Insmed Q2 Earnings Call Highlights

Key Points

• BRINSUPRI sales accelerated: Second-quarter revenue reached $309.2 million, up 49% sequentially, prompting Insmed to raise 2026 guidance to $1.25 billion–$1.4 billion. The company also increased its global peak-sales estimate to more than $7 billion.
• ARIKAYCE expansion is advancing: Revenue rose 8% year over year to $116.3 million, while Insmed pursued U.S. approval for newly diagnosed MAC lung disease and plans a Japanese regulatory filing, with potential expanded-indication launches in 2027.
• Pipeline and financial outlook strengthened: Insmed raised TPIP’s potential peak sales to more than $6 billion based on encouraging extension-study results and ongoing Phase III trials. Despite higher investment in development and commercialization, the company expects cash-flow positivity in 2027 and does not currently plan to raise capital before then.

Insmed NASDAQ: INSM reported second-quarter 2026 revenue growth driven by the continued launch of BRINSUPRI and steady sales of ARIKAYCE, while raising its full-year BRINSUPRI revenue outlook and increasing its long-term peak-sales estimates for its leading products.

BRINSUPRI generated $309.2 million in second-quarter revenue, up 49% sequentially from the first quarter, Chief Financial Officer Sara Bonstein said. ARIKAYCE revenue totaled $116.3 million, up 8% from the second quarter of 2025.

The company raised its 2026 BRINSUPRI revenue guidance to $1.25 billion to $1.4 billion, from prior guidance of more than $1 billion. It maintained ARIKAYCE revenue guidance of $450 million to $470 million for the year.

BRINSUPRI Launch Metrics and Outlook

Chair and Chief Executive Officer Will Lewis said BRINSUPRI added approximately 7,000 new patients during the second quarter, above the company’s prior expectation of roughly 6,300 starts. Insmed now expects about 7,000 new patient starts in each of the remaining quarters of 2026.

Lewis said the second-quarter patient starts reflected organic demand, adding that the previously discussed group of “ready and waiting” patients had been exhausted. As of the end of June, BRINSUPRI had more than 6,300 cumulative prescribers, an increase of approximately 1,300 from the end of March.

The company also reported increasing prescription depth. About 30% of BRINSUPRI prescribers had written prescriptions for at least five patients as of June 30, compared with about 20% at the end of the first quarter.

Bonstein said BRINSUPRI’s gross-to-net adjustment benefited from better-than-expected dynamics in the quarter. The company narrowed its full-year gross-to-net guidance for the drug to the mid-to-high 20% range, from a prior range of the mid-20% to low-30% range. She said payer access remained favorable, with an approximately 90% approval rate and approval in less than one week for the majority of patients.

Insmed raised its estimate for BRINSUPRI global peak sales to more than $7 billion, from more than $5 billion previously. Lewis said the revised estimate reflects expectations for growth in the addressable market through greater awareness, earlier diagnosis and more consistent diagnosis of bronchiectasis. The forecast does not include a potential opportunity to identify additional bronchiectasis patients among people with chronic obstructive pulmonary disease or asthma, he said.

The company said European Multicentre Bronchiectasis Audit and Research Collaboration, or EMBARC, intends to collaborate with Insmed on a three-year open-label study of brensocatib 25 mg in up to 3,000 bronchiectasis patients across six European countries. The study is intended to evaluate whether long-term treatment could modify disease progression and whether earlier use could further slow progression.

ARIKAYCE Regulatory Plans

Lewis said ARIKAYCE continued to grow globally in the high single digits year over year during the quarter. Insmed recently submitted a supplemental new drug application to the FDA seeking to expand ARIKAYCE use to newly diagnosed patients with MAC lung disease, from its current refractory MAC indication.

The company plans to submit an application to Japanese regulators in the second half of 2026. Insmed said potential launches tied to the expanded ARIKAYCE indication in the U.S. and Japan could occur in 2027, subject to regulatory decisions.

Insmed expects a regulatory decision for BRINSUPRI in Japan during the second half of 2026, though Bonstein said the company does not expect a meaningful contribution from Japan this year. Lewis said the company’s international revenue expectations for a product of this type have generally been in the 10% to 15% range, with Japan expected to account for the majority of that opportunity.

TPIP Data and Development Program

Insmed also increased its estimate for TPIP peak sales to more than $6 billion, from more than $2 billion previously. The company said this estimate assumes clinical and regulatory success in pulmonary arterial hypertension, pulmonary hypertension associated with interstitial lung disease, progressive pulmonary fibrosis and idiopathic pulmonary fibrosis.

Lewis highlighted 12-month results from an ongoing open-label extension study of TPIP in pulmonary arterial hypertension. According to the company, patients in the extension study experienced an approximately 55-meter improvement in six-minute walk distance and an approximately 60% reduction in NT-proBNP compared with the baseline of the preceding study.

Lewis said approximately 80% of patients reached Functional Class 1 or 2 at month 12, while more than 25% reached Functional Class 1. The company also reported that 65% of patients achieved refined low-risk status on the REVEAL Lite 2.0 measure at month 12. Insmed said there were no new safety signals in the extension study, and 91% of patients remained on treatment at 12 months.

The company’s Phase III studies in pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease are enrolling patients. Insmed said the first data monitoring committee meeting for the PALM-ILD study recommended that the trial continue without modification. Additional Phase III studies in progressive pulmonary fibrosis and idiopathic pulmonary fibrosis are expected to begin in the second half of 2026 and the first half of 2027, respectively.

Cash Position and Pipeline

Insmed ended the second quarter with approximately $1.2 billion in cash, cash equivalents and marketable securities. Cost of product revenue was $67.2 million, or 16% of total revenue, compared with 26% of revenue in the prior-year quarter. Combined research and development and selling, general and administrative expenses rose 38% year over year, reflecting investments in BRINSUPRI’s U.S. launch and pipeline programs.

Bonstein said the company expects to increase investment during the second half of 2026 in TPIP Phase III programs, BRINSUPRI direct-to-consumer advertising and commercial infrastructure in Japan. Insmed also expects to make $50 million in regulatory and sales-based milestone payments to AstraZeneca related to BRINSUPRI during the second half.

Despite those planned investments, the company reiterated that it expects to reach cash-flow positivity in 2027 and does not currently intend to raise additional capital before then.

Separately, Lewis said the FDA cleared the investigational new drug application for INS1033, a next-generation DPP1 inhibitor. Insmed plans to initially study the candidate in rheumatoid arthritis, followed by potential programs in ulcerative colitis and COPD. The company also named Samuele Butera as senior vice president and general manager of its Global Respiratory Therapeutic Area.

About Insmed (NASDAQ:INSM)

Insmed Incorporated is a biopharmaceutical company focused on developing and commercializing therapies for patients with rare and serious diseases, with a particular emphasis on difficult-to-treat pulmonary infections. Headquartered in Bridgewater, New Jersey, the company concentrates its research and development efforts on targeted drug delivery technologies and novel formulations intended to improve clinical outcomes for patients who have limited treatment options.

The company's principal marketed product is ARIKAYCE (amikacin liposome inhalation suspension), an inhaled liposomal formulation of the antibiotic amikacin that is approved by the U.S.

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