Item 1. Condensed Consolidated Financial Statements (Unaudited)
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Index to Condensed Consolidated Financial Statements (Unaudited) |
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Condensed Consolidated Balance Sheets as of June 30, 2022 and December 31, 2021 | | |
Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2022 and 2021 | | |
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Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2022 and 2021 | | |
Notes to Condensed Consolidated Financial Statements | | |
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share amounts) | | | | | | | | | | | | | | |
| | June 30, 2022 | | December 31, 2021 |
| | (Unaudited) | | |
Assets | | | | |
Current assets: | | | | |
Cash and cash equivalents | | $ | 235,807 | | | $ | 171,945 | |
Marketable securities | | 317,679 | | | 192,648 | |
Trade receivable, net | | 352,449 | | | 308,269 | |
Inventory | | 106,561 | | | 80,608 | |
Prepaid expenses | | 100,360 | | | 88,838 | |
Other current assets | | 61,485 | | | 33,946 | |
Total current assets | | 1,174,341 | | | 876,254 | |
Property and equipment, net | | 15,727 | | | 14,690 | |
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Intangible assets, net | | 75,112 | | | 56,438 | |
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Other assets | | 121,069 | | | 129,830 | |
Total assets | | $ | 1,386,249 | | | $ | 1,077,212 | |
Liabilities and Shareholders’ Deficit | | | | |
Current liabilities: | | | | |
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Accounts payable | | $ | 64,149 | | | $ | 51,683 | |
Accrued expenses and other current liabilities | | 545,307 | | | 420,019 | |
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Current portion of mandatorily redeemable preferred shares | | 62,500 | | | 62,500 | |
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Total current liabilities | | 671,956 | | | 534,202 | |
Long-term debt | | 764,983 | | | 626,720 | |
Liability related to sale of future royalties, net | | 388,027 | | | 367,645 | |
Mandatorily redeemable preferred shares, net | | 180,213 | | | 155,737 | |
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Derivative liabilities | | 110,129 | | | 13,110 | |
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Obligation to perform R&D services | | 29,972 | | | 50,571 | |
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Other long-term liabilities | | 46,527 | | | 12,236 | |
Total liabilities | | 2,191,807 | | | 1,760,221 | |
Commitments and contingencies (Note 15) | | | | |
Contingently redeemable non-controlling interests | | — | | | 60,000 | |
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Shareholders’ deficit: | | | | |
Common shares, no par value; 200,000,000 shares authorized as of June 30, 2022 and December 31, 2021; 71,111,071 and 66,933,531 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively | | 2,181,398 | | | 1,676,792 | |
Additional paid-in capital | | 167,021 | | | 169,656 | |
Accumulated other comprehensive loss | | (5,811) | | | (73) | |
Accumulated deficit | | (3,143,541) | | | (2,585,755) | |
Total shareholders’ deficit attributable to Biohaven Pharmaceutical Holding Company Ltd. | | (800,933) | | | (739,380) | |
Non-controlling interests in consolidated subsidiaries | | (4,625) | | | (3,629) | |
Total shareholders' deficit | | (805,558) | | | (743,009) | |
Total liabilities and shareholders’ deficit | | $ | 1,386,249 | | | $ | 1,077,212 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
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| | Three Months Ended June 30, | | Six Months Ended June 30, |
| | 2022 | | 2021 | | 2022 | | 2021 |
Revenues: | | | | | | | | |
Product revenue, net | | $ | 193,954 | | | $ | 92,933 | | | $ | 317,544 | | | $ | 136,756 | |
Collaboration and other revenue | | 21,125 | | | — | | | 216,387 | | | — | |
Total revenues | | 215,079 | | | 92,933 | | | 533,931 | | | 136,756 | |
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Operating expenses: | | | | | | | | |
Cost of sales | | 35,741 | | | 17,339 | | | 62,083 | | | 30,201 | |
Research and development | | 218,480 | | | 77,428 | | | 337,579 | | | 184,539 | |
Selling, general and administrative | | 250,455 | | | 170,057 | | | 477,698 | | | 329,580 | |
Total operating expenses | | 504,676 | | | 264,824 | | | 877,360 | | | 544,320 | |
Loss from operations | | (289,597) | | | (171,891) | | | (343,429) | | | (407,564) | |
Other income (expense): | | | | | | | | |
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Interest expense | | (17,114) | | | (7,836) | | | (34,330) | | | (15,567) | |
Interest expense on mandatorily redeemable preferred shares | | (8,077) | | | (8,042) | | | (15,994) | | | (15,985) | |
Interest expense on liability related to sale of future royalties | | (18,045) | | | (14,499) | | | (35,359) | | | (28,007) | |
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Change in fair value of derivatives | | (111,197) | | | (1,490) | | | (107,593) | | | (1,700) | |
Gain from equity method investment | | — | | | — | | | — | | | 5,261 | |
Other income (expense), net | | 2,229 | | | (3,051) | | | 2,310 | | | (4,751) | |
Total other expense, net | | (152,204) | | | (34,918) | | | (190,966) | | | (60,749) | |
Loss before provision for income taxes | | (441,801) | | | (206,809) | | | (534,395) | | | (468,313) | |
Provision for income taxes | | 84 | | | 4,350 | | | 24,387 | | | 8,174 | |
Net loss | | (441,885) | | | (211,159) | | | (558,782) | | | (476,487) | |
Net loss attributable to non-controlling interests | | 498 | | | 540 | | | 996 | | | 900 | |
Deemed dividend upon repurchase of preferred shares in consolidated subsidiary | | — | | | — | | | (92,673) | | | — | |
Net loss attributable to common shareholders of Biohaven Pharmaceutical Holding Company Ltd. | | $ | (441,387) | | | $ | (210,619) | | | $ | (650,459) | | | $ | (475,587) | |
Net loss per share attributable to common shareholders of Biohaven Pharmaceutical Holding Company Ltd. — basic and diluted | | $ | (6.21) | | | $ | (3.23) | | | $ | (9.20) | | | $ | (7.48) | |
Weighted average common shares outstanding—basic and diluted | | 71,043,693 | | | 65,112,179 | | | 70,689,949 | | | 63,584,932 | |
Comprehensive loss: | | | | | | | | |
Net loss | | $ | (441,885) | | | $ | (211,159) | | | $ | (558,782) | | | $ | (476,487) | |
Other comprehensive loss, net of tax | | (3,413) | | | (129) | | | (5,738) | | | (34) | |
Comprehensive loss | | (445,298) | | | (211,288) | | | (564,520) | | | (476,521) | |
Less: comprehensive loss attributable to non-controlling interests | | 498 | | | 540 | | | 996 | | | 900 | |
Comprehensive loss attributable to Biohaven Pharmaceutical Holding Company Ltd. | | $ | (444,800) | | | $ | (210,748) | | | $ | (563,524) | | | $ | (475,621) | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands)
(Unaudited) | | | | | | | | | | | | | | |
| | Six Months Ended June 30, |
| | 2022 | | 2021 |
Cash flows from operating activities: | | | | |
Net loss | | $ | (558,782) | | | $ | (476,487) | |
Adjustments to reconcile net loss to net cash used in operating activities: | | | | |
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Non-cash share-based compensation expense | | 122,094 | | | 74,312 | |
Interest expense on mandatorily redeemable preferred shares | | — | | | 15,985 | |
Interest expense on liability related to sale of future royalties | | 35,359 | | | 28,007 | |
Deferred interest paid-in-kind on long-term debt | | 13,037 | | | 5,649 | |
Acquisition of IPR&D asset | | 93,747 | | | — | |
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Issuance of common shares as payment for license agreement | | 1,779 | | | 4,243 | |
Change in fair value of derivatives | | 107,593 | | | 1,700 | |
Gain from equity method investment | | — | | | (5,261) | |
Depreciation and amortization | | 9,783 | | | 11,278 | |
Change in obligation to perform R&D services | | (12,326) | | | (10,205) | |
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Other non-cash items | | 373 | | | 2,993 | |
Changes in operating assets and liabilities: | | | | |
Trade receivable, net | | (44,180) | | | (48,526) | |
Inventory | | (29,088) | | | (19,046) | |
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Prepaid expenses, other current assets, and other assets | | (35,273) | | | (58,173) | |
Accounts payable | | 12,466 | | | 5,085 | |
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Accrued expenses, other current liabilities, and other liabilities | | 125,738 | | | 35,730 | |
Net cash used in operating activities | | $ | (157,680) | | | $ | (432,716) | |
Cash flows from investing activities: | | | | |
Purchases of marketable securities | | (246,816) | | | — | |
Sales of marketable securities | | 54,015 | | | 113,441 | |
Maturities of marketable securities | | 62,893 | | | 48,852 | |
Purchases of property and equipment | | (2,393) | | | (1,657) | |
Payment for intangible asset | | (20,000) | | | — | |
Payment for IPR&D asset acquisition | | (35,000) | | | — | |
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Net cash (used in) provided by investing activities | | $ | (187,301) | | | $ | 160,636 | |
Cash flows from financing activities: | | | | |
Proceeds from issuance of long-term debt | | 125,000 | | | — | |
Proceeds from issuance of common shares | | 252,000 | | | 308,743 | |
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Proceeds from obligation to perform R&D services | | — | | | 100,000 | |
Proceeds from the issuance of series B preferred shares | | 29,158 | | | 35,170 | |
Proceeds from exercise of share options | | 9,983 | | | 8,643 | |
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Payments for term loan, finance leases, and other | | (6,224) | | | (6,369) | |
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Net cash provided by financing activities | | $ | 409,917 | | | $ | 446,187 | |
Effect of exchange rate changes on cash, cash equivalents and restricted cash | | (2,722) | | | (189) | |
Net increase in cash, cash equivalents and restricted cash | | 62,214 | | | 173,918 | |
Cash, cash equivalents and restricted cash at beginning of period | | 174,343 | | | 134,231 | |
Cash, cash equivalents and restricted cash at end of period | | $ | 236,557 | | | $ | 308,149 | |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY 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 Pharmaceutical Holding Company Ltd. (“we,” “us," "our," "Biohaven" or the “Company”) was incorporated in Tortola, British Virgin Islands in September 2013. We are a biopharmaceutical company with a portfolio of innovative product candidates targeting neurological diseases, including rare disorders. The Company's lead product, NURTEC® ODT (rimegepant), was approved by the U.S. Food and Drug Administration ("FDA") in February 2020, for the acute treatment of migraine and was approved for the preventive treatment of migraine in May 2021. NURTEC ODT is the first and only calcitonin gene-related peptide ("CGRP") receptor antagonist available in a quick-dissolve orally dissolving tablet ("ODT") formulation that is approved by the FDA for both the acute and preventive treatment of migraine in adults. In April 2022, the European Commission approved rimegepant 75 mg (available as an ODT), for the prophylaxis and acute treatment of migraine. VYDURA™ (rimegepant) will be the commercial name for rimegepant in the EU. Our Neuroinnovation portfolio includes product candidates based on multiple mechanisms — CGRP receptor antagonists, glutamate modulators, myeloperoxidase inhibition, Kv7 ion channel activators ("Kv7"), and Myostatin inhibition — which we believe have the potential to significantly alter existing treatment approaches across a diverse set of neurological indications with high unmet need in both large and orphan indications.
The Company is subject to risks and uncertainties common to companies in the biopharmaceutical industry, including, but not limited to, the risks associated with developing product candidates at each stage of non-clinical and clinical development; the challenges associated with gaining regulatory approval of such product candidates; the risks associated with commercializing pharmaceutical products for marketing and sale; the potential for development by third parties of new technological innovations that may compete with the Company’s products; the dependence on key personnel; the challenges of protecting proprietary technology; the need to comply with government regulations; the high costs of drug development; and the uncertainty of being able to secure additional capital when needed to fund operations.
The Company has incurred recurring losses since its inception, had an accumulated deficit as of June 30, 2022, and expects to continue to generate operating
losses during the continued global commercial launch of rimegepant. Prior to the commercial launch of rimegepant the Company has primarily raised funds through sales of equity in private placements and public offerings, sale of revenue participation rights related to potential future royalties, and debt financings.
As of August 5, 2022, the issuance date of our condensed consolidated financial statements, the Company expects that its cash, cash equivalents and marketable securities as of June 30, 2022, its future operating cash flows from sales of NURTEC ODT, Series B Preferred Shares receipts, and product sales and other proceeds from its Pfizer Collaboration will be sufficient to fund its current forecast for operating expenses, including commercial operations, financial commitments and other cash requirements for more than one year. The Company may need to raise additional capital to execute its business plans and growth strategy until it is profitable. If no additional capital is raised through either public or private equity financings, debt financings, strategic relationships, alliances and licensing agreements, or a combination thereof, the Company may delay, limit or reduce discretionary spending in areas related to research and development activities and other general and administrative expenses in order to fund its operating costs and working capital needs.
Pfizer Merger and Distribution Agreement
On May 9, 2022, the Company, Pfizer and a wholly owned subsidiary of Pfizer (“Merger Sub”), entered into an Agreement and Plan of Merger (the “Merger Agreement”). Pursuant to the terms and subject to the conditions set forth in the Merger Agreement, Pfizer will acquire all outstanding shares of Biohaven for $148.50 per share in cash and Merger Sub will merge with and into the Company (the “Pfizer Merger”), with the Company surviving the Pfizer Merger as a wholly owned subsidiary of Pfizer.
In connection with the Merger Agreement, Biohaven and Biohaven Research Ltd. entered into a Separation and Distribution Agreement, dated as of May 9, 2022 (the “Distribution Agreement”). In connection with the Distribution Agreement, the Board of Directors of the Company approved and directed management to effect the spin-off of the Kv7 ion channel activator, glutamate modulation, MPO inhibition and myostatin inhibition platforms, preclinical product candidates, and certain corporate infrastructure currently owned by
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY 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)
Biohaven, or collectively the “Biohaven Research Business”.
To implement the spin-off, the Company expects to transfer the related license agreements, intellectual property and certain corporate infrastructure to Biohaven Research Ltd, through a series of internal restructuring transactions, referred to as the pre-closing reorganization.
To effect the spin-off, each of the Company's shareholders will receive one common share of Biohaven Research Ltd. for every two common shares of Biohaven held of record at the close of business on the record date for the distribution. Upon completion of the spin-off, Biohaven Research Ltd. will be a stand-alone, publicly traded company focused on the development of the Biohaven Research Business.
Pfizer Collaboration
On November 9, 2021, the Company entered into a strategic commercialization arrangement with Pfizer Inc. ("Pfizer"), including a collaboration and license agreement and a related sublicense agreement (the "Pfizer Collaboration"), pursuant to which Pfizer would commercialize product candidates containing the Company's proprietary compounds rimegepant (BHV-3000) and gains rights to zavegepant (BHV-3500) (the "Licensed Products") in all countries worldwide outside of the United States (the "Territory"). The Pfizer Collaboration became effective on January 4, 2022. Refer to Note 13, "Collaboration, License and Other Agreements" for further details.
2. Summary of Significant Accounting Policies
Our significant accounting policies are described in Note 2 of the notes to the consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2021 (the "2021 Form 10-K"). Updates to our accounting policies, including impacts from the adoption of new accounting standards, are discussed below in this Note 2.
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 include the accounts of the Company and its controlled subsidiaries after elimination of all significant intercompany accounts and transactions. Investments in companies in which the Company owns less than a 50% equity interest and where it exercises significant influence over the
operating and financial policies of the investee are accounted for using the equity method of accounting.
The financial statements of our subsidiaries with functional currencies other than the U.S. dollar are translated into U.S. dollars using period-end exchange rates for assets and liabilities, historical exchange rates for shareholders' equity (deficit) and weighted average exchange rates for operating results. Translation gains and losses are included in accumulated other comprehensive income, net of tax, in shareholders' deficit. Foreign currency transaction gains and losses are included in other income (expense) in the condensed consolidated statements of operations and comprehensive loss.
Reclassifications
Certain items in the prior period’s condensed consolidated financial statements have been reclassified to conform to the current period 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 income and expenses during the reporting periods. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, revenue recognition, interest expense on liability related to sale of future royalties, valuation of derivative liabilities, and income taxes. 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.
Unaudited Interim Condensed Consolidated Financial Information
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America for interim financial information. The accompanying unaudited condensed consolidated financial statements do not include all of the information and footnotes required by
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
2. Summary of Significant Accounting Policies (Continued)
accounting principles generally accepted in the United States of America 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 June 30, 2022 and the results of its operations for the three and six months ended June 30, 2022 and 2021 and its cash flows for the six months ended June 30, 2022 and 2021. The results for the three and six months ended June 30, 2022 are not necessarily indicative of results to be expected for the year ending December 31, 2022, 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, 2021.
Revenue Recognition - Collaboration and Other Revenue
The Company analyzes its collaboration arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. For collaboration arrangements within the scope of ASC 808 that contain multiple elements, the Company first determines which elements of the collaboration are deemed to be within the scope of ASC 808 and those that are more reflective of a vendor-customer relationship and, therefore, within the scope of ASC 606, Revenue from Contracts with Customers ("ASC 606"). For elements of collaboration arrangements that are accounted for pursuant to ASC 808, an appropriate recognition method is determined and applied consistently, generally by analogy to ASC 606. The accounting treatment pursuant to ASC 606 is outlined below.
The terms of licensing and collaboration agreements entered into typically include payment of one or more of the following: non-refundable, up-front
license fees; development, regulatory and commercial milestone payments; payments for manufacturing supply and research and development services and royalties on net sales of licensed products. Each of these payments results in collaboration and other revenue, except for revenues related to manufacturing supply services, which are classified as product revenue. The core principle of ASC 606 is to recognize revenue when promised goods or services are transferred to customers in an amount that reflects the consideration that is expected to be received in exchange for those goods or services.
In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under each of its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.
Amounts received prior to recognizing revenue are recorded as contract liabilities in the Company’s condensed consolidated balance sheets.
At contract inception, the Company assesses the goods or services promised in a contract with a customer and identifies those distinct goods and services that represent a performance obligation. A promised good or service may not be identified as a performance obligation if it is immaterial in the context of the contract with the customer, if it is not separately identifiable from other promises in the contract (either because it is not capable of being separated or because it is not separable in the context of the contract), or if the promised good or service does not provide the customer with a material right.
The Company considers the terms of the contract to determine the transaction price. The transaction price is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods or services to a customer. The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Variable consideration will only be included in the transaction price when it is not considered constrained, which is when it is probable that a significant reversal in
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY 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 amount of cumulative revenue recognized will not occur.
If it is determined that multiple performance obligations exist, the transaction price is allocated at the inception of the agreement to all identified performance obligations based on the relative standalone selling prices ("SSP"). The relative SSP for each deliverable is estimated using external sourced evidence if it is available. If external sourced evidence is not available, the Company uses its best estimate of the SSP for the deliverable.
Revenue is recognized when, or as, the Company satisfies a performance obligation by transferring a promised good or service to a customer. An asset is transferred when, or as, the customer obtains control of that asset, which for a service is considered to be as the services are received and used. The Company recognizes revenue over time by measuring the progress toward complete satisfaction of the relevant performance obligation using an appropriate input or output method based on the nature of the service promised to the customer.
After contract inception, the transaction price is reassessed at every period end and updated for changes such as resolution of uncertain events. Any change in the transaction price is allocated to the performance obligations on the same basis as at contract inception, or to a single performance obligation as applicable.
Management may be required to exercise considerable judgment in estimating revenue to be recognized. Judgment is required in identifying performance obligations, estimating the transaction price, estimating the SSP of identified performance obligations, which may include forecasted revenue, development timelines, estimated future costs, discount rates and probabilities of technical and regulatory success, and estimating the progress towards satisfaction of performance obligations.
Acquired In-Process Research and Development
IPR&D that the Company acquires in conjunction with the acquisition of a business represents the fair value assigned to incomplete research projects which, at the time of acquisition, have not reached technological feasibility. The amounts are capitalized and accounted for as indefinite-lived intangible assets, subject to impairment testing until completion or abandonment of the projects. Upon successful completion of each project, the asset is classified as a definite-lived intangible and the Company will make a determination as to the then-useful life of the intangible
asset, generally determined by the period in which the substantial majority of the cash flows are expected to be generated, and begin amortization.
The Company evaluates IPR&D for impairment at least annually, or more frequently if impairment indicators exist, by performing a quantitative test that compares the fair value of the IPR&D intangible asset with its carrying value. If the fair value is less than the carrying amount, an impairment loss is recognized in operating results.
If we acquire an asset or group of assets that do not meet the definition of a business under applicable accounting standards, the acquired IPR&D is expensed on its acquisition date, unless it has an alternative future use. Future costs to develop these assets are recorded to research and development expense as they are incurred.
Recently Adopted Accounting Pronouncements
Effective January 1, 2022 the Company adopted ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity. The update addresses issues identified as a result of the complexity associated with applying GAAP for certain financial instruments with characteristics of liabilities and equity. The adoption of ASU 2020-06 did not have a material effect on the Company's consolidated financial statements.
Effective January 1, 2022 the Company adopted ASU No. 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues Task Force), which provides guidance on modifications or exchanges of a freestanding equity-classified written call option that is not within the scope of another topic. An entity should treat a modification of the terms or conditions or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange as an exchange of the original instrument for a new instrument, and provides further guidance on measuring the effect of a modification or an exchange of a freestanding equity-classified written call option that remains equity classified after modification or exchange. ASU 2021-04 also provides guidance on the recognition of the effect of a modification or an exchange of a freestanding equity-
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
2. Summary of Significant Accounting Policies (Continued)
classified written call option that remains equity classified after modification or exchange on the basis of the substance of the transaction, in the same manner as if cash had been paid as consideration. The guidance has been applied prospectively and did not have a material effect on the consolidated financial statements of the Company.
Future Adoption of New Accounting Pronouncements
In January 2021 the FASB issued ASU No. 2021-01, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting, providing temporary guidance to ease the burden in accounting for reference rate reform primarily resulting from the discontinuation of LIBOR, which is currently expected to occur in mid-2023 for legacy contracts. The amendments in ASU 2021-01 are elective immediately and apply to all entities that have contracts, hedging relationships, and other transactions that
reference LIBOR or another reference rate expected to be discontinued. The Company does not expect that the adoption of ASU 2021-01 will have a material effect on its consolidated financial statements.
In June 2022 the FASB issued ASU No. 2022-03, Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions, to clarify the guidance in Topic 820 when measuring the fair value of an equity security subject to contractual restrictions that prohibit the sale of an equity security. The ASU also introduced new disclosure requirements for equity securities subject to contractual sale restrictions that are measured at fair value in accordance with Topic 820. The amendments in ASU 2022-03 are effective for fiscal years beginning after December 15, 2023. The Company does not expect the adoption ASU 2022-03 to have a material effect on its consolidated financial statements.
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 June 30, 2022 and December 31, 2021 was as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Amortized Cost | | Allowance for Credit Losses | | Net Amortized Cost | | Gross Unrealized Gains | | Gross Unrealized Losses | | Fair Value |
June 30, 2022 | | | | | | | | | | | | |
Corporate bonds | | | | | | | | | | | | |
U.S. | | $ | 220,913 | | | $ | — | | | $ | 220,913 | | | $ | — | | | $ | (2,589) | | | $ | 218,324 | |
Foreign | | 30,276 | | | — | | | 30,276 | | | — | | | (411) | | | 29,865 | |
Government related obligations | | | | | | | | | | | | |
U.S. | | 69,830 | | | — | | | 69,830 | | | — | | | (340) | | | 69,490 | |
| | | | | | | | | | | | |
Total | | $ | 321,019 | | | $ | — | | | $ | 321,019 | | | $ | — | | | $ | (3,340) | | | $ | 317,679 | |
| | | | | | | | | | | | |
December 31, 2021 | | | | | | | | | | | | |
Corporate bonds | | | | | | | | | | | | |
U.S. | | $ | 130,388 | | | $ | — | | | $ | 130,388 | | | $ | 1 | | | $ | (234) | | | $ | 130,155 | |
Foreign | | 20,643 | | | — | | | 20,643 | | | — | | | (82) | | | 20,561 | |
Government related obligations | | | | | | | | | | | | |
U.S. | | 41,939 | | | — | | | 41,939 | | | — | | | (8) | | | 41,931 | |
| | | | | | | | | | | | |
Total | | $ | 192,971 | | | $ | — | | | $ | 192,971 | | | $ | 1 | | | $ | (324) | | | $ | 192,648 | |
The Company had 68 and 53 available-for-sale debt securities in an unrealized loss position, with an aggregate fair value of $317,679 and $185,296, as of June 30, 2022 and December 31, 2021, respectively. As of June 30, 2022, the Company did not intend to sell these securities, and did not believe it was more likely than not that it would be required to sell these securities prior to the anticipated recovery of their amortized cost basis. We did not have any investments in a continuous unrealized loss position for more than twelve months as of June 30, 2022 and December 31, 2021.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
3. Marketable Securities (Continued)
The net amortized cost and fair value of debt securities available-for-sale at June 30, 2022 and December 31, 2021 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. The fair values of available for sale debt securities are classified as marketable securities in the condensed consolidated balance sheets at June 30, 2022 and December 31, 2021.
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | June 30, 2022 | | December 31, 2021 |
| | Net Amortized Cost | | Fair Value | | Net Amortized Cost | | Fair Value |
Due to mature: | | | | | | | | |
Less than one year | | $ | 294,150 | | | $ | 291,394 | | | $ | 155,359 | | | $ | 155,226 | |
One year through five years | | 26,869 | | | 26,285 | | | 37,612 | | | 37,422 | |
Total | | $ | 321,019 | | | $ | 317,679 | | | $ | 192,971 | | | $ | 192,648 | |
Net Investment Income
Sources of net investment income included in other income (expense) in the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2022 and 2021 were as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended June 30, | | Six Months Ended June 30, |
| | 2022 | | 2021 | | 2022 | | 2021 |
Gross investment income from debt securities available-for-sale | | $ | 1,084 | | | $ | 89 | | | $ | 1,224 | | | $ | 161 | |
Investment expenses | | (57) | | | (24) | | | (75) | | | (76) | |
Net investment income (excluding net realized capital gains or losses) | | 1,027 | | | 65 | | | 1,149 | | | 85 | |
Net realized capital (losses) gains | | (157) | | | — | | | (160) | | | 19 | |
Net investment income | | $ | 870 | | | $ | 65 | | | $ | 989 | | | $ | 104 | |
We utilize the specific identification method in computing realized gains and losses. The proceeds from the sale of available-for-sale debt securities and the related gross realized capital gains and losses for the three and six months ended June 30, 2022 and 2021 were the following:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended June 30, | | Six Months Ended June 30, |
| | 2022 | | 2021 | | 2022 | | 2021 |
Proceeds from sales | | $ | 54,015 | | | $ | — | | | $ | 54,015 | | | $ | 113,441 | |
Gross realized capital gains | | 9 | | | — | | | 9 | | | 19 | |
Gross realized capital losses | | $ | 166 | | | — | | | $ | 166 | | | — | |
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
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY 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)
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.
For a description of the methods and assumptions that are used to estimate the fair value and determine the fair value hierarchy classification of each class of financial instrument, see Note 4 “Fair Value of Financial Assets and Liabilities” in the 2021 Form 10-K. Financial assets and liabilities measured at fair value on a recurring basis on the condensed consolidated balance sheets at June 30, 2022 and December 31, 2021 were as follows:
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY 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)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Fair Value Measurement Using: |
Balance Sheet Classification | | Type of Instrument | | Level 1 | | Level 2 | | Level 3 | | Total |
June 30, 2022 | | | | | | | | | | |
Assets: | | | | | | | | | | |
Cash equivalents | | Money market funds | | $ | 3,142 | | | $ | — | | | $ | — | | | $ | 3,142 | |
| | | | | | | | | | |
| | | | | | | | | | |
Marketable securities | | U.S. treasury bills | | — | | | 69,489 | | | — | | | 69,489 | |
Marketable securities | | U.S. corporate bonds | | — | | | 218,326 | | | — | | | 218,326 | |
Marketable securities | | Foreign corporate bonds | | — | | | 29,865 | | | — | | | 29,865 | |
Total assets | | | | $ | 3,142 | | | $ | 317,680 | | | $ | — | | | $ | 320,822 | |
| | | | | | | | | | |
Liabilities: | | | | | | | | | | |
Derivative liabilities | | Series B preferred shares forward contracts | | $ | — | | | $ | — | | | $ | 71,110 | | | $ | 71,110 | |
Derivative liabilities | | Series B preferred shares derivative liability | | — | | | — | | | 33,760 | | | 33,760 | |
Derivative liabilities | | Series A preferred shares derivative liability | | — | | | — | | | 5,259 | | | 5,259 | |
Total liabilities | | | | $ | — | | | $ | — | | | $ | 110,129 | | | $ | 110,129 | |
| | | | | | | | | | |
December 31, 2021 | | | | | | | | | | |
Assets: | | | | | | | | | | |
Cash equivalents | | Money market funds | | $ | 32,420 | | | $ | — | | | $ | — | | | $ | 32,420 | |
| | | | | | | | | | |
Marketable securities | | U.S. treasury bills | | 5,994 | | | 35,937 | | | — | | | 41,931 | |
Marketable securities | | U.S. corporate bonds | | — | | | 130,155 | | | — | | | 130,155 | |
Marketable securities | | Foreign corporate bonds | | — | | | 20,561 | | | — | | | 20,561 | |
Total assets | | | | $ | 38,414 | | | $ | 186,653 | | | $ | — | | | $ | 225,067 | |
| | | | | | | | | | |
Liabilities: | | | | | | | | | | |
Derivative liability | | Series B preferred shares forward contracts | | $ | — | | | $ | — | | | $ | 13,110 | | | $ | 13,110 | |
| | | | | | | | |
Total liabilities | | | | $ | — | | | $ | — | | | $ | 13,110 | | | $ | 13,110 | |
There were no securities transferred between Level 1, 2 and 3 during the six months ended June 30, 2022 or 2021.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY 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)
Series B Preferred Shares Forward Contract
In August 2020, the Company entered into Series B preferred share agreement, whereby RPI will invest in the Company through the purchase of up to 3,992 Series B preferred shares (the "Series B Preferred Shares") at a price of $50,100 per share (the "RPI Series B Preferred Share Agreement"). Upon issuance of the Series B Preferred Shares, they qualify as mandatorily redeemable instruments and are initially classified at their fair value as preferred shares liabilities. The Company will then accrete the carrying value to the redemption value through interest expense using the effective interest rate method.
The Company is required to redeem the Series B Preferred Shares for 1.77 times the original purchase price, payable beginning March 31, 2025 in equal quarterly installments through December 31, 2030 (the "Normal Series B Redemption Provision").
The holders of the Company's outstanding Series B Preferred Shares will have the right to require redemption of the shares in certain circumstances, including in the event of a Change of Control, as defined in the Company's memorandum and article of association. If a Change of Control occurs, the Company will be required to sell and RPI will be required to buy the remaining unissued Series B Preferred Shares. The holders of a majority of outstanding Series B Preferred Shares will then have an option to redeem all outstanding Series B Preferred Shares in a single payment at a price equal to 1.77 times the original issuance price of the Series B Preferred Shares (the "Change of Control Series B Redemption Provision").
Accordingly, the Company has concluded that the agreement to issue Series B Preferred Shares at a future date represents a forward contract, and classified as a derivative.
The fair value of the forward contract recognized in connection with the RPI Series B Preferred Share Agreement was determined based on significant inputs not observable in the market, and therefore represents a Level 3 measurement within the fair value hierarchy. The fair value of the forward contract is made up of the probability weighted fair value of the Normal Series B Redemption Provision and the Change of Control Series B Redemption Provision for the 2,004 unissued Series B Preferred Shares at June 30, 2022. The fair value of the Normal Series B Preferred Shares Redemption Provision for the forward contract is calculated as the difference between the present value of proceeds to the
Company for the quarterly issuances of the remaining unissued Series B Preferred Shares and the present value of the required quarterly redemption payments to the holders. The fair value of the Change of Control Series B Redemption Provision for the forward contract is calculated as the difference between the present value of the proceeds to the Company on the estimated change of control date for the issuance of the remaining unissued Series B Preferred Shares and the present value of the lump sum redemption payment to the holders.
As inputs into the valuation, the Company assessed the Change of Control Series B Redemption Provision as highly likely due to Pfizer's pending acquisition of Biohaven, see Note 1 for additional details. In addition, the Company considered the amount of the payments and a risk-adjusted discount rate ranging from low single digits to low-twenty percent. Due to the uncertainty around the close date of Pfizer's pending acquisition of Biohaven, the Company's expectation of the timing of a change of control event at the reporting date could reasonably be different than the timing of an actual change of control event, and if so, would mean the estimated fair value could be significantly higher or lower than the fair value determined.
In accordance with ASC 815, Derivatives and Hedging, the fair value of the forward contract was recorded on the balance sheet as a derivative liability with changes in fair value recorded in other income (expense) in the condensed consolidated statements of operations and comprehensive loss.
The following table provides a roll forward of the aggregate fair value of the Company's series B preferred shares forward contract for which fair value is determined by Level 3 inputs for the six months ended June 30, 2022 and 2021:
| | | | | | | | | | | |
| | | Carrying Value | | |
Balance at December 31, 2021 | | | $ | 13,110 | | | |
Change in fair value of derivative liability | | | 68,574 | | | |
Partial settlement of derivative liability | | | (10,574) | | | |
Balance at June 30, 2022 | | | $ | 71,110 | | | |
| | | | | |
Balance at December 31, 2020 | | | $ | 14,190 | | | |
Change in fair value of derivative liability | | | 3,295 | | | |
Partial settlement of derivative liability | | | (1,595) | | | |
Balance at June 30, 2021 | | | $ | 15,890 | | | |
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY 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)
Series B Preferred Shares Derivative Liability
As of June 30, 2022, the Company has 1,988 Series B Preferred Shares outstanding, see Note 8 for details. As discussed in the Series B Preferred Shares Forward Contracts section above, the holders of the Company's outstanding Series B Preferred Shares will have the right to require redemption of the shares in certain circumstances, including in the event of a Change of Control, as defined in the Company's memorandum and article of association.
If a Change of Control occurs the holders of the outstanding Series B Preferred Shares will have the option to exercise the Change of Control Series B Redemption Provision. The Company would then be required to redeem the outstanding Series B Preferred Shares in a lump sum payment of 1.77 times the original issue price instead of in equal quarterly installments.
The series B preferred shares derivative liability recognized in connection with the RPI Series B Preferred Share Agreement was determined based on significant inputs not observable in the market, and therefore represents a Level 3 measurement within the fair value hierarchy. The fair value of the series B preferred shares derivative liability is calculated as the difference between the fair value of the outstanding Series B Preferred Shares with and without the derivative. The fair value of the outstanding Series B Preferred Shares both with and without the derivative is calculated as the probability weighted present value of the required quarterly redemption payments considering the likelihood of a Change of Control.
As inputs into the valuation, the Company assessed the likelihood of a Change of Control, and the risk-adjusted discount rate similarly to these same inputs for the Series B Preferred Shares Forward Contract.
In accordance with ASC 815, Derivatives and Hedging, the fair value of the series B preferred shares derivative liability was recorded on the balance sheet as a derivative liability with changes in fair value recorded in other income (expense) in the condensed consolidated statements of operations and comprehensive loss.
The following table provides a roll forward of the aggregate fair value of the Company's series B preferred shares derivative liability for which fair value
is determined by Level 3 inputs for the six months ended June 30, 2022:
| | | | | | | | | |
| | | Carrying Value |
Balance at December 31, 2021 | | | $ | — | |
Change in fair value of derivative liability | | | 33,760 | |
| | | |
Balance at June 30, 2022 | | | $ | 33,760 | |
The series B preferred shares derivative liability had no material value at December 31, 2021.
Series A Preferred Shares Derivative Liability
In April 2019, the Company sold 2,495 series A preferred shares (the "Series A Preferred Shares") to RPI at a price of $50,100 per preferred share pursuant to a Series A preferred share purchase agreement (the "RPI Series A Preferred Share Agreement"). The Company is required to redeem the Series A Preferred Shares for two times (2x) the original purchase price, payable beginning March 31, 2021 in equal quarterly installments through December 31, 2024 (the "Normal Series A Preferred Share Redemption Provision"). As of June 30, 2022, the Company had 1,559 outstanding Series A Preferred Shares, see Note 8 for additional details.
The holders of the Company's outstanding Series A Preferred Shares will have the right to require a lump sum redemption of the shares in the event of a Change of Control, as defined in the Company's memorandum and article of association. Upon exercise of the put option by the holders, the Company will be required to redeem the outstanding Series A Preferred Shares that have not previously been redeemed for two times (2x) the original purchase price of the Series A Preferred Shares payable in a lump sum at the closing of the Change of Control (the "Change of Control Series A Preferred Share Redemption Provision").
The series A preferred shares derivative liability recognized in connection with the RPI Series A Preferred Share Agreement was determined based on significant inputs not observable in the market, and therefore represents a Level 3 measurement within the fair value hierarchy. The fair value of the series A preferred shares derivative liability is calculated as the difference between the fair value of the outstanding Series A Preferred Shares with and without the derivative. The fair value of the outstanding Series A Preferred Shares both with and without the derivative is calculated as the probability weighted present value of the required redemption payments considering the likelihood of a Change of Control.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY 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)
As inputs into the valuation, the Company assessed the likelihood of a Change of Control, and the risk-adjusted discount rate similarly to these same inputs for the Series B Preferred Shares Forward Contract.
In accordance with ASC 815, Derivatives and Hedging, the fair value of the series A preferred shares derivative liability was recorded on the balance sheet as a derivative liability with changes in fair value recorded in other income (expense) in the condensed consolidated statements of operations and comprehensive loss.
The following table provides a roll forward of the aggregate fair value of the Company's series A preferred
shares derivative liability for which fair value is determined by Level 3 inputs for the six months ended June 30, 2022:
| | | | | | | | | |
| | | Carrying Value |
Balance at December 31, 2021 | | | $ | — | |
Change in fair value of derivative liability | | | 5,259 | |
| | | |
Balance at June 30, 2022 | | | $ | 5,259 | |
The series A preferred shares derivative liability had no material value as of December 31, 2021.
Financial Instruments Not Measured at Fair Value on the Consolidated Balance Sheets
The carrying value and estimated fair value classified by level of fair value hierarchy for financial instruments carried on the condensed consolidated balance sheets at adjusted cost or contract value at June 30, 2022 and December 31, 2021 were as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Carrying | | Fair Value Measurement Using: |
| Value | | Level 1 | | Level 2 | | Level 3 | | Total |
June 30, 2022 | | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
Liabilities: | | | | | | | | | |
Long-term debt(1) | $ | 764,983 | | | $ | — | | | $ | 861,877 | | | $ | — | | | $ | 861,877 | |
| | | | | | | | | |
December 31, 2021 | | | | | | | | | |
| | | | | | | | | |
| | | | | | | | | |
Liabilities: | | | | | | | | | |
Long-term debt(1) | $ | 626,720 | | | $ | — | | | $ | 646,159 | | | $ | — | | | $ | 646,159 | |
(1) Due to the $125,000 draw of the remaining delayed draw term loan commitment in June 2022, see Note 14 for details, and the announcement of the acquisition of Biohaven by Pfizer in May 2022, see Note 1 for details, the Company remeasured the fair value of its long-term debt as of June 30, 2022.
5. Balance Sheet Components
Restricted Cash
Restricted cash included in other current assets in the condensed consolidated balance sheets is primarily 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 assets in the condensed consolidated balance sheets represents collateral held by a bank for a letter of credit ("LOC") issued in connection with the leased office space in Yardley, Pennsylvania. 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 June 30, 2022
and December 31, 2021, respectively, in the condensed consolidated statements of cash flows:
| | | | | | | | | | | | | | |
| | As of June 30, 2022 | | As of December 31, 2021 |
Cash and cash equivalents | | $ | 235,807 | | | $ | 171,945 | |
Restricted cash (included in other current assets) | | — | | | 1,648 | |
Restricted cash (included in other assets) | | 750 | | | 750 | |
Cash, cash equivalents and restricted cash in the statements of cash flows | | $ | 236,557 | | | $ | 174,343 | |
Trade Receivable, Net
The Company’s trade accounts receivable consists of amounts due primarily from pharmacy wholesalers in
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
5. Balance Sheet Components (Continued)
the U.S. (collectively, its "Customers") related to sales of NURTEC ODT and have standard payment terms. For certain Customers, the trade accounts receivable for the Customer is net of distribution service fees, prompt pay discounts and other adjustments. The Company monitors the financial performance and creditworthiness of its Customers so that it can properly assess and respond to changes in their credit profile. The Company reserves against trade accounts receivable for estimated losses that may arise from a Customer’s inability to pay and any amounts determined to be uncollectible are written off against the reserve when it is probable that the receivable will not be collected. The allowance for doubtful accounts, including reserve amounts for estimated credit losses, was immaterial as of June 30, 2022 and December 31, 2021.
Inventory
Inventory consisted of the following:
| | | | | | | | | | | | | | |
| | As of June 30, 2022 | | As of December 31, 2021 |
| | | | |
Work-in-process | | $ | 168,091 | | | $ | 159,075 | |
Finished goods | | 12,576 | | | 9,269 | |
Total inventories | | 180,667 | | | 168,344 | |
Less noncurrent inventories(1) | | 74,106 | | | 87,736 | |
Total inventories classified as current | | $ | 106,561 | | | $ | 80,608 | |
(1) Included in other assets on the condensed consolidated balance sheets. There are no recoverability issues for these amounts.
Prepaid Expenses
Prepaid expenses consisted of the following:
| | | | | | | | | | | | | | | |
| | As of June 30, 2022 | | As of December 31, 2021 | |
Prepaid clinical trial costs | | $ | 59,996 | | | $ | 42,578 | | |
| | | | | |
| | | | | |
Prepaid manufacturing | | 1,152 | | | 17,448 | | |
Prepaid commercial costs | | 26,940 | | | 15,732 | | |
Other prepaid expenses | | 12,272 | | | 13,080 | | |
Prepaid expenses | | $ | 100,360 | | | $ | 88,838 | | |
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following:
| | | | | | | | | | | | | | |
| | As of June 30, 2022 | | As of December 31, 2021 |
Accrued development milestones | | $ | 25,000 | | | $ | 5,000 | |
Accrued employee compensation and benefits | | 35,917 | | | 40,109 | |
Accrued clinical trial costs | | 34,822 | | | 37,477 | |
Accrued commercialization and other professional fees | | 31,793 | | | 19,994 | |
| | | | |
| | | | |
Accrued sales discounts and allowances | | 292,292 | | | 203,760 | |
Current obligation to perform R&D services | | 30,303 | | | 22,030 | |
Other accrued expenses and other current liabilities | | 95,180 | | | 91,649 | |
Accrued expenses and other current liabilities | | $ | 545,307 | | | $ | 420,019 | |
6. Acquisitions
Acquisition of Kleo Pharmaceuticals, Inc.
On January 4, 2021, the Company acquired Kleo Pharmaceuticals, Inc. (“Kleo”). Kleo is a development-stage biopharmaceutical company focused on advancing the field of immunotherapy by developing small molecules that emulate biologics. The transaction was accounted for as the acquisition of a business using the acquisition method of accounting.
The total fair value of the consideration transferred was $20,043 which primarily consisted of the issuance of a total of 115,836 common shares of the Company to Kleo stockholders and contingent consideration in the form of a contingent value right to receive one dollar in cash for each Kleo share if certain specified Kleo biopharmaceutical products or product candidates receive the approval of the FDA prior to the expiration of 30 months following the effective time of the transaction. The maximum amount payable pursuant to the contingent value right was approximately $17,300. At December 31, 2021, the Company determined the value of the contingent value right to be immaterial and recognized a gain of $1,457 related to the contingent value right in other income (expense) during the fourth quarter of 2021. The value of the contingent value right continues to be immaterial with no value included on the condensed consolidated balance sheet as of June 30, 2022.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
6. Acquisitions (Continued)
Prior to the consummation of the transaction, the Company owned approximately 41.9% of the outstanding shares of Kleo and accounted for it as an equity method investment. As part of the transaction, the Company acquired the remainder of the shares of Kleo, and post-transaction the Company owns 100% of the outstanding shares of Kleo. The carrying value of the Company’s investment in Kleo was $1,176 immediately prior to the acquisition date. The Company determined the fair value of the existing interest was $6,437, and recognized a gain from our equity method investment during the first quarter of 2021 of $5,261 on the condensed consolidated statements of operations and comprehensive loss as a result of remeasuring to fair value the existing equity interest in Kleo.
In connection with the transaction, we recorded: net working capital of $573; property, plant and equipment of $1,257; intangible assets consisting of in progress research and development assets of $18,400 which include an oncology therapeutic candidate entering Phase I clinical trials and a COVID-19 therapeutic candidate in the planning stage for clinical development; debt assumed of $1,577; and goodwill of $1,390.
Kleo’s employees, other than its President and Chief Financial Officer, were retained as part of the transaction. In connection with the transaction agreement, the Company filed a registration statement permitting Kleo stockholders to offer and sell the common shares of the Company issued in the transaction.
Kv7 Platform Acquisition
In April 2022, the Company closed the acquisition from Knopp Biosciences LLC (“Knopp”) of Channel Biosciences, LLC (“Channel”), a wholly owned subsidiary of Knopp owning the assets of Knopp’s Kv7 channel targeting platform (the “Kv7 Platform Acquisition”), pursuant to a Membership Interest Purchase Agreement (the “Purchase Agreement”), dated February 24, 2022.
In consideration for the Kv7 Platform Acquisition, on April 4, 2022, the Company made an upfront payment comprised of $35,000 in cash and 493,254 common shares, valued at approximately $58,747, issued through a private placement. The Company has also agreed to pay additional success-based payments comprised of (i) up to $325,000 based on developmental and regulatory milestones through approvals in the United States, EMEA and Japan for the lead asset, BHV-7000 (formerly known as KB-3061), (ii) up to an additional $250,000 based on developmental and regulatory milestones for the Kv7 pipeline development in other indications and
additional country approvals, and (iii) up to $562,500 for commercial sales-based milestones of BHV-7000. Additionally, the Company has agreed to make scaled royalty payments in cash for BHV-7000 and the pipeline programs, starting at high single digits and peaking at low teens for BHV-7000 and starting at mid-single digits and peaking at low tens digits for the pipeline programs.
The Company accounted for this purchase as an asset acquisition as substantially all of the fair value of the gross assets acquired was concentrated in a single identifiable asset, in-process research and development (“IPR&D”). The IPR&D asset has no alternative future use and relates to intellectual property rights related to the Kv7 platform lead, now BHV-7000. There was no material value assigned to any other assets or liabilities acquired in the acquisition. As such, during the second quarter of 2022, the Company recorded a charge to R&D expense in the accompanying condensed consolidated statements of operations and comprehensive loss of $93,747.
In June 2022, the Company recorded a liability for a $25,000 regulatory milestone payment which became due to Knopp during the second quarter. The milestone payment was recorded as R&D expense in the accompanying condensed consolidated statements of operations and comprehensive loss during the three months ended June 30, 2022.
Excluding the milestone payment noted above, the Company has not recorded any of the possible contingent consideration payments to Knopp as a liability in the accompanying condensed consolidated balance sheet as none of the future events which would trigger a milestone payment were considered probable of occurring at June 30, 2022.
7. Liability Related to Sale of Future Royalties, net
2018 RPI Funding Agreement
In June 2018, the Company entered into a funding agreement (the "2018 RPI Funding Agreement") to sell tiered, sales-based royalty rights on global net sales of pharmaceutical products containing the compounds rimegepant or zavegepant (previously known as BHV-3500 and vazegepant) and certain derivative compounds thereof ("Products") to RPI, a Delaware statutory trust. The Company issued to RPI the right to receive certain revenue participation payments, subject to certain reductions, based on the future global net sales of the Products for each calendar quarter during the royalty term contemplated by the 2018 RPI Funding Agreement, in exchange for $100,000 in cash. Specifically, the participation rate commences at 2.1%
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
7. Liability Related to Sale of Future Royalties, net (Continued)
on annual global net sales of up to and equal to $1,500,000, declining to 1.5% on annual global net sales exceeding $1,500,000. Pursuant to the Pfizer Collaboration, Pfizer will compensate Biohaven for the related royalties on net sales outside of the U.S. owed to RPI under the 2018 RPI Funding Agreement
Concurrent with the 2018 RPI Funding Agreement, the Company entered into a common stock purchase agreement (the "Purchase Agreement") with RPI. Pursuant to the Purchase Agreement, the Company sold 1,111,111 common shares of the Company to RPI at a price of $45.00 per share, for gross proceeds of $50,000.
The Company concluded that there were two units of account for the consideration received comprised of the liability related to sale of future royalties and the common shares. The Company allocated the $100,000 from the 2018 RPI Funding Agreement and $50,000 from the Purchase Agreement among the two units of account on a relative fair value basis at the time of the transaction. The Company allocated $106,047 in transaction consideration to the liability, and $43,953 to the common shares. The Company determined the fair value of the common shares based on the closing share price on the transaction date, adjusted for the trading restrictions. The transaction costs of $377 were allocated in proportion to the allocation of total consideration to the two units of account. The effective interest rate under the 2018 RPI Funding Agreement, including transaction costs, is approximately 27% as of June 30, 2022.
2020 RPI Funding Agreement
In August 2020, the Company entered into a funding agreement with RPI 2019 Intermediate Finance Trust (“RPI 2019 IFT”) providing for up to $250,000 of funding in exchange for rights to participation payments based on global net sales of products containing zavegepant and rimegepant and certain payments based on success-based milestones relating to zavegepant (the "2020 RPI Funding Agreement"). Under the 2020 RPI Funding Agreement, RPI 2019 IFT will be entitled to receive tiered, sales based participation rights up to 3.0% of future global net sales of products containing zavegepant, 0.4% of future global net sales of products containing rimegepant, and payments tied to success-based milestones as described below. Pursuant to the Pfizer Collaboration, Pfizer will compensate Biohaven for the related royalties on net sales outside of the U.S. owed to RPI under the 2020 RPI Funding Agreement. The Company received $150,000 in cash at closing in 2020 and $100,000 in cash upon achievement of the
commencement of the oral zavegepant Phase 3 program in March 2021.
The success-based milestone payments range from 0.6x to 2.95x of the funded amount depending on the number of regulatory approvals achieved for zavegepant (including 1.9x for the first zavegepant migraine regulatory approval) and would be paid over a 10-year period. If the Company consummates a Change of Control, RPI 2019 IFT has the option to accelerate each unpaid milestone payment which has or thereafter occurs.
The Company concluded that there were two units of account for the $150,000 in initial consideration received, which comprised of a liability related to sale of future royalties for products containing rimegepant and a research and development arrangement with RPI 2019 IFT for zavegepant. The Company allocated the $150,000 from the 2020 RPI Funding Agreement among the two units of account based on the present value of probability adjusted net sales at the time of the transaction. The Company allocated $147,876 in transaction consideration to the liability related to sale of future royalties and $2,124 to the obligation to perform R&D services liability in the condensed consolidated balance sheets. The transaction costs of $400 were allocated to the liability related to sale of future royalties. The effective interest rate under the 2020 RPI Funding Agreement, including transaction costs, is approximately 8% as of June 30, 2022.
In March 2021, the Company received $100,000 from RPI 2019 IFT, pursuant to the 2020 RPI Funding Agreement, for the commencement of the oral zavegepant Phase 3 clinical program. The Company allocated the proceeds to obligation to perform R&D services liability in the condensed consolidated balance sheets.
Since there is a substantive and genuine transfer of risk to RPI 2019 IFT for the development of zavegepant, the $102,124 of consideration allocated to the development of zavegepant is being recognized by the Company as an obligation to perform contractual services and therefore is a reduction of research and development expenses as incurred.
The following table shows the activity within the obligation to perform R&D services account for the
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
7. Liability Related to Sale of Future Royalties, net (Continued)
three and six months ended June 30, 2022 and 2021, related to the 2020 RPI Funding Agreement.
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended June 30, | | Six Months Ended June 30, |
| | 2022 | | 2021 | | 2022 | | 2021 |
Reduction to research and development expenses | | $ | 5,383 | | | $ | 10,016 | | | $ | 12,326 | | | $ | 10,205 | |
The following table shows the activity within the liability related to sales of future royalties account for the six months ended June 30, 2022 and 2021, related to the 2018 and 2020 RPI Funding Agreements.
| | | | | | | | | | | | | | |
| | Six Months Ended June 30, |
| | 2022 | | 2021 |
Liability related to sale of future royalties - beginning balance | | $ | 384,283 | | | $ | 335,282 | |
| | | | |
Royalty revenues paid and payable to RPI | | (7,924) | | | (3,419) | |
Interest expense on liability related to sale of future royalties | | 35,359 | | | 28,007 | |
Liability related to sale of future royalties - ending balance | | $ | 411,718 | | | $ | 359,870 | |
8. Mandatorily Redeemable Preferred Shares, net
RPI Series A Preferred Shares
In April 2019, the Company sold 2,495 Series A Preferred Shares to RPI at a price of $50,100 per preferred share pursuant to the RPI Series A Preferred Share Agreement. The gross proceeds from the transaction with RPI were $125,000, with $105,000 of the proceeds used to purchase a priority review voucher ("PRV") issued by the United States Secretary of Health and Human Services to potentially expedite the regulatory review of the new drug application ("NDA") for the ODT formulation of rimegepant and the remainder of the proceeds to be used for other general corporate purposes.
The holders of the Company's outstanding Series A Preferred Shares will have the right to require a lump sum redemption of the shares in certain circumstances, such as in the event of a Change of Control, as defined in the Company's memorandum and article of association. Upon exercise of the put option by the holders, the Company must redeem the Series A Preferred Shares for two times (2x) the original purchase price of the
Series A Preferred Shares payable in a lump sum at the closing of the Change of Control.
The Company may redeem the Series A Preferred Shares at its option at any time for two times (2x) the original purchase price, which redemption price may be paid in a lump sum or in equal quarterly installments through December 31, 2024.
In the event that the Company defaults on any obligation to redeem Series A Preferred Shares when required, the redemption amount shall accrue interest at the rate of eighteen percent (18%) per annum. If any such default continues for at least one year, the holders of such shares shall be entitled to convert, subject to certain limitations, such Series A Preferred Shares into common shares, with no waiver of their redemption rights.
The Company is required to redeem the Series A Preferred Shares for two times (2x) the original purchase price, payable beginning March 31, 2021 in equal quarterly installments through December 31, 2024. Accordingly, the Company has concluded the Series A Preferred Shares are mandatorily redeemable instruments and classified as a liability. The Company initially measured the liability at fair value, and will subsequently accrete the carrying value to the redemption value through interest expense using the effective interest rate method. The effective interest rate under the RPI Series A Preferred Share Agreement, including transaction costs, was determined to be approximately 20% as of June 30, 2022. The Company recognized $6,112 and $7,677 in interest expense for the three months ended June 30, 2022 and 2021, respectively. The company recognized $12,575 and $15,620 in interest expense for the six months ended June 30, 2022 and 2021, respectively. The Company had 1,559 and 1,871 Series A preferred shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
8. Mandatorily Redeemable Preferred Shares, net (Continued)
The following table shows the activity within the Series A preferred share liability for the six months ended June 30, 2022 and 2021, respectively:
| | | | | | | | |
| | Carrying Value |
Gross balance at December 31, 2021 | | $ | 141,740 | |
Interest expense recognized, excluding transaction cost amortization | | 12,553 | |
Redemption of Series A preferred shares | | (31,250) | |
Gross balance at June 30, 2022 | | $ | 123,043 | |
Less: unamortized transaction costs | | (109) | |
Net balance at June 30, 2022 | | $ | 122,934 | |
| | |
Gross balance at December 31, 2020 | | $ | 174,264 | |
Interest expense recognized, including transaction cost amortization | | 15,599 | |
Redemption of Series A preferred shares | | (31,250) | |
Gross balance at June 30, 2021 | | $ | 158,613 | |
Less: unamortized transaction costs | | (152) | |
Net balance at June 30, 2021 | | $ | 158,461 | |
RPI Series B Preferred Shares
On August 7, 2020, the Company entered into the RPI Series B Preferred Share Agreement, pursuant to which RPI agreed to invest in the Company through the purchase of up to 3,992 Series B Preferred Shares at a price of $50,100 per share. The shares will be issued in quarterly increments from March 31, 2021 to December 31, 2024. Upon issuance of the Series B Preferred Shares, they qualify as mandatorily redeemable instruments and are classified as a mandatorily redeemable preferred shares liability on the condensed consolidated balance sheet. The Company initially measures the liability at fair value, and subsequently accretes the carrying value to the redemption value through interest expense using the effective interest rate method. The effective interest rate under the RPI Series B Preferred Share Agreement was determined to be approximately 7% as of June 30, 2022. The Company recognized $1,965 and $3,419 in interest expense for the three and six months ended June 30, 2022, respectively,
and $365 interest expense for the three and six months ended June 30, 2021. The Company had 1,988 and 1,406 Series B preferred shares issued and outstanding, as of June 30, 2022 and December 31, 2021, respectively.
The following table shows the activity within the Series B preferred share liability for the six months ended June 30, 2022 and 2021, respectively:
| | | | | | | | |
| | Carrying Value |
Balance at December 31, 2021 | | $ | 76,627 | |
Interest expense recognized | | 3,419 | |
Issuance of Series B preferred shares at fair value | | 39,733 | |
Balance at June 30, 2022 | | $ | 119,779 | |
| | |
Balance at December 31, 2020 | | $ | — | |
Interest expense recognized | | 365 | |
Issuance of Series B preferred shares at fair value | | 36,765 | |
Balance at June 30, 2021 | | $ | 37,130 | |
Pfizer Merger Agreement
On May 9, 2022, the Company, Pfizer and Merger Sub, entered into the Merger Agreement, see Note 1 for details. Pursuant to the terms set forth in the Merger Agreement, the Company shall (i) issue the remaining unissued Series B Preferred Shares pursuant to the Put Closing (as defined in the RPI Series B Preferred Share Agreement) and (ii) cause each Series A Preferred Shares and Series B Preferred Shares that are issued and outstanding to be redeemed by the Company. At the Closing (as defined in the Merger Agreement), Pfizer shall pay to the holders of Company's Series A Preferred Shares and Series B Preferred Shares, the redemption amount in immediately available funds. In connection with the early redemption of the Series A Preferred Shares and Series B Preferred Shares pursuant to the Merger Agreement, the Company recorded a derivative liability, see Note 4 for details.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
9. Shareholders' Deficit
Changes in shareholders’ deficit for the three and six months ended June 30, 2022 were as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Common Shares | | | | | | | | | | | | | | |
| | Shares | | Amount | | Additional Paid-in Capital | | Accumulated Deficit | | Accumulated Other Comprehensive Income | | Biohaven Shareholders' Equity (Deficit) | | Non-controlling Interests | | Total Shareholders' Equity (Deficit) | | |
Balances as of December 31, 2021 | | 66,933,531 | | | $ | 1,676,792 | | | $ | 169,656 | | | $ | (2,585,755) | | | $ | (73) | | | $ | (739,380) | | | $ | (3,629) | | | $ | (743,009) | | | |
| | | | | | | | | | | | | | | | | | |
Repurchase of preferred shares in consolidated subsidiary | | 1,232,629 | | | 152,673 | | | (92,673) | | | | | | | 60,000 | | | | | 60,000 | | | |
Issuance of common shares as payment for agreements | | 2,037,921 | | | 253,779 | | | | | | | | | 253,779 | | | | | 253,779 | | | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
Issuance of common shares under equity incentive plan | | 336,721 | | | 29,442 | | | (30,193) | | | | | | | (751) | | | | | (751) | | | |
Non-cash share-based compensation expense | | | | | | 82,790 | | | | | | | 82,790 | | | | | 82,790 | | | |
Net loss | | | | | | | | (116,399) | | | | | (116,399) | | | (498) | | | (116,897) | | | |
Other comprehensive loss | | | | | | | | | | (2,325) | | | (2,325) | | | | | (2,325) | | | |
Balances as of March 31, 2022 | | 70,540,802 | | | $ | 2,112,686 | | | $ | 129,580 | | | $ | (2,702,154) | | | $ | (2,398) | | | $ | (462,286) | | | $ | (4,127) | | | $ | (466,413) | | | |
| | | | | | | | | | | | | | | | | | |
Issuance of common shares as payment for acquisition | | 493,254 | | | 58,747 | | | — | | | — | | | — | | | 58,747 | | | — | | | 58,747 | | | |
| | | | | | | | | | | | | | | | | | |
Issuance of common shares under equity incentive plan and employee share purchase plan | | 77,015 | | | 9,965 | | | (2,826) | | | — | | | — | | | 7,139 | | | — | | | 7,139 | | | |
Non-cash share-based compensation expense | | — | | | — | | | 40,267 | | | — | | | — | | | 40,267 | | | — | | | 40,267 | | | |
Net loss | | — | | | — | | | — | | | (441,387) | | | — | | | (441,387) | | | (498) | | | (441,885) | | | |
Other comprehensive loss | | — | | | — | | | — | | | — | | | (3,413) | | | (3,413) | | | — | | | (3,413) | | | |
Balances as of June 30, 2022 | | 71,111,071 | | | $ | 2,181,398 | | | $ | 167,021 | | | $ | (3,143,541) | | | $ | (5,811) | | | $ | (800,933) | | | $ | (4,625) | | | $ | (805,558) | | | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | | |
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
9. Shareholders' Deficit (Continued)
Changes in shareholders’ equity (deficit) for the three and six months ended June 30, 2021 were as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Common Shares | | | | | | | | | | | | |
| | Shares | | Amount | | Additional Paid-in Capital | | Accumulated Deficit | | Accumulated Other Comprehensive Income | | Biohaven Shareholders' Equity (Deficit) | | Non-controlling Interests | | Total Shareholders' Equity (Deficit) |
Balance as of December 31, 2020 | | 60,436,876 | | | $ | 1,249,547 | | | $ | 98,938 | | | $ | (1,739,169) | | | $ | 314 | | | $ | (390,370) | | | $ | (1,819) | | | $ | (392,189) | |
Issuance of common shares, net of offering costs | | 4,037,204 | | | 308,243 | | | — | | | — | | | — | | | 308,243 | | | — | | | 308,243 | |
Issuance of common shares as part of acquisition | | 115,836 | | | 10,673 | | | — | | | — | | | — | | | 10,673 | | | — | | | 10,673 | |
Issuance of common shares as payment for license agreements | | 110,998 | | | 10,243 | | | — | | | — | | | — | | | 10,243 | | | — | | | 10,243 | |
Issuance of common shares under equity incentive plan | | 365,554 | | | 25,315 | | | (23,933) | | | — | | | — | | | 1,382 | | | — | | | 1,382 | |
Non-cash share-based compensation expense | | — | | | — | | | 48,726 | | | — | | | — | | | 48,726 | | | — | | | 48,726 | |
Net loss | | — | | | — | | | — | | | (264,968) | | | — | | | (264,968) | | | (360) | | | (265,328) | |
Other comprehensive income | | — | | | — | | | — | | | — | | | 95 | | | 95 | | | — | | | 95 | |
Balance as of March 31, 2021 | | 65,066,468 | | | $ | 1,604,021 | | | $ | 123,731 | | | $ | (2,004,137) | | | $ | 409 | | | $ | (275,976) | | | $ | (2,179) | | | $ | (278,155) | |
Issuance of common shares under equity incentive plan | | 173,990 | | | 14,173 | | | (6,912) | | | — | | | — | | | 7,261 | | | — | | | 7,261 | |
Non-cash share-based compensation expense | | — | | | — | | | 25,586 | | | — | | | — | | | 25,586 | | | — | | | 25,586 | |
Net loss | | — | | | — | | | — | | | (210,619) | | | — | | | (210,619) | | | (540) | | | (211,159) | |
Other comprehensive loss | | — | | | — | | | — | | | — | | | (129) | | | (129) | | | — | | | (129) | |
Balance as of June 30, 2021 | | 65,240,458 | | | $ | 1,618,194 | | | $ | 142,405 | | | $ | (2,214,756) | | | $ | 280 | | | $ | (453,877) | | | $ | (2,719) | | | $ | (456,596) | |
| | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
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| | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | |
Issuance of Common Shares for Kv7 Platform Acquisition
On April 1, 2022, the Company closed the previously announced acquisition from Knopp Biosciences LLC (“Knopp”) of Channel Biosciences, LLC (“Channel”), a wholly owned subsidiary of Knopp owning the assets of Knopp’s Kv7 channel targeting platform (the “Transaction”), pursuant to a Membership Interest Purchase Agreement (the “Purchase Agreement”), dated February 24, 2022.
In consideration for the Transaction, on April 4, 2022, Biohaven made an upfront payment comprised of $35,000 in cash and 493,254 common shares of the Company, valued at approximately $58,747, (“Biohaven Shares”) issued through a private placement.
Issuance of Common Shares for Pfizer Collaboration Agreement
In November 2021, the Company and Pfizer Inc. entered into a Subscription Agreement (the “Subscription Agreement”). In January 2022, upon expiration of the applicable waiting period under the
Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, the Company closed the sale of 2,022,581 of its common shares to Pfizer Inc. for $350,000 (the “Share Purchase”), pursuant to the terms of the Subscription Agreement. The estimated fair market value of the shares issued to Pfizer was approximately $252,000, adjusted by a discount for lack of marketability due to certain holding period restrictions, which was valued using an option pricing model (see Note 13).
Issuance of Common Shares for KU Leuven Agreement
In January 2022, Biohaven and Katholieke Universiteit Leuven ("KU Leuven") entered into an Exclusive License and Research Collaboration Agreement (the "KU Leuven Agreement") to develop and commercialize TRPM3 antagonists to address the growing proportion of people worldwide living with chronic pain disorders. As consideration, KU Leuven received an upfront cash payment of $3,000 and 15,340 shares valued at $1,779 which were both recorded as research and development expense on the Company’s condensed consolidated statements of operations.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
9. Shareholders' Deficit (Continued)
Issuance of Common Shares for the March 2021 Offering
In March 2021, the Company issued and sold 2,686,409 common shares at a public offering price of $76.00 per share for net proceeds of approximately $199,500 after deducting underwriting discounts and commissions of approximately $4,167 and other offering expenses of approximately $500. In addition, in March 2021, the underwriter of the March follow-on offering exercised its option to purchase additional shares, and the Company issued and sold 402,961 common shares for net proceeds of approximately $30,000 after deducting underwriting discounts and commissions of approximately $625. Thus, the aggregate net proceeds to the Company from the follow-on offering, after deducting underwriting discounts and commissions and other offering costs, were approximately $229,500.
Issuance of Common Shares for Acquisition of Kleo Pharmaceuticals, Inc.
On January 4, 2021, the Company acquired Kleo Pharmaceuticals, Inc. In the merger, each share of Kleo common stock issued and outstanding immediately prior to the effective time of the merger was converted into the right to receive approximately 0.007 of a common share of the Company, rounded up to the nearest whole share. Prior to the consummation of the merger, the Company owned approximately 41.9% of the outstanding shares of Kleo through its subsidiary Therapeutics, resulting in 115,836 common shares of the Company being issued to Kleo stockholders in the merger.
Issuance of Common Shares for Yale MoDE Agreement
On January 1, 2021, the Company entered into a worldwide, exclusive license agreement for the development and commercialization of a novel Molecular Degrader of Extracellular Protein (MoDEs) platform based on ground-breaking research conducted in the laboratory of Professor David Spiegel at Yale University. Under the agreement, the Company paid Yale University an upfront cash payment of $1,000 and 11,668 shares valued at $1,000, both of which were included in research and development expense in the condensed consolidated statements of operations and comprehensive loss.
Issuance of Common Shares for Consulting Agreement with Moda Pharmaceuticals LLC
On January 1, 2021, the Company entered into a consulting services agreement with Moda
Pharmaceuticals LLC to further the scientific and commercial advancement of technology, drug discovery platforms, product candidates and related intellectual property owned or controlled by the Company (Note 13). Under the agreement, the Company paid Moda Pharmaceuticals LLC an upfront cash payment of $2,700 and 37,836 shares valued at $3,243, both of which were included in research and development expense in the condensed consolidated statements of operations and comprehensive loss.
Issuance of Common Shares for Equity Distribution Agreement
In December 2020, the Company entered into the Equity Distribution Agreement. In accordance with the terms of the Equity Distribution Agreement, we may offer and sell common shares having an aggregate offering price of up to $400,000 from time to time through or to the sales agents, acting as our agents or principals. Sales of our common shares, if any, will be made in sales deemed to be “at the market offerings” as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, or the Securities Act, in ordinary brokers’ transactions, to or through a market maker, on or through the New York Stock Exchange or any other market venue where the securities may be traded, in the over-the-counter market, in privately negotiated transactions, or through a combination of any such methods of sale. The sales agents may also sell our common shares by any other method permitted by law. The sales agents are not required to sell any specific amount of securities but will act as our sales agents using commercially reasonable efforts consistent with their normal trading and sales practices, on mutually agreed terms between the sales agents and us. The Company issued and sold no shares in the three and six months ended June 30, 2022. The Company issued and sold no shares in the three months ended June 30, 2021, and 939,328 common shares for net proceeds of approximately $78,743 during the six months ended June 30, 2021.
Issuance of Series A Preferred Shares and Employee Share Options by Consolidated Subsidiary
In September 2020, the Company's Asia-Pacific Subsidiary, BioShin Limited, authorized, issued and sold 15,384,613 BioShin Series A Preferred Shares at a price of $3.90 per share for a total of $60,000 to a group of investors led by OrbiMed, with participation from Cormorant Asset Management LLC, HBM Healthcare Investments Ltd, Surveyor Capital (a Citadel Company), and Suvretta Capital Management, LLC (the "BioShin Investors"). The BioShin Series A Preferred Shares
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
9. Shareholders' Deficit (Continued)
contained both a call option by the Company and a put option held by the BioShin Investors. Due to the contingently redeemable features, the Company had classified the BioShin Series A Preferred Shares in mezzanine equity since the redemption was out of the Company's control.
In connection with the BioShin Series A Preferred Shares issuance, BioShin Limited executed the 2020 Equity Incentive Plan ("BioShin 2020 Equity Incentive Plan") and granted options under the BioShin 2020 Equity Incentive Plan to certain employees. The compensation expense is measured at the grant date based on the fair value of the award and is recognized as expense over the requisite service period of the award (generally three years) using the straight-line method. The Company is accounting for the expense being recognized over the requisite service period as non-controlling interest in shareholder's equity. The Company recognized $498 and $996 in non-controlling interest relating to the options for the three and six months ended June 30, 2022, respectively. The Company recognized $540 and $900 in non-controlling interest relating to the options for the three and six months ended June 30, 2021, respectively.
In November 2021, the Company, Biohaven Therapeutics Ltd. Atlas Merger Sub ("Merger Sub") and BioShin entered into an Agreement and Plan of Merger (the "Bioshin Merger Agreement"). The Bioshin Merger Agreement provided for the merger of the Merger Sub with and into BioShin, with BioShin surviving the merger as a wholly owned indirect subsidiary of the Company, in accordance with Section 233 of the Cayman Islands Companies Act. As a result of the satisfaction of the closing conditions described in the Biohsin Merger Agreement, on January 6, 2022, each Series A convertible preferred share of BioShin, no par value, other than Excluded Shares (as defined in the Bioshin Merger Agreement) was converted into the right to receive 0.080121 of a common share of the Company and was removed from mezzanine equity. The convertible Series A preferred shares of BioShin converted into 1,232,629 shares of the Company.
10. Accumulated Other Comprehensive Income (Loss)
Shareholders’ deficit included the following activity in accumulated other comprehensive income for the three and six months ended June 30, 2022:
| | | | | | | | | | | | | | |
| | Three Months Ended June 30, 2022 | | Six Months Ended June 30, 2022 |
| | | | |
Net unrealized investment gains (losses): | | | | |
Beginning of period balance | | $ | (2,602) | | | $ | (323) | |
Other comprehensive loss before reclassifications(1) | | (580) | | | (2,856) | |
Amounts reclassified from accumulated other comprehensive loss(1) | | (157) | | | (160) | |
Other comprehensive loss | | (737) | | | (3,016) | |
End of period balance | | (3,339) | | | (3,339) | |
| | | | |
Foreign currency translation adjustments: | | | | |
Beginning of period balance | | 204 | | | 250 | |
Other comprehensive loss(1) | | (2,676) | | | (2,722) | |
| | | | |
End of period balance | | (2,472) | | | (2,472) | |
| | | | |
Total beginning of period accumulated other comprehensive loss | | (2,398) | | | (73) | |
Total other comprehensive loss | | (3,413) | | | (5,738) | |
Total end of period accumulated other comprehensive loss | | $ | (5,811) | | | $ | (5,811) | |
(1) There was no tax on other comprehensive loss or amounts reclassified from accumulated other comprehensive income during the period.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
10. Accumulated Other Comprehensive Income (Loss) (Continued)
Shareholders’ deficit included the following activity in accumulated other comprehensive income for the three and six months ended June 30, 2021:
| | | | | | | | | | | | | | |
| | Three Months Ended June 30, 2021 | | Six Months Ended June 30, 2021 |
| | | | |
Net unrealized investment gains (losses): | | | | |
Beginning of period balance | | $ | (43) | | | $ | (125) | |
Other comprehensive income(1) | | 73 | | | 136 | |
Amounts reclassified from accumulated other comprehensive income(1) | | — | | | 19 | |
Other comprehensive income | | 73 | | | 155 | |
End of period balance | | 30 | | | 30 | |
| | | | |
Foreign currency translation adjustments: | | | | |
Beginning of period balance | | 452 | | | 439 | |
Other comprehensive loss(1) | | (202) | | | (189) | |
| | | | |
End of period balance | | 250 | | | 250 | |
| | | | |
Total beginning of period accumulated other comprehensive income | | 409 | | | 314 | |
Total other comprehensive loss | | (129) | | | (34) | |
Total end of period accumulated other comprehensive income | | $ | 280 | | | $ | 280 | |
(1) There was no tax on other comprehensive income during the period or amounts reclassified from accumulated other comprehensive income during the period.
11. Share-Based Compensation
Non-Cash Share-Based Compensation Expense
Non-cash share-based compensation is measured at the grant date based on the fair value of the award and is recognized as expense over the requisite service period of the award (generally three to four years) using the straight-line method. Non-cash share-based compensation expense, consisting of expense for stock options, Restricted Share Units ("RSUs"), Performance Share Units ("PSU"), and Employee Share Purchase Plan ("ESPP"), was classified in the condensed
consolidated statements of operations and comprehensive loss as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three months ended June 30, | | Six Months Ended June 30, |
| | 2022 | | 2021 | | 2022 | | 2021 |
Research and development expenses | | $ | 16,624 | | | $ | 9,273 | | | $ | 50,577 | | | $ | 29,331 | |
Selling, general and administrative expenses | | 23,643 | | | 16,313 | | | 71,518 | | | 44,981 | |
Total non-cash share-based compensation expense | | $ | 40,267 | | | $ | 25,586 | | | $ | 122,094 | | | $ | 74,312 | |
Less: Share-based compensation expense attributable to non-controlling interests | | 498 | | | 540 | | | 996 | | | 900 | |
Share-based compensation expense attributable to Biohaven Pharmaceutical Holding Company Ltd. | | $ | 39,769 | | | $ | 25,046 | | | $ | 121,098 | | | $ | 73,412 | |
Share-based compensation expense capitalized to inventory was $962 for the six months ended June 30, 2022. The Company did not capitalize material share-based compensation expense to inventory during the three months ended June 30, 2022 or the three and six months ended June 30, 2021.
Stock Options
All stock option grants are awarded at fair value on the date of grant. The fair value of stock options is estimated using the Black-Scholes option pricing model and stock-based compensation is recognized on a straight-line basis over the requisite service period. Stock options granted generally become exercisable over a three-year or four-year period from the grant date. Stock options generally expire 10 years after the grant date.
Under the terms of the Merger Agreement and the Distribution Agreement, upon the Pfizer merger, each post-spin Company stock option that is outstanding immediately prior to the effective time of the change in control, whether or not then vested, will be cancelled in exchange for the right to receive an amount in cash equal to the product of (i) the excess of the change in
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
11. Share-Based Compensation (Continued)
control consideration over the exercise price per Company share for such Company stock option; and (ii) the total number of Company shares subject to such Company stock option, less any withholding taxes.
The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company's common shares for those stock options that had exercise prices lower than the fair value of the Company's common shares at June 30, 2022.
As of June 30, 2022, the Company's unrecognized compensation expense related to unvested stock options totaled $95,791, which the Company expects to be recognized over a weighted-average period of 2.07 years, which does not consider the impact of a change in control. The Company expects approximately 2,486,094 of the unvested stock options to vest over the requisite service period.
The following table is a summary of the Company's stock option activity for the six months ended June 30, 2022:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Number of Shares | | Weighted Average Exercise Price | | Weighted Average Remaining Contractual Term (in years) | | Aggregate Intrinsic Value |
Outstanding as of December 31, 2021 | | 7,089,727 | | | $40.15 | | | | |
Granted | | 1,364,434 | | | $126.36 | | | | |
Exercised | | (76,161) | | | $57.92 | | | | |
Forfeited | | (19,375) | | | $80.24 | | | | |
Outstanding as of June 30, 2022 | | 8,358,625 | | | $53.96 | | 6.80 | | $ | 766,875 | |
Options exercisable as of June 30, 2022 | | 5,872,531 | | | $39.75 | | 6.12 | | $ | 622,280 | |
Vested and expected to vest as of June 30, 2022 | | 8,358,625 | | | $53.93 | | 6.80 | | $ | 766,875 | |
Restricted Share Units and Performance 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.
The Company’s PSUs contain performance vesting conditions in addition to a service vesting condition. Vesting of the Company’s PSUs is dependent upon the degree to which the Company achieves its performance goals, which are generally set for a three-year performance period and are approved at the time of grant by the Compensation Committee. The fair value of PSUs granted with service and performance vesting conditions is based on the market price of the Company's common stock on the grant date. The Company reassesses the probability of vesting at each reporting period for awards with performance conditions and adjusts compensation expense based on its probability assessment. A cumulative catch-up
adjustment is recorded when it becomes probable that the performance conditions will be achieved. The remaining compensation expense is recognized on a straight-line basis over the remaining vesting period, beginning when the accomplishment of the performance vesting conditions become probable. Certain of the PSUs also contain a market vesting condition based on the performance of the Company's common shares relative to a comparator group. The fair value of these PSUs is determined using a Monte Carlo simulation as of the grant date and is recognized over the vesting period.
Under the terms of the Merger Agreement and the Distribution Agreement, upon the Pfizer merger, each post-spin Company RSU outstanding immediately prior to the effective time of the change in control, whether or not then vested, will be cancelled in exchange for the right to receive an amount in cash equal to the product of (i) the number of Company shares subject to such Company RSU, with any performance conditions applicable to the Company RSU deemed achieved at 100%; and (ii) the change in control consideration, provided, however, that each Company RSU granted after the date of the Merger Agreement but prior to the effective time of the Pfizer Merger (other than certain Company RSUs that may be granted in exchange for or
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
11. Share-Based Compensation (Continued)
in lieu of options to acquire common shares of BioShin) will convert into a cash-based award if held by a continuing Company employee and otherwise will convert into a New Biohaven award.
As of June 30, 2022, there was $150,261 of total unrecognized compensation cost related to Company RSUs and PSUs that are expected to vest. These costs are expected to be recognized over a weighted-average period of 2.25 years, which does not consider the impact of a change in control. The total fair value of RSUs vested during the six months ended June 30, 2022 was $60,161.
The following table is a summary of the RSU and PSU activity for the six months ended June 30, 2022:
| | | | | | | | | | | | | | |
| | Number of Shares | | Weighted Average Grant Date Fair Value |
Unvested as of December 31, 2021 | | 1,218,070 | | | $78.98 |
Granted | | 1,184,787 | | | $127.32 |
Forfeited | | (30,530) | | | $99.69 |
Vested | | (637,728) | | | $94.32 |
Unvested as of June 30, 2022 | | 1,734,599 | | | $106.00 |
12. Net Loss Per Share
Basic and diluted net loss per share attributable to common shareholders of Biohaven Pharmaceutical Holding Company Ltd. was calculated as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended June 30, | | Six Months Ended June 30, |
| | 2022 | | 2021 | | 2022 | | 2021 |
Numerator: | | | | | | | | |
Net loss | | $ | (441,885) | | | $ | (211,159) | | | $ | (558,782) | | | $ | (476,487) | |
Net loss attributable to non-controlling interests | | 498 | | | 540 | | | 996 | | | 900 | |
Deemed dividend upon repurchase of preferred shares in consolidated subsidiary (1) | | — | | | — | | | (92,673) | | | — | |
Net loss attributable to common shareholders of Biohaven Pharmaceutical Holding Company Ltd. | | $ | (441,387) | | | $ | (210,619) | | | $ | (650,459) | | | $ | (475,587) | |
Denominator: | | | | | | | | |
Weighted average common shares outstanding—basic and diluted | | 71,043,693 | | | 65,112,179 | | | 70,689,949 | | | 63,584,932 | |
Net loss per share attributable to common shareholders of Biohaven Pharmaceutical Holding Company Ltd.—basic and diluted | | $ | (6.21) | | | $ | (3.23) | | | $ | (9.20) | | | $ | (7.48) | |
(1) As part of the BioShin Merger Agreement, the Company repurchased the 15,384,613 BioShin Series A Preferred Shares previously classified as mezzanine equity on the condensed consolidated balance sheet in exchange for 1,232,629 shares of the Company with a fair value of $152,673 (see Note 9 for further detail).
The Company’s potential dilutive securities, which include stock options, restricted share units, performance share units, and warrants to purchase common shares, 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
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
12. Net Loss Per Share (Continued)
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 June 30, |
| | 2022 | | 2021 |
Options to purchase common shares | | 8,358,625 | | | 8,573,800 | |
Warrants to purchase common shares | | 100,000 | | | 106,751 | |
Restricted share units and performance share units | | 1,734,599 | | | 1,179,471 | |
Total | | 10,193,224 | | | 9,860,022 | |
13. Collaboration, License and Other Agreements
Commercial and Late-stage Agreements
Pfizer Collaboration
In November 2021, the Company and Pfizer entered into a collaboration and license agreement and a related sublicense agreement (the "Pfizer Collaboration"), pursuant to which Pfizer was granted the exclusive right to commercialize product candidates containing Biohaven's proprietary compound rimegepant (BHV-3000) and may elect to commercialize zavegepant (BHV-3500) (the "Zavegepant Option"), in each case, in all countries worldwide outside of the United States. In January 2022, following the expiration or termination of applicable waiting periods under all applicable antitrust laws and the completion of the Share Purchase (as defined below), the Pfizer Collaboration became effective. In consideration therefor, Pfizer made an upfront cash payment to the Company of $150,000 and a $350,000 equity investment in the Company (as further discussed below).
In November 2021, in connection with the Pfizer Collaboration, the Company and Pfizer Inc. entered into the Subscription Agreement. In January 2022, upon expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, the Company closed the sale of 2,022,581 of its common shares to Pfizer Inc. for $350,000 (the “Share Purchase”), pursuant to the terms of the Subscription Agreement. The estimated fair market value of the shares issued to Pfizer was approximately
$252,000, adjusted by a discount for lack of marketability due to certain holding period restrictions, which was valued using an option pricing model. The issuance resulted in a $98,000 premium paid to the Company above the estimated fair value of the Company's common stock (the "Share Purchase Premium"), which forms part of the transaction price for the Collaboration Agreement as discussed below.
Under the terms of the arrangement, the Company will be eligible to receive an aggregate additional $740,000 in contingent payments based on specified commercial and sales-based milestones for the Licensed Products.
The Company is also entitled to tiered, escalating royalties from the upper teens to twenty percent of net sales of Licensed Products in the Territory. In general, Pfizer’s obligation to pay royalties continues on a product-by-product and country-by-country basis until the latest of ten years after the first commercial sale of such product in such country, the expiration of the patent rights covering such product in such country or the expiration of the period of exclusivity applicable to such product in such country. In addition to the upfront payments, contingent payments and royalties described above, Pfizer will also compensate Biohaven for a pro-rata share of certain of its sales-based milestone obligations owed to BMS under the BMS License, and related net sales royalties owed to BMS and RPI that result from Pfizer’s commercialization and sale, respectively, of the Licensed Products in the Territory.
Upon closing, the Company identified the following as material distinct performance obligations associated with the Pfizer Collaboration under ASC 606: (i) delivery of the license and sublicense to commercialize Rimegepant outside the U.S.; (ii) a material right for the delivery of the license and sublicense for Zavegepant in conjunction with the Zavegepant Option; (iii) certain future development activities to be performed by the Company, which include clinical development activities, regulatory affairs and the transfer of information required for manufacturing (the "initial development plan"); and (iv) a material right for the Company's obligation to provide product to Pfizer under the Supply Agreement.
The Company believes that the Pfizer Collaboration is a collaboration arrangement as defined in ASC 808, Collaborative Agreements. The Company also believes that Pfizer meets the definition of a customer as defined in ASC 606, Revenue From Contracts With Customers for all of the performance obligations identified at inception except for the initial
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
13. Collaboration, License and Other Agreements (Continued)
development plan. As ASC 808 does not address recognition and measurement, the Company has accounted for the initial development plan performance obligation by analogy to ASC 606.
The transaction price at inception included fixed consideration consisting of the upfront cash payment of $150,000 and the $98,000 Share Purchase Premium. Potential development, regulatory, and sales-based milestones, and royalties, will be accounted for as variable transaction price related to the Licensed Products under ASC 606. Given the uncertain nature of these payments, we determined they were fully constrained at inception and not included in the initial transaction price for the collaboration arrangement. At June 30, 2022, the Company reevaluated the transaction price and determined that $20,000 of variable consideration should no longer be constrained. We will re-evaluate the transaction price at each reporting period as uncertain events are resolved or other changes in circumstances occur.
The respective standalone value for each of the performance obligations was determined by applying the SSP method and the transaction price was allocated based on the relative SSP method with revenue recognition timing to be determined either by the provision of services or execution or expiration of an option.
The Company used an income approach to estimate the SSP for the Rimegepant license and sublicense, Zavegepant Option, and the Supply Agreement, and a cost approach for estimating the SSP of the initial development plan. The Rimegepant license and sublicense was delivered on the closing date of the collaboration arrangement and revenue allocated to this performance obligation of $194,389 was recorded as collaboration and other revenue on the condensed consolidated statements of operations and comprehensive loss during the three months ended March 31, 2022. Revenue allocated to the Zavegepant Option is deferred as a contract liability until execution or expiration of the option occurs. The initial development plan activities are expected to be delivered over time as the services are performed, with the allocated revenue being recognized over time based on costs incurred to perform the services, since the level of costs incurred over time is thought to best reflect the transfer of services to Pfizer. Revenue allocated to the Supply Agreement is deferred, and will be recognized as product revenue on the condensed consolidated statement of operations and comprehensive loss over the estimated period of the services.
In January 2022, upon the effectiveness of the agreements, a total contract liability of $53,611 was recorded relating to the remaining performance obligations under the Pfizer Collaboration. Approximately $1,729 and $2,602 of the initial contract liability was recognized as revenue during the three and six months ended June 30, 2022, respectively. Approximately $1,125 and $1,998 was recognized as collaboration and other revenue on the condensed consolidated statements of operations and comprehensive loss during the three and six months ended June 30, 2022, respectively, and $604 was recorded as product revenue for both the three and six months ended June 30, 2022. As of June 30, 2022, the total contract liability relating to the Pfizer Collaboration, which is primarily related to our obligations under the initial development plan was $51,009, of which $18,990 was classified as current and recorded to accrued expenses and other current liabilities on the condensed consolidated balance sheet. The remaining $32,019 was recorded to other long-term liabilities on the condensed consolidated balance sheet as of June 30, 2022, and expected to be recognized over several years.
In assessing the Pfizer Collaboration, management exercised considerable judgment in estimating revenue to be recognized, specifically related to estimating the discount for lack of marketability associated with the stock issuance, determining the separate performance obligations under the Collaboration Agreement, and estimating the standalone selling price of those performance obligations.
In the second quarter of 2022, the Company recorded $20,000 to collaboration and other revenue for variable consideration recognized as part of our collaboration arrangement with Pfizer. The associated receivable was included in other current assets on the condensed consolidated balance sheet as of June 30, 2022. Excluding the aforementioned variable consideration, as of June 30, 2022 the Company had not achieved any milestones or recorded any royalty revenue under the Pfizer Collaboration.
Yale University Agreement
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
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
13. Collaboration, License and Other Agreements (Continued)
disorder, post-traumatic stress disorder and depression. As part of the consideration for this license, the Company issued Yale 250,000 common shares and granted Yale the right to purchase up to 10% of the securities issued in specified future equity offerings by the Company, in addition to the obligation to issue shares to prevent anti-dilution. The obligation to contingently issue equity to Yale was no longer outstanding as of December 31, 2019.
The Yale Agreement was amended and restated in May 2019. As amended, the Company agreed to pay Yale up to $2,000 upon the achievement of specified regulatory milestones and annual royalty payments of a low single-digit percentage based on net sales of riluzole-based products from the licensed patents or from products based on troriluzole. Under the amended and restated agreement, the royalty rates are reduced as compared to the original agreement. In addition, under the amended and restated agreement, the Company may develop products based on riluzole or troriluzole. The amended and restated agreement retains a minimum annual royalty of up to $1,000 per year, beginning after the first sale of product under the agreement. If the Company grants any sublicense rights under the Yale Agreement, it must pay Yale a low single-digit percentage of sublicense income that it receives.
For the three and six months ended June 30, 2022 and 2021, the Company did not record any material expense, or make any royalty or milestone payments under the Yale Agreement.
BMS Agreement
In July 2016, the Company entered into an exclusive, worldwide license agreement with BMS (the "BMS Agreement") for the development and commercialization rights to rimegepant and zavegepant, as well as other CGRP-related intellectual property. In exchange for these rights, the Company agreed to pay BMS initial payments, milestone payments and royalties on net sales of licensed products under the agreement.
The Company is obligated to make milestone payments to BMS upon the achievement of specified development and commercialization milestones. The development milestone payments due under the BMS Agreement depend on the licensed product being developed. With respect to rimegepant, the Company is obligated to pay up to $127,500 in the aggregate upon the achievement of the development milestones. For any product other than rimegepant, the Company is obligated to pay up to $74,500 in the aggregate upon the achievement of the development milestones. In addition, the Company is obligated to pay up to $150,000 for each
licensed product upon the achievement of commercial milestones. If the Company receives revenue from sublicensing any of its rights under the BMS Agreement, it is also obligated to pay a portion of that revenue to BMS. The Company is also obligated to make tiered royalty payments to BMS based on annual worldwide net sales, with percentages in the low to mid-teens.
Under the BMS Agreement, the Company is obligated to use commercially reasonable efforts to develop licensed products and to commercialize at least one licensed product using the patent rights licensed from BMS and is solely responsible for all development, regulatory and commercial activities and costs. The Company is also required to reimburse BMS for any fees that BMS incurs related to the filing, prosecution, defending, and maintenance of patent rights licensed under the BMS Agreement. Under the BMS Agreement, BMS transferred to the Company manufactured licensed products, including certain materials that will be used by the Company to conduct clinical trials. The Company's right to sublicense its rights under the BMS agreement, other than to an affiliate or to certain third-party manufacturers, is subject to BMS's prior written consent, which cannot be unreasonably withheld or delayed.
The BMS Agreement will terminate on a licensed product-by-licensed product and country-by-country basis upon the expiration of the royalty term with respect to each licensed product in each country and can also be terminated if certain events occur, e.g., material breach or insolvency.
In March 2018, the Company entered into an amendment to the BMS Agreement (the “2018 BMS Amendment”). Under the 2018 BMS Amendment, the Company paid BMS an upfront payment of $50,000 in return for a low single-digit reduction in the royalties payable on net sales of rimegepant and a mid single-digit reduction in the royalties payable on net sales of zavegepant, which was recorded in research and development expense in the condensed consolidated statements of operations and comprehensive loss.
The 2018 BMS Amendment also removes BMS’s right of first negotiation to regain its intellectual property rights or enter into a license agreement with the Company following the Company’s receipt of topline data from its Phase 3 clinical trials with rimegepant, and clarifies that antibodies targeting CGRP are not prohibited as competitive compounds under the non-competition clause of the Original License Agreement.
In August 2020, the Company entered into a further amendment of the BMS Agreement (the “August
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
13. Collaboration, License and Other Agreements (Continued)
2020 BMS Amendment”). Under the August 2020 BMS Amendment, the Company paid BMS an upfront payment of $5,000 in return for a reduction in the royalties payable on net sales of rimegepant and zavegepant in China, with percentages in the low to mid-single digits. In addition, the Company is obligated to pay up to $22,500 for each licensed product upon the achievement of commercial milestones in China. The August 2020 BMS Amendment also amended the BMS Agreement to remove sales in China from the commercial milestone payment obligations.
In November 2020, the Company entered into a further amendment of the BMS Agreement (the “November 2020 BMS Amendment”). Under the November 2020 BMS Amendment, certain exclusivity provisions under the BMS Agreement are waived which permits the Company to develop certain CGRP compounds licensed by the Company from Heptares Therapeutics Limited (“Heptares”). Under the November 2020 Amendment, if the Company initiates clinical development of a Heptares compound prior to July 8, 2023, the Company is obligated to pay BMS certain fees based on net sales of the Heptares compounds from low single percentage to 10% and pay up to $17,500 for each Heptares compound upon the achievement of certain development milestones and up to $150,000 for each Heptares compound upon the achievement of certain commercial milestones. As of June 30, 2022 the Company has not achieved any of the development or commercial milestones for the Heptares compounds. No fees or milestones are due by the Company to BMS for Heptares compounds that begin clinical trials after July 8, 2023.
The BMS Agreement continues to provide the Company with exclusive global development and commercialization rights to rimegepant, zavegepant and related CGRP molecules, as well as related know-how and intellectual property. The Company’s obligations to make development milestone payments to BMS under the BMS Agreement remain unchanged.
In connection with the BMS Agreement, upon FDA approval of NURTEC ODT on February 27, 2020, the Company became obligated to pay BMS $40,000 in milestone payments. The Company recorded the $40,000 in milestone payments as an intangible asset on its condensed consolidated balance sheet in the first quarter of 2020, and is amortizing the expense to cost of sales on its condensed consolidated statements of operations and comprehensive loss over the patent life. The Company paid the $40,000 in milestone payments to BMS during the year ended December 31, 2020.
Prior to 2021, in connection with the BMS Agreement, the Company paid $12,000 for certain development milestones for zavegepant. In the first quarter of 2021, the Company accrued a $5,000 development milestone expense following the regulatory filing for rimegepant in Europe, which was paid in the second quarter of 2021. In the fourth quarter of 2021, the Company accrued a $5,000 development milestone expense for the planned submission of a New Drug Application to the FDA for intranasal zavegepant in the first half of 2022, which was paid in the second quarter of 2022.
In the second quarter of 2022, the Company paid a $20,000 regulatory milestone to BMS which was recorded as an intangible asset on the condensed consolidated balance sheet in the second quarter of 2022. The Company is amortizing the expense to cost of sales on its condensed consolidated statements of operations and comprehensive loss over the patent life.
For the three and six months ended June 30, 2022 and 2021, excluding the milestone payments above, the Company did not record research and development expense related to the BMS Agreement. For the three and six months ended June 30, 2022, the Company recorded $19,354 and $31,709, respectively, in royalty expense in cost of sales on the condensed consolidated statements of operations and comprehensive loss under the BMS agreement. For the three and six months ended June 30, 2021, the Company recorded $9,293 and $13,678, respectively, in royalty expense in cost of sales on the condensed consolidated statements of operations and comprehensive loss under the BMS agreement.
RPI Agreements
In June 2018, pursuant to the 2018 RPI Funding Agreement entered into by the Company and RPI (Note 7), the Company granted to RPI the right to receive certain revenue participation payments, subject to certain reductions, based on the future global net sales of the Products, for each calendar quarter during the royalty term contemplated by the 2018 RPI Funding Agreement, in exchange for $100,000 in cash. Specifically, the participation rate commences at 2.1 percent on annual global net sales of up to and equal to $1,500,000, declining to 1.5 percent on annual global net sales exceeding $1,500,000.
In connection with the 2018 RPI Funding Agreement, the Company recorded, $14,686 and $28,782 in interest expense on its liability related to sale of future royalties for the three and six months ended June 30, 2022, respectively, and $12,049 and $23,468 in interest expense on its liability related to sale of future
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
13. Collaboration, License and Other Agreements (Continued)
royalties for the three and six months ended June 30, 2021, respectively. The Company paid $2,595 and $6,620 under the 2018 RPI Funding Agreement during the three and six months ended June 30, 2022, respectively, and $920 and $1,656 for the three and six months ended June 30, 2021, respectively.
In August 2020, pursuant to the 2020 RPI Funding Agreement, the Company sold sales-based participation rights on global net sales of products containing zavegepant and rimegepant to RPI 2019 IFT for aggregate funding of $250,000, payable in two tranches. For further details on the transaction see Note 7 “Liability Related to Sale of Future Royalties, net.”
In connection with the 2020 RPI Funding Agreement, the Company recorded $3,359 and $6,577 in interest expense for the three and six months ended June 30, 2022, respectively, and $2,450 and $4,539 for the three and six months ended June 30, 2021, respectively. The Company recorded payments of $494 and $1,261 during the three and six months ended June 30, 2022, respectively, and payments of $175 and $315 under the 2020 RPI Funding Agreement during the three and six months ended June 30, 2021, respectively.
AstraZeneca License Agreement
In September 2018, the Company entered into an exclusive license agreement (the "2018 AstraZeneca Agreement") with AstraZeneca, pursuant to which AstraZeneca granted the Company a license to certain patent rights for the commercial development, manufacture, distribution and use of any products or processes resulting from development of those patent rights, including BHV-3241 (verdiperstat). Under the 2018 AstraZeneca Agreement, the Company paid AstraZeneca an upfront cash payment of $3,000 and 109,523 shares valued at $4,080 on the date of settlement, both of which were included in research and development expense, and is obligated to pay milestone payments to AstraZeneca totaling up to $55,000 upon the achievement of specified regulatory and commercial milestones and up to $50,000 upon the achievement of specified sales-based milestones. In addition, we will pay AstraZeneca tiered royalties ranging from high single-digit to low double-digits based on net sales of specified approved products, subject to specified reductions.
The Company is solely responsible, and has agreed to use commercially reasonable efforts, for all development, regulatory and commercial activities related to verdiperstat. The Company may sublicense its rights under the agreement and, if it does so, will be obligated to pay a portion of any milestone payments
received from the sublicense to AstraZeneca in addition to any milestone payments it would otherwise be obligated to pay.
The 2018 AstraZeneca Agreement terminates on a country-by-country basis and product-by-product basis upon the expiration of the royalty term for such product in such country and can also be terminated if certain events occur, e.g., material breach or insolvency.
For the three and six months ended June 30, 2022 and 2021, the Company did not record any material expense or make any milestone or royalty payments under the 2018 AstraZeneca Agreement.
Taldefgrobep Alfa License Agreement
In February 2022, following the transfer of intellectual property, the Company announced that we entered into a worldwide license agreement with BMS for the development and commercialization rights to taldefgrobep alfa (also known as BMS-986089), a novel, Phase 3-ready anti-myostatin adnectin (the "Taldefgrobep Alfa License Agreement"). Under the terms of the Taldefgrobep Alfa License Agreement, the Company will receive worldwide rights to taldefgrobep alfa and BMS will be eligible for regulatory approval milestone payments of up to $200,000, as well as tiered, sales-based royalty percentages from the high teens to the low twenties. There were no upfront or contingent payments to BMS related to the Taldefgrobep Alfa License Agreement.
For the three and six months ended June 30, 2022 and 2021, the Company did not record any material expense or make any milestone or royalty payments under the Taldefgrobep Alfa License Agreement.
Other Agreements
In addition to the agreements discussed above, the Company has entered into various other collaborations, including licensing and development programs, for assets which the Company considers to be early-stage (have not yet entered phase 3 clinical trials). The agreements generally include upfront fees, milestone payments which become payable upon achievement of certain clinical, development, regulatory and sales milestones, as well as royalties calculated as a percentage of product revenue, with rates that vary by agreement.
The Company records milestones and other payments, including funding for research arrangements, which become due under its early-stage agreements to research and development expense in the condensed consolidated statements of operations and
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
13. Collaboration, License and Other Agreements (Continued)
comprehensive loss. Amounts recorded for the period were as follows:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended June 30, | | Six Months Ended June 30, |
| | 2022 | | 2021 | | 2022 | | 2021 |
Milestone payments | | $ | — | | | $ | 500 | | | $ | — | | | $ | 650 | |
Other payments | | 761 | | | 3,527 | | | 5,206 | | | 4,956 | |
For the three and six months ended June 30, 2022 and 2021, the Company made the following upfront payments in connection with new agreements:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended June 30, | | Six Months Ended June 30, |
| | 2022 | | 2021 | | 2022 | | 2021 |
Upfront Payments: | | | | | | | | |
Cash | | $ | — | | | $ | — | | | $ | 3,000 | | | $ | 3,700 | |
Issuance of Common Stock | | — | | | — | | | 1,779 | | | 4,243 | |
As of June 30, 2022, under these agreements the Company has potential future developmental, regulatory, and commercial milestone payments of up to approximately $224,812, $299,325 and $723,121, respectively. Payments under these agreements generally become due and payable upon achievement of a specified milestone. Because the achievement of these milestones have not been considered probable as of June 30, 2022, such contingencies have not been recorded in our financial statements. Amounts related to contingent milestone payments are not considered contractual obligations as they are contingent on the successful achievement of certain development, regulatory or commercial milestones.
14. Debt
In August 2020, the Company and Biohaven Pharmaceuticals, Inc., the Company's wholly-owned subsidiary (together with the Company, the "Borrowers"), entered into a financing agreement, as amended, with Sixth Street Specialty Lending, Inc., as administrative agent, and the lenders party thereto (the "Lenders") pursuant to which the Lenders agreed to extend a senior secured credit facility to the Company providing for term loans in an aggregate principal amount up to $500,000, plus any capitalized interest paid in kind. The Borrowers drew an initial term loan of $275,000 at closing in August 2020 (the "Initial Term
Loan") and had $100,000 of immediately available delayed draw term loan commitments and $125,000 of delayed draw term loan commitments available upon achievement of the Delay Draw Sales Milestone (as defined in the Sixth Street Financing Agreement).
In March 2021, the Borrowers and certain other of the Company’s subsidiaries entered into Amendment No. 1 (the “First Amendment”) to the financing agreement pursuant to which the parties agreed to, among other things, remove the Delayed Draw Sales Milestone tied to the availability of the $125,000 tranche of delayed draw term loans. In August 2021, the Borrowers drew the $125,000 tranche of delayed draw term loans (the "DDTL-2).
In September 2021, the Borrowers, and certain other of the Company’s subsidiaries entered into Amendment No. 2 (the “Second Amendment”) to the financing agreement. Pursuant to the Second Amendment, the parties agreed to, among other things, increase the size of the credit facility by providing for additional term loans in an aggregate principal amount of $250,000 for a total facility size of $750,000 plus any capitalized interest paid in kind. At the closing of the Second Amendment, the Borrowers drew an initial term loan of $125,000 (the "2021 Term Loan") and $100,000 (the "DDTL-1"). The remaining $125,000 in delayed draw term loan commitments (the "2021 DDTL Commitment") was available to be drawn by the Borrowers until December 31, 2021 (the "Delayed Draw Term Loan Commitment Termination Date").
In November 2021, the Company entered into Amendment No. 3 and Limited Consent to Financing Agreement (“the Third Amendment and Limited Consent”) to our Sixth Street Financing Agreement. Pursuant to the Third Amendment and Limited Consent, the Lenders consented to the Company’s entry into the Collaboration Agreement with Pfizer.
In December 2021, the Company entered into Amendment No. 4 (the "Fourth Amendment") to the financing agreement (as previously amended and as amended by the Fourth Amendment, the “Sixth Street Financing Agreement”), pursuant to which the parties agreed to, among other things, extend the Delayed Draw Term Loan Commitment Termination Date to June 30, 2022. In June 2022, the Company drew the remaining $125,000 term loan available under the 2021 DDTL Commitment (the "DDTL-3").
The Company has the right to elect to pay up to 4.00% per annum of the interest on the term loans comprising such borrowing in the form of payment in kind for the first eight fiscal quarters after the date of
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
14. Debt (Continued)
such borrowing. For the loans drawn under the 2021 DDTL Commitment, the payment-in-kind election cannot exceed seven fiscal quarters after the Delayed Draw Term Loan Commitment Termination Date. Interest on amounts borrowed under the facility will be payable quarterly.
The Company will have the right to prepay borrowings under the facility in whole or in part at any time, subject to a customary prepayment fee on the principal amount prepaid, which declines over time. The Company paid customary fees with respect to amounts drawn on each credit date. The Company also agreed to pay customary fees on the funding of any delayed draw term loans.
The Sixth Street Financing Agreement contains mandatory prepayments, restrictions and covenants applicable to the Company and its subsidiaries that are customary for financings of this type. Among other requirements, the Borrowers are required to maintain a minimum unrestricted cash balance of $80,000. At the Borrowers' request, the minimum unrestricted cash balance will be waived for any fiscal quarter in which the Borrowers achieve $400,000 of net sales of the Company’s products in the four consecutive quarterly periods prior to such fiscal quarter. The Sixth Street Financing Agreement also includes representations, warranties, indemnities and events of default that are customary for financings of this type, including an event of default relating to a change of control of the Company. Upon or after an event of default, the administrative agent and the lenders may declare all or a portion of our obligations under the Sixth Street Financing Agreement to be immediately due and payable and exercise other rights and remedies provided for under the Sixth Street Financing Agreement.
The obligations under the Sixth Street Financing Agreement are and will be guaranteed by each of the Company's existing and future direct and indirect subsidiaries, subject to certain exceptions. The obligations of the Company and its subsidiaries under the Sixth Street Financing Agreement are secured, subject to customary permitted liens and other agreed upon exceptions, by a security interest in certain existing and after-acquired assets of the Company and its subsidiaries.
2020 Loans
In August 2020, the Company borrowed the Initial Term Loan for total proceeds of $262,200, net of discounts and issuance costs. In August 2021, the Company borrowed the DDTL-2 for total proceeds of $123,750, net of discounts and issuance costs. The
DDTL-2 contained the same financing terms as the Initial Term Loan. The Initial Term Loan and the DDTL-2 (collectively, the "August 2020 Loans") become due and payable in August 2025. The August 2020 Loans bear floating interest on the unpaid principal amount at a rate per annum equal to the three-month LIBOR rate, adjusted for applicable reserve requirements, and subject to a floor of 1.00%, plus 9.00%. The contractual interest rate as of June 30, 2022 for the August 2020 Loans was 11.25%, and the effective interest rate is approximately 13.04% and 12.25% for Initial Term Loan and DDTL-2, respectively. The interest expense on the August 2020 Loans, including amortization of loan discounts and issuance costs, for the three and six months ended June 30, 2022 was $11,261 and $22,262, respectively. For the August 2020 Loans, the Company elected to pay in kind the maximum amount for its interest payments made through June 30, 2022.
2021 Loans
In September 2021, the Company borrowed the 2021 Term Loan and DDTL-1, and in June 2022, the Company borrowed the DDTL-3 (collectively, the "September 2021 Loans") and received proceeds of $119,722, $97,778, and $123,307, respectively, net of discounts and issuance costs. The September 2021 Loans are due and payable in September 2026. The September 2021 Loans will bear floating interest on the unpaid principal amount at a rate per annum equal to the three-month LIBOR rate, adjusted for applicable reserve requirements, and subject to a floor of 1.00%, plus 8.25%. The contractual interest rate as of June 30, 2022 for the September 2021 Loans was 10.50% and the effective interest rate is approximately 12.19%, 11.63%, and 11.51% for 2021 Term Loan, DDTL-1, and DDTL-3, respectively.
The interest expense on the September 2021 Loans, including amortization of loan discounts and issuance costs, was $5,648 and $11,168 for the three and six months ended June 30, 2022, respectively. For the September 2021 Loans, the Company elected to pay in kind the maximum amount for its interest payments made through June 30, 2022.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
14. Debt (Continued)
The following table is a summary of the Company’s borrowing as of June 30, 2022: | | | | | | | | | | | | | | |
| | June 30, 2022 | | December 31, 2021 |
Long-term debt | | | | |
Floating rate loans due August 2025 (11.25% at June 30, 2022)(1) | | $ | 426,127 | | | $ | 417,685 | |
Floating rate loans due September 2026 (10.50% at June 30, 2022)(2) | | 356,894 | | | 227,300 | |
Total debt principal | | 783,021 | | | 644,985 | |
Unamortized debt discount and issuance costs | | (18,038) | | | (18,265) | |
| | | | |
Long-term debt | | $ | 764,983 | | | $ | 626,720 | |
(1) As of June 30, 2022 and December 31, 2021, paid in kind interest of $26,127 and $17,685, respectively, are included in the principal balance.
(2) As of June 30, 2022 and December 31, 2021, paid in kind interest of $6,894 and $2,300, respectively, are included in the principal balance.
The following is a summary of the Company's required repayments of debt principal due during each of the next five years, as of June 30, 2022: | | | | | |
2022 | $ | — | |
2023 | 10,587 | |
2024 | 39,958 | |
2025 | 411,272 | |
2026 | 321,204 | |
| |
| $ | 783,021 | |
Pfizer Merger Agreement
On May 9, 2022, the Company, Pfizer and Merger Sub, entered into the Merger Agreement, see Note 1 for
details. Pursuant to the terms set forth in the Merger Agreement, the Company will terminate the Sixth Street Financing Agreement at the Closing (as defined in the Merger Agreement), and will obtain at the Closing customary payoff letters from the lenders under the Sixth Street Financing Agreement, including, subject to the payment of any applicable payoff amount, the release of all Liens granted in connection with the Sixth Street Financing Agreement. Pfizer shall irrevocably pay off or cause to be paid off at Closing the applicable payoff amount on behalf of the Company.
15. Commitments and Contingencies
Leases
The Company has operating leases for corporate offices and operating and finance leases for vehicles. The Company determines if an arrangement is a lease at inception. The lease term includes options to extend or terminate the lease when it is reasonably certain that Biohaven will exercise that option. Real estate leases for facilities have an average remaining lease term of 3.82 years for which none include the optional extension. Vehicle leases are generally in effect for three years. The Company has made an accounting policy election not to record short-term leases (leases with an initial term of 12 months or less) on the balance sheet.
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
15. Commitments and Contingencies (Continued)
The following table is a summary of the components of total lease cost: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | Three Months Ended June 30, | | Six Months Ended June 30, | | |
| | Statement of Operations Loss Location | | 2022 | | 2021 | | 2022 | | 2021 | | |
Lease cost | | | | | | | | | | | | |
Finance lease cost: | | | | | | | | | | | | |
Amortization of right-of-use assets | | Selling, general and administrative expense | | $ | 1,274 | | | $ | 1,374 | | | $ | 2,618 | | | $ | 2,670 | | | |
Interest on lease liabilities | | Interest expense | | 84 | | | 158 | | | 189 | | | 301 | | | |
Operating lease cost | | Selling, general and administrative expense | | 681 | | | 267 | | | 948 | | | 534 | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
Total lease cost | | | | $ | 2,039 | | | $ | 1,799 | | | $ | 3,755 | | | $ | 3,505 | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | | | | | | | | | | | |
The Company recognized no material short-term or variable lease costs for the three and six months ended June 30, 2022 and 2021.
The following table summarizes supplemental cash flow information: | | | | | | | | | | | | | | |
| | Six Months Ended June 30, |
| | 2022 | | 2021 |
Cash paid for amounts included in the measurement of lease liabilities: | | | | |
Operating cash flows paid for operating leases | | $ | 657 | | | $ | 334 | |
Operating cash flows paid for interest portion of finance leases | | $ | 200 | | | $ | 335 | |
Financing cash flows paid for principal portion of finance leases | | $ | 2,576 | | | $ | 2,514 | |
Right-of-use assets obtained in exchange for new operating lease liabilities | | $ | 7,863 | | | $ | 478 | |
Right-of-use assets obtained in exchange for new finance lease liabilities | | $ | 54 | | | $ | 186 | |
| | | | |
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
15. Commitments and Contingencies (Continued)
Supplemental balance sheet information related to leases is as follows: | | | | | | | | | | | | | | | | | | | | |
In thousands, except remaining lease term and discount rate | | Balance Sheets Location | | June 30, 2022 | | December 31, 2021 |
Operating leases: | | | | | | |
Operating lease right-of-use assets | | Other assets | | $ | 12,293 | | | $ | 5,222 | |
| | | | | | |
Current portion of operating lease liabilities | | Accrued expenses and other current liabilities | | $ | 2,685 | | | $ | 439 | |
Noncurrent operating lease liabilities | | Other long-term liabilities | | 7,833 | | | 2,797 | |
Total operating lease liabilities | | | | $ | 10,518 | | | $ | 3,236 | |
| | | | | | |
Finance leases: | | | | | | |
Finance lease right-of-use assets | | | | $ | 16,418 | | | $ | 16,363 | |
Accumulated amortization | | | | (10,250) | | | (7,632) | |
Modifications affecting finance lease right-of-use assets | | | | (1,446) | | | $ | — | |
Total finance lease right-of-use assets | | Other assets | | $ | 4,722 | | | $ | 8,731 | |
| | | | | | |
Current portion of finance lease liabilities | | Accrued expenses and other current liabilities | | $ | 4,207 | | | $ | 5,410 | |
Noncurrent finance lease liabilities | | Other long-term liabilities | | 794 | | | 3,728 | |
Total finance lease liabilities | | | | $ | 5,001 | | | $ | 9,138 | |
| | | | | | |
Weighted average remaining lease term (in years) | | | | | | |
Operating leases | | | | 3.82 | | 5.75 |
Finance leases | | | | 1.16 | | 1.63 |
| | | | | | |
Weighted average discount rate | | | | | | |
Operating leases | | | | 8.86% | | 9.07% |
Finance lease | | | | 5.08% | | 5.15% |
The following table summarize maturities of lease liabilities as of June 30, 2022: | | | | | | | | | | | | | | | | | | | | |
| | Finance leases | | Operating leases | | Total |
2022 (remaining six months) | | $ | 2,216 | | | $ | 1,755 | | | $ | 3,971 | |
2023 | | 2,902 | | | 3,408 | | | 6,310 | |
2024 | | 77 | | | 3,358 | | | 3,435 | |
2025 | | 6 | | | 2,039 | | | 2,045 | |
2026 | | — | | | 1,147 | | | 1,147 | |
Thereafter | | — | | | 669 | | | 669 | |
Total lease payments | | 5,201 | | | 12,376 | | | 17,577 | |
Less: imputed interest | | (200) | | | (1,858) | | | (2,058) | |
Total lease liabilities | | $ | 5,001 | | | $ | 10,518 | | | $ | 15,519 | |
BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share amounts)
(Unaudited)
15. Commitments and Contingencies (Continued)
During the second quarter of 2022, the Company exchanged approximately half of its commercial car fleet leases for new leases. The gains on termination of the old fleet leases were treated as lease incentives that reduced the lease payments for the new fleet leases. The Company has determined that the new fleet leases are operating leases and has recorded a modification to the finance lease right-of-use assets of $1,446 for the early termination of the old fleet leases. The Company expects to exchange the remaining vehicles in the second half of 2022.
The Company's commercial commitments primarily relate to manufacturing preparation services that are enforceable and legally binding on us and that specify all significant terms, including applicable milestone payments and target completion dates, and its commercial car fleet.
Research Commitments
The Company has entered into agreements with several contract research organizations to provide services in connection with its preclinical studies and clinical trials. The Company commits to minimum payments under these arrangements.
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 certain executive officers and members of its board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. 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 specified 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 June 30, 2022 or December 31, 2021.
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 June 30, 2022, there were no matters which would have a material impact on the Company’s financial results.
16. 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 six months ended June 30, 2022 and 2021:
| | | | | | | | | | | | | | | | | | | | | | | |
| | Three Months Ended June 30, | Six Months Ended June 30, |
| | 2022 | | 2021 | 2022 | | 2021 |
Income tax provision | | $ | 84 | | | $ | 4,350 | | $ | 24,387 | | | $ | 8,174 | |
Effective income tax rate | | — | % | | 2.1 | % | 4.6 | % | | 1.7 | % |
The Company recorded an income tax provision of $84 and $24,387 for the three and six months ended
June 30, 2022, respectively, compared to a provision for income taxes of $4,350 and $8,174 for the three and six months ended June 30, 2021, respectively. The increase in income tax expense for the six months ended June 30, 2022 as compared to 2021 was primarily attributable to the mandatory capitalization of R&D expenses effective January 1, 2022 under the Tax Cuts and Jobs Act, offset by an increased benefit to the Company's foreign derived intangible income deduction. The decrease in income tax expense for the three months ended June 30, 2022 as compared to 2021 was primarily attributable to the timing of income subject to taxation for the Company's profitable operations in the United States.