Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 20, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-41477 | ||
Entity Registrant Name | Biohaven Ltd. | ||
Entity Incorporation, State or Country Code | D8 | ||
Entity Address, Address Line One | c/o Biohaven Pharmaceuticals, Inc. | ||
Entity Address, Address Line Two | 215 Church Street | ||
Entity Address, City or Town | New Haven | ||
Entity Address, State or Province | CT | ||
Entity Address, Postal Zip Code | 06510 | ||
City Area Code | 203 | ||
Local Phone Number | 404-0410 | ||
Title of 12(b) Security | Common Shares, without par value | ||
Trading Symbol | BHVN | ||
Security Exchange Name | NYSE | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 0 | ||
Entity Common Stock, Shares Outstanding | 68,212,479 | ||
Documents Incorporated by Reference | Portions of the registrant's definitive Proxy Statement to be filed pursuant to Regulation 14A under the Securities Exchange Act of 1934 for its 2023 Annual Meeting of Shareholders are incorporated by reference into Part III of this Annual Report on Form 10-K. | ||
Entity Central Index Key | 0001935979 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Audit Information [Abstract] | |
Auditor Name | Ernst & Young LLP |
Auditor Location | Hartford, Connecticut |
Auditor Firm ID | 42 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 204,877 | $ 76,057 |
Marketable securities | 260,464 | 0 |
Prepaid expenses | 20,945 | 6,734 |
Income tax receivable | 46,139 | 9,911 |
Restricted cash held on behalf of Former Parent | 35,212 | 0 |
Other current assets | 19,331 | 2,121 |
Total current assets | 586,968 | 94,823 |
Property and equipment, net | 17,512 | 13,010 |
Intangible assets | 18,400 | 18,400 |
Goodwill | 1,390 | 1,390 |
Other non-current assets | 37,513 | 14,438 |
Total assets | 661,783 | 142,061 |
Current liabilities: | ||
Accounts payable | 10,703 | 4,775 |
Due to Former Parent | 35,212 | |
Due to Former Parent | 0 | |
Accrued expenses and other current liabilities | 44,106 | 37,160 |
Total current liabilities | 90,021 | 41,935 |
Long-term operating lease liability | 30,581 | 2,797 |
Other non-current liabilities | 2,410 | 2,638 |
Total liabilities | 123,012 | 47,370 |
Commitments and contingencies (Note 12) | ||
Contingently redeemable non-controlling interests | 0 | 60,000 |
Shareholders' Equity: | ||
Net investment from Former Parent | 0 | 34,691 |
Preferred shares, no par value; 10,000,000 shares authorized, no shares issued and outstanding as of December 31, 2022; no shares authorized, issued and outstanding as of December 31, 2021 | 0 | 0 |
Common shares, no par value; 200,000,000 shares authorized, 68,190,479 shares issued and outstanding as of December 31, 2022; no shares authorized, issued and outstanding as of December 31, 2021 | 615,742 | 0 |
Additional paid-in capital | 13,869 | 0 |
Accumulated deficit | (91,124) | 0 |
Accumulated other comprehensive income | 284 | 0 |
Total shareholders' equity | 538,771 | 34,691 |
Total liabilities and shareholders' equity | $ 661,783 | $ 142,061 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0 | $ 0 |
Preferred stock, authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, issued (in shares) | 0 | 0 |
Preferred stock, outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0 | $ 0 |
Common stock, authorized (shares) | 200,000,000 | 0 |
Common stock, issued (shares) | 68,190,479 | 0 |
Common stock, outstanding (shares) | 68,190,479 | 0 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Operating expenses: | |||
Research and development | $ 437,072,000 | $ 181,486,000 | $ 98,460,000 |
General and administrative | 130,860,000 | 37,414,000 | 16,046,000 |
Total operating expenses | 567,932,000 | 218,900,000 | 114,506,000 |
Loss from operations | (567,932,000) | (218,900,000) | (114,506,000) |
Other (expense) income : | |||
Gain (loss) from equity method investment | 0 | 5,261,000 | (4,162,000) |
Other (expense) income, net | (1,909,000) | 1,209,000 | 0 |
Total other (expense) income, net | (1,909,000) | 6,470,000 | (4,162,000) |
Loss before provision for income taxes | (569,841,000) | (212,430,000) | (118,668,000) |
Provision for income taxes | 438,000 | 1,366,000 | 0 |
Net loss | $ (570,279,000) | $ (213,796,000) | $ (118,668,000) |
Net loss per share attributable to Biohaven Pharmaceutical Holding Company Ltd.—basic (in dollars per share) | $ (12.75) | $ (5.43) | $ (3.01) |
Net loss per share attributable to Biohaven Pharmaceutical Holding Company Ltd.—diluted (in dollars per share) | $ (12.75) | $ (5.43) | $ (3.01) |
Weighted average common shares outstanding—basic | 44,741,316 | 39,375,944 | 39,375,944 |
Weighted average common shares outstanding—diluted | 44,741,316 | 39,375,944 | 39,375,944 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (570,279) | $ (213,796) | $ (118,668) |
Other comprehensive income, net of tax: | |||
Foreign currency translation adjustments | 429 | 0 | 0 |
Net unrealized losses related to available-for-sale debt securities | (145) | 0 | 0 |
Other comprehensive income | 284 | 0 | 0 |
Comprehensive loss | $ (569,995) | $ (213,796) | $ (118,668) |
CONSOLIDATED STATEMENTS OF SHAR
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY - USD ($) | Total | Common Shares | Net Investment from Former Parent | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income |
Beginning balance (in shares) at Dec. 31, 2019 | 0 | |||||
Beginning balance at Dec. 31, 2019 | $ 14,451,000 | $ 0 | $ 14,451,000 | $ 0 | $ 0 | $ 0 |
Increase (Decrease) in Stockholders' Equity | ||||||
Net loss | (118,668,000) | (118,668,000) | ||||
Net transfers from Former Parent | 120,998,000 | 120,998,000 | ||||
Ending balance (in shares) at Dec. 31, 2020 | 0 | |||||
Ending balance at Dec. 31, 2020 | 16,781,000 | $ 0 | 16,781,000 | 0 | 0 | 0 |
Increase (Decrease) in Stockholders' Equity | ||||||
Net loss | (213,796,000) | (213,796,000) | ||||
Net transfers from Former Parent | 231,706,000 | 231,706,000 | ||||
Ending balance (in shares) at Dec. 31, 2021 | 0 | |||||
Ending balance at Dec. 31, 2021 | 34,691,000 | $ 0 | 34,691,000 | 0 | 0 | 0 |
Increase (Decrease) in Stockholders' Equity | ||||||
Net loss | (570,279,000) | (479,155,000) | (91,124,000) | |||
Net transfers from Former Parent | 776,630,000 | 776,630,000 | ||||
Issuance of common shares in connection with the Separation and reclassification of Net investment from Former Parent (in shares) | 39,375,944 | |||||
Issuance of common shares in connection with the Separation and reclassification of Net investment from Former Parent | 0 | $ 332,166,000 | (332,166,000) | |||
Issuance of common shares, net of offering costs (in shares) | 28,750,000 | |||||
Issuance of common shares, net of offering costs | 282,804,000 | $ 282,804,000 | ||||
Issuance of common shares under plan (in shares) | 64,535 | |||||
Issuance of common shares under plan | 451,000 | $ 772,000 | (321,000) | |||
Non-cash share-based compensation expense | 14,189,000 | 14,189,000 | ||||
Other comprehensive income | 284,000 | 284,000 | ||||
Ending balance (in shares) at Dec. 31, 2022 | 68,190,479 | |||||
Ending balance at Dec. 31, 2022 | $ 538,771,000 | $ 615,742,000 | $ 0 | $ 13,869,000 | $ (91,124,000) | $ 284,000 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | |||
Net loss | $ (570,279) | $ (213,796) | $ (118,668) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Non-cash share-based compensation | 193,556 | 65,639 | 29,500 |
Acquisition of IPR&D asset | 93,747 | 0 | 0 |
Impairment of Artizan preferred stock | 10,000 | 0 | 0 |
Depreciation and amortization | 1,386 | 1,393 | 72 |
Issuance of Former Parent common shares as payment for license and consulting agreements | 1,779 | 7,929 | 0 |
Gain (loss) from equity method investment | 0 | (5,261) | 4,162 |
Other non-cash items | 726 | (3,408) | 0 |
Changes in operating assets and liabilities: | |||
Prepaid expenses, income tax receivable, and other current assets | (41,336) | (9,073) | (2,419) |
Other non-current assets | 0 | (109) | (5,594) |
Accounts payable | 5,928 | 1,025 | 222 |
Accrued expenses and other current liabilities | 6,804 | 7,882 | 14,855 |
Other non-current liabilities | 0 | 1,939 | 1,913 |
Net cash used in operating activities | (297,689) | (145,840) | (75,957) |
Cash flows from investing activities: | |||
Purchases of marketable securities | (259,716) | 0 | 0 |
Purchases of property and equipment | (6,074) | (938) | (1,097) |
Payment for IPR&D asset acquisition | (35,000) | 0 | 0 |
Payments for leasehold improvements | 0 | 0 | (1,600) |
Cash acquired in business acquisition | 0 | 1,882 | 0 |
Purchase of Artizan preferred stock | (4,000) | 0 | 0 |
Net cash (used in) provided by investing activities | (304,790) | 944 | (2,697) |
Cash flows from financing activities: | |||
Net transfers from Former Parent | 449,130 | ||
Net transfers from Former Parent | 138,052 | 92,242 | |
Restricted cash due to Former Parent | 35,212 | 0 | 0 |
Proceeds from issuance of common shares | 283,804 | 0 | 0 |
Proceeds from sale of contingently redeemable non-controlling interests | 0 | 60,000 | |
Payments of issuance costs | (1,000) | 0 | 0 |
Other | 451 | 395 | 0 |
Net cash provided by financing activities | 767,597 | 138,447 | 152,242 |
Effect of exchange rates on cash, cash equivalents and restricted cash | 429 | 0 | 0 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 165,547 | (6,449) | 73,588 |
Cash, cash equivalents and restricted cash at beginning of period | 77,057 | 83,506 | 9,918 |
Cash, cash equivalents and restricted cash at end of period | 242,604 | 77,057 | 83,506 |
Supplemental disclosure of cash flow information: | |||
Cash paid for interest | 0 | 107 | 0 |
Cash paid for income taxes | $ 38,165 | $ 16,594 | $ 2,758 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of the Business and Basis of Presentation | Nature of the Business and Basis of Presentation Biohaven Ltd. (“we,” “us," "our," "Biohaven" or the “Company”) was incorporated in Tortola, British Virgin Islands in May 2022. Biohaven is a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies for people with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven's experienced management team brings with it a track record of delivering new drug approvals for products for diseases such as migraine, depression, bipolar and schizophrenia. The company is advancing a pipeline of therapies for diseases with little or no treatment options, leveraging its proven drug development capabilities and proprietary platforms, including Kv7 ion channel modulation for epilepsy and neuronal hyperexcitability, glutamate modulation for Obsessive-Compulsive Disorder ("OCD") and spinocerebellar ataxia ("SCA"), myostatin inhibition for neuromuscular diseases, and brain-penetrant Tyrosine Kinase 2/Janus Kinase 1 ("TYK2/JAK1") inhibition for immune-mediated brain disorders. Biohaven's portfolio of early- and late-stage product candidates also includes discovery research programs focused on TRPM3 channel activation for neuropathic pain, CD-38 antibody recruiting, bispecific molecules for multiple myeloma, antibody drug conjugates ("ADCs"), and extracellular target degrader platform technology ("MoDE") with potential application in neurological disorders, cancer, and autoimmune diseases. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts may require additional capital, additional personnel and infrastructure, and further regulatory and other capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. Separation from Biohaven Pharmaceutical Holding Company Ltd. On May 9, 2022, Biohaven Pharmaceutical Holding Company Ltd. (the "Former Parent"), Pfizer Inc. (“Pfizer”) and a wholly owned subsidiary of Pfizer (“Merger Sub”), entered into an Agreement and Plan of Merger (the “Merger Agreement”), which provided for the acquisition by Pfizer of the Former Parent through the merger of Merger Sub with and into the Former Parent (the “Merger”). In connection with the Merger Agreement, the Former Parent and Biohaven Ltd. entered into a Separation and Distribution Agreement, dated as of May 9, 2022 (the “Distribution Agreement”). In connection with the Distribution Agreement, the Board of Directors of the Former Parent approved and directed the Former Parent’s management to effect the Spin-Off of the business, operations, and activities that are not the CGRP Business (as defined below), including the Kv7 ion channel activators, glutamate modulation, MPO inhibition and myostatin inhibition platforms, preclinical product candidates, and certain corporate infrastructure currently owned by the Former Parent. To implement the Spin-Off, the Former Parent transferred the related license agreements, intellectual property and corporate infrastructure, including certain non-commercial employee agreements, share-based awards and other corporate agreements (the "Business") to Biohaven Ltd., through a series of internal restructuring transactions. Descriptions of historical business activities in these Notes to Consolidated Financial Statements are presented as if these transfers had already occurred, and the Former Parent’s activities related to such assets and liabilities had been performed by the Company. On October 3, 2022, the Former Parent completed the distribution (the “Distribution”) to holders of its common shares of all of the outstanding common shares of Biohaven Ltd. and the spin-off of Biohaven from the Former Parent (the “Spin-Off”) described in Biohaven’s Information Statement (the “Information Statement”) attached as Exhibit 99.1 to Biohaven’s Registration Statement on Form 10, as amended (Reg. No. 001-41477), which was declared effective by the Securities and Exchange Commission ("SEC") on September 22, 2022 (the “Form 10”). Each holder of Former Parent common shares received one common share of Biohaven for every two Former Parent common shares held of record as of the close of business on September 26, 2022. In the Distribution, an aggregate of 35,840,459 Biohaven common shares were issued. The aggregate number of common shares issued in connection with the Distribution did not include 2,611,392 common shares to be issued in connection with Former Parent stock options that were exercised on October 3, 2022 and 924,093 common shares to be issued in connection with Former Parent restricted stock units that vested on October 3, 2022. See Note 9, "Non-Cash Share-Based Compensation" for discussion of the Legacy Equity Award Settlement Plan. As a result of the Distribution, Biohaven Ltd. became an independent, publicly traded company. Collectively, we refer to the Distribution and Spin-Off throughout this Annual Report on Form 10-K as the "Separation." The Spin-Off generally resulted in (a) the Company directly or indirectly owning, assuming, or retaining certain assets and liabilities of the Former Parent and its subsidiaries related to the Former Parent’s pipeline assets and businesses and (b) the Former Parent directly or indirectly owning, assuming, or retaining all other assets and liabilities, including those associated with the Former Parent’s platform for the research, development, manufacture and commercialization of calcitonin gene-related receptor antagonists, including rimegepant, zavegepant and the Heptares Therapeutics Limited preclinical CGRP portfolio and related assets (the “CGRP Business”). In connection with the Separation, the Company entered into various agreements relating to transition services, licenses and certain other matters with the Former Parent. For additional information regarding these agreements, see Note 14, "Related Party Transactions." Basis of Presentation On October 3, 2022, the Company became a standalone publicly traded company, and its financial statements are now presented on a consolidated basis. Prior to the Separation on October 3, 2022, the Company’s historical combined financial statements were prepared on a standalone basis and were derived from the Former Parent's consolidated financial statements and accounting records. The financial statements for all periods presented, including the historical results of the Company prior to October 3, 2022, are now referred to as "Consolidated Financial Statements", and have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). Periods Prior to the Separation For periods prior to the Separation from the Former Parent, the consolidated financial statements present, on a historical basis, the combined assets, liabilities, expenses and cash flows directly attributable to the Business, which have been prepared from the Former Parent’s consolidated financial statements and accounting records, and are presented on a stand-alone basis as if the operations had been conducted independently from the Former Parent. The consolidated statements of operations for periods prior to the Separation include all costs directly related to the Business, including costs for facilities, functions and services utilized by the Company. The consolidated statements of operations periods prior to the Separation also include allocations for various expenses related to the Former Parent’s corporate functions, including research and development, human resources, information technology, facilities, tax, shared services, accounting, finance and legal. These expenses were allocated on the basis of direct usage or benefit when specifically identifiable, with the remainder allocated on a proportional cost allocation method primarily based on employee labor hours or direct expenses. Management believes the assumptions underlying the consolidated financial statements periods prior to the Separation, including the expense methodology and resulting allocation, are reasonable for all periods presented. However, the allocations may not include all of the actual expenses that would have been incurred by the Company and may not reflect its consolidated results of operations, financial position and cash flows had it been a standalone company during the periods presented. It is not practicable to estimate actual costs that would have been incurred had the Company been a standalone company and operated as an unaffiliated entity during the periods presented. Actual costs that might have been incurred had the Company been a standalone company would depend on a number of factors, including the chosen organizational structure, what corporate functions the Company might have performed directly or outsourced and strategic decisions the Company might have made in areas such as executive management, legal and other professional services, and certain corporate overhead functions. The income tax expense in the consolidated financial statements has been calculated on a separate return method and is presented as if the Company’s operations were separate taxpayers in the respective jurisdictions up to and including the Distribution. Cash tax payments, income taxes receivable and deferred taxes, net of valuation allowance, are reflective of its actual tax balances prior and subsequent to the Distribution. The consolidated balance sheets for periods prior to the Separation include assets and liabilities that have been determined to be specifically identifiable or otherwise attributable to the Company, including certain assets that were historically held at the corporate level in the Former Parent. All intracompany transactions within the Company have been eliminated. All intercompany transactions between the Company and the Former Parent are considered to be effectively settled in the consolidated financial statements at the time the transactions are recorded. The total net effect of these intercompany transactions considered to be settled is reflected in the consolidated statement of cash flows within financing activities and in the consolidated balance sheets as “Net investment from Former Parent.” See Note 14, "Related Party Transactions", for additional information regarding related party transactions. For periods prior to the Separation, our equity balance in these consolidated financial statements represents the excess of total assets over liabilities. Net investment from Former Parent was primarily impacted by contributions from the Former Parent, which are the result of net funding provided by or distributed to Former Parent. As a result of the Separation, the Company’s Net investment from Former Parent balance was reclassified to common shares. The Net investment from Former Parent balance reclassified to common shares included separation-related adjustments of $27,811. The adjustments related primarily to differences in the amount of assets and liabilities transferred to the Company upon the Separation and the amount of the transferred assets and liabilities reported in the company’s combined balance sheet as of September 30, 2022. Additional separation-related adjustments could be recorded in future periods. Cash on the consolidated balance sheet for periods prior to the Separation represents cash balances from the standalone entities established to operate the Business. Going Concern In accordance with Accounting Standards Codification (“ASC”) 205-40, Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. Through March 23, 2023, the Company has funded its operations primarily with proceeds from its Former Parent, its recent public offering as discussed in Note 7, "Shareholders' Equity", and the cash contribution received from the Former Parent at the Separation as discussed below. The Company has incurred recurring losses since its inception and expects to continue to generate operating losses for the foreseeable future. Pursuant to the Distribution Agreement, immediately prior to the Separation, the Former Parent made a cash contribution to the Company which resulted in a cash balance of approximately $257,799 as of October 3, 2022. Additionally, on October 25, 2022, the Company completed a public offering of its common shares which resulted in net proceeds to the Company of approximately $282,804. See Note 7, "Shareholders' Equity", for further detail on the public offering. Accordingly, as of the date of issuance of these consolidated financial statements, the Company expects its existing cash, cash equivalents and marketable securities will be sufficient to fund operating expenses, financial commitments and other cash requirements for at least one year after the issuance date of these financial statements. To execute its business plans, the Company will require funding to support its continuing operations and pursue its growth strategy. Until such time as the Company can generate significant revenue from product sales or royalties, if ever, it expects to finance its operations through the sale of public or private equity, debt financings or other capital sources, including collaborations with other companies or other strategic transactions. The Company may not be able to obtain financing on acceptable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of the Company’s shareholders. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of income and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the valuation of intangible assets, determining the allocations of costs and expenses from the Former Parent and the accrual for research and development expenses. In addition, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. Reclassifications Certain items in the prior period’s consolidated financial statements have been reclassified to conform to the current year presentation. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of 90 days or less at the date of purchase to be cash equivalents. The Company's cash equivalents are comprised of short-term money market funds and marketable securities that are highly liquid and readily convertible to known amounts of cash. Restricted Cash Restricted cash held on behalf of the Former Parent on the consolidated balance sheet as of December 31, 2022 represents cash held by the Company on behalf of the Former Parent related to the execution of the United States Distribution Services Agreement (the “Distribution Services Agreement”). Pursuant to the terms of the Distribution Services Agreement, which was entered into by the Company and the Former Parent in connection with the Separation, the Company is continuing to serve as the Former Parent’s distributor and agent for the distribution of the pharmaceutical product Nurtec ODT in the United States. As of December 31, 2022, the Company recorded a related payable of $35,212 as Due to Former Parent on the consolidated balance sheet as the balance was legally payable to the Former Parent. Refer to Note 14, "Related Party Transactions" for further information on the agreements entered into by the Company and the Former Parent in connection with the Separation. Restricted cash included in other current assets includes employee contributions to the Company's employee share purchase plan held for future purchases of the Company's outstanding shares. See Note 9, "Non-Cash Share-Based Compensation" for additional information on the Company's employee share purchase plan. The Company did not have an employee share purchase plan as of December 31, 2021. Restricted cash included in other assets in the consolidated balance sheets represents collateral held by banks for a letter of credit ("LOC") issued in connection with the leased office space in Yardley, Pennsylvania and a LOC issued in connection with the leased office space in Cambridge, Massachusetts. See Note 12, ‘‘Commitments and Contingencies’’ for additional information on the real estate leases. The following represents a reconciliation of cash and cash equivalents in the consolidated balance sheets to total cash, cash equivalents and restricted cash for the years ended December 31, 2022, 2021 and 2020, respectively, in the consolidated statements of cash flows: December 31, 2022 2021 2020 Cash and cash equivalents $ 204,877 $ 76,057 $ 82,506 Restricted cash held on behalf of Former Parent 35,212 — — Restricted cash (included in other current assets) 117 250 — Restricted cash (included in other non-current assets) 2,398 750 1,000 Total cash, cash equivalents and restricted cash at the end of the period in the consolidated statement of cash flows $ 242,604 $ 77,057 $ 83,506 Marketable Securities We invest our excess cash balances in marketable securities of highly rated financial institutions and investment-grade debt instruments. We seek to diversify our investments and limit the amount of investment concentrations for individual institutions, maturities and investment types. We classify marketable debt securities as available-for-sale and, accordingly, record such securities at fair value. We classify these securities as current assets as these investments are intended to be available to the Company for use in funding current operations. Unrealized gains and losses on our marketable debt securities that are deemed temporary are included in accumulated other comprehensive income as a separate component of stockholders’ equity. If any adjustment to fair value reflects a significant decline in the value of the security, we evaluate the extent to which the decline is determined to be other-than-temporary and would mark the security to market through a charge to our consolidated statement of operations. Credit losses are identified when we do not expect to receive cash flows sufficient to recover the amortized cost basis of a security. In the event of a credit loss, only the amount associated with the credit loss is recognized in operating results, with the amount of loss relating to other factors recorded in accumulated other comprehensive income. Acquisitions Our consolidated financial statements include the operations of acquired businesses after the completion of the acquisitions. We account for acquired businesses using the acquisition method of accounting, which requires, among other things, that assets acquired and liabilities assumed be recognized at their estimated fair values as of the acquisition date and that the fair value of acquired In-Process Research and Development ("IPR&D") be recorded on the balance sheet. Transaction costs are expensed as incurred. Any excess of the consideration transferred over the assigned values of the net assets acquired is recorded as goodwill. Contingent consideration in a business acquisition is included as part of the consideration transferred and is recognized at fair value as of the acquisition date. Fair value of IPR&D and contingent consideration is generally estimated by using a probability-weighted discounted cash flow approach. Equity Method Investments Investments in non-public companies in which the Company owns less than a 50% equity interest and where it has the ability to exercise significant influence over the operating and financial policies of the investee are accounted for using the equity method of accounting. The Company's proportionate share of the net income or loss of the equity method investment is included in other income (expense), net in the consolidated statement of operations and results in a corresponding adjustment to the carrying value of the investment on the consolidated balance sheet. Dividends received reduce the carrying value of the investment. As of December 31, 2020, the Company owned approximately 42% of the outstanding shares of Kleo Pharmaceuticals, Inc. ("Kleo"), which was accounted for as an equity method investment. In January 2021, the Company acquired the remaining 58% of Kleo's common shares that it did not previously own and ceased accounting for Kleo as an equity method investment. See Note 6, "Acquisitions" for additional details. Property and Equipment Property and equipment are recorded at cost and depreciated or amortized using the straight-line method over the estimated useful lives of the respective assets. As of December 31, 2022 and December 31, 2021, the Company's property and equipment consisted of office buildings and land, office and lab equipment, computer hardware and software, and furniture and fixtures. The fixed assets have the following useful lives: Building 30 years Office equipment 3 - 5 years Computer hardware and software 3 - 5 years Lab equipment 3 years Furniture and fixtures 3 years Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance are charged to expense as incurred. Property and equipment are monitored regularly for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Intangible Assets Acquired In-Process Research and Development IPR&D that the Company acquires in conjunction with the acquisition of a business represents the fair value assigned to incomplete research projects which, at the time of acquisition, have not reached technological feasibility. The amounts are capitalized and accounted for as indefinite-lived intangible assets, subject to impairment testing until completion or abandonment of the projects. Upon successful completion of each project, the asset is classified as a definite-lived intangible and the Company will make a determination as to the then-useful life of the intangible asset, generally determined by the period in which the substantial majority of the cash flows are expected to be generated, and begin amortization. The Company evaluates IPR&D for impairment at least annually, or more frequently if impairment indicators exist, by performing a quantitative test that compares the fair value of the IPR&D intangible asset with its carrying value. If the fair value is less than the carrying amount, an impairment loss is recognized in operating results. The Company believes no impairment of its acquired IPR&D existed as of December 31, 2022 or December 31, 2021. If we acquire an asset or group of assets that do not meet the definition of a business under applicable accounting standards, the acquired IPR&D is expensed on its acquisition date, unless it has an alternative future use. Future costs to develop these assets are recorded to research and development expense as they are incurred. In January 2021, in connection with our acquisition of Kleo, we recorded intangible assets consisting of IPR&D assets of $18,400, which included an oncology therapeutic candidate entering Phase I clinical trials and a COVID-19 therapeutic candidate in the planning stage for clinical development, and goodwill of $1,390. See Note 6, "Acquisitions" for additional details. Impairment of Long-lived Assets The Company monitors its long-lived assets for indicators of impairment. If such indicators are present, the Company assesses the recoverability of affected assets by determining whether the carrying value of such assets is less than the sum of the undiscounted future cash flows of the assets. If such assets are found not to be recoverable, the Company measures the amount of such impairment by comparing the carrying value of the assets to the fair value of the assets, with the fair value generally determined based on the present value of the expected future cash flows associated with the assets. The Company believes no impairment of long-lived assets existed as of December 31, 2022 or December 31, 2021. Fair Value Measurements Certain assets of the Company are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1— Quoted prices in active markets for identical assets or liabilities. • Level 2— Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3— Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The carrying values of other current assets, accounts payable, and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities. Leases The Company determines if an arrangement contains a lease at the inception of a contract. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Right-of-use assets and lease liabilities are recognized at the commencement date based on the present value of the remaining future minimum lease payments. If the interest rate implicit in the Company’s leases is not readily determinable, the Company utilizes an estimate of its incremental borrowing rate based on market sources including interest rates for companies with similar credit quality for agreements of similar duration, determined by class of underlying asset, to discount the lease payments. The right-of-use assets also include lease payments made before commencement and exclude lease incentives. The Company's lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Leases with an initial term of 12 months or less are not recorded on the balance sheet. Lease expense for these short-term leases are expensed as incurred over the term of the lease. Certain real estate leases require additional payments including reimbursement for real estate taxes, common area maintenance and insurance, which are expensed as incurred as variable lease costs. Other real estate leases contain one fixed lease payment that includes real estate taxes, common area maintenance and insurance. These fixed payments are considered part of the lease payment and included in the right-of-use assets and lease liabilities. For its real estate leases, which are accounted for as operating leases, the Company has elected the practical expedient to include both the lease and non-lease components as a single component. In addition, payments made by the Company for improvements to the underlying asset, if the payment relates to an asset of the lessor, are recorded as prepaid rent within other non-current assets in the consolidated balance sheets prior to lease commencement and on commencement, reclassified to the right-of-use asset. As of December 31, 2022, the Company had restricted cash of $2,398 included in other non-current assets in the consolidated financial statements, which represents collateral held by banks for letters of credit issued in connection with the leased office space in Yardley, Pennsylvania and Cambridge, Massachusetts. All restricted cash is invested in time deposits. See Note 12, ‘‘Commitments and Contingencies’’ for additional information on real estate leases. Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including salaries, non-cash share-based compensation and benefits, third-party license fees, rent and operating expenses for leased lab facilities, and external costs of vendors engaged to conduct clinical development activities and clinical trials as well as to manufacture clinical trial materials. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered. The Company has entered into various research and development-related contracts. These agreements are cancellable, and related payments are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Certain judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company's estimates. The Company's historical accrual estimates have not been materially different from the actual costs. Foreign Currency Translation The financial statements of our subsidiaries with functional currencies other than the U.S. dollar are translated into U.S. dollars using period-end exchange rates for assets and liabilities, historical exchange rates for stockholders’ equity and weighted average exchange rates for operating results. Translation gains and losses are included in accumulated other comprehensive income, net of tax, in shareholders’ equity. Foreign currency transaction gains and losses are included in other expense in the consolidated statement of operations. The Company's aggregate foreign currency transaction losses were immaterial for the years ended December 31, 2022, 2021 and 2020. Share-Based Compensation The Company measures share options and restricted share unit awards granted to employees, non-employees, and directors based on the fair value on the date of the grant and recognizes compensation expense of those awards, over the requisite service period, which is generally the vesting period of the respective award. Forfeitures are accounted for as they occur. Generally, the Company issues share options with only service-based vesting conditions and records the expense for these awards using the straight-line method. The Company classifies non-cash share-based compensation expense in its consolidated statement of operations in the same manner in which the award recipient's payroll costs are classified or in which the award recipient's service payments are classified. The fair value of each share option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The Company lacks a sufficient history of company-specific historical and implied volatility information for its shares. Therefore, it estimates its expected share price volatility based on the historical volatility of publicly traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded share price. The expected term of all of the Company's stock options has been determined utilizing the "simplified" method. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on common shares and does not expect to pay any cash dividends in the foreseeable future. Management evaluates its award grants and modifications and will adjust the fair value if any are determined to be spring-loaded. Share-Based Compensation for Periods Prior to the Separation Prior to the Separation from the Former Parent on October 3, 2022, certain of the Company’s employees have historically participated in the Former Parent’s non-cash share-based compensation plans. Non-cash share-based compensation expense for periods prior to the Separation has been allocated to the Company based on a combination of specific identification and a proportionate cost allocation method. Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company's tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The provision for income taxes includes the effects of applicable tax reserves, or unrecognized tax benefits, as well as the related net interest and penalties. Net Loss per Share Basic net loss per common share is calculated by dividing net loss by the weighted-average shares outstanding during the period. For purposes of the diluted net loss per share calculation, common share options are considered to be common share equivalents but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share were the same for all periods presented. Net Loss per Share for Periods Prior to the Separation Net loss per share for periods prior to the Separation from the Former Parent was calculated based on the 39,375,944 shares of the Company's common shares distributed to the Former Parent's shareholders at the time of the Distribution, including common shares issued in connection with Former Parent share options that were exercised on October 3, 2022 and common shares issued in connection with Former Parent restricted share units that vested on October 3, 2022. The same number of shares is being utilized for the calculation of basic and diluted earnings per share for all periods presented prior to the Spin-Off. Concentrations of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash, cash equivalents, and short-term debt securities. The Company maintains a portion of its cash deposits in government insured institutions in excess of government insured limits. The Company deposits its cash in financial institutions that it believes have high credit quality and has not experienced any losses on such accounts. The Company's cash management policy permits investments in U.S. federal government and federal agency securities, corporate bonds or commercial paper, supranational and sovereign obligations, certain qualifying money market mutual funds, certain repurchase agreements, and places restrictions on credit ratings, maturities, and concentration by type and issuer. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash in excess of government insured limits and in the event of default by corporations and governments in which it holds investments in cash equivalents and short-term debt securities, to the extent recorded on the consolidated balance sheet. Segment Information The Company manages its operations as a single segment, the development of therapies targeting neurological diseases, including rare disorders, for the purposes of assessing performance and making operating decisions. Consistent with our operational structure, the Company's chief decision maker manages and allocates resources at a consolidated level. Therefore, results of our operations are reported on a consolidated basis for the purposes of assessing performance and making operating decisions. In 2022 and 2021, materially all the Company's long-lived assets were held in the United States. Recently Adopted Accounting Pronouncements Effective January 1, 2022 the Company adopted ASU No. 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the Financial Accounting Standards Board ("FASB") Emerging Issues Task Force), which provides guidance on modifications or exchanges of a freestanding equity-classified written call option that is not within the scope of another topic. An entity should treat a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange as an exchange of the original instrument for a new instrument, and provides further guidance on measuring the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange. ASU 2021-04 also provides guidance on the recognition of the effect of a modification or an exchange of a freestanding equity- classified written call option that remains equity classified after modification or exchange on the basis of the substance of the transaction, in the same manner as if cash had been paid as consideration. The guidance has been applied prospectively and did not have a material effect on the consolidated financial statements of the Company. Recently Issued Accounting Pronouncements In June 2022, the FASB issued ASU No. 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions, to clarify the guidance in Topic 820 |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | Marketable Securities The amortized cost, gross unrealized holding gains, gross unrealized holding losses and fair value of debt securities available-for-sale by type of security at December 31, 2022 was as follows: Amortized Cost Allowance for Credit Losses Net Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value December 31, 2022 Debt securities U.S. corporate bonds $ 142,697 $ — $ 142,697 $ 25 $ (135) $ 142,587 Foreign corporate bonds 36,766 — 36,766 9 (32) 36,743 U.S. treasury bills 89,308 — 89,308 17 (5) 89,320 U.S. agency bonds 41,734 — 41,734 — (24) 41,710 Total $ 310,505 $ — $ 310,505 $ 51 $ (196) $ 310,360 The Company had no available-for-sale debt securities at December 31, 2021. The fair values of debt securities available-for-sale by classification in the consolidated balance sheet were as follows: December 31, 2022 Cash and cash equivalents $ 49,896 Marketable securities 260,464 Total $ 310,360 The net amortized cost and fair value of debt securities available-for-sale at December 31, 2022 are shown below by contractual maturity. Actual maturities may differ from contractual maturities because securities may be restructured, called or prepaid, or the Company intends to sell a security prior to maturity. December 31, 2022 Net Amortized Cost Fair Value Due to mature: Less than one year $ 310,505 $ 310,360 Total $ 310,505 $ 310,360 Summarized below are the debt securities available-for-sale the Company held at December 31, 2022 that were in an unrealized loss position, aggregated by the length of time the investments have been in that position: Less than 12 months Number of Securities Fair Value Unrealized Losses December 31, 2022 Debt securities U.S. corporate bonds 16 $ 104,508 $ (135) Foreign corporate bonds 3 31,886 (32) U.S. treasury bills 1 9,762 (5) U.S. agency bonds 4 41,710 (24) Total 20 $ 187,866 $ (196) The Company did not have any investments in a continuous unrealized loss position for more than twelve months as of December 31, 2022. The Company reviewed the securities in the table above and concluded that they are performing assets generating investment income to support the needs of the Company’s business. In performing this review, the Company considered factors such as the credit quality of the investment security based on research performed by external rating agencies and the prospects of realizing the carrying value of the security based on the investment’s current prospects for recovery. As of December 31, 2022, the Company did not intend to sell these securities and did not believe it was more likely than not that it would be required to sell these securities prior to the anticipated recovery of their amortized cost basis. Net Investment Income Sources of net investment income included in other expense, net under other income (expense) in the consolidated statements of operations for the years ended December 31, 2022 were as follows: 2022 Gross interest income from debt securities available-for-sale, money-market funds, and cash $ 3,235 Investment expenses (27) Net investment income $ 3,208 The Company had no net investment income during the year ended December 31, 2021 and 2020. We utilize the specific identification method in computing realized gains and losses on sales of debt securities. The Company had no sales of debt securities during the years ended December 31, 2022, 2021 or 2020. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities | Fair Value of Financial Assets and Liabilities The preparation of the Company’s consolidated financial statements in accordance with GAAP requires certain assets and liabilities to be reflected at their fair value and others to be reflected on another basis, such as an adjusted historical cost basis. In this note, the Company provides details on the fair value of financial assets and liabilities and how it determines those fair values. Financial Instruments Measured at Fair Value on the Consolidated Balance Sheets Certain of the Company’s financial instruments are measured at fair value on the consolidated balance sheets on a recurring basis. The fair values of these instruments are based on valuations that include inputs that can be classified within one of three levels of a hierarchy established by GAAP. See Fair Value Measurements in Note 2, "Summary of Significant Accounting Policies" for a brief description of the type of valuation information (“valuation inputs”) that qualifies a financial asset or liability for each level. Financial assets measured at fair value on a recurring basis on the consolidated balance sheet at December 31, 2022 were as follows: Fair Value Measurement Using: Balance Sheet Classification Type of Instrument Level 1 Level 2 Level 3 Total December 31, 2022 Assets: Cash equivalents Money market funds $ 72,866 $ — $ — $ 72,866 Cash equivalents U.S. treasury bills — 39,948 — 39,948 Cash equivalents U.S. corporate bonds — 9,948 — 9,948 Marketable securities U.S. treasury bills — 49,372 — 49,372 Marketable securities U.S. corporate bonds — 132,639 — 132,639 Marketable securities U.S. agency bonds — 41,710 — 41,710 Marketable securities Foreign corporate bonds — 36,743 — 36,743 Total assets $ 72,866 $ 310,360 $ — $ 383,226 The Company had no financial liabilities measured at fair value on a recurring basis as of December 31, 2022 and no financial assets and liabilities measured at fair value on a recurring basis as of December 31, 2021. There were no securities transferred between Level 1, 2, and 3 during the year ended December 31, 2022. The following is a description, including valuation methodology, of the financial assets and liabilities measured at fair value on a recurring basis: Cash Equivalents Cash equivalents at December 31, 2022 consisted of cash invested in short-term money market funds and debt securities with an original maturity of 90 days or less at the date of purchase. The carrying value of cash equivalents approximates fair value as maturities are less than three months. When quoted prices are available in an active market, cash equivalents are classified in Level 1 of the fair value hierarchy. Fair values of cash equivalent instruments that do not trade on a regular basis in active markets are classified as Level 2. Marketable Securities The fair values of the Company’s Level 2 debt securities are obtained from quoted market prices of debt securities with similar characteristics, quoted prices from identical assets in inactive markets, or discounted cash flows to estimate fair value. On a quarterly basis, the Company compares the prices of its Level 2 debt securities to prices provided by a secondary source. Variances over a specified threshold are identified and reviewed to confirm the price provided by the primary source represents an appropriate estimate of fair value. The Company did not adjust any of the prices at December 31, 2022. Contingent Value Right Liability On January 4, 2021, the Company acquired Kleo Pharmaceuticals, Inc. (“Kleo”) (see Note 6 for additional information). Included in the purchase consideration transferred was a contingent value right to receive one dollar in cash for each Kleo share if certain specified Kleo biopharmaceutical products or product candidates receive the approval of the FDA prior to the expiration of 30 months following the effective time of the transaction. The maximum amount payable pursuant to the contingent value right is approximately $17,300, and the fair value of the contingent value right was $1,457 as of the acquisition date. The Company recorded the contingent value right in other non-current liabilities on the consolidated balance sheets. The fair value of the contingent value right was determined based on significant inputs not observable in the market, which represents a Level 3 measurement within the fair value hierarchy. The Company used a discounted cash flow approach to value the contingent value right liability. As inputs into the initial valuation, the Company considered the probability of FDA approval within the 30 months period, which we estimated at approximately 10%, the amount of the payment, and a discount rate of approximately 7% determined using an implied credit spread adjusted based on companies with similar credit risk. At December 31, 2021,the Company determined the value of the contingent value right to be immaterial and recognized a gain of $1,457 related to the contingent value right in other income (expense) in the consolidated statements of operations during the fourth quarter of 2021. The value of the contingent value right continues to be immaterial with no value included on the consolidated balance sheet as of December 31, 2022. Financial Instruments Not Measured at Fair Value on the Consolidated Balance Sheets The carrying value and estimated fair value classified by level of fair value hierarchy for financial instruments carried on the consolidated balance sheets at adjusted cost or contract value at December 31, 2022 and 2021 were as follows: Carrying Fair Value Measurement Using: Value Level 1 Level 2 Level 3 Total December 31, 2022 Assets: Series A-2 Preferred Stock investment (1) — N/A N/A N/A N/A December 31, 2021 Assets: Series A-2 Preferred Stock investment (1) 6,000 N/A N/A N/A N/A (1) It was not practical to estimate the fair value of this investment as it represents Series A-2 Preferred Stock of an unlisted company. On a routine basis the Company determined if additional preferred shares of the unlisted company had been issued and adjusted the carrying value of its Series A-2 Preferred Stock investment accordingly. The Series A-2 Preferred Stock investment was recorded in other non-current assets on the consolidated balance sheet at December 31, 2021. As of December 31, 2022, due to concerns related to Artizan's inability to fund its future operations, the Company determined its investment in Artizan to be fully impaired. Accordingly, the Company had no balance on its consolidated balance sheet relating to its investment in Artizan as of December 31, 2022. See Artizan under Note 11, "License Agreements" for additional details on the Series A-2 Preferred Stock investment. |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Components | Balance Sheet Components Property and Equipment, Net Property and equipment, net consisted of the following: As of December 31, 2022 As of December 31, 2021 Building and land $ 12,297 $ 12,297 Computer hardware and software 780 1,200 Office and lab equipment 5,501 1,653 Furniture and fixtures 1,202 1,202 $ 19,780 $ 16,352 Accumulated depreciation (4,914) (3,342) 14,866 13,010 Equipment not yet in service 2,646 — Property and equipment, net $ 17,512 $ 13,010 Depreciation expense was $1,361, $673 and $72 for the years ended December 31, 2022, 2021 and 2020, respectively. As of both December 31, 2022 and 2021, computer software costs included in property and equipment were $760 and $760, respectively, net of accumulated amortization of $464 and $211, respectively. Depreciation and amortization expense for capitalized computer software costs were not material for the years ended December 31, 2022 or 2021. Equipment not yet in service primarily consisted of lab equipment that had not been placed into service as of December 31, 2022. Other Non-current Assets Other non-current assets consisted of the following: As of December 31, 2022 As of December 31, 2021 Series A-2 Preferred Stock Investment $ — $ 6,000 Operating lease right-of-use assets 34,928 5,222 Other 2,585 3,216 Other non-current assets $ 37,513 $ 14,438 In December 2020, the Company entered into a Series A-2 Preferred Stock Purchase Agreement with Artizan Biosciences Inc. (“Artizan”). Under the agreement, the Company paid Artizan 61,494 shares of the Former Parent’s common shares valued at $6,000, which were issued in January 2021. In exchange, the Company acquired 34,472,031 shares of series A-2 preferred stock of Artizan. In June 2022, the Company entered into an Amendment to the Series A-2 Preferred Stock Purchase Agreement with Artizan. Under the Amendment, the Company made a cash payment of $4,000 in exchange for 22,975,301 additional shares of series A-2 preferred stock of Artizan. The Company determined that it was not practical to estimate the fair value of this investment as it represents Series A-2 Preferred Stock of an unlisted company. As of December 31, 2022, due to concerns related to Artizan's inability to fund its future operations, the Company determined its investment in Artizan to be fully impaired. Accordingly, during the fourth quarter of 2022 the Company recognized an impairment loss of $10,000 in other income (expense) on the consolidated statement of operations. See Note 11, “License Agreements” for additional details on the Artizan Agreement. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: As of December 31, 2022 As of December 31, 2021 Accrued employee compensation and benefits $ 14,603 $ 9,538 Accrued clinical trial costs 17,788 24,051 Other accrued expenses and other current liabilities 11,715 3,571 Accrued expenses and other current liabilities $ 44,106 $ 37,160 Contingently Redeemable Non-controlling Interest In September 2020, the Company's Asia-Pacific subsidiary, BioShin Limited (“BioShin”), authorized, issued and sold 15,384,613 BioShin Series A Preferred Shares at a price of $3.90 per share for a total of $60,000 to a group of investors led by OrbiMed, with participation from Cormorant Asset Management LLC, HBM Healthcare Investments Ltd, Surveyor Capital (a Citadel Company), and Suvretta Capital Management, LLC (the "BioShin Investors"). The BioShin Series A Preferred Shares contained both a call option by the Company and a put option held by the BioShin Investors. Due to the contingently redeemable features, the Company had classified the BioShin Series A Preferred Shares in mezzanine equity since the redemption was out of the Company's control. In November 2021, the Company, Biohaven Therapeutics Ltd. (“BTL”), Atlas Merger Sub and BioShin entered into an Agreement and Plan of Merger (the “BioShin Merger Agreement”). The BioShin Merger Agreement provided for the merger of Atlas Merger Sub with and into BioShin, with BioShin surviving the merger as a wholly owned indirect subsidiary of the Former Parent, in accordance with Section 233 of the Cayman Islands Companies Act. As a result of the satisfaction of the closing conditions described in the BioShin Merger Agreement, on January 6, 2022, each Series A |
Acquisitions
Acquisitions | 12 Months Ended |
Dec. 31, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
Acquisitions | Acquisitions On January 4, 2021, the Company acquired Kleo Pharmaceuticals, Inc. (“Kleo”). Kleo is a development-stage biopharmaceutical company focused on advancing the field of immunotherapy by developing small molecules that emulate biologics. The transaction was accounted for as the acquisition of a business using the acquisition method of accounting. The total fair value of the consideration transferred was $20,043 which primarily consisted of the issuance of a total of 115,836 common shares of the Former Parent to Kleo stockholders and contingent consideration in the form of a contingent value right to receive one dollar in cash for each Kleo share if certain specified Kleo biopharmaceutical products or product candidates receive the approval of the Food and Drug Administration (the "FDA") prior to the expiration of 30 months following the effective time of the transaction. The maximum amount payable pursuant to the contingent value right was approximately $17,300. At December 31, 2021, the Company determined the value of the contingent value right to be immaterial and recognized a gain of $1,457 related to the contingent value right in other income (expense) during the fourth quarter of 2021. The value of the contingent value right continues to be immaterial with no value included on the consolidated balance sheet as of December 31, 2022. Prior to the consummation of the transaction, the Company owned approximately 41.9% of the outstanding shares of Kleo and accounted for it as an equity method investment. As part of the transaction, the Company acquired the remainder of the shares of Kleo, and post-transaction the Company owns 100% of the outstanding shares of Kleo. The carrying value of the Company’s investment in Kleo was $1,176 immediately prior to the acquisition date. The Company determined the fair value of the existing interest was $6,437, and recognized a gain from its equity method investment during the first quarter of 2021 of $5,261 on the consolidated statement of operations as a result of remeasuring to fair value the existing equity interest in Kleo. In connection with the transaction, we recorded: net working capital of $573; property and equipment of $1,257; intangible assets consisting of in progress research and development assets of $18,400 which include an oncology therapeutic candidate entering Phase I clinical trials and a Multimodal Antibody Therapy Enhancer ("MATE") conjugation asset; debt assumed of $1,577; and goodwill of $1,390. Kleo’s employees, other than its President and Chief Financial Officer, were retained as part of the transaction. In connection with the transaction agreement, the Former Parent filed a registration statement permitting Kleo stockholders to offer and sell the common shares of the Former Parent issued in the transaction. Kv7 Platform Acquisition In April 2022, the Company closed the acquisition from Knopp Biosciences LLC (“Knopp”) of Channel Biosciences, LLC (“Channel”), a wholly owned subsidiary of Knopp owning the assets of Knopp’s Kv7 channel targeting platform (the “Kv7 Platform Acquisition”), pursuant to a Membership Interest Purchase Agreement (the “Purchase Agreement”), dated February 24, 2022. In consideration for the Kv7 Platform Acquisition, on April 4, 2022, the Company made an upfront payment comprised of $35,000 in cash and 493,254 common shares of the Former Parent, valued at approximately $58,747, issued through a private placement. The Company has also agreed to pay additional success-based payments comprised of (i) up to $325,000 based on developmental and regulatory milestones through approvals in the United States, EMEA and Japan for the lead asset, BHV-7000 (formerly known as KB-3061), (ii) up to an additional $250,000 based on developmental and regulatory milestones for the Kv7 pipeline development in other indications and additional country approvals, and (iii) up to $562,500 for commercial sales-based milestones of BHV-7000. Additionally, the Company has agreed to make scaled royalty payments in cash for BHV-7000 and the pipeline programs, starting at high single digits and peaking at low teens for BHV-7000 and starting at mid-single digits and peaking at low tens digits for the pipeline programs. The Company accounted for this purchase as an asset acquisition as substantially all of the fair value of the gross assets acquired was concentrated in a single identifiable asset, IPR&D. The IPR&D asset has no alternative future use and relates to intellectual property rights related to the Kv7 platform lead, now BHV-7000. There was no material value assigned to any other assets or liabilities acquired in the acquisition. As such, during the second quarter of 2022, the Company recorded a charge to research and development (" R&D During the year ended December 31, 2022, the Company recorded $25,000 to R&D expense in the consolidated statement of operations for a regulatory milestone payment which became due to Knopp during the second quarter. Excluding the milestone payment noted above, the Company has not recorded any of the possible contingent consideration payments to Knopp as a liability in the accompanying consolidated balance sheet as none of the future events which would trigger a milestone payment were considered probable of occurring at December 31, 2022. |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Shareholders' Equity | Shareholders' Equity Issuance of Common Shares in connection with the Separation from the Former Parent On October 3, 2022, the Former Parent completed the Distribution to holders of its common shares and the spin-off of Biohaven. Each holder of Former Parent common shares received one common share of Biohaven for every two the Former Parent common shares held of record as of the close of business, New York City time, on September 26, 2022. In the Distribution, an aggregate of 35,840,459 common shares of the Company were issued. The aggregate number of common shares issued in connection with the Distribution did not include 2,611,392 common shares to be issued in connection with Former Parent share options that were exercised on October 3, 2022 and 924,093 common shares to be issued in connection with Former Parent restricted share units that vested on October 3, 2022. See Note 9, "Non-Cash Share-Based Compensation" for discussion of the Legacy Equity Award Settlement Plan. Issuance of Common Shares for the October 2022 Offering |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Accumulated Other Comprehensive Income | Accumulated Other Comprehensive Income Shareholders’ equity included the following activity in accumulated other comprehensive income (loss) for the years ended December 31, 2022: 2022 Net unrealized investment gains (losses): Beginning of period balance $ — Other comprehensive loss (1) (145) End of period balance (145) Foreign currency translation adjustments: Beginning of period balance — Other comprehensive income (1) 429 End of period balance 429 Total beginning of period accumulated other comprehensive income — Total other comprehensive income (loss) 284 Total end of period accumulated other comprehensive income $ 284 (1) There was no tax on other comprehensive income (loss) during the period. |
Non-Cash Share-Based Compensati
Non-Cash Share-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Non-Cash Share-Based Compensation | Non-Cash Share-Based Compensation 2022 Equity Incentive Plan In September 2022, the Company's shareholders approved the 2022 Equity Incentive Plan (the "2022 Plan"), which became effective on October 3, 2022. The 2022 Plan provides for the grant of incentive share options, nonstatutory share options, share appreciation rights, restricted share awards, restricted share unit awards ("RSUs"), performance-based share awards and other share-based awards. Upon the effectiveness of the 2022 Plan, there were 9,190,000 common shares reserved for issuance under the 2022 Plan. As of December 31, 2022, there were 166,250 shares of the Company's common shares available for future grants under the 2022 Plan. The number of shares reserved for issuance under the 2022 Plan automatically increases on January 1 of each calendar year by 4% of total common shares outstanding as of December 31 of the prior year, beginning October 3, 2022 through January 1, 2032. In January 2023, the number of common shares reserved for future issuance under the 2022 Plan automatically increased by 2,727,619 common shares. Legacy Equity Award Settlement Plan In September 2022, the Company's shareholders approved the Legacy Equity Award Settlement Plan (the "Legacy Plan"), which became effective on September 29, 2022. The Legacy Plan is intended solely to provide for the grant and settlement of nonstatutory share options and RSUs, issued in respect of share options and RSUs originally granted pursuant to the Former Parent's 2017 Equity Incentive Plan and 2014 Equity Incentive Plan. On October 3, 2022, the Former Parent completed the Distribution and the Separation. Each Former Parent share option and RSU outstanding prior to the Distribution was converted into .5 stock options and RSUs in the Company. In total, 4,057,121 share options and 924,093 RSUs were granted and settled into 2,611,392 and 924,093 common shares, respectively, under the Legacy Plan on October 3, 2022. Non-Cash Share-Based Compensation Expense For periods prior to the Separation from the Former Parent, non-cash share-based compensation has been allocated to the Company by using a combination of specific identification and a proportionate cost allocation method based on employee hours or directly identified operating expenses, depending on the employee’s function. The amounts presented are not necessarily indicative of future awards and do not necessarily reflect the costs that the Company would have incurred as an independent company for the periods presented. Upon the effectiveness of the Company's Spin-off from the Former Parent, each Former Parent share option and RSU outstanding vested immediately (the "Acceleration") and converted into .5 share options and RSUs in the Legacy Plan in the Company. The non-cash share-based compensation expense related to the Acceleration was then allocated to the Company using the same methodology described above and recognized immediately, resulting in $101,440 of non-cash share-based compensation expense recognized related to to the Acceleration in the fourth quarter of 2022. The share options and RSUs granted under the Legacy Plan also immediately vested and settled as a result of the Spin-off, and the Company determined that no incremental compensation should be recognized related to these awards. Non-cash share-based compensation under the Former Parent’s non-cash share-based compensation plans was measured at the grant date based on the fair value of the award and was recognized as expense over the requisite service period of the award (generally three The Company measures non-cash share-based compensation at the grant date based on the fair value of the award and is recognized as expense over the requisite service period of the award (generally three Year Ended December 31, 2022 2021 2020 Research and development expenses Allocated from Former Parent excluding the Acceleration $ 46,976 $ 39,381 $ 18,475 Allocated from Former Parent related to the Acceleration 61,749 — — 2022 Equity Incentive Plan 7,654 — — Total research and development expenses 116,379 39,381 18,475 General and administrative expenses Allocated from Former Parent excluding the Acceleration 30,951 26,258 11,025 Allocated from Former Parent related to the Acceleration 39,691 — — 2022 Equity Incentive Plan 6,535 — — Total general and administrative expenses 77,177 26,258 11,025 Total non-cash share-based compensation expense $ 193,556 $ 65,639 $ 29,500 As of December 31, 2022, total unrecognized compensation cost related to the unvested share-based awards was $31,080, which is expected to be recognized over a weighted average period of 2.75 years. Share Options All share option grants are awarded at fair value on the date of grant. The fair value of share options is estimated using the Black-Scholes option pricing model. Stock options generally expire 10 years after the grant date. The aggregate intrinsic value of share options is calculated as the difference between the exercise price of the share options and the fair value of the Company's common shares for those share options that had exercise prices lower than the fair value of the Company's common shares at December 31, 2022. The total intrinsic value of outstanding share options for the year ended December 31, 2022 was $61,639. The total intrinsic value of share options exercised for the year ended December 31, 2022 was $20,137. The assumptions that the Company used to determine the grant-date fair value of share options granted under the 2022 Plan were as follows, presented on a weighted average basis: Year Ended December 31, 2022 Risk-free interest rate 3.86% Expected term (in years) 5.75 Expected volatility 82.05% Expected dividend yield —% Exercise price $7.00 The following table is a summary of the Company's share option activity for the year ended December 31, 2022: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value (in years) Outstanding as of October 3, 2022 0 $ — Granted (1) 13,167,121 $ 5.67 Exercised (1) (4,121,656) $ 2.74 Forfeited (86,250) $ 7.00 Outstanding as of December 31, 2022 8,959,215 $ 7.00 9.75 $ 61,639 Options exercisable as of December 31, 2022 2,212,965 $ 7.00 9.75 $ 15,225 Vested and expected to vest as of December 31, 2022 8,959,215 $ 7.00 9.75 $ 61,639 (1) Includes 4,057,121 share options that were granted and exercised under the Legacy Plan on October 3, 2022 The Company expects approximately 6,746,250 of the unvested share options to vest over the requisite service period. Restricted Share Units As discussed above, in connection with the Distribution, on October 3, 2022, 924,093 RSUs were granted and settled into 924,093 common shares under the Legacy Equity Award Settlement Plan. No additional RSUs were granted under the 2022 Plan during the year ended December 31, 2022. The Company’s RSUs are considered nonvested share awards and require no payment from the employee. For each RSU, employees receive one common share at the end of the vesting period. The employee can elect to receive the one common share net of taxes or pay for taxes separately and receive the entire share. Compensation cost is recorded based on the market price of the Company’s common shares on the grant date and is recognized on a straight-line basis over the requisite service period. As of December 31, 2022, there was no unrecognized compensation cost related to Company RSUs that are expected to vest. No fair value was assigned to the RSUs vested during the year ended December 31, 2022, as all RSUs vested were related to the RSUs granted and settled under the Legacy Equity Award Settlement Plan. The following table is a summary of the RSU activity for the year ended December 31, 2022: Number of Shares Weighted Average Grant Date Fair Value Unvested restricted shares outstanding as of October 3, 2022 — $ — Granted 924,093 $ — Forfeited — $ — Vested (924,093) $ — Unvested restricted shares outstanding as of December 31, 2022 — $ — Employee Share Purchase Plan In September 2022, the Company's board of directors approved the rules and procedures of the 2022 Employee Share Purchase Plan (the "ESPP") approved by shareholders of the Company on September 28, 2022. Upon the effectiveness of the ESPP, 393,769 shares were authorized to be issued under purchase rights granted to eligible employees. The ESPP allows each eligible employee who is participating in the plan to purchase shares by authorizing payroll deductions of up to 15% of eligible earnings. Unless the participating employee has previously withdrawn from the offering, accumulated payroll deductions will be used to purchase shares on the last business day of the offering period at a price equal to 85% of the fair market value of the shares on the first business day or the last business day of the offering period, whichever is lower. Under applicable tax rules, an employee may purchase no more than $25 worth of ordinary shares, valued at the start of the offering period, under the ESPP in any calendar year. There is no minimum holding period associated with shares purchased pursuant to this plan. An employee’s purchase rights terminate immediately upon termination of employment. The number of shares reserved for issuance under the ESPP automatically increases on January 1 of each calendar year by 1% of total common shares outstanding as of December 31 of the prior year, beginning October 3, 2022 through January 1, 2032. As of December 31, 2022, 393,769 shares remained available for future issuance under the ESPP. In January 2023, 681,904 additional shares were authorized to be issued under the ESPP. The Company accounts for employee share purchases made under its ESPP using an estimate of the grant date fair value, which is determined in accordance with ASC 718, Stock Compensation. The purchase price discount and the look-back feature cause the ESPP to be compensatory and the Company to recognize compensation expense. The compensation cost is recognized on a straight-line basis over the requisite service period. The Company values ESPP shares using the Black-Scholes model. The Company did not recognize material compensation expense related to the ESPP for the year ended December 31, 2022. As of December 31, 2022, there was $221 of unrecognized non-cash share-based compensation expense related to the ESPP, which is expected to be recognized over the remaining offering period ending May 31, 2022. During the year ended December 31, 2022, no shares were issued under the ESPP. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share Basic and diluted net loss per share attributable to common shareholders of Biohaven Ltd. was calculated as follows: Year Ended December 31, 2022 2021 2020 Numerator: Net loss attributable to Biohaven Ltd. $ (570,279) $ (213,796) $ (118,668) Denominator: Weighted average common shares outstanding—basic and diluted (1) 44,741,316 39,375,944 39,375,944 Net loss per share attributable to Biohaven Ltd.—basic and diluted $ (12.75) $ (5.43) $ (3.01) (1) Prior to the Spin-Off from the Former Parent on October 3, 2022, Biohaven Ltd. did not operate as an independent company. At the time of the Distribution, 39,375,944 shares of the Company's common stock were distributed to the Former Parent's shareholders, including common shares issued in connection with Former Parent share options that were exercised on October 3, 2022 and common shares issued in connection with Former Parent restricted share units that vested on October 3, 2022. This number of shares is being utilized for the calculation of basic and diluted earnings per share for all periods presented prior to the Spin-Off. The Company's potential dilutive securities include share options which have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common shareholders of the Company is the same. The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common shareholders for the periods indicated because including them would have had an anti-dilutive effect: Year Ended December 31, 2022 Options to purchase common shares 8,959,215 |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License Agreements | License Agreements The following is a summary of all license agreements that the Company has entered into. As of December 31, 2022, the Company has potential future developmental, regulatory, and commercial milestone payments under these agreements of up to approximately $30,125, $529,850, and $582,950, respectively. As of December 31, 2022 the Company has not made any developmental, regulatory, or commercial milestone payments under these agreements. Yale Agreements In September 2013, the Company entered into an exclusive license agreement (the "Yale Agreement") with Yale University to obtain a license to certain patent rights for the commercial development, manufacture, distribution, use and sale of products and processes resulting from the development of those patent rights, related to the use of riluzole in treating various neurological conditions, such as general anxiety disorder, post-traumatic stress disorder and depression. The Yale Agreement was amended and restated in May 2019. As amended, the Company agreed to pay Yale University up to $2,000 upon the achievement of specified regulatory milestones and annual royalty payments of a low single-digit percentage based on net sales of riluzole-based products from the licensed patents or from products based on troriluzole. Under the amended and restated agreement, the royalty rates are reduced as compared to the original agreement. In addition, under the amended and restated agreement, the Company may develop products based on riluzole or troriluzole. The amended and restated agreement retains a minimum annual royalty of up to $1,000 per year, beginning after the first sale of product under the agreement. If the Company grants any sublicense rights under the Yale Agreement, it must pay Yale University a low single-digit percentage of sublicense income that it receives. For the years ended December 31, 2022, 2021 and 2020, the Company did not record any material expense or make any milestone or royalty payments under the Yale Agreement. In January 2021, the Company entered into a worldwide, exclusive license agreement with Yale University for the development and commercialization of a novel Molecular Degrader of Extracellular Protein ("MoDE") platform (the "Yale MoDE Agreement"). Under the Yale MoDE Agreement, the Company acquired exclusive, worldwide rights to Yale University's intellectual property directed to its MoDE platform. The platform pertains to the clearance of disease-causing protein and other biomolecules by targeting them for lysosomal degradation using multi-functional molecules. As part of consideration for this license, the Company paid Yale University an upfront cash payment of $1,000 and 11,668 common shares of the Former Parent valued at approximately $1,000. Under the Yale MoDE Agreement, the Company may develop products based on the MoDE platform. The Yale MoDE Agreement includes an obligation to pay a minimum annual royalty of up to $1,000 per year, and low single digit royalties on the net sales of licensed products. If the Company grants any sublicense rights under the Yale MoDE Agreement, it must pay Yale University a low single-digit percentage of sublicense income that it receives. In addition, Yale University will be eligible to receive additional development milestone payments of up to $800 and commercial milestone payments of up to $2,950. The Yale MoDE Agreement terminates on the later of twenty years from the effective date, twenty years from the filing date of the first investigational new drug application for a licensed product or the last to expire of a licensed patent. Under the Yale MoDE Agreement, the Company entered into a sponsored research agreement (the “Yale MoDE SRA”), which included funding of up to $4,000 over the life of the agreement. Excluding the upfront payments above, the Company recorded research and development expense related to the Yale MoDE Agreement of $2,666 and $150 for the years ended December 31, 2022 and 2021, respectively. For the years ended December 31, 2022 and 2021, the Company did not make any milestone or royalty payments under the Yale MoDE Agreement. ALS Biopharma Agreement In August 2015, the Company entered into an agreement (the "ALS Biopharma Agreement") with ALS Biopharma and Fox Chase Chemical Diversity Center Inc. ("FCCDC"), pursuant to which ALS Biopharma and FCCDC assigned the Company their worldwide patent rights to a family of over 300 prodrugs of glutamate modulating agents, including troriluzole, as well as other innovative technologies. Under the ALS Biopharma Agreement, the Company is obligated to use commercially reasonable efforts to commercialize and develop markets for the patent products. The Company is obligated to pay $3,000 upon the achievement of specified regulatory milestones with respect to the first licensed product and $1,000 upon the achievement of specified regulatory milestones with respect to subsequently developed products, as well as royalty payments of a low single-digit percentage based on net sales of products licensed under the ALS Biopharma Agreement, payable on a quarterly basis. The ALS Biopharma Agreement terminates on a country-by-country basis as the last patent rights expire in each such country. If the Company abandons its development, research, licensing or sale of all products covered by one or more claims of any patent or patent application assigned under the ALS Biopharma Agreement, or if the Company ceases operations, it has agreed to reassign the applicable patent rights back to ALS Biopharma. For the years ended December 31, 2022, 2021 and 2020, the Company did not record any expense or make any milestone or royalty payments under the ALS Biopharma Agreement. 2016 AstraZeneca Agreement In October 2016, the Company entered into an exclusive license agreement (the "2016 AstraZeneca Agreement") with AstraZeneca, pursuant to which AstraZeneca granted the Company a license to certain patent rights for the commercial development, manufacture, distribution and use of any products or processes resulting from development of those patent rights, including BHV-5000 and BHV-5500. In exchange for these rights, the Company agreed to pay AstraZeneca an upfront payment, milestone payments and royalties on net sales of licensed products under the agreement. The regulatory milestones due under the 2016 AstraZeneca Agreement depend on the indication of the licensed product being developed as well as the territory where regulatory approval is obtained. Regulatory milestones due under the 2016 AstraZeneca Agreement with respect to Rett syndrome total up to $30,000, and, for any indication other than Rett syndrome, total up to $60,000. Commercial milestones are based on net sales of all products licensed under the 2016 AstraZeneca Agreement and total up to $120,000. The Company has also agreed to pay royalties in two tiers, with each tiered royalty in the range from 0-10% of net sales of products licensed under the 2016 AstraZeneca Agreement. If the Company receives revenue from sublicensing any of its rights under the 2016 AstraZeneca Agreement, the Company is also obligated to pay a portion of that revenue to AstraZeneca. The Company is also required to reimburse AstraZeneca for any fees that AstraZeneca incurs related to the filing, prosecution, defending, and maintenance of patent rights licensed under the 2016 AstraZeneca Agreement. The 2016 AstraZeneca Agreement expires upon the expiration of the patent rights under the agreement or on a country-by-country basis ten years after the first commercial sale and can also be terminated if certain events occur, e.g., material breach or insolvency. For the years ended December 31, 2022, 2021 and 2020, the Company did not record any expense or make any milestone or royalty payments under the 2016 AstraZeneca Agreement. 2018 AstraZeneca License Agreement In September 2018, the Company entered into an exclusive license agreement (the "2018 AstraZeneca Agreement") with AstraZeneca, pursuant to which AstraZeneca granted the Company a license to certain patent rights for the commercial development, manufacture, distribution and use of any products or processes resulting from development of those patent rights, including BHV-3241 (verdiperstat). Under the 2018 AstraZeneca Agreement, the Company paid AstraZeneca an upfront cash payment of $3,000 and 109,523 shares valued at $4,080 on the date of settlement and is obligated to pay milestone payments to AstraZeneca totaling up to $55,000 upon the achievement of specified regulatory and commercial milestones and up to $50,000 upon the achievement of specified sales-based milestones. In addition, the Company will pay AstraZeneca royalties in three tiers, with each tiered royalty in the range from 0-10% of net sales of specified approved products, subject to specified reductions. In November 2021, the Company completed enrollment in a Phase 3 clinical trial of this product candidate, which is now referred to as verdiperstat, for the treatment of Amyotrophic Lateral Sclerosis ("ALS").In September 2022, the Company announced negative topline results from the Phase 3 clinical trial of verdiperstat for ALS. ALS is a progressive, life-threatening, and rare neuromuscular disease for which there are currently limited treatment options and no cure. The Company is solely responsible, and has agreed to use commercially reasonable efforts, for all development, regulatory and commercial activities related to verdiperstat. The Company may sublicense its rights under the agreement and, if it does so, will be obligated to pay a portion of any milestone payments received from the sublicense to AstraZeneca in addition to any milestone payments it would otherwise be obligated to pay. The 2018 AstraZeneca Agreement terminates on a country-by-country basis and product-by-product basis upon the expiration of the royalty term for such product in such country and can also be terminated if certain events occur, e.g., material breach or insolvency. For the years ended December 31, 2022, 2021 and 2020, the Company did not record any material expense or make any milestone or royalty payments under the 2018 AstraZeneca Agreement. Fox Chase Chemical Diversity Center Inc. Agreement In May 2019, the Company entered into an agreement with FCCDC (the "FCCDC Agreement") pursuant to which the Company purchased certain intellectual property relating to the TDP-43 protein from FCCDC. The FCCDC Agreement provides the Company with a plan and goal to identify one or more new chemical entity candidates for preclinical development for eventual clinical evaluation for the treatment of one or more TDP-43 proteinopathies. As consideration, the Company issued 100,000 of the Former Parent's common shares to FCCDC valued at $5,646. In addition, the Company is obligated to pay FCCDC milestone payments totaling up to $3,000 with $1,000 for each additional NDA filing. The Company also issued a warrant to FCCDC, granting FCCDC the option to purchase up to 100,000 of the Former Parent’s common shares, at a strike price of $56.46 per share, subject to vesting upon achievement of certain milestones in development of TDP-43. In connection with the Separation, the warrants issued to FCCDC were vested and settled, resulting in $4,245 being recorded as research and development expense for the year ended December 31, 2022. In connection with the FCCDC Agreement, the Company and FCCDC have established a TDP-43 Research Plan, which was amended in November 2020, under which the Company will pay FCCDC an earned royalty equal to 0% to 10% of net sales of any TD-43 patent products with a valid claim as defined in the FCCDC Agreement. The Company may also license the rights developed under the FCCDC Agreement and, if it does so, will be obligated to pay a portion of any payments received from such licensee to FCCDC in addition to any milestones it would otherwise be obligated to pay. The Company is also responsible for the prosecution and maintenance of the patents related to the TDP-43 assets. The FCCDC Agreement terminates on a country-by-country basis and product-by-product basis upon expiration of the royalty term for such product in such country and can also be terminated if certain events occur, e.g., material breach or insolvency. The Company did not record any material research and development expense or make any milestone payments related to the FCCDC Agreement in the consolidated statements of operations during the years ended December 31, 2022, 2021 and 2020. UConn In October 2018, the Company announced it had signed an exclusive, worldwide option and license agreement (the “UConn Agreement”) with the University of Connecticut (“UConn”) for the development and commercialization rights to UC1MT, a therapeutic antibody targeting extracellular metallothionein. Under the UConn Agreement, the Company had the option to acquire an exclusive, worldwide license to UC1MT and its underlying patents to develop and commercialize throughout the world in all human indications (the "UConn Option"). In September 2022, the Company exercised the UConn Option in exchange for a payment of $400. Under the UConn Agreement, UConn is entitled to milestone payments upon the achievement of specified developmental and regulatory milestones of up to $30,100 and commercial milestones of up to $50,000, and royalties of a low single-digit percentage of net sales of licensed products. Excluding the payment made in connection with the exercise of the UConn Option, for the years ended December 31, 2022, 2021 and 2020, the Company did not record any research and development expense or make any milestone payments related to the UConn Agreement. Artizan Agreement In December 2020, the Company entered into an Option and License Agreement (the "2020 Artizan Agreement") with Artizan Biosciences Inc. ("Artizan"). Pursuant to the 2020 Artizan Agreement, the Company acquired an option (“Biohaven Option”) to obtain a royalty-based license from Artizan to manufacture, use and commercialize certain products in the United States for the treatment of diseases, including, for example, inflammatory bowel disease and other gastrointestinal inflammatory disorders, e.g., Crohn’s disease. The Biohaven Option is exercisable throughout the development phase of the products at an exercise price of approximately $4,000 to $8,000, which varies based on the market potential of the products. The Company and Artizan have also formed a joint steering committee to oversee, review and coordinate the product development activities with regard to all products for which we have exercised (or will exercise in the future) the Biohaven Option. In December 2020, simultaneously with the 2020 Artizan Agreement, the Company entered into a Series A-2 Preferred Stock Purchase Agreement with Artizan. Under the agreement, the Company paid Artizan 61,494 of the Former Parent’s common shares valued at $6,000, which were issued in January 2021. In exchange, the Company acquired 34,472,031 shares of series A-2 preferred stock of Artizan. In June 2021, the Company entered into a Development and License Agreement with Artizan Biosciences Inc (the "2021 Artizan Agreement"). Pursuant to the 2021 Artizan Agreement, the Company acquired an exclusive, worldwide license under Artizan’s IgA-SEQ patented technology and know-how to develop, manufacture and commercialize certain of Artizan’s compounds for use in Parkinson’s Disease. Under the 2021 Artizan Agreement, the Company is responsible for funding the development of the compounds, obtaining regulatory approvals, manufacturing the compounds and commercializing the compounds. the Company is also responsible for the prosecution, maintenance and enforcement of Artizan’s patents. The Company will pay Artizan development milestones of $20,000 for the first licensed compound to achieve U.S. marketing authorization and $10,000 for each subsequent U.S. approval. In addition, the Company will pay Artizan commercialization milestones totaling up to $150,000 and royalties in the low- to mid-single digits. The 2021 Artizan Agreement terminates on a country-by-country basis on the later of 10 years from the first commercial sale of licensed product in such country or the expiration of Artizan’s patents in such country and can also be terminated if certain events occur, e.g., material breach or insolvency. In June 2022, the Company entered into an amendment (the "Amendment") to the Series A-2 Preferred Stock Purchase Agreement with Artizan. Under the Amendment, the Company made a cash payment of $4,000 in exchange for 22,975,301 shares of series A-2 preferred stock of Artizan out of a total of 45,950,601 shares of series A-2 preferred stock of Artizan for a total raise of $8,000 (the “A2 Extension Raise”). Along with the Amendment, the Company and Artizan executed a non-binding indication of interest (“Artizan Side Letter”), which describes terms under which the Company and Artizan would amend the 2020 Artizan Agreement to eliminate certain milestone payments required by us in exchange for limiting our option to the selection of the first licensed product. The Artizan Side Letter required Artizan to commit at least 80% of the funds raised in the A-2 Extension Raise to a certain program and to raise $35,000 of additional capital within a certain time. As of December 31, 2022, due to concerns related to Artizan's inability to fund its future operations, the Company determined its investment in Artizan to be fully impaired. Accordingly, during the fourth quarter of 2022 the Company recognized an impairment loss of $10,000 in other income (expense) on the consolidated statements of operations. For the years ended December 31, 2022, 2021 and 2020, excluding the upfront payments above, the Company did not record any research and development expense or make any milestone payments related to the 2020 Artizan Agreement and the 2021 Artizan Agreement. Moda Agreement On January 1, 2021, the Company entered into a consulting services agreement (the "Moda Agreement") with Moda Pharmaceuticals LLC ("Moda") to further the scientific advancement of technology, drug discovery platforms (including the technology licensed under the Yale MoDE Agreement), product candidates and related intellectual property owned or controlled by the Company. Under the Moda Agreement, the Company paid Moda an upfront cash payment of $2,700 and 37,836 shares of the Former Parent valued at approximately $3,243. In addition, Moda will be eligible to receive additional development milestone payments of up to $81,612 and commercial milestone payments of up to $30,171. The Moda Agreement has a term of four years and may be terminated earlier by the Company or Moda under certain circumstances including, for example, the Company's discontinuation of research on the MoDE platform or default. For the years ended December 31, 2022 and 2021, excluding the upfront payments above, the Company did not record any material research and development expense or make any milestone payments related to the Moda Agreement. Reliant Agreement In July 2021, the Company entered into a development and licensing agreement (the "Reliant Agreement") with Reliant Glycosciences LLC ("Reliant"), pursuant to which the Company and Reliant have agreed to collaborate on a program with Biohaven Labs’ multifunctional molecules to develop and commercialize conjugated antibodies for therapeutic uses relating to IgA nephropathy and treatment of other diseases and conditions. Under the Reliant Agreement, the Company paid Reliant an upfront payment in the form of issuance of common shares of the Former Parent valued at approximately $3,686, which the Company recorded as research and development expense on its consolidated statement of operations. In addition, Reliant will be eligible to receive development and regulatory milestone payments of up to $36,500, and royalties of a low single-digit percentage of net sales of licensed products. Excluding the upfront payment discussed above, for the years ended December 31, 2022 and 2021, the Company did not record any material research and development expense related to the Reliant Agreement. KU Leuven Agreement In January 2022, the Company and Katholieke Universiteit Leuven ("KU Leuven") entered into an Exclusive License and Research Collaboration Agreement (the "KU Leuven Agreement") to develop and commercialize TRPM3 antagonists to address the growing proportion of people worldwide living with chronic pain disorders. The TRPM3 antagonist platform was discovered at the Centre for Drug Design and Discovery and the Laboratory of Ion Channel Research at KU Leuven. Under the KU Leuven Agreement, the Company receives exclusive global rights to develop, manufacture and commercialize KU Leuven's portfolio of small-molecule TRPM3 antagonists. The portfolio includes the lead candidate, henceforth known as BHV-2100, which is being evaluated in preclinical pain models and will be the first to advance towards Phase 1 studies. The Company will support further basic and translational research at KU Leuven on the role of TRPM3 in pain and other disorders. As consideration, KU Leuven received an upfront cash payment of $3,000 and 15,340 shares of the Former Parent valued at $1,779, and is eligible to receive additional development, regulatory, and commercialization milestones payments of up to $327,750. In addition, KU Leuven will be eligible to receive mid-single digit royalties on net sales of products resulting from the collaboration. Excluding the upfront payments discussed above, for the year ended December 31, 2022, the Company did not record any material research and development expense related to the KU Leuven Agreement. Taldefgrobep Alfa License Agreement In February 2022, following the transfer of intellectual property, the Company announced that it entered into a worldwide license agreement with BMS for the development and commercialization rights to taldefgrobep alfa (also known as BMS-986089), a novel, Phase 3-ready anti-myostatin adnectin (the "Taldefgrobep Alfa License Agreement"). Under the terms of the Taldefgrobep Alfa License Agreement, the Company will receive worldwide rights to taldefgrobep alfa and BMS will be eligible for regulatory approval milestone payments of up to $200,000, as well as tiered, sales-based royalty percentages from the high teens to the low twenties. There were no upfront or contingent payments to BMS related to the Taldefgrobep Alfa License Agreement. For the year ended December 31, 2022, the Company did not record any material expense or make any milestone or royalty payments under the Taldefgrobep Alfa License Agreement. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies All consideration paid by the Former Parent in association with the following agreements, certain of which were assigned by the Former Parent to the Company in connection with the Spin-Off, during the periods prior to the Separation is recorded in the consolidated financial statements of the Company. Lease Agreements The Former Parent’s leases primarily consisted of lab and office space that was attributed to the Company in connection with the Spin-Off. For periods prior to Separation, lease costs were allocated to the Company based on a proportional cost allocation method. The Company's leases post-separation consist of lab and office space for use in its operations. Its leases generally have lease terms of 1 to 10 years, some of which include options to extend for up to 5 to 10 years or on a month-to-month basis. The Company includes extension options that are reasonably certain to be exercised as part of determination of lease terms. As of December 31, 2022, none of the Company's lease terms included the extension option as the Company has determined that it is unlikely to exercise the extension option. Allocated operating lease cost for periods prior to Separation and actual operating lease cost was $1,158, $264 and $0 for the years ended December 31, 2022, 2021 and 2020, respectively. The Company currently has three short-term real estate leases with immaterial lease expense. The Company had immaterial sublease income and there are no sale-leaseback transactions. Certain of the Company’s lease agreements contain variable lease payments that are adjusted for actual operating expense true-ups compared with estimated amounts; however, these amounts are immaterial. The Company’s lease agreements do not contain any material residual value guarantees or material restrictive covenants. The following table summarizes supplemental cash flow information: Years Ended December 31, 2022 2021 2020 Right-of-use assets obtained in exchange for new operating lease liabilities (1) $ 31,342 $ 478 $ 3,681 (1) This figure excludes $2,850 of opening adjustments to the right-of-use operating asset due to leasehold improvements originally classified in other non-current assets and transferred to the right-of-use operating asset at lease commencement in 2020. Operating cash flows paid for operating leases were immaterial for all periods prior to the Separation, and $780 for the year ended December 31, 2022. Supplemental balance sheet information related to leases is as follows: In thousands, except remaining lease term and discount rate December 31, 2022 December 31, 2021 Assets Other non-current assets $ 34,928 $ 5,222 Liabilities Other current liabilities $ 3,019 $ 439 Long-term operating lease liability 30,581 2,797 $ 33,600 $ 3,236 Weighted average remaining lease term (in years) 9.08 5.75 Weighted average discount rate 6.55 % 9.07 % The following table summarizes maturities of operating lease liabilities as of December 31, 2022: Operating leases 2023 4,929 2024 4,981 2025 4,742 2026 4,865 2027 4,499 Thereafter 20,563 Total lease payments 44,579 Less: imputed interest (10,979) Total lease liabilities $ 33,600 West Palm Beach Lease Agreement In June 2022, the Company entered into a lease agreement in West Palm Beach, Florida for office space (the "West Palm Beach Lease"), which will be used for general office purposes. The lease is expected to commence in late 2024 after substantial completion of building improvements, and has a term of 120 months, with an option to extend for two additional periods of 60 months each. The Company expects to record the West Palm Beach Lease as an operating lease. The Company has annual commitments relating to the West Palm Beach Lease ranging from $1,263 to $1,649. Research Commitments The Former Parent has entered into agreements with several CROs to provide services in connection with the Company’s preclinical studies and clinical trials. Research commitments entered into by the Former Parent and related to the Company were transferred to the Company upon separation. As of December 31, 2022, the Company had remaining maximum research commitments in excess of one year of approximately $18,750, which are variable based on number of trial participants, and contingent upon the achievement of certain milestones of the clinical trials covered under the agreements. If all related milestones are achieved, the Company expects these amounts to be paid over the next five years. Indemnification Agreements In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and executive officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. The Company’s amended and restated memorandum and articles of association also provide for indemnification of directors and officers in specific circumstances. To date, the Company has not incurred any material costs as a result of such indemnification provisions. The Company does not believe that the outcome of any claims under indemnification arrangements will have a material effect on its financial position, results of operations or cash flows, and it has not accrued any liabilities related to such obligations in its consolidated financial statements as of December 31, 2022 or December 31, 2021. License Agreements The Former Parent entered into license agreements with various parties that are directly attributed to the Company under which it is obligated to make contingent and non-contingent payments (see Note 11). Upon the October 3, 2022 separation from the Former Parent, license agreements entered by the Former Parent and related to the Company were transferred to the Company. Sixth Street Financing Agreement In August 2020, the Former Parent and Biohaven Pharmaceuticals, Inc., (together with the Former Parent the "Borrowers"), entered into a financing agreement, as amended, with Sixth Street Specialty Lending, Inc., as administrative agent, and the lenders party thereto (the "Lenders") pursuant to which the Lenders agreed to extend a senior secured credit facility to the Borrowers (as amended, the “Sixth Street Financing Agreement”). The Sixth Street Financing Agreement provided for term loans in an aggregate principal amount up to $750,000, plus any capitalized interest paid in kind, and was accounted for as third-party, long-term debt by the Former Parent. The Company was a co-obligor, jointly and severally with the Former Parent on its third-party long-term debt obligation under the Sixth Street Financing Agreement. The Former Parent’s third-party debt and related interest expense are not reflected in the consolidated financial statements because the Company had not agreed to pay a specified amount of the borrowings on the basis of its arrangement with the Former Parent, nor was the Company expected to pay any portion of the Former Parent’s third-party debt, and the borrowings were not specifically identifiable to the Company. On October 3, 2022, an affiliate of Pfizer, on behalf of the Former Parent, repaid in full all of the indebtedness and other obligations and liabilities owed by the Former Parent, including prepayment penalties. In connection with the termination and repayment in full of the indebtedness and other obligations and liabilities under the Sixth Street Financing Agreement, all related liens and security interests granted by or arising under the Sixth Street Financing Agreement were automatically released and discharged. Legal Proceedings From time to time, in the ordinary course of business, the Company is subject to litigation and regulatory examinations as well as information gathering requests, inquiries and investigations. As of December 31, 2022, there were no matters which would have a material impact on the Company’s financial results. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The income tax expense in the consolidated financial statements has been calculated on a separate return method and is presented as if the Company’s operations were separate taxpayers in the respective jurisdictions up to and including the Separation. Cash tax payments, income taxes receivable and deferred taxes, net of valuation allowance, are reflective of its actual tax balances prior and subsequent to the Distribution. As a company incorporated in the British Virgin Islands (“BVI”), the Company is principally subject to taxation in the BVI. Under the current laws of the BVI, the Company and all dividends, interest, rents, royalties, compensation and other amounts paid by the Company to persons who are not resident in the BVI and any capital gains realized with respect to any shares, debt obligations, or other securities of the Company by persons who are not resident in the BVI are exempt from all provisions of the Income Tax Ordinance in the BVI. The Former Parent historically outsourced all of the research and clinical development for its programs under a master services agreement with Biohaven Pharmaceuticals, Inc. (“BPI”). As a result of providing services under this agreement, BPI was profitable during the years ended December 31, 2022, 2021 and 2020, and BPI is subject to taxation in the United States. As such, in each reporting period, the Company's tax provision includes the effects of consolidating the results of operations of BPI. At December 31, 2022 and 2021, the Company continued to maintain a full valuation allowance against its net deferred tax assets, which are comprised primarily of capitalized research and development deductions, research and development tax credit carryforwards and net operating loss carryforwards, based on management’s assessment that it is more likely than not that the deferred tax assets will not be realized. The Company recorded an income tax provision during the years ended December 31, 2022, 2021 and 2020 of $438 , $1,366 and $0 respectively, which primarily represents U.S. Federal and state taxes related to the Company’s profitable operations of BPI in the U.S. Loss before provision for income taxes consisted of the following: Year Ended December 31, 2022 2021 2020 BVI $ (598,046) $ (211,334) $ (123,468) Foreign 28,205 (1,096) 4,800 Loss before provision for income taxes $ (569,841) $ (212,430) $ (118,668) The provision for income taxes consisted of the following: Year Ended December 31, 2022 2021 2020 Current income tax provision: BVI $ — $ — $ — Foreign 438 1,366 — Total current income tax provision 438 1,366 — Deferred income tax provision (benefit): BVI — — — Foreign — — — Total deferred income tax provision (benefit) — — — Total provision for income taxes $ 438 $ 1,366 $ — A reconciliation of the BVI statutory income tax rate of 0% to the Company's effective income tax rate is as follows: Year Ended December 31, 2022 2021 2020 BVI statutory income tax rate 0.0 % 0.0 % 0.0 % Foreign tax rate differential (12.6) 0.0 1.0 Tax credits (5.8) (5.0) (6.0) Change in valuation allowance 18.5 7.0 9.0 Other 0.0 (1.0) (4.0) Effective income tax rate 0.1 % 1.0 % 0.0 % Net deferred tax assets (liabilities) consisted of the following: December 31, 2022 2021 Deferred tax assets: Foreign net operating loss carryforwards $ 8,895 $ 9,573 Tax credits 60,340 26,590 Accrued bonus 3,440 — Non-cash share-based compensation 1,298 18,246 R&D capitalization 142,269 — Other 467 4,917 Valuation allowance (216,061) (54,224) Total deferred tax assets 648 5,102 Deferred tax liabilities: Depreciation (648) — Intangible assets and other — (5,102) Total deferred tax liabilities (648) (5,102) Net deferred tax asset (liability) $ — $ — In January 2021, the Company completed the acquisition of Kleo. The Company recorded a full valuation allowance against its Kleo deferred tax assets and periodically reviews its position. Due to Kleo's cumulative loss history, the Company determined that a full valuation allowance on these assets was appropriate. The Company will continue to evaluate the need for a valuation allowance on its deferred tax assets until there is sufficient positive evidence to support the reversal of all or some portion of these allowances. As of December 31, 2022, and 2021, the Company had foreign net operating loss carryforwards of $69,214 and $39,281, respectively. As of December 31, 2022, and 2021, the Company had federal and state research and development and orphan drug credits of $60,340 and $26,590, respectively, which begin to expire in 2039. Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2022 and 2021 were due primarily to generation of nondeductible research expenses and tax credit carryforwards. Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2021 and 2020 were due primarily to the acquisition of Kleo, an increase in the amount of carryforward tax credits for research and development, and an increase in future tax deductions for share awards to employees. Year Ended December 31, 2022 2021 2020 Valuation allowance as of beginning of year $ 54,224 $ 32,970 $ 23,592 Increases recorded to Purchase Accounting and Net Investment from Former Parent 50,905 6,449 (1,089) Increases recorded to income tax provision 110,932 14,805 10,467 Valuation allowance as of end of year $ 216,061 $ 54,224 $ 32,970 The Company followed the authoritative guidance for recognizing and measuring uncertainty in income taxes for tax positions taken or expected to be taken in a tax return. The beginning and ending amounts of unrecognized tax benefits reconciles as follows: Year Ended December 31, 2022 2021 2020 Beginning of period balance $ 3,800 $ 2,700 $ 1,800 Increase for tax positions taken during the current period — 50 — (Decreases) increases recorded to Purchase Accounting and Net Investment from Former Parent (1,600) 1,050 900 End of period balance $ 2,200 $ 3,800 $ 2,700 The unrecognized tax benefits relate primarily to issues common among multinational corporations. All of these unrecognized tax benefits, if recognized, would impact the Company's effective income tax rate. The Company's policy is to record interest and penalties related to income taxes, if any, as part of its income tax provision. As of December 31, 2022 and 2021, the total amount of accrued interest and penalties was not significant. BPI and Kleo file income tax returns in the U.S. and certain state jurisdictions. BPI’s U.S. federal and |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions Relationship with the Former Parent Upon the effectiveness of the Separation on October 3, 2022, the Former Parent ceased to be a related party to the Company and accordingly, no related party transactions or balances are reported subsequent to October 3, 2022. On October 3, 2022, the Company entered into agreements with the Former Parent in connection with the Separation, including the following: Transition Services Agreement. The Company entered into a Transition Services Agreement with the Former Parent (the “Transition Services Agreement”) under which the Company or one of its affiliates will provide the Former Parent, and the Former Parent or one of its affiliates will provide the Company, with certain transition services for a limited time to ensure an orderly transition following the Spin-Off. The services that the Company and the Former Parent agreed to provide to each other under the Transition Services Agreement include certain finance, information technology, clinical study support, human resources and compensation, facilities, financial reporting and accounting and other services. The Company will pay the Former Parent, and the Former Parent will pay the Company, for any such services received by the Former Parent or the Company, as applicable, at agreed amounts as set forth in the Transition Services Agreement. Amounts received in connection with the Transition Services Agreement are recorded as other income on the consolidated statement of operations, as they are outside of the normal operating business of the Company. For the year ended December 31, 2022, the Company recorded $4,024 in other income reflecting transition services provided to the Former Parent, of which $2,748 was included as a receivable in other current assets on the consolidated balance sheet as of December 31, 2022. United States Distribution Services Agreement. The Company entered into a United States Distribution Services Agreement with the Former Parent, pursuant to which the Company shall continue to serve as the Former Parent’s distributor and agent for the distribution of the pharmaceutical product Nurtec ODT in the United States for a limited period of time following the Spin-Off. Under the Distribution Services Agreement, the Former Parent and Pfizer Inc. have agreed to indemnify the Company for, among other things, losses resulting from the conduct of the distribution business or actions taken at the direction of the Former Parent. As the Company is acting as an agent of the Former Parent for services performed under the Distribution Services Agreement, no amounts for revenues or expenses relating to the services performed thereunder are included on the Company's consolidated financial statements. As of December 31, 2022, the Company recorded restricted cash held on behalf of Former Parent of $35,212 and Due to Former Parent of $35,212 on the consolidated balance sheet primarily relating to cash held in connection with the execution of the Distribution Services Agreement which is legally payable to the Former Parent. Outsourcing & Employee Transfer Agreements. The Company entered into Outsourcing & Employee Transfer Agreements, one with Pfizer Inc., Bulldog (BVI) Ltd., the Former Parent and Biohaven Pharmaceuticals, Inc. (“U.S. Employer”), and the other with Pfizer Inc., Bulldog (BVI) Ltd., the Former Parent, and BioShin (Shanghai) Consulting Services Co., Ltd. (“Chinese Employer”), pursuant to which the Chinese Employer and the U.S. Employer will, among other things, provide Pfizer Inc. with the services of, and remain the employers of, certain of their employees for a limited period of time following the Spin-Off. During such period, Pfizer Inc. or one of its affiliates will pay the U.S. Employer for employee-related expenses for its employees (including the cost of salary and wages) and will pay the Chinese Employer a service fee based on employee-related expenses for its employees (including the cost of salary and wages). Amounts received in connection with the Outsourcing & Employee Transfer Agreements are recorded against their related operating expenses as they represent reimbursements for operating expenses incurred by the Company on behalf of the Former Parent. Relationship with the Former Parent prior to the Separation Pursuant to the Distribution Agreement, immediately prior to the Separation the Former Parent made a cash contribution to the Company which resulted in a cash balance of approximately $257,799 as of October 3, 2022. Prior to the Separation, the Company did not historically operate as a standalone business and the consolidated financial statements are derived from the consolidated financial statements and accounting records of the Former Parent. The following disclosure summarizes activity between the Company and the Former Parent prior to the Separation, including the affiliates of the Former Parent that were not part of the Spin-Off. Cost Allocations The consolidated financial statements for periods prior to the Separation reflect allocations of certain expenses from the financial statements of the Former Parent, including research and development expenses and general and administrative expenses. These allocations include, but are not limited to, executive management, employee compensation and benefits, facilities and operations, information technology, business development, financial services (such as accounting, audit, and tax), legal, insurance, and non-cash share-based compensation. For periods prior to the Separation, these allocations to the Company are reflected in the consolidated statement of operations as follows: Year Ended December 31, 2022 2021 2020 Research and development $ 146,521 $ 70,929 $ 33,482 General and administrative 82,744 33,928 14,646 Total $ 229,265 $ 104,857 $ 48,128 Management believes these cost allocations are a reasonable reflection of services provided to, or the benefit derived by, the Company during the periods presented. The allocations may not, however, be indicative of the actual expenses that would have been incurred had the Company operated as a standalone public company. Actual costs that may have been incurred if the Company had been a standalone public company would depend on a number of factors, including the chosen organizational structure, what corporate functions the Company might have performed directly or outsourced and strategic decisions the Company might have made in areas such as executive management, legal and other professional services, and certain corporate overhead functions. Non-Cash Share-Based Compensation As discussed in Note 9, "Non-Cash Share-Based Compensation", prior to the Separation, Biohaven employees participated in the Former Parent’s non-cash share-based compensation plans, the costs of which, including those related to the Acceleration, have been allocated to the Company and recorded in research and development and general and administrative expenses in the consolidated statements of operations for periods prior to the Separation. Net Transfers From Former Parent Net transfers from Former Parent represent the net effect of transactions between the Company and the Former Parent prior to the Separation. The components of net transfers from Former Parent are as follows: Year Ended December 31, 2022 (1) 2021 2020 General financing activities $ 399,231 $ 98,834 $ 73,614 Corporate cost allocations, excluding non-cash share-based compensation 49,899 39,218 18,628 Net transfers from Former Parent as reflected in the Consolidated Statement of Cash Flows 449,130 138,052 92,242 Non-cash share-based compensation 179,367 65,639 29,500 Issuance of Former Parent common shares to repurchase non-controlling interest in a subsidiary 60,000 — Issuance of Former Parent common shares for building purchase — 4,871 — Issuance of Former Parent common shares as payment for IPR&D asset acquisition 58,747 — — Issuance of Former Parent common shares as payment for business acquisition — 10,673 — Issuance of Former Parent common shares as payment for Artizan investment — 6,000 — Issuance of Former Parent common shares as payment for license and consulting agreements 1,779 7,929 — Separation related adjustments (2) 27,811 — — Other non-cash adjustments (204) (1,458) (744) Net transfers from Former Parent as reflected in the Consolidated Statement of Changes in Equity $ 776,630 $ 231,706 $ 120,998 (1) The amounts for the year ended December 31, 2022 represent activity through the date of Separation. (2) Refer to Note 1 for further details on separation related adjustments. Related Party Agreements License Agreement with Yale On September 30, 2013, the Company entered into the Yale Agreement with Yale (see Note 11 for details). The Company’s Chief Executive Officer is one of the inventors of the patents that the Company has licensed from Yale and, as such, is entitled to a specified share of the glutamate product-related royalty revenues that may be received by Yale under the Yale Agreement. In January 2021, the Company entered into the Yale MoDE Agreement with Yale (see Note 11 for details). Under the license agreement, the Company acquired exclusive, worldwide rights to Yale's intellectual property directed to its MoDE platform. As part of consideration for this license, the Company paid Yale University an upfront cash payment of $1,000 and 11,668 common shares of the Former Parent valued at approximately $1,000. For the years ended December 31, 2022, 2021 and 2020, the Company recorded $3,420, $458 and $138, respectively, in research and development expense related to the Yale MoDE Agreement and Yale Agreement (the "Yale Agreements"). As of December 31, |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Agreement with Hangzhou Highlightll Pharmaceutical Co. Ltd. In March 2023, the Company and Hangzhou Highlightll Pharmaceutical Co. Ltd. ("Highlightll") entered into an exclusive, worldwide (excluding People’s Republic of China and its territories and possessions) license agreement (the "Highlightll Agreement") whereby Biohaven obtained the right to research, develop, manufacture and commercialize Highlightll’s brain penetrant dual TYK2/JAK1 inhibitor program. As partial consideration for the Highlightll Agreement, the Company is obligated to pay Highlightll a cash payment of $10,000 and common shares valued at approximately $10,000 as of the agreement execution, upon the completion of certain post-closing activities. Under the Highlightll Agreement, the Company is obligated to make milestone payments to Highlightll totaling up to $200,000 upon the achievement of specified developmental, regulatory and commercial milestones for a first indication, up to $100,000 upon the achievement of pre-specified developmental, regulatory and commercial milestones for a second indication, and up to $650,000 upon the achievement of specified sales-based milestones. Additionally, the Company has agreed to make tiered royalty payments as a percentage of net sales starting at mid single digits and peaking at low teens digits. During the royalty term, if the Company offers to include China clinical sites in its Phase 3 study sufficient for submission to Chinese National Medical Products Administration ("NMPA") and Highlightll, at its sole discretion, agrees, then Highlightll will pay royalties in the low tens digits to the Company on China sales upon approval. The Highlightll Agreement terminates on a country-by-country basis upon expiration of the royalty term and can also be terminated if certain events occur, e.g., material breach or insolvency. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of income and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the valuation of intangible assets, determining the allocations of costs and expenses from the Former Parent and the accrual for research and development expenses. In addition, management’s assessment of the Company’s ability to continue as a going concern involves the estimation of the amount and timing of future cash inflows and outflows. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates. |
Reclassifications | Reclassifications Certain items in the prior period’s consolidated financial statements have been reclassified to conform to the current year presentation. |
Cash and Cash Equivalents | Cash and Cash EquivalentsThe Company considers all highly liquid investments with an original maturity of 90 days or less at the date of purchase to be cash equivalents. The Company's cash equivalents are comprised of short-term money market funds and marketable securities that are highly liquid and readily convertible to known amounts of cash. |
Restricted Cash | Restricted cash held on behalf of the Former Parent on the consolidated balance sheet as of December 31, 2022 represents cash held by the Company on behalf of the Former Parent related to the execution of the United States Distribution Services Agreement (the “Distribution Services Agreement”). Pursuant to the terms of the Distribution Services Agreement, which was entered into by the Company and the Former Parent in connection with the Separation, the Company is continuing to serve as the Former Parent’s distributor and agent for the distribution of the pharmaceutical product Nurtec ODT in the United States. As of December 31, 2022, the Company recorded a related payable of $35,212 as Due to Former Parent on the consolidated balance sheet as the balance was legally payable to the Former Parent. Refer to Note 14, "Related Party Transactions" for further information on the agreements entered into by the Company and the Former Parent in connection with the Separation. Restricted cash included in other current assets includes employee contributions to the Company's employee share purchase plan held for future purchases of the Company's outstanding shares. See Note 9, "Non-Cash Share-Based Compensation" for additional information on the Company's employee share purchase plan. The Company did not have an employee share purchase plan as of December 31, 2021. |
Marketable Securities | Marketable Securities We invest our excess cash balances in marketable securities of highly rated financial institutions and investment-grade debt instruments. We seek to diversify our investments and limit the amount of investment concentrations for individual institutions, maturities and investment types. We classify marketable debt securities as available-for-sale and, accordingly, record such securities at fair value. We classify these securities as current assets as these investments are intended to be available to the Company for use in funding current operations. Unrealized gains and losses on our marketable debt securities that are deemed temporary are included in accumulated other comprehensive income as a separate component of stockholders’ equity. If any adjustment to fair value reflects a significant decline in the value of the security, we evaluate the extent to which the decline is determined to be other-than-temporary and would mark the security to market through a charge to our consolidated statement of operations. Credit losses are identified when we do not expect to receive cash flows sufficient to recover the amortized cost basis of a security. In the event of a credit loss, only the amount associated with the credit loss is recognized in operating results, with the amount of loss relating to other factors recorded in accumulated other comprehensive income. |
Acquisitions | Acquisitions Our consolidated financial statements include the operations of acquired businesses after the completion of the acquisitions. We account for acquired businesses |
Equity Method Investments | Equity Method Investments Investments in non-public companies in which the Company owns less than a 50% equity interest and where it has the ability to exercise significant influence over the operating and financial policies of the investee are accounted for using the equity method of accounting. The Company's proportionate share of the net income or loss of the equity method investment is included in other income (expense), net in the consolidated statement of operations and results in a corresponding adjustment to the carrying value of the investment on the consolidated balance sheet. Dividends received reduce the carrying value of the investment. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost and depreciated or amortized using the straight-line method over the estimated useful lives of the respective assets. As of December 31, 2022 and December 31, 2021, the Company's property and equipment consisted of office buildings and land, office and lab equipment, computer hardware and software, and furniture and fixtures. The fixed assets have the following useful lives: Building 30 years Office equipment 3 - 5 years Computer hardware and software 3 - 5 years Lab equipment 3 years Furniture and fixtures 3 years Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance are charged to expense as incurred. Property and equipment are monitored regularly for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. |
Intangible Assets | Intangible Assets Acquired In-Process Research and Development IPR&D that the Company acquires in conjunction with the acquisition of a business represents the fair value assigned to incomplete research projects which, at the time of acquisition, have not reached technological feasibility. The amounts are capitalized and accounted for as indefinite-lived intangible assets, subject to impairment testing until completion or abandonment of the projects. Upon successful completion of each project, the asset is classified as a definite-lived intangible and the Company will make a determination as to the then-useful life of the intangible asset, generally determined by the period in which the substantial majority of the cash flows are expected to be generated, and begin amortization. The Company evaluates IPR&D for impairment at least annually, or more frequently if impairment indicators exist, by performing a quantitative test that compares the fair value of the IPR&D intangible asset with its carrying value. If the fair value is less than the carrying amount, an impairment loss is recognized in operating results. The Company believes no impairment of its acquired IPR&D existed as of December 31, 2022 or December 31, 2021. If we acquire an asset or group of assets that do not meet the definition of a business under applicable accounting standards, the acquired IPR&D is expensed on its acquisition date, unless it has an alternative future use. Future costs to develop these assets are recorded to research and development expense as they are incurred. In January 2021, in connection with our acquisition of Kleo, we recorded intangible assets consisting of |
Impairment of Long-lived Assets | Impairment of Long-lived Assets The Company monitors its long-lived assets for indicators of impairment. If such indicators are present, the Company assesses the recoverability of affected assets by determining whether the carrying value of such assets is less than the sum of the undiscounted future cash flows of the assets. If such assets are found not to be recoverable, the Company measures the amount of such impairment by comparing the carrying value of the assets to the fair value of the assets, with the fair value generally determined based on the present value of the expected future cash flows associated with the assets. The Company believes no impairment of long-lived assets existed as of December 31, 2022 or December 31, 2021. |
Fair Value Measurements | Fair Value Measurements Certain assets of the Company are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable: • Level 1— Quoted prices in active markets for identical assets or liabilities. • Level 2— Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. • Level 3— Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. The carrying values of other current assets, accounts payable, and accrued expenses approximate |
Leases | Leases The Company determines if an arrangement contains a lease at the inception of a contract. Right-of-use assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Right-of-use assets and lease liabilities are recognized at the commencement date based on the present value of the remaining future minimum lease payments. If the interest rate implicit in the Company’s leases is not readily determinable, the Company utilizes an estimate of its incremental borrowing rate based on market sources including interest rates for companies with similar credit quality for agreements of similar duration, determined by class of underlying asset, to discount the lease payments. The right-of-use assets also include lease payments made before commencement and exclude lease incentives. The Company's lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Leases with an initial term of 12 months or less are not recorded on the balance sheet. Lease expense for these short-term leases are expensed as incurred over the term of the lease. Certain real estate leases require additional payments including reimbursement for real estate taxes, common area maintenance and insurance, which are expensed as incurred as variable lease costs. Other real estate leases contain one fixed lease payment that includes real estate taxes, common area maintenance and insurance. These fixed payments are considered part of the lease payment and included in the right-of-use assets and lease liabilities. For its real estate leases, which are accounted for as operating leases, the Company has elected the practical expedient to include both the lease and non-lease components as a single component. In addition, payments made by the Company for improvements to the underlying asset, if the payment relates to an asset of the lessor, are recorded as prepaid rent within other non-current assets in the consolidated balance sheets prior to lease commencement and on commencement, reclassified to the right-of-use asset. As of December 31, 2022, the Company had restricted cash of $2,398 included in other non-current assets in the consolidated financial statements, which represents collateral held by banks for letters of credit issued in connection with the leased office space in Yardley, Pennsylvania and Cambridge, Massachusetts. All restricted cash is invested in time deposits. See Note 12, ‘‘Commitments |
Research and Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including salaries, non-cash share-based compensation and benefits, third-party license fees, rent and operating expenses for leased lab facilities, and external costs of vendors engaged to conduct clinical development activities and clinical trials as well as to manufacture clinical trial materials. Non-refundable prepayments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered. The Company has entered into various research and development-related contracts. These agreements are cancellable, and related payments are recorded as research and development expenses as incurred. The Company records accruals for estimated ongoing research costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Certain judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company's estimates. The Company's historical accrual estimates have not been materially different from the actual costs. |
Foreign Currency Translation | Foreign Currency TranslationThe financial statements of our subsidiaries with functional currencies other than the U.S. dollar are translated into U.S. dollars using period-end exchange rates for assets and liabilities, historical exchange rates for stockholders’ equity and weighted average exchange rates for operating results. Translation gains and losses are included in accumulated other comprehensive income, net of tax, in shareholders’ equity. Foreign currency transaction gains and losses are included in other expense in the consolidated statement of operations. The Company's aggregate foreign currency transaction losses were immaterial for the years ended December 31, 2022, 2021 and 2020. |
Share-Based Compensation | Share-Based Compensation The Company measures share options and restricted share unit awards granted to employees, non-employees, and directors based on the fair value on the date of the grant and recognizes compensation expense of those awards, over the requisite service period, which is generally the vesting period of the respective award. Forfeitures are accounted for as they occur. Generally, the Company issues share options with only service-based vesting conditions and records the expense for these awards using the straight-line method. The Company classifies non-cash share-based compensation expense in its consolidated statement of operations in the same manner in which the award recipient's payroll costs are classified or in which the award recipient's service payments are classified. The fair value of each share option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The Company lacks a sufficient history of company-specific historical and implied volatility information for its shares. Therefore, it estimates its expected share price volatility based on the historical volatility of publicly traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded share price. The expected term of all of the Company's stock options has been determined utilizing the "simplified" method. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends on common shares and does not expect to pay any cash dividends in the foreseeable future. Management evaluates its award grants and modifications and will adjust the fair value if any are determined to be spring-loaded. Share-Based Compensation for Periods Prior to the Separation |
Income Taxes | Income Taxes The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company's tax returns. Deferred tax assets and liabilities are determined on the basis of the differences between the consolidated financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies. The provision for income taxes includes the effects of applicable tax reserves, or unrecognized tax benefits, as well as the related net interest and penalties. |
Net Loss per Share | Net Loss per Share Basic net loss per common share is calculated by dividing net loss by the weighted-average shares outstanding during the period. For purposes of the diluted net loss per share calculation, common share options are considered to be common share equivalents but have been excluded from the calculation of diluted net loss per share, as their effect would be anti-dilutive for all periods presented. Therefore, basic and diluted net loss per share were the same for all periods presented. Net Loss per Share for Periods Prior to the Separation Net loss per share for periods prior to the Separation from the Former Parent was calculated based on the 39,375,944 shares of the Company's common shares distributed to the Former Parent's shareholders at the time of the Distribution, including common shares issued in connection with Former Parent share options that were exercised on October 3, 2022 and common shares issued in connection with Former Parent restricted share units that vested on October 3, 2022. The same number of shares is being utilized for the calculation of basic and diluted earnings per share for all periods presented prior to the Spin-Off. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash, cash equivalents, and short-term debt securities. The Company maintains a portion of its cash deposits in government insured institutions in excess of government insured limits. The Company deposits its |
Segment Information | Segment Information The Company manages its operations as a single segment, the development of therapies targeting neurological diseases, including rare disorders, for the purposes of assessing performance and making operating decisions. Consistent with our operational structure, the Company's chief decision maker manages and allocates resources at a consolidated level. Therefore, results of our operations are reported on a consolidated basis for the purposes of assessing performance and making operating decisions. In 2022 and 2021, materially all the Company's long-lived assets were held in the United States. |
Recently Adopted and Issued Accounting Pronouncements | Recently Adopted Accounting Pronouncements Effective January 1, 2022 the Company adopted ASU No. 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the Financial Accounting Standards Board ("FASB") Emerging Issues Task Force), which provides guidance on modifications or exchanges of a freestanding equity-classified written call option that is not within the scope of another topic. An entity should treat a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange as an exchange of the original instrument for a new instrument, and provides further guidance on measuring the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange. ASU 2021-04 also provides guidance on the recognition of the effect of a modification or an exchange of a freestanding equity- classified written call option that remains equity classified after modification or exchange on the basis of the substance of the transaction, in the same manner as if cash had been paid as consideration. The guidance has been applied prospectively and did not have a material effect on the consolidated financial statements of the Company. Recently Issued Accounting Pronouncements In June 2022, the FASB issued ASU No. 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions, to clarify the guidance in Topic 820 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of reconciliation of total cash, cash equivalents and restricted cash | The following represents a reconciliation of cash and cash equivalents in the consolidated balance sheets to total cash, cash equivalents and restricted cash for the years ended December 31, 2022, 2021 and 2020, respectively, in the consolidated statements of cash flows: December 31, 2022 2021 2020 Cash and cash equivalents $ 204,877 $ 76,057 $ 82,506 Restricted cash held on behalf of Former Parent 35,212 — — Restricted cash (included in other current assets) 117 250 — Restricted cash (included in other non-current assets) 2,398 750 1,000 Total cash, cash equivalents and restricted cash at the end of the period in the consolidated statement of cash flows $ 242,604 $ 77,057 $ 83,506 |
Schedule of useful lives of fixed assets | The fixed assets have the following useful lives: Building 30 years Office equipment 3 - 5 years Computer hardware and software 3 - 5 years Lab equipment 3 years Furniture and fixtures 3 years |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of reconciliation of available-for-sale debt securities from amortized cost to fair value | The amortized cost, gross unrealized holding gains, gross unrealized holding losses and fair value of debt securities available-for-sale by type of security at December 31, 2022 was as follows: Amortized Cost Allowance for Credit Losses Net Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value December 31, 2022 Debt securities U.S. corporate bonds $ 142,697 $ — $ 142,697 $ 25 $ (135) $ 142,587 Foreign corporate bonds 36,766 — 36,766 9 (32) 36,743 U.S. treasury bills 89,308 — 89,308 17 (5) 89,320 U.S. agency bonds 41,734 — 41,734 — (24) 41,710 Total $ 310,505 $ — $ 310,505 $ 51 $ (196) $ 310,360 The Company had no available-for-sale debt securities at December 31, 2021. The fair values of debt securities available-for-sale by classification in the consolidated balance sheet were as follows: December 31, 2022 Cash and cash equivalents $ 49,896 Marketable securities 260,464 Total $ 310,360 |
Schedule of available-for-sale debt securities by contractual maturity | The net amortized cost and fair value of debt securities available-for-sale at December 31, 2022 are shown below by contractual maturity. Actual maturities may differ from contractual maturities because securities may be restructured, called or prepaid, or the Company intends to sell a security prior to maturity. December 31, 2022 Net Amortized Cost Fair Value Due to mature: Less than one year $ 310,505 $ 310,360 Total $ 310,505 $ 310,360 |
Summary of debt securities available-for-sale in an unrealized loss position, aggregated by the length of time | Summarized below are the debt securities available-for-sale the Company held at December 31, 2022 that were in an unrealized loss position, aggregated by the length of time the investments have been in that position: Less than 12 months Number of Securities Fair Value Unrealized Losses December 31, 2022 Debt securities U.S. corporate bonds 16 $ 104,508 $ (135) Foreign corporate bonds 3 31,886 (32) U.S. treasury bills 1 9,762 (5) U.S. agency bonds 4 41,710 (24) Total 20 $ 187,866 $ (196) |
Schedule of net investment income | Sources of net investment income included in other expense, net under other income (expense) in the consolidated statements of operations for the years ended December 31, 2022 were as follows: 2022 Gross interest income from debt securities available-for-sale, money-market funds, and cash $ 3,235 Investment expenses (27) Net investment income $ 3,208 |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Summary of the Company's financial assets and liabilities measured at fair value on a recurring basis | Financial assets measured at fair value on a recurring basis on the consolidated balance sheet at December 31, 2022 were as follows: Fair Value Measurement Using: Balance Sheet Classification Type of Instrument Level 1 Level 2 Level 3 Total December 31, 2022 Assets: Cash equivalents Money market funds $ 72,866 $ — $ — $ 72,866 Cash equivalents U.S. treasury bills — 39,948 — 39,948 Cash equivalents U.S. corporate bonds — 9,948 — 9,948 Marketable securities U.S. treasury bills — 49,372 — 49,372 Marketable securities U.S. corporate bonds — 132,639 — 132,639 Marketable securities U.S. agency bonds — 41,710 — 41,710 Marketable securities Foreign corporate bonds — 36,743 — 36,743 Total assets $ 72,866 $ 310,360 $ — $ 383,226 |
Schedule of carrying value and estimated fair value classified by level of fair value hierarchy for financial instruments carried at adjusted cost or contract value | The carrying value and estimated fair value classified by level of fair value hierarchy for financial instruments carried on the consolidated balance sheets at adjusted cost or contract value at December 31, 2022 and 2021 were as follows: Carrying Fair Value Measurement Using: Value Level 1 Level 2 Level 3 Total December 31, 2022 Assets: Series A-2 Preferred Stock investment (1) — N/A N/A N/A N/A December 31, 2021 Assets: Series A-2 Preferred Stock investment (1) 6,000 N/A N/A N/A N/A (1) It was not practical to estimate the fair value of this investment as it represents Series A-2 Preferred Stock of an unlisted company. On a routine basis the Company determined if additional preferred shares of the unlisted company had been issued and adjusted the carrying value of its Series A-2 Preferred Stock investment accordingly. The Series A-2 Preferred Stock investment was recorded in other non-current assets on the consolidated balance sheet at December 31, 2021. As of December 31, 2022, due to concerns related to Artizan's inability to fund its future operations, the Company determined its investment in Artizan to be fully impaired. Accordingly, the Company had no balance on its consolidated balance sheet relating to its investment in Artizan as of December 31, 2022. See Artizan under Note 11, "License Agreements" for additional details on the Series A-2 Preferred Stock investment. |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of property and equipment, net | Property and equipment, net consisted of the following: As of December 31, 2022 As of December 31, 2021 Building and land $ 12,297 $ 12,297 Computer hardware and software 780 1,200 Office and lab equipment 5,501 1,653 Furniture and fixtures 1,202 1,202 $ 19,780 $ 16,352 Accumulated depreciation (4,914) (3,342) 14,866 13,010 Equipment not yet in service 2,646 — Property and equipment, net $ 17,512 $ 13,010 |
Schedule of other assets, noncurrent | Other non-current assets consisted of the following: As of December 31, 2022 As of December 31, 2021 Series A-2 Preferred Stock Investment $ — $ 6,000 Operating lease right-of-use assets 34,928 5,222 Other 2,585 3,216 Other non-current assets $ 37,513 $ 14,438 |
Schedule of accrued expenses and other current liabilities | Accrued expenses and other current liabilities consisted of the following: As of December 31, 2022 As of December 31, 2021 Accrued employee compensation and benefits $ 14,603 $ 9,538 Accrued clinical trial costs 17,788 24,051 Other accrued expenses and other current liabilities 11,715 3,571 Accrued expenses and other current liabilities $ 44,106 $ 37,160 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Schedule of activity in accumulated other comprehensive income | Shareholders’ equity included the following activity in accumulated other comprehensive income (loss) for the years ended December 31, 2022: 2022 Net unrealized investment gains (losses): Beginning of period balance $ — Other comprehensive loss (1) (145) End of period balance (145) Foreign currency translation adjustments: Beginning of period balance — Other comprehensive income (1) 429 End of period balance 429 Total beginning of period accumulated other comprehensive income — Total other comprehensive income (loss) 284 Total end of period accumulated other comprehensive income $ 284 (1) There was no tax on other comprehensive income (loss) during the period. |
Non-Cash Share-Based Compensa_2
Non-Cash Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of non-cash share-based compensation expense | Non-cash share-based compensation expense was classified in the consolidated statements of operations as follows: Year Ended December 31, 2022 2021 2020 Research and development expenses Allocated from Former Parent excluding the Acceleration $ 46,976 $ 39,381 $ 18,475 Allocated from Former Parent related to the Acceleration 61,749 — — 2022 Equity Incentive Plan 7,654 — — Total research and development expenses 116,379 39,381 18,475 General and administrative expenses Allocated from Former Parent excluding the Acceleration 30,951 26,258 11,025 Allocated from Former Parent related to the Acceleration 39,691 — — 2022 Equity Incentive Plan 6,535 — — Total general and administrative expenses 77,177 26,258 11,025 Total non-cash share-based compensation expense $ 193,556 $ 65,639 $ 29,500 |
Schedule of assumptions used to determine the grant-date fair value of stock options granted | The assumptions that the Company used to determine the grant-date fair value of share options granted under the 2022 Plan were as follows, presented on a weighted average basis: Year Ended December 31, 2022 Risk-free interest rate 3.86% Expected term (in years) 5.75 Expected volatility 82.05% Expected dividend yield —% Exercise price $7.00 |
Schedule of stock option activity | The following table is a summary of the Company's share option activity for the year ended December 31, 2022: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term Aggregate Intrinsic Value (in years) Outstanding as of October 3, 2022 0 $ — Granted (1) 13,167,121 $ 5.67 Exercised (1) (4,121,656) $ 2.74 Forfeited (86,250) $ 7.00 Outstanding as of December 31, 2022 8,959,215 $ 7.00 9.75 $ 61,639 Options exercisable as of December 31, 2022 2,212,965 $ 7.00 9.75 $ 15,225 Vested and expected to vest as of December 31, 2022 8,959,215 $ 7.00 9.75 $ 61,639 (1) Includes 4,057,121 share options that were granted and exercised under the Legacy Plan on October 3, 2022 |
Schedule of RSU activity | The following table is a summary of the RSU activity for the year ended December 31, 2022: Number of Shares Weighted Average Grant Date Fair Value Unvested restricted shares outstanding as of October 3, 2022 — $ — Granted 924,093 $ — Forfeited — $ — Vested (924,093) $ — Unvested restricted shares outstanding as of December 31, 2022 — $ — |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of basic and diluted net loss per share | Basic and diluted net loss per share attributable to common shareholders of Biohaven Ltd. was calculated as follows: Year Ended December 31, 2022 2021 2020 Numerator: Net loss attributable to Biohaven Ltd. $ (570,279) $ (213,796) $ (118,668) Denominator: Weighted average common shares outstanding—basic and diluted (1) 44,741,316 39,375,944 39,375,944 Net loss per share attributable to Biohaven Ltd.—basic and diluted $ (12.75) $ (5.43) $ (3.01) (1) Prior to the Spin-Off from the Former Parent on October 3, 2022, Biohaven Ltd. did not operate as an independent company. At the time of the Distribution, 39,375,944 shares of the Company's common stock were distributed to the Former Parent's shareholders, including common shares issued in connection with Former Parent share options that were exercised on October 3, 2022 and common shares issued in connection with Former Parent restricted share units that vested on October 3, 2022. This number of shares is being utilized for the calculation of basic and diluted earnings per share for all periods presented prior to the Spin-Off. |
Schedule of potentially anti-dilutive securities excluded from calculation of diluted net loss per share | The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common shareholders for the periods indicated because including them would have had an anti-dilutive effect: Year Ended December 31, 2022 Options to purchase common shares 8,959,215 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of supplemental cash flow information | The following table summarizes supplemental cash flow information: Years Ended December 31, 2022 2021 2020 Right-of-use assets obtained in exchange for new operating lease liabilities (1) $ 31,342 $ 478 $ 3,681 (1) This figure excludes $2,850 of opening adjustments to the right-of-use operating asset due to leasehold improvements originally classified in other non-current assets and transferred to the right-of-use operating asset at lease commencement in 2020. |
Schedule of supplemental balance sheet information | Supplemental balance sheet information related to leases is as follows: In thousands, except remaining lease term and discount rate December 31, 2022 December 31, 2021 Assets Other non-current assets $ 34,928 $ 5,222 Liabilities Other current liabilities $ 3,019 $ 439 Long-term operating lease liability 30,581 2,797 $ 33,600 $ 3,236 Weighted average remaining lease term (in years) 9.08 5.75 Weighted average discount rate 6.55 % 9.07 % |
Schedule of maturities of financing lease liabilities | The following table summarizes maturities of operating lease liabilities as of December 31, 2022: Operating leases 2023 4,929 2024 4,981 2025 4,742 2026 4,865 2027 4,499 Thereafter 20,563 Total lease payments 44,579 Less: imputed interest (10,979) Total lease liabilities $ 33,600 |
Schedule of maturities of operating lease liabilities | The following table summarizes maturities of operating lease liabilities as of December 31, 2022: Operating leases 2023 4,929 2024 4,981 2025 4,742 2026 4,865 2027 4,499 Thereafter 20,563 Total lease payments 44,579 Less: imputed interest (10,979) Total lease liabilities $ 33,600 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of loss before provision for income taxes | Loss before provision for income taxes consisted of the following: Year Ended December 31, 2022 2021 2020 BVI $ (598,046) $ (211,334) $ (123,468) Foreign 28,205 (1,096) 4,800 Loss before provision for income taxes $ (569,841) $ (212,430) $ (118,668) |
Schedule of provision for income taxes | The provision for income taxes consisted of the following: Year Ended December 31, 2022 2021 2020 Current income tax provision: BVI $ — $ — $ — Foreign 438 1,366 — Total current income tax provision 438 1,366 — Deferred income tax provision (benefit): BVI — — — Foreign — — — Total deferred income tax provision (benefit) — — — Total provision for income taxes $ 438 $ 1,366 $ — |
Schedule of reconciliation of the BVI statutory income tax rate to the company's effective income tax rate | A reconciliation of the BVI statutory income tax rate of 0% to the Company's effective income tax rate is as follows: Year Ended December 31, 2022 2021 2020 BVI statutory income tax rate 0.0 % 0.0 % 0.0 % Foreign tax rate differential (12.6) 0.0 1.0 Tax credits (5.8) (5.0) (6.0) Change in valuation allowance 18.5 7.0 9.0 Other 0.0 (1.0) (4.0) Effective income tax rate 0.1 % 1.0 % 0.0 % |
Schedule of net deferred taxes assets (liabilities) | Net deferred tax assets (liabilities) consisted of the following: December 31, 2022 2021 Deferred tax assets: Foreign net operating loss carryforwards $ 8,895 $ 9,573 Tax credits 60,340 26,590 Accrued bonus 3,440 — Non-cash share-based compensation 1,298 18,246 R&D capitalization 142,269 — Other 467 4,917 Valuation allowance (216,061) (54,224) Total deferred tax assets 648 5,102 Deferred tax liabilities: Depreciation (648) — Intangible assets and other — (5,102) Total deferred tax liabilities (648) (5,102) Net deferred tax asset (liability) $ — $ — |
Summary of changes in valuation allowance for deferred tax assets | Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2022 and 2021 were due primarily to generation of nondeductible research expenses and tax credit carryforwards. Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2021 and 2020 were due primarily to the acquisition of Kleo, an increase in the amount of carryforward tax credits for research and development, and an increase in future tax deductions for share awards to employees. Year Ended December 31, 2022 2021 2020 Valuation allowance as of beginning of year $ 54,224 $ 32,970 $ 23,592 Increases recorded to Purchase Accounting and Net Investment from Former Parent 50,905 6,449 (1,089) Increases recorded to income tax provision 110,932 14,805 10,467 Valuation allowance as of end of year $ 216,061 $ 54,224 $ 32,970 |
Schedule of unrecognized tax benefits | The beginning and ending amounts of unrecognized tax benefits reconciles as follows: Year Ended December 31, 2022 2021 2020 Beginning of period balance $ 3,800 $ 2,700 $ 1,800 Increase for tax positions taken during the current period — 50 — (Decreases) increases recorded to Purchase Accounting and Net Investment from Former Parent (1,600) 1,050 900 End of period balance $ 2,200 $ 3,800 $ 2,700 |
Related Party Disclosures (Tabl
Related Party Disclosures (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions [Abstract] | |
Schedule of related party transactions | For periods prior to the Separation, these allocations to the Company are reflected in the consolidated statement of operations as follows: Year Ended December 31, 2022 2021 2020 Research and development $ 146,521 $ 70,929 $ 33,482 General and administrative 82,744 33,928 14,646 Total $ 229,265 $ 104,857 $ 48,128 Net transfers from Former Parent represent the net effect of transactions between the Company and the Former Parent prior to the Separation. The components of net transfers from Former Parent are as follows: Year Ended December 31, 2022 (1) 2021 2020 General financing activities $ 399,231 $ 98,834 $ 73,614 Corporate cost allocations, excluding non-cash share-based compensation 49,899 39,218 18,628 Net transfers from Former Parent as reflected in the Consolidated Statement of Cash Flows 449,130 138,052 92,242 Non-cash share-based compensation 179,367 65,639 29,500 Issuance of Former Parent common shares to repurchase non-controlling interest in a subsidiary 60,000 — Issuance of Former Parent common shares for building purchase — 4,871 — Issuance of Former Parent common shares as payment for IPR&D asset acquisition 58,747 — — Issuance of Former Parent common shares as payment for business acquisition — 10,673 — Issuance of Former Parent common shares as payment for Artizan investment — 6,000 — Issuance of Former Parent common shares as payment for license and consulting agreements 1,779 7,929 — Separation related adjustments (2) 27,811 — — Other non-cash adjustments (204) (1,458) (744) Net transfers from Former Parent as reflected in the Consolidated Statement of Changes in Equity $ 776,630 $ 231,706 $ 120,998 (1) The amounts for the year ended December 31, 2022 represent activity through the date of Separation. |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation (Details) $ in Thousands | 12 Months Ended | |||
Oct. 03, 2022 USD ($) shares | Dec. 31, 2022 USD ($) shares | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Nature of business [Line Items] | ||||
Shares issued in spinoff (in shares) | shares | 35,840,459 | |||
Net transfers from Former Parent | $ 776,630 | $ 231,706 | $ 120,998 | |
Ending cash balance after former parent contribution | $ 257,799 | |||
Issuance of common shares, net of offering costs | $ 282,804 | |||
Shares converted due to spinoff (in shares) | 0.5 | |||
Common Shares | ||||
Nature of business [Line Items] | ||||
Shares issued in spinoff (in shares) | shares | 39,375,944 | |||
Issuance of common shares under plan (in shares) | shares | 64,535 | |||
Issuance of common shares, net of offering costs | $ 282,804 | |||
Former Parent | ||||
Nature of business [Line Items] | ||||
Net transfers from Former Parent | 776,630 | 231,706 | 120,998 | |
Other Separation related adjustments | Former Parent | ||||
Nature of business [Line Items] | ||||
Net transfers from Former Parent | $ 27,811 | $ 0 | $ 0 | |
Legacy Plan | Former Parent Stock Options | ||||
Nature of business [Line Items] | ||||
Issuance of common shares under plan (in shares) | shares | 2,611,392 | |||
Legacy Plan | RSUs | ||||
Nature of business [Line Items] | ||||
Issuance of common shares under plan (in shares) | shares | 924,093 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | ||||
Cash and cash equivalents | $ 204,877 | $ 76,057 | $ 82,506 | |
Restricted cash held on behalf of Former Parent | 35,212 | 0 | 0 | |
Restricted cash (included in other current assets) | 117 | 250 | 0 | |
Restricted cash (included in other non-current assets) | 2,398 | 750 | 1,000 | |
Total cash, cash equivalents and restricted cash at the end of the period in the consolidated statement of cash flows | $ 242,604 | $ 77,057 | $ 83,506 | $ 9,918 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Narrative (Details) $ in Thousands | 12 Months Ended | |||||
Oct. 02, 2022 shares | Dec. 31, 2022 USD ($) segment shares | Dec. 31, 2021 USD ($) shares | Dec. 31, 2020 USD ($) shares | Jan. 31, 2021 | Jan. 04, 2021 USD ($) | |
Accounting Policies [Line Items] | ||||||
Due to Former Parent | $ 35,212 | |||||
Goodwill | 1,390 | $ 1,390 | ||||
Restricted cash (included in other non-current assets) | $ 2,398 | $ 750 | $ 1,000 | |||
Weighted average common shares outstanding—basic | shares | 39,375,944 | 44,741,316 | 39,375,944 | 39,375,944 | ||
Number of operating segments | segment | 1 | |||||
Kleo | ||||||
Accounting Policies [Line Items] | ||||||
Ownership interest acquired | 58% | |||||
Intangible assets acquired | $ 18,400 | |||||
Goodwill | $ 1,390 | |||||
Kleo | ||||||
Accounting Policies [Line Items] | ||||||
Ownership percentage | 41.90% | 42% |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Property and Equipment Useful Life (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Building | |
Property and Equipment, Net | |
Estimated useful life (in years) | 30 years |
Office equipment | Minimum | |
Property and Equipment, Net | |
Estimated useful life (in years) | 3 years |
Office equipment | Maximum | |
Property and Equipment, Net | |
Estimated useful life (in years) | 5 years |
Computer hardware and software | Minimum | |
Property and Equipment, Net | |
Estimated useful life (in years) | 3 years |
Computer hardware and software | Maximum | |
Property and Equipment, Net | |
Estimated useful life (in years) | 5 years |
Lab equipment | |
Property and Equipment, Net | |
Estimated useful life (in years) | 3 years |
Furniture and fixtures | |
Property and Equipment, Net | |
Estimated useful life (in years) | 3 years |
Marketable Securities - Amortiz
Marketable Securities - Amortized Cost and Fair Value of Debt Securities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value to Amortized Cost | ||
Amortized Cost | $ 310,505,000 | |
Allowance for Credit Losses | 0 | |
Net Amortized Cost | 310,505,000 | |
Gross Unrealized Gains | 51,000 | |
Gross Unrealized Losses | (196,000) | |
Fair Value | 310,360,000 | $ 0 |
Cash and cash equivalents | ||
Fair Value to Amortized Cost | ||
Fair Value | 49,896,000 | |
Marketable securities | ||
Fair Value to Amortized Cost | ||
Fair Value | 260,464,000 | |
U.S. corporate bonds | ||
Fair Value to Amortized Cost | ||
Amortized Cost | 142,697,000 | |
Allowance for Credit Losses | 0 | |
Net Amortized Cost | 142,697,000 | |
Gross Unrealized Gains | 25,000 | |
Gross Unrealized Losses | (135,000) | |
Fair Value | 142,587,000 | |
Foreign corporate bonds | ||
Fair Value to Amortized Cost | ||
Amortized Cost | 36,766,000 | |
Allowance for Credit Losses | 0 | |
Net Amortized Cost | 36,766,000 | |
Gross Unrealized Gains | 9,000 | |
Gross Unrealized Losses | (32,000) | |
Fair Value | 36,743,000 | |
U.S. treasury bills | ||
Fair Value to Amortized Cost | ||
Amortized Cost | 89,308,000 | |
Allowance for Credit Losses | 0 | |
Net Amortized Cost | 89,308,000 | |
Gross Unrealized Gains | 17,000 | |
Gross Unrealized Losses | (5,000) | |
Fair Value | 89,320,000 | |
U.S. agency bonds | ||
Fair Value to Amortized Cost | ||
Amortized Cost | 41,734,000 | |
Allowance for Credit Losses | 0 | |
Net Amortized Cost | 41,734,000 | |
Gross Unrealized Gains | 0 | |
Gross Unrealized Losses | (24,000) | |
Fair Value | $ 41,710,000 |
Marketable Securities - Contrac
Marketable Securities - Contractual Maturities (Details) - USD ($) | Dec. 31, 2022 | Dec. 31, 2021 |
Net Amortized Cost | ||
Less than one year | $ 310,505,000 | |
Net Amortized Cost, Total | 310,505,000 | |
Fair Value | ||
Less than one year | 310,360,000 | |
Fair Value, Total | $ 310,360,000 | $ 0 |
Marketable Securities - Debt Se
Marketable Securities - Debt Securities Available-for-Sale in Unrealized Loss Position (Details) $ in Thousands | Dec. 31, 2022 USD ($) investment |
Debt Securities, Available-for-sale, Unrealized Loss Position [Line Items] | |
Number of Securities, unrealized loss position less than 12 months | investment | 20 |
Fair Value, unrealized loss position less than 12 months | $ 187,866 |
Unrealized Losses, unrealized loss position less than 12 months | $ (196) |
U.S. corporate bonds | |
Debt Securities, Available-for-sale, Unrealized Loss Position [Line Items] | |
Number of Securities, unrealized loss position less than 12 months | investment | 16 |
Fair Value, unrealized loss position less than 12 months | $ 104,508 |
Unrealized Losses, unrealized loss position less than 12 months | $ (135) |
Foreign corporate bonds | |
Debt Securities, Available-for-sale, Unrealized Loss Position [Line Items] | |
Number of Securities, unrealized loss position less than 12 months | investment | 3 |
Fair Value, unrealized loss position less than 12 months | $ 31,886 |
Unrealized Losses, unrealized loss position less than 12 months | $ (32) |
U.S. treasury bills | |
Debt Securities, Available-for-sale, Unrealized Loss Position [Line Items] | |
Number of Securities, unrealized loss position less than 12 months | investment | 1 |
Fair Value, unrealized loss position less than 12 months | $ 9,762 |
Unrealized Losses, unrealized loss position less than 12 months | $ (5) |
U.S. agency bonds | |
Debt Securities, Available-for-sale, Unrealized Loss Position [Line Items] | |
Number of Securities, unrealized loss position less than 12 months | investment | 4 |
Fair Value, unrealized loss position less than 12 months | $ 41,710 |
Unrealized Losses, unrealized loss position less than 12 months | $ (24) |
Marketable Securities - Narrati
Marketable Securities - Narrative (Details) | Dec. 31, 2022 investment |
Investments, Debt and Equity Securities [Abstract] | |
Investments in continuous unrealized loss position for more than twelve months | 0 |
Marketable Securities - Net Inv
Marketable Securities - Net Investment Income (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Net investment income | |||
Gross interest income from debt securities available-for-sale, money-market funds, and cash | $ 3,235,000 | ||
Investment expenses | (27,000) | ||
Net investment income | $ 3,208,000 | $ 0 | $ 0 |
Fair Value of Financial Asset_3
Fair Value of Financial Assets and Liabilities - Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - Recurring $ in Thousands | Dec. 31, 2022 USD ($) |
Assets: | |
Total assets | $ 383,226 |
Money market funds | |
Assets: | |
Cash equivalents | 72,866 |
U.S. treasury bills | |
Assets: | |
Cash equivalents | 39,948 |
Marketable securities | 49,372 |
U.S. corporate bonds | |
Assets: | |
Cash equivalents | 9,948 |
Marketable securities | 132,639 |
U.S. agency bonds | |
Assets: | |
Marketable securities | 41,710 |
Foreign corporate bonds | |
Assets: | |
Marketable securities | 36,743 |
Level 1 | |
Assets: | |
Total assets | 72,866 |
Level 1 | Money market funds | |
Assets: | |
Cash equivalents | 72,866 |
Level 1 | U.S. treasury bills | |
Assets: | |
Cash equivalents | 0 |
Marketable securities | 0 |
Level 1 | U.S. corporate bonds | |
Assets: | |
Cash equivalents | 0 |
Marketable securities | 0 |
Level 1 | U.S. agency bonds | |
Assets: | |
Marketable securities | 0 |
Level 1 | Foreign corporate bonds | |
Assets: | |
Marketable securities | 0 |
Level 2 | |
Assets: | |
Total assets | 310,360 |
Level 2 | Money market funds | |
Assets: | |
Cash equivalents | 0 |
Level 2 | U.S. treasury bills | |
Assets: | |
Cash equivalents | 39,948 |
Marketable securities | 49,372 |
Level 2 | U.S. corporate bonds | |
Assets: | |
Cash equivalents | 9,948 |
Marketable securities | 132,639 |
Level 2 | U.S. agency bonds | |
Assets: | |
Marketable securities | 41,710 |
Level 2 | Foreign corporate bonds | |
Assets: | |
Marketable securities | 36,743 |
Level 3 | |
Assets: | |
Total assets | 0 |
Level 3 | Money market funds | |
Assets: | |
Cash equivalents | 0 |
Level 3 | U.S. treasury bills | |
Assets: | |
Cash equivalents | 0 |
Marketable securities | 0 |
Level 3 | U.S. corporate bonds | |
Assets: | |
Cash equivalents | 0 |
Marketable securities | 0 |
Level 3 | U.S. agency bonds | |
Assets: | |
Marketable securities | 0 |
Level 3 | Foreign corporate bonds | |
Assets: | |
Marketable securities | $ 0 |
Fair Value of Financial Asset_4
Fair Value of Financial Assets and Liabilities - Narrative (Details) | 3 Months Ended | |
Jan. 04, 2021 USD ($) $ / shares | Dec. 31, 2021 USD ($) | |
Measurement Input, Probability of Approval | Valuation Technique, Discounted Cash Flow | ||
Fair Value, Assets and Liabilities [Line Items] | ||
Business Combination, Contingent Consideration, Liability, Measurement Input | $ / shares | 0.10 | |
Discount Rate | Valuation Technique, Discounted Cash Flow | ||
Fair Value, Assets and Liabilities [Line Items] | ||
Business Combination, Contingent Consideration, Liability, Measurement Input | $ / shares | 0.07 | |
Kleo | ||
Fair Value, Assets and Liabilities [Line Items] | ||
Amount received per contingent value right upon regulatory approval | $ 1 | |
Contingent value right term period | 30 months | |
Maximum amount payable for contingent value rights | $ 17,300,000 | |
Recognized gain on contingent value right | $ 1,457,000 |
Fair Value of Financial Asset_5
Fair Value of Financial Assets and Liabilities - Financial Instruments Not Measured at Fair Value (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Assets: | ||
Series A-2 Preferred Stock investment | $ 0 | $ 6,000 |
Balance Sheet Components - Prop
Balance Sheet Components - Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property and Equipment, Net | ||
Accumulated depreciation | $ (4,914) | $ (3,342) |
Property and equipment, net | 17,512 | 13,010 |
Building and land | ||
Property and Equipment, Net | ||
Property and equipment, gross | 12,297 | 12,297 |
Computer hardware and software | ||
Property and Equipment, Net | ||
Property and equipment, gross | 780 | 1,200 |
Office and lab equipment | ||
Property and Equipment, Net | ||
Property and equipment, gross | 5,501 | 1,653 |
Furniture and fixtures | ||
Property and Equipment, Net | ||
Property and equipment, gross | 1,202 | 1,202 |
Equipment not yet in service | ||
Property and Equipment, Net | ||
Property and equipment, gross | 2,646 | 0 |
Depreciable Property, Plant and Equipment | ||
Property and Equipment, Net | ||
Property and equipment, gross | 19,780 | 16,352 |
Property and equipment, net | $ 14,866 | $ 13,010 |
Balance Sheet Components - Narr
Balance Sheet Components - Narrative (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
Jun. 30, 2022 | Jan. 31, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jan. 06, 2022 | |
Nature of business [Line Items] | |||||||||
Depreciation expense | $ 1,361,000 | $ 673,000 | $ 72,000 | ||||||
Computer software costs | $ 760,000 | 760,000 | 760,000 | ||||||
Accumulated amortization | 464,000 | $ 464,000 | 211,000 | ||||||
Artizan Biosciences Inc | |||||||||
Nature of business [Line Items] | |||||||||
Impairment of Artizan preferred stock | $ 10,000,000 | ||||||||
Artizan Biosciences Inc | Collaborative arrangement | |||||||||
Nature of business [Line Items] | |||||||||
Option price | $ 4,000,000 | ||||||||
BioShin Limited | |||||||||
Nature of business [Line Items] | |||||||||
Conversion rate of preferred stock to common stock per agreement (in shares) | 0.080121 | ||||||||
Series A-2 preferred stock | Artizan Biosciences Inc | |||||||||
Nature of business [Line Items] | |||||||||
Preferred shares paid (in shares) | 61,494 | 61,494 | |||||||
Preferred shares paid | $ 6,000,000 | $ 6,000,000 | |||||||
Preferred shares received (in shares) | 34,472,031 | 34,472,031 | |||||||
Series A-2 preferred stock | Artizan Biosciences Inc | Collaborative arrangement | |||||||||
Nature of business [Line Items] | |||||||||
Preferred shares received (in shares) | 22,975,301 | ||||||||
Series A convertible preferred shares | BioShin Preferred Shares | |||||||||
Nature of business [Line Items] | |||||||||
Preferred stock issued and sold (in shares) | 15,384,613 | ||||||||
Shares issued price per share | $ 3.90 | ||||||||
Proceeds from shares issued | $ 60,000 |
Balance Sheet Components - Othe
Balance Sheet Components - Other Non-current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid Expenses | ||
Series A-2 Preferred Stock Investment | $ 0 | $ 6,000 |
Other non-current assets | 34,928 | 5,222 |
Other | 2,585 | 3,216 |
Other non-current assets | $ 37,513 | $ 14,438 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued expenses and other current liabilities | ||
Accrued employee compensation and benefits | $ 14,603 | $ 9,538 |
Accrued clinical trial costs | 17,788 | 24,051 |
Other accrued expenses and other current liabilities | 11,715 | 3,571 |
Total accrued expenses and other current liabilities | $ 44,106 | $ 37,160 |
Acquisitions (Details)
Acquisitions (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||
Apr. 04, 2022 | Jan. 04, 2021 | Jun. 30, 2022 | Dec. 31, 2021 | Mar. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2020 | |
Accounting Policies [Line Items] | |||||||
Research and Development Asset Acquired Other than through Business Combination, Writeoff, Statement of Income or Comprehensive Income [Extensible Enumeration] | Research and development | ||||||
Amounts recorded: | |||||||
Goodwill | $ 1,390,000 | $ 1,390,000 | |||||
Channel | |||||||
Accounting Policies [Line Items] | |||||||
Upfront cash payment | $ 35,000,000 | ||||||
Stock issued in acquisition, number of shares | 493,254 | ||||||
Stock issued in acquisition | $ 58,747,000 | ||||||
Potential developmental and regulatory milestones on BHV-7000 | 325,000,000 | ||||||
Potential developmental and regulatory milestones on Kv7 pipeline development | 250,000,000 | ||||||
Potential commercial sales based milestones of BHV-7000 | $ 562,500,000 | ||||||
Charge to research and development expense | $ 93,747,000 | ||||||
R&D expense | $ 25,000,000 | ||||||
Kleo | |||||||
Accounting Policies [Line Items] | |||||||
Fair value of consideration transferred | $ 20,043,000 | ||||||
Aggregate common shares to be issued in merger | 115,836 | ||||||
Amount received per contingent value right upon regulatory approval | $ 1 | ||||||
Contingent value right term period | 30 months | ||||||
Maximum amount payable for contingent value rights | $ 17,300,000 | ||||||
Recognized gain on contingent value right | $ 1,457,000 | ||||||
Post-transaction ownership percentage | 100% | ||||||
Fair value of existing interest | $ 6,437,000 | ||||||
Gain resulting from remeasurement of fair value of existing interest | $ 5,261,000 | ||||||
Amounts recorded: | |||||||
Net working capital | 573,000 | ||||||
Property, plant and equipment, net | 1,257,000 | ||||||
Intangible assets acquired | 18,400,000 | ||||||
Debt assumed | 1,577,000 | ||||||
Goodwill | $ 1,390,000 | ||||||
Kleo | |||||||
Accounting Policies [Line Items] | |||||||
Ownership percentage | 41.90% | 42% | |||||
Equity method investment | $ 1,176,000 |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Oct. 03, 2022 | Oct. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2022 | |
Sale of Stock [Line Items] | ||||
Shares issued in spinoff (in shares) | 35,840,459 | |||
Shares issued in spinoff, former parent stock options (in shares) | 4,121,656 | |||
Issuance of common shares, net of offering costs | $ 282,804 | |||
Common Shares | ||||
Sale of Stock [Line Items] | ||||
Shares issued in spinoff (in shares) | 39,375,944 | |||
Issuance of common shares, net of offering costs | $ 282,804 | |||
Legacy Plan | ||||
Sale of Stock [Line Items] | ||||
Shares issued in spinoff, former parent stock options (in shares) | 26,113.92 | |||
IPO | ||||
Sale of Stock [Line Items] | ||||
Common shares sold (shares) | 25,000,000 | |||
Issuance price per share (in dollars per share) | $ 10.50 | |||
Over-allotment option | ||||
Sale of Stock [Line Items] | ||||
Common shares sold (shares) | 3,750,000 | |||
RSUs | Legacy Plan | ||||
Sale of Stock [Line Items] | ||||
Shares issued in spinoff, former parent restricted stock options (in shares) | 924,093 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Income (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
AOCI [Roll Forward] | |
Beginning balance | $ 34,691,000 |
Other comprehensive income (loss) | 284,000 |
Ending balance | 538,771,000 |
Accumulated Other Comprehensive Income | |
AOCI [Roll Forward] | |
Beginning balance | 0 |
Other comprehensive income (loss) | 284,000 |
Ending balance | 284,000 |
Net unrealized investment gains (losses) | |
AOCI [Roll Forward] | |
Beginning balance | 0 |
Other comprehensive income (loss) before reclassifications | (145,000) |
Ending balance | (145,000) |
Foreign currency translation adjustments | |
AOCI [Roll Forward] | |
Beginning balance | 0 |
Other comprehensive income (loss) before reclassifications | 429,000 |
Ending balance | $ 429,000 |
Non-Cash Share-Based Compensa_3
Non-Cash Share-Based Compensation - Narrative (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Oct. 03, 2022 shares | Jan. 31, 2023 shares | Dec. 31, 2022 USD ($) shares | Dec. 31, 2022 USD ($) shares | Dec. 31, 2022 USD ($) shares | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Sep. 30, 2022 shares | |
Share-Based Compensation | ||||||||
Stock options granted (in shares) | 13,167,121 | |||||||
Shares issued in spinoff, former parent stock options (in shares) | 4,121,656 | |||||||
Non-cash share-based compensation | $ | $ 193,556,000 | $ 65,639,000 | $ 29,500,000 | |||||
Total unrecognized compensation cost | $ | $ 31,080,000 | $ 31,080,000 | $ 31,080,000 | |||||
Weighted average period for recognition of compensation cost | 2 years 9 months | |||||||
Aggregate intrinsic value of options outstanding | $ | $ 61,639,000 | $ 61,639,000 | $ 61,639,000 | |||||
Intrinsic value of stock options exercised | $ | $ 20,137,000 | |||||||
Unvested stock options expected to vest over requisite service period. | 6,746,250 | 6,746,250 | 6,746,250 | |||||
Minimum | ||||||||
Share-Based Compensation | ||||||||
Requisite service period of award (in years) | 3 years | |||||||
Maximum | ||||||||
Share-Based Compensation | ||||||||
Requisite service period of award (in years) | 4 years | |||||||
RSUs | ||||||||
Share-Based Compensation | ||||||||
Total unrecognized compensation cost | $ | $ 0 | $ 0 | $ 0 | |||||
Fair value of RSUs vested | $ | $ 0 | |||||||
Stock options | ||||||||
Share-Based Compensation | ||||||||
Share-based award term (in years) | 10 years | |||||||
2022 Equity Incentive Plan | ||||||||
Share-Based Compensation | ||||||||
Common shares reserved for future issuance | 9,190,000 | |||||||
Common shares available for future grant | 166,250 | 166,250 | 166,250 | |||||
Number of shares reserved for issuance, percentage increase | 4% | 4% | 4% | |||||
2022 Equity Incentive Plan | Subsequent event | ||||||||
Share-Based Compensation | ||||||||
Increase in shares reserved for future issuance | 2,727,619 | |||||||
Legacy Plan | ||||||||
Share-Based Compensation | ||||||||
Stock options granted (in shares) | 4,057,121 | |||||||
Shares issued in spinoff, former parent stock options (in shares) | 26,113.92 | |||||||
Legacy Plan | Stock Options and Restricted Stock Units | ||||||||
Share-Based Compensation | ||||||||
Stock options converted, ratio | 0.5 | |||||||
Legacy Plan | RSUs | ||||||||
Share-Based Compensation | ||||||||
Shares issued in spinoff, former parent restricted stock options (in shares) | 924,093 | |||||||
Acceleration | ||||||||
Share-Based Compensation | ||||||||
Non-cash share-based compensation | $ | $ 101,440,000 | |||||||
2022 Employee Share Purchase Plan | ||||||||
Share-Based Compensation | ||||||||
Shares authorized for issuance | 393,769 | |||||||
Percentage of payroll deductions from eligible earnings for purchase of plan shares (in shares) | 15% | |||||||
ESPP | ||||||||
Share-Based Compensation | ||||||||
Common shares reserved for future issuance | 393,769 | 393,769 | 393,769 | |||||
Number of shares reserved for issuance, percentage increase | 1% | 1% | 1% | |||||
Unrecognized share compensation expense | $ | $ 221,000 | $ 221,000 | $ 221,000 | |||||
Shares issued under ESPP (in shares) | 0 | |||||||
ESPP | Subsequent event | ||||||||
Share-Based Compensation | ||||||||
Increase in shares reserved for future issuance | 681,904 |
Non-Cash Share-Based Compensa_4
Non-Cash Share-Based Compensation - Non-Cash Share-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-Based Compensation | ||||
Share-based compensation expense | $ 193,556 | $ 65,639 | $ 29,500 | |
Allocated from Former Parent related to the Acceleration | ||||
Share-Based Compensation | ||||
Share-based compensation expense | $ 101,440 | |||
Research and development expenses | ||||
Share-Based Compensation | ||||
Share-based compensation expense | 116,379 | 39,381 | 18,475 | |
Research and development expenses | Allocated from Former Parent excluding the Acceleration | ||||
Share-Based Compensation | ||||
Share-based compensation expense | 46,976 | 39,381 | 18,475 | |
Research and development expenses | Allocated from Former Parent related to the Acceleration | ||||
Share-Based Compensation | ||||
Share-based compensation expense | 61,749 | 0 | 0 | |
Research and development expenses | 2022 Equity Incentive Plan | ||||
Share-Based Compensation | ||||
Share-based compensation expense | 7,654 | 0 | 0 | |
General and administrative expenses | ||||
Share-Based Compensation | ||||
Share-based compensation expense | 77,177 | 26,258 | 11,025 | |
General and administrative expenses | Allocated from Former Parent excluding the Acceleration | ||||
Share-Based Compensation | ||||
Share-based compensation expense | 30,951 | 26,258 | 11,025 | |
General and administrative expenses | Allocated from Former Parent related to the Acceleration | ||||
Share-Based Compensation | ||||
Share-based compensation expense | 39,691 | 0 | 0 | |
General and administrative expenses | 2022 Equity Incentive Plan | ||||
Share-Based Compensation | ||||
Share-based compensation expense | $ 6,535 | $ 0 | $ 0 |
Non-Cash Share-Based Compensa_5
Non-Cash Share-Based Compensation - Stock Option Valuation (Details) - $ / shares | 3 Months Ended | 12 Months Ended |
Dec. 31, 2022 | Dec. 31, 2022 | |
Stock Option Valuation | ||
Exercise price | $ 5.67 | |
Stock options | ||
Stock Option Valuation | ||
Risk-free interest rate | 3.86% | |
Expected term (in years) | 5 years 9 months | |
Expected volatility | 82.05% | |
Expected dividend yield | 0% | |
Exercise price | $ 7 |
Non-Cash Share-Based Compensa_6
Non-Cash Share-Based Compensation - Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |
Oct. 03, 2022 | Dec. 31, 2022 | Dec. 31, 2022 | |
Number of Shares | |||
Outstanding at beginning of period (in shares) | 0 | ||
Granted (in shares) | 13,167,121 | ||
Exercised (in shares) | (4,121,656) | ||
Forfeited (in shares) | (86,250) | ||
Outstanding at end of period (in shares) | 0 | 8,959,215 | 8,959,215 |
Options exercisable (in shares) | 2,212,965 | 2,212,965 | |
Vested and expected to vest (in shares) | 8,959,215 | 8,959,215 | |
Weighted Average Exercise Price | |||
Outstanding at beginning of period (in dollars per share) | $ 0 | ||
Granted (in dollars per share) | 5.67 | ||
Exercised (in dollars per share) | 2.74 | ||
Forfeited (in dollars per share) | 7 | ||
Outstanding at end of period (in dollars per share) | $ 0 | 7 | $ 7 |
Options exercisable (in dollars per share) | 7 | 7 | |
Vested and expected to vest (in dollars per share) | $ 7 | $ 7 | |
Weighted Average Remaining Contractual Term | |||
Weighted average remaining contractual term of options outstanding (in years) | 9 years 9 months | ||
Weighted average remaining contractual term of options exercisable (in years) | 9 years 9 months | ||
Weighted average remaining contractual term of options vested and expected to vest (in years) | 9 years 9 months | ||
Aggregate intrinsic value of options outstanding | $ 61,639 | $ 61,639 | |
Aggregate intrinsic value of options exercisable | 15,225 | 15,225 | |
Aggregate intrinsic value of options vested and expected to vest | $ 61,639 | $ 61,639 | |
Share-Based Compensation | |||
Stock options granted (in shares) | 13,167,121 | ||
Legacy Plan | |||
Number of Shares | |||
Granted (in shares) | 4,057,121 | ||
Exercised (in shares) | (26,113.92) | ||
Share-Based Compensation | |||
Stock options granted (in shares) | 4,057,121 |
Non-Cash Share-Based Compensa_7
Non-Cash Share-Based Compensation - Restricted Share Units (Details) - RSUs | 3 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Number of Shares | |
Unnvested outstanding at beginning of period (in shares) | shares | 0 |
Granted (in shares) | shares | 924,093 |
Forfeited (in shares) | shares | 0 |
Vested (in shares) | shares | (924,093) |
Unnvested outstanding at end of period (in shares) | shares | 0 |
Weighted Average Grant Date Fair Value | |
Unnvested outstanding at beginning of period (in dollars per shares) | $ / shares | $ 0 |
Granted (in dollars per share) | $ / shares | 0 |
Forfeited (in dollars per share) | $ / shares | 0 |
Vested (in dollars per share) | $ / shares | 0 |
Unnvested outstanding at beginning of period (in dollars per shares) | $ / shares | $ 0 |
Non-Cash Share-Based Compensa_8
Non-Cash Share-Based Compensation - Employee Stock Purchase Plan (Details) - ESPP - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended |
Jan. 31, 2023 | Dec. 31, 2022 | |
Share-Based Compensation | ||
Common shares reserved for future issuance | 393,769 | |
Unrecognized share compensation expense | $ 221 | |
Shares issued under ESPP (in shares) | 0 | |
Subsequent event | ||
Share-Based Compensation | ||
Increase in shares reserved for future issuance | 681,904 |
Net Loss Per Share - Calculatio
Net Loss Per Share - Calculation of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Oct. 02, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Numerator: | ||||
Net loss attributable to Biohaven Ltd. | $ (570,279) | $ (213,796) | $ (118,668) | |
Denominator: | ||||
Weighted average common shares outstanding—basic | 39,375,944 | 44,741,316 | 39,375,944 | 39,375,944 |
Weighted average common shares outstanding—diluted | 44,741,316 | 39,375,944 | 39,375,944 | |
Net loss per share attributable to Biohaven Pharmaceutical Holding Company Ltd.—basic (in dollars per share) | $ (12.75) | $ (5.43) | $ (3.01) | |
Net loss per share attributable to Biohaven Pharmaceutical Holding Company Ltd.—diluted (in dollars per share) | $ (12.75) | $ (5.43) | $ (3.01) |
Net Loss Per Share - Antidiluti
Net Loss Per Share - Antidilutive Securities Excluded from Calculation (Details) | 12 Months Ended |
Dec. 31, 2022 shares | |
Options to purchase common shares | |
Securities excluded from computation of diluted net loss per share | |
Anti-dilutive securities excluded from calculation of diluted net loss per share | 8,959,215 |
License Agreements (Details)
License Agreements (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Development, regulatory and commercialization milestone payments | $ 30,125 | $ 529,850 | $ 582,950 |
License Agreements - Yale Unive
License Agreements - Yale University Agreements (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Jan. 31, 2021 | May 31, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
License agreements | |||||
Research and development | $ 437,072,000 | $ 181,486,000 | $ 98,460,000 | ||
Yale University | Yale Arrangement | |||||
License agreements | |||||
Milestone payment to be paid upon regulatory achievement | $ 2,000,000 | ||||
Minimum annual royalty payment to be paid upon sale of product | $ 1,000,000 | ||||
Yale University | Yale MoDE Agreement | |||||
License agreements | |||||
Minimum annual royalty payment to be paid upon sale of product | $ 1,000,000 | ||||
Eligible development milestone payments | 800,000 | ||||
Eligible commercial milestone payments | $ 2,950,000 | ||||
Initial term of agreement (in years) | 20 years | ||||
Amount of funding | $ 4,000,000 | ||||
Research and development | $ 2,666,000 | $ 150,000 | |||
Yale University | Yale MoDE Agreement | License agreement | |||||
License agreements | |||||
Payment for license agreement | $ 1,000,000 | ||||
Issuance of common shares as payment for assets (in shares) | 11,668 | ||||
Issuance of common shares as payment for assets | $ 1,000,000 |
License Agreements - ALS Biopha
License Agreements - ALS Biopharma Agreement (Details) | 1 Months Ended | 12 Months Ended | ||
Aug. 31, 2015 USD ($) prodrug claim | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
License agreements | ||||
Research and development | $ 437,072,000 | $ 181,486,000 | $ 98,460,000 | |
ALS Biopharma Agreement | Collaborative arrangement | ||||
License agreements | ||||
Number of prodrugs of glutamate modulating agents | prodrug | 300 | |||
Milestone payment to be paid upon regulatory achievement | $ 3,000,000 | |||
Milestone payment to be paid for subsequently developed products | $ 1,000,000 | |||
Number of claims | claim | 1 | |||
Research and development | $ 0 | $ 0 | $ 0 |
License Agreements - AstraZenec
License Agreements - AstraZeneca Agreements (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Sep. 30, 2018 | Oct. 31, 2016 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
License agreements | |||||
Research and development | $ 437,072,000 | $ 181,486,000 | $ 98,460,000 | ||
AstraZeneca | |||||
License agreements | |||||
Research and development | 0 | 0 | 0 | ||
AstraZeneca | License agreement | |||||
License agreements | |||||
Payment for license agreement | $ 3,000,000 | ||||
Issuance of common shares as payment for assets (in shares) | 109,523 | ||||
Issuance of common shares as payment for assets | $ 4,080,000 | ||||
Milestone payment due upon achievement of specified regulatory and commercial milestones | 55,000,000 | ||||
Milestone payment due upon achievement of specified sales-based milestones | $ 50,000,000 | ||||
AstraZeneca | Minimum | License agreement | |||||
License agreements | |||||
Royalty percentage | 0% | ||||
AstraZeneca | Maximum | License agreement | |||||
License agreements | |||||
Royalty percentage | 10% | ||||
AstraZeneca | Collaborative arrangement | |||||
License agreements | |||||
Research and development | $ 0 | $ 0 | $ 0 | ||
AstraZeneca | Collaborative arrangement | Minimum | |||||
License agreements | |||||
Royalty percentage | 0% | ||||
AstraZeneca | Collaborative arrangement | Maximum | |||||
License agreements | |||||
Milestone payment to be paid upon regulatory achievement | $ 30,000,000 | ||||
Milestone payment to be paid for any product other than Rett syndrome | 60,000,000 | ||||
Commercial milestone payment to be paid | $ 120,000,000 | ||||
Royalty percentage | 10% | ||||
Agreement term after first commercial sale | 10 years |
License Agreements - Fox Chase
License Agreements - Fox Chase Chemical Diversity Center Agreement (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
May 31, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Nov. 30, 2020 | |
License agreements | |||||
Issuance of common shares, net of offering costs | $ 282,804,000 | ||||
Research and development | 437,072,000 | $ 181,486,000 | $ 98,460,000 | ||
FCCDC Agreement | |||||
License agreements | |||||
Research and development | 0 | $ 0 | $ 0 | ||
FCCDC Agreement | Collaborative arrangement | |||||
License agreements | |||||
Issuance of common shares, net of offering costs (in shares) | 100,000 | ||||
Issuance of common shares, net of offering costs | $ 5,646,000 | ||||
Development milestone payment to be paid | 3,000,000 | ||||
Development milestone payments to be paid per each additional NDA filing | $ 1,000,000 | ||||
FCCDC Agreement | Collaborative arrangement | Minimum | |||||
License agreements | |||||
Earned royalty payment per agreement (percent) | 0% | ||||
FCCDC Agreement | Collaborative arrangement | Maximum | |||||
License agreements | |||||
Earned royalty payment per agreement (percent) | 10% | ||||
FCCDC Warrants | |||||
License agreements | |||||
Number of securities called by warrants (shares) | 100,000 | ||||
Exercise price of warrants (in dollars per share) | $ 56.46 | ||||
Research and development | $ 4,245,000 |
License Agreements - UCONN (Det
License Agreements - UCONN (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
License agreements | ||||
Research and development | $ 437,072,000 | $ 181,486,000 | $ 98,460,000 | |
UCONN | ||||
License agreements | ||||
Research and development | $ 0 | $ 0 | $ 0 | |
UCONN Agreement | UCONN | ||||
License agreements | ||||
Milestone payment to be paid upon developmental and regulatory achievement | $ 30,100,000 | |||
Commercial milestone payment to be paid | 50,000,000 | |||
UCONN Agreement | UCONN | License agreement | ||||
License agreements | ||||
Payment for license agreement | $ 400,000 |
License Agreements - Artizan Bi
License Agreements - Artizan Biosciences Inc (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Jun. 30, 2022 | Jun. 30, 2021 | Jan. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
License agreements | ||||||||
Research and development | $ 437,072,000 | $ 181,486,000 | $ 98,460,000 | |||||
Artizan Biosciences Inc | ||||||||
License agreements | ||||||||
Common shares sold (shares) | 45,950,601 | |||||||
Artizan Biosciences Inc | ||||||||
License agreements | ||||||||
Impairment of Artizan preferred stock | $ 10,000,000 | |||||||
Research and development | $ 0 | 0 | 0 | |||||
Artizan Biosciences Inc | Series A-2 preferred stock | ||||||||
License agreements | ||||||||
Preferred shares paid (in shares) | 61,494 | 61,494 | ||||||
Preferred shares paid | $ 6,000,000 | $ 6,000,000 | ||||||
Preferred shares received (in shares) | 34,472,031 | 34,472,031 | ||||||
Artizan Biosciences Inc | Collaborative arrangement | ||||||||
License agreements | ||||||||
Option price | 4,000,000 | |||||||
Development milestone payment to be paid | $ 20,000,000 | |||||||
Additional development milestone payment to be paid | 10,000,000 | |||||||
Commercial milestone payment to be paid | $ 150,000,000 | |||||||
Percentage of funds raised for program | 80% | |||||||
Additional capital raise required | $ 35,000,000 | |||||||
Artizan Biosciences Inc | Collaborative arrangement | Series A-2 preferred stock | ||||||||
License agreements | ||||||||
Preferred shares received (in shares) | 22,975,301 | |||||||
Artizan Biosciences Inc | Collaborative arrangement | Minimum | ||||||||
License agreements | ||||||||
Option price | $ 4,000,000 | 4,000,000 | 4,000,000 | |||||
Artizan Biosciences Inc | Collaborative arrangement | Maximum | ||||||||
License agreements | ||||||||
Option price | $ 8,000,000 | $ 8,000,000 | $ 8,000,000 |
License Agreements - Moda Pharm
License Agreements - Moda Pharmaceuticals LLC (Details) - USD ($) | 12 Months Ended | |||
Jan. 01, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
License agreements | ||||
Research and development | $ 437,072,000 | $ 181,486,000 | $ 98,460,000 | |
Moda Pharmaceuticals LLC | ||||
License agreements | ||||
Research and development | $ 0 | $ 0 | ||
Moda Pharmaceuticals LLC | Moda Agreement | ||||
License agreements | ||||
Eligible development milestone payments | $ 81,612,000 | |||
Eligible commercial milestone payments | $ 30,171,000 | |||
Initial term of agreement (in years) | 4 years | |||
Moda Pharmaceuticals LLC | Moda Agreement | License agreement | ||||
License agreements | ||||
Payment for license agreement | $ 2,700,000 | |||
Issuance of common shares as payment for assets (in shares) | 37,836 | |||
Issuance of common shares as payment for assets | $ 3,243,000 |
License Agreements - Reliant Ag
License Agreements - Reliant Agreement (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Jul. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
License agreements | ||||
Research and development | $ 437,072,000 | $ 181,486,000 | $ 98,460,000 | |
Reliant | Reliant Agreement | ||||
License agreements | ||||
Eligible development milestone payments | $ 36,500,000 | |||
Research and development | $ 0 | $ 0 | ||
Reliant | License agreement | ||||
License agreements | ||||
Issuance of common shares as payment for assets | $ 3,686,000 |
License Agreements - KU Leuven
License Agreements - KU Leuven Agreement (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
License agreements | ||||
Development, regulatory and commercialization milestone payments | $ 30,125,000 | $ 529,850,000 | $ 582,950,000 | |
Research and development | 437,072,000 | $ 181,486,000 | $ 98,460,000 | |
KU Leuven Agreement | ||||
License agreements | ||||
Research and development | $ 0 | |||
KU Leuven | KU Leuven Agreement | ||||
License agreements | ||||
Development, regulatory and commercialization milestone payments | $ 327,750,000 | |||
KU Leuven | License agreement | KU Leuven Agreement | ||||
License agreements | ||||
Payment for license agreement | $ 3,000,000 | |||
Issuance of common shares as payment for assets (in shares) | 15,340 | |||
Issuance of common shares as payment for assets | $ 1,779,000 |
License Agreements - Taldefgrob
License Agreements - Taldefgrobep Alfa BMS Agreement (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Feb. 28, 2022 | |
License agreements | ||||
Research and development | $ 437,072,000 | $ 181,486,000 | $ 98,460,000 | |
BMS | ||||
License agreements | ||||
Research and development | $ 0 | |||
BMS | Taldefgrobep Alfa License Agreement | ||||
License agreements | ||||
Eligible milestone payment per agreement upon specified performance and regulatory milestones | $ 200,000,000 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||||
Jun. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Aug. 31, 2020 | |
Other Commitments [Line Items] | |||||
Operating lease cost | $ 1,158 | $ 264 | $ 0 | ||
Operating cash flows paid for operating leases | 780 | ||||
Annual commitments | $ 44,579 | ||||
West Palm Beach Lease Agreement | |||||
Other Commitments [Line Items] | |||||
Lease agreement, term | 120 months | ||||
Option to extend, term | 60 months | ||||
Minimum | |||||
Other Commitments [Line Items] | |||||
Lease agreement, term | 1 year | ||||
Option to extend, term | 5 years | ||||
Minimum | West Palm Beach Lease Agreement | |||||
Other Commitments [Line Items] | |||||
Annual commitments | $ 1,263 | ||||
Maximum | |||||
Other Commitments [Line Items] | |||||
Lease agreement, term | 10 years | ||||
Option to extend, term | 10 years | ||||
Maximum | West Palm Beach Lease Agreement | |||||
Other Commitments [Line Items] | |||||
Annual commitments | $ 1,649 | ||||
Sixth Street Financing Agreement | Senior secured debt | |||||
Other Commitments [Line Items] | |||||
Principal amount | $ 750 | ||||
Research and Development Arrangement | |||||
Other Commitments [Line Items] | |||||
Research commitments | $ 18,750 | ||||
Research commitment period | 5 years |
Commitments and Contingencies_2
Commitments and Contingencies - Supplemental Cash Flow Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Leases, Other Information | |||
Right-of-use assets obtained in exchange for new operating lease liabilities | $ 31,342 | $ 478 | $ 3,681 |
Excluding opening adjustments due to leasehold improvements | $ 2,850 |
Commitments and Contingencies_3
Commitments and Contingencies - Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Lessee, Operating Lease, Description [Abstract] | ||
Other non-current assets | $ 34,928 | $ 5,222 |
Operating right-of-use assets [Extensible Enumeration] | Other non-current assets | Other non-current assets |
Other current liabilities | $ 3,019 | $ 439 |
Current portion of operating lease liabilities [Extensible Enumeration] | Accrued expenses and other current liabilities | Accrued expenses and other current liabilities |
Long-term operating lease liability | $ 30,581 | $ 2,797 |
Total lease liabilities | $ 33,600 | $ 3,236 |
Weighted-average remaining lease term (years) | 9 years 29 days | 5 years 9 months |
Weighted-average discount rate (percent) | 6.55% | 9.07% |
Commitments and Contingencies_4
Commitments and Contingencies - Maturities of Lease Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Lessee, Operating Lease, Liability, to be Paid [Abstract] | ||
2023 | $ 4,929 | |
2024 | 4,981 | |
2025 | 4,742 | |
2026 | 4,865 | |
2027 | 4,499 | |
Lessee, Operating Lease, Liability, to be Paid, after Year Five | 20,563 | |
Lessee, Operating Lease, Liability, to be Paid, Total | 44,579 | |
Less: imputed interest | (10,979) | |
Total lease liabilities | $ 33,600 | $ 3,236 |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Tax Credit Carryforward [Line Items] | |||
Provision for income taxes | $ 438,000 | $ 1,366,000 | $ 0 |
Foreign | Indefinite | |||
Tax Credit Carryforward [Line Items] | |||
Operating loss carryforwards | 69,214,000 | 39,281,000 | |
Federal | Research and development | |||
Tax Credit Carryforward [Line Items] | |||
Tax credits | $ 60,340,000 | $ 26,590,000 |
Income Taxes - Loss Before Prov
Income Taxes - Loss Before Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income (loss) before provision for income taxes | |||
BVI | $ (598,046) | $ (211,334) | $ (123,468) |
Foreign | 28,205 | (1,096) | 4,800 |
Loss before provision for income taxes | $ (569,841) | $ (212,430) | $ (118,668) |
Income Taxes - Provision for In
Income Taxes - Provision for Income Taxes (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Current income tax provision: | |||
BVI | $ 0 | $ 0 | $ 0 |
Foreign | 438,000 | 1,366,000 | 0 |
Total current income tax provision | 438,000 | 1,366,000 | 0 |
Deferred income tax provision (benefit): | |||
BVI | 0 | 0 | 0 |
Foreign | 0 | 0 | 0 |
Total deferred income tax provision (benefit) | 0 | 0 | 0 |
Total provision for income taxes | $ 438,000 | $ 1,366,000 | $ 0 |
Income Taxes - Effective Income
Income Taxes - Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Reconciliation of BVI statutory income tax rate | |||
BVI statutory income tax rate | 0% | 0% | 0% |
Foreign tax rate differential | (12.60%) | 0% | 1% |
Tax credits | (5.80%) | (5.00%) | (6.00%) |
Change in valuation allowance | 18.50% | 7% | 9% |
Other | 0% | (1.00%) | (4.00%) |
Effective income tax rate | 0.10% | 1% | 0% |
Income Taxes - Net Deferred Tax
Income Taxes - Net Deferred Tax Assets (Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||||
Foreign net operating loss carryforwards | $ 8,895 | $ 9,573 | ||
Tax credits | 60,340 | 26,590 | ||
Accrued bonus | 3,440 | 0 | ||
Non-cash share-based compensation | 1,298 | 18,246 | ||
R&D capitalization | 142,269 | 0 | ||
Other | 467 | 4,917 | ||
Valuation allowance | (216,061) | (54,224) | $ (32,970) | $ (23,592) |
Total deferred tax assets | 648 | 5,102 | ||
Deferred tax liabilities: | ||||
Depreciation | (648) | 0 | ||
Intangible assets and other | 0 | (5,102) | ||
Total deferred tax liabilities | (648) | (5,102) | ||
Net deferred tax asset (liability) | $ 0 | $ 0 |
Income Taxes - Valuation allowa
Income Taxes - Valuation allowance (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Valuation allowance for deferred tax assets | |||
Valuation allowance as of beginning of year | $ 54,224 | $ 32,970 | $ 23,592 |
Increases recorded to Purchase Accounting and Net Investment from Former Parent | 50,905 | 6,449 | (1,089) |
Increases recorded to income tax provision | 110,932 | 14,805 | 10,467 |
Valuation allowance as of end of year | $ 216,061 | $ 54,224 | $ 32,970 |
Income Taxes - Unrecognized Tax
Income Taxes - Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Unrecognized tax benefits | |||
Beginning of period balance | $ 3,800 | $ 2,700 | $ 1,800 |
Increase for tax positions taken during the current period | 0 | 50 | 0 |
(Decreases) increases recorded to Purchase Accounting and Net Investment from Former Parent | (1,600) | 1,050 | 900 |
End of period balance | $ 2,200 | $ 3,800 | $ 2,700 |
Related Party Transactions - Na
Related Party Transactions - Narrative (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Jan. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Oct. 03, 2022 | |
Related Party Transactions | |||||
Restricted cash held on behalf of Former Parent | $ 35,212,000 | $ 0 | $ 0 | ||
Due to former parent | 0 | ||||
Ending cash balance after former parent contribution | $ 257,799,000 | ||||
Transition Services | Former Parent | |||||
Related Party Transactions | |||||
Income from related party | 4,024,000 | ||||
Due from related party | 2,748,000 | ||||
Yale University | |||||
Related Party Transactions | |||||
Related party expense | $ 3,420,000 | $ 458,000 | $ 138,000 | ||
Yale University | License agreement | Yale MoDE Agreement | |||||
Related Party Transactions | |||||
Payment for license agreement | $ 1,000,000 | ||||
Issuance of common shares as payment for assets (in shares) | 11,668 | ||||
Issuance of common shares as payment for assets | $ 1,000,000 |
Related Party Transactions - Re
Related Party Transactions - Related Party Expenses (Details) - Cost Allocations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Related Party Transactions | |||
Related party expense | $ 229,265 | $ 104,857 | $ 48,128 |
Research and development expenses | |||
Related Party Transactions | |||
Related party expense | 146,521 | 70,929 | 33,482 |
General and administrative expenses | |||
Related Party Transactions | |||
Related party expense | $ 82,744 | $ 33,928 | $ 14,646 |
Related Party Transactions - Ne
Related Party Transactions - Net Transfers from Parent (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Related Party Transactions | |||
Net transfers from Former Parent as reflected in the Consolidated Statement of Cash Flows | $ 138,052 | $ 92,242 | |
Net transfers from Former Parent as reflected in the Consolidated Statement of Cash Flows | $ 449,130 | ||
Net transfers from Former Parent as reflected in the Consolidated Statement of Changes in Equity | 776,630 | 231,706 | 120,998 |
Former Parent | |||
Related Party Transactions | |||
Net transfers from Former Parent as reflected in the Consolidated Statement of Changes in Equity | 776,630 | 231,706 | 120,998 |
Former Parent | General financing activities | |||
Related Party Transactions | |||
Net transfers from Former Parent as reflected in the Consolidated Statement of Cash Flows | 98,834 | 73,614 | |
Net transfers from Former Parent as reflected in the Consolidated Statement of Cash Flows | 399,231 | ||
Former Parent | Corporate cost allocations, excluding non-cash share-based compensation | |||
Related Party Transactions | |||
Net transfers from Former Parent as reflected in the Consolidated Statement of Cash Flows | 39,218 | 18,628 | |
Net transfers from Former Parent as reflected in the Consolidated Statement of Cash Flows | 49,899 | ||
Former Parent | Non-cash share-based compensation | |||
Related Party Transactions | |||
Net transfers from Former Parent as reflected in the Consolidated Statement of Changes in Equity | 179,367 | 65,639 | 29,500 |
Former Parent | Issuance of Former Parent common shares to repurchase non-controlling interest in a subsidiary | |||
Related Party Transactions | |||
Net transfers from Former Parent as reflected in the Consolidated Statement of Changes in Equity | 60,000 | 0 | |
Former Parent | Issuance of Former Parent common shares for building purchase | |||
Related Party Transactions | |||
Net transfers from Former Parent as reflected in the Consolidated Statement of Changes in Equity | 0 | 4,871 | 0 |
Former Parent | Issuance of Former Parent common shares as payment for IPR&D asset acquisition | |||
Related Party Transactions | |||
Net transfers from Former Parent as reflected in the Consolidated Statement of Changes in Equity | 58,747 | 0 | 0 |
Former Parent | Issuance of Former Parent common shares as payment for business acquisition | |||
Related Party Transactions | |||
Net transfers from Former Parent as reflected in the Consolidated Statement of Changes in Equity | 0 | 10,673 | 0 |
Former Parent | Issuance of Former Parent common shares as payment for Artizan investment | |||
Related Party Transactions | |||
Net transfers from Former Parent as reflected in the Consolidated Statement of Changes in Equity | 0 | 6,000 | 0 |
Former Parent | Issuance of Former Parent common shares as payment for license and consulting agreements | |||
Related Party Transactions | |||
Net transfers from Former Parent as reflected in the Consolidated Statement of Changes in Equity | 1,779 | 7,929 | 0 |
Former Parent | Other Separation related adjustments | |||
Related Party Transactions | |||
Net transfers from Former Parent as reflected in the Consolidated Statement of Changes in Equity | 27,811 | 0 | 0 |
Former Parent | Other non-cash adjustments | |||
Related Party Transactions | |||
Net transfers from Former Parent as reflected in the Consolidated Statement of Changes in Equity | $ (204) | $ (1,458) | $ (744) |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent event - Highlightll - License agreement - Collaborative arrangement $ in Millions | Mar. 01, 2023 USD ($) |
Subsequent Events | |
Payment for license agreement | $ 10 |
Issuance of common shares as payment for assets | 10 |
Milestone payment due upon achievement of specified developmental, regulatory and commercial milestones, first indication | 200 |
Milestone payment due upon achievement of specified developmental, regulatory and commercial milestones, second indication | 100 |
Milestone payment due upon achievement of specified sales-based milestones | $ 650 |