What Insmed (INSM) Said on Its Q3 Earnings Call

Key Points

• Strong commercial growth: BRINSUPRI revenue rose 29% sequentially to $400.1 million, surpassing $1 billion in its first four full quarters, while ARIKAYCE revenue increased 9% year over year to $124.4 million.
• Guidance raised: Insmed increased its 2026 revenue outlook to $1.35–$1.4 billion for BRINSUPRI and $460–$470 million for ARIKAYCE. The company is also expanding BRINSUPRI marketing in the U.S. and has launched it in Japan.
• Pipeline and financial momentum: ARIKAYCE’s expanded-label application received FDA priority review, potentially increasing its U.S. and Japanese addressable markets to more than 100,000 patients each. Insmed ended the quarter with about $1.1 billion in cash and expects to achieve cash-flow positivity in 2027.

Insmed NASDAQ: INSM reported third-quarter 2026 revenue growth from both of its commercial respiratory products and raised the low end of its full-year revenue guidance for BRINSUPRI and ARIKAYCE.

Chair and Chief Executive Officer Will Lewis said BRINSUPRI generated $400.1 million in third-quarter revenue, up 29% sequentially. The company said the bronchiectasis treatment has generated more than $1 billion in revenue during its first four full quarters on the market, reaching what Lewis described as blockbuster status.

ARIKAYCE, Insmed’s treatment for certain patients with Mycobacterium avium complex, or MAC, lung disease, generated $124.4 million in third-quarter revenue, up 9% from the same period a year earlier.

Updated Product Guidance and Commercial Plans

Insmed raised its 2026 BRINSUPRI revenue outlook to $1.35 billion to $1.4 billion, increasing the low end of the prior range by $100 million. The company lifted ARIKAYCE guidance to $460 million to $470 million, raising the low end by $10 million.

Lewis said the company has seen strength in BRINSUPRI payer approvals, reauthorizations, persistence and dispenses, though Insmed will no longer provide individual launch metrics now that the product has completed its first full year of commercialization. He said the company expects to provide 2027 guidance around the time of its annual investor conference.

Insmed plans to begin its first branded television campaign for BRINSUPRI next month, alongside its existing unbranded outreach efforts. Lewis said the company is focusing physician engagement on high-potential prescribers and believes direct-to-consumer advertising could begin contributing to demand during the first half of 2027.

BRINSUPRI was also launched in Japan last week as the first approved medicine for bronchiectasis in that country, according to the company. Lewis said Japan has roughly 150,000 diagnosed bronchiectasis patients and is expected to be the main driver of BRINSUPRI’s sales outside the United States.

Bronchiectasis Diagnosis Efforts

Management highlighted an effort to identify patients with bronchiectasis who may also have chronic obstructive pulmonary disease, or COPD, or asthma. Lewis said the company believes comorbid bronchiectasis could represent a substantial additional opportunity beyond BRINSUPRI’s current estimated peak-sales potential of more than $7 billion.

The company is pursuing retrospective imaging work with three U.S. COPD and asthma centers, developing potential AI-enabled diagnostic tools with strategic partners, and deploying an initial group of 16 nurse disease educators. The tools are intended to help health-care providers identify possible bronchiectasis in patient records and imaging workflows.

Lewis said Insmed expects to share initial findings from these diagnostic initiatives around the middle of 2027. He added that patients diagnosed with bronchiectasis would be on-label for BRINSUPRI, regardless of whether they also have COPD or asthma.

Insmed is also supporting real-world evidence generation for BRINSUPRI. The company said the BEST-BE observational study is designed to enroll 1,000 adults at 13 U.S. sites and assess exacerbations, quality of life, safety, lung function and other outcomes over two years. Separately, EMBARC is conducting a three-year European open-label study involving up to 3,000 patients.

ARIKAYCE Regulatory Progress and Pipeline Updates

The FDA granted priority review to ARIKAYCE’s supplemental new drug application for MAC lung disease, with a target action date of Jan. 28, 2027. Lewis said the agency does not currently plan to convene an advisory committee meeting. Insmed also plans to submit ENCORE data to Japan’s Pharmaceuticals and Medical Devices Agency during the fourth quarter to support a potential label expansion there.

If approved in the U.S. and Japan, Insmed expects to launch ARIKAYCE under expanded labels in the first half of 2027. The company said the potential expansions could increase the addressable market in each region from about 15,000 patients currently to more than 100,000 patients.

Insmed’s TPIP program, a once-daily inhaled treprostinil prodrug, is advancing through four Phase III studies in pulmonary hypertension associated with interstitial lung disease, pulmonary arterial hypertension, progressive pulmonary fibrosis and idiopathic pulmonary fibrosis. The PALM-ILD study is more than 35% enrolled, and Insmed expects enrollment to conclude no later than the first half of 2028. The PALM-PAH study has enrolled its first patient, PALM-PPF has initiated its first site, and PALM-IPF remains on track to begin in the first half of 2027.

The company also said its Phase I study of INS1033 is actively recruiting healthy volunteers, with data on pharmacokinetics and blood NSP levels expected next year. Subject to positive data, Insmed plans to begin a Phase II rheumatoid arthritis study in 2027, followed by planned work in ulcerative colitis and COPD. Initial data from the company’s Phase I gene therapy programs in Duchenne muscular dystrophy and amyotrophic lateral sclerosis are expected in 2027.

Financial Position

Chief Financial Officer Sara Bonstein said cost of product revenues totaled $78.2 million, or 14.9% of revenue, compared with 20.6% in the prior-year quarter. Combined research and development and selling, general and administrative expenses rose 40% year over year as Insmed invested in the BRINSUPRI launch and its pipeline.

As of the end of the third quarter, Insmed had approximately $1.1 billion in cash equivalents and marketable securities. Bonstein said the company has “a clear line of sight” to achieving cash-flow positivity in 2027 while continuing to invest in growth initiatives and clinical development.

About Insmed (NASDAQ:INSM)

Insmed Incorporated is a global biopharmaceutical company focused on developing and commercializing therapies for serious and rare diseases. The company concentrates on conditions with significant unmet medical needs, particularly in pulmonary and infectious diseases.

Insmed's lead commercial product is ARIKAYCE (amikacin liposome inhalation suspension), an inhaled antibacterial therapy used in the United States for adults with refractory Mycobacterium avium complex lung disease as part of a combination antibacterial regimen.

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