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Watchlist
Account
Insmed
INSM
#934
Rank
โฌ23.35 B
Marketcap
๐บ๐ธ
United States
Country
106,92ย โฌ
Share price
-2.05%
Change (1 day)
-2.00%
Change (1 year)
๐ Pharmaceuticals
๐งฌ Biotech
Categories
Market cap
Revenue
Earnings
Price history
P/E ratio
P/S ratio
More
Price history
P/E ratio
P/S ratio
P/B ratio
Operating margin
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Fails to deliver
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Total liabilities
Total debt
Cash on Hand
Net Assets
Annual Reports
Annual Reports (10-K)
Insmed
Quarterly Reports (10-Q)
Financial Year FY2026 Q2
Insmed - 10-Q quarterly report FY2026 Q2
Text size:
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
10-Q
(Mark One)
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended
June 30, 2026
OR
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number
000-30739
INSMED INC
ORPORATED
(Exact name of registrant as specified in its charter)
Virginia
54-1972729
(State or other jurisdiction of incorporation or organization)
(I.R.S. employer identification no.)
700 US Highway 202/206
,
Bridgewater
,
New Jersey
08807
(Address of principal executive offices)
(Zip Code)
(
908
)
977-9900
(Registrant’s telephone number including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading symbols
Name of each exchange on which registered
Common stock, par value $0.01 per share
INSM
Nasdaq Global Select Market
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes
x
No
☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes
x
No
☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
x
Accelerated filer
o
Non-accelerated filer
o
Smaller reporting company
☐
Emerging growth company
☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
☐
No
x
As of July 31, 2026, there were
218,381,503
shares of the registrant’s common stock outstanding.
INSMED INCORPORATED
FORM 10-Q
FOR THE QUARTER ENDED JUNE 30, 2026
INDEX
PART I. FINANCIAL INFORMATION
ITEM 1
Consolidated Financial Statements
Consolidated Balance Sheet
s as of
June 30, 2026
(unaudited) and
December 31, 2025
3
Consolidated Statements of Comprehensive
Loss (unaudited) for the three
and six
months ended
June 30, 2026
and
2025
4
Consolidated Statements of Shareholders' Equity
(unaudited) for the three
and s
ix
months ended
June 30, 2026
and
2025
5
Consolidated Statements of Cash Flows (unaudited) for
the
six months ended June 30, 2026
and
2025
7
Notes to Consolidated Financial Statements (unaudited)
8
ITEM 2
Management’s Discussion and Analysis of Financial Condition and Results of Operations
24
ITEM 3
Quantitative and Qualitative Disclosures about Market Risk
35
ITEM 4
Controls and Procedures
35
PART II. OTHER INFORMATION
ITEM 1
Legal Proceedings
36
ITEM 1A
Risk Factors
36
ITEM 2
Unregistered Sales of Equity Securities and Use of Proceeds
36
ITEM 5
Other Information
36
ITEM 6
Exhibits
37
SIGNATURE
38
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
June 30, 2026
December 31, 2025
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
544,765
$
510,445
Marketable securities
615,547
919,602
Accounts receivable
215,325
140,857
Inventory
142,384
132,068
Prepaid expenses and other current assets
115,898
91,236
Total current assets
1,633,919
1,794,208
Fixed assets, net
107,219
102,942
Finance lease right-of-use assets
14,205
15,561
Operating lease right-of-use assets
13,179
20,708
Intangibles, net
93,489
97,651
Goodwill
136,110
136,110
Other assets
104,444
97,378
Total assets
$
2,102,565
$
2,264,558
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable and accrued liabilities
$
428,929
$
456,060
Finance lease liabilities
3,549
3,345
Operating lease liabilities
6,266
9,469
Total current liabilities
438,744
468,874
Debt, long-term
543,513
540,964
Royalty financing agreement
159,843
162,865
Contingent consideration
170,550
314,340
Finance lease liabilities, long-term
18,890
20,719
Operating lease liabilities, long-term
7,663
12,174
Other long-term liabilities
5,868
5,646
Total liabilities
1,345,071
1,525,582
Shareholders’ equity:
Common stock, $
0.01
par value;
500,000,000
authorized shares,
218,281,059
and
214,255,853
issued and outstanding shares at June 30, 2026 and December 31, 2025, respectively
2,183
2,143
Additional paid-in capital
6,572,181
6,372,064
Accumulated deficit
(
5,813,497
)
(
5,636,692
)
Accumulated other comprehensive (loss) gain
(
3,373
)
1,461
Total shareholders’ equity
757,494
738,976
Total liabilities and shareholders’ equity
$
2,102,565
$
2,264,558
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 June 30,
Six Months Ended June 30,
2026
2025
2026
2025
Product revenues, net
$
425,486
$
107,415
$
731,450
$
200,238
Operating expenses:
Cost of product revenues (excluding amortization of intangible assets)
67,212
28,075
114,632
49,353
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
)
Basic and diluted net loss per share
$
(
0.06
)
$
(
1.70
)
$
(
0.82
)
$
(
3.12
)
Weighted average basic and diluted common shares outstanding
217,352
189,302
216,415
185,104
Net loss
$
(
13,242
)
$
(
321,686
)
$
(
176,805
)
$
(
578,269
)
Other comprehensive income (loss):
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
)
See accompanying notes to the unaudited consolidated financial statements
4
INSMED INCORPORATED
Consolidated Statements of Sharehold
ers' Equity (unaudited)
(in thousands)
Common Stock
Additional
Paid-in
Capital
Accumulated
Deficit
Accumulated
Other
Comprehensive
Income (Loss)
Total
Shares
Amount
Balance at March 31, 2025
181,900
$
1,819
$
4,714,742
$
(
4,616,500
)
$
(
902
)
$
99,159
Comprehensive loss:
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
Issuance of common stock upon conversion of convertible notes
17,923
179
565,957
566,136
Stock-based compensation expense
42,976
42,976
Balance at June 30, 2025
211,111
$
2,111
$
6,184,078
$
(
4,938,186
)
$
1,732
$
1,249,735
Balance at March 31, 2026
216,522
$
2,165
$
6,502,938
$
(
5,800,255
)
$
4
$
704,852
Comprehensive loss:
Net loss
(
13,242
)
(
13,242
)
Other comprehensive loss
(
3,377
)
(
3,377
)
Issuance of common stock for exercise of stock options, vesting of RSUs, and ESPP
1,759
18
27,989
28,007
Stock-based compensation expense
41,254
41,254
Balance at June 30, 2026
218,281
$
2,183
$
6,572,181
$
(
5,813,497
)
$
(
3,373
)
$
757,494
See accompanying notes to the unaudited consolidated financial statements
5
INSMED INCORPORATED
Consolidated Statements of Sharehold
ers' 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
179,383
$
1,794
$
4,645,791
$
(
4,359,917
)
$
(
2,289
)
$
285,379
Comprehensive loss:
Net loss
(
578,269
)
(
578,269
)
Other comprehensive income
4,021
4,021
Issuance of common stock for exercise of stock options, vesting of RSUs and PSUs, and ESPP
4,821
48
66,639
66,687
Net proceeds from issuance of common stock
8,984
90
823,448
823,538
Issuance of common stock upon conversion of convertible notes
17,923
179
565,962
566,141
Stock-based compensation expense
82,238
82,238
Balance at June 30, 2025
211,111
$
2,111
$
6,184,078
$
(
4,938,186
)
$
1,732
$
1,249,735
Balance at December 31, 2025
214,256
$
2,143
$
6,372,064
$
(
5,636,692
)
$
1,461
$
738,976
Comprehensive loss:
Net loss
(
176,805
)
(
176,805
)
Other comprehensive loss
(
4,834
)
(
4,834
)
Issuance of common stock for exercise of stock options, vesting of RSUs, and ESPP
3,661
37
58,244
58,281
Issuance of common stock for Business Acquisition milestone achievement
364
3
54,865
54,868
Stock-based compensation expense
87,008
87,008
Balance at June 30, 2026
218,281
$
2,183
$
6,572,181
$
(
5,813,497
)
$
(
3,373
)
$
757,494
See accompanying notes to the unaudited consolidated financial statements
6
INSMED INCORPORATED
Consolidated Statements of Cash Flows (unaudited)
(in thousands)
Six Months Ended June 30,
2026
2025
Operating activities
Net loss
$
(
176,805
)
$
(
578,269
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation
6,113
4,367
Amortization of intangible assets
4,162
2,526
Stock-based compensation expense
87,008
82,238
Amortization of debt issuance costs
2,811
3,498
Royalty financing non-cash interest expense
10,243
10,215
Accretion of discount on marketable securities, net
(
11,977
)
(
15,910
)
Finance lease amortization expense
1,356
1,356
Non-cash operating lease expense
1,386
1,574
Change in fair value of contingent consideration
(
146,721
)
77,300
Changes in operating assets and liabilities:
Accounts receivable
(
75,350
)
(
781
)
Inventory
(
14,860
)
(
5,997
)
Prepaid expenses and other current assets
(
25,049
)
(
23,475
)
Other assets
(
7,587
)
12,515
Accounts payable and accrued liabilities
34,945
(
35,832
)
Other liabilities
(
1,241
)
(
2,982
)
Net cash used in operating activities
(
311,566
)
(
467,657
)
Investing activities
Purchase of fixed assets
(
9,739
)
(
13,554
)
Payment of AZ milestone
(
15,000
)
—
Purchase of marketable securities
(
399,228
)
(
907,199
)
Maturities of marketable securities
714,000
1,229,000
Net cash provided by investing activities
290,033
308,247
Financing activities
Proceeds from exercise of stock options and ESPP
58,319
66,669
Proceeds from issuance of common stock, net
—
823,538
Payments of principal of
0.75
% convertible senior notes due 2028
—
(
1,965
)
Payments of finance lease principal
(
1,626
)
(
1,438
)
Net cash provided by financing activities
56,693
886,804
Effect of exchange rates on cash and cash equivalents
(
840
)
1,900
Net increase in cash and cash equivalents
34,320
729,294
Cash and cash equivalents at beginning of period
510,445
555,030
Cash and cash equivalents at end of period
$
544,765
$
1,284,324
Supplemental disclosures of cash flow information:
Cash paid for interest
$
26,391
$
26,391
Cash paid for income taxes
$
3,636
$
2,853
See accompanying notes to the unaudited consolidated financial statements
7
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. The Company and Basis of Presentation
Insmed is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company's 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. 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 PPF and IPF
. 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 interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements and
8
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
1. The Company and Basis of Presentation (Continued)
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 $
544.8
million of cash and cash equivalents and $
615.5
million of marketable securities as of June 30, 2026 and reported a net loss of $
176.8
million for the six months ended June 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.
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.
The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiarie
s, Celtrix Pharmaceuticals, Inc., Insmed France SAS, Insmed Gene Therapy LLC, Insmed Germany GmbH, Insmed Godo Kaisha, Insmed Holdings Limited, Insmed Innovation UK Limited, Insmed Ireland Limited, Insmed Italy S.R.L., Insmed Limited, Insmed Netherlands B.V., Insmed Netherlands Holdings B.V., and Insmed Switzerland GmbH.
2. Summary of Significant Accounting Policies
The Company’s complete listing of significant accounting policies is set forth in Note 2 of the notes to the consolidated financial statements in the Company's
Annual Report on Form 10-K for the year ended December 31, 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 relevant information about past events, including historical experience, current conditions, and reasonable and supportable
9
Table of Contents
INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
2. Summary of Significant Accounting Policies (Continued)
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 months ended June 30, 2026 and their respective percentages for the six months ended June 30, 2025.
Six Months Ended June 30,
2026
2025
Customer A
38
%
28
%
Customer B
22
%
28
%
Customer C
18
%
9
%
Customer D
14
%
5
%
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 six months ended June 30, 2026 and 2025 (in thousands, except per share amounts):
Three Months Ended June 30,
Six Months Ended June 30,
2026
2025
2026
2025
Numerator:
Net loss
$
(
13,242
)
$
(
321,686
)
$
(
176,805
)
$
(
578,269
)
Denominator:
Weighted average common shares used in calculation of basic net loss per share:
217,352
189,302
216,415
185,104
Effect of dilutive securities:
Common stock options
—
—
—
—
RSUs
—
—
—
—
PSUs
—
—
—
—
Weighted average common shares outstanding used in calculation of diluted net loss per share
217,352
189,302
216,415
185,104
Net loss per share:
Basic and diluted
$
(
0.06
)
$
(
1.70
)
$
(
0.82
)
$
(
3.12
)
10
Table of Contents
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 June 30, 2026 and 2025, as their effect would have been anti-dilutive (in thousands):
As of June 30,
2026
2025
Common stock options
15,503
20,227
RSUs
3,328
3,854
PSUs
184
9
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 June 30, 2026
Fair Value
Carrying Value
Level 1
Level 2
Level 3
Assets
Cash and cash equivalents
$
544.8
$
544.8
$
—
$
—
Marketable securities
$
615.5
$
615.5
$
—
$
—
Liabilities
Contingent consideration
$
170.6
$
—
$
—
$
170.6
11
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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
$
510.4
$
510.4
$
—
$
—
Marketable securities
$
919.6
$
919.6
$
—
$
—
Liabilities
Contingent consideration
$
372.1
$
—
$
—
$
372.1
During
the six months ended June 30, 2026, there were purchases of
$
399.2
million
of marketable securities and maturities of
$
714.0
million
of marketable securities,
consisting of US Treasury Bills.
As of June 30, 2026, the Company held $
615.5
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 months ended June 30, 2026. During the six months ended June 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 months ended June 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 June 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 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 30, 2026, the Company determined that the value of the PRV milestone was
$
15.7
million.
The contingent consideration liabilities for net sales milestones were valued using an option pricing model with Monte Carlo simulation.
As of June 30, 2026, the fair value of these net sales milestones were deemed immaterial to the overall fair value of the contingent consideration.
12
Table of Contents
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 June 30, 2026, there was
no
current contingent consideration outstanding, and the fair value of the non-current contingent consideration was $
170.6
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 June 30, 2026 and December 31, 2025:
Fair Value as of June 30, 2026 (in millions)
Valuation Technique
Unobservable Inputs
Values
Development and regulatory milestones
$
149.2
Probability-adjusted
Probabilities of success
0
% -
80
%
PRV milestone
$
15.7
Probability-adjusted discounted cash flow
Probability of success
23.0
%
Discount rate
21.9
%
Fair Value as of December 31, 2025 (in millions)
Valuation Technique
Unobservable Inputs
Values
Development and regulatory milestones
$
366.9
Probability-adjusted
Probabilities of success
14
% -
90
%
A rollforward of the Company's valuations for the contingent consideration liabilities for the six months ended June 30, 2026 and 2025 follows (in thousands):
Contingent Consideration
(Level 3 Liabilities)
Balance as of December 31, 2024
$
168,900
Additions
—
Change in fair value
77,300
Payments
—
Balance as of June 30, 2025
$
246,200
Balance as of December 31, 2025
$
372,139
Additions
—
Change in fair value
(
146,721
)
Payments
(
54,868
)
Balance as of June 30, 2026
$
170,550
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
Table of Contents
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 six months ended June 30, 2026 and 2025 (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2026
2025
2026
2025
ARIKAYCE
US
$
70,186
$
68,683
$
133,070
$
132,958
International
46,130
38,732
81,356
67,280
Total
$
116,316
$
107,415
$
214,426
$
200,238
BRINSUPRI
US
$
308,555
$
—
$
515,737
$
—
International
615
—
1,287
—
Total
$
309,170
$
—
$
517,024
$
—
Total
US
$
378,741
$
68,683
$
648,807
$
132,958
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'accès compassionnel or AAC) and sales through the named patient program (NPP) in other countries.
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)
14
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INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
4. Product Revenues, Net (Continued)
estimated costs of co-payment assistance. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (prompt pay discounts and chargebacks), prepaid expenses (co-payment assistance), or as a current liability (rebates). Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as the Company's historical experience, current contractual and statutory requirements, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company's best estimates of the amount of consideration to which it is entitled based on the terms of the applicable contract. The amount of variable consideration included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known.
Customer credits: Certain of the Company's customers are offered various forms of consideration, including prompt payment discounts. The payment terms for sales to specialty pharmacies and specialty distributors for prompt payment discounts are based on contractual rates agreed with the respective specialty pharmacies and distributors. The Company anticipates that its customers will earn these discounts and, therefore, deducts the full amount of these discounts from total gross product revenues at the time such revenues are recognized.
Rebates: The Company contracts with certain government agencies and managed care organizations, or collectively, third-party payors, so that its marketed products will be eligible for purchase by, or partial or full reimbursement from, such third-party payors. The Company estimates the rebates it will provide to third-party payors and deducts these estimated amounts from total gross product revenues at the time the revenues are recognized. These reserves are recorded in the same period in which the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The current liability is included in accounts payable and accrued liabilities on the consolidated balance sheets. The Company estimates the rebates that it will provide to third-party payors based upon (i) the Company's contracts with these third-party payors, (ii) the government mandated discounts applicable to government-funded programs, (iii) a range of possible outcomes that are probability-weighted for the estimated payor mix, and (iv) information obtained from the Company's specialty pharmacies.
Chargebacks: Chargebacks are discounts that occur when certain contracted customers, currently public health service institutions and federal government entities purchasing via the Federal Supply Schedule, purchase directly from the Company's specialty distributor. Contracted customers generally purchase the product at a discounted price and the specialty distributor, in turn, charges back to the Company the difference between the price the specialty distributor initially paid and the discounted 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
June 30, 2026
December 31, 2025
Raw materials
$
39,820
$
30,623
Work-in-process
40,351
41,346
Finished goods
62,213
60,099
$
142,384
$
132,068
15
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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 June 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 paid to AstraZeneca AB (AstraZeneca) as a result of the FDA approval of BRINSUPRI in August 2025, and the milestone paid to AstraZeneca as a result of the EC approval of BRINSUPRI in November 2025. The Company began amortizing its acquired ARIKAYCE R&D and PARI milestone-related intangible assets in October 2018, over ARIKAYCE's initial regulatory exclusivity period of
12
years, and began amortizing its AstraZeneca milestone-related intangible assets in August and November 2025 over BRINSUPRI's regulatory exclusivity period of approximately
14
years. Amortization expense is estimated to be $
8.3
million per year for the years 2026 through 2029 and $
7.1
million for 2030.
Indefinite-lived Intangible Assets
As of June 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 months ended June 30, 2026 and 2025 is as follows (in thousands):
Intangible Asset
December 31, 2025
Additions
Amortization
June 30, 2026
Acquired ARIKAYCE R&D
$
23,038
$
—
$
(
2,425
)
$
20,613
PARI milestones
962
—
(
101
)
861
AstraZeneca milestones
44,051
—
(
1,636
)
42,415
Acquired IPR&D
29,600
—
—
29,600
$
97,651
$
—
$
(
4,162
)
$
93,489
Intangible Asset
December 31, 2024
Additions
Amortization
June 30, 2025
Acquired ARIKAYCE R&D
$
27,888
$
—
$
(
2,425
)
$
25,463
PARI milestones
1,164
—
(
101
)
1,063
Acquired IPR&D
29,600
—
—
29,600
$
58,652
$
—
$
(
2,526
)
$
56,126
Goodwill
The Company's goodwill balance of $
136.1
million as of June 30, 2026 and December 31, 2025, resulted from the August 2021 Business Acquisition.
16
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INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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
June 30, 2026
December 31, 2025
Building
39
$
10,437
$
10,437
Land
NA
1,963
1,963
Lab equipment
7
43,646
39,127
Furniture and fixtures
7
6,428
6,428
Computer hardware and software
3
-
5
8,697
8,425
Office equipment
7
171
171
Manufacturing equipment
7
1,336
1,336
Leasehold improvements
2
-
10
55,209
53,400
Construction in progress
—
46,027
42,410
173,914
163,697
Less: accumulated depreciation
(
66,695
)
(
60,755
)
$
107,219
$
102,942
8. Accounts Payable and Accrued Liabilities
Accounts payable and accrued liabilities consist of the following (in thousands):
As of
June 30, 2026
December 31, 2025
Accounts payable and other accrued operating expenses
$
74,555
$
79,907
Accrued clinical trial expenses
34,443
34,329
Accrued professional fees
25,014
23,658
Accrued technical operation expenses
21,730
22,533
Accrued compensation and employee related costs
61,579
111,514
Accrued royalty and milestones payable
37,774
17,101
Revenue Interest Payments payable
7,553
6,449
Accrued sales allowances and related costs
146,373
70,869
Accrued French rebate payable
9,062
6,960
Contingent consideration
—
57,799
Accrued milestone payment to AstraZeneca
—
15,000
Other accrued liabilities
10,846
9,941
$
428,929
$
456,060
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
17
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INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
9. Leases
(Continued)
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 $
5.3
million and $
3.4
million for the three months ended June 30, 2026 and 2025, respectively, and $
12.9
million and $
5.9
million for the six months ended June 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.
During the three and six months ended June 30, 2026 and 2025, the Company did not acquire any new right-of-use assets 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 June 30, 2026 and December 31, 2025, costs o
f
$
75.2
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 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.
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
18
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INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. Debt (Continued)
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 30, 2026 and December 31, 2025 (in thousands):
As of
June 30, 2026
December 31, 2025
Principal
$
500,000
$
500,000
Paid-in-kind interest capitalized
46,770
46,770
Debt discount, net
(
3,257
)
(
5,806
)
Term Loans
$
543,513
$
540,964
As of June 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
341,731
2029
205,039
2030 and thereafter
—
$
546,770
Interest Expense
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,
2026
2025
2026
2025
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
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
19
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INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
11. Royalty Financing Agreement (Continued)
$
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 period ended June 30, 2026 and year ended December 31, 2025 (in thousands):
Six Months Ended June 30, 2026
Twelve Months Ended
December 31, 2025
Royalty Financing Agreement liability - beginning balance
$
164,945
$
163,671
Revenue Interest Payments paid and payable
(
13,527
)
(
19,401
)
Interest expense recognized
10,243
20,675
Royalty Financing Agreement liability - ending balance
$
161,661
$
164,945
Royalty issuance costs, unamortized - beginning balance
$
(
2,080
)
$
(
2,604
)
Amortization of issuance costs
262
524
Royalty issuance costs, unamortized - ending balance
$
(
1,818
)
$
(
2,080
)
Royalty Financing Agreement
$
159,843
$
162,865
The Revenue Interest Payments payable in connection with the Royalty Financing Agreement were $
7.6
million and $
6.4
million as of June 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 June 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
shares of common stock issued and outstanding. In addition, as of June 30, 2026, the Company had reserved
15,503,480
shares of common stock for issuance upon the exercise of outstanding stock options,
3,327,891
shares of common stock for issuance upon the vesting of RSUs, and
267,435
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 30, 2026,
4,979,705
shares
of the Company's common stock remain reserved for the Business Acquisition.
Preferred Stock
—As of June 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.
20
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INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
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 June 30, 2026,
10,334,057
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
shares of the Company's common stock to new employees during the six months ended June 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 30, 2026,
516,635
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 June 30, 2026, there was $
146.7
million of unrecognized compensation expense related to unvested stock options.
As of June 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 30, 2026, there was $
248.9
million of unrecognized compensation expense related to unvested RSU awards.
Performance Stock Units
—As of June 30, 2026, there were
92,219
PSUs outstanding with an unrecognized compensation expense of
$
18.1
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 months ended June 30, 2026 and 2025 (in thousands):
Three Months Ended June 30,
Six Months Ended June 30,
2026
2025
2026
2025
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
14. Income Taxes
The Company recorded a provision for income taxes of $
1.9
million and $
1.2
million for the three months ended June 30, 2026 and 2025, respectively, and $
3.3
million and $
2.2
million for the six months ended June 30, 2026 and 2025, respectively. The provisions recorded for the three and six months ended June 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
21
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INSMED INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
14. Income Taxes (Continued)
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 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 30, 2026 and December 31, 2025 or the consolidated statements of comprehensive loss for the three and six months ended June 30, 2026 and 2025. The Company has
no
t recorded any accrued interest or penalties related to uncertain tax positions.
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 $
3.7
million and $
3.3
million for the three months ended June 30, 2026 and 2025, respectively, and $
7.2
million and $
6.8
million for the six months ended June 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 P
olicies
.
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.
22
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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 six months ended June 30, 2026 and 2025 is as follows (in thousands):
Three Months Ended June 30,
Six Months Ended
June 30,
2026
2025
2026
2025
Product revenues, net
$
425,486
$
107,415
$
731,450
$
200,238
Less:
Cost of product revenues (excluding amortization of intangible assets)
67,212
28,075
114,632
49,353
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
Other segment items
(a)
207,425
127,650
417,913
247,345
Depreciation
3,179
2,484
6,113
4,367
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
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
)
(a)
Other segment items include stock-based compensation, professional fees, and facility-related expenses.
23
Table of Contents
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 Europe, or to maintain US, European or Japanese approval for ARIKAYCE or US or European approval for 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 and Europe;
•
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.
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 PPF and IPF.
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:
•
Ensure successful US commercialization of BRINSUPRI;
•
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 June 30, 2026, we had an accumulated deficit of $5.8 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 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.
The information below summarizes our recent updates and anticipated near-term milestones for our marketed products and our product candidates.
Respiratory
BRINSUPRI
•
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.
ARIKAYCE
•
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 data with the Pharmaceuticals and Medical Devices Agency (PMDA) in the second half of 2026 to support potential label expansion in Japan.
TPIP
•
PALM-ILD, our Phase 3 study of TPIP in patients with PH-ILD that we initiated in the fourth quarter of 2025, continues to enroll patients.
•
In April 2026, we initiated the Phase 3 PALM-PAH study of TPIP in patients with PAH and are actively enrolling patients.
•
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.
•
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.
INS1148
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•
We continue to advance a Phase 2 development program for INS1148, initially targeting PPF and IPF, and we are exploring other diseases where inhibition of the inflammatory functions of SCF248 may be beneficial.
Neuro & Other Rare
INS1201
•
We continue to enroll patients in the Phase 1 ASCEND clinical study of INS1201 for patients with DMD.
INS1202
•
We continue to enroll patients in the Phase 1 ARMOR clinical study of INS1202 for patients with ALS.
Clinical Trial Developments
The OLE Study
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 µg 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.
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
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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, 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.
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RESULTS OF OPERATIONS
Comparison of the Three Months Ended June 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 June 30, 2026 and 2025 (in thousands):
Three Months Ended June 30,
Increase (decrease)
2026
2025
$
%
ARIKAYCE
US
$
70,186
$
68,683
$
1,503
2%
International
46,130
38,732
7,398
19%
Total
$
116,316
$
107,415
$
8,901
8%
BRINSUPRI
US
$
308,555
$
—
$
308,555
NA
International
615
—
615
NA
Total
$
309,170
$
—
$
309,170
NA
Total
US
$
378,741
$
68,683
$
310,058
451%
International
46,745
38,732
8,013
21%
Total product revenues, net
$
425,486
$
107,415
$
318,071
296%
Product revenues, net, for the three months ended June 30, 2026 were $425.5 million as compared to $107.4 million for
the same period in
2025, an increase of $318.1 million, or 296%. This increase was a result of $308.6 million of US commercial sales of BRINSUPRI following approval in August 2025 and an $8.9 million growth in sales of ARIKAYCE, primarily driven by growth in international sales. In the first quarter of 2026, we
began recognizing 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'accès compassionnel or AAC) and sales through the NPP in other countries.
Cost of Product Revenues (excluding amortization of intangible assets)
Cost of product revenues (excluding amortization of intangible assets) for the three months ended June 30, 2026 and 2025 were as follows (in thousands):
Three Months Ended June 30,
Increase (decrease)
2026
2025
$
%
Cost of product revenues (excluding amortization of intangible assets)
$
67,212
$
28,075
$
39,137
139%
Cost of product revenues, as % of revenues
15.8
%
26.1
%
Cost of product revenues (excluding amortization of intangible assets) were $67.2 million for the three months ended June 30, 2026 as compared to $28.1 million for
the same period in
2025, an increase of $39.1 million
, or 139%. 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.
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.
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R&D Expenses
R&D expenses for the three months ended June 30, 2026 and 2025 were comprised of the following (in thousands):
Three Months Ended June 30,
Increase (decrease)
2026
2025
$
%
External Expenses
Clinical development and research
$
55,897
$
41,251
$
14,646
36%
Manufacturing
37,841
41,608
(3,767)
(9)%
Regulatory, quality assurance, and medical affairs
14,090
10,798
3,292
30%
Subtotal—external expenses
$
107,828
$
93,657
$
14,171
15%
Internal Expenses
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%
R&D expenses were $210.0 million for the three months ended June 30, 2026 as compared to $177.2 million for the same period in 2025, an increase of
$32.8 million, or
19%. This increase was primarily due to a
$17.0 million increase
in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, and a $14.6 million increase in clinical development and research costs primarily related to TPIP.
External R&D expenses by product for the three months ended June 30, 2026 and 2025 were comprised of the following (in thousands):
Three Months Ended June 30,
Increase (decrease)
2026
2025
$
%
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%
SG&A Expenses
SG&A expenses for the three months ended June 30, 2026 and 2025 were comprised of the following (in thousands):
Three Months Ended June 30,
Increase (decrease)
2026
2025
$
%
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%
SG&A expenses were $247.5 million for the three months ended June 30, 2026 as compared to $154.8 million for the same period in 2025, an increase of $92.7 million, or 60%. This increase was primarily due to a $76.5 million increase in professional fees and other external expenses and a $19.2 million increase
in compensation and benefit-related expenses due to an increase in headcount
, both driven by commercial activities fo
r BRINSUPRI.
Amortization of Intangible Assets
Amortization of intangible assets was $2.1 million for the three months ended June 30, 2026 as compared to $1.3 million for the same period in 2025, an increase of $0.8 million. This increase was due to amortization of the AstraZeneca milestones achieved upon FDA and EC approvals of BRINSUPRI in August 2025 and November 2025, respectively.
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Change in Fair Value of Contingent Consideration
The change in fair value of contingent consideration for the three months ended June 30, 2026 was $99.8 million and was primarily d
ue to the decrease in our share price and to a lesser extent, the change in
probabilities of success. Contingent consideration is the potential future consideration to be paid to former equityholders of the businesses we acquired.
Investment Income
Investment income was $11.0 million for the three months ended June 30, 2026 as compared to $13.2 million for the same period in 2025, a decrease of $2.2 million, or 17%. 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 three months ended June 30, 2026 was $20.3 million as compared to $21.2 million for the same period in 2025, a decrease of $1.0 million, or 5%. 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.
RESULTS OF OPERATIONS
Comparison of the Six Months Ended June 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 six months ended June 30, 2026 and 2025 (in thousands):
Six Months Ended June 30,
Increase (decrease)
2026
2025
$
%
ARIKAYCE
US
$
133,070
$
132,958
$
112
<1%
International
81,356
67,280
14,076
21%
Total
$
214,426
$
200,238
$
14,188
7%
BRINSUPRI
US
$
515,737
$
—
$
515,737
NA
International
1,287
—
1,287
NA
Total
$
517,024
$
—
$
517,024
NA
Total
US
$
648,807
$
132,958
$
515,849
388%
International
82,643
67,280
15,363
23%
Total product revenues, net
$
731,450
$
200,238
$
531,212
265%
Product revenues, net, for the six months ended June 30, 2026 were $731.5 million as compared to $200.2 million for
the same period in
2025, an increase of $531.2 million, or 265%. This increase was a result of $515.7 million of US commercial sales of BRINSUPRI following approval in August 2025 and a $14.2 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 six months ended June 30, 2026 and 2025 were as follows (in thousands):
Six Months Ended June 30,
Increase (decrease)
2026
2025
$
%
Cost of product revenues (excluding amortization of intangible assets)
$
114,632
$
49,353
$
65,279
132%
Cost of product revenues, as % of revenues
15.7
%
24.6
%
Cost of product revenues (excluding amortization of intangible assets) were $114.6 million for the six months ended June 30, 2026 as compared to $49.4 million for
the same period in
2025, an increase of $65.3 million
, or
132%
. This
increase
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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.
R&D Expenses
R&D expenses for the six months ended June 30, 2026 and 2025 were comprised of the following (in thousands):
Six Months Ended June 30,
Increase (decrease)
2026
2025
$
%
External Expenses
Clinical development and research
$
103,853
$
81,788
$
22,065
27%
Manufacturing
75,977
63,417
12,560
20%
Regulatory, quality assurance, and medical affairs
25,123
18,470
6,653
36%
Subtotal—external expenses
$
204,953
$
163,675
$
41,278
25%
Internal Expenses
Compensation and benefit-related expenses
$
141,220
$
109,947
$
31,273
28%
Stock-based compensation
44,286
33,350
10,936
33%
Other internal operating expenses
29,060
22,795
6,265
27%
Subtotal—internal expenses
$
214,566
$
166,092
$
48,474
29%
Total R&D expenses
$
419,519
$
329,767
$
89,752
27%
R&D expenses were $419.5 million for the six months ended June 30, 2026 as compared to $329.8 million for the same period in 2025, an increase of $89.8 million
, or
27%. This increase was primarily due to a
$42.2 million increase
in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, and a $22.1 million increase in clinical development and research costs and a $12.6 million increase in manufacturing costs, both primarily related to TPIP.
External R&D expenses by product for the six months ended June 30, 2026 and 2025 were comprised of the following (in thousands):
Six Months Ended June 30,
Increase (decrease)
2026
2025
$
%
TPIP external R&D expenses
$
76,276
$
29,802
$
46,474
156%
Brensocatib external R&D expenses
32,313
54,221
(21,908)
(40)%
ARIKAYCE external R&D expenses
14,850
23,124
(8,274)
(36)%
Other external R&D expenses
81,514
56,528
24,986
44%
Total external R&D expenses
$
204,953
$
163,675
$
41,278
25%
SG&A Expenses
SG&A expenses for the six months ended June 30, 2026 and 2025 were comprised of the following (in thousands):
Six Months Ended June 30,
Increase (decrease)
2026
2025
$
%
Compensation and benefit-related expenses
$
145,313
$
106,156
$
39,157
37%
Stock-based compensation
42,722
48,888
(6,166)
(13)%
Professional fees and other external expenses
258,231
107,366
150,865
141%
Facility related and other internal expenses
48,460
39,898
8,562
21%
Total SG&A expenses
$
494,726
$
302,308
$
192,418
64%
SG&A expenses were $494.7 million for the six months ended June 30, 2026 as compared to $302.3 million for the same period in 2025, an increase of $192.4 million, or 64%. This increase was primarily due to a $150.9 million increase in professional fees and other external expenses and a $39.2 million increase
in compensation and benefit-related expenses due to an increase in headcount
, both driven by commercial activities fo
r BRINSUPRI.
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Amortization of Intangible Assets
Amortization of intangible assets was $4.2 million for the six months ended June 30, 2026 as compared to $2.5 million for the same period in 2025, an increase of $1.6 million. This increase was due to amortization of the AstraZeneca milestones achieved upon FDA and EC approvals of BRINSUPRI in August 2025 and November 2025, respectively.
Change in Fair Value of Contingent Consideration
The change in fair value of contingent consideration for the six months ended June 30, 2026 was $146.7 million and was primarily d
ue 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 $23.0 million for the six months ended June 30, 2026 as compared to $27.1 million for the same period in 2025, a decrease of $4.1 million, or 15%. 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 six months ended June 30, 2026 was $40.4 million as compared to $42.8 million for the same period in 2025, a decrease of $2.5 million, or 6%. 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 sh
ares. 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 June 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 June 30, 2026, we had cash and cash equivalents of $544.8 million, as compared to $510.4 million as of December 31, 2025. In addition, as of June 30, 2026, we had marketable securities of
$615.5 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 $1.2 billion and
$1.3 billion
as of June 30, 2026 and December 31, 2025, respectively.
Net cash
used in
operating activities was $311.6 million and $467.7 million for the six months ended June 30, 2026 and
2025, respectively.
The net cash used in operating activities during the six months ended June 30, 2026 and
2025
was primarily driven by commercial, clinical, and manufacturing activities related to ARIKAYCE, commercial and commercial readiness 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 six months ended June 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 $290.0 million and $308.2 million for the six months ended June 30, 2026 and
2025, respectively. During the six months ended June 30, 2026, net cash provided by investing activities
consisted primarily of maturities of marketable securities, partially offset by
purchases of marketable securities and
the
$15.0 million
milestone payment to AstraZeneca following EC approval of BRINSUPRI. During the
six months ended June 30, 2025
, net cash
provided by investing activities consisted primarily of maturities of marketable securities,
partially offset by purchases of marketable securities.
Net cash
provided by
financing activities was $56.7 million and $886.8 million for the six months ended June 30, 2026 and
2025, respectively. During the
six months ended June 30, 2026,
net cash provided by financing activities consisted primarily of proceeds from the exercise of stock options and ESPP. During the six months ended June 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 six months ended June 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, 202
5.
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 June 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 30, 2026, we had $615.5 million in marketable securities.
As of June 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 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 months ended June 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 June 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 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 Rule 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended June 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
, modified or
terminated
by our officers and directors (each as defined in Rule 16a-1(f) of the Exchange Act) during the second
quarter of 2026, each of which was entered into during an open trading window and is intended to satisfy the affirmative defense conditions of Ru
le 10b5-1(c) (each, a Trading Plan).
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
S. Nicole Schaeffer
Chief People Strategy Officer
05/11/2026
08/31/2026
12/01/2026
101,100
NA
(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.
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.
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ITEM 6. EXHIBITS
Exhibit Index
3.1
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).
3.2
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).
10.1*
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).
10.2*
Employment Agreement, effective as of June 23, 2026, between Insmed Incorporated and Samuele Butera (filed herewith).
31.1
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).
31.2
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).
32.1
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).
32.2
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 June 30, 2026 formatted in iXBRL (Inline eXtensible Business Reporting Language): (i) Consolidated Balance Sheets as of June 30, 2026 and December 31, 2025, (ii) Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2026 and 2025, (iii) Consolidated Statements of Shareholders' Equity for the three and six months ended June 30, 2026 and 2025, (iv) Consolidated Statements of Cash Flows for the six months ended June 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 30, 2026, formatted in iXBRL and contained in Exhibit 101.
* Management contract or compensatory plan or arrangement.
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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: August 6, 2026
By
/s/ Sara Bonstein
Sara Bonstein
Chief Financial Officer
(Principal Financial and Accounting Officer)
38