Collaboration, License and Other Agreements | 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 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 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 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 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 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. |