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Biohaven Ltd.

For the period ended Sep 30, 2026. Filed Oct 29, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2026 · Filed Oct 29, 2026

BHVN$14.48+4.2%Stored close · as of Nov 6, 2026

What changed in Risk Factors?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-10.

0001935979-26-000066

Item 1A. Risk FactorsUnregistered Sales of Equity Securities Use of Proceeds

Current report: 10-Q

Period ended 2026-09-30; filed 2026-10-29.

0001935979-26-000092

Item 1A. Risk FactorsUnregistered Sales of Equity Securities, Use of Proceeds

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 4 previous paragraphs and 25 current paragraphs.

3 unchanged; 1 reworded; 21 added; 0 removed; 0 previous and 0 current paragraphs rearranged.

Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (21)

Current report

Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our intellectual property or future revenue streams.

Current report

Until we can generate substantial product revenue, if ever, we expect to finance our operations through a combination of equity offerings, debt financings and license and development agreements in connection with any future collaborations. Other than amounts that may become payable to us under the SKBP License Agreement following the Closing (each as defined below) and amounts that may become payable to us under the Ono License Agreement (as defined below), we do not have any committed external source of funds. In the event we seek additional funds, we may raise additional capital through the sale of equity securities, including through our "at-the-market" equity program, or convertible debt securities. In such an event, our existing shareholders may experience substantial dilution, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of the holders of our common shares. Debt financing, if available, could result in increased fixed payment obligations and may involve agreements that include restrictive covenants, such as limitations on our ability to incur additional debt, make capital expenditures, acquire, sell or license intellectual property rights or declare dividends, and other operating restrictions that could hurt our ability to conduct our business.

Current report

Further, if we raise additional capital through collaborations, strategic alliances, or marketing, distribution, licensing or funding arrangements with third parties, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or product candidates, or grant licenses on terms that may not be favorable to us.

Current report

We have entered into, and may in the future enter into, additional collaborations or out-license agreements with third parties to develop and commercialize our product candidates. If these collaborations or out-license agreements are not successful, or if we are not able to establish or maintain these collaborations or out-license agreements on commercially reasonable terms, our business could be harmed.

Current report

In October 2026, Biohaven Pharmaceuticals, Inc. ("BPI"), a wholly-owned subsidiary of the Company entered into a Collaboration and License Agreement (the “Ono License Agreement”) with Ono Pharmaceutical Co., Ltd. ("Ono") under which Ono will obtain an exclusive license to develop and commercialize our 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 ("ASEAN").

Current report

Our product development programs and the potential commercialization of our product candidates will require substantial additional capital to fund expenses. For some of our product candidates, we have decided and may in the future decide to collaborate with pharmaceutical and biotechnology companies for the future development and potential commercialization of those product candidates. We also may choose to out-license product candidates at any time. Furthermore, we may find that our programs require the use of proprietary rights held by third parties, and the growth of our business may depend in part on our ability to acquire, in-license or use these proprietary rights. Collaboration arrangements and licenses are complex and time-consuming to negotiate, document, implement and maintain. We may not be successful in our efforts to establish and implement collaborations, licenses or other alternative arrangements, and the terms of any collaborations, licenses or other arrangements that we may establish may not be favorable to us.

Current report

We face significant competition in seeking appropriate collaborators, and a number of more established companies may also be pursuing strategies to license or acquire third-party intellectual property rights that we may consider attractive. These established companies may have a competitive advantage over us due to their size, financial resources and greater clinical development and commercialization capabilities. In addition, companies that perceive us to be a competitor may be unwilling to assign or license rights to us. Whether we reach a definitive agreement for a collaboration or license will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration or license and the proposed collaborator’s evaluation of a number of factors. Those factors may include the design or results of clinical trials, the likelihood of approval by regulatory authorities, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, competing or alternative products, the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge, and industry and market conditions generally. The collaborator or licensee may also have the opportunity to collaborate on other product candidates or technologies for similar indications and will have to evaluate whether such a collaboration could be more attractive than one with us. We may also be restricted under existing license agreements from entering into agreements on certain terms with potential collaborators. Even if we are able to obtain a license to intellectual property of interest, we may not be able to secure exclusive rights, in which case others could use the same rights and compete with us.

Current report

The success of our collaboration arrangements or licenses will depend heavily on the efforts and activities of our collaborators. Collaborations and licenses are subject to numerous risks, including, for example, that the collaborators may not: adequately perform their obligations under the collaboration agreement; devote sufficient resources to the collaboration to ensure success; or agree with us on the strategy or tactical aspects of the collaboration.

Current report

If any such potential future collaborations do not result in the successful development and commercialization of product candidates, or if one of our future collaborators terminates its agreement with us, we may not receive any future research funding or milestone or royalty payments under the collaboration or license agreement. For example, the SKBP License Agreement contemplates up to $150.0 million in one-time development and regulatory milestone payments, and the Ono License Agreement contemplates a $20.0 million milestone achievement payment, which is payable if Ono provides notice that it will continue with the development and commercialization of the licensed compounds. If we do not receive the funding we expect under these agreements, the development of our product candidates could be delayed, and we may need additional resources to develop our product candidates. In addition, if one of our future collaborators terminates its agreement with us, we may find it more difficult to attract new collaborators, and the perception of us in the business and financial communities could be adversely affected. All of the risks relating to product development, regulatory approval and commercialization apply to the activities of our potential future collaborators.

Current report

In August 2026, Biohaven Bioscience Ireland Limited (“BBIL”), a wholly owned subsidiary of 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”), BBIL 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 Biohaven’s 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 (“HSR”) waiting period for the SKBP License Agreement expired on October 28, 2026, next allowing for completion of remaining closing conditions. If the Closing occurs, the risks described in this risk factor, including risks that SKBP may not devote sufficient resources to, or may disagree with us regarding, the development and commercialization of the licensed product candidates, or may terminate its agreement with us, will apply to our relationship with SKBP.

Current report

If our collaboration with SKBP is not successful, we may not realize the upfront, milestone and royalty payments we expect under the SKBP License Agreement for our Kv7 platform, including opakalim.

Current report

In August 2026, BBIL entered into the SKBP License Agreement. Pursuant to the SKBP License Agreement, effective upon the Closing, BBIL will grant SKBP an exclusive, royalty-bearing, worldwide license to our Kv7 ion channel platform, including opakalim. Our control over the amount and timing of resources that SKBP dedicates to the development and commercialization of the licensed products is limited, and our ability to receive the $400.0 million upfront payment, up to $150.0 million in development and regulatory milestone payments and royalties will depend on SKBP's performance. SKBP may terminate the SKBP License Agreement, which it may do in whole or in part for convenience upon specified prior written notice, in which case we may not receive any of the payments contemplated by the SKBP License Agreement after termination and our contingent obligations to Knopp under the MIPA would revert to us. We will also continue to conduct the ongoing RISE 2 and RISE 3 studies and NDA preparation subject to approved budgets and would be subject to restrictions on our Kv7 activities. In addition, many of the risks relating to collaborations and out-licenses described above under the caption “We have entered into, and may in the future enter into, additional collaborations or out-license agreements with third parties to develop and commercialize our product candidates. If these collaborations or out-license agreements are not successful, or if we are not able to establish or maintain these collaborations or out-license agreements on commercially reasonable terms, our business could be harmed” would also apply to this collaboration with SKBP.

Current report

Risks Related to Our Intellectual Property

Current report

We are dependent on licensed intellectual property in our business. If we are unable to obtain licenses from third parties on commercially reasonable terms or lose our rights to such licensed intellectual property, or if our rights are determined to be narrower than we understand them to be, we may not be able to continue developing or commercializing our product candidates.

Current report

We are a party to a number of license agreements under which we are granted or grant rights to intellectual property that are important to our business, including, for example, an agreement with ALS Biopharma and Fox Chase Chemical Diversity Center, Inc., pursuant to which we were assigned intellectual property rights relating to troriluzole; a license agreement with Yale, pursuant to which we were granted certain patent rights to develop and commercialize riluzole-based products; another license agreement with Yale pursuant to which we acquired exclusive, worldwide rights to Yale's intellectual property directed to its MoDE platform; a license agreement with Highlightll, pursuant to which we were granted exclusive rights to develop and commercialize Highlightll’s brain penetrant dual TYK2/JAK1 inhibitor program; a license agreement with Bristol Myers Squibb, pursuant to which we were granted exclusive rights to develop and commercialize taldefgrobep alfa; a license agreement with KU Leuven, pursuant to which we were granted an exclusive license to develop and commercialize the TRPM3 antagonist platform; a license agreement with GeneQuantum pursuant to which we acquired exclusive worldwide rights, excluding China, to develop and commercialize BHV-1510; a license agreement with GeneQuantum and Aimed pursuant to which we acquired exclusive worldwide rights to develop and commercialize BHV-1530; and the Ono License Agreement, pursuant to which we granted Ono an exclusive license to develop and commercialize our MoDE™ pan IgG degrader portfolio in Japan, South Korea, Taiwan, and the countries of the Association of Southeast Asian Nations ("ASEAN"). We may enter into additional license agreements in the future. Our existing license agreements impose, and we expect that future license agreements will impose on us, various development, regulatory and/or commercial diligence obligations, payment of milestones and/or royalties and other obligations, such as non-compete periods for certain collaboration targets and rights of first negotiation for development of certain programs. Typically, in our licenses, we have control over the filing, prosecution, maintenance and enforcement of the licensed intellectual property in the countries where we are responsible for the development and commercialization. However, in some cases such as when we license our technology to others, we do not control prosecution of the licensed intellectual property, or do not have the first right to enforce such intellectual property. In those cases, we may not be able to adequately influence patent prosecution or enforcement, or prevent inadvertent lapses of coverage due to failure to pay maintenance fees.

Current report

If we fail to comply with any of our obligations under a current or future license agreement, the licensor or licensee may allege that we have breached our license agreement, and may seek to terminate our license. Termination of any of our current or future licenses could result in our loss of the right to use the licensed intellectual property, which could materially adversely affect our ability to develop, manufacture or commercialize a product candidate or product, if approved, as well as harm our competitive business position and our business prospects. Under some license agreements, termination may also result in the transfer of or granting of rights under certain of our intellectual property and information related to the product candidate being developed under the license, such as regulatory information. If our licensors fail to comply with their obligations under these agreements, such as, for example, by failing to maintain or enforce patents licensed to us, exclusivity relating to the products covered by the license may be diminished or lost. Our rights under license agreements could be determined to be narrower than we understand them to be. Also, if it is found that our licensors were not the original inventors of the licensed intellectual property, or were not the first to file patent applications, then we may lose rights to the licensed intellectual property.

Current report

Licensing of intellectual property is important to our business and involves complex legal, business and scientific issues. Disputes between us and our licensors or licensees have arisen and may arise in the future. For example, disputes may arise between us and our licensors regarding intellectual property subject to a license agreement, including:

Current report

•the scope of rights granted under the license agreement and other interpretation-related issues, including our right to sublicense patents and other rights to third parties;

Current report

•the effects of termination.

Current report

If disputes over intellectual property that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop, manufacture or commercialize the affected product candidates.

Current report

It may be necessary or desirable for us to use the patented or proprietary technology of third parties to commercialize our products, in which case we would seek to obtain a license from these third parties. If we are unable to license such technology, or if we are forced to license such technology on unfavorable terms, our business could be harmed. If we are unable to obtain a necessary license, we may be unable to develop or commercialize the affected product candidates, which could materially harm our business and the third parties owning such intellectual property rights could seek either an injunction prohibiting our sales or payment of royalties and/or other forms of compensation. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us.
Reworded paragraphs (1)

Previous wording

Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. Our risk factors have not changed materially from those described in "Part I, Item 1A. Risk Factors" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on March 2, 2026.

Current wording

Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. Except for the updated risk factors set forth immediately below, our risk factors have not changed materially from those described in "Part I, Item 1A. Risk Factors" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on March 2, 2026.