On October 30, 2025 Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, reported financial results for the third quarter ended September 30, 2025 and provided a business update.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"The third quarter of 2025 celebrated the FDA approval of BRINSUPRI and the availability of our second commercial product, underscoring our team’s dedication to bringing forward a first-in-disease therapy for patients with non-cystic fibrosis bronchiectasis. While still early in the U.S. BRINSUPRI launch, we are very encouraged by positive feedback received from both physicians and patients," said Will Lewis, Chair and Chief Executive Officer of Insmed. "This achievement is just the beginning of numerous commercial and clinical catalysts anticipated over the next 18 months across our late-stage programs – ARIKAYCE, brensocatib, and TPIP – and our growing clinical pipeline of first- or best-in-class therapies. With these opportunities ahead, our team is more dedicated than ever to transforming the lives of patients with serious diseases."
Recent Progress and Anticipated Milestones by Program:
ARIKAYCE
•
ARIKAYCE global revenue grew 22% in the third quarter of 2025 compared to the third quarter of 2024, reflecting year-over-year growth across all geographic regions.
•
The Company anticipates the topline readout of the Phase 3 ENCORE trial in the first half of 2026 in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease who have not started antibiotics.
•
Assuming successful results from the ENCORE trial, Insmed plans to submit a supplementary new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in all patients with MAC lung disease in the U.S. in the second half of 2026.
Brensocatib
•
In August 2025, the FDA approved the Company’s New Drug Application (NDA) for brensocatib for patients with non-cystic fibrosis bronchiectasis (NCFB). BRINSUPRI (brensocatib 25mg and 10mg tablets) was subsequently launched commercially in the U.S.
•
In October 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of BRINSUPRI (brensocatib 25mg tablets) for the treatment of NCFB in the European Union (EU).
•
Regulatory submissions for brensocatib for patients with bronchiectasis in the United Kingdom (UK) and Japan have been accepted. Insmed anticipates commercial launches for the EU, UK, and Japan in 2026, pending approval in each territory.
•
Insmed expects to report topline data from the Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) by early January 2026.
•
In October 2025, Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS). Insmed now expects to report topline data from CEDAR in the first half of 2026.
TPIP
•
Insmed anticipates initiating PALM-ILD, a Phase 3 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD), in the fourth quarter of 2025.
•
Insmed plans to initiate a Phase 3 study of TPIP in patients with pulmonary arterial hypertension (PAH) in early 2026.
•
The Company anticipates initiating additional Phase 3 studies of TPIP in progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF) in the second half of 2026.
Gene Therapy
•
Insmed completed dosing of the first cohort in the Phase 1 ASCEND clinical study of INS1201, an intrathecally-delivered gene therapy for patients with Duchenne muscular dystrophy (DMD).
•
The Company’s Investigational New Drug (IND) filing for INS1202, an intrathecally-delivered gene therapy for patients with Amyotrophic lateral sclerosis (ALS), has been cleared by the FDA.
•
Insmed’s third gene therapy candidate targeting Stargardt disease is currently advancing toward the clinic, with an IND filing expected in the first half of 2026.
Pre-Clinical Programs
•
Insmed’s research efforts include more than 30 identified pre-clinical programs in development, all of which have the potential to become first-in-class or best-in-class therapies for the indications being pursued.
•
The Company anticipates 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.
Corporate Updates
•
In September 2025, Insmed presented seven abstracts from across its portfolio at the European Respiratory Society (ERS) Congress 2025.
•
In October 2025, Insmed presented six abstracts from across its portfolio at the American College of Chest Physicians (CHEST) 2025 Annual Meeting.
•
In October 2025, Insmed announced that it has earned the No. 1 ranking in Science’s 2025 Top Employers Survey, marking the fifth consecutive year in which Insmed achieved the top ranking. The annual survey polls employees in biotechnology, pharmaceutical, and related industries to determine the 20 best employers, as well as their driving characteristics.
Third-Quarter 2025 Financial Results
The following table summarizes Insmed’s third-quarter and year-to-date 2025 and 2024 revenues and revenue growth across all commercial regions:
Three Months Ended
September 30,
Nine Months Ended
September 30,
(in millions)
2025
2024
Growth
2025
2024
Growth
ARIKAYCE
U.S.
$
74.0
$
66.9
11
%
$
206.9
$
187.0
11
%
International
40.3
26.6
52
%
107.6
72.3
49
%
Total
$
114.3
$
93.4
22
%
$
314.5
$
259.3
21
%
BRINSUPRI
U.S.
$
28.1
$
–
N/A
$
28.1
$
–
N/A
International
–
–
N/A
–
–
N/A
Total
$
28.1
$
–
N/A
$
28.1
$
–
N/A
Total Revenues
U.S.
$
102.0
$
66.9
53
%
$
235.0
$
187.0
26
%
International
40.3
26.6
52
%
107.6
72.3
49
%
Total
$
142.3
$
93.4
52
%
$
342.6
$
259.3
32
%
•
Cost of product revenues (excluding amortization of intangibles) was $29.4 million for the third quarter of 2025, compared to $21.2 million for the third quarter of 2024. The increase in cost of product revenues primarily reflects growth in ARIKAYCE sales and BRINSUPRI sales.
•
Research and development (R&D) expenses were $186.4 million for the third quarter of 2025, compared to $150.8 million for the third quarter of 2024. The increase in R&D expenses was primarily related to increases in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, as well as clinical development and research costs, and manufacturing costs.
•
Selling, general and administrative (SG&A) expenses for the third quarter of 2025 were $186.4 million, compared to $118.9 million for the third quarter of 2024. The increase in SG&A expenses was primarily related to increases in professional fees and other external expenses, as well as increases in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, both driven by commercial readiness and commercial activities for BRINSUPRI.
•
For the third quarter of 2025, Insmed reported a net loss of $370.0 million, or $1.75 per share, compared to a net loss of $220.5 million, or $1.27 per share, for the third quarter of 2024.
Balance Sheet, Financial Guidance, and Planned Investments
•
As of September 30, 2025, Insmed had cash, cash equivalents, and marketable securities totaling approximately $1.7 billion.
•
Insmed is raising its full-year 2025 global ARIKAYCE revenue guidance to a range of $420 million to $430 million, from a range of $405 million to $425 million previously, representing a range of 15% to 18% year-over-year growth compared to 2024.
•
The Company plans to continue to invest in the following key activities in 2025:
(i)
commercialization and expansion of BRINSUPRI in the U.S., with advancement of regulatory submissions for brensocatib in Europe, the UK, and Japan;
(ii)
commercialization and expansion of ARIKAYCE globally;
(iii)
advancement of clinical trial programs for brensocatib, including the ongoing Phase 2b BiRCh study in patients with CRSsNP and the Phase 2b CEDAR study in patients with HS;
(iv)
advancement of the Phase 3 ENCORE study for ARIKAYCE, which is intended to satisfy the post-marketing requirement for full approval of its current indication and potentially support label expansion to include all patients with a MAC lung disease;
(v)
advancement of clinical development programs for TPIP, including the initiation of a Phase 3 study in patients with PH-ILD and preparations for separate Phase 3 studies in patients with PAH, PPF, and IPF;
(vi)
advancement of the Phase 1 ASCEND study for INS1201 in DMD; and
(vii)
continued development of its pre-clinical research programs.
Conference Call
Insmed will host a conference call beginning today, October 30, 2025, at 8:00 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (888) 210-2654 (U.S.) and (646) 960-0278 (international) and referencing access code 7862189. The call will also be webcast live on the Company’s website at www.insmed.com.
A replay of the conference call will be accessible approximately 1 hour after its completion through November 6, 2025, by dialing (800) 770-2030 (U.S.) and (609) 800-9909 (international) and referencing access code 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company’s website at www.insmed.com.
(Press release, Insmed, OCT 30, 2025, View Source [SID1234657153])