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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM  10-Q
(Mark One)
☒      QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2025
OR
☐      TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from                to
Commission File Number 000-30739
INSMED INC ORPORATED
(Exact name of registrant as specified in its charter)
Virginia 54-1972729
(State or other jurisdiction of incorporation or organization) (I.R.S. employer identification no.)

700 US Highway 202/206 ,
 
Bridgewater , New Jersey
08807
(Address of principal executive offices) (Zip Code)

( 908 ) 977-9900
(Registrant’s telephone number including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section12(b) of the Act:

Title of each class Trading symbols Name of each exchange on which registered
Common stock, par value $0.01 per share INSM Nasdaq Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes   x  No  ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).  Yes   x  No  ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer   x
Accelerated filer  o

Non-accelerated filer  o
Smaller reporting company  ☐

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes  ☐  No  x
As of October 24, 2025, there wer e 213,273,469 shares of the registrant’s common stock outstanding.

INSMED INCORPORATED
FORM 10-Q
FOR THE QUARTER ENDED SEPTEMBER 30, 2025
 
INDEX
PART I.  FINANCIAL INFORMATION
 

ITEM 1
Consolidated Financial Statements

  Consolidated Balance Sheet s as of September 30, 2025 (unaudited) and December 31, 2024
3

  Consolidated Statements of Comprehensive Loss (unaudited) for the three and nine months ended September 30, 2025 and  2024
4

Consolidated Statements of Shareholders' Equity (unaudited) for the three and nine months ended September 30, 2025 and 2024
5

  Consolidated Statements of Cash Flows (unaudited) for the nine months ended September 30, 2025 and  2024
7

  Notes to Consolidated Financial Statements (unaudited)
8

ITEM 2
Management’s Discussion and Analysis of Financial Condition and Results of Operations
29

ITEM 3
Quantitative and Qualitative Disclosures about Market Risk
47

ITEM 4
Controls and Procedures
48

PART II.  OTHER INFORMATION

ITEM 1
Legal Proceedings
48

ITEM 1A
Risk Factors
48

ITEM 2
Unregistered Sales of Equity Securities and Use of Proceeds
53

ITEM 5
Other Information
53

ITEM 6
Exhibits
54

SIGNATURE
55

 
Unless the context otherwise indicates, references in this Form 10-Q to “Insmed Incorporated” refers to Insmed Incorporated, a Virginia corporation, and the “Company,” “Insmed,” “we,” “us” and “our” refer to Insmed Incorporated together with its consolidated subsidiaries. INSMED, PULMOVANCE, ARIKAYCE, and BRINSUPRI are trademarks of Insmed Incorporated. This Form 10-Q also contains trademarks of third parties. Each trademark of another company appearing in this Form 10-Q is the property of its owner.

2

PART I.  FINANCIAL INFORMATION

ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS

INSMED INCORPORATED
Consolidated Balance Sheets
(in thousands, except par value and share data)
As of As of
September 30, 2025 December 31, 2024
  (unaudited)  
Assets    
Current assets:    
Cash and cash equivalents $ 334,764   $ 555,030  
Marketable securities 1,345,222   878,796  
Accounts receivable 65,259   52,012  
Inventory 120,965   98,578  
Prepaid expenses and other current assets 65,597   37,245  
Total current assets 1,931,807   1,621,661  

Fixed assets, net 89,671   80,052  
Finance lease right-of-use assets 16,239   18,273  
Operating lease right-of-use assets 10,708   17,257  
Intangibles, net 84,588   58,652  
Goodwill 136,110   136,110  
Other assets 91,613   93,226  
Total assets $ 2,360,736   $ 2,025,231  

Liabilities and shareholders’ equity    
Current liabilities:    
Accounts payable and accrued liabilities $ 409,835   $ 285,209  

Finance lease liabilities 3,246   2,961  
Operating lease liabilities 4,133   9,358  

Total current liabilities 417,214   297,528  

Debt, long-term 539,719   1,103,382  
Royalty financing agreement 163,854   161,067  
Contingent consideration 259,600   144,200  
Finance lease liabilities, long-term 21,595   24,064  
Operating lease liabilities, long-term 7,588   9,112  
Other long-term liabilities 5,595   499  
Total liabilities 1,415,165   1,739,852  

Shareholders’ equity:    
Common stock, $ 0.01 par value; 500,000,000 authorized shares, 212,583,015 and 179,382,635 issued and outstanding shares at September 30, 2025 and December 31, 2024, respectively
2,126   1,794  
Additional paid-in capital 6,249,654   4,645,791  
Accumulated deficit ( 5,308,207 ) ( 4,359,917 )
Accumulated other comprehensive gain (loss) 1,998   ( 2,289 )
Total shareholders’ equity 945,571   285,379  
Total liabilities and shareholders’ equity $ 2,360,736   $ 2,025,231  

See accompanying notes to the unaudited consolidated financial statements
3

INSMED INCORPORATED
Consolidated Statements of Comprehensive Loss (unaudited)
(in thousands, except per share data)

  Three Months Ended September 30, Nine Months Ended September 30,
  2025 2024 2025 2024

Product revenues, net $ 142,342   $ 93,425   $ 342,580   $ 259,265  

Operating expenses:    
Cost of product revenues (excluding amortization of intangible assets) 29,365   21,170   78,718   59,591  
Research and development 186,415   150,809   516,182   418,640  
Selling, general and administrative 186,376   118,930   488,684   318,601  
Amortization of intangible assets 1,538   1,263   4,064   3,789  
Change in fair value of deferred and contingent consideration liabilities 104,653   14,682   181,953   106,482  
Total operating expenses 508,347   306,854   1,269,601   907,103  

Operating loss ( 366,005 ) ( 213,429 ) ( 927,021 ) ( 647,838 )

Investment income 18,289   16,982   45,420   36,050  
Interest expense ( 20,382 ) ( 21,054 ) ( 63,196 ) ( 63,363 )
Change in fair value of interest rate swap —   ( 3,852 ) —   ( 1,106 )

Other (expense) income, net ( 603 ) 1,843   ( 18 ) 474  
Loss before income taxes ( 368,701 ) ( 219,510 ) ( 944,815 ) ( 675,783 )

Provision for income taxes 1,320   1,014   3,475   2,441  

Net loss $ ( 370,021 ) $ ( 220,524 ) $ ( 948,290 ) $ ( 678,224 )

Basic and diluted net loss per share $ ( 1.75 ) $ ( 1.27 ) $ ( 4.89 ) $ ( 4.27 )

Weighted average basic and diluted common shares outstanding
211,759   173,721   194,087   159,013  

Net loss $ ( 370,021 ) $ ( 220,524 ) $ ( 948,290 ) $ ( 678,224 )
Other comprehensive income (loss):    
Foreign currency translation (losses) gains ( 658 ) 2,872   3,826   823  
Unrealized gain on marketable securities 924   505   461   469  
Total comprehensive loss $ ( 369,755 ) $ ( 217,147 ) $ ( 944,003 ) $ ( 676,932 )

    
See accompanying notes to the unaudited consolidated financial statements

4

INSMED INCORPORATED
Consolidated Statements of Sharehold ers' Equity (Deficit) (unaudited)
(in thousands)
  Common Stock Additional
Paid-in
Capital Accumulated
Deficit Accumulated
Other
Comprehensive
Income (Loss) Total
Shares Amount
Balance at June 30, 2024 166,667   $ 1,667   $ 3,943,826   $ ( 3,903,845 ) $ ( 2,830 ) $ 38,818  
Comprehensive loss:
Net loss ( 220,524 ) ( 220,524 )
Other comprehensive income 3,377   3,377  
Exercise of stock options and ESPP share issuance 1,219   12   26,868   26,880  
Net proceeds from issuance of common stock 5,022   50   370,928   370,978  
Issuance of common stock for vesting of RSUs 1   —  — 
Deferred payments for Business Acquisition and Vertuis Bio, Inc. 197   2   14,080   14,082  
Issuance of common stock upon conversion of convertible notes 5,741   57 224,202   224,259  
Stock-based compensation expense 25,545   25,545  
Balance at September 30, 2024 178,847   $ 1,788   $ 4,605,449   $ ( 4,124,369 ) $ 547   $ 483,415  

Balance at June 30, 2025 211,111   $ 2,111   $ 6,184,078   $ ( 4,938,186 ) $ 1,732   $ 1,249,735  
Comprehensive loss:
Net loss ( 370,021 ) ( 370,021 )
Other comprehensive income 266   266  
Exercise of stock options and ESPP share issuance 1,454   14   34,399   34,413  

Net payments for issuance of common stock —  —  ( 256 ) ( 256 )
Issuance of common stock for vesting of RSUs 10   —  — 
Issuance of common stock for vesting of PSUs 8   1   1  

Stock-based compensation expense 31,433   31,433  
Balance at September 30, 2025 212,583   $ 2,126   $ 6,249,654   $ ( 5,308,207 ) $ 1,998   $ 945,571  

See accompanying notes to the unaudited consolidated financial statements

5

INSMED INCORPORATED
Consolidated Statements of Sharehold ers' Equity (Deficit) (unaudited)
(in thousands)

  Common Stock Additional
Paid-in
Capital Accumulated
Deficit Accumulated
Other
Comprehensive
Income (Loss) Total
Shares Amount
Balance at December 31, 2023 147,978   $ 1,480   $ 3,113,487   $ ( 3,446,145 ) $ ( 745 ) $ ( 331,923 )
Comprehensive loss:
Net loss ( 678,224 ) ( 678,224 )
Other comprehensive income 1,292   1,292  
Exercise of stock options and ESPP share issuance 4,498   45   99,458   99,503  
Net proceeds from issuance of common stock 19,537   195   1,083,941   1,084,136  
Issuance of common stock for vesting of RSUs 896   9   9  

Deferred payments for Business Acquisition and Vertuis Bio, Inc. 197   2   14,080   14,082  
Issuance of common stock upon conversion of convertible notes 5,741   57 224,202   224,259  
Stock-based compensation expense 70,281   70,281  
Balance at September 30, 2024 178,847   $ 1,788   $ 4,605,449   $ ( 4,124,369 ) $ 547   $ 483,415  

Balance at December 31, 2024 179,383   $ 1,794   $ 4,645,791   $ ( 4,359,917 ) $ ( 2,289 ) $ 285,379  
Comprehensive loss:
Net loss ( 948,290 ) ( 948,290 )
Other comprehensive income 4,287   4,287  
Exercise of stock options and ESPP share issuance 4,461   44   101,038   101,082  
Issuance of common stock upon conversion of convertible notes 17,923   179   565,962   566,141  
Net proceeds from issuance of common stock 8,984   90   823,192   823,282  
Issuance of common stock for vesting of RSUs 1,172   12   12  
Issuance of common stock for vesting of PSUs 660   7   7  

Stock-based compensation expense 113,671   113,671  
Balance at September 30, 2025 212,583   $ 2,126   $ 6,249,654   $ ( 5,308,207 ) $ 1,998   $ 945,571  

See accompanying notes to the unaudited consolidated financial statements
6

INSMED INCORPORATED
Consolidated Statements of Cash Flows (unaudited)
(in thousands)

  Nine Months Ended September 30,
  2025 2024
Operating activities    
Net loss $ ( 948,290 ) $ ( 678,224 )
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation 6,825   4,483  
Amortization of intangible assets 4,064   3,789  
Stock-based compensation expense 113,671   70,281  

Amortization of debt issuance costs 4,840   5,136  
Paid-in-kind interest capitalized —   19,233  
Royalty financing non-cash interest expense 15,344   14,979  
Accretion of discount on marketable securities, net ( 27,951 ) ( 8,133 )
Finance lease amortization expense 2,034   2,034  
Non-cash operating lease expense 2,748   2,230  
Change in fair value of deferred and contingent consideration liabilities 181,953   106,482  
Change in fair value of interest rate swap —   1,106  

Changes in operating assets and liabilities:    
Accounts receivable ( 11,007 ) ( 1,115 )
Inventory ( 19,755 ) ( 14,922 )
Prepaid expenses and other current assets ( 27,207 ) ( 16,981 )
Other assets 9,664   5,625  
Accounts payable and accrued liabilities 9,727   3,462  
Other liabilities ( 4,078 ) ( 7,368 )

Net cash used in operating activities ( 687,418 ) ( 487,903 )
Investing activities    
Purchase of fixed assets ( 15,972 ) ( 15,151 )
Purchase of marketable securities ( 2,092,014 ) ( 999,782 )

Maturities of marketable securities 1,654,000   300,000  
Net cash used in investing activities ( 453,986 ) ( 714,933 )
Financing activities    
Proceeds from exercise of stock options and ESPP 101,082   99,503  
Proceeds from issuance of common stock, net 823,282   1,084,136  

Payments of principal of 0.75 % convertible senior notes due 2028
( 1,965 ) —  

Payments of finance lease principal ( 2,185 ) ( 1,924 )

Net cash provided by financing activities 920,214   1,181,715  
Effect of exchange rates on cash and cash equivalents 924   198  
Net decrease in cash and cash equivalents ( 220,266 ) ( 20,923 )
Cash and cash equivalents at beginning of period 555,030   482,374  
Cash and cash equivalents at end of period $ 334,764   $ 461,451  
Supplemental disclosures of cash flow information:    
Cash paid for interest $ 41,843   $ 25,327  
Cash paid for income taxes $ 4,030   $ 2,251  

See accompanying notes to the unaudited consolidated financial statements
7

Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

1. 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 first commercial product, ARIKAYCE, is approved in the United States (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 Mycobacterium avium complex (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 (EC) approved ARIKAYCE for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by MAC in adults with limited treatment options who do not have cystic fibrosis (CF). In March 2021, Japan's Ministry of Health, Labour and Welfare (MHLW) 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. The Company’s second commercial product, 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 adults and children 12 years and older, received US Food and Drug Administration (FDA) approval on August 12, 2025. Brensocatib is a small molecule, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), that the Company is also developing for the treatment of patients with chronic rhinosinusitis without nasal polyps (CRSsNP) and hidradenitis suppurativa (HS), which, like bronchiectasis, are neutrophil-mediated diseases.
The Company's pipeline also includes clinical-stage programs for treprostinil palmitil inhalation powder (TPIP) and INS1201, as well as pre-clinical research programs, including INS1202. TPIP is an inhaled formulation of the treprostinil prodrug treprostinil palmitil which may offer a differentiated product profile for pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH). INS1201 is an intrathecally-delivered gene therapy for patients with Duchenne muscular dystrophy (DMD). INS1202 is an intrathecally-delivered gene therapy for patients with amyotrophic lateral sclerosis (ALS). The Company's pre-clinical research programs encompass a wide range of technologies and modalities, including gene therapy, artificial intelligence-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 United Kingdom (UK), and Japan.
The accompanying unaudited interim consolidated financial statements have been prepared pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information and disclosures required by accounting principles generally accepted in the US (GAAP) for complete consolidated financial statements are not included herein. The unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 202 4 . Any references in these notes to applicable accounting guidance are meant to refer to GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Updates (ASU) of the Financial Accounting Standards Board (FASB).
     The results of operations of any interim period are not necessarily indicative of the results of operations for the full year. The unaudited interim consolidated financial information presented herein reflects all normal adjustments that are, in the opinion of management, necessary for a fair statement of the financial position, results of operations and cash flows for the periods presented. All intercompany transactions and balances have been eliminated in consolidation.
     The Company had $ 334.8 million in cash and cash equivalents and $ 1,345.2 million in marketable securities as of September 30, 2025 and reported a net loss of $ 948.3 million for the nine months ended September 30, 2025. The Company has funded its operations through public offerings of equity securities, de bt financings and revenue interest financings. The Company expects to continue to incur consolidated operating losses, including losses in its US and certain international entities, while funding research and development (R&D) activities for ARIKAYCE, brensocatib, TPIP, INS1201, INS1202 and its other pipeline programs, and commercialization and regulatory activities for ARIKAYCE and BRINSUPRI.
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, in-license or co-promote other products or product candidates, including those that address orphan or serious diseases. The
8

Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
 1. The Company and Basis of Presentation (Continued)

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 subsidiarie s, 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.

2. Summary of Significant Accounting Policies
The Company’s complete listing of significant accounting policies is set forth in Note 2 of the notes to the consolidated financial statements in the Company's Annual Report on Form 10-K for the year ended December 31, 202 4 . Selected significant accounting policies are discussed in detail below.
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 (the Royalty Financing Agreement), and accounting for R&D costs. Actual results could differ from those estimates.
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 percentage of gross product revenue represented by the Company's three largest customers for the nine months ended September 30, 2025 and their respective percentages for the nine months ended September 30, 2024.

Nine Months Ended September 30,
2025 2024
Customer A 30 % 31 %
Customer B 26 % 35 %
Customer C 21 % 19 %

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.
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.
9

Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
 2. Summary of Significant Accounting Policies (Continued)

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.
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 ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business, which requires the acquiring entity in a business combination to recognize the fair value of all assets acquired, liabilities assumed, and any non-controlling interest in the acquiree and establishes the acquisition date as the fair value measurement point. Accordingly, the Company recognizes assets acquired and liabilities assumed in business combinations, including contingent assets and liabilities, and non-controlling interest in the acquiree based on the fair value estimates as of the date of acquisition. In accordance with ASC 805, Business Combinations, the Company recognizes and measures goodwill as of the acquisition date, as the excess of the fair value of the consideration paid over the fair value of the identified net assets acquired.
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 accounts for the transaction under ASC 805-50, which requires the acquiring entity in an asset acquisition to recognize assets acquired and liabilities assumed based on the cost to the acquiring entity on a 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 as of September 30, 2025. 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
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 2. Summary of Significant Accounting Policies (Continued)

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 nine months ended September 30, 2025, the Company concluded that no 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 September 30, 2025, the Company continues to operate as one reporting unit. The Company performs an impairment test for goodwill annually as of October 1. See Note 6 - Intangibles, Net and Goodwill for further details.
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 s hareholders' 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
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 2. Summary of Significant Accounting Policies (Continued)

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 new products, the Company expenses all inventory related costs in the period incurred.
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), performance stock units (PSUs) and convertible debt securities would be anti-dilutive as the Company incurred a net loss. 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 three and nine months ended September 30, 2025 and 2024:

  Three Months Ended September 30, Nine Months Ended September 30,
  2025 2024 2025 2024
 
Numerator:    
Net loss $ ( 370,021 ) $ ( 220,524 ) $ ( 948,290 ) $ ( 678,224 )
Denominator:    
Weighted average common shares used in calculation of basic net loss per share: 211,759   173,721   194,087   159,013  
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 211,759   173,721   194,087   159,013  
Net loss per share:    
Basic and diluted $ ( 1.75 ) $ ( 1.27 ) $ ( 4.89 ) $ ( 4.27 )

The following potentially dilutive securities have been excluded from the computations of diluted weighted average common shares outstanding as of September 30, 2025 and 2024, respectively, as their effect would have been anti-dilutive (in thousands):
 
As of September 30,

  2025 2024
Common stock options 18,689   22,371  
Unvested RSUs 3,887   3,375  
Development milestone shares issuable 365   —  
PSUs —   665  
Convertible debt securities —   17,692  

Recent Accounting Pronouncements (Not Yet Adopted) — In December 2023, the FASB issued ASU 2023-09, Income Taxes—Improvements to Income Tax Disclosures, in order to enhance the transp arency and decision usefulness of
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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 guidance is effective for fiscal years beginning after December 15, 2024. The Company is adopting this new standard for the year ending December 31, 2025. The Company is evaluating the impact of the required disclosure enhancements of ASU 2023-09 on its consolidated financial statements.
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.

3. 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):

As of September 30, 2025

Fair Value
Carrying Value Level 1 Level 2 Level 3
Assets
Cash and cash equivalents $ 334.8   $ 334.8   $ —   $ —  
Marketable securities $ 1,345.2   $ 1,345.2   $ —   $ —  
Liabilities

Contingent consideration $ 302.1   $ —   $ —   $ 302.1  

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As of December 31, 2024

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 nine months ended September 30, 2025, $ 2,092.0 million of marketable securities were purchased and $ 1,654.0 million of marketable securities matured, each consisting of US Treasury Bills.
The Company recognizes transfers between levels within the fair value hierarchy, if any, at the end of each quarter. There were no transfers in or out of Level 1, Level 2, or Level 3 during the nine months ended September 30, 2025. During the nine months ended September 30, 2025, new Level 1 assets were added in connection with the Company's purchase of available-for-sale securities.
As of September 30, 2025, the Company held $ 1,345.2 million of available-for-sale securities. 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 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 nine months ended September 30, 2025.
Deferred Consideration
The deferred consideration arose from the acquisitions of Motus Biosciences, Inc. (Motus) and AlgaeneX, Inc. (AlgaeneX) (together, the Business Acquisition) in August 2021 (see Note 16 - Acquisitions ). The Company was obligated to issue to Motus equityholders an aggregate of 184,433 shares of the Company’s common stock on each of the first, second and third anniversaries of the closing date, subject to certain reductions. During August 2022, August 2023, and August 2024, the Company fulfilled the payments due on the first, second and third anniversaries of the closing date by issuing 171,427 shares, 177,203 shares an d 182,182 s hares of the Company's common stock, respectively, after certain reductions. A valuation of the deferred consideration was 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. As the deferred consideration was settled in shares, no discount rate was applied in the fair value calculation.
The deferred consideration was classified as a Level 2 recurring liability as its valuation utilized an input, the Insmed share price, which is a directly observable input at the measurement date and for the duration of the liabilities' anticipated lives. There was no remaining deferred consideration as of December 31, 2024 .
Contingent Consideration
The contingent consideration liabilities arose from the Business Acquisition in August 2021 (see Note 16 - Acquisitions ). 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 5,348,572 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. 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 September 30, 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
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3. Fair Value Measurements (Continued)

October 2025. The development milestone shares issuable liability is classified within accounts payable and accrued liabilities as of September 30, 2025.
If the Company were to receive a priority review voucher, 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 will 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 will be settled in cash. On December 20, 2024, the FDA's priority review voucher program expired. As of September 30, 2025 and December 31, 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 September 30, 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 expected to be settled within twelve months or less is classified as a current liability within accounts payable and accrued liabilities. Contingent consideration expected to be settled in more than twelve months is classified as a non-current liability. As of September 30, 2025, the fair value of the current and non-current contingent consideration was $ 42.5  million and $ 259.6  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 September 30, 2025 and December 31, 2024:

Fair Value as of September 30, 2025 (in millions)
Valuation Technique Unobservable Inputs Values
Development and regulatory milestones $ 296.7 Probability-adjusted Probabilities of success 14 % - 80 %

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 %

The following table is a summary of the changes in the fair value of the Company's valuations for the deferred and contingent consideration liabilities for the nine months ended September 30, 2025 and 2024 (in thousands):
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Deferred
 Consideration
(Level 2 Liabilities) Contingent Consideration
 (Level 3 Liabilities)
Balance as of December 31, 2023 $ 5,700   $ 84,600  
Additions —   —  
Change in fair value 7,400   99,100  
Payments ( 13,100 ) —  
Balance as of September 30, 2024 $ —   $ 183,700  

Balance as of December 31, 2024 $ —   $ 168,900  
Additions —   —  
Change in fair value —   181,953  
Milestone met and payable —   ( 48,753 )
Balance as of September 30, 2025 $ —   $ 302,100  

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 Royalty & Credit Opportunities IV, LP (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 Agreement for further details.
Secured Senior Term Loan
The carrying value of the Company's secured senior term loans are measured at amortized cost using the effective interest method and the carrying value approximates fair value. See Note - 10 Debt for further details .

4. 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.
The following tables present a summary of the Company's product revenues, net, by product and geography for the three and nine months ended September 30, 2025 and 2024 (in thousands):

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4. Product Revenues, Net (Continued)

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
ARIKAYCE
US $ 73,984   $ 66,868   $ 206,942   $ 187,010  
International 40,307 26,557 107,587 72,255
    Total $ 114,291   $ 93,425   $ 314,529   $ 259,265  

BRINSUPRI
US $ 28,051   $ —   $ 28,051   $ —  

    Total $ 28,051   $ —   $ 28,051   $ —  

Total
US $ 102,035   $ 66,868   $ 234,993   $ 187,010  
International 40,307   26,557   107,587   72,255  
    Total product revenues, net $ 142,342   $ 93,425   $ 342,580   $ 259,265  

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.
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
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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 early access programs (EAPs) in Europe. EAPs are intended to make products available on a named-patient basis before they are commercially available in accordance with local regulations.

5. Inventory
The Company's inventory balance consists of the following (in thousands):

As of
September 30, 2025 December 31, 2024

Raw materials $ 26,318   $ 19,682  
Work-in-process 37,890   39,932  
Finished goods 56,757   38,964  
$ 120,965   $ 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 contract manufacturing organizations (CMOs) to produce its inventory.

  6. Intangibles, Net and Goodwill
Intangibles, Net
Finite-lived Intangible Assets
As of September 30, 2025, the Company's finite-lived intangible assets consisted of acquired ARIKAYCE R&D, the milestones paid to PARI Pharma GmbH (PARI) for the license to use the Lamira® Nebulizer System (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, and the milestone payable to AstraZeneca AB (AstraZeneca) as a result of the FDA approval of BRINSUPRI in August 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 asset in August 2025, over BRINSUPRI's regulatory exclusivity period of approximately 14 years. Amortization of these assets during each of the next five years is estimated to be approximately $ 7.2 million per year.
Indefinite-lived Intangible Assets
As of September 30, 2025, the Company's indefinite-lived intangible assets consisted of acquired IPR&D from the Business Acquisition (see Note 16 - Acquisitions ). Indefinite-lived intangible assets are not amortized. A rollforward of the Company's intangible assets for the nine months ended September 30, 2025 and 2024 is as follows (in thousands):
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INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
6. Intangibles, Net and Goodwill (Continued)

Intangible Asset December 31, 2024 Additions Amortization September 30, 2025
Acquired ARIKAYCE R&D $ 27,888   $ —   $ ( 3,638 ) $ 24,250  
PARI milestones 1,164   —   ( 151 ) 1,013  
AstraZeneca milestone —   30,000   ( 275 ) 29,725  
Acquired IPR&D 29,600   —   —   29,600  
$ 58,652   $ 30,000   $ ( 4,064 ) $ 84,588  

Intangible Asset December 31, 2023 Additions Amortization September 30, 2024
Acquired ARIKAYCE R&D $ 32,738   $ —   $ ( 3,638 ) $ 29,100  
PARI milestones 1,366   —   ( 151 ) 1,215  
Acquired IPR&D 29,600   —   —   29,600  
$ 63,704   $ —   $ ( 3,789 ) $ 59,915  

Goodwill
The Company's goodwill balance of $ 136.1 million as of September 30, 2025 and December 31, 2024, resulted from the Business Acquisition. See Note 16 - Acquisitions for further details.  

7. Fixed Assets, Net
Fixed assets are stated at cost and depreciated using the straight-line method, based on useful lives as follows (in thousands):

Estimated
Useful Life (years) As of
Asset Description September 30, 2025 December 31, 2024

Lab equipment 7 $ 34,292   $ 26,753  
Furniture and fixtures 7 6,428   6,428  
Computer hardware and software 3 - 5
7,628   6,485  
Office equipment 7 171   171  
Manufacturing equipment 7 1,336   1,336  
Leasehold improvements 2 - 10
51,169   38,058  
Construction in progress — 45,842   51,127  
146,866   130,358  
Less: accumulated depreciation ( 57,195 ) ( 50,306 )
$ 89,671   $ 80,052  

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INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)

8. Accounts Payable and Accrued Liabilities
Accounts payable and accrued liabilities consist of the following (in thousands):

As of
September 30, 2025 December 31, 2024
Accounts payable and other accrued operating expenses $ 79,591   $ 73,033  
Accrued clinical trial expenses 30,730   26,068  
Accrued professional fees 25,776   17,895  
Accrued technical operation expenses 20,227   18,388  

Accrued compensation and employee related costs 69,712   80,312  
Accrued royalty and milestones payable 9,372   6,324  
Accrued interest payable —   359  
Revenue Interest Payments payable 4,941   4,177  
Accrued sales allowances and related costs 33,026   16,762  
Accrued French rebate payable 10,049   5,988  
Contingent consideration 42,500   24,700  
Development milestone shares issuable 48,753   —  

Accrued milestone payment to AstraZeneca 30,000   —  
Other accrued liabilities 5,158   11,203  
$ 409,835   $ 285,209  

In August 2025, a development milestone in connection with the Motus acquisition was achieved. See Note 3 - Fair Value Measurements for further details. Also in August 2025, a $ 30.0 million milestone commitment became payable to AstraZeneca upon FDA approval of BRINSUPRI. See Note 6 - Intangibles, Net and Goodwill for further details.

9. 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 than one year to ten 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 also records variable consideration for variable lease payments in excess of fixed fees or minimum guarantees. Variable consideration related to the Company's leasing arrangements was $ 15.3 million and $ 12.3 million for the three months ended September 30, 2025 and 2024, respectively, and $ 21.2 million and $ 20.4 million for the nine months ended September 30, 2025 and 2024, respectively. 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.
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INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
9. Leases (Continued)

The table below summarizes the supplemental non-cash disclosures of the Company's leases included in its consolidated financial statements (in thousands):

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
Finance right-of-use assets obtained in exchange for lease obligations $ —   $ —   $ —   $ —  
Operating right-of-use assets obtained in exchange for lease obligations $ 1,731   $ —   $ 1,731   $ 5,656  

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 UK Limited (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. Costs o f $ 66.7 million and $ 59.0 million incurred by the Company under these additional agreements have been classified within other assets in the Company's consolidated balance sheet as of September 30, 2025 and December 31, 2024, respectively. Upon the commencement date, the Company will record an operating lease ROU asset and operating lease liability.

10. Debt
Debt, long-term consists of the following commitments as of September 30, 2025 and December 31, 2024 (in thousands):

As of
September 30, 2025 December 31, 2024
Convertible notes $ —   $ 567,164  
Term Loans 539,719   536,218  

Debt, long-term $ 539,719   $ 1,103,382  

Convertible Notes
In May 2021, the Company completed an underwritten public offering of $ 575.0 million aggregate principal amount of its 0.75 % Convertible Senior Notes due 2028 (the 2028 Convertible Notes), including the exercise in full of the underwriters' option to purchase an additional $ 75.0 million in aggregate pr incipal 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 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 .
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INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. Debt (Continued)

The carrying value of the Company's convertible notes balance as of December 31, 2024 was $ 567.2 million, net of unamortized debt issuance costs of $ 7.8 million.
Secured Senior Term Loan
In October 2022, the Company entered into the $ 350.0 million loan agreement (the Loan Agreement) with Pharmakon Advisors, LP (Pharmakon) that would have matured on October 19, 2027 (the Tranche A Term Loan). The Tranche A Term Loan originally bore interest at a rate based upon the Secured Overnight Financing Rate (SOFR) , subject to a SOFR floor of 2.5 %, in addition to a margin of 7.75 % per annum. Up to 50 % of the interes t 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 in eight 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 an Amended and Restated Loan Agreement, as amended on July 10, 2025, (the A&R Loan Agreement) 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 to, among other items, add an additional $ 150.0 million senior secured term loan tranche (the Tranche B Term Loan and, together with the Tranche A Term Loan, the Term Loans). 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 in eight 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 September 30, 2025 and December 31, 2024 (in thousands):

As of
September 30, 2025 December 31, 2024
Principal $ 500,000   $ 500,000  
Paid-in-kind interest capitalized 46,770   46,770  
Debt discount, net ( 7,051 ) ( 10,552 )
Term Loans $ 539,719   $ 536,218  

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INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. Debt (Continued)

As of September 30, 2025, future principal repayments of debt for each of the years through maturity were as follows (in thousands):
 
Year Ending December 31:  
2025 $ —  
2026 —  
2027 —  
2028 341,731  
2029 205,039  
2030 and thereafter —  
  $ 546,770  

Interest Expense
Interest expense related to debt and finance leases for the three and nine months ended September 30, 2025 and 2024 is as follows (in thousands):

Three Months Ended September 30, Nine Months Ended September 30,
2025 2024 2025 2024
Convertible debt contractual interest expense $ —   $ 1,194   $ 1,678   $ 5,319  
Term Loans contractual interest expense 13,414   13,325   39,805   38,466  
Royalty Financing Agreement interest expense 5,129   5,264   15,344   14,979  
Amortization of debt issuance costs 1,342   1,485   4,840   5,136  

Swap interest income —   ( 765 ) —   ( 2,229 )
   Total debt interest expense 19,885   20,503   61,667   61,671  
Finance lease interest expense 497   551   1,529   1,692  
   Total interest expense $ 20,382   $ 21,054   $ 63,196   $ 63,363  

11. 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 % 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 global net sales of 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 $ 3.8  million, were $ 146.2  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. 
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INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
11. Royalty Financing Agreement (Continued)

The following table shows the activity within the liability account for the nine-month period ended September 30, 2025 and year ended December 31, 2024 (in thousands):

Nine Months Ended September 30, 2025 Twelve Months Ended
December 31, 2024
Royalty Financing Agreement liability - beginning balance $ 163,671   $ 158,162  
Revenue Interest Payments paid and payable ( 12,950 ) ( 14,535 )
Interest expense recognized 15,344   20,044  
  Royalty Financing Agreement liability - ending balance $ 166,065   $ 163,671  

Royalty issuance costs, unamortized - beginning balance $ ( 2,604 ) $ ( 3,128 )
Amortization of issuance costs 393   524  

  Royalty issuance costs, unamortized - ending balance $ ( 2,211 ) $ ( 2,604 )
    Royalty Financing Agreement $ 163,854   $ 161,067  

The Revenue Interest Payments payable in connection with the Royalty Financing Agreement were $ 4.9 million and $ 4.2 million as of September 30, 2025 and December 31, 2024, respectively, which were recorded within accounts payable and accrued expenses on the consolidated balance sheet. Non-cash interest expense is recorded within interest expense in the consolidated statements of comprehensive loss.

12. Shareholders' Equity
Common Stock —As of September 30, 2025, the Company had 500,000,000 shares of common stock authorized with a par value of $ 0.01 per share and 212,583,015 shares of common stock issued and outstanding. In addition, as of September 30, 2025, the Company had reserved 18,689,214 shares of common stock for issuance upon the exercise of outstanding stock options, and 3,887,249 shares of common stock for issuance upon the vesting of RSUs. 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. The shares of the Company’s common stock reserved in connection with the Motus acquisition were partly issued as acquisition consideration at closing and on the first, second and third anniversaries of the closing date of the acquisition, 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. 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.
Of the 9,406,112 shares reserved, the Company issued a total of 3,420,149 shares of the Company's common stock in connection with the Business Acquisition (see Note 16 - Acquisitions ), after certain closing-related deductions, and the subsequent anniversary share issuances.
In the second quarter of 2025, in connection with the conversions of the 2028 Convertible Notes, the Company issued 17,922,626 shares of the Company's common stock.
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 underwriter s' option to purchase additional sh ares. The Company's net proceeds from the sale of the shares, after deducting the underwriting discounts and estimated 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 sh ares. 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 first quarter of 2024, the Company entered into a sales agreement with Leerink Partners LLC (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 an “at the market” equity offering program (the ATM program), under which Leerink Partners acted as sales agent. D uring the year ended December 31, 2024, the Company issued and sold an aggregate of 5,022,295 shares of common stock
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
12. Shareholders' Equity (Continued)

through the 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 sales agreement.
Preferred Stock —As of September 30, 2025, the Company had 200,000,000 shares of preferred stock authorized with a par value of $ 0.01 per share and no shares of preferred stock were issued and outstanding.

13. 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 September 30, 2025, 11,919,435 shares remain available for future issuance under the 2019 Incentive Plan. 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 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 covering 475,754 shares of the Company's common stock to new employees during the nine months ended September 30, 2025. 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. 253,004 shares of the Company's common stock have been granted from the Insmed Incorporated 2025 Inducement Plan as of September 30, 2025.
On May 15, 2018, the 2018 Employee Stock Purchase Plan (ESPP) was approved by shareholders at the Company's 2018 Annual Meeting of Shareholders. The Company has reserved the following for issuance under the ESPP: (i) 1,000,000 shares of common stock, plus (ii) commencing on January 1, 2019 and ending on December 31, 2023, an additional number of shares to be added on the first day of each calendar year equal to the lesser of (A) 1,200,000 shares of common stock, (B) 2 % of the number of outstanding shares of common stock on such date and (C) an amount determined by the administrator.
Stock Options —As of September 30, 2025, there was $ 150.8  million of unrecognized compensation expense related to unvested stock options. As of September 30, 2025, the Company had performance-conditioned options totaling 114,780 shares outstanding which had not yet met the recognition criteria.
Restricted Stock Units —As of September 30, 2025, there was $ 146.9  million of unrecognized compensation expense related to unvested RSU awards.
Performance Stock Units —As of September 30, 2025, there were no unvested PSUs outstanding. The PSUs were subject to two performance conditions based on brensocatib milestones, both of which had been achieved as of March 31, 2025, and a service condition, 3 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 (NDA) 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. Durin g the nine months ended September 30, 2025 , 660,466 shares were issued upon vesting of the 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 the ESPP during the three and nine months ended September 30, 2025 and 2024 (in thousands): 
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
13. Stock-Based Compensation (Continued)

  Three Months Ended September 30, Nine Months Ended September 30,
  2025 2024 2025 2024
Research and development expenses $ 15,399   $ 12,586   $ 48,749   $ 34,222  
Selling, general and administrative expenses 16,034   12,959   64,922   36,059  
  Total stock-based compensation expense $ 31,433   $ 25,545   $ 113,671   $ 70,281  

14. Income Taxes
The Company recorded a provision for income taxes of $ 1.3 million and $ 1.0 million for the three months ended September 30, 2025 and 2024, respectively, and $ 3.5 million and $ 2.4 million for the nine months ended September 30, 2025 and 2024, respectively. The provisions recorded for the three and nine months ended September 30, 2025 and 2024 are primarily a result of certain of the Company's international subsidiaries, which had taxable income during the periods. Additionally, the Company is impacted by certain state taxes which effectively impose income tax on modified gross revenues. In jurisdictions where the Company has net losses, there was a full valuation allowance recorded against the Company's deferred tax assets and therefore no tax benefit was recorded.
The Company is subject to US federal, state and international income taxes and the statute of limitations for tax audit is open for the Company’s federal tax returns for the years ended 2021 and later, generally open for certain states for the years 2020 and later, and generally open for international jurisdictions for the years 2019 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. As of September 30, 2025 and December 31, 2024, the Company had recorded reserves for unrecognized income tax benefits against certain deferred tax assets in the US. However, given the Company’s valuation allowance position, these reserves do not have an impact on the balance sheet as of September 30, 2025 and December 31, 2024 or the consolidated statements of comprehensive loss for the three and nine months ended September 30, 2025 and 2024. The Company has no t recorded any accrued interest or penalties related to uncertain tax positions. The Company does not anticipate any material changes in the amount of unrecognized tax positions over the next twelve months.
The Organisation for Economic Co-operation and Development 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. 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. The Company is still evaluating the potential consequences of Pillar Two on its longer-term financial position.
On July 4, 2025, H.R.1 - One Big Beautiful Bill (the Bill) was enacted into law. The Bill provides for significant US tax law changes and modifications including reinstating the ability to deduct US-based research and development expenses rather than capitalize those expenses. Given the Company's history of net operating losses, the Bill is not expected to have a significant impact on the Company's near-term financial position. The Company is continuing to analyze the Bill to determine the longer-term impact on its financial position.

15. Commitments and Contingencies
Rent expense charged to operations was $ 3.5 million and $ 3.0 million for the three months ended September 30, 2025 and 2024, respectively, and $ 10.3 million and $ 8.9 million for the nine months ended September 30, 2025 and 2024, respectively.
Legal Proceedings
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.

16. Acquisitions
Business Combination
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
16. Acquisitions (Continued)

On August 4, 2021, the Company acquired all of the equity interests of Motus and AlgaeneX, each a privately held, pre-clinical stage company. In connection with the closing of the Company’s acquisition of Motus, the Company issued an aggregate of 2,889,367 shares of the Company’s common stock, following certain closing-related reductions, to Motus’s former stockholders and option holders and certain individuals who are entitled to receive a portion of the acquisition consideration (collectively, Motus equityholders), subject to certain adjustments . The Company was obligated to issue to Motus equityholders an aggregate of 184,433 shares of the Company’s common stock on each of the first, second and third anniversaries of the closing date. During August 2022, August 2023 and August 2024, the Company fulfilled the payments due on the first, second and third anniversaries of the closing date by issuing 171,427 shares, 177,203 shares and 182,182 shares of the Company's common stock, respectively, after 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. Following such issuance, t he Company is obligated to issue to the Motus equityholders up to 4,979,705 additional shares in the aggregate upon the achievement of the remaining development and regulatory milestone events, and to pay to the Motus equityholders an aggregate of $ 35  million upon the achievement of certain net sales-based milestones and a portion of the value of a priority review voucher (to the extent issued to the Company), in each case, subject to certain reductions.
At the closing of the Company’s acquisition of AlgaeneX, the Company paid $ 1.5  million in cash to AlgaeneX’s former stockholders and certain individuals who are entitled to receive a portion of the acquisition consideration (collectively, the AlgaeneX equityholders). The Company is obligated to issue to the AlgaeneX equityholders an aggregate of 368,867 shares of the Company’s common stock upon the achievement of a development milestone event and pay to the AlgaeneX equityholders a mid-single digits licensing fee on certain future payments received by the Company in licensing transactions for AlgaeneX’s manufacturing technology, in each case, subject to certain reductions.
The shares of the Company’s common stock issued to the Motus equityholders and the AlgaeneX equityholders were issued, and the shares issuable in the future will be issued, pursuant to Section 4(a)(2) of the Securities Act of 1933, and the numbers of such issued and issuable shares was calculated based on a per share value of $ 27.11 , which was the weighted average price per share of the Company's common stock preceding the closing of the Business Acquisition for the 45 consecutive trading day period beginning on May 24, 2021. The Company will not receive any proceeds from the issuance of common stock to the Motus equityholders or the AlgaeneX equityholders.
The Company evaluated the Business Acquisition under ASC 805 and ASU 2017-01. The Company concluded that substantially all of the fair value of the gross assets acquired is not concentrated in a single identifiable asset or a group of similar identifiable assets. The transaction does not pass the screen test and thus management performed a full assessment to determine if the acquired entities met the definition of a business. For the full assessment, management considered whether it has acquired (a) inputs, (b) substantive processes, and (c) outputs. Under ASC 805, to be considered a business, a set of activities and assets is required to have only the first two of the three elements, which together are or will be used in the future to create outputs. Management determined that the acquired entities met the definition of a business since the Company acquired inputs and substantive processes capable of producing outputs.
Therefore, the transaction has been accounted for under the acquisition method of accounting. Under the acquisition method, the total purchase price of the acquisition is allocated to the net tangible and identifiable intangible assets acquired and liabilities assumed based on the fair values as of the date of the acquisition. The fair value of the consideration totaled approximately $ 165.5  million. The results of Motus's and AlgaeneX's operations have been included in the Company's consolidated statements of comprehensive loss beginning on the acquisition date.
The fair value of IPR&D was capitalized as of the acquisition date and accounted for as indefinite-lived intangible assets until completion or disposition of the assets or abandonment of the associated research and development efforts. Upon successful completion of the development efforts, the useful lives of the IPR&D assets will be determined based on the anticipated period of regulatory exclusivity and will be amortized within operating expenses. Until that time, the IPR&D assets will be subject to impairment testing and will not be amortized. The goodwill recorded related to the acquisition is the excess of the fair value of the consideration transferred by the acquirer over the fair value of the net identifiable assets acquired and liabilities assumed at the date of acquisition. The goodwill recorded is not deductible for tax purposes.

17. 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 P olicies .
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INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
17. Segment Reporting (Continued)

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 has one reportable segment.
Segment loss, including significant segment expenses, for the three and nine months ended September 30, 2025 and 2024 is as follows (in thousands):

Three Months Ended September 30,
Nine Months Ended September 30,
2025 2024 2025 2024
Product revenues, net $ 142,342   $ 93,425   $ 342,580   $ 259,265  
Less:
Cost of product revenues (excluding amortization of intangible assets) 29,365   21,170   78,718   59,591  
ARIKAYCE external R&D expenses 9,214   16,370   32,338   45,192  
Brensocatib external R&D expenses 19,355   17,288   73,576   74,612  
TPIP external R&D expenses 28,754   16,635   58,556   45,190  
Other external R&D expenses 36,579   26,919   93,107   55,111  
R&D compensation and benefit-related expenses 63,817   50,778   173,764   136,146  
SG&A compensation and benefit-related expenses 62,287   47,578   168,443   115,250  
Other segment items (a)
150,930   94,721   398,275   261,889  
Depreciation 2,458   1,459   6,825   4,483  
Amortization of intangible assets 1,538   1,263   4,064   3,789  
Change in fair value of deferred and contingent consideration liabilities 104,653   14,682   181,953   106,482  
Investment income ( 18,289 ) ( 16,982 ) ( 45,420 ) ( 36,050 )
Interest expense 20,382   21,054   63,196   63,363  
Provision for income taxes 1,320   1,014   3,475   2,441  
Segment net loss $ ( 370,021 ) $ ( 220,524 ) $ ( 948,290 ) $ ( 678,224 )

(a) Other segment items include stock-based compensation, professional fees, and facility-related expenses.
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ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Cautionary Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended (the "Securities Act") and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) identify forward-looking statements.
                   Forward-looking statements are based on our current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause our actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following:
• failure to continue to successfully commercialize ARIKAYCE in the US, Europe or Japan (amikacin liposome inhalation suspension, Liposomal 590 mg Nebuliser Dispersion, and amikacin sulfate inhalation drug product, respectively) or failure to successfully commercialize BRINSUPRI in the US, or to maintain US, European or Japanese approval for ARIKAYCE or US approval for BRINSUPRI;
• our inability to obtain full approval of ARIKAYCE from the FDA, including the risk that we will not successfully or in a timely manner complete the confirmatory post-marketing clinical trial required for full approval of ARIKAYCE, or our failure to obtain regulatory approval to expand ARIKAYCE’s indication to a broader patient population;
• failure to obtain, or delays in obtaining, regulatory approvals for our product candidates in the US, Europe or Japan, for ARIKAYCE outside the US, Europe or Japan, including separate regulatory approval for Lamira in each market and for each usage, or for brensocatib in Europe or Japan;
• failure to successfully commercialize our product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for such product candidates, if approved;
• uncertainties or changes in the degree of market acceptance of our marketed products or, if approved, our product candidates, by physicians, patients, third-party payors and others in the healthcare community;
• our inability to obtain and maintain adequate reimbursement from government or third-party payors for our marketed products or, if approved, our product candidates, or acceptable prices for our marketed products or, if approved, our product candidates;
• inaccuracies in our estimates of the size of the potential markets for our marketed products and our product candidates or in data we have used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates;
• failure of third parties on which we are dependent to manufacture sufficient quantities of our marketed products and our product candidates for commercial or clinical needs, as applicable, to conduct our clinical trials, or to comply with our agreements or laws and regulations that impact our business;
• the risks and uncertainties associated with, and the perceived benefits of, our senior secured loan with certain funds managed by Pharmakon and our royalty financing with OrbiMed, including our ability to maintain compliance with the covenants in the agreements for the senior secured loan and royalty financing and the impact of the restrictions on our operations under these agreements;
• our inability to create or maintain an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of our marketed products or any of our product candidates that are approved in the future;
• failure to successfully conduct future clinical trials for our marketed products or our product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of our product candidates or to permit the use of ARIKAYCE in the broader population of patients with MAC lung disease, among other things;
• development of unexpected safety or efficacy concerns related to our marketed products or our product candidates;
• risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments submitted will be rejected;
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• failure to successfully predict the time and cost of development, regulatory approval and commercialization for novel gene therapy products;
• risk that interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed, or that blinded data will not be predictive of unblinded data;
• risk that our competitors may obtain orphan drug exclusivity for a product that is essentially the same as a product we are developing for a particular indication;
• our inability to attract and retain key personnel or to effectively manage our growth;
• our inability to successfully integrate our acquisitions and appropriately manage the amount of management’s time and attention devoted to integration activities;
• risks that our acquired technologies, products and product candidates will not be commercially successful;
• inability to adapt to our highly competitive and changing environment;
• inability to access, upgrade or expand our technology systems or difficulties in updating our existing technology or developing or implementing new technology;
• risk that we are unable to maintain our significant customers;
• risk that government healthcare reform materially increases our costs and damages our financial condition;
• business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises;
• risk that our current and potential future use of artificial intelligence (AI) and machine learning may not be successful;
• deterioration in general economic conditions in the US, Europe, Japan and globally, including the effect of prolonged periods of inflation, affecting us, our suppliers, third-party service providers and potential partners;
• the risk that we could become involved in costly intellectual property disputes, be unable to adequately protect our intellectual property rights or prevent disclosure of our trade secrets and other proprietary information, and incur costs associated with litigation or other proceedings related to such matters;
• restrictions or other obligations imposed on us by agreements related to our marketed products or our product candidates, including our license agreements with PARI and AstraZeneca, and failure to comply with our obligations under such agreements;
• the cost and potential reputational damage resulting from litigation to which we are or may become a party, including product liability claims;
• risk that our operations are subject to a material disruption in the event of a cybersecurity attack or issue;
• our limited experience operating internationally;
• changes in laws and regulations applicable to our business, including any pricing reform and laws that impact our ability to utilize certain third parties in the research, development or manufacture of our product candidates, and failure to comply with such laws and regulations;
• our history of operating losses, and the possibility that we never achieve or maintain profitability;
• goodwill impairment charges affecting our results of operations and financial condition;
• inability to repay our existing indebtedness and uncertainties with respect to our ability to access future capital; and
• delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities and unexpected expenses associated with those plans.
We caution readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Any forward-looking statement is based on information current as of the date of this Quarterly Report on Form 10-Q and speaks only as of the date on which such statement is made. Actual events or results may differ materially from the results, plans, intentions or expectations anticipated in these forward-looking statements as a result of a variety of factors, many of which are beyond our control. More information on factors that could cause actual results to differ materially from those anticipated is included from time to time in our reports filed with the Securities and Exchange Commission (SEC), including, but not limited to, those described in the sections titled “Risk Factors” and “Management’s Discussion and Analysis
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of Financial Condition and Results of Operations” in this Quarterly Report on Form 10-Q and included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 . We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
The following discussion should be read in conjunction with our consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and the consolidated financial statements and related notes thereto in our Annual Report on Form 10-K for the year ended December 31, 202 4 .

OVERVIEW
We are a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. Our first commercial product, ARIKAYCE, was approved in the US in September 2018, in the European Union (EU) in October 2020 and in Japan in March 2021. Our second commercial product, BRINSUPRI (brensocatib 25 mg and 10 mg tablets), an oral, once-daily treatment for NCFB, was approved in the US in August 2025. Brensocatib is a small molecule, reversible inhibitor of DPP1, which we are also developing for the treatment of patients with CRSsNP and HS, which are additional neutrophil-mediated diseases other than bronchiectasis. Our pipeline also includes the clinical-stage programs TPIP and INS1201, as well as pre-clinical research programs including INS1202. TPIP is an inhaled formulation of the treprostinil prodrug treprostinil palmitil which may offer a differentiated product profile for PH-ILD and PAH. INS1201 is an intrathecally-delivered gene therapy for patients with DMD. INS1202 is an intrathecally-delivered gene therapy for patients with ALS. Our 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.      
Prior to 2019, we had not generated significant revenue and, through September 30, 2025, we had an accumulated deficit of $5.3 billion. We have financed our operations primarily through the public offerings of our equity securities, debt financings and revenue interest financings. Although it is difficult to predict our future funding requirements, based upon our current operating plan, we anticipate that our cash and cash equivalents and marketable securities as of September 30, 2025 will enable us to fund our operations for at least the next 12 months.
Our ability to reduce our operating loss and begin to generate positive cash flow from operations depends on the continued success in commercializing our marketed products and achieving positive results from the ARIKAYCE confirmatory clinical trial program in order to obtain full approval of ARIKAYCE in the US and potentially reach more patients. Our continued success also depends on successfully commercializing BRINSUPRI, obtaining regulatory approval for brensocatib in additional indications, bringing additional clinical stage products to market, such as TPIP and INS1201, and advancement of our pre-clinical research programs, including INS1202. We expect to continue to incur substantial expenses related to our research and development activities as we continue the ARIKAYCE confirmatory clinical program, conduct studies to explore the potential of brensocatib in CRSsNP and HS, conduct trials of TPIP in PAH and PH-ILD, and fund development of our pre-clinical research programs. We also expect to continue to incur significant costs related to the commercialization of our marketed products and commercial activities as we launch BRINSUPRI for patients with bronchiectasis. Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our marketed products; the scope and progress of our research and development efforts; and the timing of certain expenses. We cannot predict whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such products and whether or when we may become profitable.
The information below summarizes our updates and anticipated near-term milestones for our marketed products and our product candidates.
ARIKAYCE
• Following the announcement of positive topline results from the ARISE trial, in June 2024, we met and aligned with the FDA on the primary endpoint for the ENCORE trial. If the data are positive, ENCORE may support a label expansion to include all MAC lung disease as well as support full approval for the current refractory indication.
• We completed enrollment in the ENCORE trial with 425 patients in the fourth quarter of 2024.
• We anticipate reporting topline data from the ENCORE trial in the first half of 2026, with the submission of a US supplementary new drug application for ARIKAYCE in all patients with MAC lung disease projected for the second half of 2026.
Brensocatib (including BRINSUPRI)
• In August 2025, BRINSUPRI (brensocatib 25 mg and 10 mg tablets), an oral, once-daily treatment for NCFB in adults and children 12 years and older, was approved in the US by the FDA. We launched BRINSUPRI in the US in the third quarter of 2025.
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• Regulatory submissions for brensocatib in the EU, the UK and Japan have been accepted. In October 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BRINSUPRI (brensocatib 25mg tablets). We anticipate commercial launches for each territory in 2026, pending approval.
• We completed enrollment in and anticipate reporting topline data fr om the Phase 2b study of brensocatib in patients with CRSsNP, which we refer to as the BiRCh trial, by early January of 2026.
• We completed enrollment in the Phase 2b study of brensocatib in patients with HS, which we refer to as the CEDAR trial. We anticipate topline data in the first half of 2026.
TPIP
• In May 2024, we reported topline safety data and certain exploratory efficacy endpoints from the Phase 2a study of TPIP in patients with PH-ILD. We anticipate initiating PALM-ILD, a Phase 3 study of TPIP in patients with PH-ILD in the fourth quarter of 2025.
• In June 2025, we announced positive topline results from the Phase 2b study of TPIP in patients with PAH. The study met its primary endpoint and secondary efficacy endpoints. We plan to initiate a Phase 3 study in patients with PAH in early 2026.
• Additional Phase 3 studies of TPIP are anticipated to be initiated in progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF) in the second half of 2026.
Gene Therapy
• In the fourth quarter of 2024, we received clearance from the FDA for our investigational new drug (IND) application for INS1201, an intrathecally-delivered gene therapy for patients with DMD. We have initiated a Phase 1 study of INS1201, which we refer to as the ASCEND trial.
• In the third quarter of 2025, we received clearance from the FDA for our IND application for INS1202, an intrathecally-delivered gene therapy for patients with ALS.
Pre-Clinical Programs
• We continue to progress our pre-clinical research programs across a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue.
To complement our internal research and development, we also actively evaluate in-licensing and acquisition opportunities for products, product candidates and technologies, including those that address serious diseases with significant unmet need.
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Our Strategy
We strive to develop and commercialize first- and best-in-class therapies that serve patient communities where the need is greatest. Our first product, 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 590mg (amikacin sulfate inhalation drug product). We are not aware of any other approved inhaled therapies specifically indicated to treat MAC lung disease in North America, Europe or Japan. We believe that ARIKAYCE has the potential to prove beneficial in other patients with refractory MAC lung disease. Our second commercial product, BRINSUPRI, was approved in the US in August 2025 for the treatment of NCFB. Regulatory submissions for brensocatib in the EU, the UK and Japan have been accepted. Our product candidates are brensocatib, which we are also developing for patients with neutrophil-mediated diseases other than bronchiectasis, TPIP, our Phase 2 product candidate that may offer a differentiated product profile for patients with PH-ILD and PAH, INS1201, our intrathecally-delivered gene therapy product candidate for patients with DMD, and INS1202, our intrathecally-delivered gene therapy product candidate for patients with ALS. We are also advancing our pre-clinical research programs en compassing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue.
Our key priorities are as follows:
• Ensure successful US commercial launch of BRINSUPRI;
• Continue to provide ARIKAYCE to appropriate patients and expand our reliable revenue stream;
• Advance commercial readiness activities to serve significantly more patients facing serious diseases;
• Produce topline clinical data readouts in the near and long term; and
• Control spending, prudently deploying capital to support the best return-generating opportunities.
ARIKAYCE for Patients with MAC Lung Disease
ARIKAYCE is our first approved product. ARIKAYCE received accelerated approval in the US in September 2018 for the treatment of refractory MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options. In October 2020, ARIKAYCE received approval in Europe for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have CF. In March 2021, ARIKAYCE received approval in Japan for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen. MAC lung disease is a rare and often chronic infection that can cause irreversible lung damage and can be fatal. Amikacin solution for parenteral administration is an established drug that has activity against a variety of NTM; however, its use is limited by the need to administer it intravenously and by toxicity to hearing, balance, and kidney function. Unlike amikacin solution for intravenous administration, our proprietary Pulmovance™ technology uses charge-neutral liposomes to deliver amikacin directly to the lungs where liposomal amikacin is taken up by the lung macrophages where the MAC infection resides. This technology also prolongs the release of amikacin in the lungs, while minimizing systemic exposure, thereby offering the potential for decreased systemic toxicities. ARIKAYCE's ability to deliver high levels of amikacin directly to the lung and sites of MAC infection via the use of our Pulmovance technology distinguishes it from intravenous amikacin. ARIKAYCE is administered once-daily using Lamira, an inhalation device developed and manufactured by PARI. Lamira is a portable nebulizer that enables aerosolization of liquid medications via a vibrating, perforated membrane, and was designed specifically for ARIKAYCE delivery.
The FDA has designated ARIKAYCE as an orphan drug and a Qualified Infectious Disease Product (QIDP) for NTM lung disease. Orphan designated drugs are eligible for seven years of exclusivity for the orphan indication. QIDP designation provides an additional five years of exclusivity for the designated indication. The FDA granted a total of 12 years of exclusivity in the indication for which ARIKAYCE was approved.
ARIKAYCE also has been included in the international treatment guidelines for NTM lung disease. The evidence-based guidelines, issued by the American Thoracic Society (ATS), European Respiratory Society (ERS), European Society of Clinical Microbiology and Infectious Diseases (ESCMID), and Infectious Diseases Society of America (IDSA), strongly recommend the use of ARIKAYCE for MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options who have failed to convert to a negative sputum culture after at least six months of treatment.
In October 2020, the FDA approved a supplemental new drug application for ARIKAYCE, adding important efficacy data regarding the durability and sustainability of culture conversion to the ARIKAYCE label. The data, which are from the Phase 3 CONVERT study of ARIKAYCE, demonstrate that the addition of ARIKAYCE to guideline-based therapy (GBT) was associated with sustained culture conversion through the end of treatment as well as durable culture conversion three months post-treatment compared with GBT alone.
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Accelerated Approval
In September 2018, the FDA granted accelerated approval for ARIKAYCE under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) for the treatment of refractory MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options. LPAD, which was enacted as part of the 21st Century Cures Act, serves to advance the development of new antibacterial drugs to treat serious or life-threatening infections in limited populations of patients with unmet needs. As required for drugs approved under the LPAD pathway, labeling for ARIKAYCE includes certain statements to convey that the drug has been shown to be safe and effective only for use in a limited population.
As a condition of accelerated approval, we must conduct a post-marketing confirmatory clinical trial. In December 2020, we commenced the post-marketing confirmatory clinical trial program for ARIKAYCE in patients with MAC lung disease consisting of the ARISE trial, an interventional study designed to validate cross-sectional and longitudinal characteristics of a PRO tool in MAC lung disease, and the ENCORE trial, designed to establish the clinical benefits and evaluate the safety of ARIKAYCE in patients with newly diagnosed or recurrent MAC lung infection who have not started antibiotics using the PRO tool validated in the ARISE trial. In September 2023, we announced positive topline results from the ARISE trial. The study met its primary objective of demonstrating that the QOL-B respiratory domain works effectively as a PRO tool in patients with MAC lung disease. In June 2024, we met and aligned with the FDA on the primary endpoint for the ENCORE study. If the data are positive, ENCORE may support a label expansion to include all MAC lung disease as well as support full approval for the current refractory indication. Based on feedback and in alignment with the FDA, we have determined that the primary endpoint for the ENCORE study will include eight questions from the QOL-B respiratory domain PRO. We completed enrollment of the ENCORE study in the fourth quarter of 2024, with 425 patients enrolled. We anticipate reporting topline data in the first half of 2026.
Regulatory Pathway Outside of the US
In October 2020, the EC granted marketing authorization for ARIKAYCE for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have CF. ARIKAYCE can now be prescribed for patients across the EU countries as well as in the UK. ARIKAYCE is reimbursed nationally in France, Belgium, the Netherlands, the UK and Ireland. We have worked with the German National Association of Statutory Health Insurance Funds towards an agreement on the price of ARIKAYCE that would allow us to better serve the needs of patients in Germany; however, since we have been unable to reach an agreement, patient supply of ARIKAYCE in Germany was enabled by import from other EU countries in September 2022. We are working to ensure an uninterrupted supply of ARIKAYCE for patients in Germany and to provide physicians and pharmacists the information they need to obtain ARIKAYCE for their patients through the importation pathway. In January 2023, we agreed upon reimbursement terms with the French authorities. To date, we have been unable to reach an acceptable agreement of a nationally reimbursed price with the Italian Medicines Agency; however, ARIKAYCE remains commercially available for physicians to prescribe in Italy under Class C, where we set the price and funding is agreed locally.
In March 2021, Japan's MHLW 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. In July 2021, we launched ARIKAYCE in Japan.
The CONVERT Study and 312 Study
Accelerated approval of ARIKAYCE was supported by preliminary data from the CONVERT study, a global Phase 3 study evaluating the safety and efficacy of ARIKAYCE in adult patients with refractory MAC lung disease, using achievement of sputum culture conversion (defined as three consecutive negative monthly sputum cultures) by Month 6 as the primary endpoint. Patients who achieved sputum culture conversion by Month 6 continued in the CONVERT study for an additional 12 months of treatment following the first monthly negative sputum culture in order to assess the durability of culture conversion, as defined by patients that have completed treatment and continued in the CONVERT study off all therapy for three months. In May 2019, we presented at the American Thoracic Society meeting that 41/65 (63.1%) of patients on ARIKAYCE plus GBT who had achieved culture conversion by Month 6 had maintained durable culture conversion for three months off all therapy compared to 0/10 (0%) on GBT only (p<0.0002). Safety data for these patients were consistent with safety data previously reported for patients by Month 6 of the CONVERT study.
Patients who did not culture convert by Month 6 may have been eligible to enroll in the 312 study, an open-label extension study for these non-converting patients who completed six months of treatment in the CONVERT study. The primary objective of the 312 study was to evaluate the long-term safety and tolerability of ARIKAYCE in combination with a standard multi-drug regimen. The secondary objectives of the 312 study included evaluating the proportion of subjects achieving culture conversion (defined in the same way as the CONVERT study) by Month 6 and the proportion of subjects achieving culture conversion by Month 12, which was the end of treatment. We previously reported interim data as of December 2017 for patients in the 312 study, with 28.4% of patients who received GBT only in the CONVERT study (19/67) and 12.3% of patients
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who had received ARIKAYCE plus GBT in the CONVERT study (7/57) achieving culture conversion by Month 6 of the 312 study. The 312 study has concluded and final efficacy data regarding culture conversion were consistent with these interim data. We have analyzed the safety and efficacy data from the 312 study, and we did not observe any new safety signals.
The ARISE Study
The ARISE trial was a global, randomized, double-blind, placebo-controlled Phase 3b study in adult patients with newly diagnosed or recurrent MAC infections that aimed to generate evidence demonstrating the domain specification, reliability, validity, and responsiveness of PRO-based scores, including a respiratory symptom score. The ARISE study met its primary objective of demonstrating that the QOL-B respiratory domain works effectively as a PRO tool in patients with MAC lung disease.
Patients in ARISE (N=99) were randomized 1:1 to treatment with ARIKAYCE plus macrolide-based background regimen (ARIKAYCE arm) or placebo plus macrolide-based background regimen (comparator arm) once daily for six months, followed by one month off treatment. ARIKAYCE-treated patients performed better than those in the comparator arm as measured by the QOL-B instrument, with 43.8% of patients achieving an improvement in QOL-B respiratory score above the estimated meaningful within-subject score difference of 14.8, compared with 33.3% of patients in the comparator arm. While the study was not powered to show a statistically significant difference between treatment arms, a strong trend toward significance was observed for improvement from baseline at Month 7 (12.24 vs. 7.76, p=0.1073). Patients in the ARIKAYCE arm also achieved nominally statistically significantly higher culture conversion rates at Month 7 versus patients in the comparator arm (78.8% vs. 47.1%, p=0.0010), and culture conversion was faster and more likely to persist through Month 7 for the ARIKAYCE arm, suggesting that ARIKAYCE-treated patients are more likely to remain negative.
Consistent with our expectations, the FDA and the Pharmaceuticals and Medical Devices Agency in Japan confirmed that it would not consider a label expansion for ARIKAYCE based on data from the ARISE study alone.
ARISE Culture Conversion
Consistent with prior clinical studies, a higher proportion of patients in the ARIKAYCE arm achieved culture conversion by Month 6 (defined as negative cultures at Months 5 and 6) compared to patients in the comparator arm (80.6% vs. 63.9%, p=0.0712). Among patients who achieved culture conversion by Month 6, more patients in the ARIKAYCE arm achieved the first of their two required monthly negative cultures for clinical conversion at Month 1 versus the comparator arm (74.3% vs. 46.7%).
Correlation Between ARISE Culture Conversion and QOL-B Performance
Patients in the ARIKAYCE arm who achieved culture conversion at both Month 6 and Month 7 had nominally statistically significantly greater improvements in QOL-B respiratory domain scores at Month 7 compared to patients in the ARIKAYCE arm who did not achieve culture conversion (15.74 vs. 3.53, p=0.0167 at Month 6 and 14.89 vs. 4.50, p=0.0416 at Month 7).
ARISE Safety and Tolerability
The discontinuation rate of ARIKAYCE or the placebo used in the comparator arm was 22.9% in the ARIKAYCE arm and 7.8% in the comparator arm. Study completion rates were 91.7% in the ARIKAYCE arm and 94.1% in the comparator arm. No new safety events were observed in the ARIKAYCE arm, and the safety profile in general was as expected in both treatment arms. Treatment-emergent adverse events (TEAEs) were reported by 91.7% of patients in the ARIKAYCE arm and 80.4% of patients in the comparator arm. The most common TEAEs were dysphonia (41.7% for the ARIKAYCE arm vs. 3.9% for the comparator arm), cough (27.1% vs. 7.8%), diarrhea (27.1% vs. 25.5%), and COVID-19 (12.5% vs. 9.8%). Of the treatment-emergent serious adverse events observed in the trial, none were determined to be related to ARIKAYCE by investigators.
Further Research and Lifecycle Management
We are currently exploring and supporting research and lifecycle management programs for ARIKAYCE beyond treatment of refractory MAC lung disease as part of a combination antibacterial regimen for adult patients who have limited or no treatment options. As noted above, we will continue to advance the post-marketing confirmatory MAC lung disease clinical trial program for ARIKAYCE, through the completed ARISE and ongoing ENCORE trials, which are intended to fulfill the FDA's post-marketing requirement to allow for the full approval of ARIKAYCE in the US, as well as to support the use of ARIKAYCE as a treatment for patients with MAC lung disease.
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The ENCORE trial is a randomized, double-blind, placebo-controlled Phase 3b study to evaluate the efficacy and safety of an ARIKAYCE-based regimen in patients with newly diagnosed or recurrent MAC infection who have not started antibiotics. Patients are randomized 1:1 to receive ARIKAYCE plus background regimen or placebo plus background regimen once daily for 12 months. Patients will then discontinue all study treatments and remain in the trial for three months for the assessment of durability of culture conversion. The primary endpoint is change from baseline to Month 13 in respiratory symptom score. The key secondary endpoint is the proportion of subjects achieving durable culture conversion at Month 15. In June 2024, we met and aligned with the FDA on the primary endpoint for the ENCORE study. If the data are positive, ENCORE may support a label expansion to include all MAC lung disease as well as support full approval for the current refractory indication. Based on feedback and in alignment with the FDA, we have determined that the primary endpoint for the ENCORE study will include eight questions from the QOL-B respiratory domain PRO. We completed enrollment of the ENCORE study in the fourth quarter of 2024, with 425 patients enrolled. We anticipate reporting topline data in the first half of 2026.
Subsequent lifecycle management studies could also potentially enable us to reach more patients. These initiatives may include new clinical studies sponsored by us and may also include investigator-initiated studies, which are independent clinical studies initiated and sponsored by physicians or research institutions, with funding from us.
BRINSUPRI
BRINSUPRI (brensocatib 25 mg and 10 mg tablets), an oral, once-daily treatment for NCFB in adults and children 12 years and older, was approved in the US by the FDA in August 2025.
Brensocatib is a small molecule, reversible inhibitor of DPP1, which we licensed from AstraZeneca in October 2016. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs) in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. Neutrophils contain the NSPs (including neutrophil elastase, proteinase 3, and cathepsin G) that have been implicated in a variety of inflammatory diseases. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs.
In June 2020, the FDA granted breakthrough therapy designation for brensocatib for the treatment of adu lt patients with NCFB for reducing exacerbations. The FDA's breakthrough therapy designation is designed to expedite the development and review of therapies that are intended to treat serious or life-threatening diseases and for which preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy. The benefits of breakthrough therapy designation include more frequent communication and meetings with the FDA, eligibility for rolling and priority review, intensive guidance on an efficient drug development program, and organizational commitment from the FDA involving senior managers. In November 2020, brensocatib was granted access to the PRIME scheme from the EMA for patients with NCFB.
In October 2021, the EMA’s Paediatric Committee approved the brensocatib Pediatric Investigational Plan for the treatment of patients with NCFB. As a result, the ASPEN trial included 41 adolescent patients between ages 12 to 17, which will fulfill the pediatric study requirements to support marketing applications in this patient population in the US, Europe and Japan.
In October 2025, CHMP of the EMA adopted a positive opinion recommending approval of BRINSUPRI (brensocatib 25mg tablets).
The WILLOW Study
The WILLOW study was a randomized, double-blind, placebo-controlled, parallel-group, multi-center, multi-national, Phase 2b study to assess the efficacy, safety and tolerability, and pharmacokinetics of brensocatib administered once daily for 24 weeks in patients with NCFB. The WILLOW study was conducted at 116 sites and enrolled 256 adult patients diagnosed with NCFB who had at least two documented pulmonary exacerbations in the 12 months prior to screening. Patients were randomized 1:1:1 to receive either 10 mg or 25 mg of brensocatib or matching placebo. The primary efficacy endpoint was the time to first pulmonary exacerbation over the 24-week treatment period in the brensocatib arms compared to the placebo arm.
WILLOW Efficacy, Safety and Tolerability Data
We announced topline data for the WILLOW study in February 2020 and full data for the WILLOW study in June 2020. In September 2020, final results from the WILLOW study were published online in the New England Journal of Medicine (NEJM). The data demonstrate that the WILLOW study met its primary endpoint of time to first pulmonary exacerbation over the 24-week treatment period for both the 10 mg and 25 mg dosage groups of brensocatib compared to placebo (p=0.027, p=0.044, respectively). The risk of exacerbation at any time during the trial was reduced by 42% for the 10 mg group versus placebo (HR 0.58, p=0.029) and by 38% for the 25 mg group versus placebo (HR 0.62, p=0.046). In addition, treatment with brensocatib 10 mg resulted in a significant reduction in the rate of pulmonary exacerbations, a key secondary endpoint, versus placebo. Specifically, patients treated with brensocatib experienced a 36% reduction in the 10 mg arm
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(p=0.041) and a 25% reduction in the 25 mg arm (p=0.167) versus placebo. Change in concentration of active neutrophil elastase in sputum versus placebo from baseline to the end of the treatment period was also statistically significant (p=0.034 for 10 mg, p=0.021 for 25 mg). Brensocatib was generally well-tolerated in the study. Rates of AEs leading to discontinuation in patients treated with placebo, brensocatib 10 mg, and brensocatib 25 mg were 10.6%, 7.4%, and 6.7%, respectively.
The ASPEN Study
Base d on the positive results of the WILLOW study, in December 2020 we commenced the ASPEN study, a global, randomized, double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety, and tolerability of brensocatib in adult patients with b ronchiectasis. Patients with bronchiectasis due to CF were not enrolled in the study. The primary endpoint was the rate of adjudicated PEs over the 52-week treatment period. Secondary endpoints included the time to first adjudicated PE, the proportion of subjects free of adjudicated PE by 52 weeks, the absolute change from baseline in post-bronchodilator FEV1, the reduction in annualized rate of severe adjudicated PE, and the change from baseline in the Bronchiectasis QOL-B Respiratory Symptoms Domain Score.
As part of the ASPEN study’s conduct, more than 460 trial sites were engaged in nearly 40 countries. After excluding sites that did not enroll any patients and all sites in Ukraine, due to the ongoing conflict, the total number of active sites in ASPEN was 391 sites in 35 countries. Adult patients (ages 18 to 85 years) were randomized 1:1:1 and adolescent patients (ages 12 to <18 years) were randomized 2:2:1 for treatment with brensocatib 10 mg, brensocatib 25 mg, or placebo once daily for 52 weeks, followed by 4 weeks off treatment.
ASPEN Safety Information and Efficacy Data
We announced positive topline results from the ASPEN trial in May 2024. Results from the ASPEN trial were published in the NEJM in April 2025. The primary efficacy analysis included data from 1,680 adult patients and 41 adolescent patients. Brensocatib was well-tolerated in the study. In addition, the study met its primary endpoint, with both dosage strengths of brensocatib demonstrating statistically significant reductions in the annualized rate of adjudicated PEs versus placebo. The study also met several of its prespecified secondary endpoints with statistical significance. In February 2025, the FDA accepted our NDA, with priority review granted, for brensocatib in patients with bronchiectasis. The FDA indicated that it does not plan to hold an advisory committee meeting to discuss the NDA.
Topline efficacy results from the ASPEN study were as follows:

Brensocatib 10 mg compared to placebo Brensocatib 25 mg
compared to placebo
Primary Endpoint
Reduction in annualized rate of PEs 21.1% p=0.0019* 19.4% p=0.0046*
Secondary Endpoints
Prolongation of time to first PE 18.7% p=0.0100* 17.5% p=0.0182*
Increase in odds of remaining exacerbation free over 52 weeks 41.2% p=0.0059* 40.0% p=0.0074*
Change from baseline in post-bronchodilator forced expiratory volume in 1 second (FEV1) at week 52 11 mL p=0.3841 38 mL p=0.0054*
Reduction in annualized rate of severe PEs 25.8% p=0.1277 26.0% p=0.1025
Change from baseline in the Quality of Life – Bronchiectasis (QOL-B) Respiratory Score at week 52 2.0 points p=0.0594 3.8 points p=0.0004^
* - Statistically significant

^ - Nominally significant p-value

Further Research and Development
In January 2023, we reported topline data from the Phase 2a, multiple-dose, pharmacokinetic/pharmacodynamic study of brensocatib in patients with CF. This Phase 2a study included both patients who were on background CFTR modulator drugs and patients who were not on CFTR modulator drugs. The study duration was approximately one month and dosed CF patients to placebo, 10 mg, 25 mg, and 40 mg of brensocatib. A clear dose-dependent and exposure-dependent inhibition of blood NSPs was observed in patients treated with brensocatib across all doses in this study, consistent with the mechanism of action of brensocatib. Safety and tolerability were consistent with what was observed during the Phase 2b WILLOW study, with no significant drug-related findings. We concluded that an additional cohort evaluating a 65 mg dose of brensocatib is not needed in this patient population.
Product Pipeline
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Brensocatib
We are conducting further studies to explore the potential of brensocatib in CRSsNP and HS, which are additional neutrophil-mediated diseases. CRSsNP currently has one approved pharmacological therapy (corticosteriod nasal spray); however, many patients do not respond to corticosteroids or endoscopic sinus surgery. The Phase 2b BiRCh trial of brensocatib in patients with CRSsNP is underway, with enrollment of 288 patients completed. We anticipate reporting topline data from the BiRCh trial by early January of 2026. We completed enrollment of the Phase 2b study of brensocatib in patients with HS. W e anticipate topline data in the first half of 2026.
Treprostinil Palmitil Inhalation Powder
TPIP is an investigational inhaled formulation of a treprostinil prodrug that has the potential to address certain of the current limitations of existing prostanoid therapies. We believe that TPIP prolongs duration of effect and may provide patients with greater consistency in pulmonary arterial pressure reduction over time. Current inhaled prostanoid therapies must be dosed four to nine times per day. Reducing dose frequency has the potential to ease treatment burden for patients and improve compliance. Additionally, we believe that TPIP may be associated with fewer side effects, including severity and/or frequency of cough, headache, throat irritation, nausea, flushing and dizziness that are associated with high initial drug levels and local upper airway exposure when using current inhaled prostanoid therapies. We believe TPIP may offer a differentiated product profile for PH-ILD and PAH.
In February 2021, we announced topline results from the Phase 1 study of TPIP in healthy volunteers. The objective of this first-in-human single ascending dose and multiple ascending dose study was to assess the pharmacokinetics and tolerability profile of TPIP. Data from the study demonstrated that TPIP was generally well tolerated, with a pharmacokinetic profile that supports continued development with once-daily dosing. The most common AEs across all cohorts in the study were cough, dizziness, headache, and nausea. Most AEs were mild in severity and consistent in nature with those typically seen with other inhaled prostanoid therapies. There were few moderate AEs and no severe or serious AEs. Subjects in the multiple dose panel that incorporated an up-titration approach beginning at 112.5 µg once-daily and progressing to 225 µg once-daily reported fewer AEs compared to the panel dosed with 225 µg once-daily from the first dose.
Overall pharmacokinetic results demonstrated that treprostinil exposure (AUC and Cmax) was dose-proportional, with low to moderate inter-subject variability. Treprostinil was detected in the plasma at 24 hours at all doses and throughout the 48-hour sampling period for the two highest doses. Compared with currently available inhaled treprostinil therapy, TPIP showed substantially lower Cmax and longer half-life.
In May 2024, we reported topline safety data and certain exploratory efficacy endpoints from the Phase 2a study of TPIP in patients with PH-ILD. We anticipate initiating PALM-ILD, a Phase 3 study of patients with PH-ILD, in the fourth quarter of 2025.
In June 2025, we announced positive topline results from the Phase 2b study of TPIP in patients with PAH. The study met its primary endpoint and secondary efficacy endpoints. For the primary endpoint, the placebo-adjusted reduction from baseline in pulmonary vascular resistance (PVR) was 35% with Least Squares (LS) mean ratio of 0.65 (95% Confidence Interval (CI): 0.54, 0.79; p<0.001). For the secondary efficacy endpoints, the placebo-adjusted improvement in six-minute walk distance (6MWD) was 35.5 meters (95% CI: 11.2, 60.7; p=0.003) and the placebo-adjusted reduction from baseline in N-terminal pro b-type natriuretic peptide (NT-proBNP) concentrations, a biomarker for cardiac stress, was 60% with LS mean ratio of 0.40 (95% CI: 0.27, 0.59; p<0.001). Efficacy of TPIP was evaluated approximately 24 hours after therapy was administered.
The TPIP PAH study was conducted at 44 sites globally, and a total of 102 patients were randomized 2:1 to receive either TPIP (n=69) or placebo (n=33) for 16 weeks. Demographics and baseline characteristics were similar in both study arms. Patients started at a dose of 80 µg once daily (TPIP or matching placebo) and were titrated up to their maximum tolerated dose, or to the maximum allowable dose of 640 µg, once daily over a three-week period, with the possibility of a final dose increase occurring at Week 5. Of the patients treated with TPIP, 84% titrated to at least 480 µg once daily (n=58) and 75% titrated to the maximum allowed dose of 640 µg once daily (n=52). Overall, 90% of patients receiving TPIP (n=62) and all patients receiving placebo completed the study.
Once-daily TPIP therapy was well-tolerated in the study. TEAEs occurred in 88.4% of patients who received TPIP versus 75.8% of patients who received placebo; serious TEAEs were observed in 7.2% of patients who received TPIP versus 3.0% of patients who received placebo; and severe TEAEs were observed in 5.8% of patients who received TPIP versus 3.0% of patients who received placebo. TEAEs leading to treatment discontinuation were experienced by 5.8% of patients taking TPIP; there were none in the placebo arm. There were no deaths in the study. The most common TEAEs occurring in at least 5.0% of patients in any study arm, and more frequently with TPIP than with placebo, were cough (40.6%, 21.2%), headache (31.9%, 15.2%), fatigue (10.1%, 3.0%), chest discomfort (8.7%, 0.0%), flushing (8.7%, 3.0%), upper respiratory tract infection (7.2%, 3.0%), and non-cardiac chest pain (5.8%, 3.0%) for TPIP and placebo, respectively.
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All patients who completed the Phase 2b study were eligible to enroll in the long-term open-label extension, which will evaluate TPIP up to a maximum allowable dose of 1,280 µg once daily. Of the patients who completed the Phase 2b study (n=95), 95% enrolled in the open-label extension.
Based on these results, we plan to initiate a Phase 3 trial in patients with PAH in early 2026. Additional Phase 3 studies of TPIP are anticipated to be initiated in PPF and IPF in the second half of 2026.
Gene Therapy
In the fourth quarter of 2024, we received clearance from the FDA for our IND application for INS1201, a microdystrophin adeno-associated virus gene replacement therapy for patients with DMD. Administered intrathecally, this approach has the potential to target both skeletal and cardiac muscles at lower doses than intravenous DMD gene therapies. We have initiated a Phase 1 study of INS1201, which we refer to as the ASCEND trial.
In the third quarter of 2025, we received clearance from the FDA for our IND application for INS1202, an intrathecally-delivered gene therapy for patients with ALS.
Pre-Clinical Development
Our early-stage research efforts are comprised of our pre-clinical programs, advanced through internal research and development and augmented through business development activities. In March 2021, we acquired a proprietary protein deimmunization platform, called Deimmunized by Design, focused on the reengineering of therapeutic proteins to evade immune recognition and reaction. In August 2021, we acquired Motus and AlgaeneX, pre-clinical stage companies engaged in the research, development and manufacturing of gene therapies for rare genetic disorders. In January 2023, we acquired Vertuis Bio, Inc., a privately held, pre-clinical stage company engaged in the research and development of gene therapies for rare genetic disorders. In June 2023, we acquired Adrestia Therapeutics Ltd., a privately held, pre-clinical stage company using precision genetic models to search for therapeutic targets, precision diagnostics, novel drug compounds and new applications for existing drugs.
We continue to progress our pre-clinical research programs across a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue.
Corporate Development
We plan to continue to develop, acquire, in-license or co-promote other products, product candidates and technologies, including those that address serious diseases that currently have significant unmet needs. We are focused broadly on serious disease therapeutics and prioritizing those areas that best align with our core competencies.