INSMED Inc
For the period ended Dec 31, 2025. Filed Feb 19, 2026.
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FY2025 · Filed Feb 19, 2026
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Item 8. CONSOLIDATED FINANCIAL STATEMENTS
(in thousands, except par value and share data)
| As of December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents | $510,445 | $555,030 |
| Marketable securities | 919,602 | 878,796 |
| Accounts receivable | 140,857 | 52,012 |
| Inventory | 132,068 | 98,578 |
| Prepaid expenses and other current assets | 91,236 | 37,245 |
| Total current assets | 1,794,208 | 1,621,661 |
| Fixed assets, net | 102,942 | 80,052 |
| Finance lease right-of-use assets | 15,561 | 18,273 |
| Operating lease right-of-use assets | 20,708 | 17,257 |
| Intangibles, net | 97,651 | 58,652 |
| Goodwill | 136,110 | 136,110 |
| Other assets | 97,378 | 93,226 |
| Total assets | $2,264,558 | $2,025,231 |
| Liabilities and shareholders' equity | ||
| Current liabilities: | ||
| Accounts payable and accrued liabilities | $456,060 | $285,209 |
| Finance lease liabilities | 3,345 | 2,961 |
| Operating lease liabilities | 9,469 | 9,358 |
| Total current liabilities | 468,874 | 297,528 |
| Debt, long-term | 540,964 | 1,103,382 |
| Royalty financing agreement | 162,865 | 161,067 |
| Contingent consideration | 314,340 | 144,200 |
| Finance lease liabilities, long-term | 20,719 | 24,064 |
| Operating lease liabilities, long-term | 12,174 | 9,112 |
| Other long-term liabilities | 5,646 | 499 |
| Total liabilities | 1,525,582 | 1,739,852 |
| Shareholders' equity: | ||
| Common stock, $0.01 par value; 500,000,000 authorized shares, 214,255,853 and 179,382,635 issued and outstanding shares at December 31, 2025 and December 31, 2024, respectively | 2,143 | 1,794 |
| Additional paid-in capital | 6,372,064 | 4,645,791 |
| Accumulated deficit | (5,636,692) | (4,359,917) |
| Accumulated other comprehensive gain (loss) | 1,461 | (2,289) |
| Total shareholders' equity | 738,976 | 285,379 |
| Total liabilities and shareholders' equity | $2,264,558 | $2,025,231 |
See accompanying notes to consolidated financial statements
Consolidated Statements of Comprehensive Loss
(in thousands, except per share data)
| Years Ended December 31, | |||
|---|---|---|---|
| 2025 | 2024 | 2023 | |
| Product revenues, net | $606,423 | $363,707 | $305,208 |
| Operating expenses: | |||
| Cost of product revenues (excluding amortization of intangible assets) | 122,938 | 85,742 | 65,573 |
| Research and development | 771,093 | 598,367 | 571,011 |
| Selling, general and administrative | 701,167 | 461,116 | 344,501 |
| Amortization of intangible assets | 6,001 | 5,052 | 5,052 |
| Change in fair value of deferred and contingent consideration | 251,993 | 91,682 | 28,697 |
| Total operating expenses | 1,853,192 | 1,241,959 | 1,014,834 |
| Operating loss | (1,246,769) | (878,252) | (709,626) |
| Investment income | 60,656 | 53,307 | 42,132 |
| Interest expense | (83,795) | (84,913) | (81,694) |
| Change in fair value of interest rate swap | — | (236) | 320 |
| Other (expense) income, net | (1,841) | 29 | 1,856 |
| Loss before income taxes | (1,271,749) | (910,065) | (747,012) |
| Provision for income taxes | 5,026 | 3,707 | 2,555 |
| Net loss | $(1,276,775) | $(913,772) | $(749,567) |
| Basic and diluted net loss per share | $(6.42) | $(5.57) | $(5.34) |
| Weighted average basic and diluted common shares outstanding | 199,014 | 164,043 | 140,433 |
| Net loss | $(1,276,775) | $(913,772) | $(749,567) |
| Other comprehensive income (loss): | |||
| Foreign currency translation gains (losses) | 3,306 | (1,855) | (2,214) |
| Unrealized gain on marketable securities | 444 | 311 | 713 |
| Total comprehensive loss | $(1,273,025) | $(915,316) | $(751,068) |
Consolidated Statements of Shareholders' Equity
| Common Stock · AdditionalPaid-inCapital · Accumulated Deficit · AccumulatedOtherComprehensiveIncome (Loss) · Total | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Shares | Amount | |||||||||
| Balance at December 31, 2022 | 135,654 | $1,357 | $2,782,416 | $(2,696,578) | $756 | $87,951 | ||||
| Comprehensive loss: | ||||||||||
| Net loss | (749,567) | (749,567) | ||||||||
| Other comprehensive loss | (1,501) | (1,501) | ||||||||
| Exercise of stock options and ESPP share issuance | 1,142 | 12 | 18,387 | 18,399 | ||||||
| Net proceeds from issuance of common stock | 6,531 | 65 | 152,410 | 152,475 | ||||||
| Issuance of common stock for vesting of RSUs | 543 | 5 | 5 | |||||||
| Deferred payments for Business Acquisition | 177 | 2 | 3,895 | 3,897 | ||||||
| Issuance of common stock for asset acquisitions | 3,931 | 39 | 81,601 | 81,640 | ||||||
| Stock-based compensation expense | 74,778 | 74,778 | ||||||||
| Balance at December 31, 2023 | 147,978 | $1,480 | $3,113,487 | $(3,446,145) | $(745) | $(331,923) | ||||
| Comprehensive loss: | ||||||||||
| Net loss | (913,772) | (913,772) | ||||||||
| Other comprehensive loss | (1,544) | (1,544) | ||||||||
| Exercise of stock options and ESPP share issuance | 5,026 | 50 | 113,193 | 113,243 | ||||||
| Net proceeds from issuance of common stock | 19,537 | 195 | 1,083,929 | 1,084,124 | ||||||
| Issuance of common stock upon conversion of convertible notes | 5,744 | 58 | 224,267 | 224,325 | ||||||
| Issuance of common stock for vesting of RSUs | 901 | 9 | 9 | |||||||
| Deferred payments for Business Acquisition and Vertuis Bio, Inc. | 197 | 2 | 14,080 | 14,082 | ||||||
| Stock-based compensation expense | 96,835 | 96,835 | ||||||||
| Balance at December 31, 2024 | 179,383 | $1,794 | $4,645,791 | $(4,359,917) | $(2,289) | $285,379 | ||||
| Comprehensive loss: | ||||||||||
| Net loss | (1,276,775) | (1,276,775) | ||||||||
| Other comprehensive income | 3,750 | 3,750 | ||||||||
| Exercise of stock options and ESPP share issuance | 5,769 | 58 | 135,659 | 135,717 | ||||||
| Net proceeds from issuance of common stock | 8,984 | 90 | 823,192 | 823,282 | ||||||
| Issuance of common stock upon conversion of convertible notes | 17,923 | 179 | 565,962 | 566,141 | ||||||
| Issuance of common stock for vesting of RSUs | 1,172 | 11 | 11 | |||||||
| Issuance of common stock for vesting of PSUs | 660 | 7 | 7 | |||||||
| Contingent payments for Business Acquisition | 365 | 4 | 48,750 | 48,754 | ||||||
| Stock-based compensation expense | 152,710 | 152,710 | ||||||||
| Balance at December 31, 2025 | 214,256 | $2,143 | $6,372,064 | $(5,636,692) | $1,461 | $738,976 | ||||
| Years Ended December 31, | |||
|---|---|---|---|
| 2025 | 2024 | 2023 | |
| Operating activities | |||
| Net loss | $(1,276,775) | $(913,772) | $(749,567) |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||
| Depreciation | 10,449 | 5,961 | 5,527 |
| Amortization of intangible assets | 6,001 | 5,052 | 5,052 |
| Stock-based compensation expense | 152,710 | 96,835 | 74,778 |
| Amortization of debt issuance costs | 6,216 | 6,884 | 7,320 |
| Paid-in-kind interest capitalized | — | 19,233 | 23,372 |
| Royalty financing non-cash interest expense | 20,675 | 20,044 | 18,846 |
| Accretion of discount on marketable securities, net | (38,348) | (19,160) | (9,383) |
| Finance lease amortization expense | 2,712 | 2,712 | 2,712 |
| Non-cash operating lease expense | 9,652 | 3,588 | 9,206 |
| Change in fair value of deferred and contingent consideration liabilities | 251,993 | 91,682 | 28,697 |
| Change in fair value of interest rate swap | — | 236 | (320) |
| Vertuis acquisition | — | — | 10,250 |
| Adrestia acquisition | — | — | 76,481 |
| Changes in operating assets and liabilities: | |||
| Accounts receivable | (88,307) | (12,932) | (11,963) |
| Inventory | (31,519) | (17,044) | (13,613) |
| Prepaid expenses and other current assets | (53,431) | (14,182) | 2,265 |
| Other assets | (2,123) | 8,335 | (20,074) |
| Accounts payable and accrued liabilities | 100,073 | 44,592 | 15,155 |
| Other liabilities | (4,992) | (11,946) | (10,988) |
| Net cash used in operating activities | (935,014) | (683,882) | (536,247) |
| Investing activities | |||
| Purchase of fixed assets | (32,561) | (21,923) | (13,288) |
| Payment of AZ milestone | (30,000) | — | — |
| Purchase of marketable securities | (2,092,014) | (1,577,252) | (588,733) |
| Cash acquired in asset acquisition | — | — | 3,417 |
| Maturities of marketable securities | 2,090,000 | 1,016,000 | 375,000 |
| Net cash used in investing activities | (64,575) | (583,175) | (223,604) |
| Financing activities | |||
| Proceeds from exercise of stock options and ESPP | 135,717 | 113,243 | 18,399 |
| Proceeds from issuance of common stock, net | 823,282 | 1,084,124 | 152,475 |
| Proceeds from issuance of Term Loan | — | 150,000 | — |
| Payments of principal of 0.75% convertible senior notes due 2028 | (1,965) | — | — |
| Payment of debt issuance costs | — | (3,737) | (1,218) |
| Payments of finance lease principal | (2,961) | (2,610) | (1,217) |
| Net cash provided by financing activities | 954,073 | 1,341,020 | 168,439 |
| Effect of exchange rates on cash and cash equivalents | 931 | (1,307) | (250) |
| Net (decrease) increase in cash and cash equivalents | (44,585) | 72,656 | (591,662) |
| Cash and cash equivalents at beginning of period | 555,030 | 482,374 | 1,074,036 |
|---|---|---|---|
| Cash and cash equivalents at end of period | $510,445 | $555,030 | $482,374 |
| Supplemental disclosures of cash flow information: | |||
| Cash paid for interest | $55,353 | $40,567 | $35,787 |
| Cash paid for income taxes | $4,141 | $2,499 | $1,955 |
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
- The Company and Basis of Presentation
Insmed is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. To complement the Company's internal research and development, the Company also actively evaluates in-licensing and acquisition opportunities for commercial products, product candidates and technologies.
The Company's firsttwo commercial products, ARIKAYCE®and BRINSUPRI®, are both part of the Respiratory therapeutic area. ARIKAYCE is approved in the US as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion and in Japan as ARIKAYCE inhalation 590 mg (amikacin sulfate inhalation drug product). ARIKAYCE received accelerated approval in the US in September 2018 for the treatment of MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options in a refractory setting. In October 2020, the European Commission approved ARIKAYCE Liposomal for the treatment of nontuberculous mycobacterial lung infections caused by MAC in adults with limited treatment options who do not have cystic fibrosis. In March 2021, Japan's Ministry of Health, Labour and Welfare approved ARIKAYCE for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen. NTM lung disease caused by MAC (which the Company refers to as MAC lung disease) is a rare and often chronic infection that can cause irreversible lung damage and can be fatal.
BRINSUPRI (brensocatib 25 mg and 10 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (referred to as bronchiectasis or NCFB) in patients 12 years of age and older, was approved in the US in August 2025. In November 2025, the EC approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. Bronchiectasis is a serious, chronic lung disease in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage.
The Company's Respiratory therapeutic area also includes clinical-stage programs for TPIP and INS1148. TPIP is an inhaled dry powder formulation of the treprostinil prodrug treprostinil palmitil which may offer a differentiated product profile for PH-ILD, PAH, PPF, and IPF. INS1148 is a monoclonal antibody targeting SCF248 for patients with interstitial lung disease and moderate to severe asthma. The Company is also exploring additional opportunities utilizing its various technologies within the Respiratory therapeutic area.
The Company's Inflammation & Immunology therapeutic area includes the development of brensocatib, a small molecule, oral, reversible inhibitor of DPP1, for the treatment of patients with HS. The Company is also exploring additional opportunities utilizing its various technologies within the Inflammation & Immunology therapeutic area.
The Company's Neuro & Other Rare therapeutic area includes the clinical-stage programs INS1201, an intrathecally delivered gene therapy for patients with DMD, and INS1202, an intrathecally delivered gene therapy for patients with ALS. The Company is also exploring additional opportunities utilizing its various technologies within the Neuro & Other Rare therapeutic area.
The Company's pre-clinical research programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue.
The Company was incorporated in the Commonwealth of Virginia on November 29, 1999 and its principal executive offices are located in Bridgewater, New Jersey. The Company has legal entities in the US, France, Germany, Ireland, Italy, the Netherlands, Switzerland, the UK, and Japan.
The Company had $510.4 million of cash and cash equivalents and $919.6 million of marketable securities as of December 31, 2025 and reported a net loss of $1,276.8 million for the year ended December 31, 2025. The Company has funded its operations through public offerings of equity securities, debt financings, revenue interest financings and revenues generated from ARIKAYCE and BRINSUPRI. The Company expects to continue to incur consolidated operating losses, including losses in its US and certain international entities, while funding research and development activities for ARIKAYCE, TPIP, brensocatib, INS1148, INS1201, INS1202 and its other pipeline programs, and commercialization and regulatory activities for BRINSUPRI and ARIKAYCE.
The Company expects its future cash requirements to be substantial. While the Company currently has sufficient funds to meet its financial needs for at least the next 12 months, the Company may raise additional capital in the future to fund its operations, its ongoing commercialization and clinical trial activities, and its future product candidates, and to develop, acquire,
- The Company and Basis of Presentation (Continued)
in-license or co-promote other products or product candidates, including those that address serious diseases with significant unmet need. The source, timing and availability of any future financing or other transaction will depend principally upon continued progress in the Company’s commercial, regulatory and development activities. Any future financing will also be contingent upon market conditions. If the Company is unable to obtain sufficient additional funds when required, the Company may be forced to delay, restrict or eliminate all or a portion of its development programs or commercialization efforts.
The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Celtrix Pharmaceuticals, Inc., Insmed France SAS, Insmed Gene Therapy LLC, Insmed Germany GmbH, Insmed Godo Kaisha, Insmed Holdings Limited, Insmed Innovation UK Limited, Insmed Ireland Limited, Insmed Italy S.R.L., Insmed Limited, Insmed Netherlands B.V., Insmed Netherlands Holdings B.V., and Insmed Switzerland GmbH.
- Summary of Significant Accounting Policies
Use of Estimates—The preparation of the consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and on various other assumptions. The amounts of assets and liabilities reported in the Company's balance sheets and the amounts of revenues and expenses reported for each period presented are affected by estimates and assumptions, which are used for, but not limited to, the accounting for revenue allowances, stock-based compensation, income taxes, loss contingencies, acquisition related intangibles including in process research and development (IPR&D) and goodwill, fair value of contingent consideration, the revenue interest purchase agreement, and accounting for R&D costs. Actual results could differ from those estimates.
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.
Accounts Receivable—Accounts receivable are recorded net of customer allowances for prompt pay discounts, chargebacks, and any estimated expected credit losses. The Company's measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. To date, credit losses have not been material.
Concentration of Credit Risk—Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash and cash equivalents and marketable securities. The Company places its cash equivalents and marketable securities with high credit-quality financial institutions and may invest its investments in US treasury securities, mutual funds and government agency bonds. The Company has established guidelines relative to credit ratings and maturities that seek to maintain safety and liquidity.
The Company is exposed to risks associated with extending credit to customers related to the sale of products. The Company does not require collateral to secure amounts due from its customers. The Company uses an expected loss methodology to calculate allowances for trade receivables. The Company's measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. The Company does not currently have a material allowance for uncollectible trade receivables.
The following table presents the customers representing 10% or more of the Company's gross product revenues for the year ended December 31, 2025 and their respective percentages for the years ended December 31, 2024 and 2023:
| Years Ended December 31, | |||
|---|---|---|---|
| 2025 · 2024 · 2023 | |||
| Customer A | 31% | 30% | 34% |
| Customer B | 26% | 34% | 35% |
| Customer C | 17% | 21% | 19% |
| Customer D | 12% | 8% | 7% |
The Company relies on third-party manufacturers and suppliers for manufacturing and supply of its products. The inability of the suppliers or manufacturers to fulfill supply requirements of the Company could materially impact future operating results. A change in the relationship with the suppliers or manufacturers, or an adverse change in their business, could materially impact future operating results.
Marketable Securities—Marketable securities consist of available-for-sale investments in US Treasury securities. Marketable securities under this classification are recorded at fair value and unrealized gains and losses are recorded within accumulated other comprehensive gain (loss). The estimated fair value of available-for-sale marketable securities is determined based on quoted market prices. Marketable securities maturing in one year or less are classified as current assets and marketable securities maturing in more than one year are classified as non-current assets. The Company did not have available-for-sale securities with a maturity of more than one year as of December 31, 2025 and December 31, 2024.
Fixed Assets, Net—Fixed assets are recorded at cost and are depreciated on a straight-line basis over the estimated useful lives of the assets. Estimated useful lives ofthree years tofive years are used for computer hardware and software. Estimated useful lives ofseven years are used for laboratory equipment, office equipment, manufacturing equipment and furniture and fixtures. Estimated useful lives of 39 years are used for building and building improvements. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the asset. Land is not depreciated.
Finite-lived Intangible Assets—Finite-lived intangible assets are measured at their respective fair values on the date they were recorded. The fair values assigned to the Company's intangible assets are based on reasonable estimates and assumptions given available facts and circumstances. See Note 6 - Intangibles, Net and Goodwill for further details.
Impairment Assessment—The Company reviews the recoverability of its finite-lived intangible assets and long-lived assets for indicators of impairments. Events or circumstances that may require an impairment assessment include negative clinical trial results, a significant decrease in the market price of the asset, or a significant adverse change in legal factors or the manner in which the asset is used. If such indicators are present, the Company assesses the recoverability of affected assets by determining if the carrying value of such assets is less than the sum of the undiscounted future cash flows of the assets. If such assets are found to not be recoverable, the Company measures the amount of the impairment by comparing the carrying value of the assets to the fair value of the assets. The Company determined thatno indicators of impairment of finite-lived intangible assets or long-lived assets existed at December 31, 2025.
Business Combinations and Asset Acquisitions—The Company evaluates acquisitions of assets and other similar transactions to assess whether or not the transaction should be accounted for as a business combination or asset acquisition by first applying a screen to determine if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If the screen is met, the transaction is accounted for as an asset acquisition. If the screen is not met, further determination is required as to whether or not the Company has acquired inputs and processes that have the ability to create outputs, which would meet the requirements of a business. If determined to be a business combination, the Company accounts for the transaction under the acquisition method of accounting as indicated in Business Combinations (Topic 805).
The consideration for the Company’s business acquisitions may include future payments that are contingent upon the occurrence of a particular event or events. The obligations for such contingent consideration payments are recorded at fair value on the acquisition date. The contingent consideration obligations are then evaluated each reporting period. Changes in the fair value of contingent consideration, other than changes due to payments, are recognized as a gain or loss and recorded within change in the fair value of deferred and contingent consideration liabilities in the consolidated statements of comprehensive loss.
If determined to be an asset acquisition, the Company recognizes the assets acquired and liabilities assumed based on the relative fair value basis, which includes transaction costs in addition to consideration given. No gain or loss is recognized as of the date of acquisition unless the fair value of non-cash assets given as consideration differs from the assets’ carrying amounts on the acquiring entity’s books. Consideration transferred that is non-cash will be measured based on either the cost (which shall be measured based on the fair value of the consideration given) or the fair value of the assets acquired and liabilities assumed, whichever is more reliably measurable. Goodwill is not recognized in an asset acquisition and any excess consideration transferred over the fair value of the net assets acquired is allocated to the identifiable assets based on relative fair values. If the in-licensed agreement for IPR&D does not meet the definition of a business and the assets have not reached technological feasibility and therefore have no alternative future use, the Company expenses payments made under such license agreements as acquired IPR&D expense within R&D expense in its consolidated statements of comprehensive loss.
Contingent consideration payments in asset acquisitions are recognized when the contingency is resolved and the consideration is paid or becomes payable, unless the contingent consideration meets the definition of a derivative, in which case the amount becomes part of the basis in the asset acquired. None of the Company's contingent consideration met the definition of a derivative. Upon recognition of the contingent consideration payment, the amount is included in the cost of the acquired asset or group of assets.
Indefinite-lived Intangible Assets—Indefinite-lived intangible assets consist of IPR&D. IPR&D acquired directly in a transaction other than a business combination is capitalized if the projects will be further developed or have an alternative future use; otherwise, they are expensed. The fair values of IPR&D project assets acquired in business combinations are capitalized. The Company generally utilizes the Multi-Period Excess Earning Method to determine the estimated fair value of the IPR&D assets acquired in a business combination. The projections used in this valuation approach are based on many factors, such as relevant market size, patent protection, and expected pricing and industry trends. The estimated future net cash flows are then discounted to the present value using an appropriate discount rate. These assets are treated as indefinite-lived intangible assets until completion or abandonment of the projects, at which time the assets are amortized over the remaining useful life or written off, as appropriate. Intangible assets with indefinite lives, including IPR&D, are tested for impairment if impairment indicators arise and, at a minimum, annually. However, an entity is permitted to first assess qualitative factors to determine if a quantitative impairment test is necessary. Further testing is only required if the entity determines, based on the qualitative assessment, that it is more likely than not that an indefinite-lived intangible asset’s fair value is less than its carrying amount. The indefinite-lived intangible asset impairment test consists of a one-step analysis that compares the fair value of the intangible asset with its carrying amount. If the carrying amount of an intangible asset exceeds its fair value, an impairment loss is recognized in an amount equal to that excess. The Company considers many factors in evaluating whether the value of its intangible assets with indefinite lives may not be recoverable, including, but not limited to, expected growth rates, the cost of equity and debt capital, general economic conditions, the Company’s outlook and market performance of the Company’s industry and recent and forecasted financial performance. The Company performs a qualitative test for its indefinite-lived intangible assets annually as of October 1. During the year ended December 31, 2025, the Company concluded thatno impairment exists.
Goodwill—Goodwill represents the amount of consideration paid in excess of the fair value of net assets acquired as a result of the Company’s business acquisitions accounted for using the acquisition method of accounting. Goodwill is not amortized and is subject to impairment testing at a reporting unit level on an annual basis or when a triggering event occurs that may indicate the carrying value of the goodwill is impaired. An entity is permitted to first assess qualitative factors to determine if a quantitative impairment test is necessary. Further testing is only required if the entity determines, based on the qualitative assessment, that it is more likely than not that the fair value of the reporting unit is less than its carrying amount. As of December 31, 2025, the Company concluded that it continues to operate asone reporting unit. As of October 1, 2025, the Company performed a qualitative impairment test for goodwill and concluded thatno impairment exists.
Leases—A lease is a contract, or part of a contract, that conveys the right to control the use of explicitly or implicitly identified property, plant or equipment in exchange for consideration. Control of an asset is conveyed to the Company if the Company obtains the right to obtain substantially all of the economic benefits of the asset or the right to direct the use of the asset. The Company recognizes right-of-use (ROU) assets and lease liabilities at the lease commencement date based on the present value of future, fixed lease payments over the term of the arrangement. ROU assets are amortized on a straight-line basis over the term of the lease or are amortized based on consumption, if this approach is more representative of the pattern in which benefit is expected to be derived from the underlying asset. Lease liabilities accrete to yield and are reduced at the time when the lease payment is payable to the vendor. Variable lease payments are recognized at the time when the event giving rise to the payment occurs and are recognized in the consolidated statements of comprehensive loss in the same line item as expenses arising from fixed lease payments.
Leases are measured at present value using the rate implicit in the lease or, if the implicit rate is not determinable, the lessee's incremental borrowing rate. As the implicit rate is not typically available, the Company uses its incremental borrowing rate based on the information available at the lease commencement date to determine the present value of future lease payments. The incremental borrowing rate approximates the rate the Company would pay to borrow on a collateralized basis over a similar term an amount equal to the lease payments. See Note 9 - Leases for further details.
Debt Issuance Costs—Debt issuance costs are amortized to interest expense using the effective interest rate method over the term of the debt. Unamortized debt issuance costs paid to the lender and third parties are reflected as a discount to the debt in the consolidated balance sheets. Unamortized debt issuance costs associated with extinguished debt are expensed in the period of the extinguishment.
Foreign Currency—The Company has operations in the US, France, Germany, Ireland, Italy, the Netherlands, Switzerland, the UK, and Japan. The results of the Company's non-US dollar based functional currency operations are translated to US dollars at the average exchange rates during the period. Assets and liabilities are translated at the exchange rate prevailing at the balance sheet date. Equity is translated at the prevailing exchange rate at the date of the equity transaction.
Translation adjustments are included in total shareholders' equity, as a component of accumulated other comprehensive gain (loss).
The Company realizes foreign currency transaction gains and losses in the normal course of business based on movements in the applicable exchange rates. These gains and losses are included as a component of other (expense) income, net.
Inventory and Cost of Product Revenues (excluding amortization of intangible assets)—Inventory is stated at the lower of cost and net realizable value. Inventory is sold on a first-in, first-out (FIFO) basis. The Company periodically reviews inventory for expiry and obsolescence and, if necessary, writes down accordingly. If quality specifications are not met during the manufacturing process, such inventory is written off to cost of product revenues (excluding amortization of intangible assets) in the period identified.
Cost of product revenues (excluding amortization of intangible assets) consist primarily of direct and indirect costs related to the manufacturing of our marketed products sold, including third-party manufacturing costs, packaging services, freight, and allocation of overhead costs, in addition to royalty expenses. Cost is determined using a standard cost method, which approximates actual cost, and assumes a FIFO flow of goods. Inventory used for clinical development purposes is expensed to R&D expense when consumed. Prior to FDA approval of a product, the Company expenses all inventory related costs in the period incurred.
Research and Development—R&D expenses consist primarily of salaries, benefits and other related costs, including stock-based compensation, for personnel serving in the Company's research and development functions. R&D expenses also include other internal operating expenses, the cost of manufacturing a product candidate, including the medical devices for drug delivery, for clinical study, the cost of conducting clinical studies, and the cost of conducting pre-clinical and research activities. In addition, R&D expenses include payments to third parties for the license rights to products in development (prior to marketing approval), and may include the cost of asset acquisitions (as described further above). The Company's expenses related to manufacturing its product candidates and medical devices for clinical study are primarily related to activities at CMOs that manufacture its clinical product supply of ARIKAYCE, TPIP, brensocatib, INS1148, INS1201, INS1202, and pre-clinical research. The Company's expenses related to clinical trials are primarily related to activities at CROs that conduct and manage clinical trials on the Company's behalf. These contracts set forth the scope of work to be completed at a fixed fee or billed on a per-unit cost, and increase proportionally to the volume of services rendered. Payments under these contracts primarily depend on performance criteria such as the successful enrollment of patients or the completion of clinical trial milestones as well as time-based fees. Expenses are accrued based on contracted amounts applied to the level of patient enrollment and to activity according to the clinical trial protocol. Deposits for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are then recognized as an expense as the related goods are delivered or the services are performed.
Stock-based Compensation—The Company recognizes stock-based compensation expense for awards of equity instruments to employees and directors based on the grant-date fair value of those awards. The grant-date fair value of the award is recognized as compensation expense ratably over the requisite service period, which generally equals the vesting period of the award. The Company may also grant performance-based stock options and performance stock units (PSUs) to employees from time to time. The grant-date fair value of performance-based stock options is recognized as compensation expense over the implicit service period once it is probable that the performance condition will be achieved. The grant-date fair value of PSUs is recognized as compensation expenseon the date(s) the performance conditions become probable. Stock-based compensation expense is included in both R&D and SG&A expenses in the consolidated statements of comprehensive loss.
Investment Income and Interest Expense—Investment income consists of interest income earned on the Company's cash and cash equivalents and marketable securities. Interest expense consists primarily of contractual interest costs related to the Company's debt, non-cash interest expense related to the Company's Royalty Financing Agreement and amortization of debt issuance costs related to the Company's debt. See Note 10 - Debtand Note 11 - Royalty Financing Agreementfor further details.
Income Taxes—The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.
A valuation allowance is recorded to reduce the deferred tax assets to the amount that is expected to be realized. In evaluating the need for a valuation allowance, the Company takes into account various factors, including the expected level of future taxable income and available tax planning strategies. If actual results differ from the assumptions made in the evaluation of a valuation allowance, the Company records a change in valuation allowance through income tax expense in the period such determination is made.
The Company may recognize the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by taxing authorities, based solely on the technical merits of the position. The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that is more likely than not to be sustained upon ultimate settlement. As any adjustment to the Company’s uncertain tax positions would not result in a cash tax liability, it has not recorded any accrued interest or penalties related to its uncertain tax positions.
The Company's policy for interest and penalties related to income tax exposures is to recognize interest and penalties as a component of the provision for income taxes in the consolidated statements of comprehensive loss.
Net Loss Per Share—Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted average number of common shares and other dilutive securities outstanding during the period. Potentially dilutive securities from stock options, restricted stock units (RSUs), PSUs and convertible debt securities would be anti-dilutive as the Company incurred a net loss in all periods presented. Potentially dilutive common shares resulting from the assumed exercise of outstanding stock options and from the assumed conversion of the Company's previously outstanding convertible notes are determined based on the treasury stock method.
The following table sets forth the reconciliation of the weighted average number of common shares used to compute basic and diluted net loss per share for the years ended December 31, 2025, 2024 and 2023:
| Years Ended December 31, | |||
|---|---|---|---|
| 2025 · 2024 · 2023 | |||
| (in thousands, except per share amounts) | |||
| Numerator: | |||
| Net loss | $(1,276,775) | $(913,772) | $(749,567) |
| Denominator: | |||
| Weighted average common shares used in calculation of basic net loss per share: | 199,014 | 164,043 | 140,433 |
| Effect of dilutive securities: | |||
| Common stock options | — | — | — |
| RSUs | — | — | — |
| PSUs | — | — | — |
| Convertible debt securities | — | — | — |
| Weighted average common shares outstanding used in calculation of diluted net loss per share | 199,014 | 164,043 | 140,433 |
| Net loss per share: | |||
| Basic and diluted | $(6.42) | $(5.57) | $(5.34) |
The following potentially dilutive securities have been excluded from the computations of diluted weighted average common shares outstanding as of December 31, 2025, 2024 and 2023 as their effect would have been anti-dilutive (in thousands):
| As of December 31, | |||
|---|---|---|---|
| 2025 | 2024 | 2023 | |
| Common stock options | 17,376 | 21,927 | 22,513 |
| RSUs | 3,889 | 3,320 | 2,750 |
| PSUs | 184 | 660 | 666 |
| Convertible debt securities | — | 17,690 | 23,438 |
Recently Adopted Accounting Pronouncements—In December 2023, the Financial Accounting Standard Board (FASB) issued ASU 2023-09, Income Taxes—Improvements to Income Tax Disclosures, in order to enhance the transparency and decision usefulness of income tax disclosures. ASU 2023-09 requires greater disaggregation of income tax disclosures related to the income tax rate reconciliation and income taxes paid. The Company adopted this new standard for the year ended December 31, 2025. These amendments have been applied retrospectively to all prior periods presented in the financial statements. The required disclosure enhancements of ASU 2023-09 did not have a material impact on the Company's consolidated financial statements. See Note 14 - Income Taxesfor further details.
Recent Accounting Pronouncements (Not Yet Adopted)—In November 2024, the FASB issued ASU 2024-03, Income Statement (Subtopic 220-40)—Expense Disaggregation Disclosures, which requires disclosure of disaggregated income statement expense information about specific categories (including purchases of inventory, employee compensation, depreciation, and intangible asset amortization) in the notes to financial statements. ASU 2024-03 will be effective for fiscal years beginning after December 15, 2026 and interim periods beginning after December 15, 2027. The guidance is applied on a prospective basis, with a retrospective option, and early adoption is permitted. The Company is currently evaluating the impact of adoption of ASU 2024-03 on its consolidated financial statements.
In July 2025, the FASB issued ASU 2025-05, Financial Instruments-Credit Losses (Topic 326)—Measurement of Credit Losses for Accounts Receivable and Contract Assets. The amendments provide an optional practical expedient for estimated expected credit losses on current accounts receivable and current contract assets arising from ASC 606 revenue transactions, allowing entities to assume that economic conditions at the balance sheet date will remain unchanged over the remaining life of the receivable. The amendments are effective for annual periods beginning after December 15, 2025, and are to be applied prospectively. The Company is currently evaluating the impact of adoption of ASU 2025-05 on its consolidated financial statements.
In September 2025, the FASB issued ASU 2025-07, Derivatives and Hedging (Topic 815) and Revenue from Contracts with Customers (Topic 606)—Derivatives Scope Refinements and Scope Clarification for Share-Based Noncash Consideration from a Customer in a Revenue Contract. The amendments clarify the scope of derivative accounting and the application of the revenue recognition guidance to share-based noncash consideration received from customers. The Company will early adopt ASU 2025-07 on January 1, 2026, using a prospective transition method, as permitted by the standard. The adoption of ASU 2025-07 will not have a material impact on the Company’s consolidated financial statements.
- Fair Value Measurements
The Company categorizes its financial assets and liabilities measured and reported at fair value in the financial statements on a recurring basis based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels, which are directly related to the amount of subjectivity associated with the inputs used to determine the fair value of financial assets and liabilities, are as follows:
Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.
Level 2—Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the assets or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life.
Level 3—Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.
Each major category of financial assets and liabilities measured at fair value on a recurring basis is categorized based upon the lowest level of significant input to the valuations. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Financial instruments in Level 1 generally include US treasuries and mutual funds listed in active markets. The Company's cash and cash equivalents permit daily redemption and the fair values of these investments are based upon the quoted prices in active markets provided by the holding financial institutions.
The following table shows assets and liabilities that are measured at fair value on a recurring basis and their carrying value (in millions):
| Fair Value | ||||
|---|---|---|---|---|
| Carrying Value | Level 1 | Level 2 | Level 3 | |
| Assets | ||||
| Cash and cash equivalents | $510.4 | $510.4 | $— | $— |
| Marketable securities | $919.6 | $919.6 | $— | $— |
| Liabilities | ||||
| Contingent consideration | $372.1 | $— | $— | $372.1 |
| Fair Value | ||||
| Carrying Value | Level 1 | Level 2 | Level 3 | |
| Assets | ||||
| Cash and cash equivalents | $555.0 | $555.0 | $— | $— |
| Marketable securities | $878.8 | $878.8 | $— | $— |
| Liabilities | ||||
| Contingent consideration | $168.9 | $— | $— | $168.9 |
During the year ended December 31, 2025, $2.1 billionof marketable securities were purchased and$2.1 billionof marketable securities matured, each consisting of US Treasury Bills.
As of December 31, 2025, the Company held $919.6 million of available-for-sale securities, including an unrealized gain of $0.4 million recorded in accumulated other comprehensive gain (loss). As of December 31, 2024, the Company held $878.8 million of available-for-sale securities, including an unrealized gain of $0.3 million in accumulated other comprehensive gain (loss).
The Company recognizes transfers between levels within the fair value hierarchy, if any, at the end of each quarter. There wereno transfers in or out of Level 1, Level 2 or Level 3 during the years ended December 31, 2025 and 2024. During the year ended December 31, 2025, new Level 1 assets were added in connection with the Company's purchase of available-for-sale securities.
The Company reviews the status of each security quarterly to determine whether an other-than-temporary impairment has occurred. In making its determination, the Company considers a number of factors, including: (1) the significance of the decline; (2) whether the security was rated below investment grade; (3) failure of the issuer to make scheduled interest or principal payments; and (4) the Company's ability and intent to retain the investment for a sufficient period of time for it to recover. The Company has determined that there were no other-than-temporary impairments during the year ended December 31, 2025.
Contingent Consideration Liabilities
The contingent consideration liabilities arose from the Business Acquisition in August 2021. The contingent consideration liabilities consist of developmental and regulatory milestones, a priority review voucher milestone, and net sales milestones. Upon the achievement of certain development and regulatory milestone events, the Company is obligated to issue to Motus equityholders up to 4,979,705 shares of the Company's common stock in the aggregate and AlgaeneX equityholders up to 368,867 shares of the Company's common stock in the aggregate as of December 31, 2025. The fair value of the development and regulatory milestones are estimated utilizing a probability-adjusted approach. The weighted average probability of success of the remaining development and regulatory milestones was 39% as of December 31, 2025. The development and regulatory milestones, if achieved, will be settled in shares of the Company's common stock. As such, there is no discount rate applied in the fair value calculation. During the third quarter of 2025, a development milestone in connection with the Motus acquisition was achieved, resulting in the issuance of 364,566 shares of the Company's common stock in October 2025.
If the Company were to receive a priority review voucher from the FDA, the Company would be obligated to pay to the Motus equityholders a portion of the value of the priority review voucher, subject to certain reductions. The potential payout would be either 50% of the after-tax net proceeds received by the Company from a sale of the priority review voucher or 50% of the average of the sales prices for the last three publicly disclosed priority review voucher sales, less certain adjustments. The fair value of the priority review voucher milestone is estimated utilizing a probability-adjusted discounted cash flow approach. This obligation would be settled in cash. On December 20, 2024, the FDA's priority review voucher program expired. As of December 31, 2025 and 2024, the Company determined that the likelihood of receiving a priority review voucher was remote and the milestone had no fair value.
The contingent consideration liabilities for net sales milestones were valued using an option pricing model with Monte Carlo simulation. As of December 31, 2025, the fair value of these net sales milestones were deemed immaterial to the overall fair value of the contingent consideration.
The contingent consideration liabilities have been classified as a Level 3 recurring liability as its valuation requires substantial judgment and estimation of factors that are not currently observable in the market. If different assumptions were used for the inputs to the valuation approach, the estimated fair value could be significantly different than the fair value the Company determined. Contingent consideration liabilities expected to be settled within twelve months are classified as a current liability within accounts payable and accrued liabilities in the consolidated balance sheet. Contingent consideration expected to be settled in more than twelve months is classified as a non-current liability. As of December 31, 2025, the fair value of the current and non-current contingent consideration was $57.8 million and $314.3 million, respectively.
A valuation of the contingent consideration liabilities is performed quarterly with gains and losses included within change in fair value of deferred and contingent consideration liabilities in the consolidated statements of comprehensive loss. The following significant unobservable inputs were used in the valuation of the contingent consideration liabilities as of December 31, 2025 and 2024:
| Contingent Consideration Liabilities | Fair Value as of December 31, 2025(in millions) | Valuation Technique | Unobservable Inputs | Values |
|---|---|---|---|---|
| Development and regulatory milestones | $366.9 | Probability-adjusted | Probabilities of success | 14% - 90% |
| Contingent Consideration Liabilities | Fair Value as of December 31, 2024(in millions) | Valuation Technique | Unobservable Inputs | Values |
|---|---|---|---|---|
| Development and regulatory milestones | $166.7 | Probability-adjusted | Probabilities of success | 14% - 97% |
A rollforward of the Company's valuations for the contingent consideration liabilities for the years ended December 31, 2025 and 2024 follows (in thousands):
| Contingent Consideration (Level 3 Liabilities) | |
|---|---|
| Balance as of December 31, 2023 | $84,600 |
| Additions | — |
| Change in fair value | 84,300 |
| Payments | — |
| Balance as of December 31, 2024 | 168,900 |
| Additions | — |
| Change in fair value | 251,993 |
| Payments | (48,754) |
| Balance as of December 31, 2025 | $372,139 |
The change in fair value of contingent consideration liabilities are due to changes in factors such as the probability of achieving milestones, the Company's stock price, or certain other estimated assumptions. Payments are made in shares of the Company's common stock.
Royalty Financing Agreement
The fair value of the Royalty Financing Agreement at the time of the transaction was based on the Company’s estimates of future royalties expected to be paid to OrbiMed over the life of the arrangement, which was determined using forecasts from market data sources, which are considered Level 3 inputs. This liability is being amortized using the effective interest method over the life of the arrangement, in accordance with ASC 470, Debt and ASC 835, Interest. The Company will utilize the prospective method to account for subsequent changes in the estimated future payments to be made to OrbiMed and will update the effective interest rate on a quarterly basis. The carrying value of the Royalty Financing Agreement approximates fair value. See Note - 11 Royalty Financing Agreementfor further details.
Secured Senior Term Loan
The carrying value of the Term Loans are measured at amortized cost using the effective interest method and the carrying value approximates fair value. See Note - 10 Debtfor further details.
- Product Revenues, Net
In accordance with ASC 606, Revenue from Contracts with Customers, the Company recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration the Company expects to receive in exchange for the goods or services provided. To determine revenue recognition for arrangements within the scope of ASC 606, the Company performs the following five steps: (1) identify the contracts with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when or as the entity satisfies a performance obligation. At contract inception, the Company assesses the goods or services promised within each contract to determine which are performance obligations and to assess whether each promised good or service is distinct. The Company then 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. For all contracts that fall into the scope of ASC 606, the Company has identified one performance obligation: the sale of its marketed products to its customers. The Company has not incurred or capitalized any incremental costs associated with obtaining contracts with customers.
Product revenues, net consist of global net sales of ARIKAYCE and US net sales of BRINSUPRI. The Company's customers in the US include specialty pharmacies and a specialty distributor. Product revenues are recognized once the Company performs and satisfies all five steps of the revenue recognition criteria described above.
- Product Revenues, Net (Continued)
The following table presents a geographic summary of the Company's product revenues, net for the years ended December 31, 2025, 2024 and 2023 (in thousands):
| Years Ended December 31, | |||
|---|---|---|---|
| 2025 | 2024 | 2023 | |
| ARIKAYCE | |||
| US | $280,294 | $254,800 | $224,195 |
| International | 153,471 | 108,907 | 81,013 |
| Total | $433,765 | $363,707 | $305,208 |
| BRINSUPRI | |||
| US | $172,658 | $— | $— |
| Total | $172,658 | $— | $— |
| Total | |||
| US | $452,952 | $254,800 | $224,195 |
| International | 153,471 | 108,907 | 81,013 |
| Total product revenues, net | $606,423 | $363,707 | $305,208 |
During the years ended December 31, 2025, 2024 and 2023, sales of ARIKAYCE in Japan comprised 80%,81% and 81% of international ARIKAYCE revenues, respectively.
Revenue is recorded at net selling price (transaction price), which includes estimates of variable consideration for which reserves are established for (a) customer credits, such as invoice discounts for prompt pay, (b) estimated government rebates, such as Medicaid and Medicare Part D reimbursements, and estimated managed care rebates, (c) estimated chargebacks, and (d) estimated costs of co-payment assistance. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (prompt pay discounts and chargebacks), prepaid expenses (co-payment assistance), or as a current liability (rebates). Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company's historical experience, current contractual and statutory requirements, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company's best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contract. The amount of variable consideration included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known.
Customer credits: Certain of the Company's customers are offered various forms of consideration, including prompt payment discounts. The payment terms for sales to specialty pharmacies and specialty distributors for prompt payment discounts are based on contractual rates agreed with the respective specialty pharmacies and distributors. The Company anticipates that its customers will earn these discounts and, therefore, deducts the full amount of these discounts from total gross product revenues at the time such revenues are recognized.
Rebates: The Company contracts with certain government agencies and managed care organizations, or collectively, third-party payors, so that its marketed products 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. These reserves are recorded in the same period in which the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The current liability is included in accounts payable and accrued liabilities on the consolidated balance sheets. 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 government mandated discounts applicable to government-funded programs, (iii) a range of possible outcomes that are probability-weighted for the estimated payor mix, and (iv) information obtained from the Company's specialty pharmacies.
- Product Revenues, Net (Continued)
Chargebacks: Chargebacks are discounts that occur when certain contracted customers, currently public health service institutions and federal government entities purchasing via the Federal Supply Schedule, purchase directly from the Company's specialty distributor. Contracted customers generally purchase the product at a discounted price and the specialty distributor, in turn, charges back to the Company the difference between the price the specialty distributor initially paid and the discounted price paid by the contracted customers. The Company estimates chargebacks provided to the specialty distributor and deducts these estimated amounts from gross product revenues, and from accounts receivable, at the time revenues are recognized.
Co-payment assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. Based upon the terms of the program and information regarding programs provided for similar specialty pharmaceutical products, the Company estimates the average co-pay mitigation amounts and the percentage of patients that it expects to participate in the program in order to establish accruals for co-payment assistance. These reserves are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue. The Company adjusts its accruals for co-pay assistance based on actual redemption activity and estimates of future redemptions related to sales in the current period.
If any, or all, of the Company's actual experience varies from its estimates, the Company may need to adjust prior period accruals, affecting revenue in the period of adjustment.
The Company also recognizes revenue related to various MAPs in Europe. During the fourth quarter of 2022, the Company agreed with French authorities on the final reimbursement price related to the temporary authorization for use (Autorisation Temporaire d'Utilisation or ATU) program in France. The accrued France ATU reimbursement payable as of December 31, 2025 relates to current year sales and is recorded within accounts payable and accrued liabilities in the consolidated balance sheets. See Note 8 - Accounts Payable and Accrued Liabilitiesfor further details.
The following table provides a summary rollforward of the Company's sales allowances and related accruals for the years ended December 31, 2025 and 2024, which have been deducted in arriving at product revenues, net (in thousands):
| Customer Credits, Fees and Discounts | Rebates, Chargebacks and Co-pay Assistance | Total | |
|---|---|---|---|
| Balance as of December 31, 2023 | $15,482 | $10,177 | $25,659 |
| Allowances for current period sales | 14,410 | 41,082 | 55,492 |
| Allowances for prior period sales | 100 | 3,380 | 3,480 |
| Payments and credits | (22,415) | (39,958) | (62,373) |
| Balance as of December 31, 2024 | $7,577 | $14,681 | $22,258 |
| Allowances for current period sales | 23,746 | 111,829 | 135,575 |
| Allowances for prior period sales | — | 500 | 500 |
| Payments and credits | (19,876) | (59,102) | (78,978) |
| Balance as of December 31, 2025 | $11,447 | $67,908 | $79,355 |
- Inventory
The Company's inventory balance consists of the following (in thousands):
| As of December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Raw materials | $30,623 | $19,682 |
| Work-in-process | 41,346 | 39,932 |
| Finished goods | 60,099 | 38,964 |
| $132,068 | $98,578 | |
Inventory is stated at the lower of cost and net realizable value and consists of raw materials, work-in-process, and finished goods. The Company has not recorded any significant inventory write-downs. The Company currently uses a limited number of third-party CMOs to produce its inventory.
- Intangibles, Net and Goodwill
Intangibles, Net
Finite-lived Intangible Assets
As of December 31, 2025, the Company's finite-lived intangible assets consisted of acquired ARIKAYCE R&D, the milestones paid to PARI for the license to use Lamira for the delivery of ARIKAYCE to patients as a result of the FDA and EC approvals of ARIKAYCE in September 2018 and October 2020, respectively, the milestone paid to AstraZeneca as a result of the FDA approval of BRINSUPRI in August 2025, and the milestone payable to AstraZeneca as a result of the EC approval of BRINSUPRI in November 2025. The Company began amortizing its acquired ARIKAYCE R&D and PARI milestone-related intangible assets in October 2018, over ARIKAYCE's initial regulatory exclusivity period of 12 years, and began amortizing its AstraZeneca milestone-related intangible assets in August and November 2025 over BRINSUPRI's regulatory exclusivity period of approximately 14 years. Amortization expense is estimated to be $8.3 million per year for the years 2026 through 2029, and approximately $7.1 million for 2030.
Indefinite-lived Intangible Assets
As of December 31, 2025, the Company's indefinite-lived intangible assets consisted of acquired IPR&D from the Business Acquisition. Indefinite-lived intangible assets are not amortized.
A rollforward of the Company's intangible assets for the years ended December 31, 2025 and 2024 follows (in thousands):
| Intangible Asset | December 31, 2024 | Additions | Amortization | December 31, 2025 |
|---|---|---|---|---|
| Acquired ARIKAYCE R&D | $27,888 | $— | $(4,850) | $23,038 |
| PARI milestones | 1,164 | — | (202) | 962 |
| AstraZeneca milestones | — | 45,000 | (949) | 44,051 |
| Acquired IPR&D | 29,600 | — | — | 29,600 |
| $58,652 | $45,000 | $(6,001) | $97,651 | |
| Intangible Asset | December 31, 2023 | Additions | Amortization | December 31, 2024 |
| Acquired ARIKAYCE R&D | $32,738 | $— | $(4,850) | $27,888 |
| PARI milestones | 1,366 | — | (202) | 1,164 |
| Acquired IPR&D | 29,600 | — | — | 29,600 |
| $63,704 | $— | $(5,052) | $58,652 |
Goodwill
The Company's goodwill balance of $136.1 million as of December 31, 2025 and 2024 resulted from the August 2021 Business Acquisition.
- Fixed Assets, Net
Fixed assets are stated at cost and depreciated using the straight-line method, based on useful lives as follows (in thousands):
| EstimatedUseful Life (years) · As of December 31, | |||
|---|---|---|---|
| Asset Description · 2025 · 2024 | |||
| Building | 39 | $10,437 | $— |
| Land | NA | 1,963 | — |
| Laboratory equipment | 7 | 39,127 | 26,753 |
| Furniture and fixtures | 7 | 6,428 | 6,428 |
| Computer hardware and software | 3 - 5 | 8,425 | 6,485 |
| Office equipment | 7 | 171 | 171 |
| Manufacturing equipment | 7 | 1,336 | 1,336 |
| Leasehold improvements | 2 - 10 | 53,400 | 38,058 |
| Construction in progress | — | 42,410 | 51,127 |
| 163,697 | 130,358 | ||
| Less accumulated depreciation | (60,755) | (50,306) | |
| $102,942 | $80,052 | ||
Depreciation expense was$10.4 million,$6.0 million and $5.5 million for the years ended December 31, 2025, 2024 and 2023, respectively.
- Accounts Payable and Accrued Liabilities
Accounts payable and accrued liabilities consist of the following (in thousands):
| As of December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Accounts payable and other accrued operating expenses | $79,907 | $73,033 |
| Accrued clinical trial expenses | 34,329 | 26,068 |
| Accrued professional fees | 23,658 | 17,895 |
| Accrued technical operation expenses | 22,533 | 18,388 |
| Accrued compensation and employee related costs | 111,514 | 80,312 |
| Accrued royalty and milestones payable | 17,101 | 6,324 |
| Accrued interest payable | — | 359 |
| Revenue Interest Payments payable | 6,449 | 4,177 |
| Accrued sales allowances and related costs | 70,869 | 16,762 |
| Accrued French rebate payable | 6,960 | 5,988 |
| Contingent consideration | 57,799 | 24,700 |
| Accrued milestone payment to AstraZeneca | 15,000 | — |
| Other accrued liabilities | 9,941 | 11,203 |
| $456,060 | $285,209 | |
In November 2025, a $15.0 million milestone commitment became payable to AstraZeneca upon EC approval of BRINSUPRI. See Note 6 - Intangibles, Net and Goodwill for further details.
- Leases
The Company's lease portfolio consists primarily of office and laboratory space, manufacturing facilities, research equipment and fleet vehicles. All of the Company's leases are classified as operating leases, except for the Company's leases of its corporate headquarters and a research facility in San Diego, which are classified as finance leases. The terms of the Company's lease agreements that have commenced range from less thanone year toten years, ten months. In its assessment of the term of each such lease, the Company has not included any options to extend or terminate the lease due to the absence of economic incentives in its lease agreements. Leases that qualify for treatment as a short-term lease are expensed as incurred. These short-term leases are not material to the Company's financial position. Furthermore, the Company does not separate lease and non-lease components for all classes of underlying assets. The Company's leases do not contain residual value guarantees and it does not sublease any of its leased assets.
The Company outsources its manufacturing operations to CMOs. Upon review of the agreements with its CMOs, the Company determined that these contracts contain embedded leases for dedicated manufacturing facilities. The Company obtains substantially all of the economic benefits from the use of the manufacturing facilities, the Company has the right to direct how and for what purpose the facility is used throughout the period of use, and the supplier does not have the right to change the operating instructions of the facility. The operating lease right-of-use assets and corresponding lease liabilities associated with the manufacturing facilities is the sum of the minimum guarantees over the life of the production contracts.
The Company records variable consideration for variable lease payments in excess of fixed fees or minimum guarantees. Variable costs related to CMO manufacturing agreements are direct costs related to the manufacturing of ARIKAYCE and are capitalized within inventory in the Company's consolidated balance sheet, while the variable costs related to other leasing arrangements, not related to the manufacturing of ARIKAYCE, have been classified within operating expenses in the Company's consolidated statements of comprehensive loss. The following table below summarizes the Company's total lease costs included in its consolidated financial statements, as well as other required quantitative disclosures (in thousands):
| As of December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Finance lease cost: | ||
| Amortization of right-of-use assets | $2,712 | $2,712 |
| Interest on lease liabilities | 2,005 | 2,230 |
| Total finance lease cost | $4,717 | $4,942 |
| Operating lease cost | 10,880 | 10,415 |
| Variable lease cost | 24,764 | 25,818 |
| Total lease cost | $40,361 | $41,175 |
| Other information: | ||
| Cash paid for amounts included in the measurement of lease liabilities | ||
| Operating cash flows for finance leases | $2,006 | $2,230 |
| Operating cash flows for operating leases | $11,040 | $10,389 |
| Financing cash flows for finance leases | $2,961 | $2,610 |
| Right-of-use assets obtained in exchange for new finance lease liabilities | $— | $— |
| Right-of-use assets obtained in exchange for new operating lease liabilities | $12,762 | $8,995 |
| Weighted average remaining lease term - finance leases | 5.7 years | 6.6 years |
| Weighted average remaining lease term - operating leases | 2.4 years | 2.9 years |
| Weighted average discount rate - finance leases | 7.8% | 7.9% |
| Weighted average discount rate - operating leases | 8.9% | 9.0% |
- Leases (Continued)
The following table below presents the maturity of lease liabilities on an annual basis for the remaining years of the Company's commenced lease agreements (in thousands):
| Year Ending December 31, | Finance Leases | Operating Leases |
|---|---|---|
| 2026 | $5,097 | $11,058 |
| 2027 | 5,228 | 9,376 |
| 2028 | 5,361 | 2,565 |
| 2029 | 5,496 | 954 |
| 2030 | 4,413 | — |
| Thereafter | 4,248 | — |
| Total | 29,843 | 23,953 |
| Less: present value discount | 5,779 | 2,310 |
| Present value of lease liabilities | $24,064 | $21,643 |
| Balance Sheet Classification at December 31, 2025: | ||
| Current lease liabilities | $3,345 | $9,469 |
| Long-term lease liabilities | 20,719 | 12,174 |
| Total lease liabilities | $24,064 | $21,643 |
In addition to the Company's lease agreements that have previously commenced and are reflected in the consolidated financial statements, the Company has entered into additional lease agreements that have not yet commenced. The Company entered into certain agreements with Patheon related to increasing its long-term production capacity for ARIKAYCE commercial inventory. The Company has determined that these agreements with Patheon contain an embedded lease for the manufacturing facility and the specialized equipment contained therein. As of December 31, 2025, costs of $69.5 million incurred by the Company under these additional agreements have been classified within other assets in the Company's consolidated balance sheet. Upon the commencement date, prepaid costs and minimum guarantees specified in the agreement will be combined to establish an operating lease ROU asset and operating lease liability.
- Debt
Debt, long-term consists of the following commitments as of December 31, 2025 and 2024 (in thousands):
| As of December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Convertible notes | $— | $567,164 |
| Term Loans | 540,964 | 536,218 |
| Debt, long-term | $540,964 | $1,103,382 |
2028 Convertible Notes
In May 2021, the Company completed an underwritten public offering of $575.0 million aggregate principal amount of the 2028 Convertible Notes, including the exercise in full of the underwriters' option to purchase an additional $75.0 million in aggregate principal amount of 2028 Convertible Notes. The Company's net proceeds from the offering, after deducting underwriting discounts and commissions and other offering expenses of $15.7 million, were approximately $559.3 million. The 2028 Convertible Notes bore interest payable semiannually in arrears on June 1 and December 1 of each year, beginning on December 1, 2021. The fair value of the liability component of the 2028 Convertible Notes on the date of issuance was estimated at $371.6 million using an effective interest rate of 7.1% and, accordingly, the residual equity component on the date of issuance was $203.4 million.
As of December 31, 2024, holders ofseventy-seven thousand dollars of aggregate principal amount of 2028 Convertible Notes elected to convert their notes, resulting in an issuance of an aggregate of 2,362 shares of the Company’s common stock. The 2028 Convertible Notes would have matured on June 1, 2028 but, on April 24, 2025, the Company issued a redemption notice for the 2028 Convertible Notes with a redemption date of June 6, 2025 (the Redemption Date). The
Company elected to settle any conversions of the 2028 Convertible Notes that occurred on or before the business day prior to the Redemption Date in shares of the Company’s common stock.
Through April 24, 2025, holders of $5.5 million of aggregate principal amount of 2028 Convertible Notes elected to convert their notes into shares of the Company’s common stock at a conversion rate of 30.7692 shares of common stock per $1,000 principal amount of notes (equivalent to a conversion price of approximately $32.50 per share of common stock), resulting in an issuance of an aggregate of 168,944 shares of the Company's common stock. After April 24, 2025, holders of $567.5 million of aggregate principal amount of the then outstanding 2028 Convertible Notes elected to convert their notes into shares of the Company's common stock at a conversion rate of 31.2861 shares of common stock per $1,000 principal amount of notes (equivalent to a conversion price of approximately $31.96 per share of common stock), resulting in the issuance of an aggregate of 17,756,196 shares of the Company’s common stock. On the Redemption Date, all then outstanding 2028 Convertible Notes were redeemed at a redemption price equal to 100% of the principal amount of such 2028 Convertible Notes, plus accrued and unpaid interest on such 2028 Convertible Notes to, but excluding, the Redemption Date (the Redemption Price). For each $1,000.00 principal amount of 2028 Convertible Notes, the Redemption Price was equal to approximately $1,000.10.
2025 Convertible Notes
In January 2018, the Company completed an underwritten public offering of $450.0 million aggregate principal of the 2025 Convertible Notes, including the exercise in full of the underwriters' option to purchase an additional $50.0 million in aggregate principal amount of 2025 Convertible Notes. The Company's net proceeds from the offering, after deducting underwriting discounts and commissions and other offering expenses of $14.2 million, were approximately $435.8 million. The 2025 Convertible Notes bore interest payable semiannually in arrears on January 15 and July 15 of each year, beginning on July 15, 2018. The fair value of the liability component of the 2025 Convertible Notes on the date of issuance was estimated at $309.1 million using an effective interest rate of 7.6% and, accordingly, the residual equity component on the date of issuance was $140.9 million.
The 2025 Convertible Notes would have matured on January 15, 2025 but on June 27, 2024, the Company called the outstanding 2025 Convertible Notes for redemption, which was completed on August 9, 2024. The Company elected to settle any conversions of the 2025 Convertible Notes that occurred on or before the business day prior to the Redemption Date in shares of the Company’s common stock. Holders of $224.8 million aggregate principal amount of the then outstanding 2025 Convertible Notes elected to convert their notes into shares of the Company's common stock at a conversion rate of 25.5384 shares of common stock per $1,000 principal amount of 2025 Convertible Notes (equivalent to an initial conversion price of approximately $39.16 per share of common stock). These conversions resulted in the issuance of an aggregate of 5,741,063 shares of the Company’s common stock.
The remaining $0.2 million aggregate principal amount of 2025 Convertible Notes outstanding were redeemed by the Company on the Redemption Date at a redemption price equal to 100% of the principal amount of the 2025 Convertible Notes, plus accrued and unpaid interest on the 2025 Convertible Notes to, but excluding, the Redemption Date (the Redemption Price). For each $1,000 principal amount of 2025 Convertible Notes, the Redemption Price was approximately $1,001.17.
The following table presents the carrying value of the Company’s convertible notes balance (in thousands):
| As of December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Face value of outstanding convertible notes | $— | $574,923 |
| Debt issuance costs, unamortized | — | (7,759) |
| Convertible notes | $— | $567,164 |
The$567.2 million carrying value of the 2028 Convertible Notes as of December 31, 2024 is net of$7.8 million of unamortized debt issuance costs.
Secured Senior Term Loan
In October 2022, the Company entered into the $350.0 million Tranche A Term Loan with Pharmakon that would have matured on October 19, 2027. The Tranche A Term Loan originally bore interest at a rate based upon the SOFR, subject to a SOFR floor of 2.5%, in addition to a margin of 7.75% per annum. Up to 50% of the interest payable during the first 24 months from the closing of the Tranche A Term Loan could have been paid-in-kind at the Company's election. If elected, paid-in-kind interest would have been capitalized and added to the principal amount of the Tranche A Term Loan. The Tranche A Term Loan, including the paid-in-kind interest, would have been repaid ineight equal quarterly payments starting in the 13th quarter following the closing of the Tranche A Term Loan (i.e., the quarter ending March 31, 2026), except that the repayment start date could have been extended at the Company's option for an additional four quarters, so that repayments start in the 17th quarter following the closing of the Tranche A Term Loan, subject to the achievement of specified ARIKAYCE data thresholds and certain other conditions. Net proceeds from the Tranche A Term Loan, after deducting the lenders fees and deal expenses of $15.1 million, were $334.9 million.
Amended and Restated Loan Agreement
In October 2024, the Company entered into the A&R Loan Agreement, as amended on July 10, 2025, with BioPharma Credit PLC, BPCR Limited Partnership and BioPharma Credit Investments V (Master) LP, which are funds managed by Pharmakon, and the guarantors party to such agreement. The A&R Loan Agreement amended and restated the Loan Agreement, dated as of October 19, 2022, pursuant to which the Tranche A Term Loan was provided. The A&R Loan Agreement, among other items, provides an additional $150.0 million senior secured term loan tranche. The A&R Loan Agreement extends the maturity of the Term Loans to September 30, 2029, subject to acceleration to February 1, 2028 on the occurrence of certain prespecified events, and amends the interest rate on the Term Loans to a fixed rate of 9.6% per annum. As consideration for the provision of the Tranche B Term Loan, the Company agreed to pay Pharmakon a fee equal to 2.0% of the Tranche B Term Loan at the closing date of the Tranche B Term Loan and an additional exit fee of 2.0% of the amount of each prepayment or repayment of the Term Loans. The Term Loans will be repaid ineight equal quarterly payments starting on January 3, 2028. Net proceeds from the Tranche B Term Loan, after deducting the lenders fees and administrative expenses of $3.7 million, were $146.3 million.
The Company evaluated whether the A&R Loan Agreement represented a debt modification or extinguishment in accordance with ASC 470-50, Debt – Modifications and Extinguishments. As the present value of the cash flows under the terms of the A&R Loan Agreement was less than 10% different from the remaining cash flows under the terms of the Tranche A Term Loan, the A&R Loan Agreement was accounted for as a debt modification. The unamortized balance of debt issuance costs incurred in connection with the Term Loans are being amortized through September 2029 utilizing the effective interest rate method. The effective interest rate of the Term Loans was 10.6% at modification.
The following table presents the carrying value of the Company’s Term Loans balance as of December 31, 2025 and 2024 (in thousands):
| As of December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Principal | $500,000 | $500,000 |
| Paid-in-kind interest capitalized | 46,770 | 46,770 |
| Debt discount, net | (5,806) | (10,552) |
| Term Loans | $540,964 | $536,218 |
As of December 31, 2025, future principal repayments of debt for each of the fiscal years through maturity were as follows (in thousands):
| Year Ending December 31: | |
|---|---|
| 2026 | $— |
| 2027 | — |
| 2028 | 341,731 |
| 2029 | 205,039 |
| 2030 | — |
| 2031 and thereafter | — |
| $546,770 | |
The estimated fair value of the debt (categorized asa Level 2 liability for fair value measurement purposes) is determined using current market factors and the ability of the Company to obtain debt at comparable terms to those that are currently in place.
Interest expense for the years ended December 31, 2025, 2024, and 2023, is as follows (in thousands):
| Years Ended December 31, | |||
|---|---|---|---|
| 2025 | 2024 | 2023 | |
| Convertible debt contractual interest expense | $1,680 | $6,397 | $8,250 |
| Term Loans contractual interest expense | 53,219 | 51,587 | 46,743 |
| Royalty Financing Agreement non-cash interest expense | 20,675 | 20,044 | 18,846 |
| Amortization of debt issuance costs | 6,216 | 6,884 | 7,320 |
| Swap interest income | — | (2,229) | (1,882) |
| Total debt interest expense | $81,790 | $82,683 | $79,277 |
| Finance lease interest expense | 2,005 | 2,230 | 2,417 |
| Total interest expense | $83,795 | $84,913 | $81,694 |
- Royalty Financing Agreement
In October 2022, the Company entered into the Royalty Financing Agreement with OrbiMed. Under the Royalty Financing Agreement, OrbiMed paid the Company $150.0 million in exchange for the right to receive, on a quarterly basis, royalties in an amount equal to 4.0% of ARIKAYCE global net sales prior to September 1, 2025 and 4.5% of ARIKAYCE global net sales on or after September 1, 2025, as well as 0.75% of brensocatib global net sales, which includes BRINSUPRI. In the event that OrbiMed has not received aggregate Revenue Interest Payments of at least $150.0 million on or prior to March 31, 2028, the Company must make a one-time payment to OrbiMed for the difference between the $150.0 million and the aggregated Revenue Interest Payments that have been paid. In addition, the royalty rate for ARIKAYCE will be increased beginning March 31, 2028 to the rate which would have resulted in aggregate Revenue Interest Payments as of March 31, 2028 equaling $150.0 million. The total Revenue Interest Payments payable by the Company to OrbiMed are capped at 1.8 x of the purchase price or up to a maximum of 1.9 x of the purchase price under certain conditions. Net proceeds from the Royalty Financing Agreement, after deducting the lenders fees and deal expenses of $3.6 million, were $146.4 million. The Royalty Financing Agreement was amended in October 2024 to, among other things, amend certain restrictions on the Company’s ability to incur indebtedness.
The fair value of the Royalty Financing Agreement at the time of the transaction was based on the Company’s estimates of future royalties expected to be paid to OrbiMed over the life of the arrangement, which was determined using forecasts from market data sources, which are considered Level 3 inputs. This liability is being amortized using the effective interest method over the life of the arrangement, in accordance ASC 470, Debt and ASC 835, Interest. The initial annual effective interest rate was determined to be 12.4%. The Company is utilizing the prospective method to account for subsequent changes in the estimated future payments to be made to OrbiMed and updates the effective interest rate on a quarterly basis.
- Royalty Financing Agreement (Continued)
The following table presents the activity of the Company’s Royalty Financing Agreement balance for the years ended December 31, 2025 and 2024 (in thousands):
| As of December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Royalty Financing Agreement liability - beginning balance | $163,671 | $158,162 |
| Revenue Interest Payments paid and payable | (19,401) | (14,535) |
| Interest expense recognized | 20,675 | 20,044 |
| Royalty Financing Agreement liability - ending balance | $164,945 | $163,671 |
| Royalty issuance costs, unamortized - beginning balance | $(2,604) | $(3,128) |
| Amortization of issuance costs | 524 | 524 |
| Royalty issuance costs, unamortized - ending balance | $(2,080) | $(2,604) |
| Royalty Financing Agreement | $162,865 | $161,067 |
The Revenue Interest Payments payable in connection with the royalty financing agreement were $6.4 million and $4.2 million as of December 31, 2025 and 2024, respectively, which were recorded within accounts payable and accrued expenses on the consolidated balance sheets. Non-cash interest expense is recorded within interest expense in the consolidated statements of comprehensive loss.
- Shareholders' Equity
Common Stock—As of December 31, 2025, the Company had 500,000,000 shares of common stock authorized with a par value of $0.01 per share and 214,255,853 shares of common stock issued and outstanding. In addition, as of December 31, 2025, the Company had reserved 17,375,581 shares of common stock for issuance upon the exercise of outstanding common stock options,3,889,230 shares of common stock for issuance upon the vesting of RSUs and 266,443 shares for issuance upon the vesting of PSUs. In connection with the Business Acquisition, the Company reserved 9,406,112 shares of the Company’s common stock, subject to certain closing-related reductions.
Of the 9,406,112 shares reserved, subject to certain closing-related reductions, the Company issued 2,889,367 shares of the Company's common stock in connection with the Business Acquisition in the third quarter of 2021, after certain closing-related deductions.171,427,177,203, and 182,182 shares of the Company’s common stock reserved in connection with the Motus acquisition were issued as acquisition consideration on the first, second and third anniversaries of the closing date of the acquisition, respectively, in each case subject to certain reductions. During the third quarter of 2025, a development milestone in connection with the Motus acquisition was achieved, resulting in the issuance of 364,566 shares of the Company's common stock in October 2025. In February 2026, a development milestone in connection with the Motus acquisition was achieved, pursuant to which 368,867 shares of the Company's common stock, subject to certain reductions, became issuable. Additional shares of the Company's common stock will also be issued upon the achievement of certain development and regulatory milestone events, subject to certain reductions. The shares of the Company’s common stock reserved in connection with the AlgaeneX acquisition will be issued upon the achievement of a development milestone event, subject to certain reductions. As of December 31, 2025,5,348,572 shares of the Company's common stock remain reserved for the Business Acquisition.
In June 2025, the Company completed an underwritten offering of 8,984,375 shares of the Company's common stock at a public offering price of$96.00 per share.1,171,875 of the shares of common stock were issued pursuant to the exercise in full of the underwriters' option to purchase additional shares. The Company's net proceeds from the sale of the shares, after deducting the underwriting discounts and offering expenses of$39.2 million, were$823.3 million.
In May 2024, the Company completed an underwritten offering of 14,514,562 shares of the Company's common stock at a public offering price of$51.50 per share.1,893,203 of the shares of common stock were issued pursuant to the exercise in full of the underwriters' option to purchase additional shares. The Company's net proceeds from the sale of the shares, after deducting the underwriting discounts and offering expenses of$34.3 million, were$713.2 million.
In the second quarter of 2023, in connection with the Company's acquisition of Adrestia, the Company issued 3,430,867 shares of the Company's common stock as consideration at closing. See Note 18 - Acquisitions for further details.
In connection with the Company’s acquisition of Vertuis, the Company reserved 550,000 shares of the Company’s common stock, subject to future adjustment. An aggregate of 500,000 of the reserved shares were issued as acquisition
- Shareholders' Equity (Continued)
consideration at closing. In July 2024, the Company issued the Vertuis equityholders an additional 14,773 shares of common stock. See Note 18 - Acquisitions for further details.
In the first quarter of 2021, the Company entered into a sales agreement with Leerink Partners, to sell shares of the Company's common stock, with aggregate gross sales proceeds of up to $250.0 million, from time to time, through the ATM program, under which Leerink Partners acts as sales agent. During the year ended December 31, 2023, the Company issued and sold an aggregate of 6,503,041 shares of common stock through the ATM program at a weighted-average public offering price of $24.12 per share and received net proceeds of $152.2 million. In the first quarter of 2024, the Company entered into the new sales agreement with Leerink Partners to sell shares of the Company's common stock, with aggregate gross sales proceeds of up to $500.0 million, from time to time, through the new ATM program, under which Leerink Partners acted as sales agent. In connection with entering into the new ATM program, the Company terminated the ATM program. During the third quarter of 2024, the Company issued and sold an aggregate of 5,022,295 shares of common stock through the new ATM program at a weighted-average public offering price of $75.64 per share and received net proceeds of $371.3 million. In November 2024, the Company terminated the new sales agreement.
Preferred Stock—As of December 31, 2025 and 2024, the Company had 200,000,000 shares of preferred stock authorized with a par value of $0.01 andno shares of preferred stock were issued and outstanding.
- Stock-Based Compensation
The Company's current equity compensation plan, the Insmed Incorporated Amended and Restated 2019 Incentive Plan (the 2019 Incentive Plan), was approved by shareholders at the Company's Annual Meeting of Shareholders on May 13, 2023. The 2019 Incentive Plan replaced the Insmed Incorporated 2019 Incentive Plan, as amended, pursuant to which the Company was authorized to grant incentive awards up to an aggregate of 13,750,000 shares. At the Company’s 2023 Annual Meeting of Shareholders, in connection with approval of the 2019 Incentive Plan, the Company's shareholders approved the issuance of an additional 10,500,000 shares under the 2019 Incentive Plan. At the Company's 2024 Annual Meeting of Shareholders, the Company's shareholders approved Amendment No. 1 to the 2019 Incentive Plan, which provides for the issuance of an additional 3,000,000 shares under the plan. At the Company's 2025 Annual Meeting of Shareholders, the Company's shareholders approved Amendment No. 2 to the 2019 Incentive Plan, which provides for the issuance of an additional 10,000,000 shares under the 2019 Incentive Plan. As of December 31, 2025,11,674,577 shares remain available for future issuance under the 2019 Incentive Plan.
The 2019 Incentive Plan is administered by the Compensation Committee of the Board of Directors of the Company. Under the terms of the 2019 Incentive Plan, the Company is authorized to grant a variety of incentive awards based on its common stock, including stock options (both incentive stock options and non-qualified stock options), RSUs, performance options/shares and other stock awards to eligible employees and non-employee directors. The 2019 Incentive Plan will terminate on April 3, 2029 unless it is extended or terminated earlier pursuant to its terms.
In addition, from time to time, the Company makes inducement grants of stock options and RSUs to new hires, which awards are made pursuant to the Nasdaq's inducement grant exception to the shareholder approval requirement for grants of equity compensation. The Company granted inducement stock options and RSUs covering 522,517,1,444,850 and 2,674,290 shares of the Company's common stock to new employees during the years ended December 31, 2025, 2024 and 2023, respectively. In February 2025, the Company adopted the Insmed Incorporated 2025 Inducement Plan, under which the Company is authorized to grant a variety of inducement awards, including stock options and RSUs, up to an aggregate of 1,000,000 shares, as an inducement to become an employee of the Company or any of its subsidiaries. As of December 31, 2025,700,233 shares remain available for future issuance under the Insmed Incorporated 2025 Inducement Plan.
On May 15, 2018, the 2018 Employee Stock Purchase Plan was approved by shareholders at the Company's 2018 Annual Meeting of Shareholders. The ESPP allows eligible employees to acquire an ownership interest in the Company by purchasing common stock, at a discount, through payroll deductions. As of December 31, 2025,4,359,032 shares remain available for future issuance under the ESPP. The ESPP is compensatory under GAAP and the Company recorded stock-based compensation expense of $4.5 million, $3.3 million and $1.9 million for the years ended December 31, 2025, 2024 and 2023, respectively.
Stock Options—The Company calculates the fair value of stock options granted using the Black-Scholes valuation model. The following table summarizes the grant date fair value and assumptions used in determining the fair value of all stock options granted, including grants of inducement options, during the years ended December 31, 2025, 2024 and 2023.
| 2025 | 2024 | 2023 | |
|---|---|---|---|
| Volatility | 61% - 65% | 61% - 69% | 62% - 70% |
| Risk-free interest rate | 3.59% - 4.45% | 3.51% - 4.64% | 3.36% - 4.72% |
| Dividend yield | 0.0% | 0.0% | 0.0% |
| Expected option term (in years) | 5.89 | 6.11 | 6.05 |
| Weighted average fair value of stock options granted | $42.52 | $20.11 | $13.12 |
The volatility factor was based on the Company’s historical volatility during the expected option term. The Company accounts for forfeitures as they occur.
From time to time, the Company has granted performance-conditioned options to certain of its employees. Vesting of these options is subject to the Company achieving certain performance criteria established at the date of grant and the grantees fulfilling a service condition (continued employment). As of December 31, 2025 and December 31, 2024, the Company had performance-conditioned options covering 114,780 shares outstanding. As of December 31, 2025 and December 31, 2024, the performance conditions are not probable and thereforeno stock-based compensation was recorded in the consolidated statements of comprehensive loss.
The following table summarizes stock option activity for stock options granted for the year ended December 31, 2025 as follows:
| Number ofShares | WeightedAverageExercisePrice | WeightedAverageRemainingContractualLife in Years | AggregateIntrinsicValue(in '000) | |
|---|---|---|---|---|
| Options outstanding at December 31, 2024 | 21,927,128 | $23.89 | ||
| Granted | 1,361,710 | $68.55 | ||
| Exercised | (5,597,272) | $22.20 | ||
| Forfeited and expired | (315,985) | $36.58 | ||
| Options outstanding at December 31, 2025 | 17,375,581 | $27.82 | 6.60 | $2,540,642 |
| Exercisable at December 31, 2025 | 9,976,481 | $22.75 | 5.62 | $1,509,208 |
The total intrinsic value of stock options exercised during the years ended December 31, 2025, 2024 and 2023 was $534.9 million, $173.4 million and $6.0 million, respectively.
As of December 31, 2025, there was $132.3 million of unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted average period of 1.9 years.
Restricted Stock Units—The Company may grant RSUs to employees and non-employee directors. Each RSU represents a right to receiveone share of the Company's common stock upon the completion of a specific period of continued service.
RSU awards granted are valued at the market price of the Company's common stock on the date of grant. The Company recognizes non-cash compensation expense for the fair values of RSUs on a straight-line basis over the requisite service period of the awards.
The following table summarizes RSU awards granted during the year ended December 31, 2025:
| Number ofRSUs | WeightedAverageGrant Price | |
|---|---|---|
| Outstanding at December 31, 2024 | 3,320,341 | $23.67 |
| Granted | 1,896,360 | $72.62 |
| Released | (1,183,350) | $23.59 |
| Forfeited | (144,121) | $38.28 |
| Outstanding at December 31, 2025 | 3,889,230 | $46.96 |
The total grant-date fair value of RSU awards vested during the years ended December 31, 2025, 2024 and 2023 was $27.9 million, $19.6 million, and $13.1 million, respectively.
As of December 31, 2025, there was $140.7 million of unrecognized compensation expense related to unvested awards, which is expected to be recognized over a weighted average period of 2.4 years.
Performance Stock Units—In December 2025, the Company granted 91,877 PSUs (the 2025 PSUs) to certain of its employees. The 2025 PSUs are subject to a performance condition and a service condition. The performance condition is the number of INDs cleared by the FDA through December 31, 2028. The service condition is continuous employment with the Company through February 1, 2029. The potential payout of the award ranges from 0% to 200% of the target, dependent on the number of INDs cleared through December 31, 2028. The Company will begin recognizing compensation cost on the date that performance condition becomes probable, with an initial recording of the cumulative expense that would have been recognized if the PSU expense had been recognized on a straight-line basis since the date of grant. The remai ning unrecognized compensation cost will then be expensed prospectively on a straight-line basis over the remaining service period. Any forfeitures of unvested awards that occur after compensation cost recognition commences will result in the cumulative reversal of expense in the period in which the forfeiture occurs. As of December 31, 2025, no performance condition was probable and therefore no stock-based compensation was recorded in the consolidated statements of comprehensive loss. As of December 31, 2025, there was an unrecognized expense related to the 2025 PSUs of$18.1 million, which assumes a 100% payout.
In January 2022, the Company issued 271,612 PSUs (the 2022 PSUs). The 2022 PSUs were subject totwo performance conditions based on brensocatib milestones, both of which had been achieved as of March 31, 2025, and a service condition, which wasthree years of continued employment. The Company achieved the first performance condition by issuing a press release announcing certain topline results from the ASPEN trial by June 30, 2024. The Company achieved the second performance condition in February 2025 upon the FDA's notification that the new drug application had been accepted for brensocatib. During the second quarter of 2024, the Company's total shareholder return was compared to the Company's Peer Group and the payout of the awards was determined to be 250% of the target. During the year ended December 31, 2025,660,466 shares were issued upon vesting of the 2022 PSUs and $10.3 million of stock-based compensation expense was recognized.
The following table summarizes the aggregate stock-based compensation expense recorded in the consolidated statements of comprehensive loss related to stock options, RSUs, PSUs and ESPP during the years ended December 31, 2025, 2024 and 2023 (in thousands):
| Years Ended December 31, | |||
|---|---|---|---|
| 2025 | 2024 | 2023 | |
| Research and development expenses | $70,046 | $47,674 | $35,880 |
| Selling, general and administrative expenses | 82,664 | 49,161 | 38,898 |
| Total stock-based compensation expense | $152,710 | $96,835 | $74,778 |
There wasno stock-based compensation expense recorded in the consolidated statements of comprehensive loss related to the 2022 PSUs during the years ended December 31, 2024 and 2023, as the performance conditions associated with the 2022 PSU awards were not probable as of these dates.
- Income Taxes
For the years ended December 31, 2025, 2024 and 2023, the Company recorded a provision for income taxes of $5.0 million, $3.7 million and $2.6 million, respectively.
The Company's loss before income taxes in the US and globally was as follows (in thousands):
| Years Ended December 31, | |||
|---|---|---|---|
| 2025 · 2024 · 2023 | |||
| US | $(1,118,491) | $(814,531) | $(666,181) |
| Foreign | (153,258) | (95,534) | (80,831) |
| $(1,271,749) | $(910,065) | $(747,012) | |
The Company's provision for income taxes consisted of the following (in thousands):
| Years Ended December 31, | |||
|---|---|---|---|
| 2025 | 2024 | 2023 | |
| Current: | |||
| Federal | $— | $— | $— |
| State | 577 | 356 | 378 |
| Foreign | 4,476 | 3,380 | 2,231 |
| Total current provision | 5,053 | 3,736 | 2,609 |
| Deferred: | |||
| Federal | — | — | (13) |
| State | (27) | (29) | (41) |
| Foreign | — | — | — |
| Total deferred benefit | (27) | (29) | (54) |
| Provision for income taxes | $5,026 | $3,707 | $2,555 |
The reconciliation between the federal statutory tax rate and the Company's effective tax rate, after the retrospective adoption of ASU 2023-09, is as follows (in thousands):
| Years Ended December 31, | ||||||
|---|---|---|---|---|---|---|
| 2025 | 2024 | 2023 | ||||
| $ | % | $ | % | $ | % | |
| Statutory federal taxes and tax rate | $(267,067) | 21.0% | $(191,114) | 21.0% | $(156,873) | 21.0% |
| State and local income taxes, net of federal income tax effect (1) | 552 | —% | 321 | —% | 338 | —% |
| Foreign tax effects | ||||||
| Switzerland | ||||||
| Changes in valuation allowance | 12,746 | (1.0)% | 9,056 | (1.0)% | 8,462 | (1.1)% |
| Other | 9,843 | (0.8)% | 7,955 | (0.9)% | 5,308 | (0.7)% |
| Other foreign jurisdictions | 14,071 | (1.1)% | 6,432 | (0.7)% | 4,813 | (0.6)% |
| Effects of cross-border tax laws | — | —% | — | —% | — | —% |
| Tax credits | ||||||
| Research and development tax credits | (38,872) | 3.1% | (30,861) | 3.4% | (22,330) | 3.0% |
| Changes in valuation allowances | 271,336 | (21.3)% | 185,366 | (20.4)% | 131,040 | (17.5)% |
| Nontaxable or nondeductible items | ||||||
| Stock-based compensation, net of nondeductible compensation | (59,412) | 4.7% | (12,574) | 1.4% | 2,443 | (0.3)% |
| Change in fair value of contingent consideration | 52,919 | (4.2)% | 19,253 | (2.1)% | 6,026 | (0.8)% |
| Asset acquisition | — | —% | — | —% | 18,217 | (2.4)% |
| Other | 729 | (0.1)% | 309 | —% | 865 | (0.1)% |
| Changes in unrecognized tax benefits | — | —% | — | —% | — | —% |
| Effect of changes in tax laws or rates enacted in the current period | — | —% | — | —% | — | —% |
| Other adjustments | 8,181 | (0.6)% | 9,564 | (1.1)% | 4,246 | (0.6)% |
| Provision for income taxes and effective tax rate | $5,026 | (0.3)% | $3,707 | (0.4)% | $2,555 | (0.1)% |
(1) The state that contributed to the majority (greater than 50%) of the tax effect in this category was Texas.
The provisions recorded for the years ended December 31, 2025, 2024 and 2023 are primarily a result of the Company’s international subsidiaries that had taxable income during the periods and certain state taxes in the US which impose income tax on modified gross revenues. There was a full valuation allowance recorded against the Company’s deferred tax assets and therefore no tax benefit was recorded.
The amounts of cash paid for income taxes by the Company are as follows:
| Years Ended December 31, | |||
|---|---|---|---|
| 2025 | 2024 | 2023 | |
| Federal | $— | $— | $— |
| State | |||
| Texas | 315 | 340 | 201 |
| Other state (1) | 64 | 62 | 117 |
| Foreign | |||
| Japan | 2,189 | 1,238 | 742 |
| Netherlands | 1,034 | 267 | 474 |
| Germany | — | 300 | 214 |
| Italy | — | 197 | — |
| Switzerland | — | — | 110 |
| Other foreign (1) | 539 | 95 | 97 |
| $4,141 | $2,499 | $1,955 | |
(1) In a period in which income taxes paid in a jurisdiction do not exceed 5% of total income taxes paid, the taxes paid to that jurisdiction are reported in other state or other foreign.
Deferred tax assets and liabilities are determined based on the difference between financial statement and tax bases using enacted tax rates in effect for the year in which the differences are expected to reverse. The components of the deferred tax assets and liabilities consist of the following:
| As of December 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Deferred tax assets: | ||
| Net operating loss and other carryforwards | $956,032 | $672,735 |
| General business credits | 267,818 | 217,859 |
| Capitalized R&D | 167,487 | 178,021 |
| Stock-based compensation | 30,852 | 30,701 |
| Other (1) | 41,635 | 38,533 |
| Deferred tax assets | 1,463,824 | 1,137,849 |
| Valuation allowance | (1,456,726) | (1,125,370) |
| Deferred tax assets, net of valuation allowance | $7,098 | $12,479 |
| Deferred tax liabilities: | ||
| Intangibles | $— | $(5,581) |
| Right-of-use assets | (7,127) | (6,953) |
| Deferred tax liabilities | $(7,127) | $(12,534) |
| Net deferred tax liabilities | $(29) | $(55) |
(1)Prior period amounts have been reclassified for consistency with the current period presentation.
The deferred tax assets, net of valuation allowance, of $7.1 million and $12.5 million at December 31, 2025 and 2024, respectively, primarily consisted of net operating loss, tax credit carryforwards and capitalized R&D for income tax purposes. As required by the 2017 Tax Cuts and Jobs Act, effective January 1, 2022, and through the year ended December 31, 2024, the Company's research and development expenditures were capitalized, resulting in a deferred tax asset. As amended by the One
Big Beautiful Bill Act (OBBBA), effective January 1, 2025, the Company’s current year US research and development expenditures are no longer required to be capitalized. Due to the Company's history of operating losses, the Company recorded a valuation allowance on its net deferred tax assets by increasing the valuation allowance by $331.4 million and $221.3 million in 2025 and 2024, respectively, as it was more likely than not that such tax benefits will not be realized.
At December 31, 2025, the Company had federal net operating loss (NOL) carryforwards for income tax purposes of approximately $3.3 billion and federal tax credit carryforwards of $270.1 million. Due to the limitation on NOLs as more fully discussed below, $3.1 billion of the NOLs are available to offset future taxable income, if any. The NOL carryovers and general business tax credits expire in various years beginning in 2026. For state tax purposes, the Company has approximately $2.1 billion of NOLs in various states available to offset against future taxable income and state tax credit carryforwards of $23.1 million, expiring in various years beginning in 2026. The Company has $301.1 million of non-trading loss carryforwards in Ireland and loss carryforwards in the UK and Switzerland of $95.7 million and $277.1 million, respectively. The loss carryforwards in Ireland and the UK carry forward indefinitely while the loss carryforward in Switzerland begins to expire in 2030. The Company has disallowed interest expense carryover of $47.7 million which carries forward indefinitely.
The Company completed an Internal Revenue Code Section 382 (Section 382) analysis in order to determine the amount of losses that are currently available for potential offset against future taxable income, if any. It was determined that the utilization of the Company's NOL and general business tax credit carryforwards generated in tax periods up to and including December 2010 were subject to substantial limitations under Section 382 due to ownership changes that occurred at various points from the Company's original organization through December 2010. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of shareholders that own, directly or indirectly, 5% or more of a corporation's stock, in the stock of a corporation by more than 50 percentage points over a testing period (usually 3 years). Since the Company's formation in 1999, it has raised capital through the issuance of common stock on several occasions which, combined with the purchasing shareholders' subsequent disposition of those shares, have resulted in multiple changes in ownership, as defined by Section 382. These ownership changes resulted in substantial limitations on the use of the Company's NOLs and general business tax credit carryforwards up to and including December 2010. The Company continues to track all of its NOLs and tax credit carryforwards but has provided a full valuation allowance to offset those amounts.
Law Changes
On July 4, 2025, H.R. 1 – OBBBA was signed into law. OBBBA provides for US tax law changes and modifications including effective beginning in 2025, the ability to deduct US based research and development expenditures, a more favorable interest expense limitation and the reinstatement of 100% bonus depreciation on qualified property. OBBBA also includes several changes to the US taxation of foreign activity, including changes to foreign tax credits, global intangible low-taxed income and foreign derived intangible income, among other things. Given the Company’s history of net operating losses, OBBBA did not have a significant impact on the Company’s financial statements.
The Organisation for Economic Co-operation and Development (OECD) recently published a framework to implement a global corporate minimum income tax rate of 15% on income arising in low-tax jurisdictions (Pillar Two). The Pillar Two proposed legislation is applicable to multinational corporations with global revenue exceeding €750 million for at least two years of the preceding four years. Over 140 countries have agreed in principle to implement Pillar Two and many have, or are in the process of, enacting related legislation. In January 2026, the OECD released a "side-by-side" package introducing new safe harbors and providing an exemption for US-based multinational companies from parts of the global minimum tax framework. The Pillar Two legislation is not anticipated to be effective for the Company until the Company’s annual global revenues have exceeded the €750 million threshold for at least two years of the preceding four years. The Company will continue to evaluate the potential consequences of Pillar Two on its longer-term financial position.
The financial statement recognition of the benefit for a tax position is dependent upon the benefit being more likely than not to be sustainable upon audit by the applicable taxing authority. If this threshold is met, the tax benefit is then measured and recognized at the largest amount that is greater than 50% likely of being realized upon ultimate settlement. If such unrecognized tax benefits were realized and not subject to valuation allowances, the Company would recognize a tax benefit of $24.7 million. The following table summarizes the gross amounts of unrecognized tax benefits (in thousands):
| 2025 | 2024 | |
|---|---|---|
| Balance as of January 1, | $19,014 | $14,753 |
| Additions related to prior period tax positions | — | — |
| Additions related to current period tax positions | 5,649 | 4,261 |
| Balance as of December 31, | $24,663 | $19,014 |
The Company is subject to US federal and state income taxes and the statute of limitations for tax audit is open for the federal tax returns for the years ended 2022 and later, and is generally open for certain states for the years 2021 and later. The Company has incurred net operating losses since inception, except for the year ended December 31, 2009. Such loss carryforwards would be subject to audit in any tax year in which those losses are utilized, notwithstanding the year of origin.
The Company's policy is to recognize interest accrued related to unrecognized tax benefits and penalties in income tax expense. The Company has recordedno such expense. As of December 31, 2025 and 2024, the Company has recorded reserves for unrecognized income tax benefits of $24.7 million and $19.0 million, respectively. As any adjustment to the Company’s uncertain tax positions would not result in a cash tax liability, it has not recorded any accrued interest or penalties related to its uncertain tax positions. If any of these unrecognized tax benefits were released, there would be no impact to the Company's effective tax rate.
- License and Other Agreements
In-License Agreements
PARI Pharma GmbH—In April 2008, the Company entered into a licensing agreement with PARI for use of the optimized Lamira Nebulizer System for delivery of ARIKAYCE in treating patients with NTM lung infections, CF and bronchiectasis. Under the licensing agreement, the Company has rights under several US and foreign issued patents and patent applications involving improvements to the optimized Lamira Nebulizer System, to exploit the system with ARIKAYCE for the treatment of such indications, but the Company cannot manufacture the nebulizers except as permitted under the commercialization agreement with PARI, which is described in further detail below. The Lamira Nebulizer System has been approved for use in the US (in combination with ARIKAYCE), the EU and Japan. Under the licensing agreement, the Company paid PARI an upfront license fee and certain milestone payments. Upon FDA acceptance of the Company's NDA and the subsequent FDA and EMA approval of ARIKAYCE, the Company paid PARI additional milestone payments of €1.0 million, €1.5 million and €0.5 million, respectively. In October 2017, the Company exercised an option to buy-down the royalties that will be paid to PARI on ARIKAYCE net sales. As a result, PARI is entitled to receive royalty payments in the mid-single digits on the annual global net sales of ARIKAYCE, pursuant to the licensing agreement, subject to certain specified annual minimum royalties. See below for information related to the commercialization agreement with PARI.
Other Agreements
Adrestia Therapeutics Ltd.—In June 2023, the Company acquired all of the issued and outstanding share capital of Adrestia, a privately held, pre-clinical stage company. At the closing of the transaction, the Company issued an aggregate of 3,430,867 shares of the Company’s common stock to Adrestia’s former shareholders (collectively, the Adrestia shareholders). The closing share price on the date of the transaction was $21.10, resulting in a purchase price of $72.4 million. The Adrestia shareholders may also become entitled to receive contingent payments up to an aggregate of $326.5 million in cash upon the achievement of certain development, regulatory and commercial milestone events, as well as royalty payments based upon a low single-digit percentage of net sales of certain products, both subject to the terms and conditions of the agreement. The Company recognized $76.5 million as IPR&D expense for the year ending December 31, 2023, after adjusting for working capital assumed in connection with the asset acquisition.
Vertuis Bio, Inc.—In January 2023, the Company acquired Vertuis, a privately held, pre-clinical stage company. At the closing of the transaction, the Company issued an aggregate of 500,000 shares of the Company’s common stock to Vertuis’ former stockholders and an individual who are entitled to receive a portion of the acquisition consideration (collectively, the Vertuis equityholders). The closing share price on the date of the transaction was $18.50. In July 2024, the Company issued the Vertuis equityholders an additional $1.0 million of shares of the Company's common stock, or 14,773 shares of common stock, based on the share price on June 28, 2024. The Company is obligated to pay the Vertuis equityholders up to an aggregate of $23.0 million in cash upon the achievement of certain development and regulatory milestone events, and up to an aggregate of
- License and Other Agreements (Continued)
$63.8 million in cash upon the achievement of certain net sales-based milestone events, in each case, subject to certain reductions. The Company recognized $10.3 million as IPR&D expense for the year ending December 31, 2023.
PPD Development, L.P.—In April 2020, the Company entered into a master services agreement with PPD pursuant to which it retained PPD to perform clinical development services in connection with certain of its clinical research programs. The master services agreement has an initial term offive years. Either party may terminate (i) any project addendum under the master services agreement for any reason and without cause upon 30 days’ written notice, (ii) any project addendum in the event of the other party’s breach of the master services agreement or such project addendum upon 30 days’ written notice, provided that such breach is not cured within such 30-day period, (iii) the master services agreement or any project addendum immediately upon the occurrence of an insolvency event with respect to the other party or (iv) any project addendum upon 30 days’ written notice if (a) the continuation of the services under such project addendum would post material ethical or safety risks to study participants, (b) any approval from a regulatory authority necessary to perform the applicable study is revoked, suspended or expires without renewal or (c) in the reasonable opinion of such party, continuation of the services provided under such project addendum would be in violation of applicable law. The Company entered into project addenda with PPD to perform clinical development services over several years for, but not limited to, its PALM-ILD and PAH studies and other trials involving brensocatib and TPIP.
Patheon UK Limited—In October 2017, the Company entered into certain agreements with Patheon related to the increase of its long-term production capacity for ARIKAYCE commercial inventory. The agreements provide for Patheon to manufacture and supply ARIKAYCE for its anticipated commercial needs. Under these agreements, the Company is required to deliver to Patheon the required raw materials, including active pharmaceutical ingredients, and certain fixed assets needed to manufacture ARIKAYCE. Patheon's supply obligations will commence once certain technology transfer and construction services are completed. The Company's manufacturing and supply agreement with Patheon will remain in effect for a fixed initial term, after which it will continue for successive renewal terms unless either party has given written notice of termination. The technology transfer agreement will expire when the parties agree that the technology transfer services have been completed. The agreements may also be terminated under certain other circumstances, including by either party due to a material uncured breach of the other party or the other party’s insolvency. These early termination clauses may reduce the amounts due to the relevant parties.
AstraZeneca AB—In October 2016, the Company entered into a license agreement (AZ License Agreement) with AstraZeneca, a Swedish corporation. Pursuant to the terms of the AZ License Agreement, AstraZeneca granted the Company exclusive global rights for the purpose of developing and commercializing AZD7986 (renamed brensocatib). In consideration of the licenses and other rights granted by AstraZeneca, the Company made an upfront payment of $30.0 million. In December 2020, the Company incurred a$12.5 million milestone payment obligation upon the first dosing in a Phase 3 clinical trial of brensocatib. In May 2024, upon the Company's release of an official public statement that the Company intended to file an NDA, the Company incurred an additional $12.5 million milestone payment obligation. Upon regulatory approval by the FDA of an NDA, the Company paid AstraZeneca an additional $30.0 million. In November 2025, a $15.0 million milestone commitment became payable to AstraZeneca upon EC approval of BRINSUPRI. Subsequent to this milestone, the Company is also obligated to make an additional $15.0 million contingent payment upon the achievement of a regulatory filing milestone. If the Company elects to develop brensocatib for a second indication, the Company will be obligated to make an additional series of contingent milestone payments to AstraZeneca totaling up to $42.5 million, the first of which occurs at the initiation of a Phase 3 trial in the additional indication. The Company is not obligated to make milestone payments for additional indications. In addition, the Company will pay AstraZeneca tiered royalties ranging from high single-digit to mid-teens on net sales of any approved product based on brensocatib and one additional payment of $35.0 million upon the first achievement of $1.0 billion in annual net sales. The AZ License Agreement provided AstraZeneca with the option to negotiate a future agreement with the Company for commercialization of brensocatib in chronic obstructive pulmonary disease or asthma. In June 2024, the negotiation period following such exercise of the final option expired. No agreement was reached between the Company and AstraZeneca to permit AstraZeneca to further develop and, if approved, commercialize brensocatib in the indications of COPD or asthma. As a result, the Company retains full worldwide development and commercialization rights for brensocatib in all indications other than COPD or asthma and AstraZeneca has no further development or commercialization rights for brensocatib in COPD, asthma or any other indication.
PARI Pharma GmbH—In July 2014, the Company entered into the Commercialization Agreement for the manufacture and supply of the Device, which is an e-Flow® nebulizer modified and optimized for use with ARIKAYCE. Under the Commercialization Agreement, PARI manufactures the Device except in the case of certain defined supply failures, when the Company will have the right to make the Device and have it made by third parties (but not certain third parties deemed under
- License and Other Agreements (Continued)
the Commercialization Agreement to compete with PARI). The Commercialization Agreement has an initial term offifteen years from the first commercial sale of ARIKAYCE in October 2018. The term of the agreement may be extended by the Company for an additional five years by providing written notice to PARI at leastone year prior to the expiration of the Initial Term. Notwithstanding the foregoing, the parties have certain rights and obligations under the agreement prior to the commencement of the Initial Term.
Resilience Biotechnologies Inc. (successor to Therapure Biopharma Inc.)—In February 2014, the Company entered into a contract manufacturing agreement with Therapure Biopharma Inc., which was assumed by Resilience for the manufacture of ARIKAYCE, on a non-exclusive basis, at a 200 kg scale. Pursuant to the agreement, the Company and Resilience collaborated to construct a production area for the manufacture of ARIKAYCE in Resilience's existing manufacturing facility in Canada. The agreement had an initial term offive years, which began in October 2018, and renews automatically for successive periods oftwo years each, unless terminated by either party by providing the requiredtwo years prior written notice to the other party. Notwithstanding the foregoing, the parties have rights and obligations under the agreement prior to the commencement of the initial term. Under the agreement, the Company is obligated to pay a minimum of $6.0 million, subject to inflation increases, for commercial ARIKAYCE batches produced and certain manufacturing activities each calendar year.
Patheon Inc.—In January 2024, the Company entered into certain agreements with Patheon Inc. related to the manufacture and supply of brensocatib by Patheon Inc. for the Company’s anticipated long-term commercial needs. Under these agreements, the Company is required to deliver to Patheon Inc. the active pharmaceutical ingredient needed to manufacture brensocatib. The master commercial manufacturing services agreement with Patheon Inc. will remain in effect for a fixed initial term, after which it will continue for successive renewal terms unless either the Company or Patheon Inc. has given written notice of termination. The agreements may also be terminated under certain other circumstances, including by either party due to a material uncured breach of the other party or the other party’s insolvency. Patheon Inc.'s supply obligations are governed by individual product agreements entered into from time to time under the master commercial manufacturing services agreement. The product agreements specify, among other things, the term and pricing for Patheon Inc.’s supply obligations.
Esteve Química, S.A—In September 2024, the Company entered into a commercial manufacturing and supply agreement with Estevefor the manufacture and supply of brensocatib's active pharmaceutical ingredient. The commercial manufacturing and supply agreement has an initial term ofthree years, after which it will continue for successive 12-month renewal terms unless either the Company or Esteve has given written notice of termination. The agreement may also be terminated under certain other circumstances, including by either party due to a material uncured breach of the other party or the other party’s insolvency, the discontinue of specified dosages or changes in the regulatory landscape. Esteve’s supply obligations are based on rolling forecasts of the Company’s anticipated demand for brensocatib.
- Commitments and Contingencies
Commitments
In September 2018, the Company entered into a lease for its new corporate headquarters in Bridgewater, New Jersey. The initial lease term commenced in October 2019 and expires in September 2030. In July 2016, the Company signed an operating lease for laboratory space, also located in Bridgewater, for which the initial lease term was extended through December 2026. In July 2023, the Company signed an amendment to expand the laboratory space in Bridgewater until 2027. In January 2022, the Company entered into a lease for research activities in San Diego, California. The lease term commenced in February 2022 and expires in June 2032. In February 2023, the Company signed an agreement to lease warehouse space in San Diego through March 2029. Future minimum rental payments under the Bridgewater leases and San Diego leases are $14.6 million and $18.0 million, respectively.
Rent expense charged to operations was $13.6 million, $11.9 million and $9.2 million for the years ended December 31, 2025, 2024 and 2023, respectively. Rent expense is recorded on a straight-line basis over the term of the applicable leases.
In addition to rent, the Company has several firm purchase commitments, primarily related to the manufacturing of ARIKAYCE and annual minimum royalties on global net sales of ARIKAYCE. Future firm purchase commitments under these agreements, the last of which ends in 2034, total $63.0 million. These amounts do not represent the Company's entire anticipated purchases in the future, but instead represent only purchases that are the subject of contractually obligated minimum
- Commitments and Contingencies (continued)
purchases. The minimum commitments disclosed are determined based on non-cancelable minimum spend amounts or termination amounts. Additionally, the Company purchases products and services as needed with no firm commitment.
From time to time, the Company is a party to various lawsuits, claims and other legal proceedings that arise in the ordinary course of business. While the outcomes of these matters are uncertain, management does not expect that the ultimate costs to resolve these matters will have a material adverse effect on the Company’s consolidated financial position, results of operations or cash flows.
- Retirement Plan
The Company has a 401(k) defined contribution plan for the benefit of most US employees and permits voluntary contributions by employees subject to IRS-imposed limitations. During the year ended December 31, 2025, the Company matched 100% of eligible employee contributions on the first 5% of employee compensation (up to the IRS maximum). During the years ended December 31, 2024 and 2023, the Company matched 100% of eligible employee contributions on the first 4% of employee compensation (up to the IRS maximum). Employer contributions for the year ended December 31, 2025, 2024 and 2023 were $12.8 million, $7.4 million and $5.5 million, respectively.
- Acquisitions
Asset Acquisitions
INS1148
In December 2025, the Company acquired the global rights to OpSCF (renamed INS1148) from Opsidio. At the closing of the transaction, the Company owed an upfront payment of $40.0 million, subject to a holdback. The Opsidio shareholders may also become entitled to receive contingent payments up to an aggregate of $382 million in cash upon the achievement of certain development, regulatory and sales milestones, as well as earnout payments based upon a low to mid single-digit percentage of net sales of certain products, both subject to the terms and conditions of the agreement.
The Company evaluated the acquisition under ASC 805 and ASU 2017-01 and concluded that substantially all of the fair value of the gross assets acquired are concentrated in a single identifiable asset or a group of similar identifiable assets and accounted for the transaction as an asset acquisition. The Company determined that the asset acquired did not have any future alternative use and, in accordance with ASC 730, Research and Development, expensed the assets within research and development in the consolidated statement of comprehensive loss as of the date of the acquisition. The Company recognized $40.0 million as IPR&D expense for the year ending December 31, 2025.
- Segment Reporting
The Company manages its business activities on a consolidated basis and operates as a single operating segment. The Company derives its revenues from the development and commercialization of therapies for patients facing serious diseases. The accounting policies of the segment are the same as those described in Note 2 –Summary of Significant Accounting Policies.
The Company has a single management team that reports to the Chief Executive Officer, the chief operating decision maker (CODM), who comprehensively manages the entire business. When evaluating the Company’s financial performance, the CODM regularly reviews total revenues, total expenses, and expenses by function, and makes decisions using this information on a global basis. The CODM uses net loss, as reported in the consolidated statements of comprehensive loss, in evaluating the performance of the segment. Decisions regarding resource allocation are made primarily during the annual budget planning process and augmented as needed throughout the year. The measure of segment assets is reported on the balance sheet as total assets. The Company does not operate separate lines of business with respect to its products or product candidates. Accordingly, the Company hasone reportable segment.
- Segment Reporting (Continued)
Segment loss, including significant segment expenses, for the years ended December 31, 2025, 2024 and 2023 is as follows (in thousands):
| For the Years Ended December 31, | ||||||
|---|---|---|---|---|---|---|
| 2025 · 2024 · 2023 | ||||||
| Product revenues, net | $606,423 | $363,707 | $305,208 | |||
| Less: | ||||||
| Cost of product revenues (excluding amortization of intangible assets) | 122,938 | 85,742 | 65,573 | |||
| ARIKAYCE external R&D expenses | 41,441 | 60,269 | 62,418 | |||
| Brensocatib external R&D expenses | 96,516 | 98,569 | 108,556 | |||
| TPIP external R&D expenses | 94,201 | 65,935 | 50,185 | |||
| INS1148 asset acquisition | 40,000 | — | — | |||
| Other external R&D expenses | 129,866 | 90,604 | 132,652 | |||
| R&D compensation and benefit-related expenses | 249,203 | 194,907 | 140,861 | |||
| SG&A compensation and benefit-related expenses | 248,498 | 168,498 | 117,926 | |||
| Other segment items(a) | 563,927 | 374,947 | 295,211 | |||
| Depreciation | 10,449 | 5,961 | 5,527 | |||
| Amortization of intangible assets | 6,001 | 5,052 | 5,052 | |||
| Change in fair value of deferred and contingent consideration liabilities | 251,993 | 91,682 | 28,697 | |||
| Investment income | (60,656) | (53,307) | (42,132) | |||
| Interest expense | 83,795 | 84,913 | 81,694 | |||
| Provision for income taxes | 5,026 | 3,707 | 2,555 | |||
| Segment net loss | $(1,276,775) | $(913,772) | $(749,567) | |||
(a) Other segment items include stock-based compensation, professional fees, and facility-related expenses.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.