INSMED INSM
INSMED reports $524.43M revenue but $100.32M net loss
- Form
- 10-Q
- Filed
- Importance
- Notable
- Accession
- 0001104506-26-000047
- Revenue: $524.43 million for the three months ended Sep 30, 2026
- Net loss: $100.32 million for the three months ended Sep 30, 2026
- Cash and equivalents: $396.56 million at Sep 30, 2026
Written from the 10-Q on EDGAR. Check the filing before you rely on it.
What changed
4 changes since the June 2026 10-Q
Compared with the 10-Q 0001104506-26-000041, filed Aug 6, 2026.
EPS down 667% from Jun 30
−$0.46, was −$0.06.
From the filings
Before
−$0.06Now
−$0.46Net income down 658% from Jun 30
−$100M, was −$13.2M.
From the filings
Before
−$13.2MNow
−$100MCash down 27% from Jun 30
$397M, was $545M.
From the filings
Before
$545MNow
$397MRevenue up 23% from Jun 30
$524M, was $425M.
From the filings
Before
$425MNow
$524M
Show the redline
Section by section. Added words and removed words against the earlier filing.
Cover page 3 changes
3 unchanged paragraphs
For the quarterly period ended June September 30, 2026
23 unchanged paragraphs
As of July 31, October 23, 2026, there were 218,381,503 219,380,309 shares of the registrant s common stock outstanding.
FOR THE QUARTER ENDED JUNE SEPTEMBER 30, 2026
1 unchanged paragraph
Financial statements 156 changes
2 unchanged paragraphs
Marketable securities 615,547 919,602
Accounts receivable 215,325 140,857
Inventory 142,384 132,068
Intangibles, net 93,489 97,651
June September 30, 2026 December 31, 2025
Cash and cash equivalents $ 544,765 396,563 $ 510,445
Marketable securities 750,063 919,602
Accounts receivable 259,270 140,857
Inventory 163,946 132,068
Prepaid expenses and other current assets 115,898 136,665 91,236
Total current assets 1,633,919 1,706,507 1,794,208
Fixed assets, net 107,219 108,341 102,942
Finance lease right-of-use assets 14,205 13,527 15,561
Operating lease right-of-use assets 13,179 17,624 20,708
Intangibles, net 138,439 97,651
1 unchanged paragraph
Other assets 104,444 97,378
Other assets 105,508 97,378
Total assets $ 2,102,565 2,226,056 $ 2,264,558
2 unchanged paragraphs
Contingent consideration 170,550 314,340
Accounts payable and accrued liabilities $ 428,929 574,538 $ 456,060
Current portion of royalty financing agreement 10,232
Finance lease liabilities 3,549 3,654 3,345
Operating lease liabilities 6,266 8,151 9,469
Total current liabilities 438,744 596,575 468,874
Debt, long-term 543,513 544,862 540,964
Royalty financing agreement 159,843 146,231 162,865
Contingent consideration 178,090 314,340
Finance lease liabilities, long-term 18,890 17,941 20,719
Operating lease liabilities, long-term 7,663 10,097 12,174
Other long-term liabilities 5,868 6,046 5,646
Total liabilities 1,345,071 1,499,842 1,525,582
1 unchanged paragraph
Common stock, $ 0.01 par value; 500,000,000 authorized shares, 218,281,059 219,320,467 and 214,255,853 issued and outstanding shares at June September 30, 2026 and December 31, 2025, respectively
Additional paid-in capital 6,572,181 6,637,877 6,372,064
Accumulated deficit ( 5,813,497 5,913,816 ) ( 5,636,692 )
Accumulated other comprehensive (loss) gain ( 3,373 40 ) 1,461
Total shareholders equity 757,494 726,214 738,976
Total liabilities and shareholders equity $ 2,102,565 2,226,056 $ 2,264,558
3 unchanged paragraphs
Three Months Ended June 30, Six Months Ended June 30,
Product revenues, net $ 425,486 $ 107,415 $ 731,450 $ 200,238
Research and development 210,034 177,190 419,519 329,767
Selling, general and administrative 247,467 154,763 494,726 302,308
Amortization of intangible assets 2,081 1,263 4,162 2,526
Change in fair value of contingent consideration ( 99,760 ) 59,000 ( 146,721 ) 77,300
Total operating expenses 427,034 420,291 886,318 761,254
Operating loss ( 1,548 ) ( 312,876 ) ( 154,868 ) ( 561,016 )
Investment income 10,979 13,225 23,019 27,131
Interest expense ( 20,273 ) ( 21,245 ) ( 40,355 ) ( 42,814 )
Other (expense) income, net ( 531 ) 453 ( 1,267 ) 585
Loss before income taxes ( 11,373 ) ( 320,443 ) ( 173,471 ) ( 576,114 )
Provision for income taxes 1,869 1,243 3,334 2,155
Net loss $ ( 13,242 ) $ ( 321,686 ) $ ( 176,805 ) $ ( 578,269 )
Three Months Ended September 30, Nine Months Ended September 30,
Product revenues, net $ 524,428 $ 142,342 $ 1,255,878 $ 342,580
Cost of product revenues (excluding amortization of intangible assets) 67,212 28,075 114,632 49,353 78,215 29,365 192,847 78,718
Research and development 269,963 186,415 689,482 516,182
Selling, general and administrative 253,029 186,376 747,755 488,684
Amortization of intangible assets 5,050 1,538 9,212 4,064
Change in fair value of contingent consideration 7,540 104,653 ( 139,181 ) 181,953
Total operating expenses 613,797 508,347 1,500,115 1,269,601
Operating loss ( 89,369 ) ( 366,005 ) ( 244,237 ) ( 927,021 )
Investment income 11,070 18,289 34,089 45,420
Interest expense ( 20,410 ) ( 20,382 ) ( 60,765 ) ( 63,196 )
Other income (expense), net 1,056 ( 603 ) ( 211 ) ( 18 )
Loss before income taxes ( 97,653 ) ( 368,701 ) ( 271,124 ) ( 944,815 )
Provision for income taxes 2,666 1,320 6,000 3,475
Net loss $ ( 100,319 ) $ ( 370,021 ) $ ( 277,124 ) $ ( 948,290 )
Basic and diluted net loss per share $ ( 0.06 0.46 ) $ ( 1.70 1.75 ) $ ( 0.82 1.28 ) $ ( 3.12 4.89 )
1 unchanged paragraph
Net loss $ ( 13,242 ) $ ( 321,686 ) $ ( 176,805 ) $ ( 578,269 )
Net loss $ ( 100,319 ) $ ( 370,021 ) $ ( 277,124 ) $ ( 948,290 )
1 unchanged paragraph
Foreign currency translation (losses) gains ( 2,906 ) 2,656 ( 3,574 ) 4,484
Unrealized loss on marketable securities ( 471 ) ( 22 ) ( 1,260 ) ( 463 )
Total comprehensive loss $ ( 16,619 ) $ ( 319,052 ) $ ( 181,639 ) $ ( 574,248 )
Foreign currency translation gains (losses) 3,671 ( 658 ) 97 3,826
Unrealized (loss) gain on marketable securities ( 338 ) 924 ( 1,598 ) 461
Total comprehensive loss $ ( 96,986 ) $ ( 369,755 ) $ ( 278,625 ) $ ( 944,003 )
3 unchanged paragraphs
Balance at March 31, 2025 181,900 $ 1,819 $ 4,714,742 $ ( 4,616,500 ) $ ( 902 ) $ 99,159
Net loss ( 321,686 ) ( 321,686 )
Other comprehensive income 2,634 2,634
Issuance of common stock for exercise of stock options, vesting of RSUs, and ESPP 2,304 23 36,955 36,978
Net proceeds from issuance of common stock 8,984 90 823,448 823,538
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and 76 more changes in the filing
Note 1: The Company and Basis of Presentation 3 changes
2 unchanged paragraphs
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 IPF . 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.
4 unchanged paragraphs
The accompanying unaudited interim consolidated financial statements have been prepared pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information and disclosures required by accounting principles generally accepted in the US (GAAP) for complete consolidated financial statements are not included herein. The unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements and
Note 1: The Company and Basis of Presentation (Continued) 2 changes
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).
1 unchanged paragraph
The Company had $ 544.8 396.6 million of cash and cash equivalents and $ 615.5 750.1 million of marketable securities as of June September 30, 2026 and reported a net loss of $ 176.8 277.1 million for the six nine months ended June September 30, 2026. The Company has funded its operations through public offerings of equity securities, de bt 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.
2 unchanged paragraphs
Note 2: Summary of Significant Accounting Policies 1 change
3 unchanged paragraphs
The Company is exposed to risks associated with extending credit to customers related to the sale of products. The Company does not require collateral to secure amounts due from its customers. The Company uses an expected loss methodology to calculate allowances for trade receivables. The Company's measurement of expected credit losses is based on relevant information about past events, including historical experience, current conditions, and reasonable and supportable
Note 2: Summary of Significant Accounting Policies (Continued) 16 changes
Six Months Ended June 30,
Customer B 22 % 28 %
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 six nine months ended June September 30, 2026 and their respective percentages for the six nine months ended June September 30, 2025.
Nine Months Ended September 30,
Customer A 38 % 28 30 %
Customer B 21 % 26 %
2 unchanged paragraphs
Three Months Ended June 30, Six Months Ended June 30,
Net loss $ ( 13,242 ) $ ( 321,686 ) $ ( 176,805 ) $ ( 578,269 )
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 six nine months ended June September 30, 2026 and 2025 (in thousands, except per share amounts):
Three Months Ended September 30, Nine Months Ended September 30,
Net loss $ ( 100,319 ) $ ( 370,021 ) $ ( 277,124 ) $ ( 948,290 )
Weighted average common shares used in calculation of basic net loss per share: 217,352 189,302 216,415 185,104 218,788 211,759 217,215 194,087
2 unchanged paragraphs
Basic and diluted $ ( 0.06 ) $ ( 1.70 ) $ ( 0.82 ) $ ( 3.12 )
Weighted average common shares outstanding used in calculation of diluted net loss per share 217,352 189,302 216,415 185,104 218,788 211,759 217,215 194,087
Basic and diluted $ ( 0.46 ) $ ( 1.75 ) $ ( 1.28 ) $ ( 4.89 )
Note 3: Fair Value Measurements 6 changes
6 unchanged paragraphs
As of September 30, 2026
1 unchanged paragraph
Marketable securities $ 615.5 $ 615.5 $ $
Contingent consideration $ 170.6 $ $ $ 170.6
Cash and cash equivalents $ 544.8 396.6 $ 544.8 396.6 $ $
Marketable securities $ 750.1 $ 750.1 $ $
Contingent consideration $ 178.1 $ $ $ 178.1
Note 3: Fair Value Measurements (Continued) 7 changes
5 unchanged paragraphs
During the six nine months ended June September 30, 2026, there were purchases of $ 399.2 794.3 million of marketable securities and maturities of $ 714.0 979.0 million of marketable securities, consisting of US Treasury Bills.
As of June September 30, 2026, the Company held $ 615.5 750.1 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 six nine months ended June September 30, 2026. During the six nine months ended June 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 six nine months ended June September 30, 2026.
1 unchanged paragraph
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 June 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 aggr egate 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 June September 30, 2026. The development and regulatory milestones, if achieve d, 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 Mot us 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 e xpired. 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 June September 30, 2026, the Company determined that the value of the PRV milestone was $ 15.7 15.5 million.
The contingent consideration liabilities for net sales milestones were valued using an option pricing model with Monte Carlo simulation. As of June September 30, 2026, the fair value of these net sales milestones were deemed immaterial to the overall fair value of the contingent consideration.
Note 4: Product Revenues, Net 18 changes
2 unchanged paragraphs
Three Months Ended June 30, Six Months Ended June 30,
International 46,130 38,732 81,356 67,280
Total $ 116,316 $ 107,415 $ 214,426 $ 200,238
International 615 1,287
Total $ 309,170 $ $ 517,024 $
International 46,745 38,732 82,643 67,280
Total product revenues, net $ 425,486 $ 107,415 $ 731,450 $ 200,238
The Company also recognizes revenue related to various managed access programs. The Company recognizes international BRINSUPRI revenue related to early access programs (EAPs) in Europe, consisting of sales to the French National Agency for Medicines and Health Products Safety, which has granted BRINSUPRI a Compassionate Access Authorisation (Autorisation d'acc s compassionnel or AAC) and sales through the named patient program (NPP) in other countries.
The following tables present a geographic summary of the Company's product revenues, net, for the three and six nine months ended June September 30, 2026 and 2025 (in thousands):
Three Months Ended September 30, Nine Months Ended September 30,
International 48,867 40,307 130,223 107,587
Total $ 124,375 $ 114,291 $ 338,801 $ 314,529
International 1,976 3,263
Total $ 400,053 $ 28,051 $ 917,077 $ 28,051
International 50,843 40,307 133,486 107,587
Total product revenues, net $ 524,428 $ 142,342 $ 1,255,878 $ 342,580
The Company also recognizes revenue related to various managed access programs. The Company recognize s 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
Note 4: Product Revenues, Net (Continued) 1 change
estimated costs of co-payment assistance. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (prompt pay discounts and chargebacks), prepaid expenses (co-payment assistance), or as a current liability (rebates). Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company's historical experience, current contractual and statutory requirements, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company's best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contract. The amount of variable consideration included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known.
5 unchanged paragraphs
Note 5: Inventory 6 changes
1 unchanged paragraph
Raw materials $ 39,820 $ 30,623
Finished goods 62,213 60,099
June September 30, 2026 December 31, 2025
Raw materials $ 54,817 $ 30,623
Work-in-process 40,351 41,438 41,346
Finished goods 67,691 60,099
Note 6: Intangibles, Net and Goodwill 13 changes
1 unchanged paragraph
As of June 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 milestone milestones paid to AstraZeneca AB (AstraZeneca) (Astra Zeneca) as a result of the FDA approval and EC approvals of BRINSUPRI in August 2025 and November 2025, respectively, the milestone paid payable to AstraZeneca as a result of the EC Japan's MHLW approval of BRINSUPRI in November 2025. 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 milestone-r elated intangible assets in October 2018, over ARIKAYCE's initial regulatory exclusivity period of 12 years. and The Company began amortizing its AstraZeneca milestone-related intangible assets in August and November 2025 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 $ 8.3 3.0 million for the remainder of 2026, $ 12.0 million per year for the years 2026 2027 through 2029 and $ 7.1 10.8 million for 2030.
1 unchanged paragraph
AstraZeneca milestones 44,051 ( 1,636 ) 42,415
As of June 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 six nine months ended June September 30, 2026 and 2025 is as follows (in thousands):
Intangible Asset December 31, 2025 Additions Amortization June September 30, 2026
Acquired ARIKAYCE R&D $ 23,038 $ $ ( 2,425 3,638 ) $ 20,613 19,400
PARI milestones 962 ( 101 151 ) 861 811
AstraZeneca milestones 44,051 50,000 ( 5,423 ) 88,628
1 unchanged paragraph
Intangible Asset December 31, 2024 Additions Amortization June September 30, 2025
Acquired ARIKAYCE R&D $ 27,888 $ $ ( 2,425 3,638 ) $ 25,463 24,250
PARI milestones 1,164 ( 101 151 ) 1,063 1,013
AstraZeneca milestones 30,000 ( 275 ) 29,725
1 unchanged paragraph
The Company's goodwill balance of $ 136.1 million as of June September 30, 2026 and December 31, 2025, resulted from the August 2021 Business Acquisition.
Note 7: Fixed Assets, Net 5 changes
2 unchanged paragraphs
Asset Description June September 30, 2026 December 31, 2025
1 unchanged paragraph
Lab equipment 7 43,646 45,494 39,127
3 unchanged paragraphs
Manufacturing equipment 7 1,336 1,537 1,336
1 unchanged paragraph
Construction in progress 46,027 47,846 42,410
Less: accumulated depreciation ( 66,695 70,077 ) ( 60,755 )
Note 8: Accounts Payable and Accrued Liabilities 13 changes
1 unchanged paragraph
June September 30, 2026 December 31, 2025
Accounts payable and other accrued operating expenses $ 74,555 84,302 $ 79,907
Accrued clinical trial expenses 34,443 44,092 34,329
Accrued professional fees 25,014 34,279 23,658
Accrued technical operation expenses 21,730 35,201 22,533
Accrued compensation and employee related costs 61,579 77,411 111,514
Accrued royalty and milestones payable 37,774 51,531 17,101
Revenue Interest Payments payable 7,553 8,597 6,449
Accrued sales allowances and related costs 146,373 168,430 70,869
Accrued French rebate payable 9,062 4,187 6,960
1 unchanged paragraph
Accrued milestone payment to AstraZeneca 50,000 15,000
Other accrued liabilities 10,846 16,508 9,941
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.
Note 9: Leases 8 changes
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,
Finance right-of-use assets obtained in exchange for lease obligations $ $ $ $
Operating right-of-use assets obtained in exchange for lease obligations $ 5,217 $ 1,731 $ 5,217 $ 1,731
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 o f $ 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.
Note 10: Debt 2 changes
1 unchanged paragraph
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
In October 2022, the Company entered into the $ 350.0 million loan agreement (the Loan Agreement) with Pharmakon Advisors LP (Pharmakon) that would have matured on October 19, 2027 (the Tranche A Term Loan). The Tranche A Term Loan originally bore interest at a rate based upon the Secured Overnight Financing Rate (SOFR) , subject to a SOFR floor of 2.5 %, in addition to a margin of 7.75 % per annum. Up to 50 % of the interes t payable during the first 24 months from the closing of the Tranche A Term Loan could have been paid-in-kind at the Company's election. If elected, paid-in-kind interest would have been capitalized and added to the principal amount of the Tranche A Term Loan. The Tranche A Term Loan, including the paid-in-kind interest, would have been repaid in eight equal quarterly payments starting in the 13th quarter following the closing of the Tranche A Term Loan (i.e., the quarter ended March 31, 2026), except that the repayment start date could have been extended at the Company's option for an additional four quarters, so that repayments start in the 17th quarter following the closing of the Tranche A Term Loan, subject to the achievement of specified ARIKAYCE data thresholds and certain other conditions. Net proceeds from the Tranche A Term Loan, after deducting the lenders fees and deal expenses of $ 15.1 million, were $ 334.9 million.
Note 10: Debt (Continued) 18 changes
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.
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 June September 30, 2026 and December 31, 2025 (in thousands):
June September 30, 2026 December 31, 2025
2 unchanged paragraphs
Term Loans $ 543,513 $ 540,964
Debt discount, net ( 3,257 1,908 ) ( 5,806 )
Term Loans $ 544,862 $ 540,964
As of June September 30, 2026, future principal repayments of debt for each of the fiscal years through maturity were as follows (in thousands):
1 unchanged paragraph
Interest expense for the three and six months ended June 30, 2026 and 2025 was as follows (in thousands):
Three Months Ended June 30, Six Months Ended June 30,
Convertible debt contractual interest expense $ $ 600 $ $ 1,678
Term Loans contractual interest expense 13,269 13,269 26,391 26,391
Royalty Financing Agreement interest expense 5,129 5,192 10,243 10,215
Amortization of debt issuance costs 1,429 1,676 2,811 3,498
Total debt interest expense 19,827 20,737 39,445 41,782
Finance lease interest expense 446 508 910 1,032
Total interest expense $ 20,273 $ 21,245 $ 40,355 $ 42,814
Note 11: Royalty Financing Agreement 2 changes
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.
Note 11: Royalty Financing Agreement (Continued) 13 changes
$ 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.
The following table presents the activity of the Company's Royalty Financing Agreement balance for the six-month nine-month period ended June September 30, 2026 and year ended December 31, 2025 (in thousands):
Six Nine Months Ended June September 30, 2026 Twelve Months Ended
1 unchanged paragraph
Revenue Interest Payments paid and payable ( 13,527 22,125 ) ( 19,401 )
Interest expense recognized 10,243 15,330 20,675
Royalty Financing Agreement liability - ending balance $ 161,661 158,150 $ 164,945
Royalty financing issuance costs:
1 unchanged paragraph
Amortization of issuance costs 262 393 524
Royalty issuance costs, unamortized - ending balance $ ( 1,818 1,687 ) $ ( 2,080 )
Less: current portion of royalty financing agreement ( 10,232 )
Royalty Financing Agreement $ 159,843 146,231 $ 162,865
The Revenue Interest Payments payable in connection with the Royalty Financing Agreement were $ 7.6 8.6 million and $ 6.4 million as of June 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.
Note 12: Shareholders' Equity 3 changes
Common Stock As of June September 30, 2026, the Company had 500,000,000 shares of common stock authorized with a par value of $ 0.01 per share and 218,281,059 219,320,467 shares of common stock issued and outstanding. In addition, as of June September 30, 2026, the Company had reserved 15,503,480 14,405,923 shares of common stock for issuance upon the exercise of outstanding stock options, 3,327,891 3,343,365 shares of common stock for issuance upon the vesting of RSUs, and 267,435 265,889 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 June September 30, 2026, 4,979,705 shares of the Company's common stock remain reserved for the Business Acquisition.
Preferred Stock As of June 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 shares of preferred stock were issued and outstanding.
Note 13: Stock-Based Compensation 14 changes
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 June September 30, 2026, 10,334,057 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 183,598 304,478 shares of the Company's common stock to new employees during the six nine months ended June 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 June September 30, 2026, 516,635 395,755 shares remain available for future issuance under the Insmed Incorporated 2025 Inducement Plan.
1 unchanged paragraph
Three Months Ended June 30, Six Months Ended June 30,
Research and development expenses $ 20,292 $ 15,970 $ 44,286 $ 33,350
Selling, general and administrative expenses 20,962 27,006 42,722 48,888
Total stock-based compensation expense $ 41,254 $ 42,976 $ 87,008 $ 82,238
Stock Options As of June September 30, 2026, there was $ 146.7 126.3 million of unrecognized compensation expense related to unvested stock options. As of June 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 June September 30, 2026, there was $ 248.9 232.0 million of unrecognized compensation expense related to unvested RSU awards.
Performance Stock Units As of June September 30, 2026, there were 92,219 91,686 PSUs outstanding with an unrecognized compensation expense of $ 18.1 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 six nine months ended June September 30, 2026 and 2025 (in thousands):
Three Months Ended September 30, Nine Months Ended September 30,
Research and development expenses $ 18,998 $ 15,399 $ 63,284 $ 48,749
Selling, general and administrative expenses 22,222 16,034 64,944 64,922
Total stock-based compensation expense $ 41,220 $ 31,433 $ 128,228 $ 113,671
Note 14: Income Taxes 1 change
The Company recorded a provision for income taxes of $ 1.9 2.7 million and $ 1.2 1.3 million for the three months ended June September 30, 2026 and 2025, respectively, and $ 3.3 6.0 million and $ 2.2 3.5 million for the six nine months ended June September 30, 2026 and 2025, respectively. The provisions recorded for the three and six nine months ended June 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 modified gross revenues
Note 14: Income Taxes (Continued) 2 changes
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 June 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 June September 30, 2026 and December 31, 2025 or the consolidated statements of comprehensive loss for the three and six nine months ended June September 30, 2026 and 2025. The Company has no t recorded any accrued interest or penalties related to uncertain tax positions.
Note 15: Commitments and Contingencies 1 change
1 unchanged paragraph
Rent expense charged to operations was $ 3.7 million and $ 3.3 3.5 million for both the three months ended June September 30, 2026 and 2025, respectively, and $ 7.2 10.7 million and $ 6.8 10.3 million for the six nine months ended June September 30, 2026 and 2025, respectively.
Note 16: Segment Reporting (Continued) 29 changes
Product revenues, net $ 425,486 $ 107,415 $ 731,450 $ 200,238
TPIP external R&D expenses 38,935 20,649 76,276 29,802
Brensocatib external R&D expenses 13,829 33,560 32,313 54,221
ARIKAYCE external R&D expenses 6,228 11,003 14,850 23,124
Other external R&D expenses 48,836 28,445 81,514 56,528
R&D compensation and benefit-related expenses 69,080 56,389 141,220 109,947
SG&A compensation and benefit-related expenses 70,520 51,320 145,313 106,156
Segment loss, including significant segment expenses, for the three and six nine months ended June September 30, 2026 and 2025 is as follows (in thousands):
Three Months Ended June September 30,
Product revenues, net $ 524,428 $ 142,342 $ 1,255,878 $ 342,580
Cost of product revenues (excluding amortization of intangible assets) 67,212 28,075 114,632 49,353 78,215 29,365 192,847 78,718
TPIP external R&D expenses 79,229 28,754 155,505 58,556
Brensocatib external R&D expenses 17,023 19,355 49,336 73,576
ARIKAYCE external R&D expenses 4,154 9,214 19,004 32,338
Other external R&D expenses 60,821 36,579 142,335 93,107
R&D compensation and benefit-related expenses 74,446 63,817 215,666 173,764
SG&A compensation and benefit-related expenses 74,303 62,287 219,616 168,443
1 unchanged paragraph
Depreciation 3,179 2,484 6,113 4,367
Amortization of intangible assets 2,081 1,263 4,162 2,526
Depreciation 3,346 2,458 9,459 6,825
Amortization of intangible assets 5,050 1,538 9,212 4,064
1 unchanged paragraph
Investment income ( 10,979 ) ( 13,225 ) ( 23,019 ) ( 27,131 )
Interest expense 20,273 21,245 40,355 42,814
Provision for income taxes 1,869 1,243 3,334 2,155
Segment net loss $ ( 13,242 ) $ ( 321,686 ) $ ( 176,805 ) $ ( 578,269 )
Investment income ( 11,070 ) ( 18,289 ) ( 34,089 ) ( 45,420 )
Interest expense 20,410 20,382 60,765 63,196
Provision for income taxes 2,666 1,320 6,000 3,475
Segment net loss $ ( 100,319 ) $ ( 370,021 ) $ ( 277,124 ) $ ( 948,290 )
1 unchanged paragraph
Forward-looking statements 176 changes
2 unchanged paragraphs
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 Europe, Japan, or to maintain US, European or Japanese approval for ARIKAYCE or US or European approval for BRINSUPRI;
1 unchanged paragraph
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, and Europe or Japan;
36 unchanged paragraphs
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. month s. 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.
1 unchanged paragraph
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 pa lmitil 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 IPF. 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.
4 unchanged paragraphs
Ensure successful Drive continued momentum in the US commercialization of BRINSUPRI;
Ensure successful commercial launch of BRINSUPRI in Japan;
3 unchanged paragraphs
Prior to 2019, we had not generated significant revenue and, through June September 30, 2026, we had an accumulated deficit of $5.8 $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 June 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.
1 unchanged paragraph
We continue to anticipate a regulatory decision for brensocatib for the treatment of NCFB in Japan in the second half of 2026.
We continue to evaluate the potential effect of evolving US policies which will then impact the timing for future potential international commercial launches.
We continue to enroll patients in the Phase 1 ASCEND clinical study of INS1201 for patients with DMD.
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.
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.
In July 2026, We submitted a US supplemental new drug application (sNDA) for ARIKAYCE in newly diagnosed patients with MAC lung disease . We also plan to review the submit data with to the Pharmaceuticals and Medical Devices Agency (PMDA) in the second half fourth quarter of 2026 to support potential label expansion in Japan.
In July 2026, we reported positive 12-month data from the ongoing open-label extension study of TPIP in patients with PAH. (the OLE Study). See below for additional detail regarding the OLE Study.
PALM-ILD, our Phase 3 study of TPIP in patients with PH-ILD, that we initiated in the fourth quarter and PALM-PAH, our Phase 3 study of 2025, continues TPIP in patients with PAH, each continue to enroll patients.
In April September 2026, we initiated the Phase 3 PALM-PAH PALM-PPF study of TPIP in patients with PAH and are actively enrolling patients. PPF.
We continue to anticipate initiating a Phase 3 study of TPIP in patients with PPF in the second half of 2026 and a Phase 3 study in patients with IPF in the first half of 2027.
We continue to advance a Phase 2 development program for INS1148, initially targeting PPF and IPF, with plans to evaluate PPF and we are exploring explore other diseases where inhibition of the inflammatory functions of pro-inflammatory and pro-fibrotic responses mediated by SCF248 may be beneficial.
The ASCEND Phase 1 study evaluating INS1201 in DMD is fully enrolled.
1 unchanged paragraph
Clinical Trial Developments
The OLE Study is a non-placebo-controlled trial and was designed to evaluate the long-term safety, tolerability, and effectiveness of TPIP over 24 months in patients who completed the lead-in TPIP PAH studies.
In July 2026, we reported positive 12-month data from the ongoing OLE Study. Data for the primary endpoint of safety and tolerability showed that once-daily TPIP therapy was generally well tolerated with no newly identified safety signals at doses up to 1,280 g through month 12. Of the 91 patients in the OLE Study, treatment-emergent adverse events (TEAEs) occurred in 89.0% of patients; serious TEAEs were observed in 18.7% of patients; and severe TEAEs were observed in 16.5% of patients in the study. TEAEs leading to study discontinuation were experienced by 7.7% of patients. There were four deaths, none of which were considered related to TPIP treatment. The most common TEAEs through month 12 occurring in 5.0% or more of all patients were headache (28.6%), cough (15.4%), nasopharyngitis (14.3%), diarrhea (11.0%), upper respiratory tract infection (9.9%), bronchitis (7.7%), dizziness (6.6%), epistaxis (6.6%), nausea (6.6%), anemia (5.5%), influenza (5.5%), and pneumonia (5.5%).
Data for secondary efficacy endpoints demonstrated sustained improvement with TPIP in six-minute walk distance (6MWD), N-terminal fragment pro-B-type natriuretic peptide (NT-proBNP) concentration, and World Health Organization (WHO) Functional Class, as well as a clinically meaningful improvement in REVEAL Lite 2.0 score at month 12. Patients in the Placebo Crossed group (n=31) showed similar outcomes to patients in the TPIP Continued group (n=60) across all efficacy measures at month 12.
At month 12, mean improvement from baseline for 6MWD was +55.7 meters for the TPIP Continued group and +54.1 meters for the Placebo Crossed group; NT-proBNP concentration was reduced by approximately 60% in both groups with geometric mean ratios to baseline of 0.40 and 0.41 in TPIP Continued and Placebo Crossed, respectively; WHO Functional Class I or II was achieved in 78.3% of TPIP Continued group and 80.6% of Placebo Crossed group patients, and more than 25% of patients across both groups achieved WHO Functional Class I; and mean REVEAL Lite 2.0 score improved 2.0-points from baseline for the TPIP Continued group and 1.4-points from baseline for the Placebo Crossed group. Approximately 65% of all patients achieved Refined Low Risk status.
16 unchanged paragraphs
Comparison of the Three Months Ended June September 30, 2026 and 2025
1 unchanged paragraph
International 46,130 38,732 7,398 19%
Total $ 116,316 $ 107,415 $ 8,901 8%
US $ 308,555 $ $ 308,555 NA
International 615 615 NA
Total $ 309,170 $ $ 309,170 NA
International 46,745 38,732 8,013 21%
Total product revenues, net $ 425,486 $ 107,415 $ 318,071 296%
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 June September 30, 2026 and 2025 (in thousands):
Three Months Ended June September 30, Increase (decrease)
International 48,867 40,307 8,560 21%
Total $ 124,375 $ 114,291 $ 10,084 9%
US $ 398,077 $ 28,051 $ 370,026 NM
International 1,976 1,976 NA
Total $ 400,053 $ 28,051 $ 372,002 NM
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 June September 30, 2026 were $425.5 $524.4 million as compared to $107.4 $142.3 million for the same period in 2025, an increase of $318.1 $382.1 million, or 296%. 268%. This increase was a result of $308.6 the $370.0 million of growth in US commercial sales of BRINSUPRI following approval in August 2025 and an $8.9 the $10.1 million growth in sales of ARIKAYCE, primarily driven by growth in international sales. In the first quarter of 2026, We began recognizing recognize international BRINSUPRI revenue related to EAPs in Europe, consisting of sales to the French National Agency for Medicines and Health Products Safety, which has granted BRINSUPRI a Compassionate Access Authorisation (Autorisation d'acc s compassionnel or AAC) and sales primarily through the NPP named patient program in other certain countries.
1 unchanged paragraph
Cost of product revenues (excluding amortization of intangible assets) for the three months ended June September 30, 2026 and 2025 were as follows (in thousands):
Three Months Ended June September 30, Increase (decrease)
Cost of product revenues (excluding amortization of intangible assets) $ 67,212 78,215 $ 28,075 29,365 $ 39,137 139% 48,850 166%
Cost of product revenues, as % of revenues 15.8 14.9 % 26.1 20.6 %
Cost of product revenues (excluding amortization of intangible assets) were $67.2 $78.2 million for the three months ended June September 30, 2026 as compared to $28.1 $29.4 million for the same period in 2025, an increase of $39.1 $48.9 million , or 139%. 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.
1 unchanged paragraph
Clinical development and research $ 55,897 $ 41,251 $ 14,646 36%
Manufacturing 37,841 41,608 (3,767) (9)%
Subtotal external expenses $ 107,828 $ 93,657 $ 14,171 15%
Compensation and benefit-related expenses $ 69,080 $ 56,389 $ 12,691 23%
Stock-based compensation 20,292 15,970 4,322 27%
Other internal operating expenses 12,834 11,174 1,660 15%
Subtotal internal expenses $ 102,206 $ 83,533 $ 18,673 22%
Total R&D expenses $ 210,034 $ 177,190 $ 32,844 19%
TPIP external R&D expenses $ 38,935 $ 20,649 $ 18,286 89%
Brensocatib external R&D expenses 13,829 33,560 (19,731) (59)%
ARIKAYCE external R&D expenses 6,228 11,003 (4,775) (43)%
Other external R&D expenses 48,836 28,445 20,391 72%
Total external R&D expenses $ 107,828 $ 93,657 $ 14,171 15%
Compensation and benefit-related expenses $ 70,520 $ 51,320 $ 19,200 37%
Stock-based compensation 20,962 27,006 (6,044) (22)%
Professional fees and other external expenses 133,267 56,805 76,462 135%
Facility related and other internal expenses 22,718 19,632 3,086 16%
Total SG&A expenses $ 247,467 $ 154,763 $ 92,704 60%
R&D expenses for the three months ended June September 30, 2026 and 2025 were comprised of the following (in thousands):
Three Months Ended June September 30, Increase (decrease)
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 14,090 10,798 3,292 30% 14,544 10,030 4,514 45%
Subtotal external expenses $ 161,227 $ 93,902 $ 67,325 72%
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 $210.0 $270.0 million for the three months ended June September 30, 2026 as compared to $177.2 $186.4 million for the same period in 2025, an increase of $32.8 $83.5 million, or 19%. 45%. This increase was primarily due to a $17.0 $48.5 million increase in compensation and benefit-related expenses and stock-based compensation manufacturing costs due to an increase in headcount, and a $14.6 $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 June September 30, 2026 and 2025 were comprised of the following (in thousands):
Three Months Ended June September 30, Increase (decrease)
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and 96 more changes in the filing
Market risk 3 changes
As of June September 30, 2026, our cash and cash equivalents were in cash accounts and money market funds. Our investments in money market f unds are not insured by the federal government. As of June September 30, 2026, we had $615.5 $750.1 million in marketable securities.
As of June 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 June 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 six nine months ended June September 30, 2026 and 2025, our results of operations were not materially affected by fluctuations in foreign currency exchange rates.
Controls and procedures 2 changes
1 unchanged paragraph
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 June September 30, 2026. The term disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities and 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 June 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.
1 unchanged paragraph
There were no changes in our internal control over financial reporting (as defined in Rule Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended June September 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Other information 14 changes
1 unchanged paragraph
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 , modified or terminated by our officers and directors (each as defined in Rule 16a-1(f) of the Exchange Act) during the second third quarter of 2026, each of which was entered into or terminated, as applicable, during an open trading window and is or was intended to satisfy the affirmative defense conditions of Ru le 10b5-1(c) (each, a Trading Plan).
1 unchanged paragraph
Chief People Strategy Officer
Chief Financial Officer
Chief Executive Officer
1 unchanged paragraph
In addition, during the period covered by this Quarterly Report on Form 10-Q, one of our officers, Samuele Butera, our SVP, General Manager, Global Respiratory, entered into a grant agreement relating to RSUs that included a sell-to-cover arrangement constituting a non-Rule 10b5-1 trading arrangement (as defined in Item 408 of Regulation S-K), requiring the pre-arranged sale of shares upon vesting to satisfy tax withholding obligations arising solely from such vesting of the RSUs and the related issuance of shares. The amount of shares to be sold to satisfy the tax withholding obligations under this arrangement is dependent on the trading price of the Company s common stock at the time of the vesting of the RSUs. The duration of this arrangement is until the final vesting date of the RSUs or the earlier forfeiture of unvested RSUs as set forth in the grant agreement.
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.
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.
Exhibits 7 changes
2 unchanged paragraphs
Form of Award Agreement for Restricted Stock Units issued to directors pursuant to the Insmed Incorporated Amended and Restated 2019 Incentive Plan for awards granted on or after May 11, 2026 (filed herewith).
Employment Agreement, effective as of June 23, 2026, between Insmed Incorporated and Samuele Butera (filed herewith).
4 unchanged paragraphs
* Management contract or compensatory plan or arrangement.
101 The following materials from Insmed Incorporated s quarterly report on Form 10-Q for the quarter ended June September 30, 2026 formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) Consolidated Balance Sheets as of June September 30, 2026 and December 31, 2025, (ii) Consolidated Statements of Comprehensive Loss for the three and six nine months ended June September 30, 2026 and 2025, (iii) Consolidated Statements of Shareholders' Equity for the three and six nine months ended June September 30, 2026 and 2025, (iv) Consolidated Statements of Cash Flows for the six nine months ended June 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 June September 30, 2026, formatted in iXBRL and contained in Exhibit 101.
1 unchanged paragraph
Date: August 6, 2026
Date: October 29, 2026
3 unchanged paragraphs
Unchanged: Notes to the financial statements, MD&A, Note 5: Inventory (Continued), Legal proceedings, Risk factors, Unregistered sales of stock
Only in the earlier filing: Note 9: Leases (Continued)
Compared by code from the two filings' text and XBRL. Not advice.
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