BHVN

Risk Factors" of this Form 10-K for further discussion on the covenants set forth in the Note Purchase Agreement.
Components of Our Results of Operations Revenue To date, we have not generated any revenue from product sales and we do not expect to generate any revenue from the sale of products in the near future.
If our development efforts for our product candidates are successful and result in regulatory approval or additional license agreements with third parties, then we may generate revenue in the future from product sales.
Operating Expenses Research and Development Expenses Research and development ("R&D") expenses consist primarily of costs incurred in connection with the development of our product candidates.
We expense research and development costs as incurred.
These expenses include: • expenses incurred under agreements with contract research organizations (“CROs”) or contract manufacturing organizations (“CMOs”), as well as investigative sites and consultants that conduct our clinical trials, preclinical studies and other scientific development services; • manufacturing scale-up expenses and the cost of acquiring and manufacturing preclinical and clinical trial materials and commercial materials, including manufacturing validation batches; • employee-related expenses, including salaries, benefits, travel and non-cash share-based compensation expense for employees engaged in research and development functions; • costs related to compliance with regulatory requirements; • development milestone payments incurred prior to regulatory approval of the product candidate; • rent and operating expenses incurred for leased lab facilities and equipment; and • payments made in cash, equity securities or other forms of consideration under third-party licensing or other agreements prior to regulatory approval of the product candidate.
We recognize external development costs based on an evaluation of the progress to completion of specific tasks using estimates from our clinical personnel and information provided to us by our service providers.
Our external direct research and development expenses are tracked on a program-by-program basis for our product candidates and consist primarily of external costs, such as fees paid to outside consultants, CROs, CMOs, and central laboratories in connection with our preclinical development, process development, manufacturing and clinical development activities.
Our direct research and development expenses by program also include fees and certain development milestones incurred under license agreements.
We do not allocate employee costs, or other indirect costs, to specific programs because these costs are deployed across multiple programs and, as such, are not separately classified.
We use internal resources primarily to oversee the research and development as well as for managing our preclinical development, process development, manufacturing and clinical development activities.
Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.
We expect that our research and development expenses will remain significant over the next several years as we increase personnel costs, conduct late-stage clinical trials, and prepare regulatory filings for our product candidates.
We also expect to incur additional expenses related to milestones payable to third parties with whom we have entered into license agreements to acquire the rights to our product candidates.
The successful development and commercialization of our product candidates is highly uncertain.
At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the preclinical and clinical development of any of our product candidates or when, if ever, material net cash inflows may commence from any of our product candidates.
This uncertainty is due to the numerous risks and uncertainties associated with product development and commercialization, including the uncertainty of: • the scope, progress, outcome and costs of our preclinical development activities, clinical trials and other research and development activities; • establishment of an appropriate safety profile with IND-enabling studies; • successful patient enrollment in, and the initiation and completion of, clinical trials; • the timing, receipt and terms of any marketing approvals from applicable regulatory authorities; • establishment of commercial manufacturing capabilities or making arrangements with third-party manufacturers; • development and timely delivery of commercial-grade drug formulations that can be used in our clinical trials and for commercial launch; • acquisition, maintenance, defense and enforcement of patent claims and other intellectual property rights; • significant and changing government regulation; • initiation of commercial sales of our product candidates, if and when approved, whether alone or in collaboration with others; and • maintenance of a continued acceptable safety profile of the product candidates following approval.
General and Administrative Expenses General and administrative ("G&A") expenses consist primarily of personnel costs, including salaries, benefits and travel expenses for our executive, finance, business, corporate development and other administrative functions; and non-cash share-based compensation expense.
General and administrative expenses also include facilities and other related expenses, including rent, depreciation, maintenance of facilities, insurance and supplies; and for public relations, audit, tax and legal services, including legal expenses to pursue patent protection of our intellectual property.
We anticipate that our general and administrative expenses, including payroll and related expenses, will remain significant in the future as we continue to support our research and development activities and prepare for potential commercialization of our product candidates, if successfully developed and approved.
We also anticipate increased expenses associated with general operations, including costs related to accounting and legal services, director and officer insurance premiums, facilities and other corporate infrastructure, and office-related costs, such as information technology costs, and certain costs to establish ourself as a standalone public company, as well as ongoing additional costs associated with operating as an independent, publicly traded company.
Other Income Other Income, Net Other income, net during the year ended December 31, 2025 primarily consists of changes in the fair value of our forward contract and derivative liabilities, net investment income, and the changes in fair value of our note payable liability under the Note Purchase Agreement.
Prior to settlement, the fair value of the forward contracts and derivative liabilities recognized in connection with the Knopp Amendment (as defined below) was determined using a Monte Carlo simulation of the Company's stock price over the respective duration and terms of each instrument being valued.
Refer to Note 4, "Fair Value of Financial Assets and Liabilities" to the accompanying consolidated financial statements included in this Form 10-K for detail on valuation inputs and methodology.
The fair value of these liabilities were recorded on the consolidated balance sheets with changes in fair value recorded in other income, net in the consolidated statements of operations.
Net investment income is comprised of interest income and net accretion and amortization on investments in addition to realized gains and losses.
Refer to Note 3, "Marketable Securities," for further discussion of our investments.
As permitted under ASC 825, "Financial Instruments," we elected the fair value option for our note payable liability under the Note Purchase Agreement.
Accordingly, the note payable was initially measured at issuance based on an estimated fair value and is subsequently remeasured on a recurring basis at each reporting period date.
Changes in fair value, other than those attributed to changes in instrument-specific credit risk, are recorded within other (expense) income, net on our consolidated statements of operations and comprehensive loss.
Refer to Note 4, "Fair Value of Financial Assets and Liabilities," to the accompanying consolidated financial statements included in this Form 10-K for detail on valuation inputs and methodology and Note 6, "Notes Payable," to the accompanying consolidated financial statements included in this Form 10-K for further discussion of the terms of the Note Purchase Agreement.
Other income, net during the year ended December 31, 2024 primarily consisted of changes in the fair value of our forward contract and derivative liabilities and net investment income.
Provision (Benefit) for Income Taxes As a company incorporated in the BVI, we are principally subject to taxation in the BVI.
Under the current laws of the BVI, the Company and all dividends, interest, rents, royalties, compensation and other amounts paid by the Company to persons who are not resident in the BVI and any capital gains realized with respect to any shares, debt obligations, or other securities of the Company by persons who are not resident in the BVI are exempt from all provisions of the Income Tax Ordinance in the BVI.
We have historically outsourced all of the research and clinical development for our programs under a master services agreement with our subsidiaries, Biohaven Pharmaceuticals, Inc.
("BPI") and Biohaven Biosciences Ireland Limited ("BBIL").
Under these arrangements, both companies were profitable during the years ended December 31, 2025, 2024, and 2023.BPI and BBIL are subject to taxation in the United States and Ireland, respectively.
As such, in each reporting period, the tax provision includes the effects of the results of profitable operations of BPI and BBIL.
At December 31, 2025 and 2024, we continued to maintain a full valuation allowance against our net deferred tax assets, comprised primarily of research and development tax credit carryforwards, and net operating loss carryforwards, based on management’s assessment that it is more likely than not that the deferred tax assets will not be realized.
Our income tax provision (benefit) primarily relates to the profitable operations of our subsidiaries in the United States and Ireland.

and 780 more.

Gone since FY2024

Risk Factors In connection with any investment decision with respect to our securities, you should carefully consider the risks described below, as well as general economic and business risks and the other information in this Annual Report on Form 10-K and in our other filings with the SEC.
The occurrence of any of the events or circumstances described below or other adverse events could have a material adverse effect on our business, results of operations and financial condition and could cause the trading price of our common shares to decline.
Additional risks or uncertainties not presently known to us or that we currently deem immaterial may also harm our business.
SUMMARY An investment in our common shares is subject to a number of risks, including risks related to our product candidates, risks related to our business and risks related to our common shares.
The following list of risk factors is not exhaustive.
Please read the information in this section captioned “1A.
Risk Factors” for a more thorough description of these and other risks.
Risks Related to Our Financial Position and Need for Additional Capital • We have a limited operating history, have incurred significant operating losses since inception and anticipate that we will continue to incur substantial operating losses for the foreseeable future. • Deterioration in general economic conditions in the United States and globally, including the effect of prolonged periods of inflation on our suppliers, third-party service providers and potential partners, may have a negative impact on our business and results of operations. • An inability to raise capital when needed or on terms favorable to us could force us to curtail our planned operations and growth strategy. • Credit risk with respect to our investments or the financial institutions at which we deposit funds could adversely affect us.
Risks Related to the Development of Our Product Candidates • We depend entirely on the success of a limited number of product candidates. • Clinical trials are very expensive, time consuming and difficult to design and implement, involve uncertain outcomes and may not be predictive of results of future trials. • Regulatory approval processes in the U.S. and foreign jurisdictions are lengthy, time consuming and unpredictable. • Our product candidates may fail to demonstrate safety and efficacy in clinical trials, or may cause serious adverse or unacceptable side effects. • We may become exposed to costly and damaging liability claims, which may not be covered by insurance.
Risks Related to Commercialization of Our Product Candidates • We have never commercialized a product candidate and may lack the necessary expertise, personnel and resources to successfully commercialize any product candidate that may receive regulatory approval. • We operate in a highly competitive and rapidly changing industry. • Failure to obtain or maintain adequate coverage and reimbursement for our approved product candidates could limit our ability to market those products and decrease our ability to generate revenue. • Our product candidates, if approved, will be subject to ongoing regulatory oversight. • Our approved product candidates may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
Risks Related to Our Dependence on Third Parties • We rely on third parties to conduct our preclinical studies and clinical trials and to supply, manufacture and distribute clinical drug supplies for our product candidates, which may expose our business to risks. • We may not establish or maintain collaborations with third parties to develop or commercialize product candidates.
Risks Related to Regulatory Compliance • Enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and may affect the prices we may set. • Our business operations and relationships with investigators, health care professionals, consultants, third-party payors and customers are subject to federal and state healthcare and other laws. • We may not obtain or maintain orphan drug designation or exclusivity for our product candidates. • Disruptions at the FDA and other government agencies could prevent new products from being developed or commercialized in a timely manner, or negatively impact the approval of an NDA, BLA or similar application.
Risks Related to Our Intellectual Property • We could lose market exclusivity earlier than expected. • If we were unable to obtain licenses from third parties on commercially reasonable terms or lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing our product candidates. • Patent terms may not provide exclusivity for our product candidates for an adequate amount of time to realize sufficient commercial benefits. • Third parties may seek to invalidate our patents. • Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a negative impact on the success of our business.
Risks Related to Our Business Operations, Employee Matters and Managing Growth • Our future growth and ability to compete depend on, among other things, retaining key personnel and recruiting additional qualified personnel and on our ability to penetrate foreign markets. • Laws and regulations governing our international operations may preclude us from developing, manufacturing and selling certain product candidates and products outside of the United States and require us to develop and implement costly compliance programs. • We may encounter difficulties in managing our growth, which could disrupt our operations. • Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs and vendors may engage in improper activities. • Our business and operations may be materially adversely affected in the event of computer system failures or security breaches.
Risks Related to Ownership of Our Common Shares • Substantially all of our total outstanding shares may be sold freely into the market.
This could cause the market price of our common shares to drop significantly, even if our business is doing well. • Because we do not expect to pay dividends on our common shares in the foreseeable future, capital appreciation, if any, would be your sole source of gain. • The trading price of our common shares has been and may continue to be volatile. • If we are or become a passive foreign investment company, there could be adverse U.S. federal income tax consequences to U.S. holders. • We are a British Virgin Islands ("BVI") business company limited by shares, and the rights of shareholders are more limited under BVI law than under U.S. law.
It may be difficult to enforce a U.S. or foreign judgment against us, our directors and our officers outside the United States.
Risks Related to Our Financial Position and Need for Additional Capital We have a limited operating history and have never generated any product revenues, which may make it difficult to evaluate the success of our business to date and to assess our future viability.
We were incorporated on May 2, 2022 as a direct, wholly-owned subsidiary of the Former Parent.
Our operations to date have been largely focused on organizing and staffing, raising capital and in-licensing the rights to, and advancing the development of, our product candidates, including conducting preclinical studies and clinical trials.
We have not yet demonstrated an ability to obtain marketing approvals for any product candidates, manufacture products on a commercial scale, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful commercialization.
Consequently, predictions about our future success or viability may not be as accurate as they could be if we had a longer operating history or a history of successfully developing and commercializing products.
We expect our financial condition and operating results to continue to fluctuate from quarter to quarter and year to year due to a variety of factors, many of which are beyond our control.
We will need to eventually transition from a company with a research and development focus to a company capable of undertaking commercial activities.
We may encounter unforeseen expenses, difficulties, complications and delays, and may not be successful in such a transition.
Deterioration in general economic conditions in the United States and globally, including the effect of prolonged periods of inflation on our suppliers, third-party service providers and potential partners, may have a negative impact on our business and results of operations.
Our business and results of operations could be adversely affected by changes in national or global economic conditions.
These conditions include, but are not limited to, volatility in inflation and interest rates, volatility in the capital markets, energy availability and costs, the negative impacts from pandemics and public health crises, negative impacts resulting from the military conflict between Russia and Ukraine, geopolitical and trade tensions between the U.S. and China or other geopolitical events, potential protectionist trade policies adopted by the U.S. and other governments, and the effects of governmental initiatives to manage economic conditions.
Impacts of such conditions could be passed on to our business in the form of higher costs for labor and materials, higher investigator fees, possible reductions in pharmaceutical industry-wide spending on research and development and acquisitions and higher costs of capital.
We have incurred significant operating losses since our inception as a business of the Former Parent and anticipate that we will continue to incur substantial operating losses for the foreseeable future and may never achieve or maintain profitability.
Since our inception as a business of the Former Parent, we have incurred significant operating losses.
Our net loss was $846.4 million, $408.2 million and $570.3 million for the years ended December 31, 2024, 2023 and 2022, respectively.
We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future.
None of our product candidates has been approved for marketing in the United States, or in any other jurisdiction, and may never receive such approval.
It could be several years, if ever, before we have a commercialized product that generates significant revenues.
As a result, we are uncertain when or if we will achieve profitability and, if so, whether we will be able to sustain it.
The net losses we incur have in the past and may in the future fluctuate significantly from quarter to quarter and year to year.
Our expenses have increased, and we anticipate that our expenses will further increase substantially as we: • initiate, continue, or complete planned or ongoing clinical trials of our current product candidates, including related support activities; • continue to initiate and progress other supporting studies required for regulatory approval of our product candidates, including long-term safety studies, drug-drug interaction studies, preclinical toxicology and carcinogenicity studies; • make required milestone and royalty payments under the license agreements by which we acquired some of the rights to our product candidates; • initiate preclinical studies and clinical trials for any additional indications for our current product candidates and any future product candidates that we may pursue; • continue to build our portfolio of product candidates through the acquisition or in-license of additional product candidates or technologies; • continue to develop, maintain, expand and protect our intellectual property portfolio; • pursue regulatory approvals for our current and future product candidates that successfully complete clinical trials; • ultimately establish a sales, marketing and distribution infrastructure to commercialize any product candidate for which we may obtain marketing approval; • hire additional clinical, medical, commercial, and development personnel; and • incur additional legal, accounting and other expenses in operating as a public company.
To become and remain profitable, we must develop and eventually commercialize one or more product candidates with significant market potential.
This will require us to be successful in a range of challenging activities, including completing clinical trials of our product candidates, developing commercial scale manufacturing processes, obtaining marketing approval, manufacturing, marketing and selling any current and future product candidates for which we may obtain marketing approval, and satisfying any post-marketing requirements.

and 752 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

Watch BHVN. Know when insiders buy.

One email the day a filing lands. Free.