an additional performance obligation besides the license granted at IND option exercise, then the effects of the changes in the arrangement will be evaluated under the modification guidance of ASC 606. The Company is not obligated to perform manufacturing activities. Per the terms of the Collaboration Agreement, to the extent that the Company, at its discretion, conducts a program, the Company shall be responsible for the manufacture of collaboration candidates and collaboration products for use in such program, as well as the associated costs. Delivery of manufactured compound (clinical product supply) is not deemed a performance obligation under ASC 606 as the Company is not obligated to transfer supply of collaboration product to BMS unless BMS exercises its right to participate in the Phase 1 development. Compensation for the Company’s provision of inventory supply, to the extent requested by BMS would be paid to Prothena by BMS at a reasonable stand-alone selling price for such supply. Given that (i) there is substantial uncertainty about the development of the programs, (ii) the pricing for the inventory is at its standalone selling price and (iii) the manufacturing services require the entity to transfer additional goods or services that are incremental to the goods and services provided prior to the resolution of the contingency, the Company’s supply of product is not a material right. Therefore, the inventory supply is not considered a p |
Shareholders' Equity
Shareholders' Equity | 3 Months Ended |
Mar. 31, 2021 | |
Equity [Abstract] | |
Shareholders' Equity | Shareholders' Equity Ordinary Shares As of March 31, 2021, the Company had 100,000,000 ordinary shares authorized for issuance with a par value of $0.01 per ordinary share and 44,175,792 ordinary shares issued and outstanding. Each ordinary share is entitled to one vote and, on a pro rata basis, to dividends when declared and the remaining assets of the Company in the event of a winding up. Euro Deferred Shares As of March 31, 2021, the Company had 10,000 Euro Deferred Shares authorized for issuance with a nominal value of €22 per share. No Euro Deferred Shares are outstanding at March 31, 2021. The rights and restrictions attaching to the Euro Deferred Shares rank pari passu with the ordinary shares and are treated as a single class in all respects. March 2021 Offering In March 2021, the Company completed an underwritten public offering of an aggregate of 4,025,000 of its ordinary shares at a public offering price of $20.75 per ordinary share. The Company received aggregate net proceeds of approximately $78.1 million, after deducting the underwriting discount and offering costs. |
Share-Based Compensation
Share-Based Compensation | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Compensation | Share-Based Compensation 2018 Long Term Incentive Plan In May 2018, the Company’s shareholders approved the 2018 Long Term Incentive Plan. In May 2020, the Company's shareholders approved an amendment to the 2018 Long Term Incentive Plan (as amended, the “2018 LTIP”) to increase the number of ordinary shares available for issuance under that Plan by 1,500,000 ordinary shares. Under the 2018 LTIP, the number of ordinary shares authorized for issuance under the 2018 LTIP is equal to the sum of (a) 3,300,000 ordinary shares, (b) 1,177,933 ordinary shares that were available for issuance under the 2012 LTIP as of the May 15, 2018, effective date of the 2018 LTIP, and (c) any ordinary shares subject to issued and outstanding awards under the 2012 Long Term Incentive Plan (the “2012 LTIP”) that expire, are cancelled or otherwise terminate following the effective date of the 2018 LTIP; provided, that no more than 2,500,000 ordinary shares may be issued pursuant to the exercise of ISOs. The 2018 LTIP provides for the grant of ISOs, NQSOs, SARs, restricted shares, RSUs, performance bonus awards, performance share units awards, dividend equivalents and other share or cash-based awards to eligible individuals. Options under the 2018 LTIP may be granted for periods up to ten years. All options granted to date, with the exception of options granted pursuant to the Option Exchange (as discussed below), have had a ten Amended and Restated 2012 Long Term Incentive Plan Prior to the effective date of the 2018 LTIP, employees and consultants of the Company, its subsidiaries and affiliates, as well as members of the Company’s Board of Directors, received equity awards under the 2012 LTIP. All options under the 2012 LTIP were granted for periods of ten years. 2020 Employment Inducement Incentive Plan On February 25, 2020, the Company's Board of Directors approved the 2020 Employment Inducement Incentive Plan. The 2020 EIIP provides for the grant of NQSOs, SARs, restricted shares, RSUs, performance bonus awards, performance share units awards, or other share or cash-based awards to eligible individuals. Options under the 2020 EIIP may be granted for periods up to ten years. All options issued to date have had a ten Shares Available for Grant The Company grante d 2,550,977 (1,372,587 of which were replacement options granted pursuant to the Option Exchange (as discussed below) and 1,455,450 options during the three months ended March 31, 2021, and 2020, respectively, in aggregate under its equity plans. The Company’s option awards generally vest over four years. As of March 31, 2021, 1,434,506 ordinary shares remained available for grant under the 2018 LTIP and options to purchase 8,825,499 ordinary shares in aggregate under the Company's equity plans were outstanding with a weighted-average exercise price of approximately $16.23 per share. 2020 Option Exchange Program On May 19, 2020, the Company's shareholders approved a proposal to allow for a one-time option exchange program (the "Option Exchange") designed to give its employees, including our named executive officers, and non-employee directors of the Company, who are employed by or providing services to the Company through the completion of the Option Exchange, the opportunity to exchange eligible options for new replacement options with an exercise price equal to the fair market value of the Company’s ordinary shares on the date the replacement options are granted. Any new replacement options would be subject to a new initial one-year vesting period from the replacement option grant date and after such initial one-year vesting period would vest in substantially equal installments on the remaining original vesting dates of each exchanged option. Additionally, any new replacement options would have a term equal to the remaining term of the applicable exchanged option. On November 9, 2020, the Company commenced the Option Exchange which closed on February 12, 2021. Options to purchase approximately 2.1 million ordinary shares were exchanged for options to purchase approximately 1.4 million ordinary shares with an exercise price of $22.85 per share. Options were eligible to exchange if they had an exercise price equal to or greater than $17.63 per share, were granted prior to April 23, 2018, under the 2012 LTIP, and were held by an eligible participant. No incremental share-based compensation expense was recognized for the Option Exchange. Share-based Compensation Expense The Company estimates the fair value of share-based compensation on the date of grant using an option-pricing model. The Company uses the Black-Scholes model to value share-based compensation, excluding RSUs, which the Company values using the fair market value of its ordinary shares on the date of grant. The Black-Scholes option-pricing model determines the fair value of share-based payment awards based on the share price on the date of grant and is affected by assumptions regarding a number of complex and subjective variables. These variables include, but are not limited to, the Company’s share price, volatility over the expected life of the awards and actual and projected employee stock option exercise behaviors. Since the Company does not have sufficient historical employee share option exercise data, the simplified method has been used to estimate the expected life of all options. The Company uses its historical volatility for the Company’s stock to estimate expected volatility starting January 1, 2018. Although the fair value of share options granted by the Company is estimated by the Black-Scholes model, the estimated fair value may not be indicative of the fair value observed in a willing buyer and seller market transaction. As share-based compensation expense recognized in the Condensed Consolidated Financial Statements is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from estimates. Forfeitures were estimated based on estimated future turnover and historical experience. Share-based compensation expense will continue to have an adverse impact on the Company’s results of operations, although it will have no impact on its overall financial position. The amount of unearned share-based compensation currently estimated to be expensed from now through the year 2025 related to unvested share-based payment awards at March 31, 2021, is $44.8 million. The weighted-average period over which the unearned share-based compensation is expected to be recognized is 2.27 years. If there are any modifications or cancellations of the underlying unvested securities, the Company may be required to accelerate and/or increase any remaining unearned share-based compensation expense. Future share-based compensation expense and unearned share-based compensation will increase to the extent that the Company grants additional equity awards. Share-based compensation expense recorded in these Condensed Consolidated Financial Statements for the three months ended March 31, 2021, and 2020 was based on awards granted under the 2012 LTIP, the 2018 LTIP, and the 2020 EIIP. The following table summarizes share-based compensation expense for the periods presented (in thousands): Three Months Ended March 31, 2021 2020 Research and development $ 1,954 $ 2,017 General and administrative 4,222 3,519 Total share-based compensation expense $ 6,176 $ 5,536 The Company recognized tax benefits from share-based awards of $1.2 million and $1.1 million for the three months ended March 31, 2021 and 2020, respectively. With the exception of options granted pursuant to the Option Exchange, the fair value of the options granted to employees and non-employee directors during the three months ended March 31, 2021, and 2020 was estimated as of the grant date using the Black-Scholes option-pricing model assuming the weighted-average assumptions listed in the following table: Three Months Ended March 31, 2021 2020 Expected volatility 81.3 % 81.5 % Risk-free interest rate 1.0 % 1.2 % Expected dividend yield — — % Expected life (in years) 6.0 6.0 Weighted average grant date fair value $ 15.09 $ 8.32 The fair value of employee stock options is being amortized on a straight-line basis over the requisite service period for each award. Each of the inputs discussed above is subjective and generally requires significant management judgment to determine. The following table summarizes the Company’s stock option activity during the three months ended March 31, 2021: Options Weighted Weighted Aggregate Outstanding at December 31, 2020 8,744,765 $ 20.42 7.19 $ 4,656 Granted (1) 2,550,977 22.39 Exercised (229,379) 13.43 Forfeited (2) (236,876) 30.60 Expired (3) (2,003,988) 40.98 Outstanding at March 31, 2021 8,825,499 $ 16.23 7.44 $ 81,230 Vested and expected to vest at March 31, 2021 8,290,411 $ 16.15 7.37 $ 77,128 Vested at March 31, 2021 3,356,692 $ 14.60 6.48 $ 37,958 ________________ (1) Includes replacement options to purchase 1,372,587 ordinary shares granted pursuant to the Option Exchange. (2) Includes unvested options to purchase 179,959 ordinary shares that were exchanged pursuant to the Option Exchange. (3) Includes vested options to purchase 1,934,446 ordinary shares that were exchanged pursuant to the Option Exchange. The total intrinsic value of options exercised was approximately $2.5 million and $35,000 during the three months ended March 31, 2021, and 2020, respectively, determined as of the date of exercise. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The major taxing jurisdictions for the Company are Ireland and the U.S. The Company recorded an income tax provision of $4.7 million and an income tax benefit of $0.2 million for the three months ended March 31, 2021 and 2020, respectively. The provision for income taxes differs from the statutory tax rate of 12.5% applicable to Ireland primarily due to Irish net operating losses for which a tax provision benefit is not recognized, U.S. income taxed at different rates, and net tax shortfall from cancellations of stock options. The income tax provision reflects the estimate of the effective tax rate expected to be applicable for the full year and the Company re-evaluates this estimate each quarter based on its forecasted tax expense for the full year. Jurisdictions with a projected loss for the year where no tax benefit can be recognized are excluded from the estimated annual effective tax rate. On January 1, 2021, the Company adopted the Accounting Standards Update 2019-12 ("ASU 2019-12"), Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. There were no impacts from the provisions of ASU 2019-12 on the Company’s tax provision for the three months ended March 31, 2021. Pursuant to ASU 2016-09, the Company recorded a net tax shortfall of a $0.1 million for the three months ended March 31, 2021, and a net tax shortfall of $0.1 million for the three months ended March 31, 2020, all of which were recorded as part of its income tax provision in the Condensed Consolidated Statements of Operations. On January 1, 2019, the Company adopted ASC 842, and it recorded a reduction in deferred tax assets of $1.0 million as part of the $3.8 million change in the opening balance of the accumulated deficit for the cumulative effect of applying ASC 842. Deferred income taxes reflect the net tax effect of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The Company's deferred tax assets (“DTA”) are composed primarily of its Irish subsidiaries' net operating loss carryforwards, state net operating loss carryforwards available to reduce future taxable income of the Company's U.S. subsidiaries, federal and California tax credit carryforwards, share-based compensation and other temporary differences. The Company maintains a valuation allowance against certain U.S. federal and state and Irish deferred tax assets. Each reporting period, the Company evaluates the need for a valuation allowance on its deferred tax assets by jurisdiction. For the three months en ded March 31, 2021, the Company recorded a reduction in DTA of $4.6 million, primarily due to changes in the Company’s 162(m) limitations of $3.5 million as a result of the Company’s option exchange program that closed on February 12, 2021, which was considered a material modification from a tax perspective and a $0.9 million DTA reduction related to the newly issued American Rescue Plan Act, which expanded the list of covered employees. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent EventOn May 10, 2021, the Company announced that the first patient was dosed in the global Phase 2b PADOVA study of prasinezumab in early Parkinson’s disease, which is being conducted by Roche. Prasinezumab is the focus of a worldwide collaboration between the Company and Roche. In connection with the dosing of the first patient in the PADOVA study, the Company will receive a $60.0 million milestone payment. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Preparation and Presentation of Financial Information | Basis of Preparation and Presentation of Financial Information These accompanying Unaudited Interim Condensed Consolidated Financial Statements have been prepared in accordance with the accounting principles generally accepted in the U.S. (“GAAP”) and with the instructions for Form 10-Q and Regulation S-X statements. Accordingly, they do not include all of the information and notes required for complete financial statements. These interim Condensed Consolidated Financial Statements should be read in conjunction with the Consolidated Financial Statements and Notes thereto contained in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 26, 2021 (the “2020 Form 10-K”). These Unaudited Interim Condensed Consolidated Financial Statements are presented in U.S. dollars, which is the functional currency of the Company and its consolidated subsidiaries. These Unaudited Interim Condensed Consolidated Financial Statements include the accounts of the Company and its consolidated subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Unaudited Interim Financial Information The accompanying Unaudited Interim Condensed Consolidated Financial Statements and related disclosures are unaudited, have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair presentation of the results of operations for the periods presented. The year-end condensed consolidated balance sheet data was derived from audited financial statements, however certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted. The condensed consolidated results of operations for any interim period are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period. |
Use of Estimates | Use of Estimates The preparation of the Condensed Consolidated Financial Statements in conformity with GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates, including critical accounting policies or estimates related to revenue recognition, share-based compensation, research and development expenses and leases. The Company bases its estimates on historical experience and on various other market specific and other relevant assumptions that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Because of the uncertainties inherent in such estimates, actual results may differ materially from these estimates. |
Segment and Concentration of Risk | Segment and Concentration of Risks The Company operates in one segment. The Company’s chief operating decision maker (the “CODM”), its Chief Executive Officer, manages the Company’s operations on a consolidated basis for purposes of allocating resources. When evaluating the Company’s financial performance, the CODM reviews all financial information on a consolidated basis. Financial instruments that potentially subject the Company to concentration of credit risk consist of cash and cash equivalents and accounts receivable. The Company places its cash equivalents with high credit quality financial institutions and, by policy, limits the amount of credit exposure with any one financial institution. Deposits held with banks may exceed the amount of insurance provided on such deposits. The Company has not experienced any losses on its deposits of cash and cash equivalents and its credit risk exposure is up to the extent recorded on the Company's Consolidated Balance Sheet. The receivables recorded in the Condensed Consolidated Balance Sheet include amounts due from a Roche entity located in Switzerland. Collaboration revenue recorded in the Condensed Consolidated Statements of Operations consists of reimbursement from Roche for research and development services. The Company's credit risk exposure is up to the extent recorded on the Company's Condensed Consolidated Balance Sheet. As of March 31, 2021, $2.3 million of the Company’s property and equipment, net were held in the U.S. and none were in Ireland. As of December 31, 2020, $2.6 million of the Company's property and equipment, net were held in the U.S. and none were in Ireland. The Company does not own or operate facilities for the manufacture, packaging, labeling, storage, testing or distribution of nonclinical or clinical supplies of any of its drug candidates. The Company instead contracts with and relies on third-parties to manufacture, package, label, store, test and distribute all preclinical development and clinical supplies of our drug candidates, and it plans to continue to do so for the foreseeable future. The Company also relies on third-party consultants to assist in managing these third-parties and assist with its manufacturing strategy. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements There were no new accounting pronouncements or changes to accounting pronouncements during the three months ended March 31, 2021 that are of significance or potential significance to the Company. |
Composition of Certain Balanc_2
Composition of Certain Balance Sheet Items (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Composition of Certain Balance Sheet Items [Abstract] | |
Schedule of Property and Equipment | Property and equipment, net consisted of the following (in thousands): March 31, December 31, 2021 2020 Machinery and equipment $ 9,350 $ 9,343 Leasehold improvements 1,318 1,278 Purchased computer software 1,424 1,423 12,092 12,044 Less: accumulated depreciation and amortization (9,797) (9,493) Property and equipment, net $ 2,295 $ 2,551 |
Schedule of Other Current Liabilities | Other current liabilities consisted of the following (in thousands): March 31, 2021 2020 Payroll and related expenses $ 3,516 $ 5,927 Professional services 510 696 Other 246 516 Other current liabilities $ 4,272 $ 7,139 |
Net Loss Per Ordinary Share (Ta
Net Loss Per Ordinary Share (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Earnings Per Share [Abstract] | |
Calculation of Basic and Diluted Net Income or Loss Per Ordinary Share | Net loss per ordinary share was determined as follows (in thousands, except per share amounts): Three Months Ended March 31, 2021 2020 Numerator: Net loss $ (36,735) $ (23,569) Denominator: Weighted-average ordinary shares outstanding 40,250 39,909 Net loss per share: Basic and diluted net loss per share $ (0.91) $ (0.59) |
Ordinary Shares Equivalent Not Included in Diluted Net Loss Per Share | The equivalent ordinary shares not included in diluted net loss per share because their effect would be anti-dilutive are as follows (in thousands): Three Months Ended March 31, 2021 2020 Stock options to purchase ordinary shares 8,825 8,412 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of lease liability maturity analysis and future minimum rentals to be received | Future minimum payments under the above-described noncancelable operating leases, including a reconciliation to the lease liabilities recognized in the Condensed Consolidated Balance Sheets, and future minimum rentals to be received under the Sub-Sublease as of March 31, 2021, are as follows (in thousands): Year Ended December 31, Operating Leases Sub-Sublease Rental 2021 (9 months) 4,662 2,216 2022 6,350 3,047 2023 6,535 3,019 2024 — — Total 17,547 $ 8,282 Less: Present value adjustment (1,027) Nominal lease payments (19) Lease liability $ 16,501 |
Schedule of Contractual Obligations by Fiscal Year Maturity | The following is a summary of the Company's non-cancelable purchase commitments and contractual obligations as of March 31, 2021 (in thousands): Total 2021 2022 2023 2024 2025 Thereafter Purchase Obligations (1) $ 11,921 $ 11,921 $ — $ — $ — $ — $ — Contractual obligations under license agreements (2) 740 135 70 70 60 60 345 Total $ 12,661 $ 12,056 $ 70 $ 70 $ 60 $ 60 $ 345 ________________ (1) Purchase obligations consist of non-cancelable purchase commitments to suppliers. (2) Excludes future obligations pursuant to the cost-sharing arrangement under the Company's License Agreement with Roche. Amounts of such obligations, if any, cannot be determined at this time. |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Share-Based Compensation Expense | The following table summarizes share-based compensation expense for the periods presented (in thousands): Three Months Ended March 31, 2021 2020 Research and development $ 1,954 $ 2,017 General and administrative 4,222 3,519 Total share-based compensation expense $ 6,176 $ 5,536 |
Fair Value of Options Granted | With the exception of options granted pursuant to the Option Exchange, the fair value of the options granted to employees and non-employee directors during the three months ended March 31, 2021, and 2020 was estimated as of the grant date using the Black-Scholes option-pricing model assuming the weighted-average assumptions listed in the following table: Three Months Ended March 31, 2021 2020 Expected volatility 81.3 % 81.5 % Risk-free interest rate 1.0 % 1.2 % Expected dividend yield — — % Expected life (in years) 6.0 6.0 Weighted average grant date fair value $ 15.09 $ 8.32 |
Summary of Company's Share Option Activity | The following table summarizes the Company’s stock option activity during the three months ended March 31, 2021: Options Weighted Weighted Aggregate Outstanding at December 31, 2020 8,744,765 $ 20.42 7.19 $ 4,656 Granted (1) 2,550,977 22.39 Exercised (229,379) 13.43 Forfeited (2) (236,876) 30.60 Expired (3) (2,003,988) 40.98 Outstanding at March 31, 2021 8,825,499 $ 16.23 7.44 $ 81,230 Vested and expected to vest at March 31, 2021 8,290,411 $ 16.15 7.37 $ 77,128 Vested at March 31, 2021 3,356,692 $ 14.60 6.48 $ 37,958 ________________ (1) Includes replacement options to purchase 1,372,587 ordinary shares granted pursuant to the Option Exchange. (2) Includes unvested options to purchase 179,959 ordinary shares that were exchanged pursuant to the Option Exchange. (3) Includes vested options to purchase 1,934,446 ordinary shares that were exchanged pursuant to the Option Exchange. |
Organization - Additional Infor
Organization - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Accumulated deficit | $ (819,764) | $ (819,764) | $ (783,029) | |
Cash and cash equivalents | $ 342,993 | 342,993 | $ 295,380 | $ 352,685 |
Underwritten Public Offering [Line Items] | ||||
Issuance of ordinary shares in public offering, net of issuance costs of $5.5 million | $ 78,054 | |||
Ordinary Shares | ||||
Underwritten Public Offering [Line Items] | ||||
Number of shares issued in underwritten public offering (in shares) | 4,025,000 | |||
Issuance of ordinary shares in public offering, net of issuance costs of $5.5 million | $ 40 | |||
Ordinary Shares | Underwritten Public Offering | ||||
Underwritten Public Offering [Line Items] | ||||
Number of shares issued in underwritten public offering (in shares) | 4,025,000 | |||
Issuance of ordinary shares in public offering, net of issuance costs of $5.5 million | $ 78,100 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Significant accounting policies [line item] | ||
Property and equipment, net | $ 2,295 | $ 2,551 |
UNITED STATES | ||
Significant accounting policies [line item] | ||
Property and equipment, net | 2,300 | 2,600 |
IRELAND | ||
Significant accounting policies [line item] | ||
Property and equipment, net | $ 0 | $ 0 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Detail) - USD ($) $ in Millions | Mar. 31, 2021 | Dec. 31, 2020 |
Level 1 | ||
Fair Value Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Money market funds at carrying value | $ 273.1 | $ 226.1 |
Composition of Certain Balanc_3
Composition of Certain Balance Sheet Items - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Composition of Certain Balance Sheet Items [Abstract] | ||
Machinery and equipment | $ 9,350 | $ 9,343 |
Leasehold improvements | 1,318 | 1,278 |
Purchased computer software | 1,424 | 1,423 |
Property and equipment, gross | 12,092 | 12,044 |
Less: accumulated depreciation and amortization | (9,797) | (9,493) |
Property and equipment, net | $ 2,295 | $ 2,551 |
Composition of Certain Balanc_4
Composition of Certain Balance Sheet Items - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Composition of Certain Balance Sheet Items [Abstract] | ||
Depreciation expense | $ 0.3 | $ 0.4 |
Composition of Certain Balanc_5
Composition of Certain Balance Sheet Items - Schedule of Other Current Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Composition of Certain Balance Sheet Items [Abstract] | ||
Payroll and related expenses | $ 3,516 | $ 5,927 |
Professional services | 510 | 696 |
Other | 246 | 516 |
Other current liabilities | $ 4,272 | $ 7,139 |
Net Loss Per Ordinary Share - C
Net Loss Per Ordinary Share - Calculation of Basic and Diluted Net Loss Per Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Numerator: | ||
Net loss | $ (36,735) | $ (23,569) |
Denominator: | ||
Weighted-average ordinary shares outstanding (in shares) | 40,250 | 39,909 |
Net Loss Per Share, Basic and Diluted | ||
Basic and diluted net loss per share (in dollars per share) | $ (0.91) | $ (0.59) |
Net Loss Per Ordinary Share - O
Net Loss Per Ordinary Share - Ordinary Shares Equivalent Not Included in Diluted Net Loss Per Share (Detail) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Options to purchase ordinary shares | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Stock options to purchase ordinary shares not included in diluted net loss per share (in shares) | 8,825 | 8,412 |
Commitment and Contingencies -
Commitment and Contingencies - Lease Narrative (Details) | Sep. 24, 2018 | Jul. 18, 2018USD ($)ft² | Dec. 31, 2016USD ($) | Apr. 30, 2016USD ($) | Mar. 31, 2016ft² | Mar. 31, 2021USD ($) | Mar. 31, 2020USD ($) |
Lease Description [Line Items] | |||||||
Operating lease cost | $ 1,600,000 | $ 1,600,000 | |||||
Total cash paid against operating lease liability | $ 1,500,000 | 1,500,000 | |||||
Discount rate, percent | 4.25% | ||||||
Operating lease (area) | ft² | 128,751 | ||||||
Operating lease, weighted average remaining lease term | 2 years 9 months | ||||||
Lease expiration date | Dec. 31, 2023 | ||||||
Tenant improvement allowance | $ 14,200,000 | ||||||
Area of sub-sublease rental | ft² | 46,641 | ||||||
Sublease income | $ 700,000 | $ 700,000 | |||||
Sub-sublease rentals, initial annual base rent | $ 2,700,000 | ||||||
Sub-sublease rentals, percent annual rent increase | 3.50% | ||||||
Sub-sublease rentals, term of contract | 5 years 2 months 12 days | ||||||
Sub-sublease rentals, percent of rental gain attributable to sublandlord | 50.00% | ||||||
Operating lease, future minimum payments due | 17,547,000 | ||||||
Total lease payments due over lease term | $ 39,200,000 | ||||||
Term of contract (in years) | 7 years 9 months 30 days | ||||||
Letter of Credit | |||||||
Lease Description [Line Items] | |||||||
Line of credit facility | 4,100,000 | ||||||
Face amount reduction on third anniversary | 1,400,000 | ||||||
Face amount reduction on fifth anniversary | $ 1,400,000 | ||||||
Line of credit has been used | 0 | ||||||
Restricted cash | $ 2,700,000 |
Commitment and Contingencies _2
Commitment and Contingencies - Dublin Lease (Details) | 1 Months Ended | |||
Sep. 30, 2018ft² | Mar. 31, 2021EUR (€) | Mar. 31, 2021USD ($) | Sep. 27, 2018 | |
Lease Description [Line Items] | ||||
Operating lease, future minimum payments due | $ | $ 17,547,000 | |||
Dublin, Ireland | ||||
Lease Description [Line Items] | ||||
Operating lease, Dublin, area of office space (in sq ft) | ft² | 133 | |||
Operating lease, Dublin, renewal term | 3 months | |||
Operating lease, future minimum payments due | € 16,000 | $ 19,000 |
Commitment and Contingencies _3
Commitment and Contingencies - Schedule of Lease Liability Maturity Analysis and Future Minimum Rentals to be Received - (Details) $ in Thousands | Mar. 31, 2021USD ($) |
Operating Lease | |
2021 (9 months) | $ 4,662 |
2022 | 6,350 |
2023 | 6,535 |
2024 | 0 |
Total | 17,547 |
Less: Present value adjustment | (1,027) |
Nominal lease payments | (19) |
Lease liability | 16,501 |
Sub-Sublease Rental | |
2021 (9 months) | 2,216 |
2022 | 3,047 |
2023 | 3,019 |
2024 | 0 |
Total | $ 8,282 |
Commitment and Contingencies Co
Commitment and Contingencies Commitment and Contingencies - Commitment Narrative (Details) $ in Thousands | Mar. 31, 2021USD ($) |
Long-term Purchase Commitment [Line Items] | |
Purchase obligation | $ 11,921 |
Contractual obligations under license agreements | 700 |
Accrued Current Liabilities | |
Long-term Purchase Commitment [Line Items] | |
Commitment to suppliers included in accrued current liabilities | 3,600 |
Contractual obligations under license agreements included in accrued current liabilities | $ 100 |
Commitment and Contingencies _4
Commitment and Contingencies - Contractual Obligations (Details) $ in Thousands | Mar. 31, 2021USD ($) |
Purchase Obligations | |
Total | $ 11,921 |
2021 | 11,921 |
2022 | 0 |
2023 | 0 |
2024 | 0 |
2025 | 0 |
Thereafter | 0 |
Contractual obligations under license agreements | |
Total | 700 |
Total | |
Total | 12,661 |
2021 | 12,056 |
2022 | 70 |
2023 | 70 |
2024 | 60 |
2025 | 60 |
Thereafter | 345 |
License Agreements [Member] | |
Contractual obligations under license agreements | |
Total | 740 |
2021 | 135 |
2022 | 70 |
2023 | 70 |
2024 | 60 |
2025 | 60 |
Thereafter | $ 345 |
Significant Agreements - Roche
Significant Agreements - Roche License Agreement (Details) - USD ($) | 1 Months Ended | 3 Months Ended | ||||
Jun. 30, 2017 | May 31, 2014 | Feb. 28, 2014 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
License Agreement [Line Items] | ||||||
Accounts receivable | $ 1,000 | $ 15,000 | ||||
Collaboration revenue | $ 160,000 | $ 141,000 | ||||
Collaborative Arrangement | ||||||
License Agreement [Line Items] | ||||||
Portion of revenue and expenses attributable to company, Percentage | 30.00% | |||||
Roche | ||||||
License Agreement [Line Items] | ||||||
Revenue, Remaining performance obligation, Amount | $ 0 | 0 | ||||
License agreement, Development services, Payment term | 45 days | |||||
License agreement, Milestone payments, Payment term (in days) | 45 days | |||||
Roche | Collaborative Arrangement | ||||||
License Agreement [Line Items] | ||||||
Collaboration revenue, License, Upfront payment | $ 30,000,000 | |||||
Milestone payment received, Clinical milestone | $ 15,000,000 | |||||
Milestone achievement, Clinical milestone | $ 30,000,000 | |||||
Potential payment upon achievement of development, regulatory and various first commercial sales milestones | $ 350,000,000 | |||||
Potential payment for achievement of non U.S. commercial sales milestones | $ 175,000,000 | |||||
Portion of revenue and expenses attributable to company, Percentage | 70.00% | |||||
Potential alternative commercial sales milestones | $ 155,000,000 | |||||
License agreement, Initial transaction price | 55,100,000 | |||||
Cost sharing payments recognized as research and development expense | 4,400,000 | 3,900,000 | ||||
Accounts receivable | $ 1,000 | 3,000 | ||||
License agreement, Cost allocation, Percentage | 100.00% | |||||
Roche | Research Reimbursement | ||||||
License Agreement [Line Items] | ||||||
Revenue, Remaining performance obligation, Amount | $ 0 | $ 0 | ||||
Royalty Bearing License | Roche | ||||||
License Agreement [Line Items] | ||||||
Allocated consideration to performance obligations | 48,900,000 | |||||
ASC 605 allocated consideration to deliverables | 35,600,000 | |||||
Royalty Bearing License | Roche | Collaborative Arrangement | ||||||
License Agreement [Line Items] | ||||||
License agreement, Initial transaction price | 45,000,000 | |||||
IND and Development Services | Roche | ||||||
License Agreement [Line Items] | ||||||
Allocated consideration to performance obligations | 4,600,000 | |||||
ASC 605 allocated consideration to deliverables | 3,300,000 | |||||
IND and Development Services | Roche | Collaborative Arrangement | ||||||
License Agreement [Line Items] | ||||||
License agreement, Initial transaction price | 9,100,000 | |||||
Supply Services | Roche | ||||||
License Agreement [Line Items] | ||||||
Allocated consideration to performance obligations | 600,000 | |||||
ASC 605 allocated consideration to deliverables | 400,000 | |||||
Supply Services | Roche | Collaborative Arrangement | ||||||
License Agreement [Line Items] | ||||||
License agreement, Initial transaction price | 1,100,000 | |||||
Clinical Product Supply | Roche | ||||||
License Agreement [Line Items] | ||||||
Allocated consideration to performance obligations | 1,100,000 | |||||
ASC 605 allocated consideration to deliverables | 800,000 | |||||
Collaboration revenue | ||||||
License Agreement [Line Items] | ||||||
Collaboration revenue | $ 110,000 | $ 141,000 |
Significant Agreements - Celgen
Significant Agreements - Celgene Collaboration Agreement (Details) $ / shares in Units, $ in Millions | Mar. 20, 2018USD ($)agreement_term$ / sharesshares |
Collaboration Program, US Rights | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Collaboration agreement, potential regulatory milestone payments per program | $ 90 |
Collaboration agreement, potential commercial milestone payments per program | 375 |
Collaboration Program, US Rights | Minimum | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Collaboration agreement, expected allocation of initial transaction price | 15 |
Collaboration Program, US Rights | Maximum | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Collaboration agreement, expected allocation of initial transaction price | 25 |
Collaboration Program, Global Rights | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Collaboration agreement, potential regulatory milestone payments per program | 187.5 |
Collaboration agreement, potential commercial milestone payments per program | 375 |
Collaboration Program, Global Rights | Minimum | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Collaboration agreement, expected allocation of initial transaction price | 10 |
Collaboration Program, Global Rights | Maximum | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Collaboration agreement, expected allocation of initial transaction price | 18 |
Celgene | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Collaboration agreement, upfront payment | 100 |
Collaboration agreement, potential regulatory and commercial milestone payments per program | $ 562.5 |
Collaboration agreement, term of agreement | 6 years |
Collaboration agreement, number of additional 12 month period extension allowed | agreement_term | 2 |
Collaboration agreement, extension fee per extension period | $ 10 |
Collaboration agreement, upfront payment, payment term | 10 days |
Collaboration agreement, option fees and milestone payments, payment term | 30 days |
Celgene | Collaboration Program, US Rights | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Collaboration agreement, exercise fee per program | $ 80 |
Celgene | Collaboration Program, Global Rights | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Collaboration agreement, exercise fee per program | $ 55 |
Celgene | Private Placement | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Share subscription agreement, number of ordinary shares issued in transaction (in shares) | shares | 1,174,536 |
Share subscription agreement, price per share (in dollars per share) | $ / shares | $ 42.57 |
Share subscription agreement, consideration received on transaction | $ 50 |
Share subscription agreement, premium received on transaction | 10.2 |
Collaborative Arrangement | Celgene | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |
Collaboration agreement, Initial transaction price | $ 110.2 |
Shareholders' Equity (Details)
Shareholders' Equity (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | ||||
Mar. 31, 2021USD ($)shares | Mar. 31, 2021USD ($)voteshares | Mar. 31, 2021€ / sharesshares | Mar. 31, 2021$ / sharesshares | Dec. 31, 2020€ / sharesshares | Dec. 31, 2020$ / sharesshares | |
Equity [Abstract] | ||||||
Ordinary shares, number of authorized shares (in shares) | 100,000,000 | 100,000,000 | 100,000,000 | 100,000,000 | ||
Ordinary shares, par value (in dollars per share) | $ / shares | $ 0.01 | $ 0.01 | ||||
Ordinary shares, number of issued shares (in shares) | 44,175,792 | 44,175,792 | 39,921,413 | 39,921,413 | ||
Ordinary shares, number of outstanding shares (in shares) | 44,175,792 | 44,175,792 | 39,921,413 | 39,921,413 | ||
Votes per share | vote | 1 | |||||
Euro deferred shares, number of shares authorized (in shares) | 10,000 | 10,000 | 10,000 | 10,000 | ||
Euro deferred shares, nominal value (in euros per share) | € / shares | € 22 | € 22 | ||||
Euro deferred shares, number of outstanding shares (in shares) | 0 | 0 | 0 | 0 | ||
Underwritten Public Offering [Line Items] | ||||||
Issuance of ordinary shares in public offering, net of issuance costs of $5.5 million | $ | $ 78,054 | |||||
Ordinary Shares | ||||||
Underwritten Public Offering [Line Items] | ||||||
Number of shares issued in underwritten public offering (in shares) | 4,025,000 | |||||
Issuance of ordinary shares in public offering, net of issuance costs of $5.5 million | $ | $ 40 | |||||
Underwritten Public Offering | ||||||
Underwritten Public Offering [Line Items] | ||||||
Price per share at public offering (in dollars per share) | $ / shares | $ 20.75 | |||||
Underwritten Public Offering | Ordinary Shares | ||||||
Underwritten Public Offering [Line Items] | ||||||
Number of shares issued in underwritten public offering (in shares) | 4,025,000 | |||||
Issuance of ordinary shares in public offering, net of issuance costs of $5.5 million | $ | $ 78,100 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) - USD ($) | Feb. 12, 2021 | May 19, 2020 | Feb. 25, 2020 | May 15, 2018 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 |
Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||||
Options granted (in shares) | 2,550,977 | 1,455,450 | |||||
Vesting period (in years) | 4 years | ||||||
Options outstanding (in shares) | 8,825,499 | 8,744,765 | |||||
Weighted average exercise price (in dollars per share) | $ 16.23 | $ 20.42 | |||||
Share-based compensation cost not yet recognized, Stock Options | $ 44,800,000 | ||||||
Expected recognition period of share-based compensation not yet recognized | 2 years 3 months 7 days | ||||||
Options, granted (in shares) | 1,372,587 | 2,550,977 | |||||
Weighted average exercise price, granted (in dollars per share) | $ 22.85 | $ 22.39 | |||||
Exercise price (in dollars per share) | $ 17.63 | ||||||
Share-based Payment Arrangement, Tranche One | |||||||
Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||||
Vesting period (in years) | 1 year | ||||||
Stock Option | |||||||
Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||||
Tax benefit recognized from share-based compensation expense | $ 1,200,000 | $ 1,100,000 | |||||
Intrinsic value of options exercised | $ 2,500,000 | $ 35,000 | |||||
2018 Long Term Incentive Plan | |||||||
Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||||
Number of additional shares authorized (in shares) | 1,500,000 | 1,177,933 | |||||
Authorized shares for issuance (in shares) | 3,300,000 | ||||||
Maximum number of shares to be issued - ISO exercise (in shares) | 2,500,000 | ||||||
Grant period | 10 years | 10 years | |||||
Number of shares available for grant (in shares) | 1,434,506 | ||||||
2012 Long Term Incentive Plan | |||||||
Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||||
Grant period | 10 years | ||||||
2020 Employment Inducement Incentive Plan | |||||||
Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | |||||||
Number of additional shares authorized (in shares) | 75,000 | ||||||
Authorized shares for issuance (in shares) | 785,000 | 710,000 | |||||
Grant period | 10 years | 10 years | |||||
Number of shares available for grant (in shares) | 0 |
Share-Based Compensation - Opti
Share-Based Compensation - Option Exchange Program (Details) - $ / shares | Feb. 12, 2021 | Mar. 31, 2021 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period (in years) | 4 years | |
Number of Ordinary Shares Tendered for Exchange | 2,100,000 | |
Weighted average exercise price, granted (in dollars per share) | $ 22.85 | $ 22.39 |
Minimum Exchange Threshold Exercise Price for Options Eligible for Exchange | $ 17.63 | |
Options, granted (in shares) | 1,372,587 | 2,550,977 |
Share-based Payment Arrangement, Tranche One | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period (in years) | 1 year |
Share-based Compensation - Shar
Share-based Compensation - Share-based Compensation Plan - Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | Feb. 12, 2021 | Mar. 31, 2021 | Dec. 31, 2020 |
Options | |||
Options, outstanding beginning balance (in shares) | 8,744,765 | ||
Options, granted (in shares) | 1,372,587 | 2,550,977 | |
Options, exercised (in shares) | (229,379) | ||
Options, forfeited (in shares) | (236,876) | ||
Options, expired (in shares) | (2,003,988) | ||
Options, outstanding ending balance (in shares) | 8,825,499 | 8,744,765 | |
Options, vested and expected to vest ending balance (in shares) | 8,290,411 | ||
Options, Vested (in shares) | 3,356,692 | ||
Weighted Average Exercise Price | |||
Weighted average exercise price, outstanding beginning balance (in dollars per share) | $ 20.42 | ||
Weighted average exercise price, granted (in dollars per share) | $ 22.85 | 22.39 | |
Weighted average exercise price, exercised (in dollars per share) | 13.43 | ||
Weighted average exercise price, forfeited (in dollars per share) | 30.60 | ||
Weighted average exercise price, expired (in dollars per share) | 40.98 | ||
Weighted average exercise price, outstanding ending balance (in dollars per share) | 16.23 | $ 20.42 | |
Weighted average exercise price, vested and expected to vest, ending balance (in dollars per share) | 16.15 | ||
Weighted Average Exercise Price, vested (in dollars per shares) | $ 14.60 | ||
Options, Additional Disclosures | |||
Weighted average remaining contractual term, outstanding (in years) | 7 years 5 months 8 days | 7 years 2 months 8 days | |
Weighted average remaining contractual term, vested and expected to vest (in years) | 7 years 4 months 13 days | ||
Weighted Average Remaining Contractual Term, vested (in years) | 6 years 5 months 23 days | ||
Aggregate intrinsic value, outstanding | $ 81,230 | $ 4,656 | |
Aggregate intrinsic value, vested and expected to vest, ending balance | 77,128 | ||
Aggregate intrinsic value, vested | $ 37,958 | ||
Unvested options, forfeited (in shares) | 179,959 | ||
Unvested options, expired (in shares) | 1,934,446 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | $ 6,176 | $ 5,536 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | 1,954 | 2,017 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Share-based compensation expense | $ 4,222 | $ 3,519 |
Share-Based Compensation - Fair
Share-Based Compensation - Fair Value of Options Granted (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Share-based Payment Arrangement [Abstract] | ||
Expected volatility | 81.30% | 81.50% |
Risk-free interest rate | 1.00% | 1.20% |
Expected dividend yield | 0.00% | 0.00% |
Expected life (in years) | 6 years | 6 years |
Weighted average fair value (in dollars per share) | $ 15.09 | $ 8.32 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 3 Months Ended | |||
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | Jan. 01, 2019 | |
Income Taxes [Line Items] | ||||
Income tax expense (benefit) | $ 4,660,000 | $ (166,000) | ||
Net tax shortfall (excess tax benefit) booked to income tax provision, amount | 100,000 | $ 100,000 | ||
Reduction to deferred tax assets | (4,600,000) | |||
Reduction to deferred tax assets due to changes in 162(m) limitations | (3,500,000) | |||
Reduction in Deferred Tax Assets due to American Rescue Plan Act | (900,000) | |||
Accumulated deficit | $ (819,764,000) | $ (783,029,000) | ||
Revenue Commissioners, Ireland | ||||
Income Taxes [Line Items] | ||||
Effective income tax rate, percent | 12.50% | |||
Internal Revenue Service (IRS) | ||||
Income Taxes [Line Items] | ||||
Potential withholding tax rate | 5.00% | |||
ASC-842 | ||||
Income Taxes [Line Items] | ||||
Reduction to deferred tax assets due to adoption of ASC 842 | $ (1,000,000) | |||
Accumulated deficit | $ 3,800,000 |
Subsequent Event (Details)
Subsequent Event (Details) - Roche - USD ($) $ in Millions | May 05, 2021 | Mar. 31, 2021 |
Subsequent Event [Line Items] | ||
License agreement, Milestone payments, Payment term (in days) | 45 days | |
Subsequent Event | ||
Subsequent Event [Line Items] | ||
Milestone achievement, Clinical milestone | $ 60 |