v3.26.1
Significant Accounting Policies and Concentrations of Risk (Policies)
6 Months Ended
Jun. 30, 2026
Accounting Policies [Abstract]  
The Company
The Company
BioCryst Pharmaceuticals, Inc. (the “Company”) is a global biotechnology company focused on developing and commercializing medicines for hereditary angioedema (“HAE”) and other rare diseases, driven by the Company’s deep commitment to improving the lives of people living with these conditions. The Company has built an established commercial infrastructure supporting ORLADEYO®, an oral, once-daily therapy discovered and developed internally for the prevention of HAE attacks, and is advancing a pipeline of potential first-in-class or best-in-class oral small-molecule and injectable protein therapeutics for a range of rare diseases. The Company was founded in 1986 and incorporated in Delaware in 1991, and its headquarters is located in Durham, North Carolina.
The Company’s marketed products include ORLADEYO® for the prevention of HAE attacks and RAPIVAB® (peramivir injection) for the treatment of acute uncomplicated influenza in the United States. ORLADEYO has received regulatory approval in the United States and other global markets. The Company is commercializing ORLADEYO in each of these territories directly or through other parties. In addition to its approval in the United States, peramivir injection has received regulatory approvals in Canada (RAPIVAB), Australia (RAPIVAB), Japan (RAPIACTA), Taiwan (RAPIACTA) and Korea (PERAMIFLU).
Based on the Company’s expectations for revenue and operating expenses, the Company believes its financial resources available at June 30, 2026 will be sufficient to fund its operations for at least the next 12 months. The Company may, in the future, issue securities, including common stock, preferred stock, depositary shares, purchase contracts, warrants, debt securities and units, through private placement transactions or registered public offerings. The Company’s future liquidity needs, and ability to address those needs, will largely be determined by the success of its products and product candidates; the success of its business development efforts; the timing, scope and magnitude of its research and development and commercial expenses; and key regulatory and operational developments.
Basis of Presentation
Basis of Presentation
The Company’s unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial reporting and the instructions to Form 10-Q and do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. Such financial statements reflect all adjustments that are, in management’s opinion, necessary to present fairly, in all material respects, the Company’s condensed consolidated financial position, results of operations, and cash flows. There were no adjustments other than normal recurring adjustments. Certain prior year amounts have been reclassified to conform to the current year presentation.
The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, including Astria Therapeutics Inc., which was acquired by the Company on January 23, 2026 (See “Note 2—Acquisition of Astria Therapeutics, Inc.”). All intercompany transactions and balances among the consolidated entities have been eliminated from the condensed consolidated financial statements. The Company operates and manages its business as one reportable and operating segment (see “Note 14—Segment Information”).
These condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the fiscal year ended December 31, 2025 and the notes thereto included in the Company’s 2025 Annual Report on Form 10-K as filed with the Securities and Exchange Commission (the “SEC”) on February 26, 2026. Interim operating results are not necessarily indicative of operating results for the full fiscal year. The condensed consolidated balance sheet as of December 31, 2025 was derived from the audited consolidated financial statements included in the Company’s most recent Annual Report on Form 10-K.
Sale of European ORLADEYO Business
On June 27, 2025, the Company entered into a stock purchase agreement (the “Stock Purchase Agreement”) with BioCryst Ireland Limited (“BioCryst Ireland”) and Neopharmed Gentili S.p.A., (“Neopharmed”). On October 1, 2025, the Company sold to Neopharmed all of its equity interests in BioCryst Ireland, which, together with its subsidiaries, holds certain assets, rights, and employees related to the European ORLADEYO business. The Company and BioCryst Ireland also amended and restated their existing intellectual property licence agreement, pursuant to which the Company is entitled to receive quarterly royalty payments from BioCryst Ireland equal to amounts owed under its Royalty Purchase Agreements with RPI and OMERS for the sale of ORLADEYO products in the Territory, as defined in the Stock Purchase Agreement (See “Note 7—Royalty Financing Obligations”). The condensed consolidated financial statements for the three and six months ended June 30, 2025 include the accounts of BioCryst Ireland, which was a wholly owned subsidiary of the Company prior to October 1, 2025. As of June 30, 2025, the assets and liabilities of BioCryst Ireland were classified as a disposal group held for sale in the Company’s condensed consolidated balance sheet.
Use of Estimates
Use of Estimates
The preparation of the condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. Actual results could differ from those estimates.
Revenue Recognition
Revenue Recognition
Pursuant to Accounting Standards Codification (“ASC”) Topic 606, Revenue from Contracts with Customers (“Topic 606”), the Company recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve this core principle, Topic 606 includes provisions within a five-step model that includes (i) identifying the contract with a customer, (ii) identifying the performance obligations in the contract, (iii) determining the transaction price, (iv) allocating the transaction price to the performance obligations, and (v) recognizing revenue when, or as, an entity satisfies a performance obligation.
At contract inception, the Company identifies the goods or services promised within each contract, assesses whether each promised good or service is distinct and determines those that are performance obligations. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when, or as, the performance obligation is satisfied.
Product Sales, Net
The Company’s sources of product sales are sales of ORLADEYO and peramivir (RAPIVAB/RAPIACTA/PERAMIFLU). The Company generally ships ORLADEYO directly to patients through a single specialty pharmacy in the United States and through specialty distributors outside of the United States, which are considered its customers. The Company generally sells peramivir to its licensing partners, hospitals, and, in 2025, to the U.S. Department of Health and Human Services.
The Company recognizes revenue when the customer obtains control of the product, which generally occurs upon delivery.
Net revenue from sales of ORLADEYO is recorded at net selling price (transaction price), which includes reserves for variable consideration such as (i) estimated government rebates, including Medicaid and Medicare Part D reimbursements, and estimated managed care rebates, (ii) estimated chargebacks, (iii) estimated costs of co-payment assistance programs and (iv) product returns. These reserves, representing the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contracts and statutory requirements, are based on the amounts earned or to be claimed on the related sales and are classified as reductions of trade receivables if no payments are required of the Company or a current liability if a payment is required of the Company. Actual amounts of consideration may differ from the Company’s estimates. Any differences are recognized as adjustments to net product revenue and earnings in the period such variances become known.
Government and Managed Care Rebates. The Company contracts with group purchasing organizations associated with managed care organizations and participates in certain government programs, collectively, third-party payors, so that ORLADEYO will be eligible for purchase by, or partial or full reimbursement from, such third-party payors. The Company estimates the rebates it will provide to third-party payors and deducts these estimated amounts from total gross product revenues at the time the revenues are recognized, resulting in a reduction of product revenue and the establishment of a current liability. The Company estimates the rebates that it will provide to third-party payors based upon (i) the Company’s
contracts with these third-party payors, (ii) the contractually mandated discounts applicable to the programs, and (iii) product distribution information obtained from the Company’s specialty pharmacy regarding payor mix.
Chargebacks. Chargebacks are discounts that occur when certain contracted customers, pharmacy benefit managers, insurance companies, and government programs purchase directly from the Company’s specialty pharmacy. These customers purchase the Company’s product under contracts negotiated between them and the Company’s specialty pharmacy. The specialty pharmacy, in turn, charges back to the Company the difference between the price that the specialty pharmacy paid and the negotiated price paid by the contracted customers, which may be higher or lower than the specialty pharmacy’s purchase price with the Company. The Company estimates chargebacks and adjusts gross product revenues and establishes a current liability at the time revenues are recognized.
Co-payment assistance programs. Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. Based upon the terms of the program and co-payment assistance utilization reports received from the specialty pharmacy, the Company estimates the co-payment assistance amounts, which are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue and establishment of a current liability.
Patient assistance programs. The Company offers a patient assistance program that provides free drug product, for a limited period of time, to allow a patient’s insurance coverage to be established. Based on patient assistance program utilization reports provided by the specialty pharmacy, the Company records gross revenue of the product provided and a full reduction of the revenue amount for the free drug discount.
Product returns. The Company does not provide contractual return rights to its customers, except in instances where the product is damaged or defective. Non-acceptance by the patient of shipped drug product by the specialty pharmacy is reflected as a reversal of sales in the period in which the sales were originally recorded. Reserves for estimated non-acceptances by patients are recorded as a reduction of revenue in the period that the related revenue is recognized, as well as a reduction to accounts receivable. Estimates of non-acceptance are based on quantitative information provided by the specialty pharmacy.
License and Collaborative and Other Revenues
The Company has collaboration and license agreements with a number of third parties. The terms of the agreements typically include one or more of the following: upfront license fees; development, regulatory and sales-based milestone payments; and royalties on net sales of licensed products. For agreements with multiple performance obligations, revenue is allocated to each performance obligation based on its relative standalone selling price. The Company uses judgment to identify performance obligations and determine whether variable consideration should be included in the transaction price.
Upfront license fees. Arrangements that include upfront payments may require deferral of revenue recognition to a future period until obligations under such arrangements are fulfilled. If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from upfront license fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For agreements with multiple performance obligations, the Company develops assumptions that require judgment to determine the standalone selling price for each performance obligation, the determination of the transaction price, and the application of the constraints. The Company re-evaluates the transaction price at each reporting period and adjusts the estimate as changes in circumstances occur. The Company determines whether the performance obligations are satisfied over time or at a point in time and, if over time, determines the appropriate method of measuring progress for purposes of recognizing revenue.
Development, regulatory or commercial milestone payments. At the inception of each arrangement that includes payments based on the achievement of certain development, regulatory and commercial events, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the Company’s or the customer’s control are not considered probable until the milestone is achieved. Each subsequent reporting period, the Company re-evaluates the probability of achieving such development and regulatory milestones and any related constraint, and if necessary, adjusts the Company’s estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis and recognized as revenue during the period of adjustment.
Sales-based milestone payments and royalties. For arrangements that include sales-based royalties, including milestone payments based on the volume of sales, the Company determines whether the license is deemed to be the predominant item to which the royalties or sales-based milestones relate and if such is the case, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
Cash and Cash Equivalents
Cash and Cash Equivalents
The Company considers cash equivalents to be highly liquid investments with maturities of three months or less from the date of purchase.
Restricted Cash
Restricted Cash
Total restricted cash was $1,412 and $1,601 as of June 30, 2026 and December 31, 2025, respectively, and primarily consisted of $933 and $1,400 as of June 30, 2026 and December 31, 2025, respectively, for a letter of credit the Company is required to maintain associated with its Birmingham lease. The long-term portion of the letter of credit associated with the Birmingham lease of $933 and $1,400 as of June 30, 2026 and December 31, 2025, respectively, is reflected within other assets in the Condensed Consolidated Balance Sheets.
Investments
Investments
The Company invests in high credit quality investments in accordance with its investment policy. The objectives of the Company’s investment policy are to eliminate or greatly minimize the probability of a loss of principal value, maintain sufficient liquidity to meet cash flow requirements, and earn a competitive level of return. The Company places its excess cash with high credit quality financial institutions to limit the amount of its credit exposure. In accordance with its policy, the Company is able to invest in marketable debt securities that may consist of U.S. Treasury obligations, U.S government agency securities, money market funds, certificates of deposits and corporate notes and bonds. The Company’s investment policy requires it to purchase high-quality marketable securities with a maximum individual maturity of two years and requires an average portfolio maturity of no more than 12 months. Some of the securities in which the Company invests may have market risk. This means that a change in prevailing interest rates may cause the principal amount of the investment to fluctuate. To minimize this risk, the Company schedules its investments with maturities that coincide with expected cash flow needs, thus avoiding the need to redeem an investment prior to its maturity date. Accordingly, the Company does not believe it has a material exposure to interest rate risk arising from its investments. The Company has not realized any significant losses from its investments.
The Company classifies all of its investments as available-for-sale, which are reported at fair value at each condensed consolidated balance sheet date. The Company evaluates its securities in an unrealized loss position at the end of each reporting period to determine whether a credit loss exists. Credit-related impairments are recognized through an allowance for credit losses on the condensed consolidated balance sheet with a corresponding charge to earnings. Unrealized losses not attributable to credit-related factors and unrealized gains are recognized in accumulated other comprehensive (loss) income, net of applicable taxes.
Realized gains and losses are reflected in other expense, net in the Condensed Consolidated Statements of Comprehensive Income (Loss) and are determined using the specific identification method with transactions recorded on a settlement date basis. Investments with original maturities at date of purchase beyond three months and which mature at or less than 12 months from the condensed consolidated balance sheet date are classified as current. Investments with a maturity beyond 12 months from the condensed consolidated balance sheet date are classified as long-term.
Fair Value Measurements
Fair Value Measurements
Assets and liabilities recorded at fair value on a recurring basis in the Condensed Consolidated Balance Sheets are categorized based upon the level of judgment associated with the inputs used to measure their fair values. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.
Assets measured at fair value on a recurring basis include cash equivalents and investments (See “Note 4—Fair Value Measurements and Investments”). The carrying amounts reflected in the Condensed Consolidated Balance Sheets for
cash, trade receivables, prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair values due to the short-term nature of these assets and liabilities.
Trade Receivables
Trade Receivables
The Company’s trade receivables represent amounts due from its customers and partners for product sales and from its license and collaboration agreements. Trade receivables are generally stated at the invoiced amount with standard payment terms that require payment within 30 to 90 days and do not bear interest.
The Company provides reserves against trade receivables for estimated losses that may result from a customer’s inability to pay. Trade receivables are evaluated to determine if any allowance should be recorded based on consideration of the current economic environment, expectations of future economic conditions, specific circumstances and the Company’s own historical collection experience. Amounts determined to be uncollectible are charged or written-off against the allowance.
Inventory
Inventory
The Company values its inventory at the lower of cost or estimated net realizable value and classifies inventory as short-term or long-term based on whether it is expected to be consumed or sold within 12 months of the condensed consolidated balance sheet date. The Company uses an actual cost method and determines the cost of its inventory on a first-in, first-out basis. Raw materials and work-in-process include all inventory costs prior to packaging and labeling, including raw material, active product ingredient, and the drug product. Finished goods include packaged and labeled products.
The Company’s inventory is subject to expiration dating. At each condensed consolidated balance sheet date, the Company evaluates inventory for excess, obsolete, short-dated, unmarketable, or otherwise impaired items and records valuation reserves as necessary. Inventory is also subject to strict quality control and monitoring that is performed throughout the manufacturing process, including release of work-in-process to finished goods. If certain batches or units of product do not meet quality specifications, the Company records a write-down of any potential unmarketable inventory to its estimated net realizable value with the resulting charge recorded as cost of product in the Condensed Consolidated Statements of Comprehensive Income (Loss).
Prior to obtaining initial regulatory approval for an investigational product candidate, the Company expenses costs relating to production of pre-launch inventory as research and development expense in its Condensed Consolidated Statements of Comprehensive Income (Loss) in the period incurred. After regulatory approval has been received, the Company capitalizes inventory costs.
Property and Equipment
Property and Equipment
Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. Computer equipment and office equipment are depreciated over a life of three years. Laboratory equipment, software, and furniture and fixtures are depreciated over a life of five years. Leasehold improvements are amortized over their estimated useful lives or the expected lease term, whichever is less. Construction in progress reflects amounts incurred for construction or improvements of property and equipment that have not been placed in service.
The Company periodically reviews its property and equipment for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down to their estimated fair values. Property and equipment to be disposed of are reported at the lower of carrying amount or fair value less cost to sell.
Accrued Expenses
Accrued Expenses
The Company enters into contractual agreements with third-party vendors who provide research and development, manufacturing, distribution, and other services in the ordinary course of business. Some of these contracts are subject to milestone-based invoicing and involve services completed over extended periods. The Company records liabilities under these contractual commitments when obligations are incurred, regardless of the invoice timing. Accrued expenses are estimated as of each condensed consolidated balance sheet date based on the facts and circumstances known at that time,
which may include assumptions such as expected patient enrollment, site activation and estimated project duration. The Company accrues expenses for clinical trial activities based on the estimates of services received pursuant to contracts with multiple research institutions and clinical research organizations (“CROs”) that conduct and manage clinical trials on the Company’s behalf.
The Company periodically confirms the accuracy of its estimates with the service providers and adjusts if necessary. Examples of estimated accrued expenses include (i) fees paid to CROs in connection with preclinical and toxicology studies and clinical trials; (ii) fees paid to investigative sites in connection with clinical trials; (iii) fees paid to contract manufacturers in connection with the production of the Company’s raw materials, drug substance, drug products, and product candidates; and (iv) professional fees. If the Company underestimates or overestimates the level of these costs, actual expenses could differ from such estimates.
Cost of Product Sales
Cost of Product Sales
Cost of product sales includes the cost of inventory recognized as expense in connection with product revenue during the respective period, including costs associated with the acquisition and manufacture of inventory. Cost of product sales also includes inventory write-downs and excess or obsolete inventory charges, as well as other costs directly associated with the production of the Company’s commercial products.
Research and Development Expenses
Research and Development Expenses
Research and development expenses include all direct and indirect expenses relating to research and development activities, including costs associated with product development efforts, preclinical trials, clinical trials and manufacturing activities. Research and development expenses are expensed as incurred. Most of the Company’s clinical and preclinical studies are performed by third-party CROs. Costs for studies performed by CROs are accrued based upon estimates of the actual work completed in accordance with the third-party agreements. Advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are expensed when the related goods are delivered or the related services are performed.
Direct expenses consist of compensation for research and development personnel and costs of outside parties to conduct laboratory studies, develop manufacturing processes and manufacture the product candidate, conduct and manage clinical trials, as well as other costs related to the Company’s clinical and preclinical studies. Additionally, direct expenses consist of those costs necessary to discontinue and close out a development program, including termination fees and other commitments. Indirect expenses consist of lab supplies and services, facility expenses, depreciation of development equipment and an allocation of general and administrative overhead costs that support the Company’s research and development efforts.
Selling, General and Administrative Expenses
Selling, General and Administrative Expenses
Selling, general and administrative expenses represent costs incurred to commercialize the Company’s products and support its operations. Sales and marketing expenses include personnel-related costs, activities supporting the commercialization and distribution of marketed products, market research, marketing, medical affairs, market access, and advertising costs.
General and administrative expenses include personnel-related costs and other expenses associated with quality, finance, human resources, information technology, legal, compliance, and other administrative functions, including transaction-related costs. All patent related costs are expensed to general and administrative expenses when incurred as recoverability of such expenditures is uncertain.
Leases
Leases
The Company leases certain assets under operating and finance leases, which consist of real estate leases, laboratory equipment leases and office equipment leases as of June 30, 2026. The Company determines whether a contract is, or contains, a lease at inception. The Company accounts for lease obligations in accordance with ASC Topic 842, Leases, which requires a lessee to recognize a right-of-use asset and a lease liability in its condensed consolidated balance sheet for most leases. For leases with an initial lease term of twelve months or less, the Company recognizes lease expense on a straight-line basis over the lease term. The Company does not separate non-lease components from lease components and instead accounts for them as a single lease component.
Certain of the Company’s leases provide for renewal options, which can vary by lease. The right-of-use asset and lease liabilities in the Condensed Consolidated Balance Sheets represent payments over the lease term, which include renewal options for certain real estate leases that the Company is reasonably certain to exercise. Certain operating leases include rent escalation provisions, which the Company recognizes as expense on a straight-line basis.
The discount rate used to determine the Company’s right-of-use asset and lease liability is the Company’s incremental borrowing rate on a collateralized basis over a similar term and amount in a similar economic environment, as generally an implicit rate in the lease is not readily determinable.
The Company has not made any residual value guarantees related to its leases; therefore, the Company has no corresponding liability recorded in its Condensed Consolidated Balance Sheets.
Stock-Based Compensation
Stock-Based Compensation
All share-based payments, including grants of stock option awards and restricted stock unit awards, are recognized in the Condensed Consolidated Statements of Comprehensive Income (Loss) based on their fair values. Stock-based compensation cost is estimated at the grant date based on the fair value of the award and is recognized as expense on a straight-line basis over the requisite service period of the award. Determining the appropriate fair value model and the related assumptions for the model requires judgment, including estimating the stock price volatility and the expected term. The Company utilizes the Black-Scholes option-pricing model or binomial lattice model to value its stock option awards. The Company reduces stock-based compensation expense for estimated forfeitures. The estimation of share-based payment awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from the Company’s current estimates, such amounts will be recorded as a cumulative adjustment in the period estimates are revised. Actual results, and future changes in estimates, may differ substantially from the Company’s current estimates.
Debt and Royalty Financing Obligations
Debt
Costs directly associated with term loan borrowings are capitalized and netted against the corresponding debt liabilities in the Condensed Consolidated Balance Sheets. These costs are amortized to interest expense over the terms of the corresponding borrowings using the effective interest rate method.
Royalty Financing Obligations
Royalty financing obligations are repaid through royalties based on net sales of ORLADEYO. Interest expense is recognized using the effective interest rate method over the estimated period during which each of the related liabilities will be paid. This requires the Company to estimate the total future royalty payments expected to be generated from product sales over the life of the each agreement. The Company reassesses the expected royalty payments each reporting period and accounts for any changes through adjustments to the effective interest rates on a prospective basis. The assumptions used in determining the expected repayment terms of the debt and amortization periods of the issuance costs require that the Company make estimates that could impact the carrying values of each of the liabilities, as well as the periods over which associated issuance costs will be amortized. Significant changes in forecasted net sales could materially impact each of the liability balances, interest expense and the time periods for repayment.
Income Taxes
Income Taxes
The asset and liability method is used in the Company’s accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse.
Deferred tax assets are reduced by a valuation allowance when, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. In assessing the realizability of deferred tax assets, the Company considers all available positive and negative evidence, including historical operating results, forecasts of future taxable income, the reversal of taxable temporary differences and available tax planning strategies.
The Company accounts for uncertain tax positions in accordance with U.S. GAAP and recognizes the financial statement effects of a tax position only when it is more likely than not that the position will be sustained upon examination by the relevant taxing authority. The Company adjusts the amount of the liability to reflect any subsequent changes in the
relevant facts and circumstances surrounding the uncertain tax positions. The Company recognizes interest and penalties related to income tax matters in income tax expense.
Foreign research and development costs are capitalized and amortized over a 15-year period in accordance with Section 174 of the Internal Revenue Code of 1986, as amended (“IRC”). The amortization period begins with the midpoint of any taxable year that IRC Section 174 costs are first incurred, regardless of whether the expenditures were made prior to or after July 1, and runs until the midpoint of year sixteen.
Certain countries in which the Company has operations have adopted legislation influenced by the Organization for Economic Cooperation and Development (“OECD”) Pillar Two rules, including a minimum tax rate of 15%. It is uncertain whether the U.S. will enact legislation to adopt the OECD Pillar Two framework. While the Company is currently not within the scope of the rules, it is continuing to review and evaluate additional guidance released by the OECD, along with the pending legislative adoption by additional individual countries where the Company operates.

On July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law, making permanent certain provisions of the Tax Cuts and Jobs Act, including permanent 100% bonus depreciation, expensing of domestic research costs, and amendments to the business interest expense limitation. In accordance with ASC Topic 740, Income Taxes, the Company recognized the effects of the new tax law in the period of enactment. As the Company maintains a full valuation allowance on its U.S. federal deferred tax assets, the legislation did not have a material impact on its condensed consolidated financial statements for the three and six months ended June 30, 2026.
Foreign Currency
Foreign Currency
The functional currency of each of the Company’s foreign subsidiaries is primarily the local currency of the country in which the subsidiary operates. The Company’s asset and liability accounts are translated at the current exchange rate as of the condensed consolidated balance sheet date. Revenue and expense accounts are translated at the average exchange rate over the period. Adjustments resulting from the translation of the financial statements of the Company’s foreign subsidiaries into U.S. dollars are accumulated as a separate component of stockholders’ deficit within accumulated other comprehensive (loss) income. Gains or losses resulting from transactions denominated in foreign currencies are included in foreign currency gains (losses), net, within the Condensed Consolidated Statement of Comprehensive Income (Loss).
Net Income (Loss) Per Share
Net Income (Loss) Per Share
Basic net income (loss) per share is calculated using the weighted average number of common shares outstanding during the period. Diluted net income (loss) per share includes the effect of potentially dilutive common shares outstanding during the period, as determined using the treasury stock method. Potentially dilutive common shares include shares that the Company could be obligated to issue from its outstanding stock-based compensation awards. In periods of net loss, all potential common shares would be anti-dilutive and therefore are excluded from the calculation of diluted net income (loss) per share.
Accumulated Other Comprehensive (Loss) Income
Accumulated Other Comprehensive (Loss) Income
Accumulated other comprehensive (loss) income is comprised of cumulative foreign currency translation adjustments and unrealized gains and losses on available-for-sale investments and is disclosed as a separate component of stockholders’ deficit. Realized gain and loss amounts on available-for-sale investments are reclassified from accumulated other comprehensive (loss) income and recorded as other expense, net in the Condensed Consolidated Statements of Comprehensive Income (Loss). There were no realized gains or losses reclassified out of accumulated other comprehensive (loss) income for the three and six months ended June 30, 2026 and 2025.
Significant Customers and Other Risks
Significant Customers and Other Risks
Significant Customers
The Company’s primary source of revenue and cash flow is sales of ORLADEYO in the United States.
ORLADEYO is generally distributed through an arrangement with a single specialty pharmacy in the United States. The specialty pharmacy subsequently sells ORLADEYO to its customers (pharmacy benefit managers, insurance companies, government programs and group purchasing organizations) who dispense product to patients. On August 5, 2026, the Company announced that it has engaged a new sole source specialty pharmacy for ORLADEYO shipments to patients.
For the three and six months ended June 30, 2026 and 2025, ORLADEYO and peramivir were distributed through the same specialty pharmacy in the United States. Product revenue where this specialty pharmacy was considered the customer was approximately 97% and 95% of total product sales for the three and six months ended June 30, 2026, respectively. Product revenue where this specialty pharmacy was considered the customer was approximately 86% and 85% of total product sales for the three and six months ended June 30, 2025, respectively.
The Company distributes ORLADEYO in other global markets directly or through other parties.
Risks from Third-Party Manufacturing and Distribution Concentration
The Company relies on a single source manufacturer for active pharmaceutical ingredient and finished drug product manufacturing of product candidates in development and on a single specialty pharmacy for distribution of approved drug product in the United States. Delays or disruption in the manufacture or distribution of any product could adversely impact the future procurement stockpiling of the Company’s commercial product, commercial revenue and product candidates.
Further, the Company’s drug development activities are performed by a limited group of third-party vendors. If any of these vendors were unable to perform its services, this could significantly impact the Company’s ability to complete its drug development activities.
Credit Risk
Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash and cash equivalents, investments, and trade receivables. The Company maintains its cash and cash equivalents with high-credit quality financial institutions in the United States. Such amounts may exceed federally-insured limits. The Company believes it has established guidelines for investment of its excess cash relative to diversification and maturities that maintain safety and liquidity. To minimize the exposure due to adverse shifts in interest rates, the Company maintains a portfolio of investments with an average maturity of approximately 12 months or less.
The Company’s trade receivables from sales of ORLADEYO are primarily due from its significant customer, as discussed above, resulting in a concentration of credit risk.
Recently Adopted Accounting Pronouncements And New Accounting Pronouncements Not Yet Adopted
Recently Adopted Accounting Pronouncements
In September 2025, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2025-06, Intangibles - Goodwill and Other - Internal-Use Software (Subtopic 350-40): Targeted Improvements to the Accounting for Internal-Use Software, which clarifies and modernizes the accounting for costs related to internal-use software, eliminating references to project stages and clarifying the threshold entities apply to begin capitalizing costs. ASU 2025-06 is effective for fiscal years beginning after December 15, 2027, and interim periods within those annual reporting periods, with early adoption permitted. The Company adopted ASU 2025-06 as of January 1, 2026. The adoption of this standard did not have a material effect on the Company’s Condensed Consolidated Balance Sheet, Condensed Consolidated Statement of Comprehensive Income (Loss), or Condensed Consolidated Statement of Cash Flows.
New Accounting Pronouncements Not Yet Adopted
In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, which requires public entities, on an annual and interim basis, to provide disaggregated disclosure of certain income statement expenses into specified categories within the footnotes to the financial statements. ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2024-03 will have on its disclosures. The Company does not expect the adoption of ASU 2024-03 to have a material effect on its Condensed Consolidated Balance Sheet, Condensed Consolidated Statement of Comprehensive Income (Loss), or Condensed Consolidated Statement of Cash Flows.
The Company does not expect any other recently issued accounting standards to have a material impact to its condensed consolidated financial statements or disclosures.