
| • |
BRINSUPRI global revenue grew 29% in the third quarter of 2026 compared to the second quarter of 2026, driven by strong growth in the U.S. market.
|
| • |
In August 2026, Japan's Ministry of Health, Labour and Welfare (MHLW) approved BRINSUPRI Tablets 25 mg (brensocatib hydrate) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adults
and pediatric patients 12 years and older.
|
| • |
In October 2026, Insmed launched BRINSUPRI Tablets 25 mg, the first and only MHLW-approved treatment for NCFB, in Japan.
|
| • |
ARIKAYCE global revenue grew 9% in the third quarter of 2026 compared to the third quarter of 2025, primarily driven by strong growth in international markets.
|
| • |
In September 2026, the U.S. Food and Drug Administration (FDA) accepted Insmed’s Supplemental New Drug Application (sNDA) for review of ARIKAYCE for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen. The FDA granted Priority Review to the sNDA and set a target action date of January 28,
2027, under the Prescription Drug User Fee Act (PDUFA).
|
| • |
Insmed plans to submit data from the Phase 3 ENCORE study to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in the fourth quarter of 2026 to support potential ARIKAYCE label expansion to
all patients with MAC lung disease.
|
| • |
Insmed has now enrolled more than 35% of patients in the Phase 3 PALM-ILD study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with
interstitial lung disease (PH-ILD) and expects to complete enrollment in the first half of 2028.
|
| • |
In July 2026, Insmed enrolled its first patient in the Phase 3 PALM-PAH study of TPIP in patients with pulmonary arterial hypertension (PAH).
|
| • |
In September 2026, Insmed initiated the Phase 3 PALM-PPF study of TPIP in patients with progressive pulmonary fibrosis (PPF).
|
| • |
Insmed continues to anticipate initiating a Phase 3 study of TPIP in patients with idiopathic pulmonary fibrosis (IPF) in the first half of 2027.
|
| • |
Insmed continues to advance a Phase 2 development program for INS1148, initially targeting IPF, with plans to evaluate PPF and other diseases where inhibition of the pro-inflammatory and
pro-fibrotic responses mediated by stem cell factor 248 (SCF248) may be beneficial.
|
| • |
In September 2026, the Phase 1 study of INS1033, a dipeptidyl peptidase 1 (DPP1) inhibitor cleared by the FDA for patients with rheumatoid arthritis (RA), began active enrollment of healthy
volunteers.
|
| • |
Insmed completed enrollment of the Phase 1 ASCEND clinical study of INS1201, an intrathecally delivered gene therapy for patients with Duchenne muscular dystrophy (DMD).
|
| • |
Insmed continues to enroll patients in the Phase 1 ARMOR study of INS1202, an intrathecally delivered gene therapy for patients with amyotrophic lateral sclerosis (ALS).
|
| • |
In September 2026, Insmed presented five abstracts from across its Respiratory therapeutic area at the European Respiratory Society (ERS) Congress 2026.
|
| • |
In October 2026, Insmed presented data across its respiratory portfolio at the American College of Chest Physicians (CHEST) 2026 Annual Meeting and IDWeek 2026.
|
| • |
In October 2026, Insmed announced the appointment of Paul Hudson, former Chief Executive Officer of Sanofi and Novartis Pharmaceuticals, and Utpal Koppikar, current Chief Financial Officer of
Verily Health, to its Board of Directors.
|
|
INSMED INCORPORATED
Revenue by Region
(in millions)
|
|
Three Months Ended September 30,
|
Nine Months Ended September 30,
|
|||||||||||||||||||||||
|
(in millions)
|
2026
|
2025
|
Growth
|
2026
|
2025
|
Growth
|
||||||||||||||||||
|
ARIKAYCE
|
||||||||||||||||||||||||
|
U.S.
|
$
|
75.5
|
$
|
74.0
|
2%
|
|
$
|
208.6
|
$
|
206.9
|
1%
|
|
||||||||||||
|
International
|
48.9
|
40.3
|
21%
|
|
130.2
|
107.6
|
21%
|
|
||||||||||||||||
|
Total
|
$
|
124.4
|
$
|
114.3
|
9%
|
|
$
|
338.8
|
$
|
314.5
|
8%
|
|
||||||||||||
|
BRINSUPRI
|
||||||||||||||||||||||||
|
U.S.
|
$
|
398.1
|
$
|
28.1
|
|
NM
|
$
|
913.8
|
$
|
28.1
|
|
NM
|
||||||||||||
|
International
|
2.0
|
-
|
N/A
|
3.3
|
-
|
N/A
|
||||||||||||||||||
|
Total
|
$
|
400.1
|
$
|
28.1
|
|
NM
|
$
|
917.1
|
$
|
28.1
|
|
NM
|
||||||||||||
|
Total Revenues
|
||||||||||||||||||||||||
|
U.S.
|
$
|
473.6
|
$
|
102.0
|
364%
|
|
$
|
1,122.4
|
$
|
235.0
|
378%
|
|
||||||||||||
|
International
|
50.8
|
40.3
|
26%
|
|
133.5
|
107.6
|
24%
|
|
||||||||||||||||
|
Total
|
$
|
524.4
|
$
|
142.3
|
268%
|
|
$
|
1,255.9
|
$
|
342.6
|
267%
|
|
||||||||||||
| • |
Cost of product revenues (excluding amortization of intangibles) were $78.2 million for the third quarter of 2026, compared to $29.4 million for the third quarter of 2025. The increase in cost of
product revenues in the third quarter of 2026 primarily reflects the increase in total product revenues for ARIKAYCE and BRINSUPRI. Cost of product revenues as a percentage of revenues decreased in the third quarter of 2026 due to sales of
BRINSUPRI, which has lower manufacturing costs than ARIKAYCE.
|
| • |
Research and development (R&D) expenses were $270.0 million for the third quarter of 2026, compared to $186.4 million for the third quarter of 2025. The increase in R&D expenses for the
third quarter of 2026 was related to an increase in manufacturing costs, an increase in clinical development and research costs, both primarily related to TPIP, and an increase in compensation and benefit-related expenses and stock-based
compensation costs due primarily to an increase in headcount.
|
| • |
Selling, general and administrative (SG&A) expenses for the third quarter of 2026 were $253.0 million, compared to $186.4 million for the third quarter of 2025. The increase in SG&A
expenses for the third quarter of 2026 was primarily related to increases in professional fees and other external expenses, and an increase in compensation and benefit-related expenses due to an increase in headcount, both driven by
commercial activities for BRINSUPRI.
|
| • |
For the third quarter of 2026, Insmed reported a net loss of $100.3 million, or $0.46 per share, compared to a net loss of $370.0 million, or $1.75 per share, for the third quarter of 2025.
|
| • |
As of September 30, 2026, Insmed had cash, cash equivalents, and marketable securities totaling approximately $1.1 billion.
|
| • |
The Company raised its full-year 2026 revenue guidance for BRINSUPRI to a range of $1.35 billion to $1.4 billion from the previous guidance of $1.25 billion to $1.4 billion.
|
| • |
The Company raised its full-year 2026 revenue guidance for ARIKAYCE to a range of $460 million to $470 million from the previous guidance of $450 million to $470 million.
|
| • |
The Company continues to anticipate peak revenues for BRINSUPRI to be more than $7 billion, TPIP to be more than $6 billion, and ARIKAYCE to be more than $1 billion.
|
| • |
The Company continues to anticipate submitting an average of one to two INDs per year from its pre-clinical research programs.
|
| • |
Insmed continues to anticipate that the totality of its pre-clinical research programs will comprise less than 20% of overall expenditures.
|
| • |
The Company plans to continue to invest in the following key activities in 2026:
|
| (i) |
acceleration of BRINSUPRI commercial efforts in the U.S. and Japan;
|
| (ii) |
strengthening of ARIKAYCE commercial efforts;
|
| (iii) |
preparation for full approval for ARIKAYCE in the U.S. and label expansion to include all patients with MAC lung disease in the U.S. and Japan;
|
| (iv) |
advancement of the clinical development programs for TPIP, including the Phase 3 studies in patients with PH-ILD, PAH, PPF, and IPF;
|
| (v) |
advancement of clinical trial programs for INS1148 in IPF;
|
| (vi) |
advancement of the clinical trial programs for INS1201 in DMD and INS1202 in ALS, as well as IND-enabling activities for additional programs;
|
| (vii) |
advancement of clinical trial programs for INS1033 in RA; and
|
| (viii) |
continued development of its pre-clinical research programs.
|
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
|
2026
|
2025
|
2026
|
2025
|
|||||||||||||
|
Product revenues, net
|
$
|
524,428
|
$
|
142,342
|
$
|
1,255,878
|
$
|
342,580
|
||||||||
|
Operating expenses:
|
||||||||||||||||
|
Cost of product revenues (excluding amortization of intangible assets)
|
78,215
|
29,365
|
192,847
|
78,718
|
||||||||||||
|
Research and development
|
269,963
|
186,415
|
689,482
|
516,182
|
||||||||||||
|
Selling, general and administrative
|
253,029
|
186,376
|
747,755
|
488,684
|
||||||||||||
|
Amortization of intangible assets
|
5,050
|
1,538
|
9,212
|
4,064
|
||||||||||||
|
Change in fair value of contingent consideration liabilities
|
7,540
|
104,653
|
(139,181
|
)
|
181,953
|
|||||||||||
|
Total operating expenses
|
613,797
|
508,347
|
1,500,115
|
1,269,601
|
||||||||||||
|
Operating loss
|
(89,369
|
)
|
(366,005
|
)
|
(244,237
|
)
|
(927,021
|
)
|
||||||||
|
Investment income
|
11,070
|
18,289
|
34,089
|
45,420
|
||||||||||||
|
Interest expense
|
(20,410
|
)
|
(20,382
|
)
|
(60,765
|
)
|
(63,196
|
)
|
||||||||
|
Other income (expense), net
|
1,056
|
(603
|
)
|
(211
|
)
|
(18
|
)
|
|||||||||
|
Loss before income taxes
|
(97,653
|
)
|
(368,701
|
)
|
(271,124
|
)
|
(944,815
|
)
|
||||||||
|
Provision for income taxes
|
2,666
|
1,320
|
6,000
|
3,475
|
||||||||||||
|
Net loss
|
$
|
(100,319
|
)
|
$
|
(370,021
|
)
|
$
|
(277,124
|
)
|
$
|
(948,290
|
)
|
||||
|
Basic and diluted net loss per share
|
$
|
(0.46
|
)
|
$
|
(1.75
|
)
|
$
|
(1.28
|
)
|
$
|
(4.89
|
)
|
||||
|
Weighted average basic and diluted common shares outstanding
|
218,788
|
211,759
|
217,215
|
194,087
|
||||||||||||
|
As of
|
||||||||
|
September 30, 2026
|
December 31, 2025
|
|||||||
|
(unaudited)
|
||||||||
|
Assets
|
||||||||
|
Current assets:
|
||||||||
|
Cash and cash equivalents
|
$
|
396,563
|
$
|
510,445
|
||||
|
Marketable securities
|
750,063
|
919,602
|
||||||
|
Accounts receivable
|
259,270
|
140,857
|
||||||
|
Inventory
|
163,946
|
132,068
|
||||||
|
Prepaid expenses and other current assets
|
136,665
|
91,236
|
||||||
|
Total current assets
|
1,706,507
|
1,794,208
|
||||||
|
Fixed assets, net
|
108,341
|
102,942
|
||||||
|
Finance lease right-of-use assets
|
13,527
|
15,561
|
||||||
|
Operating lease right-of-use assets
|
17,624
|
20,708
|
||||||
|
Intangibles, net
|
138,439
|
97,651
|
||||||
|
Goodwill
|
136,110
|
136,110
|
||||||
|
Other assets
|
105,508
|
97,378
|
||||||
|
Total assets
|
$
|
2,226,056
|
$
|
2,264,558
|
||||
|
Liabilities and shareholders' equity
|
||||||||
|
Current liabilities:
|
||||||||
|
Accounts payable and accrued liabilities
|
$
|
574,538
|
$
|
456,060
|
||||
|
Current portion of royalty financing agreement
|
10,232
|
-
|
||||||
|
Finance lease liabilities
|
3,654
|
3,345
|
||||||
|
Operating lease liabilities
|
8,151
|
9,469
|
||||||
|
Total current liabilities
|
596,575
|
468,874
|
||||||
|
Debt, long-term
|
544,862
|
540,964
|
||||||
|
Royalty financing agreement
|
146,231
|
162,865
|
||||||
|
Contingent consideration
|
178,090
|
314,340
|
||||||
|
Finance lease liabilities, long-term
|
17,941
|
20,719
|
||||||
|
Operating lease liabilities, long-term
|
10,097
|
12,174
|
||||||
|
Other long-term liabilities
|
6,046
|
5,646
|
||||||
|
Total liabilities
|
1,499,842
|
1,525,582
|
||||||
|
Shareholders' equity:
|
||||||||
|
Common stock, $0.01 par value; 500,000,000 authorized shares, 219,320,467 and 214,255,853 issued and outstanding shares at September 30, 2026 and December 31, 2025, respectively
|
2,193
|
2,143
|
||||||
|
Additional paid-in capital
|
6,637,877
|
6,372,064
|
||||||
|
Accumulated deficit
|
(5,913,816
|
)
|
(5,636,692
|
)
|
||||
|
Accumulated other comprehensive (loss) gain
|
(40
|
)
|
1,461
|
|||||
|
Total shareholders' equity
|
726,214
|
738,976
|
||||||
|
Total liabilities and shareholders' equity
|
$
|
2,226,056
|
$
|
2,264,558
|
||||