INSMED Inc 10-Q for FY2026 Q3
INSMED Inc (INSM)
10-Q
2026-10-29
For: 2026-09-30
View Original
Added on
October 29, 2026
About this 10-Q
INSMED Inc filed this 10-Q on October 29, 2026, covering the quarter ended September 30, 2026 (FY2026 Q3).
Headline figures
Quarter ended September 30, 2026, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $524.43M
- up 268.4% from $142.34M a year earlier
- Net loss
- $100.32M
- compared with a net loss of $370.02M a year earlier
- Diluted EPS
- -$0.46
- compared with -$1.75 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
For the quarterly period ended September 30, 2026
OR
For the transition period from to
Commission File Number 000-30739
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of incorporation or organization) | (I.R.S. employer identification no.) | |||||||
| (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 Section 12(b) of the Act:
| Title of each class | Trading symbols | Name of each exchange on which registered | ||||||
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.
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 23, 2026, there were 219,380,309 shares of the registrant’s common stock outstanding.
INSMED INCORPORATED
FORM 10-Q
FOR THE QUARTER ENDED SEPTEMBER 30, 2026
INDEX
Consolidated Balance Sheets as of September 30, 2026 (unaudited) and December 31, 2025 | ||||||||
Consolidated Statements of Comprehensive Loss (unaudited) for the three and nine months ended September 30, 2026 and 2025 | ||||||||
Consolidated Statements of Shareholders' Equity (unaudited) for the three and nine months ended September 30, 2026 and 2025 | ||||||||
Consolidated Statements of Cash Flows (unaudited) for the nine months ended September 30, 2026 and 2025 | ||||||||
Unless the context otherwise indicates, references in this Form 10-Q to “Insmed Incorporated” refer 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, 2026 | December 31, 2025 | ||||||||||
| (unaudited) | |||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
| Marketable securities | |||||||||||
| Accounts receivable | |||||||||||
| Inventory | |||||||||||
| Prepaid expenses and other current assets | |||||||||||
| Total current assets | |||||||||||
| Fixed assets, net | |||||||||||
| Finance lease right-of-use assets | |||||||||||
| Operating lease right-of-use assets | |||||||||||
| Intangibles, net | |||||||||||
| Goodwill | |||||||||||
| Other assets | |||||||||||
| Total assets | $ | $ | |||||||||
| Liabilities and shareholders’ equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable and accrued liabilities | $ | $ | |||||||||
| Current portion of royalty financing agreement | |||||||||||
| Finance lease liabilities | |||||||||||
| Operating lease liabilities | |||||||||||
| Total current liabilities | |||||||||||
| Debt, long-term | |||||||||||
| Royalty financing agreement | |||||||||||
| Contingent consideration | |||||||||||
| Finance lease liabilities, long-term | |||||||||||
| Operating lease liabilities, long-term | |||||||||||
| Other long-term liabilities | |||||||||||
| Total liabilities | |||||||||||
| Shareholders’ equity: | |||||||||||
Common stock, $ | |||||||||||
| Additional paid-in capital | |||||||||||
| Accumulated deficit | ( | ( | |||||||||
| Accumulated other comprehensive (loss) gain | ( | ||||||||||
| Total shareholders’ equity | |||||||||||
| Total liabilities and shareholders’ equity | $ | $ | |||||||||
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, | ||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||
| $ | $ | $ | $ | ||||||||||||||||||||
| Operating expenses: | |||||||||||||||||||||||
| Research and development | |||||||||||||||||||||||
| Selling, general and administrative | |||||||||||||||||||||||
| Amortization of intangible assets | |||||||||||||||||||||||
| Change in fair value of contingent consideration | ( | ||||||||||||||||||||||
| Total operating expenses | |||||||||||||||||||||||
| Operating loss | ( | ( | ( | ( | |||||||||||||||||||
| Investment income | |||||||||||||||||||||||
| Interest expense | ( | ( | ( | ( | |||||||||||||||||||
| Other income (expense), net | ( | ( | ( | ||||||||||||||||||||
| Loss before income taxes | ( | ( | ( | ( | |||||||||||||||||||
| Provision for income taxes | |||||||||||||||||||||||
| Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
| Basic and diluted net loss per share | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
Weighted average basic and diluted common shares outstanding | |||||||||||||||||||||||
| Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
| Other comprehensive income (loss): | |||||||||||||||||||||||
| Foreign currency translation gains (losses) | ( | ||||||||||||||||||||||
| Unrealized (loss) gain on marketable securities | ( | ( | |||||||||||||||||||||
| Total comprehensive loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
See accompanying notes to the unaudited consolidated financial statements
4
INSMED INCORPORATED
Consolidated Statements of Shareholders' Equity (unaudited)
(in thousands)
| Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total | |||||||||||||||||||||||||||||||
| Shares | Amount | ||||||||||||||||||||||||||||||||||
| Balance at June 30, 2025 | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||
| Comprehensive loss: | |||||||||||||||||||||||||||||||||||
| Net loss | ( | ( | |||||||||||||||||||||||||||||||||
| Other comprehensive income | |||||||||||||||||||||||||||||||||||
| Issuance of common stock for exercise of stock options, vesting of RSUs and PSUs, and ESPP | |||||||||||||||||||||||||||||||||||
| Net proceeds from issuance of common stock | ( | ( | |||||||||||||||||||||||||||||||||
| Stock-based compensation expense | |||||||||||||||||||||||||||||||||||
| Balance at September 30, 2025 | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||
| Balance at June 30, 2026 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
| Comprehensive loss: | |||||||||||||||||||||||||||||||||||
| Net loss | ( | ( | |||||||||||||||||||||||||||||||||
| Other comprehensive income | |||||||||||||||||||||||||||||||||||
| Issuance of common stock for exercise of stock options, vesting of RSUs, and ESPP | |||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | |||||||||||||||||||||||||||||||||||
| Balance at September 30, 2026 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
See accompanying notes to the unaudited consolidated financial statements
5
INSMED INCORPORATED
Consolidated Statements of Shareholders' Equity (unaudited)
(in thousands)
| Common Stock | Additional Paid-in Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total | ||||||||||||||||||||||||||||||||||
| Shares | Amount | |||||||||||||||||||||||||||||||||||||
| Balance at December 31, 2024 | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||
| Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||
| Net loss | ( | ( | ||||||||||||||||||||||||||||||||||||
| Other comprehensive income | ||||||||||||||||||||||||||||||||||||||
| Issuance of common stock for exercise of stock options, vesting of RSUs and PSUs, and ESPP | ||||||||||||||||||||||||||||||||||||||
| Net proceeds from issuance of common stock | ||||||||||||||||||||||||||||||||||||||
| Issuance of common stock upon conversion of convertible notes | ||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | ||||||||||||||||||||||||||||||||||||||
| Balance at September 30, 2025 | $ | $ | $ | ( | $ | $ | ||||||||||||||||||||||||||||||||
| Balance at December 31, 2025 | $ | $ | $ | ( | $ | $ | ||||||||||||||||||||||||||||||||
| Comprehensive loss: | ||||||||||||||||||||||||||||||||||||||
| Net loss | ( | ( | ||||||||||||||||||||||||||||||||||||
| Other comprehensive loss | ( | ( | ||||||||||||||||||||||||||||||||||||
| Issuance of common stock for exercise of stock options, vesting of RSUs, and ESPP | ||||||||||||||||||||||||||||||||||||||
| Issuance of common stock for Business Acquisition milestone achievement | ||||||||||||||||||||||||||||||||||||||
| Stock-based compensation expense | ||||||||||||||||||||||||||||||||||||||
| Balance at September 30, 2026 | $ | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||||||||||
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, | |||||||||||
| 2026 | 2025 | ||||||||||
| Operating activities | |||||||||||
| Net loss | $ | ( | $ | ( | |||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
| Depreciation | |||||||||||
| Amortization of intangible assets | |||||||||||
| Stock-based compensation expense | |||||||||||
| Amortization of debt issuance costs | |||||||||||
| Royalty financing non-cash interest expense | |||||||||||
| Accretion of discount on marketable securities, net | ( | ( | |||||||||
| Finance lease amortization expense | |||||||||||
| Non-cash operating lease expense | |||||||||||
| Change in fair value of contingent consideration | ( | ||||||||||
| Changes in operating assets and liabilities: | |||||||||||
| Accounts receivable | ( | ( | |||||||||
| Inventory | ( | ( | |||||||||
| Prepaid expenses and other current assets | ( | ( | |||||||||
| Other assets | ( | ||||||||||
| Accounts payable and accrued liabilities | |||||||||||
| Other liabilities | ( | ( | |||||||||
| Net cash used in operating activities | ( | ( | |||||||||
| Investing activities | |||||||||||
| Purchase of fixed assets | ( | ( | |||||||||
| Payment of AZ milestone | ( | ||||||||||
| Purchase of marketable securities | ( | ( | |||||||||
| Maturities of marketable securities | |||||||||||
| Net cash provided by (used in) investing activities | ( | ||||||||||
| Financing activities | |||||||||||
| Proceeds from exercise of stock options and ESPP | |||||||||||
| Proceeds from issuance of common stock, net | |||||||||||
Payments of principal of | ( | ||||||||||
| Payments of finance lease principal | ( | ( | |||||||||
| Net cash provided by financing activities | |||||||||||
| Effect of exchange rates on cash and cash equivalents | ( | ||||||||||
| Net decrease in cash and cash equivalents | ( | ( | |||||||||
| Cash and cash equivalents at beginning of period | |||||||||||
| Cash and cash equivalents at end of period | $ | $ | |||||||||
| Supplemental disclosures of cash flow information: | |||||||||||
| Cash paid for interest | $ | $ | |||||||||
| Cash paid for income taxes | $ | $ | |||||||||
See accompanying notes to the unaudited consolidated financial statements
7
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 commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. To complement the Company's internal research and development, the Company also actively evaluates in-licensing and acquisition opportunities for commercial products, product candidates, and technologies.
The Company's first two commercial products, ARIKAYCE® and BRINSUPRI®, are both part of the Respiratory therapeutic area. 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 Liposomal 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.
BRINSUPRI (brensocatib 25 mg and 10 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (referred to as bronchiectasis or NCFB) in patients 12 years of age and older, was approved in the US in August 2025. In November 2025, the EC approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. In February 2026, the United Kingdom's (UK) Medicines and Healthcare products Regulatory Agency (MHRA) approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of NCFB in patients 12 years of age and older with two or more flare-ups or worsening of symptoms in the past 12 months. In August 2026, Japan's MHLW approved BRINSUPRI Tablets 25 mg (brensocatib hydrate) for the treatment of NCFB in patients 12 years of age and older. Bronchiectasis is a serious, chronic lung disease in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage.
The Company's Respiratory therapeutic area also includes clinical-stage programs for treprostinil palmitil inhalation powder (TPIP) and INS1148. TPIP is an inhaled dry powder formulation of the treprostinil prodrug treprostinil palmitil which may offer a differentiated product profile for pulmonary hypertension associated with interstitial lung disease (PH-ILD), pulmonary arterial hypertension (PAH), progressive pulmonary fibrosis (PPF), and idiopathic pulmonary fibrosis (IPF). INS1148 is a monoclonal antibody targeting a specific isoform of Stem Cell Factor, called Stem Cell Factor 248 (SCF248), which we plan to initially develop for IPF, with plans to evaluate PPF and explore other diseases where inhibition of the pro-inflammatory and pro-fibrotic responses mediated by SCF248 may be beneficial. The Company is also exploring additional opportunities utilizing its various technologies within the Respiratory therapeutic area.
The Company's Immunology & Inflammation therapeutic area is exploring opportunities utilizing its various technologies.
The Company's Neuro & Other Rare therapeutic area includes the clinical-stage programs INS1201, an intrathecally delivered gene therapy for patients with Duchenne muscular dystrophy (DMD), and INS1202, an intrathecally delivered gene therapy for patients with amyotrophic lateral sclerosis (ALS). The Company is also exploring additional opportunities utilizing its various technologies within the Neuro & Other Rare therapeutic area.
The Company's research engine is advancing a wide range of technologies and modalities, including gene therapy, artificial intelligence (AI)-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates.
The Company was incorporated in the Commonwealth of Virginia on November 29, 1999 and its principal executive offices are located in Bridgewater, New Jersey. The Company has legal entities in the US, France, Germany, Ireland, Italy, the Netherlands, Switzerland, the UK, and Japan.
The 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
8
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
1. The Company and Basis of Presentation (Continued)
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, 2025. 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 and recurring 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. Certain prior period line items within the consolidated statements of shareholders' equity have been combined to conform to the current period presentation.
The Company had $396.6 million of cash and cash equivalents and $750.1 million of marketable securities as of September 30, 2026 and reported a net loss of $277.1 million for the nine months ended September 30, 2026. The Company has funded its operations through public offerings of equity securities, debt financings, revenue interest financings, and revenues generated from ARIKAYCE and BRINSUPRI. The Company expects to continue to incur consolidated operating losses, including losses in its US and certain international entities, while funding research and development (R&D) activities for ARIKAYCE, TPIP, INS1148, INS1201, INS1202, and its other pipeline programs, and commercialization and regulatory activities for BRINSUPRI and ARIKAYCE.
The Company expects its future cash requirements to be substantial. While the Company currently has sufficient funds to meet its financial needs for at least the next 12 months, the Company may raise additional capital in the future to fund its operations, its ongoing commercialization and clinical trial activities, and its future product candidates, and to develop, acquire, in-license, or co-promote other products or product candidates, including those that address serious diseases with significant unmet need. The source, timing, and availability of any future financing or other transaction will depend principally upon continued progress in the Company’s commercial, regulatory, and development activities. Any future financing will also be contingent upon market conditions. If the Company is unable to obtain sufficient additional funds when required, the Company may be forced to delay, restrict, or eliminate all or a portion of its development programs or commercialization efforts.
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, 2025. 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
9
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
2. Summary of Significant Accounting Policies (Continued)
relevant information about past events, including historical experience, current conditions, and reasonable and supportable forecasts that affect the collectability of the reported amount. The Company does not currently have a material allowance for uncollectible trade receivables.
The following table presents the customers representing 10% or more of the Company's gross product revenues for the nine months ended September 30, 2026 and their respective percentages for the nine months ended September 30, 2025.
| Nine Months Ended September 30, | |||||||||||||||||||||||
| 2026 | 2025 | ||||||||||||||||||||||
| Customer A | |||||||||||||||||||||||
| Customer B | |||||||||||||||||||||||
| Customer C | |||||||||||||||||||||||
| Customer D | |||||||||||||||||||||||
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.
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), and performance stock units (PSUs) 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, 2026 and 2025 (in thousands, except per share amounts):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||
| Numerator: | |||||||||||||||||||||||
| Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
| Denominator: | |||||||||||||||||||||||
| Weighted average common shares used in calculation of basic net loss per share: | |||||||||||||||||||||||
| Effect of dilutive securities: | |||||||||||||||||||||||
| Common stock options | |||||||||||||||||||||||
| RSUs | |||||||||||||||||||||||
| PSUs | |||||||||||||||||||||||
| Weighted average common shares outstanding used in calculation of diluted net loss per share | |||||||||||||||||||||||
| Net loss per share: | |||||||||||||||||||||||
| Basic and diluted | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
10
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
2. Summary of Significant Accounting Policies (Continued)
The following potentially dilutive securities have been excluded from the computations of diluted weighted average common shares outstanding as of September 30, 2026 and 2025, as their effect would have been anti-dilutive (in thousands):
As of September 30, | |||||||||||
| 2026 | 2025 | ||||||||||
| Common stock options | |||||||||||
| RSUs | |||||||||||
| Development milestone shares issuable | |||||||||||
| PSUs | |||||||||||
Recent Accounting Pronouncements (Not Yet Adopted)—In November 2024, the FASB issued ASU 2024-03, Income Statement (Subtopic 220-40)—Expense Disaggregation Disclosures, which requires disclosure of disaggregated income statement expense information about specific categories (including purchases of inventory, employee compensation, depreciation, and intangible asset amortization) in the notes to financial statements. ASU 2024-03 will be effective for fiscal years beginning after December 15, 2026 and interim periods beginning after December 15, 2027. The guidance is applied on a prospective basis, with a retrospective option, and early adoption is permitted. The Company is currently evaluating the impact of adoption of ASU 2024-03 on its consolidated financial statements.
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, 2026 | |||||||||||||||||||||||
| Fair Value | |||||||||||||||||||||||
| Carrying Value | Level 1 | Level 2 | Level 3 | ||||||||||||||||||||
| Assets | |||||||||||||||||||||||
| Cash and cash equivalents | $ | $ | $ | $ | |||||||||||||||||||
| Marketable securities | $ | $ | $ | $ | |||||||||||||||||||
| Liabilities | |||||||||||||||||||||||
| Contingent consideration | $ | $ | $ | $ | |||||||||||||||||||
11
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
3. Fair Value Measurements (Continued)
As of December 31, 2025 | |||||||||||||||||||||||
| Fair Value | |||||||||||||||||||||||
| Carrying Value | Level 1 | Level 2 | Level 3 | ||||||||||||||||||||
| Assets | |||||||||||||||||||||||
| Cash and cash equivalents | $ | $ | $ | $ | |||||||||||||||||||
| Marketable securities | $ | $ | $ | $ | |||||||||||||||||||
| Liabilities | |||||||||||||||||||||||
| Contingent consideration | $ | $ | $ | $ | |||||||||||||||||||
During the nine months ended September 30, 2026, there were purchases of $794.3 million of marketable securities and maturities of $979.0 million of marketable securities, consisting of US Treasury Bills.
As of September 30, 2026, the Company held $750.1 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 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, 2026. During the nine months ended September 30, 2026, new Level 1 assets were added in connection with the Company's purchase of available-for-sale securities.
The Company reviews the status of each security quarterly to determine whether an other-than-temporary impairment has occurred. In making its determination, the Company considers a number of factors, including: (1) the significance of the decline; (2) whether the security was rated below investment grade; (3) failure of the issuer to make scheduled interest or principal payments; and (4) the Company's ability and intent to retain the investment for a sufficient period of time for it to recover. The Company has determined that there were no other-than-temporary impairments during the nine months ended September 30, 2026.
Contingent Consideration
The contingent consideration liabilities arose from the acquisition of Motus Biosciences, Inc. and AlgaeneX, Inc. in August 2021 (together, the Business Acquisition). The contingent consideration liabilities consist of developmental and regulatory milestones, a priority review voucher (PRV) milestone, and net sales milestones. As of September 30, 2026, the Company was obligated to issue to Motus equityholders up to 4,610,838 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 upon the achievement of certain development and regulatory milestone events. 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 28 % as of September 30, 2026. 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 and first quarter of 2026, development milestones in connection with the Motus acquisition were achieved, resulting in the issuance of 364,566 shares of the Company's common stock in October 2025 and 364,397 shares of the Company's common stock in March 2026, respectively.
If the Company were to receive a PRV, the Company would be obligated to pay to the Motus equityholders a portion of the value of the PRV, 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 PRV or 50 % of the average of the sales prices for the last three publicly disclosed PRV sales, less certain adjustments. The fair value of the PRV 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 PRV program expired. As of December 31, 2025, the Company determined that the likelihood of receiving a PRV was remote and the related milestone had no fair value. On February 3, 2026, the PRV program was reauthorized. As of September 30, 2026, the Company determined that the value of the PRV milestone was $15.5 million.
The contingent consideration liabilities for net sales milestones were valued using an option pricing model with Monte Carlo simulation. As of September 30, 2026, the fair value of these net sales milestones were deemed immaterial to the overall fair value of the contingent consideration.
12
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
3. Fair Value Measurements (Continued)
The contingent consideration liabilities have been classified as a Level 3 recurring liability as its valuation requires substantial judgment and estimation of factors that are not currently observable in the market. If different assumptions were used for the inputs to the valuation approach, the estimated fair value could be significantly different than the fair value the Company determined. Contingent consideration liabilities expected to be settled within twelve months are classified as a current liability within accounts payable and accrued liabilities. Contingent consideration liabilities expected to be settled in more than twelve months are classified as a non-current liability. As of September 30, 2026, there was no current contingent consideration outstanding, and the fair value of the non-current contingent consideration was $178.1 million.
A valuation of the contingent consideration liabilities is performed quarterly with gains and losses included within change in fair value of contingent consideration 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, 2026 and December 31, 2025:
Fair Value as of September 30, 2026 (in millions) | Valuation Technique | Unobservable Inputs | Values | |||||||||||
| Development and regulatory milestones | $ | Probability-adjusted | Probabilities of success | |||||||||||
| PRV milestone | $ | Probability-adjusted discounted cash flow | Probability of success | |||||||||||
| Discount rate | ||||||||||||||
Fair Value as of December 31, 2025 (in millions) | Valuation Technique | Unobservable Inputs | Values | |||||||||||
| Development and regulatory milestones | $ | Probability-adjusted | Probabilities of success | |||||||||||
A rollforward of the Company's valuations for the contingent consideration liabilities for the nine months ended September 30, 2026 and 2025 follows (in thousands):
| Contingent Consideration (Level 3 Liabilities) | |||||||||||
| Balance as of December 31, 2024 | $ | ||||||||||
| Additions | |||||||||||
| Change in fair value | |||||||||||
| Milestone met and payable | ( | ||||||||||
| Balance as of September 30, 2025 | $ | ||||||||||
| Balance as of December 31, 2025 | $ | ||||||||||
| Additions | |||||||||||
| Change in fair value | ( | ||||||||||
| Payments | ( | ||||||||||
| Balance as of September 30, 2026 | $ | ||||||||||
The change in fair value of contingent consideration liabilities is due to changes in factors such as the probability of achieving milestones, the Company's stock price, or certain other estimated assumptions. Payments were made in shares of the Company's common stock.
Royalty Financing Agreement
The fair value of the Royalty Financing Agreement at the time of the transaction was based on the Company’s estimates of future royalties expected to be paid to OrbiMed 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
13
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
3. Fair Value Measurements (Continued)
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 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 geographic summary of the Company's product revenues, net, for the three and nine months ended September 30, 2026 and 2025 (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||
| ARIKAYCE | |||||||||||||||||||||||
| US | $ | $ | $ | $ | |||||||||||||||||||
| International | |||||||||||||||||||||||
| Total | $ | $ | $ | $ | |||||||||||||||||||
| BRINSUPRI | |||||||||||||||||||||||
| US | $ | $ | $ | $ | |||||||||||||||||||
| International | |||||||||||||||||||||||
| Total | $ | $ | $ | $ | |||||||||||||||||||
| Total | |||||||||||||||||||||||
| US | $ | $ | $ | $ | |||||||||||||||||||
| International | |||||||||||||||||||||||
| Total product revenues, net | $ | $ | $ | $ | |||||||||||||||||||
The Company also recognizes revenue related to various managed access programs. The Company recognizes certain international revenue related to early access programs (EAPs) in Europe.
Revenue is recorded at net selling price (transaction price), which includes estimates of variable consideration, with reserves 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
14
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
4. Product Revenues, Net (Continued)
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 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.
5. Inventory
The Company's inventory balance consists of the following (in thousands):
| As of | |||||||||||
| September 30, 2026 | December 31, 2025 | ||||||||||
| Raw materials | $ | $ | |||||||||
| Work-in-process | |||||||||||
| Finished goods | |||||||||||
| $ | $ | ||||||||||
15
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
5. Inventory (Continued)
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, 2026, 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, the milestones paid to AstraZeneca AB (AstraZeneca) as a result of the FDA and EC approvals of BRINSUPRI in August 2025 and November 2025, respectively, the milestone payable to AstraZeneca as a result of Japan's MHLW approval of BRINSUPRI in August 2026, and the pending milestone payable to AstraZeneca for the probable achievement of $1.0 billion in net sales of BRINSUPRI in a calendar year. 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. The Company began amortizing its AstraZeneca milestone-related intangible assets over BRINSUPRI's regulatory exclusivity period of approximately 14 years beginning August 2025 upon FDA approval of BRINSUPRI, November 2025 upon EC approval of BRINSUPRI, and August 2026 upon Japan's MHLW approval of BRINSUPRI. As of September 30, 2026, the Company determined the achievement of the AstraZeneca $1.0 billion net sales in a calendar year of BRINSUPRI milestone was probable, triggering a pending $35.0 million payable and intangible asset. During the third quarter of 2026, the Company also recognized incremental cumulative amortization expense related to the recognition of this milestone. Amortization expense is estimated to be $3.0 million for the remainder of 2026, $12.0 10.8 million for 2030.
Indefinite-lived Intangible Assets
As of September 30, 2026, the Company's indefinite-lived intangible assets consisted of acquired IPR&D from the Business Acquisition. Indefinite-lived intangible assets are not amortized.
A rollforward of the Company's intangible assets for the nine months ended September 30, 2026 and 2025 is as follows (in thousands):
| Intangible Asset | December 31, 2025 | Additions | Amortization | September 30, 2026 | ||||||||||||||||||||||
| Acquired ARIKAYCE R&D | $ | $ | $ | ( | $ | |||||||||||||||||||||
| PARI milestones | ( | |||||||||||||||||||||||||
| AstraZeneca milestones | ( | |||||||||||||||||||||||||
| Acquired IPR&D | ||||||||||||||||||||||||||
| $ | $ | $ | ( | $ | ||||||||||||||||||||||
| Intangible Asset | December 31, 2024 | Additions | Amortization | September 30, 2025 | ||||||||||||||||||||||
| Acquired ARIKAYCE R&D | $ | $ | $ | ( | $ | |||||||||||||||||||||
| PARI milestones | ( | |||||||||||||||||||||||||
| AstraZeneca milestones | ( | |||||||||||||||||||||||||
| Acquired IPR&D | ||||||||||||||||||||||||||
| $ | $ | $ | ( | $ | ||||||||||||||||||||||
Goodwill
The Company's goodwill balance of $136.1
16
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, 2026 | December 31, 2025 | ||||||||||||||||||
| Building | $ | $ | ||||||||||||||||||
| Land | NA | |||||||||||||||||||
| Lab equipment | ||||||||||||||||||||
| Furniture and fixtures | ||||||||||||||||||||
| Computer hardware and software | ||||||||||||||||||||
| Office equipment | ||||||||||||||||||||
| Manufacturing equipment | ||||||||||||||||||||
| Leasehold improvements | ||||||||||||||||||||
| Construction in progress | — | |||||||||||||||||||
| Less: accumulated depreciation | ( | ( | ||||||||||||||||||
| $ | $ | |||||||||||||||||||
8. Accounts Payable and Accrued Liabilities
Accounts payable and accrued liabilities consist of the following (in thousands):
| As of | |||||||||||
| September 30, 2026 | December 31, 2025 | ||||||||||
| Accounts payable and other accrued operating expenses | $ | $ | |||||||||
| Accrued clinical trial expenses | |||||||||||
| Accrued professional fees | |||||||||||
| Accrued technical operation expenses | |||||||||||
| Accrued compensation and employee related costs | |||||||||||
| Accrued royalty and milestones payable | |||||||||||
| Revenue Interest Payments payable | |||||||||||
| Accrued sales allowances and related costs | |||||||||||
| Accrued French rebate payable | |||||||||||
| Contingent consideration | |||||||||||
| Accrued milestone payment to AstraZeneca | |||||||||||
| Other accrued liabilities | |||||||||||
| $ | $ | ||||||||||
In August 2026, a $15.0 million milestone became payable to AstraZeneca upon Japan's MHLW approval of BRINSUPRI. As of September 30, 2026, a $35.0 million sales milestone payable to AstraZeneca became probable pending achievement of the $1.0 billion in net sales of BRINSUPRI in a calendar year. See Note 6 - Intangibles, Net and Goodwill for further details.
17
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 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 $11.7 million and $15.3 million for the three months ended September 30, 2026 and 2025, respectively, and $24.6 million and $21.2 million for the nine months ended September 30, 2026 and 2025, 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.
The table below summarizes the supplemental non-cash disclosures of the Company's leases (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | |||||||||||||||||||||||||||||
| Finance right-of-use assets obtained in exchange for lease obligations | $ | $ | $ | $ | ||||||||||||||||||||||||||||
| Operating right-of-use assets obtained in exchange for lease obligations | $ | $ | $ | $ | ||||||||||||||||||||||||||||
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. As of September 30, 2026 and December 31, 2025, costs of $77.9 million and $69.5 million, respectively, incurred by the Company under these additional agreements have been classified within other assets in the Company's consolidated balance sheet. Upon the commencement date, prepaid costs and minimum guarantees specified in the agreement will be combined to establish an operating lease ROU asset and operating lease liability.
10. Debt
Amended and Restated Loan Agreement
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 interest payable during the first 24 months from the closing of the Tranche A Term Loan could have been paid-in-kind at the Company's election. If elected, paid-in-kind interest would have been capitalized and added to the principal amount of the Tranche A Term Loan. The Tranche A Term Loan, including the paid-in-kind interest, would have been repaid in eight equal quarterly payments starting in the 13th quarter following the closing of the Tranche A Term Loan (i.e., the quarter ended March 31, 2026), except that the repayment start date
18
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. Debt (Continued)
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.
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. The A&R Loan Agreement, among other items, provides 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 following table presents the carrying value of the Company’s Term Loans balance as of September 30, 2026 and December 31, 2025 (in thousands):
| As of | ||||||||||||||||||||
| September 30, 2026 | December 31, 2025 | |||||||||||||||||||
| Principal | $ | $ | ||||||||||||||||||
| Paid-in-kind interest capitalized | ||||||||||||||||||||
| Debt discount, net | ( | ( | ||||||||||||||||||
| Term Loans | $ | $ | ||||||||||||||||||
As of September 30, 2026, future principal repayments of debt for each of the fiscal years through maturity were as follows (in thousands):
| Year Ending December 31: | |||||
| 2026 | $ | ||||
| 2027 | |||||
| 2028 | |||||
| 2029 | |||||
| 2030 and thereafter | |||||
| $ | |||||
19
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. Debt (Continued)
Interest Expense
Interest expense for the three and nine months ended September 30, 2026 and 2025 was as follows (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||
| Convertible debt contractual interest expense | $ | $ | $ | $ | |||||||||||||||||||
| Term Loans contractual interest expense | |||||||||||||||||||||||
| Royalty Financing Agreement interest expense | |||||||||||||||||||||||
| Amortization of debt issuance costs | |||||||||||||||||||||||
| Total debt interest expense | |||||||||||||||||||||||
| Finance lease interest expense | |||||||||||||||||||||||
| Total interest expense | $ | $ | $ | $ | |||||||||||||||||||
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 4.0 % of ARIKAYCE global net sales prior to September 1, 2025 and 4.5 % of ARIKAYCE global net sales on or after September 1, 2025, as well as 0.75 % of brensocatib global net sales, which includes BRINSUPRI (the Revenue Interest Payments). 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 with 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 presents the activity of the Company's Royalty Financing Agreement balance for the nine-month period ended September 30, 2026 and year ended December 31, 2025 (in thousands):
| Nine Months Ended September 30, 2026 | Twelve Months Ended December 31, 2025 | |||||||||||||
| Royalty Financing Agreement liability - beginning balance | $ | $ | ||||||||||||
| Revenue Interest Payments paid and payable | ( | ( | ||||||||||||
| Interest expense recognized | ||||||||||||||
| Royalty Financing Agreement liability - ending balance | $ | $ | ||||||||||||
| Royalty financing issuance costs: | ||||||||||||||
| Royalty issuance costs, unamortized - beginning balance | $ | ( | $ | ( | ||||||||||
| Amortization of issuance costs | ||||||||||||||
| Royalty issuance costs, unamortized - ending balance | $ | ( | $ | ( | ||||||||||
| $ | $ | |||||||||||||
| Less: current portion of royalty financing agreement | ( | |||||||||||||
| Royalty Financing Agreement | $ | $ | ||||||||||||
The Revenue Interest Payments payable in connection with the Royalty Financing Agreement were $8.6 million and $6.4 million as of September 30, 2026 and December 31, 2025, 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, 2026, the Company had 500,000,000 shares of common stock authorized with a par value of $0.01 per share and 219,320,467 14,405,923 shares of common stock for issuance upon the exercise of outstanding stock options, 3,343,365 shares of common stock for issuance upon the vesting of RSUs, and 265,889 shares for issuance upon the vesting of PSUs. In connection with the Business Acquisition, the Company reserved 9,406,112 shares of the Company’s common stock, subject to certain closing-related reductions.
Of the 9,406,112 shares reserved, subject to certain closing-related reductions, the Company issued 2,889,367 shares of the Company's common stock in connection with the Business Acquisition in the third quarter of 2021, after certain closing-related deductions. 171,427 , 177,203 , and 182,182 shares of the Company’s common stock reserved in connection with the Motus acquisition were issued as acquisition consideration on the first, second and third anniversaries of the closing date of the acquisition, respectively, in each case subject to certain reductions. During the third quarter of 2025 and first quarter of 2026, development milestones in connection with the Motus acquisition were achieved, resulting in the issuance of 364,566 shares of the Company's common stock in October 2025 and 364,397 shares of the Company's common stock in March 2026, respectively. 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. As of September 30, 2026, 4,979,705 shares of the Company's common stock remain reserved for the Business Acquisition.
Preferred Stock—As of September 30, 2026, the Company had 200,000,000 shares of preferred stock authorized with a par value of $0.01 per share and no
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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, and provided for awards of up to an aggregate of 24,250,000 shares (including the shares previously available for grant under the Insmed Incorporated 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 2019 Incentive 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, 2026, 10,494,454 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 and RSUs to new hires, which awards are made pursuant to the Nasdaq's inducement grant exception to the shareholder approval requirement for grants of equity compensation. The Company granted inducement stock options and RSUs covering 304,478 shares of the Company's common stock to new employees during the nine months ended September 30, 2026. In February 2025, the Company adopted the Insmed Incorporated 2025 Inducement Plan, under which the Company is authorized to grant a variety of inducement awards, including stock options and RSUs, up to an aggregate of 1,000,000 shares, as an inducement to become an employee of the Company or any of its subsidiaries. As of September 30, 2026, 395,755 shares remain available for future issuance under the Insmed Incorporated 2025 Inducement Plan.
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 ESPP allows eligible employees to acquire an ownership interest in the Company by purchasing common stock, at a discount, through payroll deductions. 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 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, 2026, there was $126.3 million of unrecognized compensation expense related to unvested stock options. As of September 30, 2026, 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, 2026, there was $232.0 million of unrecognized compensation expense related to unvested RSU awards.
Performance Stock Units—As of September 30, 2026, there were 91,686 PSUs outstanding with an unrecognized compensation expense of $18.0 million, which assumes a 100 % payout for these awards.
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, 2026 and 2025 (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||
| Research and development expenses | $ | $ | $ | $ | |||||||||||||||||||
| Selling, general and administrative expenses | |||||||||||||||||||||||
| Total stock-based compensation expense | $ | $ | $ | $ | |||||||||||||||||||
14. Income Taxes
The Company recorded a provision for income taxes of $2.7 million and $1.3 million for the three months ended September 30, 2026 and 2025, respectively, and $6.0 million and $3.5 million for the nine months ended September 30, 2026 and 2025, respectively. The provisions recorded for the three and nine months ended September 30, 2026 and 2025 are primarily a result of the Company's international subsidiaries that had taxable income during the periods and income tax on
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INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
14. Income Taxes (Continued)
modified gross revenues imposed by certain US states. 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 2022 and later, generally open for certain states for the years 2021 and later, and generally open for international jurisdictions for the years 2020 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, 2026 and December 31, 2025, 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, 2026 and December 31, 2025 or the consolidated statements of comprehensive loss for the three and nine months ended September 30, 2026 and 2025. The Company has no
15. Commitments and Contingencies
Commitments
The Company has entered into various commitments including, but not limited to, asset acquisition and license agreements. See Note 16 - Commitments and Contingencies in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025 for further information.
Rent expense charged to operations was $3.5 10.7 million and $10.3 million for the nine months ended September 30, 2026 and 2025, 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. Segment Reporting
The Company manages its business activities on a consolidated basis and operates as a single operating segment. The Company derives its revenues from the development and commercialization of therapies for patients facing serious diseases. The accounting policies of the segment are the same as those described in Note 2 – Summary of Significant Accounting Policies.
The Company has a single management team that reports to the Chief Executive Officer, the chief operating decision maker (CODM), who comprehensively manages the entire business. When evaluating the Company’s financial performance, the CODM regularly reviews total revenues, total expenses, and expenses by function, and makes decisions using this information on a global basis. The CODM uses net loss, as reported in the consolidated statements of comprehensive loss, in evaluating the performance of the segment. Decisions regarding resource allocation are made primarily during the annual budget planning process and augmented as needed throughout the year. The measure of segment assets is reported on the balance sheet as total assets. The Company does not operate separate lines of business with respect to its products or product candidates. Accordingly, the Company has one reportable segment.
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INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
16. Segment Reporting (Continued)
Segment loss, including significant segment expenses, for the three and nine months ended September 30, 2026 and 2025 is as follows (in thousands):
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||
| 2026 | 2025 | 2026 | 2025 | ||||||||||||||||||||||||||
| Product revenues, net | $ | $ | $ | $ | |||||||||||||||||||||||||
| Less: | |||||||||||||||||||||||||||||
| Cost of product revenues (excluding amortization of intangible assets) | |||||||||||||||||||||||||||||
| TPIP external R&D expenses | |||||||||||||||||||||||||||||
| Brensocatib external R&D expenses | |||||||||||||||||||||||||||||
| ARIKAYCE external R&D expenses | |||||||||||||||||||||||||||||
| Other external R&D expenses | |||||||||||||||||||||||||||||
| R&D compensation and benefit-related expenses | |||||||||||||||||||||||||||||
| SG&A compensation and benefit-related expenses | |||||||||||||||||||||||||||||
Other segment items(a) | |||||||||||||||||||||||||||||
| Depreciation | |||||||||||||||||||||||||||||
| Amortization of intangible assets | |||||||||||||||||||||||||||||
Change in fair value of contingent consideration | ( | ||||||||||||||||||||||||||||
| Investment income | ( | ( | ( | ( | |||||||||||||||||||||||||
| Interest expense | |||||||||||||||||||||||||||||
| Provision for income taxes | |||||||||||||||||||||||||||||
| Segment net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||||||||
(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 Japan, or to maintain US, European or Japanese approval for ARIKAYCE or BRINSUPRI;
•our inability to obtain full approval of ARIKAYCE from the FDA, 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 of the US, Europe and Japan, including separate regulatory approval for Lamira in each market and for each usage, or for BRINSUPRI outside of the US, 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;
•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;
•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 healthcare legislation or other government action materially adversely affects our business;
•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 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;
•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;
•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 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, 2025. 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,
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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, 2025.
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 commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. To complement our internal research and development, we also actively evaluate in-licensing and acquisition opportunities for commercial products, product candidates, and technologies. For a more complete discussion of our business, strategy, products and pipeline, see Part I, Item 1, “Business,” of our Annual Report on Form 10-K for the year ended December 31, 2025.
Our Marketed Products
Our two commercial products, ARIKAYCE and BRINSUPRI, are both part of our Respiratory therapeutic area. ARIKAYCE is approved in the US as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion and in Japan as ARIKAYCE inhalation 590 mg (amikacin sulfate inhalation drug product). ARIKAYCE received accelerated approval in the US in September 2018 for the treatment of MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options in a refractory setting. In October 2020, the EC approved ARIKAYCE Liposomal for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have CF. 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. NTM lung disease caused by MAC (which we refer to as MAC lung disease) is a rare and often chronic infection that can cause irreversible lung damage and can be fatal. We are not aware of any other approved inhaled therapies specifically indicated to treat MAC lung disease in North America, Europe, or Japan.
BRINSUPRI (brensocatib 25 mg and 10 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (referred to as bronchiectasis or NCFB) in patients 12 years of age and older, was approved in the US in August 2025. In November 2025, the EC approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. In February 2026, the MHRA granted a marketing authorisation for BRINSUPRI (brensocatib 25 mg tablets) to treat patients 12 years and older with NCFB who have experienced two or more flare-ups or worsening of symptoms in the past 12 months. In August 2026, Japan's MHLW approved BRINSUPRI Tablets 25 mg (brensocatib hydrate) for the treatment for NCFB in adults and pediatric patients 12 years and older. Bronchiectasis is a serious, chronic lung disease in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage. We are not aware of any other approved therapies in the US, Europe, or Japan for the treatment of patients with bronchiectasis.
Our Product Candidates & Research
Our Respiratory therapeutic area also includes the clinical-stage programs TPIP and INS1148. TPIP is an inhaled dry powder formulation of the treprostinil prodrug treprostinil palmitil which may offer a differentiated product profile for PH-ILD, PAH, PPF, and IPF. INS1148 is a monoclonal antibody targeting SCF248, which we plan to initially develop for IPF, with plans to evaluate PPF and explore other diseases where inhibition of the pro-inflammatory and pro-fibrotic responses mediated by SCF248 may be beneficial. We are exploring additional opportunities utilizing our various technologies within the Respiratory therapeutic area.
Our Immunology & Inflammation therapeutic area is exploring opportunities utilizing our various technologies.
The clinical-stage programs in our Neuro & Other Rare therapeutic area are INS1201, an intrathecally delivered gene therapy for patients with DMD, and INS1202, an intrathecally delivered gene therapy for patients with ALS. We are exploring additional opportunities utilizing our various technologies within the Neuro & Other Rare therapeutic area.
We are advancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates.
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Our Strategy
We plan to continue to develop, acquire, in-license, or co-promote other first- and best-in-class commercial 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 within our three therapeutic areas. Our key priorities are as follows:
•Drive continued momentum in the US commercialization of BRINSUPRI;
•Ensure successful commercial launch of BRINSUPRI in Japan;
•Continue to provide ARIKAYCE to appropriate patients and expand our label;
•Advance our pipeline and produce topline clinical data readouts in the near and long term; and
•Control spending, prudently deploying capital to support the best return-generating opportunities.
Prior to 2019, we had not generated significant revenue and, through September 30, 2026, we had an accumulated deficit of $5.9 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, 2026 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 obtaining full approval of ARIKAYCE in the US. Our continued success also depends on bringing additional clinical stage products, such as TPIP, INS1148, INS1201, and INS1202, to market, and advancing our pre-clinical research programs. We expect to continue to incur substantial expenses related to our research and development activities as we conduct trials of TPIP in PH-ILD, PAH, PPF, and IPF, and fund development of our clinical and pre-clinical programs. We also expect to continue to incur significant costs related to the commercialization of our marketed products. 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. Due to the challenging healthcare funding environment in Europe and evolving policies in the US, we do not plan to pursue a traditional commercialization model in Europe for the foreseeable future. However, there are certain other pathways available for patients to receive treatment.
The information below summarizes our recent updates and anticipated near-term milestones for our marketed products and our product candidates.
Respiratory
BRINSUPRI
•In August 2026, Japan's MHLW approved BRINSUPRI Tablets 25 mg (brensocatib hydrate) for the treatment of NCFB in adults and pediatric patients 12 years and older. We launched BRINSUPRI Tablets 25 mg (brensocatib hydrate) in Japan in October 2026.
ARIKAYCE
•In September 2026, our US supplemental new drug application (sNDA) for ARIKAYCE in patients with MAC lung disease was accepted and granted priority review by the FDA as part of a combination antibacterial drug regimen, with a target action date of January 28, 2027.
•We also plan to submit data to the Pharmaceuticals and Medical Devices Agency (PMDA) in the fourth quarter of 2026 to support potential label expansion in Japan.
TPIP
•In July 2026, we reported positive 12-month data from the ongoing open-label extension study of TPIP in patients with PAH.
•PALM-ILD, our Phase 3 study of TPIP in patients with PH-ILD, and PALM-PAH, our Phase 3 study of TPIP in patients with PAH, each continue to enroll patients.
•In September 2026, we initiated the Phase 3 PALM-PPF study of TPIP in patients with PPF.
•We continue to anticipate initiating a Phase 3 study of TPIP in patients with IPF in the first half of 2027.
INS1148
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•We continue to advance a Phase 2 development program for INS1148, initially targeting IPF, with plans to evaluate PPF and explore other diseases where inhibition of the pro-inflammatory and pro-fibrotic responses mediated by SCF248 may be beneficial.
Neuro & Other Rare
INS1201
•The ASCEND Phase 1 study evaluating INS1201 in DMD is fully enrolled.
INS1202
•We continue to enroll patients in the Phase 1 ARMOR clinical study of INS1202 for patients with ALS.
KEY COMPONENTS OF OUR RESULTS OF OPERATIONS
Product Revenues, Net
Product revenues, net, consist of net sales of ARIKAYCE and BRINSUPRI. We recognize revenue for product received by our customers net of allowances for customer credits, including prompt pay discounts, service fees, estimated rebates, including government rebates, such as Medicaid rebates and Medicare Part D reimbursements in the US, chargebacks, and co-payment assistance.
Cost of Product Revenues (Excluding Amortization of Intangible Assets)
Cost of product revenues (excluding amortization of intangible assets) consist primarily of direct and indirect costs related to the manufacturing of ARIKAYCE and BRINSUPRI sold, including third-party manufacturing costs, packaging services, freight, and allocation of overhead costs, in addition to royalty expenses.
Research and Development Expenses
R&D expenses consist of salaries, benefits and other related costs, including stock-based compensation, for personnel serving in our research and development functions. R&D expenses also include other internal operating expenses, the cost of manufacturing product candidates, including the medical devices for drug delivery, for clinical study, the cost of conducting clinical studies, and the cost of conducting pre-clinical and research activities. In addition, R&D expenses include payments to third parties for the license rights to products in development (prior to marketing approval), and may include the cost of asset acquisitions. Our R&D expenses related to manufacturing our product candidates and medical devices for clinical study are primarily related to activities at CMOs that manufacture our product candidates and early-stage research activities. Our R&D expenses related to clinical trials are primarily related to activities at contract research organizations (CROs) that conduct and manage clinical trials on our behalf. These contracts with CROs set forth the scope of work to be completed at a fixed fee or billed at a per-unit cost, and increase proportionally to the volume of services rendered. Payments under these contracts with CROs primarily depend on performance criteria such as the successful enrollment of patients or the completion of clinical trial milestones as well as time-based fees. Expenses are accrued based on contracted amounts applied to the level of patient enrollment and to activity according to the clinical trial protocol. Deposits for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are then recognized as an expense as the related goods are delivered or the services are performed.
Selling, General and Administrative (SG&A) Expenses
SG&A expenses consist of salaries, benefits and other related costs, including stock-based compensation, for our non-employee directors and personnel serving in our executive, finance and accounting, legal and compliance, commercial and pre-commercial, corporate development, field sales, information technology and human resource functions. SG&A expenses also include professional fees for legal services, advertising costs, consulting services, including commercial activities, insurance, board of director fees, tax and accounting services.
Amortization of Intangible Assets
Upon regulatory approval of each of ARIKAYCE and BRINSUPRI, the related intangible assets began to be amortized over their estimated useful lives. The fair values assigned to our intangible assets are based on estimates and assumptions we believe are reasonable based on available facts and circumstances. Unanticipated events or circumstances may occur that require us to review the assets for impairment.
Change in Fair Value of Contingent Consideration
In connection with the Business Acquisition, we recorded contingent consideration liabilities related to potential future milestone payments. Adjustments to the fair value are due to changes in the probability of achieving milestones, our stock price,
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or certain other estimated assumptions. The change in fair value of contingent consideration is calculated quarterly with gains and losses recorded in the consolidated statements of comprehensive loss.
Investment Income and Interest Expense
Investment income consists of interest and dividend income earned on our cash and cash equivalents and marketable securities. Interest expense consists primarily of contractual interest costs, Royalty Financing Agreement non-cash interest expense and the amortization of debt issuance costs. Debt issuance costs are amortized to interest expense using the effective interest rate method over the term of the debt. Our consolidated balance sheets reflect debt, net of the debt issuance costs paid to the lender, and other third-party costs.
RESULTS OF OPERATIONS
Comparison of the Three Months Ended September 30, 2026 and 2025
Product Revenues, Net
Product revenues, net, consists of net sales of ARIKAYCE and BRINSUPRI. The following table summarizes revenue by product and geography for the three months ended September 30, 2026 and 2025 (in thousands):
| Three Months Ended September 30, | Increase (decrease) | ||||||||||||||||||||||
| 2026 | 2025 | $ | % | ||||||||||||||||||||
| ARIKAYCE | |||||||||||||||||||||||
| US | $ | 75,508 | $ | 73,984 | $ | 1,524 | 2% | ||||||||||||||||
| International | 48,867 | 40,307 | 8,560 | 21% | |||||||||||||||||||
| Total | $ | 124,375 | $ | 114,291 | $ | 10,084 | 9% | ||||||||||||||||
| BRINSUPRI | |||||||||||||||||||||||
| US | $ | 398,077 | $ | 28,051 | $ | 370,026 | NM | ||||||||||||||||
| International | 1,976 | — | 1,976 | NA | |||||||||||||||||||
| Total | $ | 400,053 | $ | 28,051 | $ | 372,002 | NM | ||||||||||||||||
| Total | |||||||||||||||||||||||
| US | $ | 473,585 | $ | 102,035 | $ | 371,550 | 364% | ||||||||||||||||
| International | 50,843 | 40,307 | 10,536 | 26% | |||||||||||||||||||
| Total product revenues, net | $ | 524,428 | $ | 142,342 | $ | 382,086 | 268% | ||||||||||||||||
Product revenues, net, for the three months ended September 30, 2026 were $524.4 million as compared to $142.3 million for the same period in 2025, an increase of $382.1 million, or 268%. This increase was a result of the $370.0 million growth in US commercial sales of BRINSUPRI following approval in August 2025 and the $10.1 million growth in sales of ARIKAYCE, primarily driven by growth in international sales. We recognize international BRINSUPRI revenue related to EAPs in Europe, primarily through the named patient program in certain countries.
Cost of Product Revenues (excluding amortization of intangible assets)
Cost of product revenues (excluding amortization of intangible assets) for the three months ended September 30, 2026 and 2025 were as follows (in thousands):
| Three Months Ended September 30, | Increase (decrease) | ||||||||||||||||||||||
| 2026 | 2025 | $ | % | ||||||||||||||||||||
| Cost of product revenues (excluding amortization of intangible assets) | $ | 78,215 | $ | 29,365 | $ | 48,850 | 166% | ||||||||||||||||
| Cost of product revenues, as % of revenues | 14.9 | % | 20.6 | % | |||||||||||||||||||
Cost of product revenues (excluding amortization of intangible assets) were $78.2 million for the three months ended September 30, 2026 as compared to $29.4 million for the same period in 2025, an increase of $48.9 million, or 166%. This increase was primarily attributable to the increase in total product revenues discussed above. Cost of product revenues as a percent of revenues decreased in the current period due to sales of BRINSUPRI, which has lower manufacturing costs than ARIKAYCE.
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All product costs for BRINSUPRI incurred prior to FDA approval on August 12, 2025 were expensed as R&D expenses. We expect this to benefit our cost of product revenues (excluding amortization of intangible assets) in 2026 and beyond as we sell through inventory that was expensed prior to FDA approval of BRINSUPRI.
R&D Expenses
R&D expenses for the three months ended September 30, 2026 and 2025 were comprised of the following (in thousands):
| Three Months Ended September 30, | Increase (decrease) | ||||||||||||||||||||||
| 2026 | 2025 | $ | % | ||||||||||||||||||||
| External Expenses | |||||||||||||||||||||||
| Clinical development and research | $ | 60,768 | $ | 46,457 | $ | 14,311 | 31% | ||||||||||||||||
| Manufacturing | 85,915 | 37,415 | 48,500 | 130% | |||||||||||||||||||
| Regulatory, quality assurance, and medical affairs | 14,544 | 10,030 | 4,514 | 45% | |||||||||||||||||||
| Subtotal—external expenses | $ | 161,227 | $ | 93,902 | $ | 67,325 | 72% | ||||||||||||||||
| Internal Expenses | |||||||||||||||||||||||
| Compensation and benefit-related expenses | $ | 74,446 | $ | 63,817 | $ | 10,629 | 17% | ||||||||||||||||
| Stock-based compensation | 18,998 | 15,399 | 3,599 | 23% | |||||||||||||||||||
| Other internal operating expenses | 15,292 | 13,297 | 1,995 | 15% | |||||||||||||||||||
| Subtotal—internal expenses | $ | 108,736 | $ | 92,513 | $ | 16,223 | 18% | ||||||||||||||||
| Total R&D expenses | $ | 269,963 | $ | 186,415 | $ | 83,548 | 45% | ||||||||||||||||
R&D expenses were $270.0 million for the three months ended September 30, 2026 as compared to $186.4 million for the same period in 2025, an increase of $83.5 million, or 45%. This increase was primarily due to a $48.5 million increase in manufacturing costs and a $14.3 million increase in clinical development and research costs, both primarily related to TPIP, and a $14.2 million increase in compensation and benefit-related expenses and stock-based compensation costs due primarily to an increase in headcount.
External R&D expenses by product for the three months ended September 30, 2026 and 2025 were comprised of the following (in thousands):
| Three Months Ended September 30, | Increase (decrease) | |||||||||||||||||||||||||
| 2026 | 2025 | $ | % | |||||||||||||||||||||||
| TPIP external R&D expenses | $ | 79,229 | $ | 28,754 | $ | 50,475 | 176% | |||||||||||||||||||
| Brensocatib external R&D expenses | 17,023 | 19,355 | (2,332) | (12)% | ||||||||||||||||||||||
| ARIKAYCE external R&D expenses | 4,154 | 9,214 | (5,060) | (55)% | ||||||||||||||||||||||
| Other external R&D expenses | 60,821 | 36,579 | 24,242 | 66% | ||||||||||||||||||||||
| Total external R&D expenses | $ | 161,227 | $ | 93,902 | $ | 67,325 | 72% | |||||||||||||||||||
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SG&A Expenses
SG&A expenses for the three months ended September 30, 2026 and 2025 were comprised of the following (in thousands):
| Three Months Ended September 30, | Increase (decrease) | ||||||||||||||||||||||||||||
| 2026 | 2025 | $ | % | ||||||||||||||||||||||||||
| Compensation and benefit-related expenses | $ | 74,303 | $ | 62,287 | $ | 12,016 | 19% | ||||||||||||||||||||||
| Stock-based compensation | 22,222 | 16,034 | 6,188 | 39% | |||||||||||||||||||||||||
| Professional fees and other external expenses | 132,087 | 83,447 | 48,640 | 58% | |||||||||||||||||||||||||
| Facility related and other internal expenses | 24,417 | 24,608 | (191) | (1)% | |||||||||||||||||||||||||
| Total SG&A expenses | $ | 253,029 | $ | 186,376 | $ | 66,653 | 36% | ||||||||||||||||||||||
SG&A expenses were $253.0 million for the three months ended September 30, 2026 as compared to $186.4 million for the same period in 2025, an increase of $66.7 million, or 36%. This increase was primarily due to a $48.6 million increase in professional fees and other external expenses and a $18.2 million increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, both driven by commercial activities for BRINSUPRI.
Amortization of Intangible Assets
Amortization of intangible assets was $5.1 million for the three months ended September 30, 2026 as compared to $1.5 million for the same period in 2025, an increase of $3.5 million. This increase was due to amortization of the AstraZeneca milestone for the pending achievement of $1.0 billion in net sales of BRINSUPRI in a calendar year as of September 2026, and the FDA, EC and MHLW approvals of BRINSUPRI in August 2025, November 2025, and August 2026, respectively.
Change in Fair Value of Contingent Consideration
The change in fair value of contingent consideration for the three months ended September 30, 2026 was $7.5 million and was primarily due to the increase in our share price. Contingent consideration is the potential future consideration to be paid to former equityholders of the businesses we acquired.
Investment Income
Investment income was $11.1 million for the three months ended September 30, 2026 as compared to $18.3 million for the same period in 2025, a decrease of $7.2 million, or 39%. This decrease was due to lower average cash and marketable securities balances and lower interest rates in 2026 relative to the same period in 2025.
Interest Expense
Interest expense was $20.4 million for both the three months ended September 30, 2026 and 2025. See Note 10 - Debt and Note 11 - Royalty Financing Agreement in this Quarterly Report on Form 10-Q for further details.
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RESULTS OF OPERATIONS
Comparison of the Nine Months Ended September 30, 2026 and 2025
Product Revenues, Net
Product revenues, net, consists of net sales of ARIKAYCE and BRINSUPRI. The following table summarizes revenue by product and geography for the nine months ended September 30, 2026 and 2025 (in thousands):
| Nine Months Ended September 30, | Increase (decrease) | ||||||||||||||||||||||
| 2026 | 2025 | $ | % | ||||||||||||||||||||
| ARIKAYCE | |||||||||||||||||||||||
| US | $ | 208,578 | $ | 206,942 | $ | 1,636 | 1% | ||||||||||||||||
| International | 130,223 | 107,587 | 22,636 | 21% | |||||||||||||||||||
| Total | $ | 338,801 | $ | 314,529 | $ | 24,272 | 8% | ||||||||||||||||
| BRINSUPRI | |||||||||||||||||||||||
| US | $ | 913,814 | $ | 28,051 | $ | 885,763 | NM | ||||||||||||||||
| International | 3,263 | — | 3,263 | NA | |||||||||||||||||||
| Total | $ | 917,077 | $ | 28,051 | $ | 889,026 | NM | ||||||||||||||||
| Total | |||||||||||||||||||||||
| US | $ | 1,122,392 | $ | 234,993 | $ | 887,399 | 378% | ||||||||||||||||
| International | 133,486 | 107,587 | 25,899 | 24% | |||||||||||||||||||
| Total product revenues, net | $ | 1,255,878 | $ | 342,580 | $ | 913,298 | 267% | ||||||||||||||||
Product revenues, net, for the nine months ended September 30, 2026 were $1,255.9 million as compared to $342.6 million for the same period in 2025, an increase of $913.3 million, or 267%. This increase was a result of an $885.8 million growth in US commercial sales of BRINSUPRI following approval in August 2025 and a $24.3 million growth in sales of ARIKAYCE, primarily driven by growth in international sales.
Cost of Product Revenues (excluding amortization of intangible assets)
Cost of product revenues (excluding amortization of intangible assets) for the nine months ended September 30, 2026 and 2025 were as follows (in thousands):
| Nine Months Ended September 30, | Increase (decrease) | ||||||||||||||||||||||
| 2026 | 2025 | $ | % | ||||||||||||||||||||
| Cost of product revenues (excluding amortization of intangible assets) | $ | 192,847 | $ | 78,718 | $ | 114,129 | 145% | ||||||||||||||||
| Cost of product revenues, as % of revenues | 15.4 | % | 23.0 | % | |||||||||||||||||||
Cost of product revenues (excluding amortization of intangible assets) were $192.8 million for the nine months ended September 30, 2026 as compared to $78.7 million for the same period in 2025, an increase of $114.1 million, or 145%. This increase was primarily attributable to the increase in total product revenues discussed above. Cost of product revenues as a percent of revenues decreased in the current period due to sales of BRINSUPRI, which has lower manufacturing costs than ARIKAYCE.
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R&D Expenses
R&D expenses for the nine months ended September 30, 2026 and 2025 were comprised of the following (in thousands):
| Nine Months Ended September 30, | Increase (decrease) | ||||||||||||||||||||||
| 2026 | 2025 | $ | % | ||||||||||||||||||||
| External Expenses | |||||||||||||||||||||||
| Clinical development and research | $ | 164,621 | $ | 128,245 | $ | 36,376 | 28% | ||||||||||||||||
| Manufacturing | 161,892 | 100,832 | 61,060 | 61% | |||||||||||||||||||
| Regulatory, quality assurance, and medical affairs | 39,667 | 28,500 | 11,167 | 39% | |||||||||||||||||||
| Subtotal—external expenses | $ | 366,180 | $ | 257,577 | $ | 108,603 | 42% | ||||||||||||||||
| Internal Expenses | |||||||||||||||||||||||
| Compensation and benefit-related expenses | $ | 215,666 | $ | 173,764 | $ | 41,902 | 24% | ||||||||||||||||
| Stock-based compensation | 63,284 | 48,749 | 14,535 | 30% | |||||||||||||||||||
| Other internal operating expenses | 44,352 | 36,092 | 8,260 | 23% | |||||||||||||||||||
| Subtotal—internal expenses | $ | 323,302 | $ | 258,605 | $ | 64,697 | 25% | ||||||||||||||||
| Total R&D expenses | $ | 689,482 | $ | 516,182 | $ | 173,300 | 34% | ||||||||||||||||
R&D expenses were $689.5 million for the nine months ended September 30, 2026 as compared to $516.2 million for the same period in 2025, an increase of $173.3 million, or 34%. This increase was primarily due to a $61.1 million increase in manufacturing costs and a $36.4 million increase in clinical development and research costs, both primarily related to TPIP, and a $56.4 million increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount.
External R&D expenses by product for the nine months ended September 30, 2026 and 2025 were comprised of the following (in thousands):
| Nine Months Ended September 30, | Increase (decrease) | |||||||||||||||||||||||||
| 2026 | 2025 | $ | % | |||||||||||||||||||||||
| TPIP external R&D expenses | $ | 155,505 | $ | 58,556 | $ | 96,949 | 166% | |||||||||||||||||||
| Brensocatib external R&D expenses | 49,336 | 73,576 | (24,240) | (33)% | ||||||||||||||||||||||
| ARIKAYCE external R&D expenses | 19,004 | 32,338 | (13,334) | (41)% | ||||||||||||||||||||||
| Other external R&D expenses | 142,335 | 93,107 | 49,228 | 53% | ||||||||||||||||||||||
| Total external R&D expenses | $ | 366,180 | $ | 257,577 | $ | 108,603 | 42% | |||||||||||||||||||
SG&A Expenses
SG&A expenses for the nine months ended September 30, 2026 and 2025 were comprised of the following (in thousands):
| Nine Months Ended September 30, | Increase (decrease) | ||||||||||||||||||||||||||||
| 2026 | 2025 | $ | % | ||||||||||||||||||||||||||
| Compensation and benefit-related expenses | $ | 219,616 | $ | 168,443 | $ | 51,173 | 30% | ||||||||||||||||||||||
| Stock-based compensation | 64,944 | 64,922 | 22 | —% | |||||||||||||||||||||||||
| Professional fees and other external expenses | 390,318 | 190,813 | 199,505 | 105% | |||||||||||||||||||||||||
| Facility related and other internal expenses | 72,877 | 64,506 | 8,371 | 13% | |||||||||||||||||||||||||
| Total SG&A expenses | $ | 747,755 | $ | 488,684 | $ | 259,071 | 53% | ||||||||||||||||||||||
SG&A expenses were $747.8 million for the nine months ended September 30, 2026 as compared to $488.7 million for the same period in 2025, an increase of $259.1 million, or 53%. This increase was primarily due to a $199.5 million increase in professional fees and other external expenses and a $51.2 million increase in compensation and benefit-related expenses due to an increase in headcount, both driven by commercial activities for BRINSUPRI.
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Amortization of Intangible Assets
Amortization of intangible assets was $9.2 million for the nine months ended September 30, 2026 as compared to $4.1 million for the same period in 2025, an increase of $5.1 million. This increase was due to amortization of the AstraZeneca milestone for the pending achievement of $1.0 billion in net sales of BRINSUPRI in a calendar year as of September 2026, and the FDA, EC and MHLW approvals of BRINSUPRI in August 2025, November 2025, and August 2026, respectively.
Change in Fair Value of Contingent Consideration
The change in fair value of contingent consideration for the nine months ended September 30, 2026 was $139.2 million and was primarily due to the decrease in our share price and to a lesser extent, the change in probabilities of success, partially offset by an increase in the obligation associated with the reauthorization of the PRV program.
Investment Income
Investment income was $34.1 million for the nine months ended September 30, 2026 as compared to $45.4 million for the same period in 2025, a decrease of $11.3 million, or 25%. This decrease was due to lower average cash and marketable securities balances and lower interest rates in 2026 relative to the same period in 2025.
Interest Expense
Interest expense for the nine months ended September 30, 2026 was $60.8 million as compared to $63.2 million for the same period in 2025, a decrease of $2.4 million, or 4%. This decrease was primarily due to the redemption of the Company's outstanding 0.75% Convertible Senior Notes due 2028 in the second quarter of 2025. See Note 10 - Debt and Note 11 - Royalty Financing Agreement in this Quarterly Report on Form 10-Q for further details.
LIQUIDITY AND CAPITAL RESOURCES
Overview
There is considerable time and cost associated with developing potential pharmaceutical products to the point of regulatory approval and commercialization. We commenced commercial shipments of ARIKAYCE in October 2018 and BRINSUPRI in August 2025. We expect to continue to incur consolidated operating losses, including losses at our US and certain international entities, as we plan to fund R&D for ARIKAYCE, TPIP, INS1148, INS1201, INS1202, and our other pipeline programs, continue commercialization and regulatory activities for ARIKAYCE and BRINSUPRI, and engage in other general and administrative activities.
In June 2025, we completed an underwritten offering of 8,984,375 shares of our common stock at a public offering price of $96.00 per share. 1,171,875 of the shares of common stock were issued pursuant to the exercise in full of the underwriters' option to purchase additional shares. Our net proceeds from the sale of the shares, after deducting the underwriting discounts and offering expenses of $39.2 million, were $823.3 million.
Based on our current operating plan, we anticipate that our cash and cash equivalents and marketable securities as of September 30, 2026 will enable us to fund our operations. While we believe we currently have sufficient funds to meet our financial needs for at least the next 12 months, we may raise additional capital to fund future development of our product candidates, and to develop, acquire, in-license or co-promote other products or product candidates, including those that address serious diseases with significant unmet need. Our cash requirements for the next 12 months will be impacted by a number of factors, the most significant of which we expect to be expenses related to our commercialization efforts for ARIKAYCE and BRINSUPRI and development costs for our clinical-stage assets and, to a lesser extent, our pre-clinical research programs.
Cash Flows
As of September 30, 2026, we had cash and cash equivalents of $396.6 million, as compared to $510.4 million as of December 31, 2025. In addition, as of September 30, 2026, we had marketable securities of $750.1 million, as compared to $919.6 million as of December 31, 2025. The net decrease in cash and cash equivalents and marketable securities was primarily due to the cash used in operating activities and the $15.0 million milestone payment to AstraZeneca following EC approval of BRINSUPRI, partially offset by proceeds from the exercise of stock options. Our working capital was $1.1 billion and $1.3 billion as of September 30, 2026 and December 31, 2025, respectively.
Net cash used in operating activities was $348.0 million and $687.4 million for the nine months ended September 30, 2026 and 2025, respectively. The net cash used in operating activities during the nine months ended September 30, 2026 and 2025 was primarily driven by commercial, clinical, and manufacturing activities related to ARIKAYCE, commercial activities for BRINSUPRI, as well as other SG&A expenses, and clinical trial expenses related to brensocatib and TPIP. The decrease in cash used in operating activities for the nine months ended September 30, 2026 as compared to the same period in 2025 was primarily due to the decrease in net loss, excluding the adjustments to reconcile net loss to net cash used in operating activities.
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Net cash provided by investing activities was $154.4 million for the nine months ended September 30, 2026, as compared to $454.0 million net cash used in investing activities for the nine months ended September 30, 2025. During the nine months ended September 30, 2026, net cash provided by investing activities consisted primarily of maturities of marketable securities, partially offset by purchases of marketable securities and fixed assets and the $15.0 million milestone payment to AstraZeneca following EC approval of BRINSUPRI. During the nine months ended September 30, 2025, net cash used in investing activities consisted primarily of purchases of marketable securities, partially offset by maturities of marketable securities.
Net cash provided by financing activities was $80.3 million and $920.2 million for the nine months ended September 30, 2026 and 2025, respectively. During the nine months ended September 30, 2026, net cash provided by financing activities consisted primarily of proceeds from the exercise of stock options and ESPP. During the nine months ended September 30, 2025, net cash provided by financing activities consisted primarily of net proceeds from the issuance of common stock and proceeds from the exercise of stock options and ESPP.
Contractual Obligations
There were no material changes outside of the ordinary course of business in our contractual obligations during the nine months ended September 30, 2026 from those disclosed in Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—Contractual Obligations” in our Annual Report on Form 10-K for the year ended December 31, 2025.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources. We do not have any interest in special purpose entities, structured finance entities or other variable interest entities.
CRITICAL ACCOUNTING ESTIMATES
There have been no material changes to our critical accounting policies and estimates as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025. For the required interim disclosure updates related to our accounting policies and estimates, see Note 2 - Summary of Significant Accounting Policies in this Quarterly Report on Form 10-Q.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
As of September 30, 2026, our cash and cash equivalents were in cash accounts and money market funds. Our investments in money market funds are not insured by the federal government. As of September 30, 2026, we had $750.1 million in marketable securities.
As of September 30, 2026, we had our $500.0 million Term Loans outstanding. The Term Loans accrue interest quarterly at a fixed rate of 9.6% per annum. If a 10% change in interest rates had occurred on September 30, 2026, it would not have had a material effect on the fair value of our debt as of that date, nor would it have a material effect on our future earnings or cash flows.
The majority of our business is conducted in US dollars. However, we do conduct certain transactions in other currencies, including Euros, British Pounds, Swiss Francs and Japanese Yen. Historically, fluctuations in foreign currency exchange rates have not materially affected our results of operations. During the nine months ended September 30, 2026 and 2025, our results of operations were not materially affected by fluctuations in foreign currency exchange rates.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, under the supervision and with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2026. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act), means controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file or submit with the SEC is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and to ensure that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure. Based on that evaluation as of September 30, 2026, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control Over Financial Reporting
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There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended September 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
From time to time, we are party to various lawsuits, claims and other legal proceedings that arise in the ordinary course of our 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 our consolidated financial position, results of operations or cash flows.
ITEM 1A. RISK FACTORS
Our business is subject to substantial risks and uncertainties. You should carefully consider the information contained in this Quarterly Report on Form 10-Q, the risks and uncertainties below, and the risk factors and other information contained in our other public filings in evaluating our business, including our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the SEC on February 19, 2026. Any of the risks and uncertainties described herein and in our other filings with the SEC, either alone or taken together, could materially and adversely affect our business, financial condition, results of operations, prospects for growth, and the value of an investment in our common stock. In addition, these risks and uncertainties could cause actual results to differ materially from those expressed or implied by forward-looking statements contained in this Form 10-Q (please read "Cautionary Note Regarding Forward-Looking Statements" in this Quarterly Report on Form 10-Q).
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 5. OTHER INFORMATION
Rule 10b5-1 Trading Plans
Our policy governing transactions in our securities by our directors, officers and employees permits our directors, officers and employees to enter into trading plans complying with Rule 10b5-1 under the Exchange Act. The following table describes the written plans for the sale of our securities adopted or terminated
| Name and Title | Date of Adoption of Trading Plan | Scheduled Start Date of Trading Plan | Scheduled Expiration Date of Trading Plan (1) | Maximum Shares Subject to Trading Plan | Date Plan Terminated | |||||||||||||||||||||||||||
| 12/03/2026 | N/A | |||||||||||||||||||||||||||||||
| 11/27/2026 | N/A | |||||||||||||||||||||||||||||||
| 11/07/2025 | 02/23/2026 | |||||||||||||||||||||||||||||||
| 12/15/2026 | N/A | |||||||||||||||||||||||||||||||
(1) A Trading Plan may expire on an earlier date if all contemplated transactions are completed before such Trading Plan’s expiration date, upon termination by broker or the holder of the Trading Plan, or as otherwise provided in the Trading Plan.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
As previously disclosed, Sara Bonstein, the Company’s Chief Financial Officer, is separating from the Company on October 30, 2026, and the Company is conducting a search to identify a successor. The Company has designated William Lewis, the Company’s Chief Executive Officer, as the Company’s interim principal financial officer, and Patrick Kane, the Company’s Vice President, Corporate Controller, as the Company’s interim principal accounting officer, in each case effective as of October 30, 2026.
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Mr. Kane, age 52, joined the Company in 2015 and has served as Vice President, Corporate Controller since July 1, 2024. Prior to this role, Mr. Kane served as Executive Director, Corporate Controller since July 1, 2023, and Executive Director, Assistant Corporate Controller prior to that. Mr. Kane received his B.A. in Accountancy from Hofstra University, his M.B.A. from Rutgers University, and obtained his Certified Public Accountant license in the State of New York.
Mr. Kane’s base salary is $406,030, and he is eligible to participate in the Company’s benefit and equity compensation plans. Mr. Kane has an annual target bonus of 35% of his base salary.
Mr. Kane’s employment agreement provides for payment of the following upon Mr. Kane’s death or disability: (i) any accrued obligations; (ii) any earned but unpaid annual bonus in respect to any completed fiscal year that has ended on or prior to the termination; (iii) a pro-rata portion of his annual bonus based on actual performance during the year of the termination; (iv) any insurance benefits to which he and his beneficiaries are entitled as a result of his death or disability; and, solely upon death, (v) accelerated vesting of all time-vested equity awards.
If Mr. Kane’s employment is terminated by the Company without cause or by him for good reason (such a termination, a “Qualifying Termination”) prior to a change in control or more than one year following a change in control, Mr. Kane would be eligible to receive: (i) any accrued obligations; (ii) any earned but unpaid annual bonus in respect to any completed fiscal year that has ended on or prior to the termination; (iii) a pro-rata portion of his annual bonus based on actual performance during the year of the termination; (iv) a severance amount equal to six months of base salary; (v) accelerated vesting of all time-vested equity awards that would have otherwise vested within six months following the termination; and (vi) provided Mr. Kane timely elects coverage under COBRA, for six months, the monthly COBRA cost of continued health and dental coverage of Mr. Kane and his qualified beneficiaries paid by Mr. Kane under the health and dental plans of the Company, less the amount that Mr. Kane would be required to contribute for health and dental coverage if Mr. Kane were an active employee of the Company (collectively, the “Termination Benefits”).
In the event of a Qualifying Termination within one year following a change in control, Mr. Kane would be eligible to receive the Termination Benefits, with the following enhancements: (i) the severance amount would be doubled; (ii) the COBRA benefit would be extended to 12 months; and (iii) all of Mr. Kane’s equity awards would vest in full (other than any performance share units, which would vest in accordance with the applicable award agreement).
There are no arrangements or understandings between Mr. Kane and any other person pursuant to which he was selected as an officer, and there are no family relationships between Mr. Kane and any of the Company’s directors or executive officers. Other than as disclosed herein, there are no transactions involving Mr. Kane that are required to be disclosed pursuant to Item 404(a) of Regulation S-K.
In connection with his appointment, the Company and Mr. Kane will enter into the Company’s standard indemnification agreement for directors and officers.
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ITEM 6. EXHIBITS
Exhibit Index
| Articles of Incorporation of Insmed Incorporated, as amended through June 14, 2012 (incorporated by reference from Exhibit 3.1 to Insmed Incorporated’s Annual Report on Form 10-K filed on March 18, 2013). | ||||||||
| Amended and Restated Bylaws of Insmed Incorporated (effective as of May 11, 2023) (incorporated by reference from Exhibit 3.1 to Insmed Incorporated’s Current Report on Form 8-K filed on May 11, 2023). | ||||||||
| Certification of William H. Lewis, Chair and Chief Executive Officer (Principal Executive Officer) of Insmed Incorporated, pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002 (filed herewith). | ||||||||
| Certification of Sara Bonstein, Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) of Insmed Incorporated, pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002 (filed herewith). | ||||||||
| Certification of William H. Lewis, Chair and Chief Executive Officer (Principal Executive Officer) of Insmed Incorporated, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002 (furnished herewith). | ||||||||
| Certification of Sara Bonstein, Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) of Insmed Incorporated, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002 (furnished herewith). | ||||||||
| 101 | The following materials from Insmed Incorporated’s quarterly report on Form 10-Q for the quarter ended September 30, 2026 formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) Consolidated Balance Sheets as of September 30, 2026 and December 31, 2025, (ii) Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2026 and 2025, (iii) Consolidated Statements of Shareholders' Equity for the three and nine months ended September 30, 2026 and 2025, (iv) Consolidated Statements of Cash Flows for the nine months ended September 30, 2026 and 2025, (v) Notes to the Unaudited Consolidated Financial Statements, and (vi) Cover Page. | |||||||
| 104 | The cover page from the Quarterly Report on Form 10-Q for the quarter ended September 30, 2026, formatted in iXBRL and contained in Exhibit 101. | |||||||
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SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| INSMED INCORPORATED | ||||||||
Date: October 29, 2026 | By | /s/ Sara Bonstein | ||||||
| Sara Bonstein | ||||||||
| Chief Financial Officer | ||||||||
| (Principal Financial and Accounting Officer) | ||||||||
40
EXHIBIT 31.1
Section 302 Certification
I, William H. Lewis, Chief Executive Officer of Insmed Incorporated, certify that:
(1) I have reviewed this quarterly report on Form 10-Q of Insmed Incorporated;
(2) Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
(3) Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
(4) The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
(5) The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Date: October 29, 2026
| /s/ William H. Lewis | ||
| William H. Lewis | ||
| Chair and Chief Executive Officer | ||
| (Principal Executive Officer) | ||
EXHIBIT 31.2
Section 302 Certification
I, Sara Bonstein, Chief Financial Officer of Insmed Incorporated, certify that:
(1) I have reviewed this quarterly report on Form 10-Q of Insmed Incorporated;
(2) Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
(3) Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
(4) The registrant's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
(5) The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Date: October 29, 2026
| /s/ Sara Bonstein | ||
| Sara Bonstein | ||
| Chief Financial Officer | ||
| (Principal Financial and Accounting Officer) | ||
EXHIBIT 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2003
In connection with this Quarterly Report on Form 10-Q of Insmed Incorporated (the "Company") for the period ended September 30, 2026 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, William H. Lewis, Chief Executive Officer of the Company, certify, pursuant to 18 USC. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2003, that:
(1)the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
(2)the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| /s/ William H. Lewis | ||
| William H. Lewis | ||
| Chair and Chief Executive Officer | ||
| (Principal Executive Officer) | ||
October 29, 2026
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Insmed Incorporated under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.
EXHIBIT 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2003
In connection with this Quarterly Report on Form 10-Q of Insmed Incorporated (the "Company") for the period ended September 30, 2026 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), I, Sara Bonstein, Chief Financial Officer of the Company, certify, pursuant to 18 USC. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2003, that:
(1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| /s/ Sara Bonstein | ||
| Sara Bonstein | ||
| Chief Financial Officer | ||
| (Principal Financial and Accounting Officer) | ||
October 29, 2026
This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Insmed Incorporated under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.