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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2024
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission File Number: 001-41477
Biohaven Ltd.
(Exact name of registrant as specified in its charter) | | | | | | | | |
British Virgin Islands | | Not applicable |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
| | |
c/o Biohaven Pharmaceuticals, Inc. | | |
215 Church Street, New Haven, Connecticut | | 06510 |
(Address of principal executive offices) | | (Zip Code) |
(203) 404-0410
(Registrant’s telephone number, including area code)
N/A
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act: | | | | | | | | |
Title of each class | Trading Symbol | Name of each exchange on which registered |
Common Shares, no par value | BHVN | New York Stock Exchange |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and "emerging growth company" in Rule 12b-2 of the Exchange Act. | | | | | | | | | | | | | | | | | | | | |
| Large accelerated filer | ☒ | | Accelerated filer | ☐ | |
| Non-accelerated filer | ☐ | | Small reporting company | ☐ | |
| | | | Emerging growth company | ☐ | |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of November 8, 2024, the registrant had 101,122,246 common shares, without par value per share, outstanding.
| | | | | | | | |
| TABLE OF CONTENTS | |
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Part I | Financial Information | |
Item 1: | | |
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Item 2: | | |
Item 3: | | |
Item 4: | | |
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Part II | Other Information | |
Item 1: | | |
Item 1A: | | |
Item 2: | | |
Item 5. | | |
Item 6: | | |
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PART I - FINANCIAL INFORMATION
Item 1. Unaudited Condensed Consolidated Financial Statements
BIOHAVEN LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share amounts)
| | | | | | | | | | | | | | |
| | September 30, 2024 | | December 31, 2023 |
| | (Unaudited) | | |
Assets | | | | |
Current assets: | | | | |
Cash and cash equivalents | | $ | 84,390 | | | $ | 248,402 | |
Marketable securities | | 294,426 | | | 133,417 | |
| | | | |
| | | | |
Prepaid expenses | | 55,168 | | | 35,242 | |
Income tax receivable | | 5,318 | | | 13,252 | |
| | | | |
Other current assets | | 1,198 | | | 12,133 | |
Total current assets | | 440,500 | | | 442,446 | |
Property and equipment, net | | 18,276 | | | 17,191 | |
| | | | |
| | | | |
| | | | |
Intangible assets | | 18,400 | | | 18,400 | |
Goodwill | | 1,390 | | | 1,390 | |
| | | | |
Other non-current assets | | 31,957 | | | 33,785 | |
Total assets | | $ | 510,523 | | | $ | 513,212 | |
Liabilities and Shareholders' Equity | | | | |
Current liabilities: | | | | |
| | | | |
Accounts payable | | $ | 19,744 | | | $ | 15,577 | |
| | | | |
Accrued expenses and other current liabilities | | 63,520 | | | 39,846 | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
Forward contract liability | | 69,030 | | | — | |
Total current liabilities | | 152,294 | | | 55,423 | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
Non-current operating lease liabilities | | 25,312 | | | 27,569 | |
| | | | |
| | | | |
Derivative liability, non-current | | 12,320 | | | — | |
Other non-current liabilities | | 4,591 | | | 2,245 | |
Total liabilities | | 194,517 | | | 85,237 | |
Commitments and contingencies (Note 11) | | | | |
| | | | |
| | | | |
Shareholders' Equity: | | | | |
| | | | |
Preferred shares, no par value; 10,000,000 shares authorized, no shares issued and outstanding as of September 30, 2024 and December 31, 2023 | | — | | | — | |
Common shares, no par value; 200,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 94,899,193 and 81,115,723 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively | | 1,381,699 | | | 887,528 | |
Additional paid-in capital | | 93,038 | | | 39,804 | |
| | | | |
Accumulated deficit | | (1,158,871) | | | (499,292) | |
Accumulated other comprehensive income (loss) | | 140 | | | (65) | |
| | | | |
| | | | |
Total shareholders' equity | | 316,006 | | | 427,975 | |
Total liabilities and shareholders' equity | | $ | 510,523 | | | $ | 513,212 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
BIOHAVEN LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
Operating expenses: | | | | | | | | |
| | | | | | | | |
Research and development | | $ | 157,607 | | | $ | 95,517 | | | $ | 628,398 | | | $ | 238,468 | |
General and administrative | | 20,561 | | | 15,030 | | | 66,782 | | | 43,872 | |
Total operating expenses | | 178,168 | | | 110,547 | | | 695,180 | | | 282,340 | |
Loss from operations | | (178,168) | | | (110,547) | | | (695,180) | | | (282,340) | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
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| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
Other income, net | | 17,805 | | | 4,686 | | | 36,288 | | | 18,757 | |
Loss before (benefit) provision for income taxes | | (160,363) | | | (105,861) | | | (658,892) | | | (263,583) | |
(Benefit) provision for income taxes | | (59) | | | (3,287) | | | 687 | | | (171) | |
Net loss | | $ | (160,304) | | | $ | (102,574) | | | $ | (659,579) | | | $ | (263,412) | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
| | | | | | | | |
Net loss per share — basic and diluted | | $ | (1.70) | | | $ | (1.50) | | | $ | (7.50) | | | $ | (3.86) | |
Weighted average common shares outstanding—basic and diluted | | 94,372,159 | | | 68,320,125 | | | 87,936,923 | | | 68,258,757 | |
Comprehensive loss: | | | | | | | | |
Net loss | | $ | (160,304) | | | $ | (102,574) | | | $ | (659,579) | | | $ | (263,412) | |
Other comprehensive income (loss), net of tax | | 218 | | | 138 | | | 205 | | | (126) | |
| | | | | | | | |
| | | | | | | | |
Comprehensive loss | | $ | (160,086) | | | $ | (102,436) | | | $ | (659,374) | | | $ | (263,538) | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
BIOHAVEN LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
(Unaudited)
| | | | | | | | | | | | | |
| Nine Months Ended September 30, | | |
| 2024 | | 2023 | | |
Cash flows from operating activities: | | | | | |
Net loss | $ | (659,579) | | | $ | (263,412) | | | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | | |
Depreciation and amortization | 5,394 | | | 5,018 | | | |
Non-cash share-based compensation | 59,269 | | | 12,916 | | | |
Issuance of common shares as payment for acquisition of IPR&D asset | 10,811 | | | — | | | |
Issuance of common shares as payment under license and other agreements | 71,627 | | | — | | | |
Fair value of forward contract and derivative liabilities under license agreement | 102,529 | | | — | | | |
Change in fair value of forward contract and derivative liabilities | (21,179) | | | — | | | |
Issuance of warrant under license agreement | 3,340 | | | — | | | |
Other non-cash items, net | (6,749) | | | (4,696) | | | |
Changes in operating assets and liabilities, net of effects of acquisition: | | | | | |
Prepaid expenses and other current and non-current assets | (290) | | | 28,428 | | | |
Accounts payable | 2,425 | | | (1,188) | | | |
Accrued expenses and other current and non-current liabilities | 20,691 | | | 6,090 | | | |
Net cash used in operating activities | (411,711) | | | (216,844) | | | |
Cash flows from investing activities: | | | | | |
Proceeds from maturities of marketable securities | 312,364 | | | 214,224 | | | |
Proceeds from sales of marketable securities | — | | | 4,920 | | | |
Purchases of marketable securities | (466,053) | | | (82,822) | | | |
Purchases of property and equipment | (4,000) | | | (2,578) | | | |
Cash acquired from acquisition of IPR&D asset | 391 | | | — | | | |
| | | | | |
Net cash (used in) provided by investing activities | (157,298) | | | 133,744 | | | |
Cash flows from financing activities: | | | | | |
Proceeds from issuance of common shares | 394,881 | | | — | | | |
Payment of issuance costs | (800) | | | — | | | |
Change in restricted cash due to Former Parent | — | | | (35,184) | | | |
Proceeds from equity incentive plan and employee share purchase plan | 8,582 | | | — | | | |
Other financing activities, net | 2,258 | | | 1,857 | | | |
Net cash provided by (used in) financing activities | 404,921 | | | (33,327) | | | |
Effects of exchange rates on cash, cash equivalents, and restricted cash | (13) | | | (187) | | | |
Net decrease in cash, cash equivalents, and restricted cash | (164,101) | | | (116,614) | | | |
Cash, cash equivalents, and restricted cash at beginning of period | 252,120 | | | 242,604 | | | |
Cash, cash equivalents, and restricted cash at end of period | $ | 88,019 | | | $ | 125,990 | | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
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 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 ("ARMs") 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 October 3, 2022, Biohaven Pharmaceutical Holding Company Ltd. (the “Former Parent”) completed the distribution (the “Distribution”) to holders of its common shares of all of the outstanding common shares of Biohaven Ltd. and the spin-off of Biohaven Ltd.
from the Former Parent (the “Spin-Off”) described in Biohaven’s Information Statement attached as Exhibit 99.1 to Biohaven’s Registration Statement on Form 10, as amended (Reg. No. 001-41477). Collectively, we refer to the Distribution and Spin-Off throughout this Quarterly Report on Form 10-Q as the "Separation." As a result of the Separation, Biohaven Ltd. became an independent, publicly traded company as of October 3, 2022, and commenced regular way trading under the symbol “BHVN”’ on the New York Stock Exchange (the "NYSE") on October 4, 2022. Where we describe historical business activities in this report, we do so as if the Former Parent’s activities related to such assets and liabilities had been performed by the Company.
Basis of Presentation
The accompanying condensed consolidated financial statements 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. The accompanying condensed consolidated financial statements include the accounts of Biohaven Ltd. and our wholly owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation.
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 condensed consolidated financial statements are issued.
Through November 12, 2024, the Company has funded its operations primarily with funding from the Former Parent, proceeds from the sale of its common shares, and the cash contribution received from the Former Parent at the Separation. 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 condensed consolidated financial statements, the Company expects its existing cash, cash equivalents, and marketable securities will be sufficient to fund operating and financial commitments, and other cash requirements for at least one year after the issuance date of these financial statements.
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
1. Nature of the Business and Basis of Presentation (Continued)
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
Our significant accounting policies are described in Note 2, "Summary of Significant Accounting Policies" to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023 (the "2023 Form 10-K"). Updates to our accounting policies are discussed below in this Note 2.
Unaudited Interim Condensed Consolidated Financial Information
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with GAAP for interim financial information. The accompanying unaudited condensed consolidated financial statements do not include all of the information and footnotes required by GAAP for complete consolidated financial statements. The accompanying year-end condensed consolidated balance sheet was derived from audited financial statements, but does not include all disclosures required by accounting principles generally accepted in the United States of America. The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2024, the results of its operations for the three and nine months ended September 30, 2024 and 2023, and its cash flows for the nine months ended September 30, 2024 and 2023. The results for the three and nine months ended September 30, 2024 are not necessarily
indicative of results to be expected for the year ending December 31, 2024, any other interim periods or any future year or period. The financial information included herein should be read in conjunction with the financial statements and notes in the Company's Annual Report on Form 10-K for the year ended December 31, 2023.
Reclassifications
Certain items in the prior period’s condensed consolidated financial statements have been reclassified to conform to the current year presentation.
Use of Estimates
The preparation of condensed 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 condensed consolidated financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, the accrual for research and development expenses and valuation of forward contract and derivative liabilities. 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.
Restricted Cash
Restricted cash included in other current assets in the condensed consolidated balance sheets consists primarily of employee contributions to the Company's employee share purchase plan held for future purchases of the Company's outstanding shares.
Restricted cash included in other non-current assets in the condensed 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 LOCs issued in connection with the leased office and lab spaces in Cambridge, Massachusetts and Pittsburgh, Pennsylvania. See Note 11, ‘‘Commitments and Contingencies’’ for additional information on the real estate leases.
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
2. Summary of Significant Accounting Policies (Continued)
The following represents a reconciliation of cash and cash equivalents in the condensed consolidated balance sheets to total cash, cash equivalents and restricted cash as of September 30, 2024 and September 30, 2023, respectively, in the condensed consolidated statements of cash flows:
| | | | | | | | | | | | | | |
| | As of September 30, 2024 | | As of September 30, 2023 |
Cash and cash equivalents | | $ | 84,390 | | | $ | 111,697 | |
Restricted cash held on behalf of Former Parent | | — | | | 28 | |
Restricted cash (included in other current assets) | | 582 | | | 11,890 | |
Restricted cash (included in other non-current assets) | | 3,047 | | | 2,375 | |
Total cash, cash equivalents and restricted cash at the end of the period in the condensed consolidated statement of cash flows | | $ | 88,019 | | | $ | 125,990 | |
Forward Contracts and Derivative Liabilities
The Company evaluates certain of its financial and business development transactions to determine the accounting classification of equity linked instruments issued in those transactions. The Company first assesses whether a freestanding equity linked instrument meets liability classification in accordance with ASC 480-10 Distinguishing Liabilities from Equity and ASC 815-40 Derivatives and Hedging - Contracts in Entity's Own Equity. Under ASC 480-10 an instrument is considered liability classified if the instrument is mandatorily redeemable, obligate the issuer to settle an instrument or the underlying shares by paying cash or other assets, or must or may require settlement by issuing variable number of shares.
If an instrument does not meet liability classification under ASC 480-10, the Company assesses the requirements under ASC 815-40, which states that contracts that require or may require net cash settlement are liabilities recorded at fair value. If the instrument does not require liability classification under ASC 815-40, in order to conclude equity classification, the Company assesses whether the instrument is indexed to its common stock and whether the instrument is classified as equity under ASC 815-40 or other applicable GAAP.
Equity linked instruments that are accounted for in accordance with ASC 815-40 are reported as liabilities on the condensed consolidated balance sheets at fair
value. Any change in fair value, as determined at each measurement period, is recorded as a component of other income, net on the condensed consolidated statements of operations and comprehensive loss. Changes in fair value are reported on the condensed consolidated statements of cash flows as change in fair value of forward contract and derivative liabilities.
The Company accounted for certain consideration agreed to in connection with the amendment, dated as of May 1, 2024 (the "Knopp Amendment"), to the Membership Interest Purchase Agreement, dated as of February 24, 2022 (the "Purchase Agreement") entered into with Knopp Biosciences, LLC ("Knopp") as derivative liabilities under ASC 815 (see Notes 4, "Fair Value of Financial Assets and Liabilities" and 10, "License, Acquisitions and Other Agreements").
Warrants
The Company evaluates warrants issued as either equity instruments, liabilities or derivative liabilities in accordance with ASC Topic 480, Distinguishing Liabilities from Equity ("ASC 480") and/or ASC Topic 815, Derivatives and Hedging ("ASC 815"), depending on the specific terms of the warrant agreement.
The Company assessed the warrants issued to Knopp in May 2024 (the "Knopp Warrants") and concluded that they met the criteria for equity classification under ASC 480 and ASC 815. Accordingly, the Knopp Warrants were recorded within additional paid-in capital on the condensed consolidated balance sheet at the time of issuance and are not subject to remeasurement. See Note 6, Shareholders' Equity for further detail on the Knopp Warrants.
Fair Value Measurements
Certain assets and liabilities of the Company are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
•Level 1—Quoted prices in active markets for identical assets or liabilities.
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
2. Summary of Significant Accounting Policies (Continued)
•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.
The Company has accounted for certain consideration agreed to in connection with the Knopp Amendment as forward contract liabilities, which are recorded on the condensed consolidated balance sheets at fair value. Any changes in fair value, as determined each measurement period, are recorded as a component of other income, net on the condensed consolidated statements of operations and comprehensive loss. The fair value of the forward contract liabilities is determined based on significant inputs not observable in the market, and therefore represents a Level 3 measurement within the fair value hierarchy. The valuations are based on a Monte Carlo simulation of the Company's share price, which requires judgement and assumption on the volatility of Biohaven's share price, discounted to present value using a risk-free rate plus Biohaven specific credit risk since payable in a variable number of shares. (see Notes 4, "Fair Value of Financial Assets and Liabilities" and 10, "License, Acquisitions and Other Agreements").
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.
In November 2024, the FASB issued ASU No. 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40), which requires disclosure, in the notes to the financial statements, of specified information about certain costs and expenses. This ASU is effective for public entities for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. The Company is currently evaluating the impact ASU 2024-03 will have on its consolidated financial statements.
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
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 September 30, 2024 and December 31, 2023 were as follows:
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| | Amortized Cost | | Allowance for Credit Losses | | Net Amortized Cost | | Gross Unrealized Gains | | Gross Unrealized Losses | | Fair Value |
September 30, 2024 | | | | | | | | | | | | |
Debt securities | | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
U.S. treasury bills | | $ | 294,211 | | | $ | — | | | $ | 294,211 | | | $ | 215 | | | $ | — | | | $ | 294,426 | |
| | | | | | | | | | | | |
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| | | | | | | | | | | | |
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 | |
The fair value of debt securities available-for-sale by classification in the condensed consolidated balance sheets was as follows:
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| | September 30, 2024 | | December 31, 2023 | | |
Cash and cash equivalents | | $ | — | | | $ | 33,902 | | | |
Marketable securities | | 294,426 | | | 133,417 | | | |
Total | | $ | 294,426 | | | $ | 167,319 | | | |
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| | | | | | |
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The net amortized cost and fair value of debt securities available-for-sale at September 30, 2024 and December 31, 2023 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.
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | September 30, 2024 | | December 31, 2023 |
| | Net Amortized Cost | | Fair Value | | Net Amortized Cost | | Fair Value |
Due to mature: | | | | | | | | |
Less than one year | | $ | 294,211 | | | $ | 294,426 | | | $ | 167,316 | | | $ | 167,319 | |
| | | | | | | | |
| | | | | | | | |
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
3. Marketable Securities (Continued)
The Company did not hold any debt securities available-for-sale that were in an unrealized loss position at September 30, 2024. Summarized below are the debt securities available-for-sale the Company held at December 31, 2023 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) | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | | | | | |
The Company did not have any investments in a continuous unrealized loss position for more than twelve months as of September 30, 2024 or December 31, 2023.
The Company reviewed its securities and concluded that they are performing assets, considering 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 September 30, 2024, the Company did not intend to sell its securities and did not believe it was more likely than not that it would be required to sell its securities prior to the anticipated recovery of their amortized cost basis.
Net Investment Income
Gross investment income includes income from debt securities available-for-sale, money-market funds, cash and restricted cash. Net investment income included in other income, net in the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2024 and 2023 were as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
Debt securities (including realized losses) | | $ | 3,843 | | | $ | 2,280 | | | $ | 8,912 | | | $ | 7,914 | |
Other investments | | 1,850 | | | 1,551 | | | 6,252 | | | 4,278 | |
Gross investment income (including realized losses) | | 5,693 | | | 3,831 | | | 15,164 | | | 12,192 | |
Investment expenses | | (45) | | | (65) | | | (115) | | | (203) | |
Net investment income | | $ | 5,648 | | | $ | 3,766 | | | $ | 15,049 | | | $ | 11,989 | |
We utilize the specific identification method in computing realized gains and losses. There were no proceeds from the sale of available-for-sale debt securities or related gross realized capital gains or losses for the three months ended September 30, 2024 and 2023. The proceeds from the sale of available-for-sale debt securities and the related gross realized capital losses for the nine months ended September 30, 2024 and 2023 were as follows:
| | | | | | | | | | | | | | | | | | |
| | | | Nine Months Ended September 30, |
| | | | | | 2024 | | 2023 |
Proceeds from sales | | | | | | $ | — | | | $ | 4,920 | |
| | | | | | | | |
Gross realized capital losses | | | | | | $ | — | | | $ | 39 | |
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
4. Fair Value of Financial Assets and Liabilities
The preparation of the Company’s condensed 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 Condensed Consolidated Balance Sheets
Certain assets of the Company are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
•Level 1 — Quoted prices in active markets for identical assets or liabilities.
•Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
•Level 3 — Unobservable inputs that are supported by little or no market activity that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
4. Fair Value of Financial Assets and Liabilities (Continued)
Financial assets measured at fair value on a recurring basis on the condensed consolidated balance sheets at September 30, 2024 and December 31, 2023 and financial liabilities measured at fair value on a recurring basis on the condensed consolidated balance sheets at September 30, 2024 were as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Fair Value Measurement Using: |
Balance Sheet Classification | | Type of Instrument | | Level 1 | | Level 2 | | Level 3 | | Total |
September 30, 2024 | | | | | | | | | | |
Assets: | | | | | | | | | | |
Cash and cash equivalents | | Money market funds | | $ | 65,497 | | | $ | — | | | $ | — | | | $ | 65,497 | |
| | | | | | | | | | |
| | | | | | | | | | |
Marketable securities | | U.S. treasury bills | | 15,828 | | | 278,598 | | | — | | | 294,426 | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
Other non-current assets | | Money market funds | | 2,548 | | | — | | | — | | | 2,548 | |
Total assets | | | | $ | 83,873 | | | $ | 278,598 | | | $ | — | | | $ | 362,471 | |
| | | | | | | | | | |
Liabilities: | | | | | | | | | | |
Forward contract liability | | Forward contract, current | | $ | — | | | $ | — | | | $ | 69,030 | | | $ | 69,030 | |
| | | | | | | | | | |
Derivative liability, non-current | | Written put option, non-current | | — | | | — | | | 12,320 | | | 12,320 | |
| | | | | | | | | | |
Total liabilities | | | | $ | — | | | $ | — | | | $ | 81,350 | | | $ | 81,350 | |
| | | | | | | | | | |
December 31, 2023 | | | | | | | | | | |
Assets: | | | | | | | | | | |
Cash and cash equivalents | | Money market funds | | $ | 59,199 | | | $ | — | | | $ | — | | | $ | 59,199 | |
Cash and cash equivalents | | U.S. treasury bills | | — | | | 27,901 | | | — | | | 27,901 | |
Cash and 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 | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | |
| | | | | | | | | | |
The Company had no financial liabilities measured at fair value on a recurring basis on the condensed consolidated balance sheets at December 31, 2023.
There were no securities transferred into or out of Level 3 during the three and nine months ended September 30, 2024 or 2023.
The following is a description, including valuation methodology, of the financial assets measured at fair value on a recurring basis:
Cash Equivalents
Cash equivalents 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.
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
4. Fair Value of Financial Assets and Liabilities (Continued)
Marketable Securities and Other Non-Current Assets
Quoted prices for identical assets in active markets are considered Level 1 and consist of on-the-run U.S. Treasuries and money market funds. 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.
Forward Contract and Derivative Liabilities
In connection with the Knopp Amendment, Knopp had the option to request a one-time cash true-up payment from the Company in December 2024, as defined in the agreement (the "2024 Knopp True-up"). As of September 30, 2024, the Company determined the fair value of its liability for the 2024 Knopp True-Up to be $0. Also in connection with the Knopp Amendment, the Company agreed to issue to Knopp additional common shares of the Company with an approximate value of $75,000 within 60 days of the first anniversary of execution of the Knopp Amendment (the “2025 Additional Consideration”). In addition, Knopp has the option to request a one-time cash true-up payment from the Company in December 2025, as defined in the agreement (the "2025 Knopp True-up"). See Note 10, "License, Acquisitions and Other Agreements," for further details.
The following table provides a roll forward of the fair value of the Company's forward contract and derivative liabilities related to the Knopp Amendment for which fair value is determined by Level 3 inputs from inception on May 1, 2024 to September 30, 2024:
| | | | | | | | | | |
| | Carrying Value | | |
Fair value at May 1, 2024 | | $ | 93,290 | | | |
Change in fair value of forward contract and derivative liabilities in other income, net | | (11,940) | | | |
Fair value at September 30, 2024 | | $ | 81,350 | | | |
The fair value of the forward contract and remaining derivative liability recognized in connection with the Knopp Amendment were determined based on significant inputs not observable in the market, and therefore represents a Level 3 measurement within the fair value hierarchy. The valuation is based on a Monte Carlo simulation of Biohaven's share price, which requires judgement and assumption on the volatility of Biohaven's share price, discounted to present value using a risk-free rate plus Biohaven specific credit risk since payable in a variable number of shares for the 2025 Additional Consideration or potentially cash for the 2025 Knopp True-up. A summary of the unobservable inputs (Level 3 inputs) used in measuring the Company’s forward contract and derivative liability related to the Knopp Amendment as of September 30, 2024 and May 1, 2024 are as follows, presented on a weighted-average basis based on relative fair value:
| | | | | | | | | | | | | | |
| | As of September 30, 2024 | | As of May 1, 2024 |
| | | | |
Time to payment and potential payment (years) | | 0.74 | | 1.08 |
Volatility (annual) | | 65.0 | % | | 80.0 | % |
Discount rate | | 12.7 | % | | 14.8 | % |
Our expectations of the volatility of Biohaven's share price at the reporting date could be materially different than our actual future volatility, and if so, would mean the estimated fair value could be significantly higher or lower than the fair value determined. The Company expects the fair value of the forward contract to be approximately $75,000 on the first anniversary of the Knopp Amendment. An increase in the derivative liability related to the 2025 Knopp True-up between the reporting date and settlement date of the derivative would have a material adverse effect on the Company's financial performance.
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
5. Balance Sheet Components
Property and Equipment, Net
Property and equipment, net consisted of the following:
| | | | | | | | | | | | | | | | |
| | As of September 30, 2024 | | As of December 31, 2023 | | |
Building and land | | $ | 14,078 | | | $ | 11,728 | | | |
Leasehold improvements | | 824 | | | 802 | | | |
Computer hardware and software | | 875 | | | 875 | | | |
Office and lab equipment | | 11,362 | | | 9,961 | | | |
Furniture and fixtures | | 1,793 | | | 1,550 | | | |
| | $ | 28,932 | | | $ | 24,916 | | | |
Accumulated depreciation | | (11,201) | | | (8,283) | | | |
| | 17,731 | | | 16,633 | | | |
Equipment not yet in service | | 544 | | | 558 | | | |
Property and equipment, net | | $ | 18,276 | | | $ | 17,191 | | | |
Depreciation expense was $1,000 and $2,918 for the three and nine months ended September 30, 2024, respectively, and $857 and $2,421 for the three and nine months ended September 30, 2023, respectively.
Equipment not yet in service primarily consisted of lab equipment that had not been placed into service as of September 30, 2024 and December 31, 2023.
Other Non-current Assets
Other non-current assets consisted of the following:
| | | | | | | | | | | | | | | |
| | As of September 30, 2024 | | As of December 31, 2023 | |
| | | | | |
| | | | | |
| | | | | |
Operating lease right-of-use assets | | $ | 28,909 | | | $ | 31,385 | | |
Other | | 3,048 | | | 2,400 | | |
Other non-current assets | | $ | 31,957 | | | $ | 33,785 | | |
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following:
| | | | | | | | | | | | | | |
| | As of September 30, 2024 | | As of December 31, 2023 |
| | | | |
Accrued employee compensation and benefits | | $ | 15,881 | | | $ | 837 | |
Accrued clinical trial costs | | 35,454 | | | 29,501 | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
Operating lease liabilities - current portion | | 3,676 | | | 3,308 | |
Other accrued expenses and other current liabilities | | 8,509 | | | 6,200 | |
Accrued expenses and other current liabilities | | $ | 63,520 | | | $ | 39,846 | |
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
6. Shareholders' Equity
Changes in shareholders’ equity for the three and nine months ended September 30, 2024 and September 30, 2023 were as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Common Shares | | | | | | | | | | |
| | Shares | | Amount | | | | Additional Paid-in Capital | | Accumulated Deficit | | Accumulated Other Comprehensive Loss | | Total Shareholders' Equity |
Balances as of December 31, 2023 | | 81,115,723 | | | $ | 887,528 | | | | | $ | 39,804 | | | $ | (499,292) | | | $ | (65) | | | $ | 427,975 | |
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Net loss | | — | | | — | | | | | — | | | (179,504) | | | — | | | (179,504) | |
Issuance of common shares as payment for acquisition of IPR&D asset | | 242,958 | | | 10,347 | | | | | — | | | — | | | — | | | 10,347 | |
Issuance of common shares as payment under license and other agreements | | 97,233 | | | 5,637 | | | | | — | | | — | | | — | | | 5,637 | |
Issuance of common shares under 2022 Equity Incentive Plan | | 351,307 | | | 7,452 | | | | | (5,296) | | | — | | | — | | | 2,156 | |
Non-cash share-based compensation expense | | — | | | — | | | | | 34,877 | | | — | | | — | | | 34,877 | |
Other comprehensive loss | | — | | | — | | | | | — | | | — | | | (41) | | | (41) | |
Balances as of March 31, 2024 | | 81,807,221 | | | 910,964 | | | | | 69,385 | | | (678,796) | | | (106) | | | 301,447 | |
Net loss | | — | | | — | | | | | — | | | (319,771) | | | — | | | (319,771) | |
Issuance of common shares, net of offering costs | | 8,544,951 | | | 317,720 | | | | | — | | | — | | | — | | | 317,720 | |
Issuance of common shares as payment for acquisition of IPR&D asset | | 10,452 | | | 446 | | | | | — | | | — | | | — | | | 446 | |
Issuance of common shares as payment under license and other agreements | | 1,872,874 | | | 65,981 | | | | | — | | | — | | | — | | | 65,981 | |
Issuance of common shares under 2022 Equity Incentive Plan and 2022 Employee Share Purchase Plan | | 110,834 | | | 3,442 | | | | | (1,125) | | | — | | | — | | | 2,317 | |
Issuance of warrant as payment under license agreement | | — | | | — | | | | | 3,340 | | | — | | | — | | | 3,340 | |
Non-cash share-based compensation expense | | — | | | — | | | | | 12,232 | | | — | | | — | | | 12,232 | |
Other comprehensive income | | — | | | — | | | | | — | | | — | | | 28 | | | 28 | |
Balances as of June 30, 2024 | | 92,346,332 | | | 1,298,553 | | | | | 83,832 | | | (998,567) | | | (78) | | | 383,740 | |
Net loss | | — | | | — | | | | | — | | | (160,304) | | | — | | | (160,304) | |
Issuance of common shares, net of offering costs | | 2,154,857 | | | 76,361 | | | | | — | | | — | | | — | | | 76,361 | |
Issuance of common shares as payment for acquisition of IPR&D asset | | 428 | | | 18 | | | | | — | | | — | | | — | | | 18 | |
Issuance of common shares under 2022 Equity Incentive Plan | | 397,422 | | | 6,758 | | | | | (2,954) | | | — | | | — | | | 3,804 | |
Issuance of common shares as payment under license and other agreements | | 154 | | | 9 | | | | | — | | | — | | | — | | | 9 | |
Non-cash share-based compensation expense | | — | | | — | | | | | 12,160 | | | — | | | — | | | 12,160 | |
| | | | | | | | | | | | | | |
Other comprehensive income | | — | | | — | | | | | — | | | — | | | 218 | | | 218 | |
Balance as of September 30, 2024 | | 94,899,193 | | | $ | 1,381,699 | | | | | $ | 93,038 | | | $ | (1,158,871) | | | $ | 140 | | | $ | 316,006 | |
| | | | | | | | | | | | | | |
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
6. Shareholders' Equity (Continued)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Common Shares | | | | | | | | | | |
| | Shares | | Amount | | | | Additional Paid-in Capital | | Accumulated Deficit | | Accumulated Other Comprehensive Income | | Total Shareholders' Equity |
Balances as of December 31, 2022 | | 68,190,479 | | | $ | 615,742 | | | | | $ | 13,869 | | | $ | (91,124) | | | $ | 284 | | | $ | 538,771 | |
Net loss | | — | | | — | | | | | — | | | (70,492) | | | — | | | (70,492) | |
Issuance of common shares under 2022 Equity Incentive Plan | | 22,000 | | | 504 | | | | | (172) | | | — | | | — | | | 332 | |
Non-cash share-based compensation expense | | — | | | — | | | | | 3,765 | | | — | | | — | | | 3,765 | |
Other comprehensive loss | | — | | | — | | | | | — | | | — | | | (118) | | | (118) | |
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
| | | | | | | | | | | | | | |
Balances as of March 31, 2023 | | 68,212,479 | | | 616,246 | | | | | 17,462 | | | (161,616) | | | 166 | | | 472,258 | |
Net loss | | — | | | — | | | | | — | | | (90,346) | | | — | | | (90,346) | |
Issuance of common shares under 2022 Equity Incentive Plan and 2022 Employee Share Purchase Plan | | 104,474 | | | 1,264 | | | | | (470) | | | — | | | — | | | 794 | |
Non-cash share-based compensation expense | | — | | | — | | | | | 4,695 | | | — | | | — | | | 4,695 | |
Other comprehensive loss | | — | | | — | | | | | — | | | — | | | (146) | | | (146) | |
Balance as of June 30, 2023 | | 68,316,953 | | | 617,510 | | | | | 21,687 | | | (251,962) | | | 20 | | | 387,255 | |
Net loss | | — | | | — | | | | | — | | | (102,574) | | | — | | | (102,574) | |
Issuance of common shares under 2022 Equity Incentive Plan | | 47,190 | | | 1,251 | | | | | (520) | | | — | | | — | | | 731 | |
Non-cash share-based compensation expense | | — | | | — | | | | | 4,456 | | | — | | | — | | | 4,456 | |
Other comprehensive income | | — | | | — | | | | | — | | | — | | | 138 | | | 138 | |
Balance as of September 30, 2023 | | 68,364,143 | | | $ | 618,761 | | | | | $ | 25,623 | | | $ | (354,536) | | | $ | 158 | | | $ | 290,006 | |
Knopp Amendment
In May 2024, the Company entered into the Knopp Amendment under which the parties thereto agreed to revise the success-based payment and royalty payment obligations under the Membership Purchase Agreement. As consideration, the Company issued 1,872,874 Biohaven Shares to Knopp, valued at approximately $65,981 in May 2024.
As further consideration for the revisions to the success-based payment and royalty payment obligations in the Knopp Amendment, the Company issued to Knopp a warrant to purchase 294,195 of the Company's common shares with a purchase price of $67.98, subject to certain specified development milestones and the Company achieving a specified market capitalization.
The warrant was recorded at its initial fair value of $3,340 within additional paid-in capital on the condensed consolidated balance sheet during the second quarter of
2024 and is not subject to remeasurement. See Note 10 for further detail on the Knopp Amendment.
2024 Public Offerings
On April 22, 2024, the Company closed an underwritten public offering of 6,451,220 of its common shares, which included the exercise in full of the underwriters' option to purchase additional shares, at a price of $41.00 per share. The net proceeds raised in the offering, after deducting underwriting discounts and expenses of the offering payable by Biohaven, were approximately $247,830. The Company intends to use the net proceeds received from the offering for general corporate purposes.
On October 2, 2024, the Company closed an underwritten public offering of 6,052,631 of its common shares, which included the exercise in full of the underwriters' option to purchase additional shares, at a price of $47.50 per share. The net proceeds raised in the offering, after deducting underwriting discounts and expenses of the offering payable by Biohaven, were approximately $269,935. The Company intends to use the net proceeds received from the offering for general corporate purposes.
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
6. Shareholders' Equity (Continued)
Pyramid Acquisition
In January 2024, the Company acquired Pyramid pursuant to the Pyramid Agreement. In consideration for the Pyramid acquisition, Biohaven made an upfront payment of 255,794 Company common shares, valued at approximately $10,894. As of September 30, 2024, 253,838 of these common shares have been issued by the Company.
During the first quarter of 2024, the Company recorded $5,689 of R&D expense in the condensed consolidated statement of operations and comprehensive loss for a developmental milestone which became due under the Pyramid Agreement, to be paid in 98,129 Company common shares. As of September 30, 2024, 97,387 of these common shares have been issued by the Company. Refer to Note 10, "License, Acquisitions and Other Agreements" for further discussion of the Pyramid acquisition.
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 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.
In August 2024, the Company entered into an amendment to the Equity Distribution Agreement pursuant to which the Company may offer and sell common shares having an aggregate offering price of up to $450,000 from time to time through or to the sales agent, acting as its agent or principal.
As of September 30, 2024, the Company sold and issued 4,248,588 common shares under the Equity Distribution Agreement, as amended, for total net proceeds of approximately $146,250. As of September 30, 2024, additional common shares having an aggregate offering price of up to $300,000 remain available to be issued.
7. Accumulated Other Comprehensive (Loss) Income
Shareholders’ equity included the following activity in accumulated other comprehensive (loss) income for the three and nine months ended September 30, 2024:
| | | | | | | | | | | | | | |
| | Three Months Ended September 30, 2024 | | Nine Months Ended September 30, 2024 |
| | | | |
Net unrealized investment gains (losses): | | | | |
Beginning of period balance | | $ | (3) | | | $ | 3 | |
| | | | |
| | | | |
Other comprehensive income(1) | | 218 | | | 212 | |
End of period balance | | 215 | | | 215 | |
| | | | |
Foreign currency translation adjustments: | | | | |
Beginning of period balance | | (75) | | | (68) | |
Other comprehensive loss(1) | | — | | | (7) | |
| | | | |
End of period balance | | (75) | | | (75) | |
| | | | |
Total beginning of period accumulated other comprehensive loss | | (78) | | | (65) | |
Total other comprehensive income | | 218 | | | 205 | |
Total end of period accumulated other comprehensive income | | $ | 140 | | | $ | 140 | |
| | | | |
(1) There was no tax on other comprehensive income (loss) and no amounts reclassified from accumulated other comprehensive (loss) income during the period.
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
7. Accumulated Other Comprehensive (Loss) Income (Continued)
Shareholders’ equity included the following activity in accumulated other comprehensive income for the three and nine months ended September 30, 2023:
| | | | | | | | | | | | | | |
| | Three Months Ended September 30, 2023 | | Nine Months Ended September 30, 2023 |
| | | | |
Net unrealized investment gains (losses): | | | | |
Beginning of period balance | | $ | (262) | | | $ | (145) | |
Other comprehensive income before reclassifications(1) | | 178 | | | 22 | |
Amounts reclassified from accumulated other comprehensive income(1)(2) | | — | | | 39 | |
Other comprehensive income(1) | | 178 | | | 61 | |
End of period balance | | (84) | | | (84) | |
| | | | |
Foreign currency translation adjustments: | | | | |
Beginning of period balance | | 282 | | | 429 | |
Other comprehensive loss(1) | | (40) | | | (187) | |
| | | | |
End of period balance | | 242 | | | 242 | |
| | | | |
Total beginning of period accumulated other comprehensive income | | 20 | | | 284 | |
Total other comprehensive income (loss) | | 138 | | | (126) | |
Total end of period accumulated other comprehensive income | | $ | 158 | | | $ | 158 | |
| | | | |
(1) There was no tax on other comprehensive income (loss) and immaterial tax on amounts reclassified from accumulated other comprehensive income (loss) during the period.
(2) Amounts reclassified from accumulated other comprehensive income (loss) for specifically identified debt securities are included in other income, net on the condensed consolidated statement of operations and comprehensive loss.
8. Non-Cash Share-Based Compensation
Non-Cash Share-based Compensation Expense
The Company measures non-cash share-based compensation at the grant date based on the fair value of the award and recognizes non-cash shared-based compensation 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 share options, restricted share units ("RSUs"), performance share options, and the Employee Share Purchase Plan ("ESPP"), was classified in the condensed consolidated statements of operations and comprehensive loss as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
Research and development expenses | | $ | 7,164 | | | $ | 2,184 | | | $ | 35,526 | | | $ | 6,882 | |
General and administrative expenses | | 4,996 | | | 2,272 | | | 23,743 | | | 6,034 | |
Total non-cash share-based compensation expense | | $ | 12,160 | | | $ | 4,456 | | | $ | 59,269 | | | $ | 12,916 | |
Share Options
All share option grants are awarded at fair value on the date of grant. The fair value of share options is estimated using the Black-Scholes option pricing model. Stock options generally expire 10 years after the grant date.
The aggregate intrinsic value of share options is calculated as the difference between the exercise price of the share options and the fair value of the Company's common shares for those share options that had exercise prices lower than the fair value of the Company's common shares at September 30, 2024.
As of September 30, 2024, total unrecognized compensation cost related to the unvested share options was $78,570, which is expected to be recognized over a weighted average period of 2.13 years, which does not consider the impact of a change in control. The weighted average grant date fair value per share of share options granted under the Company's share option plan during the nine months ended September 30, 2024 and 2023 was $30.60 and $18.01, respectively. The Company
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
8. Non-Cash Share-Based Compensation (Continued)
expects approximately 7,901,963 of the unvested stock options to vest over the requisite service period.
The following table is a summary of the Company's share option activity for the nine months ended September 30, 2024:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Number of Shares | | Weighted Average Exercise Price | | Weighted Average Remaining Contractual Term | | Aggregate Intrinsic Value |
| | | | | | (in years) | | |
Outstanding as of December 31, 2023 | | 11,379,429 | | $ | 11.48 | | | | | |
Granted | | 2,503,161 | | $ | 42.04 | | | | | |
Exercised | | (684,124) | | $ | 9.49 | | | | | |
Forfeited | | (104,448) | | $ | 20.53 | | | | | |
Outstanding as of September 30, 2024 | | 13,094,018 | | $ | 17.36 | | | 8.44 | | $ | 427,203 | |
Options exercisable as of September 30, 2024 | | 5,192,055 | | $ | 13.72 | | | 8.30 | | $ | 188,273 | |
Vested and expected to vest as of September 30, 2024 | | 13,094,018 | | $ | 17.36 | | | 8.44 | | $ | 427,203 | |
Restricted Share Units
The Company’s RSUs are considered nonvested share awards and require no payment from the employee. For each RSU, employees receive one common share at the end of the vesting period. The employee can elect to receive the one common share net of taxes or pay for taxes separately and receive the entire share. Compensation cost is recorded based on the market price of the Company’s common shares on the grant date and is recognized on a straight-line basis over the requisite service period.
As of September 30, 2024, there was $8,989 of total unrecognized compensation cost related to Company RSUs that are expected to vest. These costs are expected to be recognized over a weighted-average period of 2.31 years, which does not consider the impact of a change in control. The total fair value of RSUs vested during the three and nine months ended September 30, 2024 was $221 and $3,991.
The following table is a summary of the RSU activity for the nine months ended September 30, 2024:
| | | | | | | | | | | | | | |
| | Number of shares | | Weighted Average Grant Date Fair Value |
Unvested as of December 31, 2023 | | — | | | $ | — | |
Granted | | 381,011 | | | $ | 41.88 | |
Forfeited | | (6,045) | | | $ | 41.93 | |
Vested | | (95,309) | | | $ | 41.88 | |
Unvested as of September 30, 2024 | | 279,657 | | | $ | 41.87 | |
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
9. Net Loss Per Share
Basic and diluted net loss per share attributable to common shareholders of Biohaven was calculated as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | | Nine Months Ended September 30, |
| | 2024 | | 2023 | | 2024 | | 2023 |
Numerator: | | | | | | | | |
| | | | | | | | |
Net loss | | $ | (160,304) | | | $ | (102,574) | | | $ | (659,579) | | | $ | (263,412) | |
Denominator: | | | | | | | | |
Weighted average common shares outstanding—basic and diluted | | 94,372,159 | | | 68,320,125 | | | 87,936,923 | | | 68,258,757 | |
Net loss per share — basic and diluted | | $ | (1.70) | | | $ | (1.50) | | | $ | (7.50) | | | $ | (3.86) | |
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:
| | | | | | | | | | | | | | |
| | As of September 30, |
| | 2024 | | 2023 |
Options to purchase common shares | | 13,094,018 | | | 9,740,921 | |
Warrants to purchase common shares | | 294,195 | | | — | |
Restricted share units | | 279,657 | | | — | |
Total | | 13,667,870 | | | 9,740,921 | |
10. License, Acquisitions and Other Agreements
The Company has entered into various licensing, developmental and acquisition agreements which provide the Company with rights to certain know-how, technology and patent rights. The agreements generally include upfront fees, milestone payments upon achievement of certain developmental, regulatory and commercial and sales milestones, as well as sales-
based royalties, with percentages that vary by agreement.
License and Other Agreements
As of September 30, 2024, the Company has potential future developmental, regulatory and commercial milestone payments under its license and other agreements of up to approximately $140,650, $641,975, and $2,150,450, respectively. See below for a detailed discussion of these agreements. The Company has not recorded these potential contingent consideration payments as liabilities in the accompanying condensed consolidated balance sheet as none of the future events which would trigger a milestone payment were considered probable of occurring at September 30, 2024.
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 of September 30, 2024, under the amended Yale Agreement, the Company has remaining contingent regulatory approval milestone payments of up to $2,000 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 three and nine months ended September 30, 2024 and 2023, the Company did not record any material milestone or royalty payments under the Yale Agreement.
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
10. License, Acquisitions and Other Agreements (Continued)
In January 2021, the Company entered into a worldwide, exclusive license agreement with Yale University for the development and commercialization of a novel Molecular Degrader of Extracellular Protein ("MoDE") platform (the "Yale MoDE Agreement"). The platform pertains to the clearance of disease-causing protein and other biomolecules by targeting them for lysosomal degradation using multi-functional molecules. 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. As of September 30, 2024, under the Yale MoDE Agreement, the Company has remaining contingent development and commercial milestone payments of up to $650 and $2,950, respectively. 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.
The Company did not record any material milestone or royalty payments under the Yale MoDE Agreement for the three months ended September 30, 2024. For the nine months ended September 30, 2024, the Company recorded research and development expense of $150 related to the achievement of a developmental milestone under the Yale MoDE Agreement. For the three and nine months ended September 30, 2023, the Company did not record any material milestone or royalty payments under the Yale MoDE Agreement.
ALS Biopharma Agreement
In August 2015, the Company entered into an agreement (the "ALS Biopharma Agreement") with ALS Biopharma and Fox Chase Chemical Diversity Center Inc. ("FCCDC"), pursuant to which ALS Biopharma and FCCDC assigned the Company their worldwide patent rights to a family of over 300 prodrugs of glutamate modulating agents, including troriluzole, as well as other innovative technologies. Under the ALS Biopharma Agreement, the Company is obligated to use commercially reasonable efforts to commercialize and develop markets for the patent products. As of September 30, 2024, under the ALS Biopharma Agreement, the Company has remaining contingent regulatory approval milestone payments of up to $4,000, 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 three and nine months ended September 30, 2024 and 2023, the Company did not record any material milestone or royalty payments under the ALS Biopharma 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").
As of September 30, 2024, under the Taldefgrobep Alfa License Agreement, the Company has remaining contingent 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 three and nine months ended September 30, 2024 and 2023, the Company did not record any material milestone or royalty payments under the Taldefgrobep Alfa License Agreement.
Agreement with Hangzhou Highlightll Pharmaceutical Co. Ltd.
In March 2023, the Company and Hangzhou Highlightll Pharmaceutical Co. Ltd. ("Highlightll") entered into an exclusive, worldwide (excluding People’s Republic of China and its territories and possessions) license agreement (the "Highlightll Agreement") 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
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
10. License, Acquisitions and Other Agreements (Continued)
December 2023, the Company entered into 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 fourth quarter of 2023.
As of September 30, 2024, under the Highlightll Agreement, the Company has remaining contingent development, regulatory approval, and commercial milestone payments of up to $75,000, $37,500, and $837,500, respectively. 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.
For the three and nine months ended September 30, 2024 and 2023, the Company did not record any material milestone or royalty payments related to the Highlightll Agreement.
Other Agreements
In addition to the agreements detailed above, the Company has entered into various other license agreements and development programs. The Company records milestones and other payments, including funding for research arrangements, which become due under these agreements to research and development expense in the condensed consolidated statements of operations and comprehensive loss. Amounts recorded for the period were as follows:
| | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | Nine Months Ended September 30, |
| | 2024 | | 2023 | 2024 | | 2023 |
Milestone payments | | $ | — | | | $ | 1,250 | | $ | 1,875 | | | $ | 1,250 | |
| | | | | | | |
For the three and nine months ended September 30, 2024 and 2023, the Company did not make any upfront payments under these agreements.
Acquisitions
Kv7 Platform Acquisition
In April 2022, the Company closed the acquisition from 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 the Purchase Agreement, dated February 24, 2022.
Under the Purchase Agreement, the Company agreed to make success-based payments based on developmental and regulatory milestones through approvals in the United States, Europe, the Middle East and Asia ("EMEA") and Japan for the lead asset, BHV-7000 (formerly known as KB-3061), developmental and regulatory milestones for the Kv7 pipeline development in other indications and additional country approvals, and commercial sales-based milestones of BHV-7000. Additionally, the Company agreed to make scaled royalty payments in cash for BHV-7000 and the pipeline programs, with percentages 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.
In May 2024, the Company entered into the Knopp Amendment under which the parties thereto agreed to replace the scaled high single digit to low teens royalty payment obligations with a flat royalty payment in the mid-single digits for BHV-7000 and the pipeline programs. The parties also agreed to reduce the success-based payments payable under the Purchase Agreement. The Company retains the ability to pay these contingent milestone payments in cash or in the Company's common shares at Biohaven's election, subject to the same increases if the Company elects to pay in the Company's common shares. As of September 30, 2024, under the Purchase Agreement, as amended, the Company had remaining success-based payments comprised of (i) to up to $185,000 based on regulatory approvals in the United States and EMEA for BHV-7000 and (ii) up to an additional $60,000 based on regulatory approval in the United States for the other Kv7 pipeline programs.
In consideration of the revisions to the success-based payment and royalty payment obligations, the Company agreed to issue to Knopp 1,872,874 Company common shares, valued at approximately $75,000, through a private placement within 60 days of the date of
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
10. License, Acquisitions and Other Agreements (Continued)
execution of the Knopp Amendment (the “2024 Additional Consideration”) and additional Company common shares with an approximate value of $75,000 within 60 days of the first anniversary of execution of the Knopp Amendment (the “2025 Additional Consideration”). The Company has also given Knopp the option to request a one-time cash true-up payment from the Company in December 2024 in the event that Knopp continues to hold the Company's common shares representing the 2024 Additional Consideration and the value of such shares has declined (the "2024 Knopp True-Up"), and a one-time cash true-up payment from the Company in December 2025 in the event that Knopp continues to hold the Company's common shares representing the 2025 Additional Consideration and the value of such shares has declined (the "2025 Knopp True-Up"), in each case, subject to certain conditions.
The Company concluded that the agreement to issue the 2024 Additional Consideration at a future date represented a fixed forward contract under ASC 815 and classified the commitment as a forward contract liability on its condensed consolidated balance sheet on the execution date of the Knopp Amendment. The Company initially measured the forward contract associated with the 2024 Additional Consideration at a fair value of $75,220, which was recorded as R&D expense during the three months ended June 30, 2024 in its condensed consolidated statements of operations and comprehensive loss. In May 2024, the Company issued the 2024 Additional Consideration at an approximate value of $65,981. The Company recognized no gains or losses related to the 2024 Additional Consideration for the three months ended September 30, 2024 and gains of $9,239 for the nine months ended September 30, 2024 in other income, net in its condensed consolidated statement of operations and comprehensive loss. The gain on settlement of the 2024 Additional Consideration was due to the decline in fair value of the 2024 Additional Consideration from the execution date to the issuance date due to a decline in Biohaven's share price. Refer to Note 4, "Fair Value of Financial Assets and Liabilities" and Note 6, "Shareholders' Equity" for further discussion.
The 2024 Additional Consideration True-up represents a net cash settled written put option measured at fair value on a recurring basis. The Company has concluded that the 2024 Additional Consideration True-up represents a net cash settled written put option on the Company’s shares and is a freestanding derivative liability under ASC 815. Accordingly, the Company classified the 2024 Additional Consideration True-up as a current derivative liability on its condensed consolidated balance sheet. The Company
initially recorded the 2024 Additional Consideration True-up at a fair value of $15,540, which was recorded as R&D expense during the three months ended June 30, 2024 in its condensed consolidated statements of operations and comprehensive loss. The Company subsequently remeasures the fair value of the derivative liability and recognizes any gains or losses through other income, net in its condensed consolidated statement of operations and comprehensive loss. The Company recognized gains related to the 2024 Additional Consideration True-Up of $16,130 and $15,540 for the three and nine months ended September 30, 2024, respectively, in other income, net in its condensed consolidated statement of operations and comprehensive loss. Refer to Note 4, "Fair Value of Financial Assets and Liabilities" for further discussion.
The Company has concluded that the agreement to issue the 2025 Additional Consideration at a future date represents a forward contract settleable in a variable number of shares under ASC 480, and classified the commitment as a current forward contract liability on its condensed consolidated balance sheet. The Company initially measured the 2025 Additional Consideration at a fair value of $63,940, which was recorded as R&D expense during the three months ended June 30, 2024 in its condensed consolidated statements of operations and comprehensive loss. The Company subsequently remeasures the fair value of the forward contract liability and recognizes any gains or losses through other income, net in its condensed consolidated statement of operations and comprehensive loss. The Company recognized expense of $3,940 and $5,090 for the three and nine months ended September 30, 2024, respectively, related to the 2025 Additional Consideration. Refer to Note 4, "Fair Value of Financial Assets and Liabilities" for further discussion.
The Company has concluded that the 2025 Additional Consideration True-up represents a net cash settled written put option on the Company’s shares and is a freestanding derivative liability under ASC 815. Accordingly, the Company classified the 2025 Additional Consideration True-up as a non-current derivative liability on its condensed consolidated balance sheet. The Company initially recorded the 2025 Additional Consideration True-up at a fair value of $13,810, which was recorded as R&D expense during the three months ended June 30, 2024. The Company subsequently remeasures the fair value of the derivative liability and recognizes any gains or losses through other income, net in its condensed consolidated statement of operations and comprehensive loss. The Company recognized expense of $140 and a gain of $1,490 for the three and nine months ended September 30, 2024,
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
10. License, Acquisitions and Other Agreements (Continued)
related to the 2025 Additional Consideration True-up. Refer to Note 4, "Fair Value of Financial Assets and Liabilities" for further discussion.
As further consideration for the revisions to the success-based payment and royalty payment obligations in the Knopp Amendment, the Company issued to Knopp a warrant (the “Warrant”) to purchase 294,195 Company common shares at a purchase price per share of $67.98, subject to certain specified development milestones and the Company achieving a specified market capitalization. Refer to Note 6, "Shareholders' Equity" for further discussion.
The Company has not recorded any of the remaining contingent consideration payments to Knopp as a liability in the accompanying condensed consolidated balance sheet as none of the future events which would trigger a milestone payment were considered probable of occurring at September 30, 2024.
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 255,794 Company common shares, valued at approximately $10,894.
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 primarily to BHV-1510. There was no material value assigned to any other assets or liabilities acquired in the acquisition. As such, the upfront payment discussed above was recorded as a charge to R&D expense in the accompanying condensed consolidated statements of operations and comprehensive loss during the three months ended March 31, 2024.
As of September 30, 2024, under the Pyramid Agreement, the Company has remaining success-based payments comprised of (i) up to $5,000 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.
The Company has not recorded any of the remaining contingent consideration payments as a liability in the accompanying condensed consolidated balance sheet as none of the future events which would trigger a milestone payment were considered probable of occurring at September 30, 2024.
During the first quarter of 2024, the Company recorded $5,689 of R&D expense in the condensed consolidated statement of operations and comprehensive loss for a developmental milestone which became due under the Pyramid Agreement, to be paid in 98,129 common shares of the Company. See Note 6, "Shareholders' Equity" for discussion of common shares issued to as part of the Pyramid Agreement.
11. Commitments and Contingencies
Lease Agreements
The Company leases certain office and laboratory space. Other than the Pittsburgh Centre Avenue Lease described below, there have been no material changes to the lease obligations from those disclosed in Note 11, "Commitments and Contingencies" to the consolidated financial statements included in the 2023 Form 10-K.
Pittsburgh Centre Avenue Lease Agreement
In March 2024, the Company entered into a lease agreement in Pittsburgh, Pennsylvania for lab space (the "Pittsburgh Centre Avenue Lease"), which will be used to support the research and development of the Company's ion channel platform and replace the Company's current operating lease in Pittsburgh. The lease is expected to commence in mid 2025 after substantial completion of building improvements, and has a term of 122 months, with an option to extend for one additional period of 60 months. The Company expects to record the Pittsburgh Centre Avenue Lease as an operating lease. The Company has annual commitments relating to the Pittsburgh Centre Avenue Lease ranging from $1,859 to $2,373, excluding any additional tenant improvement allowance that would increase the base rent.
Research Commitments
The Company has agreements with several contract manufacturing organizations ("CMOs") and contract research organizations ("CROs") to provide products and services in connection with the Company’s preclinical studies and clinical trials. As of September
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
11. Commitments and Contingencies (Continued)
30, 2024, the Company had no remaining maximum research commitments in excess of 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 condensed consolidated financial statements as of September 30, 2024 or December 31, 2023.
License, Acquisition and Other Agreements
The Company has entered into licensing, developmental and acquisition agreements with various parties under which it is obligated to make contingent and non-contingent payments (see Note 10, "License, Acquisitions and Other Agreements").
Other Agreements
Moda Agreement
On January 1, 2021, the Company entered into a consulting services agreement (the "Moda Agreement") with Moda Pharmaceuticals LLC ("Moda") to further the scientific advancement of technology, drug discovery platforms (including the technology licensed under the Yale MoDE Agreement), product candidates and related intellectual property owned or controlled by the Company.
Under the Moda Agreement, the Company paid Moda an upfront cash payment of $2,700 and 37,836 shares of the Former Parent valued at approximately
$3,243. In addition, Moda will be eligible to receive additional development, regulatory, and commercial milestone payments of up to $111,783. 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. In August 2023, the Company entered into an amendment to the Moda Agreement with Moda. Under the amendment, Moda will be eligible to receive development, regulatory, and commercial milestone payments of up to $48,200, in addition to the milestones noted above.
The Company did not record any material milestone payments related to the Moda Agreement for the three months ended September 30, 2024. For the nine months ended September 30, 2024, the Company recorded research and development expense of $850 related to developmental milestones under the Moda Agreement. For the three and nine months ended September 30, 2023, the Company did not record any material 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 September 30, 2024, there were no matters which would have a material impact on the Company’s financial results.
12. Income Taxes
The following table provides a comparative summary of the Company's income tax provision and effective income tax rate for the three and nine months ended September 30, 2024 and 2023:
| | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended September 30, | Nine Months Ended September 30, |
| | 2024 | | 2023 | 2024 | | 2023 |
Income tax (benefit) provision | | $ | (59) | | | $ | (3,287) | | $ | 687 | | | $ | (171) | |
Effective income tax rate | | — | % | | (3.1) | % | 0.1 | % | | (0.1) | % |
The change in income tax provisions for the three months ended September 30, 2024 as compared to the same period in 2023 was primarily attributable to the Company adopting the guidance contained in a Notice of
BIOHAVEN LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
12. Income Taxes (Continued)
Proposed Rule Making issued during the third quarter of 2023 by the United States Internal Revenue Service ("the Notice"). The Notice allows the Company to immediately deduct certain R&D expenditures which were incurred in the US and reimbursed by the Company’s foreign parent. Previously, these expenditures were required to be capitalized under the Tax Cuts and Jobs Act, which was effective for tax years beginning on or after January 1, 2022.
The change in income tax provisions for the nine months ended September 30, 2024 as compared to the same period in 2023 was primarily attributable to an increase in income in the US, partially offset by windfall tax deductions arising from non-cash share-based compensation.
13. 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 of the Company.
On October 3, 2022, the Company entered into agreements with the Former Parent in connection with the Separation, including a Transition Services Agreement. For a full discussion of agreements entered into with the Former Parent, refer to Note 14, "Related Party Transactions" to the consolidated financial statements included in the 2023 Form 10-K. The Company did not record any material income for transition services provided to the Former Parent during the three and nine months ended September 30, 2024. For the three and nine months ended September 30, 2023, the Company recorded $1,233 and $6,753, respectively, in other income reflecting transition services provided to the Former Parent.
Related Party Agreements
License Agreement with Yale University
On September 30, 2013, the Company entered into the Yale Agreement with Yale University (see Note 10). The Company’s Chief Executive Officer is one of the inventors of the patents that the Company has licensed from Yale University and, as such, is entitled to a specified share of the glutamate product-related royalty revenues that may be received by Yale University under the Yale Agreement.
In January 2021, the Company entered into the Yale MoDE Agreement with Yale University (see Note 10 for details). Under the license agreement, the Company acquired exclusive, worldwide rights to Yale University's
intellectual property directed to its MoDE platform. Under the Yale MoDE Agreement, the Company entered into the Yale MoDE SRA (see Note 10 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 three and nine months ended September 30, 2024, the Company recorded $422 and $1,449, respectively, in R&D expense, including certain administrative expenses, related to the Yale MoDE Agreement, the Yale Agreement, and the 2023 Yale SRA (collectively, the "Yale Agreements"). For the three and nine months ended September 30, 2023, the Company recorded $614 and $2,313, respectively, in research and development expense, including certain administrative expenses, related to the Yale Agreements. As of September 30, 2024, the Company did not owe any amounts to Yale University.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2023 (the "2023 Form 10-K") filed with the Securities and Exchange Commission (the “SEC”). Some of the statements contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, constitute forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). We have based these forward-looking statements on our current expectations and projections about future events. The following information and any forward-looking statements should be considered in light of factors discussed elsewhere in this Quarterly Report on Form 10-Q and our other filings with the SEC.
Our actual results and timing of certain events may differ materially from the results discussed, projected, anticipated, or indicated in any forward-looking statements. We caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, among other things, may differ materially from the forward-looking statements contained in this Quarterly Report on Form 10-Q. Statements made herein are as of the date of the filing of this Form 10-Q with the SEC and should not be relied upon as of any subsequent date. Even if our results of operations, financial condition and liquidity, and the development of the industry in which we operate are consistent with the forward-looking statements contained in this Quarterly Report on Form 10-Q, they may not be predictive of results or developments in future periods. We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
We caution readers not to place undue reliance on any forward-looking statements made by us, which speak only as of the date they are made.
Overview
We are a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. We are advancing our innovative portfolio of therapeutics, leveraging our proven drug development experience and multiple proprietary drug development platforms. Our extensive clinical and pre