v3.26.3
License, Acquisitions and Other Agreements
9 Months Ended
Sep. 30, 2026
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
License, Acquisitions and Other Agreements License, Acquisitions and Other Agreements
The Company has entered into various licensing, developmental and acquisition agreements which provide the Company with rights to certain know-how, technology and patent rights. The agreements generally include upfront fees, milestone payments upon achievement of certain developmental, regulatory and commercial and sales milestones, as well as sales-based royalties, with percentages that vary by agreement. The Company has also entered into agreements under which it will grant a third party rights to develop and commercialize certain of the Company's product candidates in exchange for upfront, milestone and royalty payments to the Company.
Out-License Arrangements
SKBP License Agreement
In August 2026, the Company entered into a License Agreement (the “SKBP License Agreement”) with SK Biopharmaceuticals Co., Ltd. (“SKBP”). Pursuant to the SKBP License Agreement, effective upon the closing of the transactions contemplated thereby (the “Closing”), the Company will grant SKBP an exclusive, royalty-bearing, worldwide license, with the right to grant sublicenses subject to the terms of the SKBP License Agreement, to our Kv7 ion channel platform, led by opakalim (BHV-7000), and other Kv7 compounds and products covered by the SKBP License Agreement. The applicable Hart-Scott-Rodino waiting period for the SKBP License Agreement expired on October 28, 2026.
Under the SKBP License Agreement, SKBP will pay the Company a non-creditable and non-refundable upfront fee of $400,000, consisting of $350,000 payable at the Closing and $50,000 payable one year after the Closing. The Company will also be eligible to receive up to $150,000 in one-time development and regulatory milestone payments. In addition, SKBP will pay the Company tiered royalties ranging from the mid-teens to the low twenties on U.S. net sales of opakalim and certain other antiseizure products, mid-single-digit royalties on ex-U.S. net sales of opakalim and certain other
antiseizure products, and additional royalties on net sales of certain other licensed products, in each case subject to specified reductions and adjustments. The applicable royalty term for each licensed product in each country begins upon the first commercial sale of such product in such country and ends upon the latest of (i) 10 years after such first commercial sale, (ii) expiration of applicable regulatory exclusivity and (iii) expiration of the last-to-expire licensed patent claim in such country covering the composition of matter of the applicable licensed compound.
Following the Closing, the Company will continue to conduct specified ongoing development and regulatory activities, including the ongoing RISE 2 and RISE 3 clinical studies and preparation and filing of the new drug application for opakalim. SKBP will also reimburse specified pre-Closing program costs and fund certain development plan costs incurred by the Company. SKBP is required to use commercially reasonable efforts to develop and seek regulatory approval for opakalim in the United States, Europe and Japan and, following regulatory approval in the applicable market, to commercialize opakalim in that market.
The SKBP License Agreement also contains specified restrictions on each party’s activities involving competing Kv7 activators. Unless earlier terminated, the SKBP License Agreement will continue until the expiration of all applicable royalty terms. Upon expiration of the applicable royalty term for a licensed product in a country, the corresponding license will become fully paid-up, royalty-free, perpetual and irrevocable in that country. Following the Closing, SKBP may terminate the SKBP License Agreement, in whole or in part, for convenience upon specified prior written notice. The parties also have specified termination rights, including for uncured material breach and specified bankruptcy or insolvency events. Upon any such post-Closing termination, the license granted to SKBP will terminate with respect to the applicable terminated products or territories, subject in specified circumstances to limited rights to sell off existing inventory. Following any such termination, the parties will cooperate to wind down or transition ongoing activities. The SKBP License Agreement also provides for specified reversion rights in favor of the Company with respect to certain intellectual property and regulatory filings relating to the terminated products or territories.
Partial MIPA Assignment and Assumption Agreement
Also in August 2026, the Company and SKBP entered into a Partial MIPA Assignment and Assumption Agreement (the “Assignment Agreement”), which will become effective only upon the Closing. The Assignment Agreement provides for the assignment and assumption of certain rights and obligations under the Membership Interest Purchase Agreement, dated February 24, 2022, by and among Biohaven Therapeutics Ltd., Knopp Biosciences LLC (“Knopp”) and Channel Biosciences, LLC, as amended (the “MIPA” or "Purchase Agreement"). Effective upon the Closing, the Company will assign to SKBP its rights under Section 2.4 (Contingent Consideration) of the MIPA and specified related provisions, and SKBP will assume the related obligations arising from and after the Closing. For a complete discussion of the MIPA and its terms, refer to the below section titled "Kv7 Platform Acquisition," included in this Note 11.
The Knopp obligations to be assumed by SKBP include aggregate potential milestone obligations of up to $245,000, consisting of $185,000 in milestone obligations tied to U.S. and EMA regulatory approval of opakalim, and up to $60,000 in milestone obligations tied to U.S. regulatory approvals of up to three other Kv7 products, as well as a mid-single-digit royalty on worldwide net sales of Kv7 products. These obligations are separate from, and not creditable against, SKBP’s milestone and royalty obligations to the Company under the SKBP License Agreement. The Company will retain all other rights and obligations under the MIPA. If the SKBP License Agreement is terminated before the Closing, the Assignment Agreement will automatically terminate without becoming effective.
Ono License Agreement
In October 2026, the Company entered into a Collaboration and License Agreement (the “Ono License Agreement”) with Ono Pharmaceutical Co., Ltd. (“Ono”). Pursuant to the Ono License Agreement, the Company granted Ono an exclusive, royalty-bearing license, with the right to grant sublicenses subject to the terms of the Ono License Agreement, to develop and commercialize the Company's MoDE pan IgG degrader portfolio, led by BHV-1300 and including next-generation follow-on degraders BHV-1310 and BHV-1320, in Japan, South Korea, Taiwan and the countries of the Association of Southeast Asian Nations (the “Ono Licensed Territory”), subject to the terms of the Ono License Agreement. The Company retains all rights to the licensed portfolio outside the Ono Licensed Territory, including in the United States, Europe and China.
Under the Ono License Agreement, Ono paid the Company a one-time, non-creditable and non-refundable upfront payment of $80,000 in October 2026 upon closing and will pay the Company another $20,000 upon a milestone
achievement, following Ono’s receipt of specified stability test results and subject to Ono’s election to continue development and commercialization of the licensed compounds and products in the Ono Licensed Territory. In addition, Ono will pay Biohaven royalties of approximately 20% on net sales of licensed products in the Ono Licensed Territory, subject to specified reductions and adjustments. If Ono elects not to continue the program after receipt of specified stability test results in accordance with the Ono License Agreement, the Ono License Agreement will terminate and the milestone achievement payment and royalties will not become payable.
Ono is generally responsible, at its own expense, for development, regulatory activities and commercialization of the licensed compounds and products in the Ono Licensed Territory and is required to use commercially reasonable efforts to conduct these activities. The Company will continue to conduct specified ongoing studies and development activities, with Ono funding specified activities conducted in the Ono Licensed Territory and sharing specified costs of global clinical studies.
The Ono License Agreement contains specified restrictions on each party’s activities involving competing IgG degraders and provides Ono with a right of first negotiation with respect to certain follow-on compounds in the Ono Licensed Territory.
Unless earlier terminated, the Ono License Agreement will continue until the expiration of all applicable royalty terms. Ono may terminate the Ono License Agreement, in whole or on a product-by-product or country-by-country basis, for convenience upon specified prior written notice. The parties also have specified termination rights, including for uncured material breach and specified bankruptcy or insolvency events. The Company has additional termination rights for certain cessations of development and specified patent challenges. Upon termination, the applicable license rights granted to Ono will terminate, subject in specified circumstances to limited rights to sell existing inventory. The Ono License Agreement also provides for specified transition and reversion rights in favor of the Company relating to regulatory filings, clinical trials and intellectual property.
In-License and Other Agreements
As of September 30, 2026, the Company had potential future developmental, regulatory and commercial milestone payments under its license and other agreements of up to approximately $139,313, $711,600, and $3,187,488, respectively. See below for a detailed discussion of these agreements. The Company has not recorded these potential contingent consideration payments as liabilities in the accompanying condensed consolidated balance sheet as none of the future events which would trigger a milestone payment were considered probable of occurring at September 30, 2026.
Yale Agreements
In September 2013, the Company entered into an exclusive license agreement (the "Yale Agreement") with Yale University ("Yale") to obtain a license to certain patent rights for the commercial development, manufacture, distribution, use and sale of products and processes resulting from the development of those patent rights, related to the use of riluzole in treating various neurological conditions, such as general anxiety disorder, post-traumatic stress disorder and depression.
The Yale Agreement was amended and restated in May 2019. As of September 30, 2026, under the amended Yale Agreement, the Company had remaining contingent regulatory approval milestone payments of up to $2,000 and annual royalty payments of a low single-digit percentage based on net sales of riluzole-based products from the licensed patents or from products based on troriluzole. Under the amended and restated agreement, the royalty rates are reduced as compared to the original agreement. In addition, under the amended and restated agreement, the Company may develop products based on riluzole or troriluzole. The amended and restated agreement retains a minimum annual royalty of up to $1,000 per year, beginning after the first sale of product under the agreement. If the Company grants any sublicense rights under the Yale Agreement, it must pay Yale a low single-digit percentage of sublicense income that it receives.
For the three and nine months ended September 30, 2026 and 2025, the Company did not record any material milestone or royalty payments under the Yale Agreement.
In January 2021, the Company entered into a worldwide, exclusive license agreement with Yale for the development and commercialization of a novel MoDE platform (the "Yale MoDE Agreement"). The platform pertains to the clearance of disease-causing protein and other biomolecules by targeting them for lysosomal degradation using multi-functional
molecules. The Yale MoDE Agreement includes an obligation to pay a minimum annual royalty of up to $1,000 per year, and low single digit royalties on the net sales of licensed products. If the Company grants any sublicense rights under the Yale MoDE Agreement, it must pay Yale a low single-digit percentage of sublicense income that it receives. As of September 30, 2026, under the Yale MoDE Agreement, the Company had remaining contingent development and commercial milestone payments of up to $1,063 and $4,988, respectively. The Yale MoDE Agreement terminates on the later of twenty years from the effective date, twenty years from the filing date of the first investigational new drug application for a licensed product or the last to expire valid claim of a licensed patent.
During the second quarter of 2026, the Company recorded R&D expense of $250 for a development milestone which the Company determined to have become probable during the period under the Yale MoDE Agreement. The development milestone is expected to be paid during the fourth quarter of 2026. Excluding this $250 development milestone, for the three and nine months ended September 30, 2026 and 2025, the Company did not record any material milestone or royalty payments under the Yale MoDE Agreement.
ALS Biopharma Agreement
In August 2015, the Company entered into an agreement (the "ALS Biopharma Agreement") with ALS Biopharma and Fox Chase Chemical Diversity Center Inc. ("FCCDC"), pursuant to which ALS Biopharma and FCCDC assigned the Company their worldwide patent rights to a family of over 300 prodrugs of glutamate modulating agents, including troriluzole, as well as other innovative technologies. Under the ALS Biopharma Agreement, the Company is obligated to use commercially reasonable efforts to commercialize and develop markets for the patent products. As of September 30, 2026, under the ALS Biopharma Agreement, the Company had remaining contingent regulatory approval milestone payments of up to $4,000, as well as royalty payments of a low single-digit percentage based on net sales of products licensed under the ALS Biopharma Agreement, payable on a quarterly basis.
The ALS Biopharma Agreement terminates on a country-by-country basis as the last patent rights expire in each such country. If the Company abandons its development, research, licensing or sale of all products covered by one or more claims of any patent or patent application assigned under the ALS Biopharma Agreement, or if the Company ceases operations, it has agreed to reassign the applicable patent rights back to ALS Biopharma.
For the three and nine months ended September 30, 2026 and 2025, the Company did not record any material milestone or royalty payments under the ALS Biopharma Agreement.
Taldefgrobep Alfa License Agreement
In February 2022, following the transfer of intellectual property, the Company announced that it entered into a worldwide license agreement with Bristol Myers Squibb ("BMS") for the development and commercialization rights to taldefgrobep alfa (also known as BMS-986089), a novel, Phase 3-ready anti-myostatin adnectin (the "Taldefgrobep Alfa License Agreement").
As of September 30, 2026, under the Taldefgrobep Alfa License Agreement, the Company had remaining contingent regulatory approval milestone payments of up to $200,000, as well as tiered, sales-based royalty percentages from the high teens to the low twenties. There were no upfront or contingent payments to BMS related to the Taldefgrobep Alfa License Agreement.
For the three and nine months ended September 30, 2026 and 2025, the Company did not record any material milestone or royalty payments under the Taldefgrobep Alfa License Agreement.
Agreement with Hangzhou Highlightll Pharmaceutical Co. Ltd.
In March 2023, the Company and Hangzhou Highlightll Pharmaceutical Co. Ltd. ("Highlightll") entered into an exclusive, worldwide (excluding People’s Republic of China and its territories and possessions) license agreement (the "Highlightll Agreement") pursuant to which Biohaven obtained the right to research, develop, manufacture and commercialize Highlightll’s brain penetrant dual Tyrosine Kinase 2/Janus Kinase 1 ("TYK2/JAK1") inhibitor program.
As of September 30, 2026, under the Highlightll Agreement, the Company had remaining contingent development, regulatory approval, and commercial milestone payments of up to $60,000, $37,500, and $837,500, respectively. Additionally, the Company has agreed to make tiered royalty payments as a percentage of net sales starting at mid-single
digits and peaking at low teens digits. During the royalty term, if the Company offers to include China clinical sites in its Phase 3 study sufficient for submission to Chinese National Medical Products Administration and Highlightll, at its sole discretion, agrees, then Highlightll will pay royalties in the low tens digits to the Company on China sales upon approval.
The Highlightll Agreement terminates on a country-by-country basis upon expiration of the royalty term and can also be terminated if certain events occur, such as material breach or insolvency.
In July 2025, the Highlightll Agreement was amended to permit the Company to conduct clinical trials for BHV-8000 in China and its territories and possessions (the "Highlightll Territory") and seek marketing authorization in the Highlightll Territory. Any marketing authorizations obtained by the Company for BHV-8000 in the Highlightll Territory would be transferred to Highlightll for commercialization, and Highlightll would pay royalties to the Company as noted above. In addition, the amendment provides for a low single digit reduction in the royalties payable by the Company to Highlightll.
For the three and nine months ended September 30, 2026, the Company did not record any material milestone or royalty payments related to the Highlightll Agreement. During the second quarter of 2025, the Company recorded R&D expense of $15,000 for a development milestone which the Company determined to have become probable during the period. The developmental milestone was paid during the third quarter of 2025. Excluding this $15,000 development milestone, for the three and nine months ended September 30, 2025, the Company did not record any material milestone or royalty payments related to the Highlightll Agreement.
Other Agreements
In addition to the agreements detailed above, the Company has entered into various other license agreements and development programs. The Company records milestones and other payments, including funding for research arrangements, which become due under these agreements to research and development expense in the condensed consolidated statements of operations and comprehensive loss. Amounts recorded for the period were as follows:
Three Months Ended September 30,
Nine Months Ended September 30,
2026202520262025
Milestone payments
$— $— $— $10,000 
Upfront Payments - Cash*
— — — 5,000 
Upfront Payments - Issuance of Common Shares
$— $— $858 $4,884 
*The amount for the nine months ended September 30, 2025 included $1,250 recorded to research and development expense related to cash owed for upfront payments which were not yet paid as of September 30, 2025 and was recorded within accrued expenses and other current liabilities on the condensed consolidated balance sheet as of September 30, 2025.
Acquisitions
Kv7 Platform Acquisition
In April 2022, the Company closed the acquisition from Knopp of Channel Biosciences, LLC (“Channel”), a wholly owned subsidiary of Knopp owning the assets of Knopp’s Kv7 channel targeting platform (the “Kv7 Platform Acquisition”), pursuant to the Purchase Agreement.
Under the Purchase Agreement, the Company agreed to make success-based payments based on developmental and regulatory milestones through approvals in the United States, Europe, the Middle East and Asia ("EMEA") and Japan for the lead asset, opakalim (formerly known as KB-3061 and also referred to as BHV-7000), developmental and regulatory milestones for the Kv7 pipeline development in other indications and additional country approvals, and commercial sales-based milestones of opakalim. Additionally, the Company agreed to make scaled royalty payments in cash for opakalim and the pipeline programs, with percentages starting at high single digits and peaking at low teens for opakalim and starting at mid-single digits and peaking at low tens digits for the pipeline programs.
In May 2024, the Company entered into the Knopp Amendment under which the parties thereto agreed to replace the scaled high single digit to low teens royalty payment obligations with a flat royalty payment in the mid-single digits for opakalim and the pipeline programs. The parties also agreed to reduce the success-based payments payable under the
Purchase Agreement. The Company retains the ability to pay these contingent milestone payments in cash or in the Company's common shares at the Company's election, subject to the same increases if the Company elects to pay in the Company's common shares. As of September 30, 2026, under the Purchase Agreement, as amended, the Company had remaining success-based payments comprised of (i) up to $185,000 based on regulatory approvals in the United States and EMEA for opakalim and (ii) up to an additional $60,000 based on regulatory approval in the United States for the other Kv7 pipeline programs.
In consideration of the revisions to the success-based payment and royalty payment obligations, the Company agreed to issue to Knopp 1,872,874 Company common shares, valued at approximately $75,000, through a private placement within 60 days of the date of execution of the Knopp Amendment (the “2024 Additional Consideration”) and additional Company common shares with an approximate value of $75,000 within 60 days of the first anniversary of execution of the Knopp Amendment (the “2025 Additional Consideration”). On May 1, 2025, the total number of common shares to be issued for the 2025 Additional Consideration was determined to be 3,588,688. The Company also gave Knopp the option to request a one-time cash true-up payment from the Company in December 2024 in the event that Knopp continued to hold the Company's common shares representing the 2024 Additional Consideration and the value of such shares had declined (the "2024 Additional Consideration True-Up"), and a one-time cash true-up payment from the Company in December 2025 in the event that Knopp continued to hold the Company's common shares representing the 2025 Additional Consideration and the value of such shares had declined (the "2025 Additional Consideration True-Up"), in each case, subject to certain conditions.
The Company concluded that the agreement to issue the 2024 Additional Consideration at a future date represented a fixed forward contract under ASC 815, Derivatives and Hedging ("ASC 815"), and classified the commitment as a forward contract liability on its condensed consolidated balance sheet on the execution date of the Knopp Amendment. The Company initially measured the forward contract associated with the 2024 Additional Consideration at a fair value of $75,220, which was recorded as R&D expense during the three months ended June 30, 2024 in its condensed consolidated statements of operations and comprehensive loss. In May 2024, the Company issued the 2024 Additional Consideration at an approximate value of $65,981 and recognized a gain of $9,239 in other (expense) income, net in its condensed consolidated statement of operations and comprehensive loss. The gain on settlement of the 2024 Additional Consideration was due to the decline in fair value of the 2024 Additional Consideration from the execution date to the issuance date due to a decline in Biohaven's share price.
The Company concluded that the 2024 Additional Consideration True-Up represented a net cash settled written put option on the Company’s shares and was a freestanding derivative liability under ASC 815. Accordingly, the Company classified the 2024 Additional Consideration True-Up as a current derivative liability on its condensed consolidated balance sheet. The Company initially recorded the 2024 Additional Consideration True-Up at a fair value of $15,540, which was recorded as R&D expense during the three months ended June 30, 2024 in its condensed consolidated statements of operations and comprehensive loss. The Company subsequently remeasured the fair value of the derivative liability and recognized gains or losses through other (expense) income, net in its condensed consolidated statement of operations and comprehensive loss. The 2024 Additional Consideration True-Up was settled in December 2024, with no cash payment due upon expiration.
The Company concluded that the agreement to issue the 2025 Additional Consideration at a future date represented a forward contract settleable in a variable number of shares under ASC 480, Distinguishing Liabilities from Equity, and classified the commitment as a current forward contract liability on its condensed consolidated balance sheet. The Company initially measured the 2025 Additional Consideration at a fair value of $63,940, which was recorded as R&D expense during the three months ended June 30, 2024 in its condensed consolidated statement of operations and comprehensive loss. The Company subsequently remeasured the fair value of the forward contract liability and recognized gains or losses through other (expense) income, net in its condensed consolidated statement of operations and comprehensive loss. In June 2025, the Company issued the 2025 Additional Consideration at an approximate value of $51,426. The Company recognized a gain of $20,074 for the nine months ended September 30, 2025 related to the 2025 Additional Consideration. The gain on settlement of the 2025 Additional Consideration was due to the decline in fair value of the 2025 Additional Consideration from the one year anniversary of the execution date to the issuance date due to a decline in Biohaven's share price.
The Company concluded that the 2025 Additional Consideration True-Up represented a net cash settled written put option on the Company’s shares and was a freestanding derivative liability under ASC 815. Accordingly, the Company
classified the 2025 Additional Consideration True-Up as a non-current derivative liability on its condensed consolidated balance sheet. The Company initially recorded the 2025 Additional Consideration True-Up at a fair value of $13,810, which was recorded as R&D expense during the three months ended June 30, 2024. The Company subsequently remeasured the fair value of the derivative liability and recognized gains or losses through other (expense) income, net in its condensed consolidated statement of operations and comprehensive loss. The Company recognized gains of $3,960 and losses of $8,800 for the three and nine months ended September 30, 2025, respectively, related to the 2025 Additional Consideration True-Up. The 2025 Additional Consideration True-Up was settled in December 2025, and a cash payment of $42,710 was owed to Knopp as of December 31, 2025. The cash payment due to Knopp was recorded within accrued expenses and other current liabilities on the condensed consolidated balance sheet as of December 31, 2025 and was made to Knopp in the first quarter of 2026.
As further consideration for the revisions to the success-based payment and royalty payment obligations in the Knopp Amendment, the Company issued to Knopp a warrant (the “Warrant”) to purchase 294,195 Company common shares at a purchase price per share of $67.98, subject to certain specified development milestones and the Company achieving a specified market capitalization. The Warrant was recorded at its initial fair value of $3,340 within additional paid-in capital on the condensed consolidated balance sheet during the second quarter of 2024 and is not subject to remeasurement. In December 2025, Knopp elected to surrender the Warrant to the Company for cancellation.
The Company has not recorded any of the remaining contingent consideration payments to Knopp as a liability in the accompanying condensed consolidated balance sheet as none of the future events which would trigger a milestone payment were considered probable of occurring at September 30, 2026.
Pyramid Acquisition
In January 2024, the Company acquired Pyramid Biosciences, Inc. ("Pyramid"), pursuant to an Agreement and Plan of Merger, dated January 7, 2024 (the "Pyramid Agreement"). In consideration for the Pyramid acquisition, Biohaven made an upfront payment of 255,794 Company common shares, valued at approximately $10,894.
The Company accounted for this purchase as an asset acquisition as substantially all of the fair value of the gross assets acquired was concentrated in a single identifiable asset, In Process Research and Development ("IPR&D"). The IPR&D asset has no alternative future use and relates primarily to BHV-1510. There was no material value assigned to any other assets or liabilities acquired in the acquisition. As such, the upfront payment discussed above was recorded as a charge to R&D expense in the accompanying condensed consolidated statement of operations and comprehensive loss during the three months ended March 31, 2024.
As of September 30, 2026, under the Pyramid Agreement, the Company had remaining success-based payments comprised of (i) up to $5,000 based on developmental and regulatory milestones for the lead asset, BHV-1510 (formerly known as PBI-410), (ii) up to an additional $30,000 based on developmental and regulatory milestones for a second asset (formerly known as PBI-200) and (iii) up to $40,000 for commercial sales-based milestones of BHV-1510. Contingent developmental and regulatory milestone payments may be paid in cash or Company common shares at the election of the Company, and commercial sales-based milestones are to be made in cash.
The Company has not recorded any of the remaining contingent consideration payments as a liability in the accompanying condensed consolidated balance sheet as none of the future events which would trigger a milestone payment were considered probable of occurring at September 30, 2026.
For the three and nine months ended September 30, 2026 and 2025, the Company did not record any material milestone payments related to the Pyramid Agreement.