INSMED (INSM) Company Report

Insmed launched Brenzavvy in August, reporting 2,500 new patient starts and 1,700 prescribers in the first six weeks, with an estimated global peak sales potential of $5 billion for bronchiectasis. The drug also received EU approval.
Upcoming data readouts include Arikayce label expansion data in H1 2026, potentially increasing the addressable patient population tenfold to 250,000.
The Birch trial for Brensocatib in chronic rhinosinusitis (CRS) is expected to read out by early January, with potential to be a significant market opportunity.
Insmed is advancing its pipeline with TPIP (Treprostinil palmitil inhalation powder) in Phase 3 for PH-ILD, IPF, and PPF, and early-stage programs like DMD, ALS, and next-gen DPP1s moving into the clinic.
The company anticipates a ramp-up in OpEx over time due to multiple forthcoming Phase 3 trials.

2 days ago

Transcript

Insmed CFO Discusses 2026 Outlook, Product Launches, and Pipeline Progress

INSM

Product Launch

Guidance Update

New Projects/Investments

Insmed anticipates a "tremendous 2026" following a strong 2025, driven by several key data readouts and program advancements.
The company expects a potential expansion of its Arikayce addressable patient population from 25,000 to 250,000 patients in its three territories, pending Encore data readout in the first half of next year.
Brenzavvy, launched in August, recorded over 2,500 new patient starts and 1,700 prescribers in its initial six weeks of sales, with global peak sales for bronchiectasis estimated at $5 billion.
Data for Brensocatib's Birch trial (chronic rhinosinusitis) is expected by early January, with the potential to be as large or larger than the bronchiectasis opportunity, targeting a U.S. patient population of 30 million.

2 days ago

Transcript

Insmed CFO Discusses 2026 Outlook, Brenzavvy Launch, and Pipeline Progress

INSM

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Insmed's CFO, Sara Bonstein, highlighted the company's strong performance in 2025 and anticipates a significant 2026 driven by product launches and clinical data readouts.
Brenzavvy, launched in August 2025, recorded over 2,500 new patient starts and 1,700 prescribers in its initial six weeks, with a global peak sales potential of $5 billion for bronchiectasis. The company expects to launch Brenzavvy in Europe in the first half of 2026 and Japan in the second half.
Key clinical data readouts expected in 2026 include Arikayce's Encore data in the first half, potentially expanding its addressable patient population from 25,000 to 250,000. The Birch trial data for Brensocatib in chronic rhinosinusitis (CRS) is expected by early January, with the potential to be as large as the bronchiectasis opportunity.
Insmed is advancing TPIP into Phase 3 for four indications, including PH-ILD, IPF, and PPF, with initial PAH open-label extension data potentially available in the second half of 2026.
The company anticipates a substantial ramp in operating expenses due to multiple ongoing and forthcoming Phase 3 programs across its pipeline, including CRS, HS, and TPIP indications.

2 days ago

Transcript

Insmed Announces European Commission Approval of BRINSUPRI for Non-Cystic Fibrosis Bronchiectasis

INSM

Product Launch

New Projects/Investments

Insmed Incorporated (INSM) announced on November 18, 2025, that the European Commission (EC) has approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.
This approval establishes BRINSUPRI as the first and only approved treatment for NCFB in the European Union (EU), a condition affecting an estimated 600,000 people in the region.
The approval is based on data from the Phase 3 ASPEN study, which demonstrated a 19.4% reduction in the annual rate of exacerbations for patients receiving BRINSUPRI 25 mg compared to placebo.
Insmed anticipates securing access for eligible patients across the EU starting in early 2026.

Nov 18, 2025, 9:15 PM

8-K

Insmed's BRINSUPRI Receives European Commission Approval for NCFB

INSM

Product Launch

New Projects/Investments

The European Commission has approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.
This approval makes BRINSUPRI the first and only approved treatment indicated for NCFB in the European Union (EU), following an accelerated assessment by the EMA.
Clinical data from the Phase 3 ASPEN study showed that BRINSUPRI 25 mg resulted in a 19.4% reduction in the annual rate of exacerbations compared to placebo and significantly prolonged the time to first exacerbation.
Insmed will engage with authorities across the EU to secure patient access to BRINSUPRI starting in early 2026.

Nov 18, 2025, 4:00 PM

Press Release

Insmed Provides Update on Product Launches and Pipeline Developments

INSM

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Insmed reported $28 million in revenue for Brinsupri (brensocatib) in its initial partial quarter launch for bronchiectasis, with CEO Will Lewis stating the medicine could achieve $5 billion in peak sales in this indication.
Key data for brensocatib in Chronic Rhinosinusitis (CRS) is expected by the end of 2025, with public release in early January 2026, targeting a potential market of over 30 million patients in the U.S..
The ENCORE trial readout for ARIKAYCE is anticipated in the first half of 2026, potentially expanding its addressable market from 30,000 to over 250,000 patients.
Insmed plans to initiate Phase 3 trials for TPIP (Treprostinil Palmitil Inhalation Powder) in PAH, PH-ILD, IPF, and PPF, building on Phase 2 data showing a 35.5% reduction in pulmonary vascular resistance.

Nov 18, 2025, 8:30 AM

Transcript

Insmed Discusses Strong Brensocatib Launch and Future Pipeline Growth

INSM

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Insmed reported a strong early launch for Brensocatib in bronchiectasis, achieving $28 million in revenue in its partial first quarter, with projections for over $5 billion in peak sales in this indication alone.
The company anticipates key data readouts, including for CRS without nasal polyps by early January 2026, which could unlock a "skeleton key" medicine, and the ARIKAYCE ENCORE trial in the first half of next year, potentially expanding its market opportunity from 30,000 to 250,000 patients.
Insmed plans to initiate four Phase 3 programs for TPIP in PAH, PH-ILD, IPF, and PPF, with analysts modeling $7 billion in peak sales for TPIP in PAH alone.
With a robust R&D pipeline and the revenue generation potential of Brensocatib, Insmed is on an "almost inevitable journey to cash flow positivity".

Nov 18, 2025, 8:30 AM

Transcript

Insmed Highlights Strong Brensocatib Launch, ARIKAYCE Expansion, and TPIP Phase 3 Advancement

INSM

Product Launch

New Projects/Investments

Revenue Acceleration/Inflection

Insmed's newly approved drug, Brensocatib, for bronchiectasis, generated $28 million in revenue in its initial partial quarter, with management projecting over $5 billion in peak sales for this indication alone.
The company anticipates significant market expansion for ARIKAYCE with the ENCORE trial readout in the first half of next year, potentially increasing the addressable patient population from 30,000 to 250,000 across the U.S., Europe, and Japan.
Insmed is advancing TPIP into Phase 3 trials for multiple indications, including PAH, PH-ILD, IPF, and PPF, following Phase 2 data showing a 35.5% reduction in pulmonary vascular resistance in PAH, with some models projecting $7 billion in peak sales for PAH alone.
Key upcoming catalysts include data readouts for Brensocatib in CRS (by year-end 2025, public in early January 2026), targeting a market of over 30 million patients in the U.S. and potentially exceeding the bronchiectasis opportunity, and the company expects Brensocatib's revenue to drive the company towards cash flow positivity.

Nov 18, 2025, 8:30 AM

Transcript

Insmed Reports Q3 2025 Financial Results and BRINSUPRI Launch Performance

INSM

Earnings

Guidance Update

Product Launch

Insmed's new product, BRINSUPRI, achieved $28 million in net sales in its first partial quarter of launch, with approximately 2,550 new patients starting treatment and about 1,700 physicians writing at least one prescription.
The company raised its 2025 full-year global ARIKAYCE net revenue guidance to $420 million-$430 million, an increase from the previous range of $405 million-$425 million.
As of the end of Q3 2025, Insmed reported approximately $1.7 billion in cash, cash equivalents, and marketable securities.
Regulatory progress for brensocatib includes a positive opinion from Europe's CHMP for approval in the EU, with a decision expected by year-end 2025 and a potential launch in early 2026. Filings are also progressing in the U.K. and Japan.
The CDER trial for brensocatib in HS is fully enrolled with 214 participants, and top-line results are now expected in the first half of 2026.

Oct 30, 2025, 12:00 PM

Transcript

Insmed Reports Q3 2025 Results with Strong Brensupri Launch and Raised ARIKAYCE Guidance

INSM

Earnings

Guidance Update

Product Launch

Insmed's new commercial product, Brensupri, generated $28 million in net sales during its first partial quarter of launch in Q3 2025, representing approximately six weeks of sales.
ARIKAYCE achieved its largest quarter of revenue ever in Q3 2025, growing 22% compared to the same quarter last year, leading Insmed to raise its 2025 full-year global net revenue guidance for ARIKAYCE to $420 million to $430 million.
The company maintained a strong financial position with approximately $1.7 billion in cash, cash equivalents, and marketable securities as of the end of Q3 2025, with significant clinical catalysts expected, including Phase 2 BIRCH study results in early January and Phase 3 ENCORE trial data in H1 2026.

Oct 30, 2025, 12:00 PM

Transcript

Earnings Transcripts

Quarterly earnings call transcripts for INSMED.

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