Item 9A. Controls and Procedures
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
The term "disclosure controls and procedures," as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act"), refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company's management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.
In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.
Based on the evaluation of our disclosure controls and procedures, our Chief Executive Officer and Chief Financial Officer have concluded that, as of December
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31, 2023, our disclosure controls and procedures were effective at the reasonable assurance level.
Management's Report on Internal Control over Financial Reporting
Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Management conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, 2023 based on the framework in Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission ("COSO"). Based on that evaluation, management has concluded that the Company's internal control over financial reporting was effective as of December 31, 2023.
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Report of Independent Registered Public Accounting Firm
The effectiveness of our internal control over financial reporting as of December 31, 2023 has been audited by Ernst & Young LLP., an independent registered public accounting firm, as stated in their report, which is included below.
Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of Biohaven Ltd.
Opinion on Internal Control Over Financial Reporting
We have audited Biohaven Ltd.’s internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Biohaven Ltd. (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2023, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the consolidated balance sheets of the Company as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive loss, shareholders' equity and cash flows for each of the three years in the period ended December 31, 2023, and the related notes and our report dated February 29, 2024 expressed an unqualified opinion thereon.
Basis for Opinion
The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Report on Internal Control over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects.
Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
Definition and Limitations of Internal Control Over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
/s/ Ernst & Young LLP
Hartford, Connecticut
February 29, 2024
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Changes in Internal Controls over Financial Reporting
There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the three months ended December 31, 2023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
During the quarter ended December 31, 2023, none of our directors or officers adopted or terminated a "Rule 10b5-1 trading arrangement" or "non-Rule 10b5-1 trading arrangement," as each term is defined in Item 408 of Regulation S-K.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
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PART III
We will file a definitive Proxy Statement for our 2024 Annual Meeting of Shareholders (the "2024 Proxy Statement") with the SEC, pursuant to Regulation 14A, not later than 120 days after the end of our fiscal year. Accordingly, certain information required by Part III has been omitted under General Instruction G(3) to Form 10 ‑ K. Only those sections of the 2024 Proxy Statement that specifically address the items set forth herein are incorporated by reference.
Item 10. Directors, Executive Officers and Corporate Governance
The information required by this Item is incorporated herein by reference to the information that will be contained in our 2024 Proxy Statement under the captions "Information Regarding the Board of Directors and Corporate Governance," "Election of Directors," "Executive Officers" and "Delinquent Section 16(a) Reports."
Item 11. Executive Compensation
The information required by this Item is incorporated herein by reference to the information that will be contained in the 2024 Proxy Statement under the captions "Executive Compensation" and "Director Compensation."
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Shareholder Matters
The information required by this Item is incorporated herein by reference to the information that will be contained in the 2024 Proxy Statement under the captions "Security Ownership of Certain Beneficial Owners and Management" and "Securities Authorized for Issuance under Equity Compensation Plans."
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this Item is incorporated herein by reference to the information that will be contained in the 2024 Proxy Statement under the captions "Transactions with Related Persons" and "Independence of the Board of Directors."
Item 14. Principal Accountant Fees and Services
The information required by this Item is incorporated herein by reference to the information that will be contained in the 2024 Proxy Statement under the caption "Ratification of Selection of Independent Auditors."
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PART IV
Item 15. Exhibit and Financial Statement Schedules
a. The following documents are filed as part of this report:
(1) Financial Statements:
The financial statements required by this item are submitted in a separate section beginning on page F-1 of this report.
(2) Financial Statement Schedules:
All other financial statement schedules have been omitted because they are not applicable, not required or the information required is shown in the consolidated financial statements or the notes thereto.
(3) Exhibits.
Exhibit
Number
Description of Document
2.1 Separation and Distribution Agreement, dated as of May 9, 2022, by and among Pfizer Inc., Bulldog (BVI) Ltd. and Biohaven Pharmaceutical Holding Company Ltd. (incorporated by reference to Exhibit 2.1 to the Company's Form 10 (File No. 001-41477) filed on August 10, 2022) .
2.2 Agreement and Plan of Merger, dated as of May 9, 2022, by and among Pfizer Inc., Bulldog (BVI) Ltd. and Biohaven Pharmaceutical Holding Company Ltd. (incorporated by reference to Exhibit 2.2 to the Company's Form 10 (File No. 001-41477) filed on August 10, 2022) .
2.3 # Membership Interest Purchase Agreement, dated as of February 24, 2022, by and among Biohaven Therapeutics LTD., Knopp Biosciences LLC, Channel Biosciences, LLC and Biohaven Pharmaceutical Holding Company Ltd., solely for the purpose of Section 9.14 (incorporated by reference to Exhibit 2.3 to the Company's Form 10 (File No. 001-41477) filed on August 10, 2022) .
3.1 Amended & Restated Memorandum and Articles of Association of Biohaven Ltd. (incorporated by reference to Exhibit 3.1 to the Company's Current Report on Form 8-K (File No. 001-41477) filed on October 3, 2022).
10.1 # Amended and Restated Agreement, by and between the Registrant and Yale University, dated as of May 6, 2019 (incorporated by reference to Exhibit 10.1 to the Company's Form 8-K (File No. 001-41477) filed on October 3, 2022).
10.2 # License Agreement, by and between the Registrant and AstraZeneca AB, dated as of September 4, 2018 (incorporated by reference to Exhibit 10.2 to the Company's Form 10 (File No. 001-41477) filed on August 10, 2022) .
10.3 # License Agreement between Biohaven Therapeutics LTD. and Bristol-Myers Squibb Company, dated as of December 23, 2021 (incorporated by reference to Exhibit 10.3 to the Company's Form 10 (File No. 001-41477) filed on August 10, 2022) .
10.4 # ALS Biopharma Agreement, by and among the registrant, ALS Biopharma, LLC and Fox Chase Chemical Diversity Center Inc., dated as of August 10, 2015 (incorporated by reference to Exhibit 10.4 to the Company's Form 10 (File No. 001-41477) filed on August 10, 2022) .
10.5 Amendment and Assignment, by and among the Registrant, ALS Biopharma, LLC, Fox Chase Chemical Diversity Center and Biohaven Therapeutics Ltd, dated as of May 29, 2019 (incorporated by reference to Exhibit 10.5 to the Company's Form 10 (File No. 001-41477) filed on August 10, 2022) .
10.6 + Employment Agreement dated May 9, 2017 by and between Biohaven Pharmaceuticals, Inc. and Vlad Coric (incorporated by reference to Exhibit 10.6 to the Company's Form 10 (File No. 001-41477) filed on August 10, 2022) .
10.7 + Employment Agreement, dated December 8, 2021, between Biohaven Pharmaceuticals, Inc. and Matthew Buten (incorporated by reference to Exhibit 10.7 to the Company's Form 10 (File No. 001-41477) filed on August 10, 2022) .
10.8 + Employment Agreement dated February 1, 2014 by and between Biohaven Pharmaceuticals, Inc. and Kimberly A. Gentile (incorporated by reference to Exhibit 10.9 to the Company's Form 10 (File No. 001-41477) filed on August 10, 2022).
10.9 + Employment Agreement, dated March 29, 2016, between Biohaven Pharmaceutical Holding Company Ltd. and John Tilton (incorporated by reference to Exhibit 10.10 to the Company's Form 10 (File No. 001-41477) filed on August 10, 2022) .
10.10 + 2022 Equity Incentive Plan (incorporated by reference to Exhibit 4.2 to Company’s Registration Statement on Form S-8 filed on October 11, 2022).
10.11 + Form of Restricted Share Unit Grant Notice and Restricted Share Unit Award Agreement under 2022 Equity Incentive Plan (incorporated by reference to Exhibit 10.12 to the Company's Form 10 (File No. 001-41477) filed on September 7, 2022).
10.12 + Form of Share Option Grant Notice and Share Option Agreement under 2022 Equity Incentive Plan (incorporated by reference to Exhibit 10.13 to the Company's Form 10 (File No. 001-41477) filed on September 7, 2022).
10.13 + Legacy Equity Award Settlement Plan (incorporated by reference to Exhibit 4.4 to Company’s Registration Statement on Form S-8 filed on October 11, 2022).
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10.14 + 2022 Employee Share Purchase Plan (incorporated by reference to Exhibit 4.3 to Company’s Registration Statement on Form S-8 filed on October 11, 2022).
10.15 + Form of Employment Agreement by and between Biohaven Ltd. and Vladimir Coric Form of Employment Agreement by and between Biohaven Ltd. and Matthew Buten (incorporated by reference to Exhibit 10.16 to the Company's Form 10 (File No. 001-41477) filed on September 7, 2022).
10.16 + Form of Employment Agreement by and between Biohaven Ltd. and Matthew Buten (incorporated by reference to Exhibit 10.17 to the Company's Form 10 (File No. 001-41477) filed on September 7, 2022).
10.17 + Amended and Restated Offer of Employment, by and between Biohaven Pharmaceuticals, Inc. and Bruce Car (Incorporated by reference to E xhi bit 10.18 to the Company's Form 10-K (File No. 001-41477 ) filed on March 23, 2023 ) .
10.18 #
Development and License Agreement, dated as of March 21, 2023, by and between Hangzhou Highlightll Pharmaceutical Co. Ltd. and Biohaven Therapeutics LTD. (incorporated by reference to Exhibit 10.1 to the Company's Form 10-Q (File No. 001-41477) filed on May 12, 2023).
10.19 #
Amendment to Development and License Agreement dated March 21, 2023, dated as of April 14, 2023, by and between Hangzhou Highlightll Pharmaceutical Co. Ltd. and Biohaven Therapeutics LTD. (incorporated by reference to Exhibit 10. 2 to the Company's Form 10-Q (File No. 001-41477) filed on May 12, 2023).
10.20 + Form of Nonstatutory Share Option Grant Notice (Early Exercise) and Share Option Agreement under the 2022 Equity Incentive Plan (incorporated by reference to Exhibit 10. 3 to the Company's Form 10-Q (File No. 001-41477) filed on May 12, 2023).
10.21 + Form of Amendment to Share Option Grant Notice and Option Agreement under the 2022 Equity Incentive Plan (incorporated by reference to Exhibit 10. 4 to the Company's Form 10-Q (File No. 001-41477) filed on May 12, 2023).
10.22 #
Second Amendment to Development and License Agreement dated March 21, 2023, dated as of December 10 , 2023, by and between Hangzhou Highlightll Pharmaceutical Co. Ltd. and Biohaven Therapeutics LTD.
21.1 Subsidiaries of the Registrant.
23.1 Consent of Ernst & Young LLP.
24.1 Power of Attorney (contained on signature page hereto).
31.1 Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act.
31.2 Certification of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act.
32.1 * Certifications of Principal Executive Officer and Principal Financial Officer under Section 906 of the Sarbanes-Oxley Act.
97 Incentive Compensation Recovery Policy.
101 The following materials from the Registrant's Annual Report on Form 10-K for the year ended December 31, 2023 formatted in Inline XBRL (Extensible Business Reporting Language): (i) the Consolidated Balance Sheets, (ii) the Consolidated Statements of Operations, (iii) the Consolidated Statements of Comprehensive Loss, (iv) the Consolidated Statements of Shareholders' Equity, (v) the Consolidated Statements of Cash Flows, (vi) Notes to Consolidated Financial Statements, and (vi) Cover Page, tagged as blocks of text.
104 The cover page from the Registrant's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, formatted in Inline XBRL (included as Exhibit 101).
_______________________________________________________________________________
# Portions of this exhibit (indicated by asterisks) have been omitted as such information is (i) not material and (ii) would likely cause competitive harm to the Registrant if publicly disclosed.
+ Indicates management contract or compensatory plan.
* These certifications are being furnished solely to accompany this Annual Report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the Registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 16. Form 10-K Summary
Not applicable.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
BIOHAVEN LTD.
Dated: February 29, 2024
By: /s/ VLAD CORIC, M.D.
Vlad Coric, M.D.
Chief Executive Officer
(On behalf of the Registrant and as the Principal Executive Officer)
By: /s/ MATTHEW BUTEN
Matthew Buten
Chief Financial Officer
(Principal Financial Officer)
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Vlad Coric as his or her true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign this Annual Report on Form 10-K of Biohaven Ltd., and any or all amendments thereto, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises hereby ratifying and confirming all that said attorney-in-fact and agent, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
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Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Signature Title Date
/s/ VLAD CORIC, M.D. Chief Executive Officer and Director
(Principal Executive Officer)
February 29, 2024
Vlad Coric, M.D.
/s/ MATTHEW BUTEN Chief Financial Officer
(Principal Financial Officer) February 29, 2024
Matthew Buten
/s/ GEORGE C. CLARK Chief Accounting Officer
(Principal Accounting Officer) February 29, 2024
George C. Clark
/s/ GREGORY H. BAILEY, M.D. Director February 29, 2024
Gregory H. Bailey, M.D.
/s/ JOHN W. CHILDS Director February 29, 2024
John W. Childs
/s/ JULIA P. GREGORY Director February 29, 2024
Julia P. Gregory
/s/ MICHAEL HEFFERNAN Director February 29, 2024
Michael Heffernan
/s/ ROBERT J. HUGIN Director February 29, 2024
Robert J. Hugin
/s/ KISHEN MEHTA Director February 29, 2024
Kishen Mehta
/s/ IRINA ANTONIJEVIC Director February 29, 2024
Irina Antonijevic
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Biohaven Ltd.
Financial Statements
For the Years Ended December 31, 2023, 2022 and 2021
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID: 42 )
2
Consolidated Balance Sheets
4
Consolidated Statements of Operations
5
Consolidated Statements of Comprehensive Loss
6
Consolidated Statements of Shareholders' Equity
7
Consolidated Statements of Cash Flows
8
Notes to Consolidated Financial Statements
9
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Report of Independent Registered Public Accounting Firm
To the Shareholders and the Board of Directors of Biohaven Ltd.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Biohaven Ltd. (the Company) as of December 31, 2023 and 2022, the related consolidated statements of operations, comprehensive loss, shareholders' equity and cash flows for each of the three years in the period ended December 31, 2023, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023, in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company's internal control over financial reporting as of December 31, 2023, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated February 29, 2024 expressed an unqualified opinion thereon.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
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Accounting for Research and Development Costs and Related Prepaid and Accrued Costs
Description of the Matter
As discussed in Note 2 to the consolidated financial statements, the Company recognizes estimated ongoing research costs based on management’s analysis of the progress of the studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. During 2023, the Company incurred $373.3 million in research and development expense. As of December 31, 2023, the Company recorded prepaid expenses of $35.2 million which included prepayment for certain clinical trial costs and recorded $29.5 million for accrued clinical trial costs.
Auditing management’s accounting for research and development costs was challenging due to the estimation required by management to determine the cost incurred for the services rendered on or prior to the balance sheet date for preclinical development activities, preclinical and clinical studies and drug substance and drug product formulation for preclinical and clinical trial material. The Company has contracts with multiple clinical research organizations (“CROs”) that conduct and manage studies on its behalf, as well as contract manufacturing organizations (“CMOs”) that perform manufacturing activities. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows during the period.
How We Addressed the Matter in Our Audit
We obtained an understanding, evaluated the design, and tested the operating effectiveness of relevant controls over the Company’s accounting for research and development costs, including controls over the determination of estimates of the progress completed, expected milestones or expected service period and the completeness and accuracy of the data used in determining prepaid and accrued research and development expenses estimate.
To evaluate the completeness, measurement and valuation of the research and development costs and related prepaid and accrued costs, our audit procedures included, among others, reading certain contracts with CROs and CMOs to evaluate the financial and other relevant contractual terms, testing the accuracy and completeness of the underlying data used by management to estimate the recorded balances, and testing the mathematical accuracy of the calculation of the accrued or prepaid balances. We also evaluated management’s estimates of progress, expected milestones, or expected service period for a sample of clinical trials and manufacturing efforts by making direct inquiries of the Company’s research and development personnel who oversee the research and development program. Further, we requested direct confirmation of total contract value, costs incurred, amounts invoiced, invoices unpaid and expected service period as of December 31, 2023, from a sample of CROs and CMOs. To evaluate the completeness of the accrued research and development costs we also examined invoices received from a sample of vendors and a sample of cash disbursements made to third-party service providers subsequent to December 31, 2023, to the extent such invoices were received, or payments were made prior to the date that the financial statements were issued.
/s/ Ernst & Young LLP
We have served as the Company’s auditor since 2022.
Hartford, Connecticut
February 29, 2024
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BIOHAVEN LTD.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share amounts)
December 31,
2023 2022
Assets
Current assets:
Cash and cash equivalents $ 248,402 $ 204,877
Marketable securities 133,417 260,464
Prepaid expenses 35,242 20,945
Income tax receivable 13,252 46,139
Restricted cash held on behalf of Former Parent — 35,212
Other current assets 12,133 19,331
Total current assets 442,446 586,968
Property and equipment, net 17,191 17,512
Intangible assets 18,400 18,400
Goodwill 1,390 1,390
Other non-current assets 33,785 37,513
Total assets $ 513,212 $ 661,783
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $ 15,577 $ 10,703
Due to Former Parent — 35,212
Accrued expenses and other current liabilities 39,846 44,106
Total current liabilities 55,423 90,021
Long-term operating lease liability 27,569 30,581
Other non-current liabilities 2,245 2,410
Total liabilities 85,237 123,012
Commitments and contingencies (Note 12)
Shareholders' Equity:
Preferred shares, no par value; 10,000,000 shares authorized, no shares issued and outstanding as of December 31, 2023 and 2022
— —
Common shares, no par value; 200,000,000 shares authorized as of December 31, 2023 and 2022; 81,115,723 and 68,190,479 shares issued and outstanding as of December 31, 2023 and 2022, respectively
887,528 615,742
Additional paid-in capital 39,804 13,869
Accumulated deficit ( 499,292 ) ( 91,124 )
Accumulated other comprehensive (loss) income
( 65 ) 284
Total shareholders' equity 427,975 538,771
Total liabilities and shareholders' equity $ 513,212 $ 661,783
The accompanying notes are an integral part of these consolidated financial statements.
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BIOHAVEN LTD.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share amounts)
Year Ended December 31,
2023 2022 2021
Operating expenses:
Research and development $ 373,281 $ 437,072 $ 181,486
General and administrative 62,770 130,860 37,414
Total operating expenses 436,051 567,932 218,900
Loss from operations ( 436,051 ) ( 567,932 ) ( 218,900 )
Other income (expense):
Gain from equity method investment
— — 5,261
Other income (expense), net
26,500 ( 1,909 ) 1,209
Total other income (expense), net
26,500 ( 1,909 ) 6,470
Loss before (benefit) provision for income taxes
( 409,551 ) ( 569,841 ) ( 212,430 )
(Benefit) provision for income taxes
( 1,383 ) 438 1,366
Net loss $ ( 408,168 ) $ ( 570,279 ) $ ( 213,796 )
Net loss per share — basic and diluted $ ( 5.73 ) $ ( 12.75 ) $ ( 5.43 )
Weighted average common shares outstanding—basic and diluted 71,200,527 44,741,316 39,375,944
The accompanying notes are an integral part of these consolidated financial statements.
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BIOHAVEN LTD.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(Amounts in thousands)
Year Ended December 31,
2023 2022 2021
Net loss $ ( 408,168 ) $ ( 570,279 ) $ ( 213,796 )
Other comprehensive (loss) income, net of tax:
Foreign currency translation adjustments ( 497 ) 429 —
Net unrealized gain (loss) related to available-for-sale debt securities
148 ( 145 ) —
Other comprehensive (loss) income
( 349 ) 284 —
Comprehensive loss $ ( 408,517 ) $ ( 569,995 ) $ ( 213,796 )
The accompanying notes are an integral part of these consolidated financial statements.
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BIOHAVEN LTD.
CONSOLIDATED STATEMENTS OF SHAREHOLDERS' EQUITY
(Amounts in thousands, except share amounts)
Common Shares
Shares Amount Net Investment from Former Parent Additional Paid-in Capital Accumulated Deficit Accumulated Other Comprehensive (Loss) Income
Total Shareholders' Equity
Balances as of December 31, 2020 — $ — $ 16,781 $ — $ — $ — $ 16,781
Net loss — — ( 213,796 ) — — — ( 213,796 )
Net transfers from Former Parent 231,706 231,706
Balances as of December 31, 2021 — — 34,691 — — — 34,691
Net loss — — ( 479,155 ) — ( 91,124 ) — ( 570,279 )
Net transfers from Former Parent, including separation related adjustments — — 776,630 — — — 776,630
Issuance of common shares in connection with the Separation and reclassification of Net investment from Former Parent 39,375,944 332,166 ( 332,166 ) — — — —
Issuance of common shares, net of offering costs 28,750,000 282,804 — — — — 282,804
Issuance of common shares under 2022 Equity Incentive Plan 64,535 772 — ( 321 ) — — 451
Non-cash share-based compensation expense — — — 14,189 — — 14,189
Other comprehensive income — — — — — 284 284
Balances as of December 31, 2022 68,190,479 615,742 — 13,869 ( 91,124 ) 284 538,771
Net loss — — — — ( 408,168 ) — ( 408,168 )
Issuance of common shares, net of offering costs 11,761,363 242,425 — — — — 242,425
Issuance of common shares as payment for license agreement
721,136 21,814 — — — — 21,814
Issuance of common shares under 2022 Equity Incentive Plan and employee share purchase plan
442,745 7,547 — ( 2,852 ) — — 4,695
Non-cash share-based compensation expense — — — 28,787 — — 28,787
Other comprehensive loss
— — — — — ( 349 ) ( 349 )
Balances as of December 31, 2023
81,115,723 $ 887,528 $ — $ 39,804 $ ( 499,292 ) $ ( 65 ) $ 427,975
The accompanying notes are an integral part of these consolidated financial statements.
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BIOHAVEN LTD.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
Year ended December 31,
2023 2022 2021
Cash flows from operating activities:
Net loss $ ( 408,168 ) $ ( 570,279 ) $ ( 213,796 )
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash share-based compensation 28,787 193,556 65,639
Acquisition of IPR&D asset — 93,747 —
Impairment of Artizan preferred stock — 10,000 —
Depreciation and amortization 6,912 1,386 1,393
Issuance of Former Parent common shares as payment for license and consulting agreements — 1,779 7,929
Issuance of common shares as payment for license agreement
21,814 — —
Gain from equity method investment
— — ( 5,261 )
Other non-cash items ( 5,683 ) 726 ( 3,408 )
Changes in operating assets and liabilities:
Prepaid expenses, income tax receivable, and other current and non-current assets
27,176 ( 41,336 ) ( 9,182 )
Accounts payable 4,874 5,928 1,025
Accrued expenses and other current and non-current liabilities
( 7,437 ) 6,804 9,821
Net cash used in operating activities $ ( 331,725 ) $ ( 297,689 ) $ ( 145,840 )
Cash flows from investing activities:
Proceeds from maturities of marketable securities
322,079 — —
Proceeds from sales of marketable securities
4,920 — —
Purchases of marketable securities ( 194,121 ) ( 259,716 ) —
Purchases of property and equipment ( 3,048 ) ( 6,074 ) ( 938 )
Payment for IPR&D asset acquisition — ( 35,000 ) —
Cash acquired in business acquisition — — 1,882
Purchase of Artizan preferred stock — ( 4,000 ) —
Net cash provided by (used in) investing activities
$ 129,830 $ ( 304,790 ) $ 944
Cash flows from financing activities:
Net transfers from Former Parent — 449,130 138,052
Change in restricted cash due to Former Parent
( 35,212 ) 35,212 —
Proceeds from issuance of common shares 243,225 283,804 —
Payments of issuance costs ( 800 ) ( 1,000 ) —
Proceeds from issuance of common shares under 2022 Equity Incentive Plan and employee share purchase plan
4,695 451 395
Net cash provided by financing activities $ 211,908 $ 767,597 $ 138,447
Effect of exchange rates on cash, cash equivalents and restricted cash ( 497 ) 429 —
Net increase (decrease) in cash, cash equivalents and restricted cash 9,516 165,547 ( 6,449 )
Cash, cash equivalents and restricted cash at beginning of period 242,604 77,057 83,506
Cash, cash equivalents and restricted cash at end of period $ 252,120 $ 242,604 $ 77,057
Supplemental disclosure of cash flow information:
Cash paid for interest $ — $ — $ 107
Cash (received) paid for income taxes
$ ( 33,300 ) $ 38,165 $ 16,594
The accompanying notes are an integral part of these consolidated financial statements.
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BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
1. 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 biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. The Company is advancing its innovative therapeutic portfolio of therapeutics, leveraging its proven drug development experience and multiple, proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy and mood disorders; extracellular protein degradation for immunological diseases; Transient Receptor Potential Melastatin 3 ("TRPM3") antagonism for migraine and neuropathic pain; Tyrosine Kinase 2/Janus Kinase 1 ("TYK2/JAK1") inhibition for neuroinflammatory disorders; glutamate modulation for obsessive-compulsive disorder (“OCD”); and spinocerebellar ataxia ("SCA"); myostatin inhibition for neuromuscular and metabolic diseases, including spinal muscular atrophy ("SMA") and obesity; and antibody recruiting, bispecific molecules and antibody drug conjugates ("ADCs") for cancer.
The Company is subject to risks and uncertainties common to 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 Bulldog (BVI) Ltd., 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 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 (as defined below) of the business, operations, and activities that are not the calcitonin gene-related peptide ("CGRP") Business (as defined below), including the Kv7 ion channel activators, glutamate modulation, myeloperoxidase ("MPO") inhibition and myostatin inhibition platforms, preclinical product candidates, and certain corporate infrastructure 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, through a series of internal restructuring transactions. Descriptions of historical business activities in these Notes to the 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 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 (the "SEC") on September 22, 2022. 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 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 became an independent, publicly traded
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BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
1. Nature of the Business and Basis of Presentation (Continued)
company. Collectively, we refer to the Distribution and Spin-Off throughout this Annual Report on Form 10-K as the "Separation."
The Separation 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
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 SEC.
Periods Prior to the Separation
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.
For periods prior to the Separation, 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 for 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 for 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 amounts in the consolidated financial statements for the periods prior to the Separation were calculated on a separate return method and is presented as if the Company’s operations were separate taxpayers in the respective jurisdiction. Therefore, tax expense, cash tax payments, and items of current and deferred taxes may not be reflective of the Company's actual tax balances prior to or 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 as “Net transfers from Former Parent.” See Note 14, "Related Party
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BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
1. Nature of the Business and Basis of Presentation (Continued)
Transactions," for additional information regarding related party transactions.
For periods prior to the Separation, the Company's equity balance in these consolidated financial statements represents the excess of total assets over liabilities. Net investment from Former Parent is primarily impacted by contributions from the Former Parent, which are the result of net funding provided by or distributed to the 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 during the fourth quarter of 2022 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.
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 February 29, 2024, the Company has funded its operations primarily with funding from the Former Parent, proceeds from the public offerings of its common shares (refer to Note 7, "Shareholders' Equity"), and the cash contribution received from the Former Parent at the Separation (refer to Note 14, "Related Party Transactions.") The Company has incurred recurring losses since its inception and expects to continue to generate operating losses for the foreseeable future.
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.
2. 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 expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, 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 represents cash held
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BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
2. Summary of Significant Accounting Policies (Continued)
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 continued to serve as the Former Parent’s distributor and agent for the distribution of the pharmaceutical product Nurtec ODT in the United States. The Distribution Services Agreement was terminated during the second quarter of 2023, and, as such, restricted cash held on behalf of the Former Parent on the consolidated balance sheet was $ 0 as of December 31, 2023. 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 primarily 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.
Restricted cash included in other non-current 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, 2023, 2022 and 2021, respectively, in the consolidated statements of cash flows:
December 31,
2023 2022 2021
Cash and cash equivalents $ 248,402 $ 204,877 $ 76,057
Restricted cash held on behalf of Former Parent
— 35,212 —
Restricted cash (included in other current assets) 1,318 117 250
Restricted cash (included in other non-current assets) 2,400 2,398 750
Total cash, cash equivalents and restricted cash at the end of the period in the consolidated statement of cash flows $ 252,120 $ 242,604 $ 77,057
Marketable Securities
We invest our excess cash balances in marketable securities of highly rated financial institutions, which consist of 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 on the consolidated balance sheets. 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 shareholders’ 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.
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, 2023 and December 31, 2022, the
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BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
2. Summary of Significant Accounting Policies (Continued)
Company's property and equipment consisted of building and land, office and lab equipment, computer hardware and software, furniture and fixtures, and leasehold improvements.
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
Leasehold improvements
Shorter of the useful life or remaining lease term
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 reviews amounts capitalized as acquired IPR&D for impairment annually, as of November 30, and whenever events or changes in circumstances indicate that the carrying value of the assets might not be recoverable. If impairment indicators are present, the Company performs 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 did not record any impairment charges relating to its acquired IPR&D for the years ended December 31, 2023, 2022 or 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 Pharmaceuticals, Inc. (“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 Multimodal Antibody Therapy Enhancer ("MATE") conjugation asset in the planning stage for clinical development, and goodwill of $ 1,390 .
Impairment of Long-lived Assets
The Company reviews its long-lived assets for indicators of impairment annually, as of November 30, and whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. 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 did not record any impairment charges relating to its long-lived assets for the years ended December 31, 2023, 2022 or 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
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BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
2. Summary of Significant Accounting Policies (Continued)
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, 2023, the Company had restricted cash of $ 2,400 included in other non-current assets and $ 250 included in other 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. Restricted cash is generally invested in time deposits and short-term money market funds. 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. 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 expenses are recorded as research and development expenses are 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.
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BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
2. Summary of Significant Accounting Policies (Continued)
Foreign Currency
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 shareholders’ equity and weighted average exchange rates for operating results. The resulting translation gains and losses are included in accumulated other comprehensive (loss) income, net of tax, in shareholders’ equity.
For U.S. dollar functional currency subsidiaries, foreign currency assets and liabilities are remeasured into U.S. dollars at end-of-period exchange rates, except for nonmonetary balance sheet accounts which are remeasured at historical exchange rates. Revenues and expenses are remeasured at average exchange rates in effect during each period, except for those expenses related to the nonmonetary balance sheet amounts which are remeasured at historical exchange rates. Gains or losses from foreign currency remeasurement are included in other income (expense), net in the consolidated statement of operations.
The Company's aggregate foreign currency transaction gains and losses and effects of foreign currency remeasurements were immaterial for the years ended December 31, 2023, 2022 and 2021.
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 and restricted share units with only service-based vesting conditions and records the expense for these awards using the straight-line method. The Company also issues share options with performance-based vesting conditions and records expense for these awards when the Company concludes that it is probable that the performance condition will be achieved.
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 share 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
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BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
2. Summary of Significant Accounting Policies (Continued)
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 sheets.
Segment Information
The Company manages its operations as a single segment, the development of therapies targeting areas including neuroscience, immunology and oncology. 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 2023 and 2022, materially all the Company's long-lived assets were held in the United States.
Recently Issued Accounting Pronouncements
In November 2023, the FASB issued ASU No. 2023-07, Segment Reporting—Improvements to Reportable Segment Disclosures, which improves reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The amendments in ASU No. 2023-07 apply to public entities, including those with a single reportable segment, and are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact ASU No. 2023-07 will have on its consolidated financial statements
In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to improve the transparency of income tax disclosures by requiring consistent categories and greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The ASU also includes certain other amendments to improve the effectiveness of income tax disclosures. The amendments in ASU 2023-09 are effective for fiscal years beginning after December 15, 2024, with early adoption permitted for annual financial statements that have not yet been issued or made available for issuance. The Company is currently evaluating the impact ASU No. 2023-09 will have on its consolidated financial statements.
F-16
BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
3. 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, 2023 and December 31, 2022 is as follows:
Amortized Cost Allowance for Credit Losses Net Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value
December 31, 2023
Debt securities
U.S. corporate bonds $ 46,228 $ — $ 46,228 $ 7 $ ( 24 ) $ 46,211
Foreign corporate bonds 7,180 — 7,180 — ( 7 ) 7,173
U.S. treasury bills 113,908 — 113,908 27 — 113,935
Total $ 167,316 $ — $ 167,316 $ 34 $ ( 31 ) $ 167,319
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 fair values of debt securities available-for-sale by classification in the consolidated balance sheets were as follows:
December 31, 2023 December 31, 2022
Cash and cash equivalents $ 33,902 $ 49,896
Marketable securities 133,417 260,464
Total $ 167,319 $ 310,360
The net amortized cost and fair value of debt securities available-for-sale at December 31, 2023 and 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, 2023 December 31, 2022
Net Amortized Cost Fair Value Net Amortized Cost Fair Value
Due to mature:
Less than one year $ 167,316 $ 167,319 $ 310,505 $ 310,360
F-17
BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
3. Marketable Securities (Continued)
Summarized below are the debt securities available-for-sale the Company held at December 31, 2023 and 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, 2023
Debt securities
U.S. corporate bonds 6 $ 29,537 $ ( 24 )
Foreign corporate bonds 1 7,173 ( 7 )
Total 7 $ 36,710 $ ( 31 )
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 24 $ 187,866 $ ( 196 )
The Company did no t have any investments in a continuous unrealized loss position for more than twelve months as of December 31, 2023 or 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, 2023, 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
Gross investment income includes interest income from debt securities available-for-sale, money-market funds, cash, and restricted cash. Net investment income included in other income (expense), net in the consolidated statements of operations for the years ended December 31, 2023 and December 31, 2022 were as follows:
2023 2022
Debt securities (including realized losses)
$ 10,490 $ 1,454
Other investments
7,432 $ 1,781
Gross investment income (including realized losses)
17,922 $ 3,235
Investment expenses ( 236 ) ( 27 )
Net investment income $ 17,686 $ 3,208
The Company had no net investment income during the year ended December 31, 2021.
F-18
BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
3. Marketable Securities (Continued)
We utilize the specific identification method in computing realized gains and losses on sales of debt securities. The proceeds from the sale of debt securities available-for-sale and the related gross realized losses for the year ended December 31, 2023 were as follows:
2023
Proceeds from sales
$ 4,920
Gross realized losses
$ 39
The Company had no sales of debt securities during the years ended December 31, 2022 or 2021.
4. 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 sheets at December 31, 2023 and 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, 2023
Assets:
Cash equivalents Money market funds $ 59,199 $ — $ — $ 59,199
Cash equivalents U.S. treasury bills — 27,901 — 27,901
Cash equivalents U.S. corporate bonds — 6,001 — 6,001
Marketable securities U.S. treasury bills 9,874 76,160 — 86,034
Marketable securities U.S. corporate bonds — 40,210 — 40,210
Marketable securities Foreign corporate bonds — 7,173 — 7,173
Other non-current assets
Money market funds
1,900 — — 1,900
Total assets $ 70,973 $ 157,445 $ — $ 228,418
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
F-19
BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
4. Fair Value of Financial Assets and Liabilities (Continued)
The Company had no financial liabilities measured at fair value on a recurring basis as of December 31, 2023 or December 31, 2022.
There were no securities transferred between Level 1, 2, and 3 during the years ended December 31, 2023 or 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, 2023 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
Quoted prices for identical assets in active markets are considered Level 1 and consist of on-the-run U.S. Treasury bills. 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.
5. Balance Sheet Components
Property and Equipment, Net
Property and equipment, net consisted of the following:
As of December 31, 2023 As of December 31, 2022
Building and land $ 11,728 $ 12,297
Leasehold improvements
802 —
Computer hardware and software 875 780
Office and lab equipment 9,961 5,501
Furniture and fixtures 1,550 1,202
$ 24,916 $ 19,780
Accumulated depreciation ( 8,283 ) ( 4,914 )
16,633 14,866
Equipment not yet in service 558 2,646
Property and equipment, net $ 17,191 $ 17,512
Depreciation expense was $ 3,369 , $ 1,361 and $ 673 for the years ended December 31, 2023, 2022 and 2021, respectively.
Equipment not yet in service primarily consisted of lab equipment that had not been placed into service as of December 31, 2023 or 2022.
Other Non-current Assets
Other non-current assets consisted of the following:
As of December 31, 2023 As of December 31, 2022
Operating lease right-of-use assets $ 31,385 $ 34,928
Other 2,400 2,585
Other non-current assets $ 33,785 $ 37,513
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following:
As of December 31, 2023 As of December 31, 2022
Accrued employee compensation and benefits $ 837 $ 14,603
Accrued clinical trial costs 29,501 17,788
Operating lease liability - current portion
3,308 3,019
Other accrued expenses and other current liabilities 6,200 8,696
Accrued expenses and other current liabilities
$ 39,846 $ 44,106
6. Acquisitions
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
F-20
BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
6. Acquisitions (Continued)
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. 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 ") expense in the accompanying consolidated statement of operations of $ 93,747 .
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 and was paid to Knopp during 2022.
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, 2023.
Pyramid Acquisition
In January 2024, the Company acquired Pyramid Biosciences, Inc. ("Pyramid"), pursuant to an Agreement and Plan of Merger, dated January 7, 2024 ("the Pyramid Agreement"). In consideration for the Pyramid acquisition, Biohaven made an upfront payment of $ 10,000 in common shares of the Company.
Biohaven has also agreed to make additional success-based payments comprised of (i) up to $ 10,000 based on developmental and regulatory milestones for
the lead asset, BHV-1510 (formerly known as PBI-410), (ii) up to an additional $ 30,000 based on developmental and regulatory milestones for a second asset (formerly known as PBI-200) and (iii) up to $ 40,000 for commercial sales-based milestones of BHV-1510. Contingent developmental and regulatory milestone payments may be paid in cash or Biohaven common shares at the election of Biohaven and commercial sales-based milestones are to be made in cash.
During the first quarter of 2024, the Company incurred $ 5,000 of R&D expense related to a regulatory milestone which became due under the Pyramid Agreement.
7. Shareholders' Equity
Issuance of common shares for the Highlightll Agreement
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") pursuant to which Biohaven obtained the right to research, develop, manufacture and commercialize Highlightll's brain penetrant dual TYK2/JAK1 inhibitor program. In connection with the Highlightll Agreement, in December 2023, the Company issued 721,136 common shares valued at $ 21,814 . See Note 11, "License Agreements," for further detail on the Highlightll Agreement.
Issuance of Common Shares for the October 2023 Offering
In October 2023, the Compan y completed an underwritten public offering of 11,761,363 of its common shares, including the exercise in full of the underwriters' option to purchase additional common shares, at a price to the public of $ 22.00 per share, pursuant to a registration statement on Form S-3 filed with the SEC. The net proceeds raised in the offering, after deducting underwriting discounts and expenses of the offering payable by the Company, were approximately $ 242,425 .
Equity Distribution Agreement
In October 2023, the Company entered into an equity distribution agreement pursuant to which the Company may offer and sell common shares having an aggregate offering price of up to $ 150,000 from time to time through or to the sales agent, acting as its agent or principal (the "Equity Distribution Agreement"). Sales of the Company's common shares, if any, will be made in sales deemed to be “at-the-market offerings”. The sales agent is not required to sell any specific amount of securities but will act as the Company's sales agent
F-21
BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
7. Shareholders' Equity (Continued)
using commercially reasonable efforts consistent with its normal trading and sales practices, on mutually agreed terms between the sales agent and the Company. The Company currently plans to use the net proceeds from any at-the-market offerings of its common shares for general corporate purposes.
As of December 31, 2023, the Company has issued and sold no common shares under the Equity Distribution Agreement.
Issuance of Common Shares for the October 2022 Offering
In October 2022, the Company commenced a public offering of 25,000,000 of its common shares at a price of $ 10.50 per share, pursuant to a registration statement on Form S-1 filed with the SEC, which was declared effective by the SEC on October 20, 2022. The Company also granted the underwriters a 30-day option to purchase up to an additional 3,750,000 common shares. On October 25, 2022, the Company closed the offering, including a full exercise of the underwriters' option to purchase additional shares. The net proceeds raised in the offering, after deducting underwriting discounts and expenses of the offering payable by the Company, were approximately $ 282,804 .
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 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 issued in connection with Former Parent share options that were exercised on October 3, 2022 and 924,093 common shares 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.
8. Accumulated Other Comprehensive (Loss) Income
Shareholders’ equity included the following activity in accumulated other comprehensive (loss) income for the years ended December 31, 2023 and 2022:
2023 2022
Net unrealized investment gains (losses):
Beginning of period balance $ ( 145 ) $ —
Other comprehensive income (loss) 1)
109 ( 145 )
Amounts reclassified from accumulated other comprehensive income (loss) (2)
39 —
Other comprehensive income (loss)
148 ( 145 )
End of period balance 3 ( 145 )
Foreign currency translation adjustments:
Beginning of period balance 429 —
Other comprehensive (loss) income (1)
( 497 ) 429
End of period balance ( 68 ) 429
Total beginning of period accumulated other comprehensive income 284 —
Total other comprehensive (loss) income
( 349 ) 284
Total end of period accumulated other comprehensive (loss) income
$ ( 65 ) $ 284
(1) There was no tax on other comprehensive income (loss) and immaterial tax on amounts reclassified from accumulated other comprehensive (loss) income during the period.
(2) Amounts reclassified from accumulated other comprehensive (loss) income for specifically identified debt securities are included in other income (expense), net in the consolidated statements of operations.
No amounts were reclassified from accumulated other comprehensive (loss) income during the years ended December 31, 2022 or 2021. The Company had no accumulated other comprehensive (loss) income included in shareholders' equity as of December 31, 2021.
9. 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
F-22
BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
9. Non-Cash Share-Based Compensation (Continued)
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, 2023, the 2022 Plan allows for a maximum of 11,917,619 shares of the Company's common shares to be reserved and available for grants. Also as of December 31, 2023, there were 173,899 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 2024, the number of common shares reserved for future issuance under the 2022 Plan automatically increased by 3,244,628 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 to four years ) using the straight-line method.
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 years ) using the straight-line method. Non-cash share-based compensation expense, consisting of expense for stock options, RSUs, and the 2022 Employee Share
F-23
BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
9. Non-Cash Share-Based Compensation (Continued)
Purchase Plan (the "ESPP"), was classified in the consolidated statements of operations as follows:
Year Ended December 31,
2023 2022 2021
Research and development expenses
Allocated from the Former Parent excluding the Acceleration
$ — $ 46,976 $ 39,381
Allocated from the Former Parent related to the Acceleration
— 61,749 —
2022 Equity Incentive Plan 15,985 7,654 —
Total research and development expenses 15,985 116,379 39,381
General and administrative expenses
Allocated from the Former Parent excluding the Acceleration
— 30,951 26,258
Allocated from the Former Parent related to the Acceleration
— 39,691 —
2022 Equity Incentive Plan 12,802 6,535 —
Total general and administrative expenses 12,802 77,177 26,258
Total non-cash share-based compensation expense $ 28,787 $ 193,556 $ 65,639
As of December 31, 2023, total unrecognized compensation cost related to the unvested share-based awards was $ 52,190 , which is expected to be recognized over a weighted average period of 2.36 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. Share 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, 2023. The total intrinsic value of outstanding share options for the years ended December 31, 2023 and 2022 was $ 356,369 and $ 61,639 , respectively. The total intrinsic value of share options exercised for the year ended December 31, 2023 was $ 7,756 . The tax benefit from share options exercised for the years ended December 31, 2023 and 2022 was not material.
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,
2023 2022
Risk-free interest rate 4.32 % 3.86 %
Expected term (in years) 5.93 5.75
Expected volatility 84.60 % 82.05 %
Expected dividend yield — % — %
Exercise price $ 24.57 $ 7.00
F-24
BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
9. Non-Cash Share-Based Compensation (Continued)
The following table is a summary of the Company's share option activity for the year ended December 31, 2023:
Number of
Shares
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term
Aggregate
Intrinsic
Value
(in years)
Outstanding as of December 31, 2022 8,959,215 $ 7.00
Granted
2,929,616 $ 24.57
Exercised
( 299,756 ) $ 7.68
Forfeited ( 209,646 ) $ 8.17
Outstanding as of December 31, 2023 11,379,429 $ 11.48 8.99 $ 356,369
Options exercisable as of December 31, 2023 4,746,876 $ 9.46 8.88 $ 158,284
Vested and expected to vest as of December 31, 2023 11,379,429 $ 11.48 8.99 $ 356,369
The weighted average grant date fair value per share of share options granted under the Company’s share option plans during the years ended December 31, 2023 and 2022 was $ 18.01 and $ 4.97 , respectively. The Company expects approximately 6,632,553 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 years ended December 31, 2023 or 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.
There were no unvested restricted share units outstanding as of December 31, 2023 and 2022. No restricted share units were granted, forfeited, or vested, in the year ended December 31, 2023.
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 approved by shareholders of the Company on September 28, 2022.
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, 2023, the ESPP allows for a maximum of 1,075,673 shares of the Company's common shares to be reserved and available for issuance under the ESPP. As of December 31, 2023, 916,484 shares remained available for future issuance under the ESPP. In January 2024, 811,157 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
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
9. Non-Cash Share-Based Compensation (Continued)
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 recognized compensation expense of $ 1,341 for the year ended December 31, 2023. The Company did not recognize material compensation expense related to the ESPP for the year ended December 31, 2022.
As of December 31, 2023, there was $ 638 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, 2024. During the year ended December 31, 2023, 159,189 shares were issued under the ESPP.
10. Net Loss Per Share
Basic and diluted net loss per share attributable to common shareholders of Biohaven was calculated as follows:
Year Ended December 31,
2023 2022 2021
Numerator:
Net loss
$ ( 408,168 ) $ ( 570,279 ) $ ( 213,796 )
Denominator:
Weighted average common shares outstanding—basic and diluted (1)
71,200,527 44,741,316 39,375,944
Net loss per share—basic and diluted
$ ( 5.73 ) $ ( 12.75 ) $ ( 5.43 )
(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,
2023 2022
Options to purchase common shares 11,379,429 8,959,215
11. License Agreements
The following is a summary of all license agreements that the Company has entered into. As of December 31, 2023, the Company has potential future developmental, regulatory, and commercial milestone payments under these agreements of up to approximately $ 101,800 , $ 547,350 , and $ 1,270,450 , respectively.
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, 2023, 2022 and 2021, 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
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
11. License Agreements (Continued)
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.
The Company recorded research and development expense related to the Yale MoDE SRA of $ 1,333 , $ 2,666 and $ 150 for the years ended December 31, 2023, 2022 and 2021, respectively. For the years ended December 31, 2023, 2022 and 2021, the Company did not make any milestone or royalty payments under the Yale MoDE Agreement.
In May 2023, the Company entered into an additional sponsored research agreement with Yale University (the "2023 Yale SRA"), which included funding of up to $ 612 over the life of the agreement. For the year ended December 31, 2023, the company recorded $ 367 in research and development expense related to the 2023 Yale SRA.
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, 2023, 2022 and 2021, the Company did no t 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
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
11. License Agreements (Continued)
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, 2023, 2022 and 2021, the Company did no t 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, 2023, 2022 and 2021, the Company did no t 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
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
11. License Agreements (Continued)
country and can also be terminated if certain events occur, e.g., material breach or insolvency.
The Company did no t 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, 2023, 2022 and 2021.
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 in September 2022, for the years ended December 31, 2023, 2022 and 2021, the Company did no t 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 2023, the 2020 Artizan Agreement and 2021 Artizan Agreement were both terminated.
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.
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BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
11. License Agreements (Continued)
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),net on the consolidated statements of operations.
For the years ended December 31, 2023, 2022 and 2021, excluding the upfront payments above, the Company did no t record any research and development expense or make any material milestone payments related to the 2020 Artizan Agreement and the 2021 Artizan 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, 2023, 2022 and 2021, the Company did no t 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.
For the year ended December 31, 2023, the Company recorded $ 3,250 to R&D expense in the consolidated statements of operations related to developmental milestones which became due to KU Leuven during 2023. Excluding the upfront payments discussed above, for the year ended December 31, 2022, the Company did no t 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 years ended December 31, 2023 and 2022, the Company did no t record any material expense or make any milestone or royalty payments under the Taldefgrobep Alfa License Agreement.
Agreement with Hangzhou Highlightll Pharmaceutical Co. Ltd.
In March 2023, the Company entered into the Highlightll Agreement pursuant to which Biohaven obtained the right to research, develop, manufacture and commercialize Highlightll’s brain penetrant dual TYK2/JAK1 inhibitor program. In connection with the Highlightll Agreement, the Company was obligated to pay Highlightll a cash payment of $ 10,000 and 721,136 common shares (collectively, "the Highlightll Upfront Payments"), upon the completion of certain post-closing activities. In December 2023, the Company entered into
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BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
11. License Agreements (Continued)
a second amendment to the Highlightll Agreement, which granted the Company an exclusive option and right of first refusal to any Selective TYK2 Inhibitor being developed by or on behalf of Highlightll or its affiliates and provided for the payment of the Highlightll Upfront Payments. As a result, the Company made a $ 10,000 cash payment and issued 721,136 shares, valued at $ 21,814 , to Highlightll during the fourth quarter of 2023, which was recorded as R&D expense during the year ended December 31, 2023.
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 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.
Excluding the Highlightll Upfront Payments discussed above, for the year ended December 31, 2023, the Company did not record any material milestone or royalty payments related to the Highlightll Agreement.
12. 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 Company's leases primarily 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, 2023, 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. For periods prior to Separation, lease costs were allocated to the Company based on a proportional cost allocation method. Allocated operating lease cost for periods prior to Separation and actual operating lease cost was $ 5,874 , $ 1,158 and $ 264 for the years ended December 31, 2023, 2022 and 2021, respectively.
The Company currently has one 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,
2023 2022 2021
Right-of-use assets obtained in exchange for new operating lease liabilities
$ — $ 31,342 $ 478
Operating cash flows paid for operating leases were immaterial for all periods prior to the Separation, and were $ 4,854 and $ 780 for the years ended December 31, 2023 and December 31, 2022.
Supplemental balance sheet information related to leases is as follows:
In thousands, except remaining lease term and discount rate December 31, 2023 December 31, 2022
Assets
Other non-current assets
$ 31,385 $ 34,928
Liabilities
Other current liabilities $ 3,308 $ 3,019
Long-term operating lease liability
27,569 30,581
$ 30,877 $ 33,600
Weighted average remaining lease term (in years) 8.21 9.08
Weighted average discount rate 6.47 % 6.55 %
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BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
12. Commitments and Contingencies (Continued)
The following table summarizes maturities of operating lease liabilities as of December 31, 2023:
Operating leases
2024 $ 5,020
2025 4,782
2026 4,905
2027 4,509
2028 3,945
Thereafter 16,619
Total lease payments 39,780
Less: imputed interest ( 8,903 )
Total lease liabilities $ 30,877
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 Company has entered into agreements with several CROs to provide services in connection with the Company’s preclinical studies and clinical trials. As of December 31, 2023, the Company had remaining maximum research commitments in excess of one year of approximately $ 9,025 , 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 approximately one year .
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, 2023 or December 31, 2022.
License Agreements
The Company has entered into license agreements with various parties for which it is obligated to make contingent and non-contingent payments. See Note 11, "License Agreements," for additional details.
Other Agreements
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, 2023, 2022 and 2021, excluding the upfront payments above, the Company did no t record any material research and development expense or make any milestone payments related to the Moda Agreement.
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
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
12. Commitments and Contingencies (Continued)
December 31, 2023, there were no matters which would have a material impact on the Company’s financial results.
13. 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 Company, including the Former Parent for periods prior to the Separation, has 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, 2023, 2022 and 2021, 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, 2023 and 2022, 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 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.
The Company recorded an income tax benefit during the year ended December 31, 2023 of $ 1,383 and income tax provisions of $ 438 and $ 1,366 during the years ended December 31, 2022 and 2021, respectively, which primarily represent Federal and state taxes
related to the Company’s profitable operations in the U.S. and Ireland.
Loss before provision for income taxes consisted of the following:
Year Ended December 31,
2023 2022 2021
BVI $ ( 424,647 ) $ ( 598,046 ) $ ( 211,334 )
Foreign 15,096 28,205 ( 1,096 )
Loss before provision for income taxes $ ( 409,551 ) $ ( 569,841 ) $ ( 212,430 )
The provision for income taxes consisted of the following:
Year Ended December 31,
2023 2022 2021
Current income tax (benefit) provision:
BVI $ — $ — $ —
Foreign ( 1,383 ) 438 1,366
Total current income tax (benefit) provision
( 1,383 ) 438 1,366
Deferred income tax provision (benefit):
BVI — — —
Foreign — — —
Total deferred income tax provision (benefit) — — —
Total (benefit) provision for income taxes
$ ( 1,383 ) $ 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,
2023 2022 2021
BVI statutory income tax rate 0.0 % 0.0 % 0.0 %
Foreign tax rate differential 1.3 ( 12.6 ) 0.0
Tax credits ( 12.7 ) ( 5.8 ) ( 5.0 )
Change in valuation allowance 10.6 18.5 7.0
Other 0.5 0.0 ( 1.0 )
Effective income tax rate ( 0.3 ) % 0.1 % 1.0 %
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BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
13. Income Taxes (Continued)
The Company's income tax (benefit) provision primarily represents Federal and state taxes related to the profitable operations of its subsidiaries in the United States and Ireland. The income tax benefit recorded during the year ended December 31, 2023 was primarily attributable to the adoption of the guidance contained in a Notice of Proposed Rule Making issued by the United States Internal Revenue Service during the third quarter of 2023 ("the Notice"). The Notice indicates that BPI has the ability to immediately deduct R&D expenditures which were incurred in the US and reimbursed by its foreign parent. Previously these expenditures were capitalized, as was generally required under the Tax Cuts and Jobs Act, which was effective for tax years beginning on or after January 1, 2022. Based on this guidance and its application to the Company's specific facts, Biohaven deducted these expenditures on its 2022 tax return, substantially reducing its taxable income in the US and capitalized R&D expenditures, resulting in an increase to its federal net operating loss carryforward of $ 598.7 million that can be carried forward indefinitely. The Company's adoption of the Notice in 2023 also increased its State net operating losses, resulting in the reversal of $ 0.8 million of state income taxes recorded in 2022.
Net deferred tax assets (liabilities) consisted of the following:
December 31,
2023 2022
Deferred tax assets:
Foreign net operating loss carryforwards $ 138,480 $ 8,895
Tax credits 111,660 60,340
R&D capitalization 887 142,269
Other 15,944 5,205
Valuation allowance ( 259,448 ) ( 216,061 )
Total deferred tax assets 7,523 648
Deferred tax liabilities:
Other
( 7,523 ) ( 648 )
Total deferred tax liabilities ( 7,523 ) ( 648 )
Net deferred tax asset (liability) $ — $ —
As of December 31, 2023, and 2022, the Company had foreign net operating loss carryforwards of $ 847,582 and $ 69,214 , respectively. As of December 31, 2023, and 2022, the Company had federal and state research and development and orphan drug credits of $ 111,660 and $ 60,340 , respectively, which begin to expire in 2039.
Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2023 and 2022 were due primarily to generation of net operating losses and tax credit carryforwards. 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.
Year Ended December 31,
2023 2022 2021
Valuation allowance as of beginning of year $ 216,061 $ 54,224 $ 32,970
Increases recorded to Purchase Accounting and Net Investment from Former Parent — 50,905 6,449
Increases recorded to income tax provision 43,387 110,932 14,805
Valuation allowance as of end of year $ 259,448 $ 216,061 $ 54,224
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,
2023 2022 2021
Beginning of period balance $ 2,200 $ 3,800 $ 2,700
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
End of period balance $ 2,200 $ 2,200 $ 3,800
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, 2023 and 2022, 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 state income tax returns are subject to tax examinations for the tax year ended December 31, 2019 and
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BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
13. Income Taxes (Continued)
subsequent years. The federal tax return for BPI is currently under audit by the IRS for the period ended December 31, 2019.
14. 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, 2023, the Company recorded $ 9,250 in other income (expense), net on the consolidated statements of operations reflecting transition services provided to the Former Parent, of which $ 396 was included as a receivable in other current assets on the consolidated balance sheet as of December 31, 2023. For the year ended December 31, 2022, the Company recorded $ 4,024 in other income (expense), net on the consolidated statements of operations 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 was 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 were 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 was legally payable to the Former Parent. The Company did not hold any restricted cash on behalf of the Former Parent as of December 31, 2023.
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
F-35
BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
14. Related Party Transactions (Continued)
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
Research and development $ 146,521 $ 70,929
General and administrative 82,744 33,928
Total $ 229,265 $ 104,857
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.
F-36
BIOHAVEN LTD.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
14. Related Party Transactions (Continued)
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
General financing activities $ 399,231 $ 98,834
Corporate cost allocations, excluding non-cash share-based compensation 49,899 39,218
Net transfers from Former Parent as reflected in the Consolidated Statement of Cash Flows 449,130 138,052
Non-cash share-based compensation 179,367 65,639
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 )
Net transfers from Former Parent as reflected in the Consolidated Statement of Changes in Equity $ 776,630 $ 231,706
(1) The amounts for the year ended December 31, 2022 represent activity through the date of Separation.
(2) Refer to Note 1, "Nature of the Business and Basis of Presentation," for further details on separation related adjustments.
Related Party Agreements
License Agreements with Yale
On September 30, 2013, the Company entered into the Yale Agreement with Yale (see Note 11, "License Agreements," 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, "License Agreements," 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 . Under the Yale MoDE Agreement, the Company entered into the Yale MoDE SRA (see Note 11, "License Agreements," for details), which included funding of up to $ 4,000 over the life of the agreement. In May 2023, the Company entered into an additional sponsored research agreement with Yale University (the "2023 Yale SRA"), which includes funding of up to $ 612 over the life of the agreement.
For the years ended December 31, 2023, 2022 and 2021, the Company recorded $ 2,942 , $ 3,420 and $ 458 , respectively, in research and development expense, including certain administrative expenses, related to the Yale MoDE Agreement and the Yale MoDE SRA, the Yale Agreement, and the 2023 Yale SRA (the "Yale Agreements"). As of December 31, 2023, the Company did not owe any amounts to Yale.
F-37